Adopted Rules Title 25

TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 135. AMBULATORY SURGICAL CENTERS

The Executive Commissioner of the Health and Human Services Commission (commission) on behalf of the Department of State Health Services (department) adopts the repeal of §§135.1 - 135.29, 135.41, 135.42, 135.51 - 135.54 and new §§135.1 - 135.29, 135.41 - 135.43, and 135.51 - 135.56, concerning the regulation of ambulatory surgical centers. The new §§135.2, 135.9, 135.11, 135.13 - 135.15, 135.20, 135.22, 135.41 - 135.43, 135.52, 135.54, and 135.55 are adopted with changes to the proposed text as published in the December 5, 2008, issue of the Texas Register (33 TexReg 9860). The repeal of §§135.1 - 135.29, 135.41, 135.42, and 135.51 - 135.54 and new §§135.1, 135.3 - 135.8, 135.10, 135.12, 135.16 - 135.19, 135.21, 135.23 - 135.29, 135.51, 135.53, and 135.56 are adopted without changes and, therefore, the sections will not be republished.

BACKGROUND AND PURPOSE

The repeals and new sections are necessary to update, reorganize, and clarify the rules and to implement legislation by the 80th Legislature, Regular Session, 2007, specifically, the amendment to Health and Safety Code, Chapter 324, Consumer Access to Health Care Information (Senate Bill 1731).

Government Code, §2001.039, requires that each state agency review and consider for readoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedure Act). Sections 135.1 - 135.29, 135.41, 135.42, and 135.51 - 135.54 have been reviewed, and the department has determined that reasons for adopting the sections continue to exist because rules on this subject are needed.

SECTION-BY-SECTION SUMMARY

New §§135.1 - 135.29, 135.41 - 135.43, and 135.51 - 135.56 provide clarification to the rules, update references to statutes, rules, codes, guidelines and standards, the names and contact information of associations, boards, commissions, conferences, societies and the department programs. The new §135.1 deletes language that is not statutory. The new §135.2 deletes definitions not used in the rules and revises the definition of advanced practice nurse, certified registered nurse anesthetist (CRNA), licensed vocational nurse, physician, and registered nurse. The new §135.4 requires ambulatory surgical centers (ASCs) to comply with Health and Safety Code, Chapter 324, Consumer Access to Health Care Information. The new §135.9 requires a preanesthesia evaluation by an individual qualified to administer anesthesia. The new §135.11 requires all ASCs to document all approvals or delegations of anesthesia services and include the training, experience, and qualifications of the person who provided the service, and revises the language concerning the physician evaluation of the patient immediately prior to the procedure using the language from the Medicare conditions for coverage for ambulatory surgical services for consistency. New §135.13 clarifies that the discretion of the governing body to require preoperative laboratory orders is upon the recommendation of the medical staff. The new §135.20 updates the license term from annual to two years and specifies background information the applicant must provide regarding the applicant, the applicant's affiliates, and the applicant's managers. The new §135.22 and §135.29 update the license term from annual to two years. The new §135.27 deletes the requirement for ASCs to submit an annual patient safety program report to the department, as the authorizing section of Health and Safety Code, Chapter 243, Subchapter B, Patient Safety Program, expired September 1, 2007. The new §135.42 contains existing language and adds language similar to the hospital licensing rules for clarity and consistency. The new §135.43 adds requirements for the use of alcohol-based hand rubs and gasoline and gasoline powered equipment. The new §135.52 clarifies the prohibition relating to construction in designated 100-year flood plains; clarifies the design for the handicapped; decreases the spatial requirement for the general storage from 50 to 30 square feet per operating room; adds the requirement for a hand washing fixture in the postoperative recovery suite; deletes the requirement for emergency eyewash; increases the spatial requirement for the treatment room from 100 to 120 square feet; increases the spatial requirement for the examination room from 80 to 100 square feet; adds the requirement for a soap dispenser at each hand washing facility; clarifies that a pressure monitoring devices must be mounted below the ceiling line so that it can be observed; changes the requirement for hot water temperature not to exceed 110 degrees to a range of 105 to 120 degrees Fahrenheit; adds the requirement for ground fault circuit interrupters; and adds the requirement for the nurses calling system to have a signal in the sterile processing room and equipment storage. The new §§135.53 - 135.55 are reorganized for clarity and to be consistent with the hospital licensing rules. The new §135.56 updates existing tables.

COMMENTS

The department, on behalf of the commission, has reviewed and prepared responses to the comments received regarding the proposed rules during the comment period, which the commission has reviewed and accepts. The commenters were individuals, associations, and/or groups, including the following: Texas Ambulatory Surgery Center Society, Texas Association of Nurse Anesthetists, Texas Council of PeriOperative Registered Nurses (TCORN), Texas Society of Anesthesiologists, Texas Society of Gastroenterology and Endoscopy, Travis County Medical Society, Texas Nurses Association, Coalition for Nurses in Advanced Practice, Harris County Hospital District, and L3 Healthcare Design Inc. The commenters were not against the rules in their entirety; however, the commenters recommended changes as discussed in the summary of comments.

Comment: Concerning §135.2(4), two commenters requested that the term "advanced practice nurse" be changed to "advanced practice registered nurse" throughout the proposed rules to agree with amendments to the Texas Board of Nursing Rules adopted on November 14, 2008.

Response: The commission agrees and has replaced "advanced practice nurse" with "advanced practice registered nurse" in §§135.2, 135.9, 135.11, 135.13, 135.14, and 135.20.

Comment: Concerning §135.2(8), one commenter requested that the words "currently licensed" and "authorized" be deleted to remove redundancy from the definition.

Response: The commission agrees regarding "currently licensed" and has deleted "currently licensed." The commission disagrees with deleting "authorized" because the term "authorized" remains in agreement with the 22 Texas Administrative Code §221.2.

Comment: Concerning §135.9(j)(5), one commenter stated that the rules do not address the issue of who can evaluate and who can't evaluate.

Response: The commission disagrees. Section 135.9(j)(5) requires the ASC to include a preanesthesia evaluation in a patient's medical record. The person who needs to perform the preanesthesia evaluation must be an individual qualified to administer anesthesia. No change has been made to the rule as a result of this comment.

Comment: Concerning §135.9(j)(5), one commenter stated that the proposed rule, which allows a registered nurse (RN) to perform the preanesthesia evaluation for some types of anesthesia, appears to be inconsistent with the proposed rule at §135.11(a)(5). The commenter suggested changing the phrase "an individual qualified to administer anesthesia" to "the operating surgeon, an anesthesiologist, or a certified registered nurse anesthetist (CRNA)."

Response: The commission disagrees. Section 135.9(j)(5) requires the ASC to include a patient's medical record a preanesthesia evaluation performed by an individual qualified to administer anesthesia. This includes an RN who administers anesthesia in compliance with the rules at §135.11(a)(4). The preanesthesia evaluation required by §135.9(j)(5) does not necessarily need to be done immediately before the procedure. Section 135.11(a)(5) requires the operating surgeon to evaluate the patient immediately before the procedure to assess the risk of the anesthesia and of the procedure to be performed. No change has been made to the rule as a result of the comment.

Comment: Concerning §135.9(j)(9), one commenter suggested deleting the phrase "that includes either general, local, or regional anesthetic" after "anesthesia administration record," as anesthesia services described at §135.11(a)(1) are not limited to general, local, and regional anesthesia.

Response: The commission agrees and has deleted the phrase "that includes either general, local, or regional anesthetic."

Comment: Concerning §135.11(a)(3), one commenter requested removal of the words "licensing" and "licensed," in order to avoid any confusion or misinterpretation of the department's intent regarding the important role of anesthesiologist assistants in providing anesthesia care in ambulatory surgical centers.

Response: The commission disagrees. The rules and standards referenced in this rule are the licensing rules and standards applicable to those categories of licensed professionals qualified to administer anesthesia. Section 135.11(a)(4) allows the facility to approve anesthesiologist assistants to administer anesthesia in accordance with the Medical Practice Act, Occupations Code Subtitle B. No change has been made to the rule as a result of this comment.

Comment: Concerning §135.11(a)(4), one commenter stated that the rules do not allow a registered nurse (RN) to give conscious sedation.

Response: The commission disagrees. This rules allows a qualified RN who is not a CRNA, in accordance with the orders of the operating surgeon or an anesthesiologist, to administer topical anesthesia, local anesthesia, minimal sedation and moderate sedation (conscious sedation), in accordance with all applicable rules, polices, directives and guidelines issued by the Texas Board of Nursing. The Texas Board of Nursing position statement 15.8, The Role of the Nurse in Moderate Sedation, states that employing institutions should develop policies and procedures to guide the RN or non-CRNA advanced practice nurse in administration of medications and patient monitoring associated with moderate sedation. Policies and procedures should include but not be limited to performance of a pre-sedation health assessment by the individual ordering the sedation and the nurse administering the sedation. No change has been made to the rule as a result of this comment.

Comment: Concerning §135.11(a)(4), one commenter suggested adding the words "or CRNA" as a CRNA may need to direct an RN to administer a sedative drug during surgery.

Response: The commission agrees and has added the words "or CRNA."

Comment: Concerning §135.11(a)(5), one commenter requested that "physician" be replaced with "operating surgeon."

Response: The commission agrees and has replaced "physician" with "operating surgeon."

Comment: Concerning §135.11(a)(5), one commenter (first commenter) requested that the rule be changed to require the operating surgeon to evaluate the patient immediately prior to the procedure to assess the risk of the procedure to be performed, and the person administering anesthesia to evaluate the patient immediately prior to the procedure to evaluate the risk of anesthesia. Another commenter (second commenter) objected to this change as it would compromise patient safety, and evaluation of a patient for risks associated with anesthesia should be performed by a physician. Then the first commenter withdrew the first comment and requested the rule be changed to require the operating surgeon, an anesthesiologist, or the certified registered nurse anesthetist (CRNA) who will be administering the anesthesia to evaluate the patient immediately prior to surgery to assess the risk of anesthesia relative to the surgical procedure to be performed.

Response: The commission disagrees with the first commenter. This was discussed during the stakeholder meeting. The second commenter had objected to the proposed language as it is true that medical risks associated with specific procedures should be evaluated. However, it is unwise to limit a preanesthetic assessment to only a planned surgical procedure. It was decided that since most ASCs are Medicare certified, the language in the Medicare ambulatory surgical services conditions for coverage would be used. No change has been made to the rule as a result of these comments.

Comment: Concerning §135.11(a)(5), one commenter requested changing "physician" to "operating surgeon, an anesthesiologist, or the CRNA who will be administering the anesthesia" to allow CRNAs to perform preanesthesia evaluations on their patients.

Response: The commission disagrees. Medicare Conditions of Coverage require physicians to evaluate the patient immediately prior to surgery. No change has been made to the rule as a result of this comment.

Comment: Concerning §135.11(a)(6), one commenter (first commenter) requested that "anesthesiologist" be replaced with "the person administering the anesthesia." Another commenter (second commenter) objected to this change as it ignores the possibility of medical complications beyond recovery from anesthesia of the types administered by registered nurses and which require physician intervention. The second commenter submitted that evaluation of a patient prior to dismissal should be carried out by a physician or, at the very least, an advanced practice nurse, not a registered nurse. Then the second commenter withdrew the first comment and requested that CRNA be added to the list of available personnel.

Response: The commission agrees with the second commenter and has added "advanced practice nurse."

Comment: Concerning §135.11(a)(6), one commenter suggested adding the words "or CRNA" to allow CRNAs to be available instead of the operating surgeon when the surgery has been performed by a surgeon working with a CRNA.

Response: The commission agrees but has used the broader term of "advanced practice registered nurse" because it includes "CRNA."

Comment: Concerning §135.15(a)(2)(C), three commenters requested clarification that surgical technologists and licensed vocational nurses may be permitted to serve in the scrub nurse role, and requested the deletion of the exception allowing surgical technologists and licensed vocational nurses to function as circulating nurses in the operating room in ASCs where no general anesthesia is administered and when there is an adequate number of RNs immediately available for an emergency situation. These revisions would support the Association of periOperative Registered Nurses's and TCORN's position regarding the need for every patient having a surgical or other invasive procedure to have an RN as the circulator regardless of the type of anesthetic provided.

Response: The commission agrees and has made the recommended changes.

Comment: Concerning §135.52(a)(3)(B), two commenters stated that the 100-year flood plain restriction will create an obstacle to access to surgery care in some areas of Texas and requested adding the phrase "the floor of the ASC is above the flood plain in new construction."

Response: The commission agrees and has made the recommended change.

Comment: Concerning §135.52(d)(9)(B)(i), (E)(ii), and (10)(B)(ii), one commenter stated that the requirement of four feet at the foot of the bed does not address patient safety or quality but it merely increases costs, which must be passed on to the patient.

Response: The commission disagrees. This requirement is not a change. This requirement is in the current rules. No change has been made to the rule as a result of this comment.

Comment: Concerning §135.52(d)(9)(D) and (10)(B)(iv), one commenter asked if the requirement of one sink for every four beds includes the sinks that are in the bathrooms and suggested that the bathroom sinks located in these areas be counted.

Response: The commission disagrees. The rules follow closely the sink requirements of the American Institute of Architects Academy of Architecture for Health, Guidelines for Design and Construction of Health Care Facilities, 2006 edition (AIA Guidelines). The focus was to assure minimal requirements and to follow national standards and trends for health care facilities. The new language concurs with the AIA Guidelines, which require hand-washing stations with at least one station for every four stretchers or portion thereof, and uniform distribution to provide equal access from each patient position within the post-anesthesia recovery room(s) care area. No change has been made to the language as a result of this comment.

Comment: Concerning §135.52(d)(16)(C), one commenter stated that increasing the square feet requirement to 120 from 100 is an additional expense that has to go into construction. The requirement of 100 square feet has worked very well, and in endoscopy suites you don't need more that 100 square feet.

Response: The commission disagrees. The proposed rules follow closely the 120 square feet for treatment room requirements of the American Institute of Architects Academy of Architecture for Health, Guidelines for Design and Construction of Health Care Facilities, 2006 edition (AIA Guidelines). The focus was to assure minimal requirements and to follow national standards and trends for health care facilities. The new language concurs with the AIA Guidelines, which require that rooms for minor surgical and cast procedures, if provided, shall have a minimum floor area of 120 square feet. This square footage shall exclude vestibule, toilet, closets, and fixed casework. The minimum room dimension shall be 10 feet. No change has been made to the language as a result of this comment.

Comment: Concerning §135.52(e)(1)(B)(iii)(I), one commenter stated that the minimum clear and unobstructed width of a public corridor of four feet in the current rules is misleading due to American Disability Act (ADA) and NFPA 101 requirements.

Response: The commission agrees that the codes are different, but disagrees that this should not be a licensing requirement. NFPA 101, 2003: §20.2.3.2 requires at a minimum the clear width of any corridor or passageway required for exit access to be not less than 44 inches. The minimum width clear for an accessible route by ADA is 36 inches. There are additional requirements for ADA accessible routes for passing spaces and wheelchair turn around. At least one ADA accessible route shall meet the requirements and elements in building or facility. These differences have been in the codes for years. The department adopted 48 inches in clear unobstructed width to assure a reasonable means of transporting a patient on a gurney to an exit and the ability of staff, patients, and visitors to pass each other without someone having to step aside. The requirement of 48-inch width of a public corridor has been a requirement since 1986. No change has been made to the rule as a result of this comment.

Comment: Concerning §135.52(e)(1)(B)(iii)(III), one commenter stated that the requirement that the eight-foot communicating corridor open directly to one exit could be misleading in the use of the term "Exit" especially in a multi-story building.

Response: The commission disagrees. "Exit" is defined in the National Fire Protection Association (NFPA) 101, Life Safety Code, 2003 Edition (NFPA 101), §3.3.62 Exit, §3.3.63 Exit Access and §3.3.64 Exit Discharge. There are three components to the means of egress, the "Exit" which is a portion of the means that is protected from all other spaces of a building or structure, the "Exit Access" is the portion of a means of egress that leads to an "Exit," and the "Exit Discharge" is the termination portion of a means of egress between the termination of an exit and public way. The communicating corridor leading to an "Exit" can either be to a door to the exterior of the building or in the case of multi-story building to a stair. No change has been made to the rule as a result of this comment.

Comment: Concerning §135.53(b)(1), one commenter stated that an elevator can open to an exit and allow people to exit the building.

Response: The commission disagrees. An "Exit" is not the same as an "Exit Access" corridor. NFPA 101, 2003: §3.3.62, defines the "Exit" as that portion of a means of egress that is separated from all other spaces of a building or structure by construction or equipment as required to provide a protected way of travel to the exit discharge. An elevator can open into an "Exit Access" corridor but not into an "Exit." No change has been made to the rule as a result of this comment.

The department staff on behalf of the commission provided comments, and the commission has reviewed and agrees to the following changes.

Change: Concerning §135.9(j)(6), the words "podiatrist, dentist," were added for accuracy.

Change: Concerning §135.9(j)(12) and (b)(18), the term "physician" was revised to "operating surgeon" for accuracy.

Change: Concerning §§135.22, 135.41 - 135.43, and 135.54, grammatical revisions and minor rule text revisions were added for clarification.

Change: Concerning §135.52(f)(3)(A)(iii), the words "soiled workrooms" were added as this was inadvertently left out in the proposed rule.

Change: Concerning §135.52(d)(3), the department reduced the square footage requirement for the exam room from 100 square feet to 80 square feet. The 80 square feet for the exam room was determined to be sufficient.

Change: Concerning §135.52(e)(1)(B)(vi), the department deleted the word "treatment" after the word "examination" as this was inadvertently added in this sentence.

Change: Concerning §135.52(h)(5)(G), the language was deleted as it is a duplicate of §135.52(h)(5)(F). Subsequent subparagraphs were re-lettered.

Change: Concerning §135.52(i)(15)(J), the words "shall be provided" were added to complete the sentence.

Change: Concerning §135.55(c)(1)(E), the rule reference "135.52(h)(6)(C)(iv)" was corrected to "135.52(h)(1)(C)(iv)."

LEGAL CERTIFICATION

The Department of State Health Services General Counsel, Lisa Hernandez, certifies that the rules, as adopted, have been reviewed by legal counsel and found to be a valid exercise of the agencies' legal authority.

SUBCHAPTER A. OPERATING REQUIREMENTS FOR AMBULATORY SURGICAL CENTERS

25 TAC §§135.1 - 135.29

STATUTORY AUTHORITY

The repeals are adopted under the Health and Safety Code, §243.009, concerning rules and minimum standards to protect and promote the public health and welfare by providing for the issuance, renewal, denial, suspension, and revocation of each license; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001. Review of the rules implements Government Code, §2001.039.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on May 29, 2009.

TRD-200902086

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: June 18, 2009

Proposal publication date: December 5, 2008

For further information, please call: (512) 458-7111 x6972

25 TAC §§135.1 - 135.29

STATUTORY AUTHORITY

The new sections are adopted under the Health and Safety Code, §243.009, concerning rules and minimum standards to protect and promote the public health and welfare by providing for the issuance, renewal, denial, suspension, and revocation of each license; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001. Review of the rules implements Government Code, §2001.039.

§135.2.Definitions.

The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise.

(1) Act--Texas Ambulatory Surgical Center Licensing Act, Health and Safety Code, Chapter 243.

(2) Action plan--A written document that includes specific measures to correct identified problems or areas of concern; identifies strategies for implementing system improvements; and includes outcome measures to indicate the effectiveness of system improvements in reducing, controlling or eliminating identified problem areas.

(3) Administrator--A person who is a physician, is a registered nurse, has a baccalaureate or postgraduate degree in administration or a health-related field, or has one year of administrative experience in a health care setting.

(4) Advanced practice registered nurse (APRN)--A registered nurse approved by the Texas Board of Nursing to practice as an advanced practice registered nurse in Texas. The term includes a nurse practitioner, nurse midwife, nurse anesthetist, and clinical nurse specialist. The term is synonymous with "advanced nurse practitioner."

(5) Ambulatory Surgical Center (ASC)--A facility that primarily provides surgical services to patients who do not require overnight hospitalization or extensive recovery, convalescent time or observation. The planned total length of stay for an ASC patient shall not exceed 23 hours. Patient stays of greater than 23 hours shall be the result of an unanticipated medical condition and shall occur infrequently. The 23-hour period begins with the induction of anesthesia.

(6) Autologous blood units--Units of blood or blood products derived from the recipient.

(7) Available--Able to be physically present in the facility to assume responsibility for the delivery of patient care services within five minutes.

(8) Certified registered nurse anesthetist (CRNA)--A registered nurse who has current certification from the Council on Certification of Nurse Anesthetists and who is currently authorized to practice as an advanced practice registered nurse by the Texas Board of Nursing.

(9) Change of ownership--

(A) a sole proprietor who transfers all or part of the ASC's ownership to another person or persons;

(B) the removal, addition, or substitution of a person or persons as a general, managing, or controlling partner in an ASC owned by a partnership and the tax identification number of that ownership changes; or

(C) a corporation that transfers all or part of the corporate stock which represents the ASC's ownership to another person or persons and the tax identification number of that ownership changes.

(10) Dentist--A person who is currently licensed under the laws of this state to practice dentistry.

(11) Department--The Department of State Health Services.

(12) Disposal--The discharge, deposit, injection, dumping, spilling, leaking, or placing of any solid waste or hazardous waste (whether containerized or uncontainerized) into or on any land or water so that such solid waste or hazardous waste or any constituent thereof may enter the environment or be emitted into the air or discharge into any waters, including ground waters.

(13) Extended observation--The period of time that a patient remains in the facility following recovery from anesthesia and discharge from the postanesthesia care unit, during which additional comfort measures or observation may be provided.

(14) Health care practitioners (qualified medical personnel)--Individuals currently licensed under the laws of this state who are authorized to provide services in an ASC.

(15) Licensed vocational nurse (LVN)--A person who is currently licensed by the Texas Board of Nursing as a licensed vocational nurse.

(16) Medicare-approved reference laboratory--A facility that has been certified and found eligible for Medicare reimbursement, and includes hospital laboratories which may be Joint Commission or American Osteopathic Association accredited or nonaccredited Medicare approved hospitals, and Medicare certified independent laboratories.

(17) Person--Any individual, firm, partnership, corporation, or association.

(18) Physician--An individual licensed by the Texas Medical Board and authorized to practice medicine in the State of Texas.

(19) Premises--A building where patients receive outpatient surgical services.

(20) Registered nurse (RN)--A person who is currently licensed by the Texas Board of Nursing as a registered nurse.

(21) Title XVIII--Title XVIII of the United States Social Security Act, 42 United States Code (USC), §§1395 et seq.

§135.9.Medical Records.

(a) The ambulatory surgical center (ASC) shall develop and maintain a system for the collection, processing, maintenance, storage, retrieval, and distribution of patient's medical records.

(b) An individual medical record shall be established for each person receiving care.

(c) All clinical information relevant to a patient shall be readily available to health care practitioners involved in the care of that patient.

(d) Except when otherwise required by law, any record that contains clinical, social, financial, or other data on a patient shall be strictly confidential and shall be protected from loss, tampering, alteration, destruction, and unauthorized or inadvertent disclosure.

(e) A person shall be designated to be in charge of medical records whose responsibilities include, but are not limited to:

(1) the confidentiality, security, and safe storage of medical records;

(2) the timely retrieval of individual medical records upon request;

(3) the specific identification of each patient's medical record;

(4) the supervision of the collection, processing, maintenance, storage, retrieval, and distribution of medical records; and

(5) the maintenance of a predetermined organized medical record format.

(f) Policies concerning medical records shall follow current statute in regard to retention of active records, retirement of inactive records, and the release of information contained in the record.

(g) Except when otherwise required by law, the content and format of medical records, including the sequence of information, shall be uniform.

(h) Reports, histories and physicals, progress notes, and other patient information (such as laboratory reports, X-ray readings, and consultation) shall be incorporated into the medical record in a timely manner.

(i) Medical records shall be available to authorized health care practitioners any time the ASC is open to patients.

(j) The ASC shall include the following in patients' medical records:

(1) patient identification;

(2) allergies and untoward reactions to drugs recorded in a prominent and uniform location;

(3) all preoperative, postoperative medications administered and drug/dose/route/frequency/quantity of all postoperative drugs dispensed to the patient by the ASC and entered on the patient's record;

(4) significant medical history and results of physical examination;

(5) a preanesthesia evaluation by an individual qualified to administer anesthesia;

(6) preoperative diagnostic studies entered before surgery, if required by policy or ordered by a physician, podiatrist, dentist, or advanced practice registered nurse;

(7) findings and techniques of the operation (operative report);

(8) pathology report on all tissues removed during surgery, except those exempted by the governing body;

(9) anesthesia administration record;

(10) documentation of a properly executed informed consent;

(11) evidence of evaluation of the patient by a physician or advanced practice registered nurse prior to dismissal;

(12) evidence that the patient left the facility in the company of a responsible adult, unless the operating surgeon or advanced practice registered nurse writes an order that the patient may leave the facility without the company of a responsible adult; and

(13) for patients with a length of stay greater than eight hours, an evaluation of nutritional needs and evidence of how identified needs were met.

(k) Appropriate medical advice given to a patient by telephone shall be entered in the patient's medical record and appropriately signed or initialed.

(l) Entries in patients' medical records shall be legible to clinical personnel, and shall be accurate and completed promptly.

(m) Any notation in a patient's medical record indicating diagnostic or therapeutic intervention as part of clinical research shall be clearly contrasted with entries regarding the provision of nonresearch-related care.

(n) When necessary for assuring continuity of care, summaries of records of a patient who was treated elsewhere (such as by another physician, hospital, ambulatory surgical center, nursing home, or consultant) shall be obtained.

(o) When necessary for assuring continuity of care, summaries or photocopies of the patient's record shall be transferred to the health care practitioner to whom the patient was referred and, if appropriate, to the facility where future care will be rendered.

(p) Certain repetitive procedures are suitable for pre-printed operative notes. These operative notes are suitable as long as they are approved by the governing body, are signed by the surgeon, and transmit to a knowledgeable reader the events of the surgical procedure.

(q) All final tissue and abnormal cytology reports from the Medicare-approved reference laboratory shall be signed by a pathologist.

§135.11.Anesthesia and Surgical Services.

(a) Anesthesia services.

(1) Anesthesia services provided in the ambulatory surgical center (ASC) shall be limited to those that are approved by the governing body, which may include the following.

(A) Topical anesthesia--An anesthetic agent applied directly or by spray to the skin or mucous membranes, intended to produce transient and reversible loss of sensation to the circumscribed area.

(B) Local anesthesia--Administration of an agent that produces a transient and reversible loss of sensation to a circumscribed portion of the body.

(C) Regional anesthesia--Anesthetic injected around a single nerve, a network of nerves, or vein that serves the area involved in a surgical procedure to block pain.

(D) Minimal sedation (anxiolysis)--A drug-induced state during which patients respond normally to verbal commands. Although cognitive function and coordination may be impaired, ventilatory and cardiovascular functions are unaffected.

(E) Moderate sedation/analgesia ("conscious sedation")--A drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained. (Reflex withdrawal from a painful stimulus is NOT considered a purposeful response.)

(F) Deep sedation/analgesia--A drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained. (Reflex withdrawal from a painful stimulus is NOT considered a purposeful response.)

(G) General anesthesia--A drug-induced loss of consciousness during which patients are not arousable, even by painful stimulation. The ability to independently maintain ventilatory function is often impaired. Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired.

(2) The anesthesia department shall be under the medical direction of a physician approved by the governing body upon the recommendation of the ASC medical staff.

(3) The medical staff shall develop written policies and practice guidelines for the anesthesia service, which shall be approved, implemented and enforced by the governing body. The policies and guidelines shall include consideration of the applicable practice standards and guidelines of the American Society of Anesthesiologists, the American Association of Nurse Anesthetists, and the licensing rules and standards applicable to those categories of licensed professionals qualified to administer anesthesia.

(4) Only personnel who have been approved by the facility to provide anesthesia services shall administer anesthesia. All approvals or delegations of anesthesia services as authorized by law shall be documented and include the training, experience, and qualifications of the person who provided the service. A qualified registered nurse (RN) who is not a certified registered nurse anesthetist (CRNA), in accordance with the orders of the operating surgeon, anesthesiologist, or CRNA, may administer topical anesthesia, local anesthesia, minimal sedation and moderate sedation, in accordance with all applicable rules, polices, directives and guidelines issued by the Texas Board of Nursing. When an RN who is not a CRNA administers sedation, as permitted in this paragraph, the facility shall:

(A) verify that the registered nurse has the requisite training, education, and experience;

(B) maintain documentation to support that the registered nurse has demonstrated competency in the administration of sedation;

(C) with input from the facility's qualified anesthesia providers, develop, implement and enforce detailed, written policies and procedures to guide the registered nurse; and

(D) ensure that, when administering sedation during a procedure, the registered nurse has no other duties except to monitor the patient.

(5) Anesthesia shall not be administered unless the operating surgeon has evaluated the patient immediately prior to the procedure to assess the risk of the anesthesia and of the procedure to be performed.

(6) The advanced practice registered nurse, the anesthesiologist, or the operating surgeon shall be available until all of his or her patients operated on that day have been discharged from the postanesthesia care unit.

(7) Patients who have received anesthesia shall be evaluated for proper anesthesia recovery by the operating surgeon or the person administering the anesthesia prior to discharge from the postanesthesia care unit using criteria approved by the medical staff.

(8) Patients who remain in the facility for extended observation following discharge from the postanesthesia care unit shall be evaluated immediately prior to leaving the facility by a physician, the person administering the anesthesia, or a registered nurse acting in accordance with physician's orders and written policies, procedures, and criteria developed by the medical staff.

(9) A physician shall be on call and able to respond physically or by telephone within 30 minutes until all patients have been discharged from the ASC.

(10) Emergency equipment and supplies appropriate for the type of anesthesia services provided shall be maintained and accessible to staff at all times.

(A) Functioning equipment and supplies which are required for all facilities include:

(i) suctioning equipment, including a source of suction and suction catheters in appropriate sizes for the population being served;

(ii) source of compressed oxygen;

(iii) basic airway management equipment, including oral and nasal airways, face masks, and self-inflating breathing bag valve set;

(iv) blood pressure monitoring equipment; and

(v) emergency medications specified by the medical staff and appropriate to the type of surgical procedures and anesthesia services provided by the facility.

(B) In addition to the equipment and supplies required under subparagraph (A) of this paragraph, facilities which provide moderate sedation/analgesia, deep sedation/analgesia, regional analgesia and/or general anesthesia shall provide the following:

(i) intravenous equipment, including catheters, tubing, fluids, dressing supplies, and appropriately sized needles and syringes;

(ii) advanced airway management equipment, including laryngoscopes and an assortment of blades, endotracheal tubes and stylets in appropriate sizes for the population being served;

(iii) a mechanism for monitoring blood oxygenation, such as pulse oximetry;

(iv) electrocardiographic monitoring equipment;

(v) cardiovertor-defibrillator; and

(vi) pharmacologic antagonists as specified by the medical staff and appropriate to the type of anesthesia services provided.

(b) Surgical services.

(1) Surgical procedures performed in the ASC shall be limited to those procedures that are approved by the governing body upon the recommendation of qualified medical personnel.

(2) Adequate supervision of surgery conducted in the ASC shall be a responsibility of the governing body, shall be recommended by qualified medical personnel, and shall be provided by appropriate personnel.

(3) Surgical procedures shall be performed only by health care practitioners who are licensed to perform such procedures within Texas and who have been granted privileges to perform those procedures by the governing body of the ASC, upon the recommendation of qualified medical personnel and after medical review of the practitioner's documented education, training, experience, and current competence.

(4) Surgical procedures to be performed in the ASC shall be reviewed periodically as part of the peer review portion of the ASC's quality assurance program.

(5) An appropriate history, physical examination, and pertinent preoperative diagnostic studies shall be incorporated into the patient's medical record prior to surgery.

(6) The necessity or appropriateness of the proposed surgery, as well as any available alternative treatment techniques, shall be discussed with the patient prior to scheduling the patient for surgery.

(7) Licensed nurses and other personnel assisting in the provision of surgical services shall be appropriately trained and supervised and shall be available in sufficient numbers for the surgical care provided.

(8) Each operating room shall be designed and equipped so that the types of surgery conducted can be performed in a manner that protects the lives and assures the physical safety of all persons in the area.

(A) If flammable agents are present in an operating room the room shall be constructed and equipped in compliance with standards established by the National Fire Protection Association (NFPA 99, Annex 2, Flammable Anesthetizing Locations, 1999) and with applicable state and local fire codes.

(B) If nonflammable agents are present in an operating room the room shall be constructed and equipped in compliance with standards established by the National Fire Protection Association (NFPA 99, Chapters 4 and 8, 1999) and with applicable state and local fire codes.

(9) With the exception of those tissues exempted by the governing body after medical review, tissues removed during surgery shall be examined by a pathologist, whose signed report of the examination shall be made a part of the patient's medical record.

(10) A description of the findings and techniques of an operation shall be accurately and completely written or dictated immediately after the procedure by the health care practitioner who performed the operation. If the description is dictated, an accurate written summary shall be immediately available to the health care practitioners providing patient care and shall become part of the patient's medical record. Refer to §135.9(p) of this title (relating to Medical Records).

(11) A safe environment for treating surgical patients, including adequate safeguards to protect the patient from cross infection, shall be assured through the provision of adequate space, equipment, and personnel.

(A) Provisions shall be made for the isolation or immediate transfer of patients with communicable diseases.

(B) All persons entering operating rooms shall be properly attired.

(D) Only authorized persons shall be allowed in the surgical area.

(E) Suitable equipment for rapid and routine sterilization shall be available to assure that operating room materials are sterile.

(F) Environmental controls shall be implemented to assure a safe and sanitary environment.

(G) Operating rooms shall be appropriately cleaned before each operation.

(12) Written policies and procedures for decontamination, disinfection, sterilization, and storage of sterile supplies shall be developed, implemented and enforced. Policies shall include, but not be limited to, the receiving, cleaning, decontaminating, disinfecting, preparing, and sterilization of critical items (reusable items), as well as for the assembly, wrapping, storage, distribution, and the monitoring and control of sterile items and equipment.

(A) Policies and procedures shall be developed following standards, guidelines, and recommendations issued by the Association of periOperative Registered Nurses (AORN), the Association for Professionals in Infection Control and Epidemiology (APIC), the Centers for Disease Control and Prevention (CDC) and, if applicable, the Society of Gastroenterology Nurses and Associates (SGNA). Standards, guidelines, and recommendations of these organizations are available for review at the Department of State Health Services, Exchange Building, 8407 Wall Street, Austin, Texas. Copies may also be obtained directly from each organization, as follows: AORN, 2170 South Parker Road, Suite 300, Denver Colorado, 80231, (800) 755-2676; APIC, 1275 K Street, Northwest, Suite 1000, Washington, District of Columbia, 20005-4006, (202) 789-1890; CDC, 1600 Clifton Road, Atlanta, Georgia, 30333, (800) 311-3435; SGNA, 401 North Michigan Avenue, Chicago, Illinois, 60611-4267, (312) 321-5165.

(B) Policies and procedures shall also address proper use of external chemical indicators and biological indicators.

(D) Preventive maintenance of all sterilizers shall be completed according to manufacturer's recommendations on a scheduled basis. A preventive maintenance record shall be maintained for each sterilizer. These records shall be retained at least one year and shall be available for review to the facility within two hours of request by the department.

(13) Emergency power adequate for the type of surgery performed shall be available in the operative and postoperative recovery areas.

(14) Periodic calibration and/or preventive maintenance of all equipment shall be provided in accordance with manufacturer's guidelines.

(15) The informed consent of the patient or, if applicable, of the patient's legal representative shall be obtained before an operation is performed.

(16) A written procedure shall be established for observation and care of the patient during the preoperative preparation and postoperative recovery period.

(17) Written protocols shall be established for instructing patients in self-care after surgery, including written instructions to be given to patients who receive conscious sedation, regional, and general anesthesia.

(18) Patients who have received anesthesia shall only be allowed to leave the facility in the company of a responsible adult, unless the operating surgeon or an advanced practice registered nurse writes an order that the patient may leave without the company of a responsible adult.

(19) An effective written procedure for the immediate transfer to a hospital of patients requiring emergency care beyond the capabilities of the ASC shall be developed. The ASC shall have a written transfer agreement with a hospital, or all physicians on staff at the ASC shall have admitting privileges at a local hospital.

§135.13.Pathology and Medical Laboratory Services.

Pathological and clinical services shall be provided or made available when appropriate to meet the needs of the patients and adequately support the ambulatory surgical center's (ASC's) clinical capabilities.

(1) Pathology and clinical laboratory services shall include, but are not limited to:

(A) conducting laboratory procedures that are appropriate to the needs of the patients;

(B) performing tests in a timely manner;

(C) distributing test results within 24 hours after completion of a test and maintaining a copy of the results in the laboratory; and

(D) performing and documenting appropriate quality assurance procedures, including, but not limited to, calibrating equipment periodically and validating test results through use of standardized control specimens or laboratories.

(2) Preoperative laboratory procedures may be required as follows.

(A) It shall be at the discretion of the governing body upon the recommendation of the medical staff to require preoperative laboratory orders.

(B) If specific preoperative laboratory work is required, the medical staff shall approve them in accordance with the medical staff bylaws. Other laboratory work shall be performed only on the order of a physician, podiatrist, dentist, or advanced practice registered nurse and written on the patient's chart.

(C) These services shall be provided either directly within or through an effective contract arrangement with a Medicare-approved reference laboratory.

(D) The contractual agreement with the Medicare-approved reference laboratory shall provide for routine and stat work to include pathology, clinical, and blood bank services, if blood is authorized by the ASC, and shall be available for review.

(3) The patient may be instructed to go directly to the Medicare-approved reference laboratory, or the specimen may be collected on the ambulatory surgical center's premises and then referred to the Medicare-approved reference laboratory.

(4) If the specimens are collected on the premises only, the following shall be maintained:

(A) procedures and policies governing the Medicare-approved reference laboratory specimen requirements; identification, collection, labeling, storage, and transportation of the specimen, and preventive maintenance of equipment used in processing and storage of specimen;

(B) a log book which shall include patient name and identification number, doctor's name, date the specimen was drawn and sent to the Medicare-approved reference laboratory, laboratory tests ordered, date the final report came back from the reference laboratory, and condition of the specimen. The final report shall be on the patient's chart, with copies kept in the ASC's laboratory.

(5) If laboratory tests are performed on the premises, the following shall be maintained:

(A) procedures governing identification, collection, labeling, and storage of specimens;

(B) a log book, which shall include patient name and identification number, practitioner's name, date the specimen was drawn, test ordered, and results;

(C) procedures for each test procedure performed by the laboratory, including source of reagents, standards, and calibration procedures, and information concerning the basis for the tested normal ranges;

(D) procedures and documentation of performed maintenance on equipment used to process laboratory work;

(E) dated reports of all examinations performed and made a part of the patient's medical record; and

(F) proficiency testing.

(6) Quality control of the laboratory shall be monitored through the quality assurance committee.

(7) If the ASC designates its laboratory to perform as an independent laboratory, it shall be surveyed according to 42 Code of Federal Regulations, §§493.1 - 493.1780.

(8) The ASC can allow laboratory work to be performed and brought in from other Medicare-approved reference laboratories or practitioners' offices, and the reports shall be on the patient's charts before surgery.

(A) Written criteria describing the length of time tests can be done prior to surgery shall be developed by the medical staff and approved by the governing body.

(B) Laboratory work shall be performed in a Medicare-approved reference laboratory or in the patient's healthcare practitioner's office. This shall be written in a policy accepted by the medical staff and governing body.

(9) If it is the ASC's policy to administer blood, policies shall be developed on administration of blood transfusions to include autologous blood units in accordance with the ASC's operative procedures. If the operative procedure(s) performed in the ASC requires or may require the necessity for transfusions, policies and procedures shall include provisions for stat and routine transfusions. These policies and procedures shall include, but are not limited to, collection, labeling, and transportation of specimen in accordance with the ASC or contract service policies. All patient results shall appear in the patient's chart.

(10) If the ASC performs surgery which incorporates the removal of a tissue specimen or the freezing of a tissue specimen, the specimen shall be submitted to a Medicare-approved reference laboratory. The following shall be maintained:

(A) procedures governing the Medicare-approved reference laboratory specimen requirements, identification, collection, labeling, storage, and transportation of the specimen;

(B) documentation to include patient name and identification number, practitioner's name, date the tissue specimen was collected and referred to the Medicare-approved reference laboratory, and date the final report came back from the Medicare-approved reference laboratory. Final copies shall be placed in the patient's chart, with copies kept in the ASC; and

(C) the medical staff bylaws may exempt tissue specimens from pathology examination, and the list of exemptions shall be available for review.

(11) The medical staff bylaws shall define those specimens for macroscopic pathology examination only and both macroscopic and microscopic pathology examinations.

(12) The original pathology report shall be included in the patient's chart.

(13) Pathology tissue reports and positive cytology reports shall have the authorized signature of the pathologist interpreting the report.

§135.14.Radiology Services.

(a) Radiology services shall be provided or made available when appropriate to meet the needs of the patients and adequately support the ambulatory surgical center's (ASC's) clinical capabilities. Policy and procedures shall be available for emergency and/or routine radiological procedures.

(b) A radiologist shall authenticate all examination reports, except reports of specific procedures that may be authenticated by physicians who are not radiologists, but who have been granted privileges by the governing body or its designee to authenticate such reports.

(c) Services shall be provided either directly within or through a Medicare-approved facility, and the contracts shall be available for review.

(d) If X-ray services are performed within the ASC, the X-ray department shall be surveyed according to 42 Code of Federal Regulations §482.26 or §§486.100 - 486.110.

(e) Procedure manuals shall include procedures for all examinations performed, infection control in the ASC and operating rooms to include dress code of personnel and cleaning of equipment.

(f) Policies shall address the quality aspects of radiology services, including, but not limited to:

(1) performing radiology services only upon the written order of a physician, dentist, advanced practice registered nurse, or other authorized health care practitioner (such orders shall be accompanied by a concise statement of the reason for the examination); and

(2) limiting the use of any radioactive sources in the ASC to physicians who have been granted privileges for such use on the basis of their training, experience, and current competence.

(g) Policies shall address the safety aspects of radiology services, including, but not limited to:

(1) regulation of the use, removal, handling, and storage of any radioactive material which is required to be licensed by the Department of State Health Services, Radiation Safety Licensing Branch;

(2) precautions against electrical, mechanical, and radiation hazards;

(3) proper shielding where radiation sources are used;

(4) acceptable monitoring devices for all personnel who might be exposed to radiation (monitoring devices shall be worn by such personnel in any area with a radiation hazard);

(5) maintenance of radiation exposure records on personnel; and

(6) authenticated, dated reports of all examinations performed shall be made a part of the patient's medical record.

(h) Laser equipment shall be licensed as required by the Department of State Health Services, Radiation Safety Licensing Branch. Policies and procedures shall be established and implemented for laser technology which include laser safety programs, education and training of laser personnel, credentialing for each specific laser, and a requirement for all personnel working with lasers to be adequately trained in the safety and use of each type of laser utilized.

§135.15.Facility Staffing and Training.

(a) Nursing services.

(1) There shall be an organized nursing service under the direction of a qualified registered nurse (RN). The ambulatory surgical center (ASC) shall be staffed to assure that the nursing needs of all patients are met.

(2) There shall be a written plan of administrative authority for all nursing services with responsibilities and duties of each category of nursing personnel delineated and a written job description for each category. The scope of nursing service shall include, but is not limited to, nursing care rendered to patients preoperatively, intraoperatively, and postoperatively.

(A) The responsible individual for nursing services shall be a qualified registered nurse (RN) whose responsibility and authority for nursing service shall be clearly defined and includes supervision of both personnel performance and patient care.

(B) There shall be a written delineation of functions, qualifications, and patient care responsibilities for all categories of nursing personnel.

(C) Surgical technicians and licensed vocational nurses may be permitted to serve in the scrub nurse role under the direct supervision of an RN; they shall not be permitted to function as circulating nurses in the operating rooms. Licensed vocational nurses and surgical technicians may assist in circulatory duties under the direct supervision of a qualified RN.

(D) Nursing services shall be provided in accordance with current recognized standards or recommended practices.

(3) There shall be an adequate number of RNs on duty to meet the following minimum staff requirements: director of the department (or designee), and supervisory and staff personnel for each service area to assure the immediate availability of an RN for emergency care or for any patient when needed.

(A) An RN shall assign the nursing care of each patient to other nursing personnel in accordance with the patient's needs and the preparation and qualifications of the nursing staff available.

(B) There shall be other nursing personnel in sufficient numbers to provide nursing care not requiring the service of an RN.

(4) An RN qualified, at a minimum, with current certification in basic cardiac life support shall be on duty and on the premises at all times whenever patients are present in the facility.

(b) Additional staffing requirements. In addition to meeting the requirements for nursing staff under subsection (a) of this section, facilities shall comply with the following minimum staffing requirements.

(1) Facilities that provide only topical anesthesia, local anesthesia and/or minimal sedation are required to have a second individual on duty on the premises who is trained and currently certified in basic cardiac life support until all patients have been discharged from the facility.

(2) Facilities that provide moderate sedation/analgesia are required to have the following additional staff:

(A) a second individual on duty on the premises who is trained and currently certified in basic cardiac life support until all patients have been discharged from the facility; and

(B) an individual trained and currently certified in advanced cardiac life support and, if surgery is performed on pediatric patients, pediatric advanced life support shall be available until all patients have been discharged from the postanesthesia care unit.

(3) Facilities that provide deep sedation/analgesia, general anesthesia, and/or regional anesthesia shall have the following additional staff:

(A) a second individual on duty on the premises who is trained and currently certified in basic cardiac life support until all patients have been discharged from the facility; and

(B) an individual who is trained and currently certified in advanced cardiac life support and, if surgery is performed on pediatric patients, pediatric advanced life support shall be on duty on the premises and sufficiently free of other duties to enable the individual to respond rapidly to emergency situations until all patients have been discharged from the postanesthesia care unit.

§135.20.Initial Application and Issuance of License.

(a) All first-time applications for licensing, including those from unlicensed operating ambulatory surgical centers (ASCs) and licensed ASCs for which a change of ownership or relocation is anticipated, are applications for an initial license.

(b) Upon written or verbal request, the department shall furnish a person with an application form for an ASC license. The applicant shall submit to the department a completed original application and the nonrefundable license fee.

(1) The applicant shall provide:

(A) the name and address of the owner of the ASC, or a list of names and addresses of persons who own an interest in the ASC;

(B) the name, Texas license number, and license expiration date of the medical chief of staff;

(D) the name, Texas license number, and license expiration date of the director of nursing of the ASC;

(E) whether the ASC has applied for certification under Title XVIII of the Social Security Act; and

(F) number of surgery suites.

(G) the following data concerning the applicant, the applicant's affiliates, and the managers of the applicant:

(i) denial, suspension, probation, or revocation of an ambulatory surgical center license in any state, a license for any health care facility or a license for a home and community support services agency (agency) in any state; or any other enforcement action, such as (but not limited to) court civil or criminal action in any state;

(ii) denial, suspension, probation, or revocation of or other enforcement action against an ambulatory surgical center license in any state, a license for any health care facility in any state, or a license for an agency in any state which is or was proposed by the licensing agency and the status of the proposal;

(iii) surrendering a license before expiration of the license or allowing a license to expire in lieu of the department proceeding with enforcement action;

(iv) federal or state (any state) criminal felony arrests or convictions;

(v) Medicare or Medicaid sanctions or penalties relating to the operation of a health care facility or agency;

(vi) operation of a health care facility or agency that has been decertified or terminated from participation in any state under Medicare or Medicaid; or

(vii) debarment, exclusion, or contract cancellation in any state from Medicare or Medicaid; and

(H) for the two-year period preceding the application date, the following data concerning the applicant, the applicant's affiliates, and the managers of the applicant:

(i) federal or state (any state) criminal misdemeanor arrests or convictions;

(ii) federal or state (any state) tax liens;

(iii) unsatisfied final judgments;

(iv) eviction involving any property or space used as an ambulatory surgical center or health care facility in any state;

(v) injunctive orders from any court; or

(vi) unresolved final federal or state (any state) Medicare or Medicaid audit exceptions.

(2) Upon receipt of the application, the department shall review the application to determine whether it is complete. All documents submitted to the department shall be originals. The address provided on the application shall be the address at which the ASC is operating.

(3) If the department determines that the application for an unlicensed ASC is complete and correct, a representative of the department shall schedule a pre-survey conference with the applicant in order to inform the applicant of the standards for the operation of the ASC. A pre-survey conference may, at the department's discretion, be waived for an applicant of a licensed ASC for which a change of ownership is anticipated.

(4) After a pre-survey conference has been held or waived at the department's discretion and the facility has received an approved architectural inspection conducted by the department, the department may issue a license to an ASC to provide ambulatory surgical services in accordance with these sections.

(c) When it is determined that the facility is in compliance with subsection (b) of this section, the department shall issue the license to the applicant.

(1) Effective date. The license shall be effective on the date the facility is determined to be in compliance with subsection (b) of this section.

(2) Expiration date.

(A) If the effective date of the license is the first day of a month, the license expires on the last day of the 23rd month after issuance.

(B) If the effective date of the license is the second or any subsequent day of a month, the license expires on the last day of the 24th month after issuance.

(d) If an applicant decides not to continue the application process for a license, the application may be withdrawn. The applicant shall submit a written request to withdraw to the department. The department shall acknowledge receipt of the request to withdraw.

(e) During the initial licensing period, the department shall conduct a survey of the ASC to ascertain compliance with the provisions of the Health and Safety Code, Chapter 243, and this chapter.

(1) The ASC shall request that an on-site survey be conducted after the ASC has provided services to a minimum of one patient.

(2) The ASC shall be providing services at the time of the survey.

(3) If the ASC has applied to participate in the federal Medicare program, the Medicare survey may be conducted in conjunction with the licensing survey.

(4) The initial licensing survey may be waived if the ASC provides documented evidence of accreditation by the Joint Commission, the Accreditation Association for Ambulatory Health Care, or the American Association for Accreditation of Ambulatory Surgery Facilities and Medicare deemed status.

§135.22.Renewal of License.

(a) The department shall send written notice of expiration of a license to an ambulatory surgical center (ASC) at least 60 days before the expiration date. If the applicant has not received notice, it is the duty of the ASC to notify the department and request a renewal application.

(b) The department shall issue a renewal license to an ASC that meets the minimum standards for a license set forth in these sections.

(1) The ASC shall submit the following to the department no later than 30 days prior to the expiration date of the license:

(A) a completed renewal application form;

(B) a nonrefundable license fee; and

(C) if the ASC is accredited by the Joint Commission, the Accreditation Association for Ambulatory Health Care, or the American Association for Accreditation of Ambulatory Surgery Facilities, documented evidence of current accreditation status.

(2) Renewal licenses shall be valid for two years.

(c) If the applicant fails to timely submit an application and fee in accordance with subsection (b) of this section, the department shall notify the applicant that the ASC shall cease providing ambulatory surgical services. If the ASC can provide the department with sufficient evidence that the submission was completed in a timely manner and all dates were adhered to, the cease to perform shall be dismissed. If the ASC cannot provide sufficient evidence, the ASC shall immediately thereafter return the license by certified mail. If the applicant wishes to provide ambulatory surgical services after the expiration date of the license, the applicant shall reapply for a license under §135.20 of this title (relating to Initial Application and Issuance of License).

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on May 29, 2009.

TRD-200902087

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: June 18, 2009

Proposal publication date: December 5, 2008

For further information, please call: (512) 458-7111 x6972

SUBCHAPTER B. SAFETY REQUIREMENTS FOR NEW AND EXISTING AMBULATORY SURGICAL CENTERS

25 TAC §135.41, §135.42

STATUTORY AUTHORITY

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on May 29, 2009.

TRD-200902088

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: June 18, 2009

Proposal publication date: December 5, 2008

For further information, please call: (512) 458-7111 x6972

SUBCHAPTER B. FIRE PREVENTION AND SAFETY REQUIREMENTS

25 TAC §§135.41 - 135.43

STATUTORY AUTHORITY

§135.41.Fire Prevention and Protection.

(a) Compliance. An ambulatory surgical center (ASC) shall comply with the provisions of this section with respect to fire prevention and protection.

(1) Fire inspections. An ASC shall comply with local fire codes.

(2) Fire reporting. Except as required under §135.43(b)(6) of this title (relating to Handling and Storage of Gases, Anesthetics, and Flammable Liquids), an ASC shall report all occurrences of fire to the local fire authority and in writing to the department's facility licensing group manager as soon as possible but not later than 10 calendar days following the occurrence. Any fire occurrence causing injury to a person shall be reported no later than the next business day to the facility licensing group manager by fax, (512) 834-4514, or overnight mail to Department of State Health Services, Facility Licensing Group Manager, Post Office Box 149347, Austin, Texas 78714-9347.

(3) Smoking policy. An ASC shall adopt, implement and enforce a written smoking policy. The policy shall include the minimum provisions of National Fire Protection Association 101, Life Safety Code, 2003 Edition (NFPA 101), §20.7.4. All documents published by National Fire Protection Association (NFPA) as referenced in this section may be obtained by writing or calling the NFPA at the following address or telephone number: National Fire Protection Association, 1 Batterymarch Park, Quincy, Massachusetts 02269-9101 or (800) 344-3555.

(b) Fire extinguishing systems. An ASC shall adopt, implement, and enforce a written policy for periodic inspection, testing and maintenance of fire-fighting equipment, portable fire extinguishers, and when installed sprinkler systems. If installed, fire sprinkler systems shall comply with National Fire Protection Association 13, Standard for the Installation of Sprinkler Systems, 2002 Edition (NFPA 13).

(1) Water-based fire protection systems. All fire sprinkler systems, fire pumps, fire standpipe and hose systems, water storage tanks, and valves and fire department connections shall be inspected, tested and maintained in accordance with National Fire Protection Association 25, Standard for the Inspection, Testing and Maintenance of Water-Based Fire Protection Systems, 2002 Edition.

(2) Portable fire extinguishers. Every portable fire extinguisher located in an ASC or upon ASC property shall be installed, tagged, and maintained in accordance with National Fire Protection Association 10, Standard for Portable Fire Extinguishers, 2002 Edition.

(c) Fire protection and evacuation plan. A plan for the protection of patients in the event of fire and their evacuation from the building when necessary shall be formulated according to NFPA 101, §20.7. Copies of the plan shall be available to all staff.

(1) Posting requirements. An evacuation floor plan shall be prominently and conspicuously posted for display throughout the ASC in public areas that are readily visible to patients, employees, and visitors.

(2) Annual training. Each ASC shall conduct an annual training program for instruction of all personnel in the location and use of fire-fighting equipment. All employees shall be instructed regarding their duties under the fire protection and evacuation plan.

(3) Fire drills. The ASC shall conduct at least one fire drill per shift, per quarter. Each drill shall include the use of communication of alarms, use of fire-fighting equipment, simulation of evacuation of patients, discussion with patients, visitors, other occupants, employees and staff about the evacuation plan. Written reports shall be maintained to include evidence of staff and patient participation. Fire exit drills shall incorporate the minimum requirements of NFPA 101, §§20.7.1.2 through 20.7.2.3.

(4) Fire-fighting equipment. All staff shall be familiar with the locations of fire-fighting equipment. Fire-fighting equipment shall be located so that a person shall not have to travel more than 75 feet from any point to reach the equipment.

(d) Fire alarm system. A fire alarm system shall be installed, maintained and tested, in accordance with National Fire Protection Association 72, National Fire Alarm Code, 2002 Edition (NFPA 72) and NFPA 101, §20.3.4.

(e) System for communicating an alarm of fire. A reliable communication system shall be provided as a means of reporting a fire to the fire department. This is in addition to the automatic alarm transmission to the fire department required by NFPA 101, §20.3.4.4.

(f) Fire department access. As an aid to fire department services, every ASC shall provide the following.

(1) Driveways. The ASC shall maintain driveways, free from all obstructions, to main buildings for fire department apparatus use.

(2) Submission of plans. Upon request, the ASC shall submit a copy of the floor plans of the building to the local fire department officials.

(3) Outside identification. The ASC shall place proper identification on the outside of the main building showing the locations of siamese connections and standpipes as required by the local fire department services.

(g) Fire department protection. When an ASC is located outside of the service area or range of the public fire protection, arrangements shall be made to have the nearest fire department respond in case of a fire.

(h) Physical environment. A facility shall provide a physical environment that protects the health, welfare, and safety of patients, personnel and the public. The physical premises of the facility and those areas of the facility's surrounding physical structure that are used by the patients (including all stairwells, corridors and passageways) must meet the local building and fire safety codes as they relate to safe access and patient privacy.

§135.42.General Safety.

(a) Safety officer. The governing body shall appoint a safety officer who is knowledgeable in safety practices in health care facilities. The safety officer shall carry out the functions of the safety program.

(b) Safety activities.

(1) Incident reports. The safety officer shall establish an incident reporting system which includes a mechanism to ensure that all incidents recorded are evaluated, and documentation is provided to show follow-up and corrective actions.

(2) Safety policies and procedures. Safety policies and procedures for each department or service shall be developed, implemented, and enforced.

(3) Safety training and continuing education. Safety training shall be established as part of new employee orientation and in the continuing education of all employees.

(c) Written authority. The authority of the safety officer to take action, when conditions exist that are a possible threat to life, health, or building damage, shall be defined in writing and approved by the governing body.

(d) Safety manual. Each department or service shall have a safety policy and procedure manual within its own area that becomes a part of the overall facility safety manual.

(e) Emergency communication system. An emergency communication system shall be provided in each facility. The system shall be self-sufficient and capable of operating without reliance on the building's service or emergency power supply. Such system shall have the capability of communicating with the available community or state emergency networks, including police and fire departments.

(f) Fans. All portable fans and ceiling fans shall not be utilized in any patient treatment areas/rooms.

(g) Electrical extension cords and cables. Electrical extension cords and cables shall not be used for permanent wiring. Temporary electrical cords or cables shall be secured and protected to prevent tripping.

§135.43.Handling and Storage of Gases, Anesthetics, and Flammable Liquids.

(a) An ambulatory surgical center (ASC) shall comply with the requirements of this section for handling and storage of gases, anesthetics, and flammable liquids. The ASC premises shall be kept free from accumulations of combustible materials not necessary for immediate operation of the facility.

(b) Flammable germicides. If flammable germicides, including alcohol-based products, are used for preoperative surgical skin preparation, the facility shall:

(1) use only self-contained, single-use, pre-measured applicators to apply the surgical skin preparations;

(2) follow all manufacturer product safety warnings and guidelines;

(3) develop, implement, and enforce written policies and procedures outlining the safety precautions required related to the use of the products, which, at a minimum, shall include minimum drying times, prevention and management of product pooling, parameters related to draping and the use of ignition sources, staff responsibilities related to ensuring safe use of the product, and documentation requirements sufficient to evaluate compliance with the written policies and procedures;

(4) ensure that all staff working in the surgical environment where flammable surgical skin preparation products are in use have received training on product safety and the facility policies and procedures related to the use of the product;

(5) develop, implement and enforce an interdisciplinary team process for the investigation and analysis of all surgical suite fires and alleged violations of the policies; and

(6) provide a written report of all occurrences of surgical suite fires within two business days to the department in care of the facility licensing group, and complete an investigation of the occurrence and develop and implement a corrective action plan within 30 days.

(c) Flammable and nonflammable gases and liquids. Flammability of liquids and gases shall be determined by National Fire Protection Association 329, Handling Releases of Flammable and Combustible Liquids and Gases, 2002 Edition. All documents published by National Fire Protection Association (NFPA) as referenced in this section may be obtained by writing or calling the NFPA at the following address or telephone number: National Fire Protection Association, 1 Batterymarch Park, Quincy, Massachusetts 02269-9101 or (800) 344-3555.

(1) Nonflammable gases (examples include, but are not limited to, oxygen and nitrous oxide) shall be stored and distributed in accordance with Chapter 5 of the National Fire Protection Association 99, Standard for Health Care Facilities, 2002 Edition (NFPA 99).

(A) Medical gases and liquefied medical gases shall be handled in accordance with the requirements of NFPA 99, Chapter 9.

(B) Oxygen shall be administered in accordance with NFPA 99, §9.6.

(2) Piped flammable gas systems intended for use in laboratories and piping systems for fuel gases shall comply with requirements of NFPA 99, §11.11.

(3) Flammable gases shall be stored in accordance with NFPA 99, §11.10.

(4) Flammable and combustible liquids used in laboratories shall be handled and stored in accordance with NFPA 99, §11.7, and National Fire Protection Association 101, Life Safety Code, 2003 Edition, §20.3.2.2.

(5) Other flammable agents shall be stored in accordance with NFPA 99, Chapter 7, Materials.

(d) Alcohol-based hand rubs. Alcohol-based hand rubs (ABHRs) are considered flammable. When used, the ABHRs shall meet the following requirements.

(1) The dispensers may be installed in a corridor so long as the corridor width is six feet or greater. The dispensers shall be installed at least four feet apart.

(2) The maximum individual dispenser fluid capacity is 1.2 liters for dispensers in rooms, corridors, and areas open to corridors, and 2.0 liters for dispensers in suites of rooms.

(3) The dispensers shall not be installed over or directly adjacent to electrical outlets and switches.

(4) Dispensers installed directly over carpeted surfaces shall be permitted only in sprinklered smoke compartments.

(5) Each smoke compartment may contain a maximum aggregate of 10 gallons of ABHR solution in dispensers and a maximum of five gallons in storage.

(e) Gasoline and gasoline powered equipment. No motor vehicles including gasoline powered standby generators or any amount of gasoline shall be located within the ASC building. Other devices which may cause or communicate fire, and which are not necessary for patient treatment or care, shall not be stored within the ASC building. All such devices and materials when necessary shall be used within the building only with precautions ensuring a reasonable degree of safety from fire.

(f) Gas fired appliances. The installation, use, and maintenance of gas fired appliances and gas piping installations shall comply with the National Fire Protection Association 54, National Fuel Gas Code, 2002 Edition. The use of portable gas heaters and unvented open flame heaters is specifically prohibited.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on May 29, 2009.

TRD-200902089

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: June 18, 2009

Proposal publication date: December 5, 2008

For further information, please call: (512) 458-7111 x6972

SUBCHAPTER C. PHYSICAL PLANT AND CONSTRUCTION REQUIREMENTS FOR NEW AND EXISTING AMBULATORY SURGICAL CENTERS

25 TAC §§135.51 - 135.54

STATUTORY AUTHORITY

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on May 29, 2009.

TRD-200902090

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: June 18, 2009

Proposal publication date: December 5, 2008

For further information, please call: (512) 458-7111 x6972

SUBCHAPTER C. PHYSICAL PLANT AND CONSTRUCTION REQUIREMENTS

25 TAC §§135.51 - 135.56

STATUTORY AUTHORITY

§135.52.Construction Requirements for a New Ambulatory Surgical Center.

(a) Ambulatory surgical center (ASC) location. Any proposed new ASC shall be easily accessible to the community and to service vehicles such as delivery trucks, ambulances, and fire protection apparatus. No building may be converted for use as an ASC which, because of its location, physical condition, state of repair, or arrangement of facilities, would be hazardous to the health and safety of the patients. An ASC may be a distinct separate part of an existing hospital, it may occupy an entire separate independent structure, or it may be located within another building such as an office building or commercial building.

(1) Means of egress. An ASC shall have at least two exits remotely located in accordance with National Fire Protection Association (NFPA) 101, Life Safety Code, 2003 Edition (NFPA 101), §20.2.4.1. When a required means of egress from the ASC is through another portion of the building, that means of egress shall comply with the requirements of NFPA 101 which are applicable to the occupancy of that other building. Such means of egress shall be open, available, unlocked, unrestricted, and lighted at all times during the ASC hours of operation. All documents published by National Fire Protection Association (NFPA) as referenced in this section may be obtained by writing or calling the NFPA at the following address or telephone number: National Fire Protection Association, 1 Batterymarch Park, Quincy, Massachusetts 02269-9101 or 800-344-3555.

(2) Hazardous location.

(A) Underground and above ground hazards. A new ASC or an addition(s) to an existing ASC shall not be constructed within 150 feet of easement boundaries or setbacks of hazardous underground locations including but not limited to liquid butane or propane, liquid petroleum or natural gas transmission lines, high pressure lines, and not within the easement of high voltage electrical lines.

(B) Fire hazards. A new ASC and an addition to an existing ASC shall not be built within 300 feet of above ground or underground storage tanks containing liquid petroleum or other flammable liquids used in connection with a bulk plant, marine terminal, aircraft refueling, bottling plant of a liquefied petroleum gas installation, or near other hazardous or hazard producing plants.

(3) Undesirable locations.

(A) Nuisance producing sites. A new ASC shall not be located near nuisance producing sites such as industrial sites, feed lots, sanitary landfills, or manufacturing plants which produce excessive noise or air pollution.

(B) Flood plains.

(i) New construction. When a new ASC is constructed in a designated 100-year flood plain, the building finished floor elevation shall be one foot above the set base flood plain elevation. The building shall meet all local flood code ordinances and local flood control requirements.

(ii) Previously licensed ASC. To obtain a license as an ASC, a previously licensed ASC and an existing building or a portion of an existing building located in a designated 100-year flood plain shall meet the requirement of subparagraph (B)(i) of this paragraph.

(iii) Existing ASC. ASC required functional components shall be constructed above the designated flood plain in a new addition to an existing ASC located in a designated 100-year flood plain. The new addition shall meet the requirement of subparagraph (B)(i) of this paragraph.

(b) ASC site. The ASC site shall include paved roads, walkways, and parking in accordance with the requirements set out in this subsection.

(1) Paved roads and walkways.

(A) Paved roads shall be provided within lot lines for access from public roads to the main entrance and to service entrances.

(B) Finished surface walkways shall be provided for pedestrians. When public transportation or walkways serve the site, finished surface walkways or paved roads shall extend from the public conveyance to the building entrance.

(2) Parking and disability requirements.

(A) Parking requirements. Off-street parking shall be provided at the minimum ratio of two spaces for each operating room, one space for each staff member, and one visitor's space for each operating room.

(B) Design for the handicapped. Special considerations benefiting handicapped staff, visitors, and patients shall be provided. Each ASC shall comply with the Americans with Disabilities Act (ADA) of 1990, Public Law 101 - 336, 42 United States Code, Chapter 126, and Title 36 Code of Federal Regulations, Part 1191, Appendix A, Accessibility Guidelines for Buildings and Facilities or 16 Texas Administrative Code, §68.20 (relating to Buildings and Facilities Subject to Compliance with the Texas Accessibility Standards), Texas Accessibility Standards (TAS), April 1, 1994 edition, issued by the Texas Department of Licensing and Regulation, under the Texas Architectural Barriers Act, Texas Government Code, Chapter 469.

(c) Building design and construction requirements. Every building and every portion thereof shall be designed and constructed to sustain all dead and live loads in accordance with accepted engineering practices and standards and local governing building codes. Where there is no local governing building code, the ASC shall be constructed in accordance with the International Building Code, 2003 edition, published by the International Code Council, 500 New Jersey Avenue, Northwest, 6th Floor, Washington, District of Columbia 20001-2070, (888) 422-7233.

(1) General architectural requirements. All new construction, including conversion of an existing building to an ASC or establishing a separately licensed ASC within another existing building, shall comply with NFPA 101, Chapter 20, New Ambulatory Health Care Occupancies, of the National Fire Protection Association 101, Life Safety Code, 2003 Edition (NFPA 101), and Subchapters B and C of this chapter (relating to Fire Prevention and Safety Requirements, and Physical Plant and Construction Requirements, respectively). Construction documents shall be submitted to the department in accordance with §135.54 of this title (relating to Preparation, Submittal, Review and Approval of Plans, and Retention of Records).

(A) Construction types for multiple building occupancy.

(i) When an ASC is part of a larger building which complies with NFPA 101, §20.1.6, Minimum Construction Requirements for (fire resistance) construction type, the designated ASC shall be separated from the remainder of the building with a minimum of one-hour fire-rated construction.

(ii) When an ASC is located in a multistory building of two or more stories, the entire building shall meet the construction requirements of NFPA 101, §20.1.6.3. An ASC shall not be located in a multistory building which does not comply with the minimum construction requirements of NFPA 101, §20.1.6.3.

(iii) When an ASC is part of a one-story building that does not comply with the construction requirements of NFPA 101, §20.1.6.2, the ASC shall be separated from the remainder of the building with a two-hour fire-rated construction. The designated ASC portion shall have the construction type upgraded to comply with NFPA 101, §20.1.6.2.

(B) Special design provisions. Special provisions shall be made in the design of a facility if located in a region where local experience shows loss of life or extensive damage to buildings resulting from hurricanes, tornadoes, or floods.

(2) Physical environment. A physical environment that protects the health, welfare, and safety of patients, personnel, and the public shall be provided in each facility. The physical premises of the facility and those areas of the facility's physical structure that are used by the patients (including all stairwells, corridors, and passageways) shall meet the local building and fire safety codes and the requirements of this chapter.

(3) Other regulations. The more stringent standard, code or requirement shall apply when a difference in requirements for construction exists.

(4) Exceeding minimum requirements. Nothing in this subchapter shall be construed to prohibit a better type of building construction, more exits, or otherwise safer conditions than the minimum requirements specified in this subchapter.

(5) Equivalency. Nothing in this subchapter is intended to prevent the use of systems, methods, or devices of equivalent or superior quality, strength, fire resistance, effectiveness, durability, and safety to those prescribed by this subchapter, provided technical documentation which demonstrates equivalency is submitted to the department for approval.

(6) Freestanding buildings (not for patient use). Separate freestanding buildings for nonpatient use such as the heating plant, boiler plant, laundry, repair workshops, or general storage may be of unprotected noncombustible construction, protected noncombustible construction, or fire-resistive construction and be designed and constructed in accordance with other occupancy classifications requirements listed in NFPA 101.

(d) Spatial requirements.

(1) Administration and public areas.

(A) Entrance. Entrances shall be located at grade level, be accessible to individuals with disabilities, and be protected against inclement weather from the point of passenger loading/unloading to the building entrance. When an ASC is located on a floor above grade level, elevators shall be accessible and shall meet the requirements of §135.53 of this title (relating to Elevators, Escalators, and Conveyors).

(B) Waiting area. A waiting area or lobby shall be provided within the ASC and include having the following rooms and items:

(i) public toilet facilities;

(ii) telephone(s) for public use; and

(iii) access to potable drinking water.

(D) Interview space(s). Space shall be provided for private interviews or family members, relating to social services, credit, or admission.

(E) General or individual office(s). An office(s) shall be provided for business transactions, records, and administrative and professional staff.

(F) Medical records area. The medical records area shall have adequate space for reviewing, dictating, sorting, or recording records. If electronic imaging devices are employed (i.e., microfilm, digital, or optical disc), the medical records area shall have adequate space for transcribing records in the electronic format. Medical record storage space shall be located within a secure designated area under direct visual supervision of administrative staff.

(G) General storage room.

(i) A minimum of 30 square feet per operating room shall be provided exclusive of soiled holding, sterile supplies, clean storage, drug storage, locker rooms, and surgical equipment storage. General storage may be located in one or more rooms or closets, and shall be located outside of the patient treatment areas.

(ii) General storage room(s) shall be separated from adjacent areas by fire-rated construction in accordance with the NFPA 101, §38.3.2.1 and §38.3.2.2.

(H) Wheelchair storage space or alcove. Storage space for wheelchairs shall be provided and shall be out of the direct line of traffic.

(2) Engineering services and equipment areas. Equipment rooms with adequate space shall be provided for mechanical and electrical equipment. These areas shall be separate from public, patient, and staff areas.

(3) Examination room. An examination room is not required, but when provided, the room shall have:

(A) a minimum clear floor area of at least 80 square feet exclusive of fixed or moveable cabinets, counters, or shelves; and

(B) a work counter with space for writing and a hand washing fixture with hands-free operable controls.

(4) Janitor's closet. In addition to the janitor's closet exclusive to the surgery suite, a sufficient number of janitor's closets shall be provided throughout the facility to maintain a clean and sanitary environment. The closet shall contain a floor receptor or service sink and storage space for housekeeping supplies and equipment.

(5) Laboratory.

(A) General. Laboratory services shall be provided within the ASC or through a contract or other arrangement with a hospital or accredited laboratory.

(B) Special requirements. When the laboratory is located on site the following minimum items shall be provided:

(i) a room with work counter, utility sink, and storage cabinets or closet(s); and

(ii) specimen collection facilities. For dip stick urinalysis, urine collection rooms shall be equipped with a water closet and lavatory. Blood collection facilities shall have space for a chair, work counter, and a hand washing fixture with hands-free operable controls.

(i) Construction for fire protection in laboratories employing quantities of flammable, combustible, or other hazardous material shall be in accordance with the National Fire Protection Association 99, Health Care Facilities, 2002 Edition, (NFPA 99).

(ii) Laboratories shall comply with the requirements of NFPA 99, Health Care Facilities, 2002 Edition, Chapter 11, as applicable and the requirements of NFPA 45, Standards on Fire Protection for Laboratories Using Chemicals, 2000 Edition, as applicable.

(6) Laundry and linen processing area(s). Laundry and linen processing may be done within the center or off site at a commercial laundry.

(A) On-site linen processing. When on-site linen processing is provided, soiled and clean processing operations shall be separated and arranged to provide a one-way traffic pattern from soiled to clean areas. The following rooms and items shall be provided:

(i) a soiled linen processing room which includes areas for receiving, holding, sorting, and washing;

(ii) a clean linen processing room which includes areas for drying, sorting, folding, and holding prior to distribution;

(iii) supply storage cabinets in the soiled and clean linen processing rooms;

(iv) a hand washing fixture with hands-free operable controls within the soiled linen processing room; and

(v) a storage room for clean linen located within the surgical suite. Clean linen storage may be combined with the clean work room.

(B) Off-site linen processing. When linen is processed off site, the following rooms or items shall be provided:

(i) a storage room for clean linen located within the surgical suite. Clean linen storage may be combined with the clean work room; and

(ii) a soiled linen holding room or area located within the surgical suite. Soiled linen holding may be combined with the soiled workroom.

(7) Medical waste processing. Space and facilities shall be provided for the safe storage and disposal of waste as appropriate for the material being handled and in compliance with all applicable rules and regulations.

(8) Pharmacy. A pharmacy work room or alcove shall be provided and located separate from patient and public areas and under the direct supervision of staff. A work counter, refrigerator, medication storage, and locked storage for biologicals and drugs shall be provided. A hand washing fixture with hands-free operable controls shall be located in the pharmacy room or alcove.

(9) Postoperative recovery suite.

(A) General. A postoperative recovery suite shall be distinct and separate from preoperative areas. The postoperative recovery suite shall be arranged to provide a one-way traffic pattern from the restricted surgical corridor to the postoperative recovery suite, and then to the extended observation rooms or discharge.

(B) Postanesthesia care unit. A minimum of one patient station per operating room, plus one additional station, shall be provided.

(i) In a multiple-bed postoperative recovery area, the clearance between the side of a bed/gurney and a wall/partition shall be a minimum of three feet. The clearance between sides of beds/gurneys shall be a minimum of four feet six inches. The minimum distance at the foot of the bed/gurney shall not be less than six feet for single load area/room or nine feet for double load area/room. Four feet of the passage space at the foot of the bed may be shared between two beds/gurneys. The fixed and moveable cabinets and shelves shall not encroach upon the bed/gurney clear floor space/area.

(ii) The minimum clear floor space in a private postoperative recovery room shall be 100 square feet exclusive of aisles and fixed and moveable cabinets and selves. A minimum of nine feet width shall be provided for the head wall.

(C) Patient toilet. A toilet room with a water closet and a hand washing fixture with hands-free operable controls shall be provided. The toilet room may be shared with the preoperative patient holding area, if located conveniently between both areas.

(D) Hand washing fixture. One hand washing fixture with hands-free operable controls shall be provided for every four recovery beds or fraction thereof in open wards. Fixtures shall be uniformly distributed. One hand washing fixture shall be provided within each single-bed recovery room.

(E) Extended observation rooms. Separate supervised rooms or areas may be provided for patients who are sufficiently stabilized to leave the postanesthesia care unit, but require additional time in the facility for observation or comfort measures prior to being discharged.

(i) When individual rooms are provided for extended observation, the rooms shall have an area of at least 60 square feet. When such rooms include a bed or recliner, a minimum clearance of three feet at the foot and on each side of the bed or recliner shall be provided.

(ii) When an open or ward area for extended observation is provided, the minimum clearance from the bed or recliner to the side wall shall not be less than three feet; and a space of four feet shall be provided at the foot of each bed or recliner. The minimum clearance between beds or recliners shall not be less than three feet.

(iii) A toilet room with a water closet and a hand washing fixture with hands-free operable controls shall be provided. The toilet room may be shared with the postoperative recovery area, if located conveniently between both areas.

(10) Preoperative patient holding room.

(A) General. A preoperative holding area shall be provided and arranged in a one-way traffic pattern so that patients entering from outside the surgical suite can change, gown, and move directly into the restricted corridor of the surgical suite. The holding area shall be separate from the postoperative recovery suite and the restricted corridor.

(B) Patient station. A minimum of one patient station per operating room shall be provided.

(i) When individual rooms are provided, the minimum clear floor space in a private preoperative holding room shall be 80 square feet exclusive of aisles and fixed and moveable cabinets and shelves. The rooms shall include a bed or recliner with a minimum clearance of three feet at the foot and on each side of the bed or recliner.

(ii) In a multiple-bed preoperative holding area, a minimum area of 60 square feet shall be provided for each patient station. The minimum clearance from the gurney or bed to a sidewall shall not be less than three feet. A space of four feet shall be provided at the foot of the gurney or bed and the minimum clearance between gurneys or beds shall not be less than four feet six inches.

(iii) Space shall be made available for storing and securing patient's personal effects.

(iv) One hand washing fixture with hands-free operable controls shall be provided for every four preoperative beds or fraction thereof in open wards. Fixtures shall be uniformly distributed. One hand washing fixture shall be provided within each single-bed preoperative holding room.

(C) Patient toilet. A toilet room with handicapped accessible water closet and hand washing facilities shall be provided. The toilet room may be shared with the postoperative recovery suite, if located conveniently between both areas.

(D) Duty station. A hand washing fixture with hands-free operable controls and a counter or shelf space for writing shall be provided for staff use within or convenient to the preoperative area. The staff hand washing fixture with hands-free operable controls shall be separate from and in addition to patient toilet accommodations.

(11) Radiology.

(A) Special requirements. When radiology services are provided on site, the following minimum facilities shall be provided:

(i) film processing facilities, if used;

(ii) viewing capabilities;

(iii) storage facilities for exposed film, if used, located in rooms or areas constructed in accordance with the NFPA 101, §38.3.2.1 and §38.3.2.2; and

(iv) dressing area(s) shall be required, depending on services provided, with convenient access to toilets, and may be shared with patient changing/preoperative rooms.

(B) Fluoroscopy room. When fluoroscopy services are provided on site in a dedicated fluoroscopy room, a toilet room with a water closet and a hand washing fixture with hands-free operable controls shall be directly accessible to the room.

(12) Soiled workroom. In addition to the soiled workroom provided in the surgical suite, a separate soiled workroom(s) shall be required when a treatment room is provided, except as allowed in subparagraph (B) of this paragraph.

(A) Special requirements. The workroom(s) shall contain a clinical sink or equivalent flushing type fixture, work counter, designated space for waste and linen receptacles, and a hand washing fixture with hands-free operable controls.

(B) Shared functions. The soiled workroom required in support of a treatment room may be combined with a surgical suite soiled work room with two means of entry. A separate door into the soiled workroom shall serve a treatment room located outside the surgical suite.

(13) Surgical staff clothing change area.

(A) Surgical staff changing rooms. Appropriately sized areas shall be provided for male and female personnel working within the surgical suite. These areas shall contain lockers, showers, toilets, hand washing fixtures with hands-free operable controls, and space to change into scrub suits and boots. Separate locker/changing rooms shall be provided for male and female staff. The shower and toilet room(s) may be unisex. These areas shall be arranged to provide a traffic pattern so that personnel entering from outside the surgical suite can shower, change, and move directly into the restricted areas of the surgical suite.

(B) Surgical staff lounge. When a surgical staff lounge is provided, the lounge shall be located to permit the use without leaving the surgical suite and may be accessed from the clothing changing rooms. The surgical staff lounge shall not have direct access from outside the surgical suite. When the lounge is remote from the clothing change rooms, toilet facilities and a hand washing fixture with hands-free operable controls accessible from the lounge shall be provided.

(14) Sterilizing facilities. A system for sterilizing equipment and supplies shall be provided. Sterilizing procedures may be done on site or off site, or disposables may be used to satisfy functional needs.

(A) Off-site sterilizing. When sterilizing is provided off site and disposables and prepackage surgical supplies are used, the following rooms shall be provided near the operating room.

(i) Soiled holding room. A room for receiving contaminated/soiled material and equipment from the operating room shall be provided. The room shall be physically separate from all other areas of the suite. The room shall include a work counter(s) or a table(s), clinical sink or equivalent flushing type fixture, equipment for initial disinfection and preparation for transport to off-site sterilizing, and a hand washing fixture with hands-free operable controls. The soiled holding room may be combined with the surgical suite soiled workroom.

(ii) Clean workroom. A clean workroom shall be provided for the exclusive use of the surgical suite. The workroom shall contain a work counter with space for receiving, disassembling and organizing clean supplies, storage cabinets or shelving, and a hand washing fixture with hands-free operable controls.

(iii) Sterilizer equipment. Sterilizer equipment shall be located in a separate room convenient to the operating room(s), in an alcove adjacent to the restricted corridor, or in the clean workroom.

(B) On-site sterilizing facilities. When sterilizing facilities are provided on site they shall be located near the operating room and provide the following rooms.

(i) Receiving/decontamination room. The receiving/decontamination room shall be physically separate from all other areas of the surgical suite. The room shall include a work counter(s) or table(s), clinical sink or equivalent flushing type fixture, equipment for initial washing/disinfection, and a hand washing fixture with hands-free operable controls. Pass-through dutch doors, windows, and washer/sterilizer decontaminators shall serve in delivering material to the clean workroom. The receiving/decontamination room may be combined with the surgical suite soiled workroom.

(ii) Clean/assembly workroom. The clean/assembly workroom shall include a counter(s) or table(s) with space for organizing, assembling, and packaging of medical/surgical supplies and equipment, equipment for terminal sterilizing, and a hand washing fixture with hands-free operable controls. Clean and soiled work areas shall be physically separated.

(iii) Sterile storage. A storage room for clean and sterile supplies shall be provided. The storage room shall have adequate areas and counters for breakdown of manufacturers' clean/sterile medical/surgical supplies. This room may be combined with the clean assembly/workroom.

(iv) Cart storage room or alcove. The storage space for distribution carts shall be adjacent to clean and sterile storage area(s) and close to main distribution points.

(15) Surgical suite. The surgical suite shall be arranged to preclude unrelated traffic through the suite. The surgical suite shall contain at least one operating room and all surgical service areas required under subparagraph (B) of this paragraph.

(A) Operating room. The operating room(s) shall have a clear floor area of at least 240 square feet exclusive of fixed or moveable cabinets, counters, or shelves. The minimum clear dimension between built-in cabinets, counters, and shelves shall be 14 feet.

(B) Surgical service areas.

(i) Restricted corridor. The restricted corridor shall serve as the primary passageway for staff and patients within the surgical suite. The following rooms and areas shall have direct access to the restricted corridor:

(I) preoperative patient holding area;

(II) operating room(s);

(III) postoperative recovery suite;

(IV) soiled workroom;

(V) clean workroom;

(VI) janitor's closet;

(VII) equipment storage;

(VIII) sterilizing facilities;

(IX) anesthesia workroom when provided; and

(X) area for emergency crash cart.

(ii) Soiled workroom. A soiled workroom shall be provided for the exclusive use of the surgical suite staff. The workroom shall contain a clinical sink or equivalent flushing type fixture, work counter, designated space for waste and linen receptacles, and a hand washing fixture with hands-free operable controls. The soiled workroom shall not have direct connection with operating room(s) or other sterile activity room(s).

(iii) Clean linen storage. A storage room or alcove shall be provided for storing clean linen.

(iv) Scrub facilities. A scrub station shall be located in the restricted corridor within five feet of the entrance of each operating room. One scrub station with dual faucets with hands free operable controls may serve two operating rooms if the scrub stations are located adjacent to the entrance of both operating rooms. Scrub facilities shall be arranged to minimize any incidental splatter on nearby personnel, medical equipment, or supply carts. Viewing panels shall be provided for observation of the surgical room interior. The scrub sinks shall be recessed out of the main traffic areas. The scrub sink alcove shall be located within the restricted areas of the surgical suite. Scrub sinks shall not be located inside the sterile area.

(v) Janitor's closet. A janitor's closet shall be provided for the exclusive use of the surgical suite. The closet shall contain a floor receptor or service sink and storage space for housekeeping supplies and equipment.

(vi) Equipment storage. A room, alcove, or designated area shall be provided for storing equipment and supplies used in the surgical suite. The storage room or area shall be a minimum of 50 square feet per operating room.

(vii) Medical gas storage room. When provided or required by NFPA 101, a medical gas storage room shall comply with the requirements of NFPA 99, 2002, Chapter 5, Gas and Vacuum Systems.

(viii) Area for emergency crash cart. An area or alcove located out of traffic and convenient to the operating room(s) shall be provided for an emergency crash cart.

(ix) Stretcher storage area. An area or alcove shall be located convenient for use and out of the direct line of traffic for the storage of stretchers as required. Stored stretchers shall not encroach on corridor widths.

(16) Treatment room.

(A) A treatment room is not required, but when provided, it shall be used only for minor procedures.

(B) If inhalation anesthesia is administered in the treatment room, the room shall comply with NFPA 99, §14.4.1 requirements for an anesthetizing location.

(C) The treatment room shall have a clear floor area of at least 120 square feet exclusive of fixed or moveable cabinets, counters, or shelves.

(D) The treatment room shall contain an examination table, a counter for writing, and a hand washing fixture with hands-free operable controls.

(e) General detail and finish requirements. Details and finishes in new construction projects, including additions and alterations, shall be in compliance with this subsection, with NFPA 101, Chapter 20, and with local building codes.

(1) General detail requirements.

(A) Fire safety. Fire safety features, including smoke compartmentation, means of egress, automatic extinguishing systems, inspections, smoking regulations, and other details relating to fire prevention and fire protection shall comply with NFPA 101, Chapter 20. The Fire Safety Evaluation System for Health Care Occupancies contained in the National Fire Protection Association 101A, Alternative Approaches to Life Safety, 2001 Edition, Chapter 3, shall not be used in new building construction, renovations, or additions to existing ASCs.

(B) Exits, corridors and doors.

(i) Number of exits. A facility shall provide two exits remote from each other in accordance with NFPA 101, §20.2.4.1. At least one exit door shall be accessible by an ambulance from the outside. This door may also serve as an entry for loading or receiving goods.

(ii) Encroachment into the means of egress. Items such as drinking fountains, telephone booths or stations, and vending machines shall be so located as to not project into and restrict exit corridor traffic or reduce the exit corridor width below the required minimum. Portable equipment shall not be stored so as to project into and restrict exit corridor traffic or reduce the exit corridor width below the required minimum.

(iii) Corridors.

(I) Public corridor. The minimum clear and unobstructed width of a public corridor shall be at least four feet.

(II) Communicating corridor. The communicating corridor shall be used to convey patients by stretcher, gurney, or bed.

(III) The communicating corridor shall link the preoperative holding area, operating room(s), and postoperative recovery suite, and shall be continuous to at least one exit.

(IV) The minimum clear and unobstructed width of the communicating corridor shall be eight feet.

(iv) Door types. Doors at all openings between corridors and rooms or spaces subject to occupancy shall be swing type. Elevator doors are excluded from this requirement.

(v) Door swing. Doors, except doors to spaces such as small closets which are not subject to occupancy, shall not swing into corridors in a manner that might obstruct traffic flow or reduce the required corridor width. Large walk-in type closets are considered as occupiable spaces.

(vi) Patient access doors. The minimum width of doors for patient access to examination and consultation rooms shall be three feet. The minimum width of doors requiring access for beds and gurneys (preoperative holding area, operating room, postoperative recovery suite, treatment rooms) shall be three feet eight inches.

(vii) Emergency access. Rooms containing a water closet, intended for patient use, shall be provided with at least one door having hardware which will permit access from the outside in any emergency. Door leaf width of such doors shall not be less than 36 inches.

(viii) Sliding doors. Horizontal sliding doors serving an occupant load of fewer than 10 shall be permitted. The area served by the door shall have no high hazard contents. The door shall be readily operable from either side without special knowledge or effort. The force required to operate the door in the direction of door travel shall be not more than 30 pounds per foot to set the door in motion, and shall be not more than 15 pounds per foot to close the door or open in the minimum required width. The door assembly shall comply with any required fire protection rating, and, where rated, shall be self-closing or automatic closing. The sliding doors opening to the egress corridor doors shall have a latch or other mechanism that ensures that the doors will not rebound into a partially open position if forcefully closed. The sliding doors may have breakaway provisions and shall be installed to resist passage of smoke. The latching sliding panel shall have a minimum clear opening of 36 inches in the fully open position. The fixed panels may have recessed tracks.

(ix) Fire doors. All fire doors shall be listed by an independent testing laboratory and shall meet the construction requirements for fire doors in National Fire Protection Association 80, Standard for Fire Doors and Fire Windows, 1999 Edition. Reference to a labeled door shall be construed to include labeled frame and hardware.

(C) Glazing. Glass doors, lights, sidelights, borrowed lights, and windows located within 12 inches of a door jamb or with a bottom-frame height of less than 18 inches and a top-frame height of more than 36 inches above the finished floor which may be broken accidentally by pedestrian traffic shall be glazed with safety glass or plastic glazing material that will resist breaking and will not create dangerous cutting edges when broken. Similar materials shall be used for wall openings in activity areas such as recreation and exercise rooms, unless otherwise required for fire safety. Safety glass, tempered or plastic glazing materials shall be used for shower doors and bath enclosures, interior windows and doors. Plastic and similar materials used for glazing shall comply with the flame spread ratings of NFPA 101, §18.3.3.

(D) Grab bars. Grab bars shall be provided at patient toilets and showers. The bars shall be one and one-half inches in diameter, shall have either one and one-fourth or one and one-half inches clearance to walls, and shall have sufficient strength and anchorage to sustain a concentrated vertical or horizontal load of 250 pounds. Grab bars intended for use by the disabled shall also comply with ADA requirements.

(E) Hand washing facilities. Location and arrangement of fittings for hand washing facilities shall permit their proper use and operation. Hand washing fixtures with hands-free controls shall be provided in each examination room, treatment room, preoperative area, postoperative recovery suite, extended observation room or area, soiled utility room, fluoroscopy room, clean work room, and toilet room. Particular care shall be given to the clearances required for blade-type operating handles. Lavatories and hand washing facilities shall be securely anchored to withstand an applied vertical load of not less than 250 pounds on the front of the fixture. In addition to the specific areas noted, hand washing facilities shall be conveniently located for staff use in rooms and areas noted under spatial requirements in subsection (d) of this section and throughout the center where patient care services are provided.

(F) Soap dispensers. A liquid or foam soap dispenser shall be located at each hand washing facility.

(G) Hand drying. Provisions for hand drying shall be included at all hand washing facilities. There shall be hot air dryers or individual paper or cloth units enclosed in such a way as to provide protection against dust or soil and ensure single-unit dispensing.

(H) Signage. A sign shall be posted at the entrance to each toilet/restroom to identify the facility for public, staff, or patient use.

(I) Ceiling heights. The minimum ceiling height shall be eight feet six inches with the following exceptions.

(i) Rooms containing ceiling-mounted light fixtures or equipment. Operating rooms or other rooms containing ceiling-mounted light fixtures or equipment shall have ceiling heights of not less than nine feet. Additional ceiling height may be required to accommodate special fixtures or equipment.

(ii) Minor rooms. Ceilings in storage rooms, toilet rooms, and other minor rooms shall be not less than seven feet six inches

(iii) Boiler rooms. Boiler rooms shall have ceiling clearances not less than two feet six inches above the main boiler header and connecting piping.

(iv) Overhead clearance. Suspended tracks, rails, pipes, signs, lights, door closers, exit signs, and other fixtures that protrude into the path of normal traffic shall not be less than six feet eight inches above the finished floor.

(J) Areas producing impact noises. Recreation rooms, exercise rooms, and similar spaces where impact noises may be generated shall not be located directly over operating rooms or special procedure rooms unless special provisions are made to minimize noise.

(K) Rooms with heat-producing equipment. Rooms containing heat-producing equipment, such as mechanical and electrical equipment and laundry rooms, shall be insulated and ventilated to prevent floors of any occupied room located above it from exceeding a temperature differential of 10 degrees Fahrenheit above the ambient room temperature.

(L) Radiation protection. Shielding shall be designed, tested, and approved by a medical physicist licensed under the Medical Physics Practice Act, Occupations Code, Chapter 602. The ASC shall obtain a certificate of registration issued by the Radiation Safety Licensing Branch to use radiation machines.

(f) General finishes requirements.

(1) Privacy screens, cubicle curtains, and draperies.

(A) Cubicle curtains or privacy screens shall be provided to assure patient privacy when required or requested by a patient.

(B) Cubicle curtains, draperies and other hanging fabrics shall be noncombustible or flame retardant and shall pass both the small-scale and the large-scale tests of National Fire Protection Association 701, Standard Methods of Fire Tests for Flame-Resistant Textiles and Films, 1999 Edition. Copies of laboratory test reports for installed materials shall be submitted to the department at the time of the final construction inspection.

(2) Flame spread, smoke development and noxious gases. Flame spread and smoke developed limitations of interior finishes shall comply with Table 4 of §135.56(d) of this title (relating to Construction Tables) and NFPA 101, §10.2. The use of materials known to produce large or concentrated amounts of noxious or toxic gases shall not be used in exit accesses or in patient areas. Copies of laboratory test reports for installed materials tested in accordance with National Fire Protection Association 255, Standard Method of Test of Surface Burning Characteristics of Building Materials, 2000 Edition, and National Fire Protection Association 258, Standard Research Test Method for Determining Smoke Generation of Solid Materials, 2001 Edition, shall be provided.

(3) Floor finishes.

(A) Flooring shall be easy to clean and have wear resistance appropriate for the location involved. Floors that are subject to traffic while wet (such as shower and bath areas, and similar work areas) shall have a nonslip surface. In all areas frequently subject to wet cleaning methods, floor materials shall not be physically affected by germicidal and cleaning solutions. The following are acceptable floor finishes:

(i) painted concrete for mechanical, electrical, communication rooms, and janitor's closets;

(ii) vinyl and vinyl composition tiles and sheets tiles for offices, lobbies, administrative areas, storage, staff and public toilet rooms, examination rooms, support spaces, and nontreatment areas;

(iii) monolithic or seamless flooring shall be provided for all operating rooms, special procedure rooms, treatment rooms, patient toilet rooms, soiled workrooms, and sterilizing facility(ies). Seamless flooring shall be impervious to water, coved and installed integral with the base, tightly sealed to the wall, and without voids that can harbor insects or retain dirt particles. The base shall not be less then six inches in height. Welded joint flooring is acceptable;

(iv) marble, ceramic and quarry tile for offices, lobbies, staff and public toilet rooms, administrative areas, wet areas, and similar spaces;

(v) carpet flooring for offices, lobbies, and administrative areas. Carpeting shall not be installed in any preoperative holding, toilet rooms, treatment rooms, examination rooms, and similar spaces; and

(vi) terrazzo for offices, lobbies, administrative areas, and similar spaces.

(B) Threshold and expansion joint covers. Thresholds at doorways shall not exceed 3/4 inch in height for exterior sliding doors or 1/2 inch for other type doors. Raised thresholds and floor level changes at accessible doorways shall be beveled with a slope no greater than 1:2. Expansion joint covers shall not exceed 1/2 inch in height and shall have beveled edges with a slope no greater than 1:2.

(4) Wall finishes. Wall finishes shall be smooth, washable, moisture resistant, and cleanable by standard housekeeping practices. Wall finishes shall be in compliance with the requirements of NFPA 101, §38.3.3, relating to flame spread.

(A) Finishes at plumbing fixtures. Wall finishes shall be water-resistant in the immediate area of plumbing fixtures.

(B) Wet cleaning methods. Wall finishes in areas subject to frequent wet cleaning methods shall be impervious to water, tightly sealed, and without voids.

(5) Ceiling finishes. All occupied rooms and spaces shall be provided with finished ceilings, unless otherwise noted. Ceilings which are a part of a rated roof/ceiling assembly or a floor/ceiling assembly shall be constructed of listed components and installed in accordance with the listing. Three types of ceilings that are required in various areas of the ASC are:

(A) ordinary ceilings. Ceilings are required in all areas or rooms in the ASC unless otherwise noted. This includes ceilings such as acoustical tiles installed in a metal grid which are dry cleanable with equipment used in daily housekeeping activities such as dusters and vacuum cleaners;

(B) washable ceilings. When ceilings that dictate this type of cleaning or protection for these spaces such as soil utility or soil workroom, the ceilings shall be made of washable, smooth, moisture impervious materials such as painted lay-in gypsum wallboard or vinyl faced acoustic tile in a metal grid; and

(C) monolithic ceilings. Ceilings which are monolithic from wall to wall (painted solid gypsum wallboard), smooth and without fissures, open joints, or crevices and with a washable and moisture impervious finish shall be provided in the operating rooms, special procedure rooms, and sterilizing facilities.

(D) Nonceiling requirements. Finished ceilings may be omitted in mechanical, electrical, communication rooms and equipment spaces, shops, and similar spaces unless required for fire-resistive purposes.

(6) Floor, wall, and ceiling penetrations. Floor, wall, and ceiling penetrations by pipes, ducts, and conduits, or any direct openings shall be tightly sealed to minimize entry of dirt particles, rodents, and insects. Joints of structural elements shall be similarly sealed.

(7) Materials finishes. Materials known to produce noxious gases when burned shall not be used for mattresses, upholstery, and wall finishes.

(g) General mechanical requirements. This subsection contains requirements for mechanical systems; air conditioning, heating and ventilating systems; steam and hot and cold water systems; and thermal and acoustical insulation.

(1) Cost. All mechanical systems shall be designed for overall efficiency and life cycle costing, including operational costs. Recognized engineering practices shall be followed to achieve the most economical and effective results except that in no case shall patient care or safety be sacrificed for conservation.

(2) Equipment location. Mechanical equipment may be located indoors or outdoors (when in a weatherproof enclosure), or in a separate building(s).

(3) Vibration isolation. Mechanical equipment shall be mounted on vibration isolators as required to prevent unacceptable structure-borne vibration. Ducts, pipes, etc. connected to mechanical equipment which is a source of vibration shall be isolated from the equipment with vibration isolators.

(4) Performance and acceptance. Prior to completion and acceptance of the facility, all mechanical systems shall be tested, balanced, and operated to demonstrate to the design engineer or his representative that the installation and performance of these systems conform to the requirements of the plans and specifications.

(A) Material lists. Upon completion of the contract, the owner shall obtain from the construction contractor parts lists and procurement information with numbers and descriptions for each piece of equipment.

(B) Instructions. Upon completion of the contract, the owner shall obtain from the construction contractor instructions in the operational use and maintenance of systems and equipment as required.

(5) Heating, ventilating, and air conditioning (HVAC) systems.

(A) All central HVAC systems shall comply with and shall be installed in accordance with the requirements of NFPA 90A, Standard for the Installation of Air Conditioning and Ventilating Systems, 2002 Edition, or NFPA 90B, Standard for the Installation of Warm Air Heating and Air-Conditioning Systems, 2002 Edition, as applicable and the requirements contained in this paragraph. Air handling units serving two or more rooms are considered to be central units.

(B) Noncentral air handling systems, i.e., individual room units that are used for heating and cooling purposes (e.g., fan-coil units, heat pump units, and packaged terminal air conditioning units) shall be equipped with permanent (cleanable) or replaceable filters. The filters shall have an average efficiency of 25 - 30% and an average arrestance of 85% based on American Society of Heating, Refrigerating, and Air-Conditioning Engineers (ASHRAE), Inc., Standard 52.2, 1999 edition, Method of Testing General Ventilation Air Cleaning Devices for Removal Efficiency by Particle Size. These units shall be used as air recirculating units only. All outdoor air requirements shall be met by a separate central air handling system with the proper filtration, as required in Table 1 of §135.56(a) of this title.

(C) General ventilation requirements. All rooms and areas in the ASC shall have provision for positive ventilation. Fans serving exhaust systems shall be located at the discharge end and shall be conveniently accessible for service. Exhaust systems may be combined, unless otherwise noted, for efficient use of recovery devices required for energy conservation. The ventilation rates shown in Table 1 of §135.56(a) of this title shall be used only as minimum requirements, since they do not preclude the use of higher rates that may be appropriate.

(i) Cost reduction methods. To reduce utility costs, facility design may utilize energy conserving procedures including recovery devices, variable air volume, load shedding, systems shutdown, or reduction of ventilation rates (when specifically permitted) in certain areas when unoccupied. In no case shall patient care be jeopardized.

(ii) Economizer cycle. Mechanical systems shall be arranged to take advantage of outside air conditions by using an economizer cycle when appropriate to reduce heating and cooling systems loads. Innovative design that provides for additional energy conservation while meeting the intent of this section for acceptable patient care may be presented to the department for consideration.

(iii) Areas requiring fully ducted systems. Fully ducted supply, return and exhaust air for HVAC systems shall be provided for all critical care areas, sensitive care areas, all patient care areas, all areas requiring a sterile regimen, clean storage rooms, and where required for fire safety purposes. Combination systems, utilizing both ducts and plenums for movement of air in these areas, shall not be permitted. Ductwork access panels shall be labeled.

(iv) Temperatures and humidities. The designed capacity of the systems shall be capable of providing the ranges of temperatures and humidities as shown in Table 1 of §135.56(a) of this title.

(v) Thermometers and humidity gauges. Each operating room, special procedure room, and postoperative recovery suite shall have temperature and humidity indicating devices mounted at eye level.

(vi) Outside air intake locations.

(I) Outside air intakes shall be located at least 25 feet from exhaust outlets of ventilating systems, combustion equipment stacks, medical-surgical vacuum system outlets, plumbing vents, or areas which may collect vehicular exhaust or other noxious fumes. (Prevailing winds and proximity to other structures may require other arrangements).

(II) Plumbing and vacuum vents that terminate five feet above the level of the top of the air intake may be located as close as 10 feet to the air intake.

(III) The bottom of outside air intakes serving central systems shall be located as high as practical but at least six feet above ground level, or if installed above the roof, three feet above the roof level.

(vii) Contaminated air exhaust outlets. Exhaust outlets from areas (laboratory hoods, etc.) that exhaust contaminated air shall be above the roof and be arranged to exhaust upward unless the air has been treated by an appropriate means where sidewall exhaust will be allowed. Exhaust outlets from areas containing ethylene oxide sterilizers and other contaminants, e.g., glutaraldehyde, shall terminate not less than eight feet above the roof level (or be appropriately labeled as "hazardous exhaust") and arranged to exhaust upward.

(viii) Directional air flow. Ventilation systems shall be designed and balanced to provide pressure relationships contained in Table 1 of §135.56(a) of this title. For reductions and shut down of ventilation systems when a room is unoccupied, the provisions in Note 4 of Table 1 of §135.56(a) of this title shall be followed.

(ix) Air distribution devices. Design shall consider turbulence and other factors of air movement to minimize airborne particulate matter. Where extraordinary procedures require special designs, the installation shall be reviewed on a case-by-case basis.

(I) All supply diffusers grilles shall be located on the ceiling or on a wall near the ceiling.

(II) Air supply for the operating rooms and special procedure rooms shall be from ceiling outlets near the center of the work area to efficiently control air movement.

(III) A minimum of two return air inlets located diagonally opposite from one another and near floor level shall be provided. Bottoms of return air grilles in operating rooms and other anesthetizing locations shall be located not more than 12 inches above the finished floor nor less than six inches above the finished floor.

(x) Ventilation start-up requirements. Air handling systems shall not be started or operated without the filters installed in place. This includes the 90% and 99.97% efficiency filters where required. This includes during construction operations. Ducts shall be cleaned thoroughly and throughout by a National Air Duct Cleaners Association (NADCA) certified air duct cleaning contractor when the air handling systems have been operating without the required filters in place. When ducts are determined to be dirty or dusty, the department shall require a written report assuring cleanliness of duct and clean air quality.

(xi) Humidifier location. When duct humidifiers are located upstream of the final filters, they shall be located at least 15 feet from the filters. Duct work with duct-mounted humidifiers shall be provided with a means of removing water accumulation. An adjustable high-limit humidistat shall be located downstream of the humidifier to reduce the potential of condensation inside the duct. All duct takeoffs shall be sufficiently downstream of the humidifier to ensure complete moisture absorption. Reservoir-type water spray or evaporative pan humidifiers shall not be used.

(xii) Filtration requirements. All air handling units shall be equipped with filters having efficiencies equal to, or greater than, those specified in Table 2 of §135.56(b) of this title. Filter efficiencies shall be average dust spot efficiencies tested in accordance with American Society of Heating, Refrigerating, and Air-Conditioning Engineers (ASHRAE), Inc., Standard 52.2, 1999 edition, Method of Testing General Ventilation Air-Cleaning Devices for Removal Efficiency by Particle Size. All joints between filter segments, and between filter segments and the enclosing ductwork, shall have gaskets and seals to provide a positive seal against air leakage. Air handlers serving more than one room shall be considered as central air handlers. All documents published by ASHRAE as referenced in this section may be obtained by writing or calling the ASHRAE, Inc. at the following address or telephone number: ASHRAE, 1791 Tullie Circle, Northeast, Atlanta, Georgia 30329; telephone (404) 636-8400.

(I) Filtration requirements for air handling units serving single rooms requiring asepsis control. Dedicated air handlers serving only one room where asepsis control is required, such as, but not limited to, operating rooms, special procedure rooms, and treatment rooms shall be equipped with filters having efficiencies equal to, or greater than, those specified for patient care areas in Table 2 of §135.56(b) of this title.

(II) Filtration requirements for air handling units serving other single rooms. Dedicated air handlers serving all other single rooms shall be equipped with nominal filters installed at the return air system.

(III) Location of multiple filters. Where two filter beds are required by Table 2 of §135.56(b) of this title, filter bed number one shall be located upstream of the air conditioning equipment, and filter bed number two shall be downstream of the supply air blowers, cooling and heating coils.

(IV) Location of single filters. Where only one filter bed is required by Table 2 of §135.56(b) of this title, it shall be located upstream of the supply fan. Filter frames shall be durable and constructed to provide an airtight fit with the enclosing ductwork.

(V) Pressure monitoring devices. A manometer or draft gauge shall be installed across each filter bed having a required efficiency of 75% or more, including laboratory hoods requiring high efficiency particulate air (HEPA) filters. The pressure monitoring device shall be mounted below the ceiling line within the ASC such that it can be observed by staff.

(D) Thermal and acoustical insulation for air handling systems. Asbestos containing insulation materials shall not be used.

(i) Thermal duct insulation. Air ducts and casings with outside surface temperature below the ambient dew point or temperature above 80 degrees Fahrenheit shall be provided with thermal insulation.

(ii) Insulation in air plenums and ducts. When installed, linings in air ducts and equipment shall meet the Erosion Test Method described in Underwriters Laboratories (UL), Standard 181, relating to Factory-Made Duct Materials and Air Duct Connectors, April 4, 1996 edition. This document may be obtained from the Underwriters Laboratories, 333 Pfingsten Road, Northbrook, Illinois 60062-2096.

(iii) Insulation flame spread and smoke developed ratings. Interior and exterior insulation, including finishes and adhesives on the exterior surfaces of ducts and equipment, shall have a flame spread rating of 25 or less and a smoke developed rating of 50 or less as required by NFPA 90A, Chapters 4 and 5 and as determined by an independent testing laboratory in accordance with NFPA 255, A Standard Method of Test of Surface Burning Characteristics of Building Materials, 2000 Edition.

(iv) Linings and acoustical traps. Duct lining and acoustical traps exposed to air movement shall not be used in ducts serving critical care areas. This requirement shall not apply to mixing boxes and acoustical traps that have approved nonabrasive coverings over such linings.

(v) Frangible insulation. Insulation of soft and spray-on types shall not be used where it is subject to air currents or mechanical erosion or where loose particles may create a maintenance problem or occupant discomfort.

(vi) Existing duct linings. Internal linings shall not be used in ducts, terminal boxes, or other air system components supplying operating rooms and the postoperative recovery suite, unless terminal filters of at least 90% efficiency are installed downstream of linings.

(E) Ventilation for anesthetizing locations. When anesthesia is administered, ventilation for anesthetizing locations, as defined in NFPA 99, §3-3, shall comply with NFPA 99, §13.4.1.2 and any specific ventilation requirements of clauses (i) - (iii) of this subparagraph.

(i) Smoke removal systems for anesthetizing locations. Smoke removal systems shall be provided in all windowless anesthetizing locations in accordance with NFPA 99, §6.4.1.2. Supply and exhaust systems for windowless anesthetizing locations shall be arranged to automatically exhaust smoke and products of combustion, prevent recirculation of smoke originating within the surgical suite, and prevent the circulation of smoke entering the system intakes, without in either case interfering with the exhaust function of the system.

(ii) Smoke removal systems for surgical suites. Smoke removal systems shall be provided in all surgical suites in accordance with NFPA 99, §6.4.1.3.

(iii) Smoke exhaust grilles. Exhaust grilles for smoke evacuation systems shall be ceiling-mounted or wall-mounted within 12 inches of the ceiling.

(F) Location of return and exhaust air devices. The bottoms of wall-mounted return and exhaust air openings shall be at least four inches above the floor. Return air openings located less than six inches above the floor shall be provided with nominal filters. All exhaust air openings and return air openings located higher than six inches but less than seven feet above the floor shall be protected with grilles or screens having openings through which a one-half inch sphere will not pass.

(G) Ray protection. Ducts which penetrate construction intended for X-ray or other ray protection shall not impair the effectiveness of the protection.

(H) Fire damper requirements. Fire dampers shall be located and installed in all ducts at the point of penetration of a required two-hour or higher fire-rated wall or floor in accordance with the requirements of NFPA 101, §18.5.2.

(I) Smoke damper requirements. Smoke dampers shall be located and installed in accordance with the requirements of NFPA 101, §20.3.7.3, and NFPA 90A, Chapter 5.

(i) Protection of ducts penetrating fire and smoke partitions. Combination fire and smoke leakage limiting dampers (Class II) shall be installed in accordance with manufacturer's instructions for all ducts penetrating one and two-hour rated fire and smoke partitions required by NFPA 101, §20.3.7, Subdivision of Building Space (not required in ASCs meeting the provisions of NFPA 101, §20.3.7.2, Exception Number 1).

(ii) Fail-safe installation. Combination smoke and fire dampers shall close on activation of the fire alarm system by smoke detectors installed and located as required by National Fire Protection Association 72, National Fire Alarm Code, 2002 Edition (NFPA 72), Chapter 8; NFPA 90A, Chapter 6; and NFPA 101, §20.3.5; the fire sprinkler system; and upon loss of power. Smoke dampers shall not close by fan shutdown alone unless it is a part of an engineered smoke removal system.

(iii) Interconnection of air handling fans and smoke dampers. Air handling fans and smoke damper controls may be interconnected so that closing of smoke dampers will not damage the ducts.

(iv) Frangible devices. Use of frangible devices for shutting smoke dampers is not permitted.

(J) Acceptable damper assemblies. Only fire damper and smoke damper assemblies integral with sleeves and listed for the intended purpose shall be acceptable.

(K) Duct access doors. Unobstructed access to duct openings in accordance with NFPA 90A, §4.3, shall be provided in ducts within reach and sight of every fire damper, smoke damper and smoke detector. Each opening shall be protected by an internally insulated door which shall be labeled externally to indicate the fire protection device located within.

(L) Restarting controls. Controls for restarting fans may be installed for convenient fire department use to assist in evacuation of smoke after a fire is controlled, provided that provisions are made to avoid possible damage to the system because of closed dampers. To accomplish this, smoke dampers shall be equipped with remote control devices.

(M) Make-up air. If air supply requirements in Table 2 of §135.56(b) of this title do not provide sufficient air for use by exhaust hoods and safety cabinets, filtered make-up air shall be ducted to maintain the required air flow direction in that room. Make-up systems for hoods shall be arranged to minimize short circuiting of air and to avoid reduction in air velocity at the point of contaminant capture.

(h) Piping systems and plumbing fixture requirements. All piping systems and plumbing fixtures shall be designed and installed in accordance with the requirements of the National Standard Plumbing Code Illustrated published by the National Association of Plumbing-Heating-Cooling Contractors (PHCC), 2003 edition, and this paragraph. The National Standard Plumbing Code may be obtained by writing or calling the PHCC at the following address or telephone number: Plumbing-Heating-Cooling Contractors, Post Office Box 6808, Falls Church, Virginia 22046; telephone (800) 533-7694.

(1) Piping systems.

(A) Water supply piping systems. Water service pipe to point of entrance to the building shall be brass pipe, copper tube (not less than type M when buried directly), copper pipe, cast iron water pipe, galvanized steel pipe, or approved plastic pipe. Domestic water distribution system piping within buildings shall be brass pipe, copper pipe, copper tube, or galvanized steel pipe. Piping systems shall be designed to supply water at sufficient pressure to operate all fixtures and equipment during maximum demand.

(i) Valves. Each water service main, branch main, riser, and branch to a group of fixtures shall be equipped with accessible and readily identifiable shutoff valves. Stop valves shall be provided at each fixture.

(ii) Backflow preventers. Backflow preventers (vacuum breakers) shall be installed on hose bibs, laboratory sinks, janitor sinks, bedpan flushing attachments, and all other fixtures to which hoses or tubing can be attached. Connections to high hazard sources, e.g., X-ray film processors, shall be from a cold water hose bib through a reduced pressure principle type backflow preventer (RPBFP).

(iii) Flushing valves. Flush valves installed on plumbing fixtures shall be of a quiet operating type, equipped with silencers.

(iv) Capacity of water heating equipment. Water heating equipment shall have sufficient capacity to supply water for all clinical needs based on accepted engineering practices using actual number and type of fixtures and for heating, when applicable.

(v) Domestic hot water system. Hot water distribution system serving all patient care areas shall be under constant recirculation to provide continuous hot water at each hot water outlet.

(vi) Water temperature measurements. Water temperatures shall be measured at hot water point of use or at the inlet to processing equipment. Hot water temperature at point of use for patients, staff, and visitors shall be in the range of 105 to 120 degrees Fahrenheit.

(vii) Water storage tanks. Domestic water storage tank(s) shall be fabricated of corrosion-resistant metal or lined with noncorrosive material. When potable water storage tanks (hot and cold) are used, the water shall be used and replenished. Water shall not be stored in tanks for future use unless the water is tested weekly for contaminates/bacteria.

(viii) Purified water supply system. Purified water distribution system piping shall be task specific and include, but not necessarily be limited to, polypropylene (PP), polyvinylidene fluoride (PVDF) or polyvinyl chloride (PVC) pipe. Final installed purified water system piping assemblies shall be UL approved and fully comply with applicable American Society for Testing and Materials (ASTM) Fire Resistant/Smoke Density requirements. The applicable documents are available from ASTM International, 100 Barr Harbor Drive, Post Office Box C700, West Conshohocken, Pennsylvania 19428-2959.

(ix) Dead-end piping. Dead-end piping (risers with no flow, branches with no fixture) shall not be installed. In any renovation work, dead-end piping shall be removed. Empty risers, mains and branches installed for future use are permitted.

(B) Fire sprinkler systems. When provided, fire sprinkler systems shall comply with the requirements of NFPA 101, §9.7, Automatic Sprinklers and Other Extinguishing Equipment, and the requirements of this subparagraph. All fire sprinkler systems shall be designed, installed, and maintained in accordance with the requirements of NFPA 13, Standard for the Installation of Sprinkler Systems, 2002 Edition, and shall be certified as required by §135.55(c)(1)(C) of this title (relating to Construction, Inspections, and Approval of Project).

(C) Piped nonflammable medical gas and clinical vacuum systems. When provided, piped nonflammable medical gas and clinical vacuum system installations shall be designed, installed, and certified in accordance with the requirements of NFPA 99, §5.1 for Level 1 Piped Systems and the requirements of this subparagraph.

(i) Outlets. Nonflammable medical gas and clinical vacuum outlets shall be provided in accordance with Table 3 of §135.56(c) of this title.

(ii) Installer qualifications. All installations of the medical gas piping systems including source tanks and related piping shall be done only by, or under the direct supervision of, a holder of a master plumber license or a journeyman plumber license with a medical gas piping installation endorsement issued by the Texas State Board of Plumbing Examiners.

(iii) Installer tests. Prior to closing of walls, the installer shall perform an initial pressure test, a blowdown test, a secondary pressure test, a cross-connection test, and a purge of the piping system as required by NFPA 99.

(iv) Qualifications for conducting verification tests and inspections. Verification testing shall be performed and inspected by a party, other than the installer, installing contractor, or material vendor. Testing shall be conducted by a medical gas system verifier registered with an acceptable organization by this department and is technically competent and experienced in the field of medical gas and vacuum pipeline testing and meets the requirements of The American Society of Safety Engineers (ASSE) Personnel Standard 6030, Professional Qualifications Standard for Medical Gas Systems. The document published by ASSE Personnel Standard 6030, Professional Qualifications Standard for Medical Gas Systems as referenced in this rule may be obtained by writing or calling The American Society of Safety Engineers (ASSE) at ASSE International Office, 901 Canterbury, Suite A, Westlake, Ohio 44145, telephone (440) 885-3040.

(v) Verification tests. Upon completion of the installer inspections and tests and after closing of walls, verification tests of the medical gas piping systems, the warning system, and the gas supply source shall be conducted. The verification tests shall include a cross-connection test, valve test, flow test, piping purge test, piping purity test, final tie-in test, operational pressure tests, and medical gas concentration test.

(vi) Verification test requirements. Verification tests of the medical gas piping system and the warning system shall be performed on all new piped medical gas systems, additions, renovations, or repaired portions of an existing system. All systems that are breached and components that are added, renovated, or replaced shall be inspected and appropriately tested. The breached portions of the systems subject to inspection and testing shall be all of the new and existing components in the immediate zone or area located upstream of the point or area of intrusion and downstream to the end of the system or a properly installed isolation valve.

(vii) Warning system verification tests. Verification tests of piped medical gas systems shall include tests of the source alarms and monitoring safeguards, master alarm systems, and the area alarm systems.

(viii) Source equipment verification tests. Source equipment verification tests shall include medical gas supply sources (bulk and manifold) and the compressed air source systems (compressors, dryers, filters, and regulators).

(ix) ASC responsibility. Before new piped medical gas systems, additions, renovations, or repaired portions of an existing system are put into use, ASC medical personnel shall be responsible for ensuring that the gas delivered at the outlet is the gas shown on the outlet label and that the proper connecting fittings are checked against their labels.

(x) Written certification. Upon successful completion of all verification tests, written certification for affected piped medical gas systems and piped medical vacuum systems including the supply sources and warning systems shall be provided by a party technically competent and experienced in the field of medical gas pipeline testing stating that the provisions of NFPA 99 have been adhered to and systems integrity has been achieved. The written certification shall be submitted directly to the ASC and the installer. A copy shall be available at final department construction inspection.

(xi) Documentation of medical gas and clinical vacuum outlets. Documentation of the installed, modified, extended or repaired medical gas piping system shall be submitted to the department by the same party certifying the piped medical gas systems. The number and type of medical gas outlets (e.g., oxygen, vacuum, medical air, nitrogen, nitrous oxide) shall be documented and arranged tabularly by room numbers and room types.

(D) Medical gas storage facilities. Main storage of medical gases may be outside or inside the ASC in accordance with NFPA 99, §5.1. Provision shall be made for additional separate storage of reserve gas cylinders necessary to complete at least one day's procedures.

(E) Multiple gas outlets on one medical gas outlet. Y-connections, "twinning", or other similar devices shall not be used on any medical gas outlet.

(F) Waste anesthetic gas disposal (WAGD) systems. Each space routinely used for administering inhalation anesthesia shall be provided with a WAGD system as required by NFPA 99, §5.1.3.7.

(2) Steam and hot water systems.

(A) Boilers. When provided, the boilers shall have the capacity, based upon the net ratings as published in The I-B-R Ratings Book for Boilers, Baseboard Radiation and Finned Tube (commercial) by the Hydronics Institute Division of GAMA, to supply the normal heating, hot water, and steam requirements of all systems and equipment. The document published by the Hydronics Institute Division of GAMA as referenced in this rule may be obtained by writing or calling the Hydronics Institute Division of GAMA at 35 Russo Place, Post Office Box 218, Berkeley Heights, New Jersey 07922, telephone (908) 464-8200.

(i) Boiler accessories. Boiler feed pumps, heating circulating pumps, condensate return pumps, and fuel oil pumps shall be connected and installed to provide normal and standby service.

(ii) Valves. Supply and return mains and risers of cooling, heating, and process steam systems shall be valved to isolate the various sections of each system. Each piece of equipment shall be valved at the supply and return ends except that vacuum condensate returns need not be valved at each piece of equipment.

(B) Boiler certification. When required, the ASC shall ensure compliance with Texas Department of Licensing and Regulation, Boiler Section, Texas Boiler Law, (Health and Safety Code, Chapter 755, Boilers), which requires certification documentation for boilers to be posted on site at each boiler installation.

(3) Drainage systems. Building sewers shall discharge into a community sewage system. Where such a system is not available, a facility providing sewage treatment shall conform to applicable local and state regulations.

(A) Above ground piping. Soil stacks and roof drains installed above ground within buildings shall be drain-waste-vent (DWV) weight or heavier and shall be: copper pipe, copper tube, cast iron pipe, or Schedule 40 polyvinyl chloride (PVC) pipe. Buildings or portions of buildings remodeled to an ASC need not comply with this requirement.

(B) Underground piping. All underground building drains shall be cast iron soil pipe, hard temper copper tube (DWV or heavier), acrylonitrile-butodiene-styrene (ABS) plastic pipe (DWV Schedule 40 or heavier), or PVC pipe (DWV Schedule 40 or heavier. Underground piping shall have at least 12 inches of earth cover or comply with local codes. Existing buildings or portions of buildings that are being remodeled need not comply with this subparagraph.

(C) Drains for chemical wastes. Separate drainage systems for chemical wastes (acids and other corrosive materials) shall be provided. Materials acceptable for chemical waste drainage systems shall include chemically resistant borosilicate glass pipe, high silicone content cast iron pipe, polypropylene plastic pipe, or plastic lined pipe.

(D) Drainage and waste piping. Drainage and waste piping shall not be installed above or below ceilings in operating rooms, special procedure rooms, and sterile processing rooms unless precautions are taken to protect the space below from leakage and condensation from necessary overhead piping. Secondary protection shall be required to drain. Any required secondary protection shall be labeled, "code required secondary drain system" every 20 feet in a highly visible print or label.

(4) Thermal insulation for piping systems and equipment. Asbestos containing insulation materials shall not be used.

(A) Insulation. Insulation shall be provided for the following:

(i) boilers, smoke breeching, and stacks;

(ii) steam supply and condensate return piping;

(iii) hot water piping and all hot water heaters, generators, converters, and storage tanks;

(iv) chilled water, refrigerant, other process piping, equipment operating with fluid temperatures below ambient dew point, and water supply and drainage piping on which condensation may occur. Insulation on cold surfaces shall include an exterior vapor barrier; and

(v) other piping, ducts, and equipment as necessary to maintain the efficiency of the system.

(B) Insulation flame spread. Flame spread shall not exceed 25 and smoke development rating shall not exceed 50 for pipe insulation as determined by an independent testing laboratory in accordance with NFPA 255, Standard Method of Test of Surface Burning Characteristics of Building Materials, 2000 Edition.

(5) Plumbing fixtures. Plumbing fixtures shall be made of nonabsorptive, acid-resistant materials and shall comply with the requirements of the National Standard Plumbing Code, and this paragraph.

(A) Sink and lavatory controls. All lavatories used by medical and nursing staff and by patients shall be trimmed with valves or electronic controls which can be operated without the use of hands. Blade handles used for this purpose shall not be less than four inches in length. Single lever or wrist blade devices may also be used.

(B) Clinical sink traps. Clinical sinks shall have an integral trap in which the upper portion of a visible trap seal provides a water surface.

(C) Sinks for disposal of plaster of paris. Sinks that are used for the disposal of plaster of paris shall have a plaster trap.

(D) Back-flow or siphoning. All plumbing fixtures and equipment shall be designed and installed to prevent the back-flow or back-siphonage of any material into the water supply. The over-the-rim type water inlet shall be used wherever possible. Vacuum-breaking devices shall be properly installed when an over-the-rim type water inlet cannot be utilized.

(E) Drinking fountain. Each drinking fountain shall be designed so that the water issues at an angle from the vertical, the end of the water orifice is above the rim of the bowl, and a guard is located over the orifice to protect it from lip contamination.

(F) Sterilizing equipment. All sterilizing equipment shall be designed and installed to prevent not only the contamination of the water supply but also the entrance of contaminating materials into the sterilizing units.

(G) Hose attachment. No hose shall be affixed to any faucet if the end of the hose can become submerged in contaminated liquid unless the faucet is equipped with an approved, properly installed vacuum breaker.

(H) Bedpan washers and sterilizers. When provided, bedpan washers and sterilizers shall be designed and installed so that both hot and cold water inlets shall be protected against back-siphonage at maximum water level.

(I) Flood level rim clearance. The water supply spouts for lavatories and sinks required in patient care areas shall be mounted so that their discharge points are a minimum of five inches above the rim of the fixture.

(J) Scrub sink controls. Freestanding scrub sinks and lavatories used for scrubbing in procedure rooms shall be trimmed with foot, knee, or electronic hands-free controls. Single lever wrist blades are not acceptable at scrub sinks.

(K) Floor drains or floor sinks. Where floor drains or floor sinks are installed, they shall be of a type that can be easily cleaned by removal of the cover. Removable stainless steel mesh shall be provided in addition to a grilled drain cover to prevent entry of large particles of waste which might cause stoppages.

(L) Under counter piping. Under counter piping and above floor drains shall be arranged (raised) so as not to interfere with cleaning of the floor below the equipment.

(M) Ice machines. All ice-making machines used for human consumption shall be of the self-dispensing type. Copper tubing shall be provided for supply connections to ice machines.

(i) General electrical requirements. This paragraph contains common electrical and essential emergency system requirements.

(1) Electrical requirements. All electrical material and equipment, including conductors, controls, and signaling devices, shall be installed in compliance with applicable sections of the NFPA 70, National Electrical Code, 2002 Edition, §517; NFPA 99, Chapter 14; the requirements of this subsection; and as necessary to provide a complete electrical system. Electrical systems and components shall be listed by nationally recognized listing agencies as complying with available standards and shall be installed in accordance with the listings and manufacturer's instructions.

(A) All fixtures, switches, sockets, and other pieces of apparatus shall be maintained in a safe and working condition.

(B) Extension cords and cables shall not be used for permanent wiring.

(C) All electrical heating devices shall be equipped with a pilot light to indicate when the device is in service, unless equipped with a temperature limiting device integral with the heater.

(D) All equipment, fixtures, and appliances shall be properly grounded in accordance with NFPA 70.

(E) Under counter electrical installations shall be arranged (raised) to not interfere with cleaning of the floor below the equipment.

(2) Installation testing and certification.

(A) Installation testing. The electrical installations, including grounding continuity, fire alarm, nurses calling system and communication systems, shall be tested to demonstrate that equipment installation and operation is appropriate and functional. A written record of performance tests on special electrical systems and equipment shall show compliance with applicable codes and standards and shall be available to the department upon request.

(B) Grounding system testing. The grounding system shall be tested as described in NFPA 99, §4.3.3, for patient care areas in new or renovated work. The testing shall be performed by a qualified electrician or their qualified electrical testing agent. The electrical contractor shall provide a letter stating that the grounding system has been tested in accordance with NFPA 99, the testing device use complies with NFPA 99, and whether the grounding system passed the test. The letter shall be signed by the qualified electrical contractor, or their designated qualified electrical testing agent, certifying that the system has been tested and the results of the test are indicated.

(3) Electrical safeguards. Shielded isolation transformers, voltage regulators, filters, surge suppressors, and other safeguards shall be provided as required where power line disturbances are likely to affect fire alarm components, data processing, equipment used for treatment, and automated laboratory diagnostic equipment.

(4) Services and switchboards. Electrical service and switchboards serving the required ASC components shall be installed above the designated 100-year flood plain. Main switchboards shall be located in separate rooms, separated from adjacent areas with one-hour fire-rated enclosures containing only electrical switchgear and distribution panels and shall be accessible to authorized persons only. These rooms shall be ventilated to provide an environment free of corrosive or explosive fumes and gases, or any flammable and combustible materials. Switchboards shall be located convenient for use and readily accessible for maintenance as required by NFPA 70, Article 384. Overload protective devices shall operate properly in ambient temperatures.

(5) Panelboard. Panelboards serving normal lighting and appliance circuits shall be located on the same floor as the circuits they serve. Panelboards serving critical branch emergency circuits shall be located on each floor that has major users (operating rooms, special procedure room, etc.) and may also serve the floor above and the floor below. Panelboards serving life safety branch circuits may serve three floors, the floor where the panelboard is located, and the floors above and below.

(6) Wiring. All conductors for controls, equipment, lighting and power operating at 100 volts or higher shall be installed in metal or metallic raceways in accordance with the requirements of NFPA 70, Article 517. All surface mounted wiring operating at less than 100 volts shall be protected from mechanical injury with metal raceways to a height of seven feet above the floor. Conduits and cables shall be supported in accordance with NFPA 70, Article 300.

(7) Mechanical protection of the emergency system. The wiring of the emergency system shall be mechanically protected by installation in nonflexible metal raceways in accordance with NFPA 70, §517.30(C)(3).

(8) Lighting.

(A) Lighting intensity for staff and patient needs shall comply with guidelines for health care facilities set forth in the Illuminating Engineering Society of North America (IESNA) Handbook, 2000 edition, published by the IESNA, 120 Wall Street, Floor 17, New York, New York 10005.

(i) Consideration shall be given to controlling light intensity and wavelength to prevent harm to the patient's eyes.

(ii) Approaches to buildings and parking lots, and all spaces within buildings shall have fixtures that can be illuminated as necessary. All rooms including storerooms, electrical and mechanical equipment rooms, and all attics shall have sufficient artificial lighting so that all spaces shall be clearly visible.

(iii) Consideration shall be given to the special needs of the elderly. Excessive contrast in lighting levels that makes effective sight adaptation difficult shall be minimized.

(B) Means of egress and exit sign lighting intensity shall comply with NFPA 101, §§7.8, 7.9, and 7.10.

(C) Electric lamps, which may be subject to breakage or which are installed in fixtures in confined locations when near woodwork, paper, clothing, or other combustible materials, shall be protected by wire guards, or plastic shields.

(D) Ceiling mounted surgical and examination light fixtures shall be suspended from rigid support structures mounted above the ceiling.

(E) Operating rooms shall have general lighting in addition to local lighting provided by special lighting units at the surgical tables. Each fixed special lighting unit at the tables, except for portable units, shall be connected to an independent circuit.

(F) X-ray film illuminators for handling at least two films simultaneously shall be provided in each operating room and special procedure room. When the entire surgical suite is provided with digital imaging system capabilities the film illuminators may be omitted.

(9) Receptacles. Only listed hospital grade single-grounding or duplex-grounding receptacles shall be used in the operating rooms, special procedure rooms, postoperative recovery suite, and all patient care areas. This does not apply to special purpose receptacles.

(A) Installations of multiple-ganged receptacles shall not be permitted in patient care areas.

(B) Electrical outlets powered from the critical branch shall be provided in all patient care, procedure and treatment locations in accordance with NFPA 99, §4.4.2.2.2.3. At least one receptacle at each patient treatment or procedure location shall be powered from the normal power panel. All receptacles powered from the critical branch shall be colored red.

(C) Replacement of malfunctioning receptacles and installation of new receptacles powered from the critical branch in existing facilities shall be accomplished with receptacles of the same distinct color as the existing receptacles.

(D) All critical care area receptacles shall be identified. The face plate for the receptacle(s) shall have a nonremovable label or be engraved indicating the panel and circuit number.

(E) In locations where mobile X-ray or other equipment requiring special electrical configuration is used, the additional receptacles shall be distinctively marked for the special use.

(F) Each receptacle shall be grounded to the reference grounding point by means of a green insulated copper equipment grounding conductor in accordance with NFPA 70, §517-13.

(G) Each operating room and special procedure room shall have at least four duplex receptacles located convenient to the head of the procedure table and one receptacle on the other walls.

(H) Each work table or counter shall have access to one duplex receptacle for every six feet of table or counter space or fraction thereof.

(I) A minimum of one duplex receptacle in each wall shall be installed in each work area or room other than storage or lockers.

(J) Appliances shall be grounded in accordance with NFPA 99, Chapter 9.

(K) Ground fault circuit interrupters (GFCI) receptacles shall be provided for all general use receptacles located within three feet of a wash basin or sink. When GFCI receptacles are used, they shall be connected to not affect other devices connected to the circuit in the event of a trip. Receptacles connected to the critical branch that may be used for equipment that should not be interrupted do not have to be GFCI protected. Receptacles in wet locations, as defined by NFPA 70, §§517.20 and 517.21, shall be GFCI protected regardless of the branch of the electrical system serving the receptacle.

(10) Equipment.

(A) The following shall be powered from the Type I essential electrical system in accordance with the requirements of NFPA 99, §§3-4.2.2.3, when such a system is required for safe operation of the ASC referenced in paragraph (14) of this subsection.

(i) Boiler accessories including feed pumps, heat-circulating pumps, condensate return pumps, fuel oil pumps, and waste heat boilers shall be connected to the equipment system.

(ii) Ventilating system serving preoperative areas, operating rooms, and the postoperative recovery suite shall be connected to the equipment system in accordance with the requirements of NFPA 99, Chapter 3.

(B) Laser equipment shall be installed according to manufacturer recommendations and shall be registered with Department of State Health Services, Radiation Safety Licensing Branch, Post Office Box 149347, Austin, Texas 78714-9347.

(C) A "kill switch" shall be provided for disconnection of each HVAC serving the building in accordance with the requirements of NFPA 90A, §6.2.1.

(11) Wet patient care location. Wet patient care locations shall be protected against shock in accordance with the requirements of NFPA 99, §4.3.2.2.9.1.

(12) Grounding requirements. Fixed electrical equipment shall be grounded in accordance with the requirements of NFPA 99, §4.3.3.1, and NFPA 70, Article 517.

(13) Nurses calling systems.

(A) A nurse emergency calling system shall be installed in all toilets used by patients to summon nursing staff in an emergency. Activation of the system shall sound an audible signal which repeats every five seconds at a staffed location, and shall activate a distinct visible signal outside of toilet room where the call originated. The visible and audible signals shall be cancelable only at the patient calling station. Activation of the system shall also activate distinct visible signals in the clean workroom, in the soiled workroom, and if provided, in the nourishment station.

(B) A staff emergency assistance calling system station shall be located in each operating room, treatment room, examination room, postoperative recovery, and preoperative holding area to be used by staff to summon additional help in an emergency. Activation of the system shall sound an audible signal at a staffed location, indicate type and location of call on the system monitor, and activate a distinct visible signal in the corridor at the door. Additional visible signals shall be installed at corridor intersections in multi-corridor facilities. Distinct visible and audible signals shall be activated in the clean workroom, in soiled workroom, sterile processing room, equipment storage, and if provided, in the nourishment station.

(14) Essential electrical system. The essential electrical system shall comply with the requirements of NFPA 99, §4.4.

(A) A Type 1 essential electrical system shall be installed, maintained and tested in each ASC in accordance with requirements of NFPA 99, §4.4; NFPA 101, §20.2.9; and National Fire Protection Association 110, Standard for Emergency and Standby Power Systems, 2002 Edition.

(i) At least one autoclaving/sterilizing equipment shall be connected to the emergency electrical essential power system.

(ii) One electrical outlet connected to the life safety branch of the electrical system shall be provided adjacent to (or on) the emergency generator.

(iii) The battery charger for emergency lighting at the emergency generator shall be connected to the life safety branch of the electrical system.

(B) Fuel storage capacity for an on-site generator for a Type 1 essential electrical system shall allow continuous operation, under full load for eight hours of testing as required by NFPA 99, §4.4.4.1.1.2.

(C) When a vapor liquefied petroleum gas (LPG - natural gas) system is used, the 24-hour fuel capacity on-site is not required. The vapor withdrawal LPG system shall require a dedicated fuel supply.

(D) When the emergency generator(s) and electrical transformer(s) are located within the same area, they shall be located at least 10 feet apart.

(15) Fire alarm system. A fire alarm system which complies with NFPA 101, §20.3.4, and with NFPA 72, Chapter 6 requirements, shall be provided in each facility. The required fire alarm system components are as follows.

(A) A fire alarm control panel (FACP) shall be installed at a visual location such as the main lobby. A remote fire alarm annunciator listed for fire alarm service and installed at a continuously attended location and capable of indicating both visual and audible alarm, trouble, and supervisory signals in accordance with the requirements of NFPA 72 may be substituted for the FACP.

(B) Manual fire alarm pull stations shall be installed in accordance with NFPA 101, §20.3.4.

(C) Ceiling-mounted smoke detector(s) shall be installed in room containing the FACP when this room is not attended continuously by staff as required by NFPA 72, §4.4.5.

(D) Smoke detectors shall be installed in air ducts in accordance with NFPA 72, §5.14.4.2 and §5.14.5 and NFPA 90A, §6.4.2.

(E) Smoke detectors shall be installed in return air ducts in accordance with requirements of NFPA 72 §5.14.4.2.2 and §5.14.5 and NFPA 90A, §6.4.2.2.

(F) Fire sprinkler system water flow switches shall be installed in accordance with requirements of NFPA 101, §9.6.2; NFPA 13, §6.9; and NFPA 72, §8.5.3.3.3.4.

(G) Sprinkler system valve supervisory switches shall be installed in accordance with the requirements of NFPA 72, §6.8.5.5.

(H) A fire alarm signal notification which complies with NFPA 101, §9.6.3, shall be provided to alert occupants of fire or other emergency.

(I) Audible alarm indicating devices shall be installed in accordance with the requirements of NFPA 101, §20.3.4, and NFPA 72, §7.4.

(J) Visual fire alarm indicating devices which comply in accordance with the requirements of NFPA 72, §7.5, shall be provided.

(K) Devices for transmitting alarm for alerting the local fire brigade or municipal fire department of fire or other emergency shall be provided. The devices shall be listed for the fire alarm service by a nationally recognized laboratory, and be installed in accordance with such listing and the requirements of NFPA 72.

(L) Wiring for fire alarm detection circuits and fire alarm notification circuits shall comply with requirements of NFPA 70, Article 760.

§135.54.Preparation, Submittal, Review and Approval of Plans, and Retention of Records.

(a) General.

(1) Ambulatory surgical center (ASC) owners/operators shall not begin construction of a new building, additions to or renovations or conversions of existing buildings until the department approves final construction documents.

(2) Plans and specifications describing the construction of new buildings and additions to or renovations and conversions of existing buildings shall be prepared by registered architects and/or licensed professional engineers and meet the requirements of this subchapter.

(3) The names of spaces used in the functional program narrative, preliminary documents, final construction documents and specifications shall be consistent with the names of the spaces used in this chapter.

(4) The department shall notify the ASC owner/operator of the result of its review of each type of submission discussed in this section.

(5) The ASC owner/operator shall respond to all department requests for additional information, including providing a plan of correction for deficiencies cited by the department.

(6) Once final construction documents are approved, the ASC owner/operator shall request inspections in accordance with §135.55 of this title (relating to Construction, Inspections, and Approval of Project).

(7) When construction is delayed for longer than one year from the plan approval or self-certification approval date, construction documents shall be resubmitted to the department for review and approval. The plans shall be accompanied by a new application for plan review and functional program narrative.

(8) The ASC owner/operator shall provide written notification to the department when a project has been placed on hold, canceled, or abandoned.

(9) The department may close a project file after one year of assigning an application number to a project if the project has been placed on hold.

(b) Submission of projects and assignment of application number.

(1) The ASC owner/operator or representative shall submit the following items to the department in care of the mailing or overnight delivery address that appears on the application for plan review:

(A) a completed and signed application for plan review. The application for plan review may be obtained by calling the department's architectural review group by telephone at (512) 834-6649 or visit the Architectural Review at www.dshs.state.tx.us/hfp;

(B) a functional program narrative in accordance with subsection (d) of this section; and

(2) The cost of submitting documents/plans and specifications shall be borne by the sender.

(3) Once the department has determined that the submission required in paragraph (1) of this subsection is complete, the department shall assign an application number to the project that shall be referenced on all documents and correspondence related to the project. Final construction documents shall be reviewed in the chronological order received.

(4) All deficiencies noted in the final plan review shall be satisfactorily resolved before approval of project for construction will be granted.

(5) Construction shall not begin until the ASC owner/operator of the facility receives written notification from the department that the final construction documents have been approved.

(c) Feasibility conference. An ASC owner/operator or representative may request a feasibility conference. A feasibility conference is an informal meeting between a member of the department's architectural review group staff and the ASC owner/operator or representative to determine the feasibility of a project, for consultation and informational purposes, and to facilitate and establish understanding of compliance with the rules and codes.

(1) A feasibility conference is not a substitute for plan review.

(2) An ASC owner/operator or representative may schedule a feasibility conference by calling the department's architectural review group by telephone number (512) 834-6649.

(3) The ASC owner/operator or representative shall provide at the feasibility conference the items in subsection (b)(1)(A) - (C) of this section and a set of preliminary plans or final construction documents.

(4) The ASC owner/operator or representative is responsible for recording conference notes and shall submit the notes to the department.

(d) Functional program narrative. The ASC owner/operator shall submit a functional program narrative to the department with each new project in accordance with subsection (b)(1)(B) of this section. The functional program narrative shall be presented on facility letterhead, signed by ASC administration, include the functional description of each space, and the following:

(1) departmental relationships and other basic information relating to the fulfillment of the facility's objectives;

(2) a description of each function to be performed, approximate space needed for these functions, occupants of the various spaces, projected occupant load, types of equipment required, interrelationship of various functions and spaces, and any special design features;

(3) energy conservation measures, included in building, mechanical, and electrical designs;

(4) a description of the type of asepsis control in diagnostic and treatment areas; and

(5) the type of construction (existing or proposed) as stated in §20.1.6 of National Fire Protection Association 101, Life Safety Code, 2003 Edition (NFPA 101), published by the National Fire Protection Association. All documents published by the NFPA as referenced in this section may be obtained by writing or calling the NFPA at the following address and telephone number: 1 Batterymarch Park, Quincy, Massachusetts 02169-7471, (800) 344-3555.

(e) Preliminary documents. The department may request preliminary documents. If requested by the department, the submission shall consist of the items in subsection (b)(1)(A) - (C) of this section, preliminary plans, and outline specifications. The documents shall contain sufficient information to establish the project scope, description of functions to be performed, project location, required fire safety and exiting requirements, building construction type, compartmentation showing fire and smoke barriers, and the usage of all spaces, areas, and rooms on every floor level.

(f) Final construction documents. Final construction documents and specifications shall be submitted to the department for review and approval prior to start of construction. All final documents and specifications shall be appropriately sealed and signed by the projects's registered architect and professional engineer(s) licensed by the State of Texas.

(1) Submission of final construction documents. The ASC owner/operator shall submit to the department for review and approval the items in subsection (b)(1)(A) - (C) of this section (if not previously submitted with preliminary documents) and one set of final construction documents and specifications covering the construction of new buildings or alterations, additions, conversions, modernizations, or renovations to existing buildings.

(2) Preparation of final construction documents. Construction documents shall be well-prepared so that clear and distinct prints may be obtained, shall be accurately and adequately dimensioned, shall include all necessary explanatory notes, schedules, and legends, and shall be adequate for contract purposes. Compliance with model building codes and this chapter shall be indicated. The type of construction, as classified by National Fire Protection Association 220, Standard on Types of Building Construction, 1999 Edition, shall be provided for existing and new facilities. Final plans shall be drawn to a sufficiently large-scale to clearly illustrate the proposed design but not less than one-eighth inch equals one foot. All spaces shall be identified by usage (using the names of spaces used in this chapter) on all plans (architectural, fire safety, mechanical, electrical, etc.) submitted. Separate drawings shall be prepared for each of the following branches of work.

(A) Architectural plans. Architectural drawings shall include the following:

(i) a map of the area within a 500 foot radius of the facility site shall be provided and any hazardous and undesirable location noted in §135.52(a) of this title (relating to Construction Requirements for a New Ambulatory Surgical Center) shall be identified;

(ii) site plan showing all new topography, newly established levels and grades, existing structures on the site (if any), new buildings and structures, roadways, parking, walks, easement, overhead or underground utilities or service lines, and the extent of the areas to be landscaped. All structures which are to be removed under the construction contract and improvements shall be shown. A general description of the immediate area surrounding the site shall be provided;

(iii) plan of each floor and roof to include fire and smoke separation, means of egress, and identification of all spaces;

(iv) schedules of doors, windows, and finishes;

(v) elevations of each facade;

(vi) sections through building; and

(vii) scaled details as necessary.

(B) Fire safety plans. These drawings shall be provided for all newly constructed buildings, conversions of existing buildings for facilities, additions to existing licensed facilities, and remodeled portions of existing buildings containing licensed facilities. Fire safety plans shall be of a sufficiently large-scale to clearly illustrate the proposed design but not less than one-sixteenth inch equals one foot and shall include the following information:

(i) separate fire safety plans (preferably one floor plan per sheet) shall indicate location of fire protection rated walls and partitions, location and fire resistance rating of each fire damper, and the required means of egress (corridors, stairs, exits, exit passageways);

(I) when a new building is to contain a proposed facility, when an existing building is converted to a facility, or when an addition is made to an existing facility building, plans of each floor and roof shall be provided;

(II) when a portion of a building is remodeled or when a new service is added, only the plan of the floor where the remodeling will take place or new service will be introduced, and the plan of the floor of discharge shall be provided;

(ii) designated smoke compartments with floor areas of each compartment, location, and fire resistance rating (one or two hour) of each smoke partition, location, type, and fire resistance rating of each smoke damper;

(iii) location of all required fire alarm devices, including all fire alarm control panels, manual pull stations, audible and visual fire alarm signaling devices, smoke detectors (ceiling and duct-mounted), fire alarm annunciators, fire alarm transmission devices, fire sprinkler flow switches, and control valve supervisory switches on each of the floor plans; and

(iv) areas protected with fire sprinkler systems (pendant, sidewall or upright, normal or quick response, and temperature rating shall be indicated), stand pipe system risers and sizes with valves and inside and outside fire department connections, fire sprinkler risers and sizes, location and type of portable fire extinguishers.

(i) all equipment necessary for the operation of the facility as planned. The design shall indicate provisions for the installation of large and special items of equipment and for service accessibility;

(ii) fixed equipment (equipment which is permanently affixed to the building or which must be permanently connected to a service distribution system designed and installed during construction for the specific use of the equipment). The term "fixed equipment" includes items such as laundry extractors, walk-in refrigerators, communication systems, and built-in casework (cabinets);

(iii) movable equipment (equipment not described in clause (ii) of this subparagraph as fixed). The term "moveable equipment" includes wheeled equipment, plug-in type monitoring equipment, and relocatable items; and

(iv) equipment which is not included in the construction contract but which requires mechanical or electrical service connections or construction modifications. The equipment described in this clause shall be identified on the drawings to ensure its coordination with the architectural, mechanical, and electrical phases of construction.

(D) Structural drawings. Structural drawings shall include:

(i) plans for foundations, floors, roofs, and all intermediate levels;

(ii) a complete design with sizes, sections, and the relative location of the various members;

(iii) a schedule of beams, girders, and columns;

(iv) dimensioned floor levels, column centers, and offsets;

(v) details of all special connections, assemblies, and expansion joints; and

(vi) special openings and pipe sleeves dimensioned or otherwise noted for easy reference.

(E) Mechanical drawings. Mechanical drawings shall include:

(i) complete ventilation systems (supply, return, exhaust), all fire and smoke partitions, locations of all dampers, registers, and grilles, air volume flow at each device, and identification of all spaces (e.g., corridor, patient room, operating room);

(ii) boilers, chillers, heating and cooling piping systems (steam piping, hot water, chilled water), and associated pumps;

(iii) cold and warm water supply systems, water heaters, storage tanks, circulating pumps, plumbing fixtures, emergency water storage tank(s) (if provided), and special piping systems such as for deionized water;

(iv) nonflammable medical gas piping (oxygen, compressed medical air, vacuum systems, nitrous oxide), emergency shutoff valves, pressure gages, alarm modules, gas outlets;

(v) drain piping systems (waste and soiled piping systems, laboratory drain systems, roof drain systems);

(vi) fire protection piping systems (sprinkler piping systems, fire standpipe systems, water or chemical extinguisher piping system for cooking equipment);

(vii) piping riser diagrams, equipment schedules, control diagrams or narrative description of controls, filters, and location of all duct-mounted smoke detectors; and

(viii) laboratory exhaust and safety cabinets.

(F) Electrical drawings. Electrical drawings shall include:

(i) electrical service entrance with service switches, service feeders to the public service feeders, and characteristics of the light and power current including transformers and their connections;

(ii) location of all normal electrical system and essential electrical system conduits, wiring, receptacles, light fixtures, switches, and equipment which require permanent electrical connections, on plans of each building level:

(I) light fixtures marked distinctly to indicate connection to critical or life safety branch circuits or to normal lighting circuits; and

(II) outlets marked distinctly to indicate connection to critical, life safety, or normal power circuits;

(iii) telephone and communication, fixed computers, terminals, connections, outlets, and equipment;

(iv) nurses calling system showing all stations, signals, and annunciators on the plans;

(v) in addition to electrical plans, single line diagrams prepared for:

(I) complete electrical system consisting of the normal electrical system and the essential electrical system including the on-site generator(s), transfer switch(es), emergency system (life safety branch and critical branch), equipment system, panels, subpanels, transformers, conduit, wire sizes, main switchboard, power panels, light panels, and equipment for additions to existing buildings, proposed new facilities, and remodeled portions of existing facilities. Feeder and conduit sizes shall be shown with schedule of feeder breakers or switches;

(II) complete nurses calling system with all stations, signals, annunciators, etc. with room number noted by each device and indicating the type of system (nurses regular calling system, nurses emergency calling system, or staff emergency assistance calling system);

(III) a single line diagram of the complete fire alarm system showing all control panels, signaling and detection devices and the room number where each device is located; and

(vi) schedules of all panels indicating connection to life safety branch, critical branch, equipment system or normal system, and connected load at each panel.

(3) Construction document changes. Any changes to the final construction documents which affect or change the function, design, or designated use of an area shall be submitted to the department for approval prior to authorization of the modifications.

(g) Special submittals.

(1) Self-certification.

(A) In an effort to shorten the plan review and approval process, the ASC owner/operator or representative may request approval of final construction documents under the self-certification review process.

(i) The owner/operator shall submit the items in subsection (b)(1)(A) - (C) of this section and a completed self-certification form, signed by the ASC owner/operator, architect of record, and engineer(s) of record attesting that the plans and specifications are based upon and comply with the requirements of this chapter.

(ii) By signing and submitting the self-certification form, the ASC owner/operator accepts the following conditions.

(I) The department retains the right to review the final construction documents, conduct inspections of the project, and withdraw its approval.

(II) The ASC owner/operator has a continuing obligation to make any changes the department requires to comply with the licensing rules whether or not physical plant construction or alterations have been completed.

(III) The ASC owner/operator is ultimately responsible for compliance with Health and Safety Code, Chapter 243, Texas Ambulatory Surgical Center Licensing Act, and this chapter.

(B) The department shall review the request for self-certification and notify the ASC owner/operator if the request is approved or denied. If denied, the department shall review the final construction documents in the chronological order in which the documents were received. Construction shall not begin until the final construction documents have been reviewed and approved.

(2) Minor project. If a ASC owner/operator believes that a proposed project is a minor project, the ASC owner/operator shall provide to the department a brief written description of the proposed project and floor plans of the areas of work. The minor project request shall be mailed or faxed.

(A) If it is determined that the proposed project is a minor project, the department shall notify the ASC owner/operator of the approval, and state the number of inspections that shall be required. A minimum of one inspection shall be conducted.

(B) The department shall notify the ASC owner/operator that a proposed project is not approved as a minor project, if the project involves any of the following:

(i) remodeling or alterations which involve alterations to load bearing members or partitions;

(ii) a change in functional operation;

(iii) a change that affects fire safety (e.g., modifications to the fire, smoke, and corridor walls);

(iv) additional services for which the ASC is not currently licensed; and

(v) a significant change to the mechanical, electrical, plumbing, fire protection, or piped medical system.

(C) The ASC owner/operator shall submit final construction documents in accordance with subsection (f) of this section if the department determines the project is not a minor project.

(3) Fire sprinkler systems.

(A) When the sole purpose of a project is installation of a sprinkler system, whether a partial or complete system, the ASC owner/operator shall submit to the department for approval the items in subsection (b)(1)(A) - (C) of this section and sprinkler documents.

(B) Fire sprinkler systems shall comply with the requirements of National Fire Protection Association 13, Standard for the Installation of Sprinkler Systems, 2002 Edition (NFPA 13), and shall be designed or reviewed by an engineer who is registered by the Texas Board of Professional Engineers in fire protection specialty or is experienced in hydraulic design and fire sprinkler system installation. A short resume shall be submitted if registration is not in fire protection specialty.

(i) Fire sprinkler working plans, complete hydraulic calculations and water supply information shall be prepared in accordance with NFPA 13, §§14.1, 14.2 and 14.3, for new fire sprinkler systems, alterations of and additions to existing ones.

(ii) One set of fire sprinkler working plans, calculations, and water supply information shall be forwarded to the department together with the professional engineer's (P.E. licensed in the State of Texas) certification letter stating that the sprinkler system design complies with the requirements of NFPA 13. Certification of the fire sprinkler system shall be submitted prior to system installation.

(iii) Upon completion of the fire sprinkler system installation and any required corrections, written certification by the engineer, stating that the fire sprinkler system is installed in accordance with NFPA 13 requirements, shall be submitted prior to or with the written request for the final construction inspection of the project.

(h) Retention of drawings, manuals, and design data.

(1) As built drawings. Upon occupancy of the building or portion thereof, the owner shall retain as part of the ASC's permanent records, a complete set of legible architectural plans of each building level, fire safety plans as described in subsection (f)(2)(B) of this section for each floor reflecting fire safety requirements, and all single line diagrams described in subsection (f)(2)(F)(v) of this section, drawings for fixed equipment, and mechanical and electrical systems, as installed or built.

(2) Manuals. Upon completion of the contract, the owner shall retain as part of the ASC's permanent records a complete set of manufacturers' operating, maintenance, and preventive maintenance instructions; parts lists; and procurement information with numbers and a description for each piece of equipment. Facility staff shall also be provided with instructions on how to properly operate systems and equipment. Required information shall include energy ratings as needed for future conservation calculations.

(3) Design data. The owner shall retain in the ASC's permanent records complete design data for the facility. This shall include structural design loadings; summary of heat loss assumption and calculations; estimated water consumption; medical gas outlet listing; list of applicable codes; and electric power requirements of installed equipment. All such data shall be supplied to facilitate future alterations, additions, and changes, including, but not limited to, energy audits and retrofit for energy conservation.

§135.55.Construction, Inspections, and Approval of Project.

(a) Construction.

(1) Major construction. Construction, of other than minor alterations, shall not commence until the final plan review deficiencies have been satisfactorily resolved, the appropriate licensing fee has been paid, and the department has issued a letter granting approval to begin construction. Such authorization does not constitute release from the requirements contained in this chapter. If the construction takes place in or near occupied areas, adequate provision shall be made for the safety and comfort of occupants.

(2) Construction commencement notification. The architect of record or the ambulatory surgical center (ASC) owner/operator shall provide written notification to the department when construction will commence. The department shall be notified in writing of any change in the completion schedules.

(3) Completion. Construction shall be completed in compliance with the construction documents including all addenda or modifications approved for the project.

(b) Construction inspections. All ASCs including those which maintain certification under Title XVIII of the Social Security Act (42 United States Code, §§1395 et seq.), and those which maintain accreditation by a Centers for Medicare and Medicaid Services-approved organization are subject to construction inspections.

(1) Number of construction inspections. A minimum of two construction inspections of the project is generally required for the purpose of verifying compliance with subchapters B and C of this chapter and the approved plans and specifications. The final plan approval letter or the self-certification approval letter shall inform the architect of record and the owner as to the minimum number of inspections required for the project.

(2) Requesting an inspection. The architect of record or the ASC owner/operator shall request an inspection by submitting, at least three weeks in advance of the requested inspection date, an application for inspection for each intermediate inspection, final inspection, and reinspection requested. Inspection requests by contractors shall not be honored.

(A) The architect of record or the ASC owner/operator shall request an intermediate construction inspection to occur at approximately 80% completion. All major work above the ceiling shall be completed at the time of the intermediate inspection; however, ceilings shall not be installed.

(B) The architect of record or the ASC owner/operator shall request a final construction inspection at 100% completion. One hundred percent completion means that the project is completed to the extent that all equipment is operating in accordance with specifications, all necessary furnishings are in place, and patients could be admitted and treated in all areas of the project.

(3) Reinspections. Depending upon the number and nature of the deficiencies cited during the final inspection, the inspector may require that a reinspection be conducted to confirm correction of all deficiencies cited. The inspector may also require a reinspection, if he determines that the project was not sufficiently complete to warrant a final inspection. The request for reinspection shall be submitted in accordance with paragraph (2) of this subsection.

(c) Approval of project. Patients and staff shall not occupy a new structure or remodeled or renovated space until approval has been received from the local building and fire authorities and the department.

(1) Documentation requirements. The ASC owner/operator shall submit the following documents to the department before the project will be approved:

(A) written approval of the project by the fire authority;

(B) a certificate of occupancy for the project issued by the local building authority;

(C) a copy of a letter or certification from a professional engineer (P.E.) licensed in the State of Texas indicating the fire sprinkler working plans, hydraulic calculation, the testing, and field inspection of the installation of the new or modified sprinkler system is in compliance with the requirements of NFPA 13, Standard for the Installation of Sprinkler Systems, 2002 Edition, if applicable. A copy of a letter or certification of changes in existing fire sprinkler system is not required, when relocation of not more than twenty sprinkler heads and hydraulic calculation is involved;

(D) fire alarm system certification (form FML-009A of the State Fire Marshal's Office), if applicable;

(E) a signed copy of a letter of certification from a qualified certification agency or individual for the piped-in medical gas system that was installed or modified and verification inspection testing in this project in accordance with §135.52(h)(1)(C)(iv), (x) and (xi) of this title (relating to Construction Requirements for a New Ambulatory Surgical Center), if applicable;

(F) a copy of the test and a letter from the electrical contractor certifying that the electrical system was tested and complies with the standards of NFPA 99, Health Care Facilities, 2002 Edition, §4.3.2.2.8 (Special Grounding) and §4.3.3.1 (Grounding System Testing), if applicable to the project;

(G) a copy of documentation indicating the flame spread rating and the smoke development rating of any wall covering installed in this project. A signed letter or statement corroborating the installation of the product in the project shall be provided;

(H) a copy of documentation indicating that draperies, curtains (including cubicle curtains), and other similar loosely hanging furnishings and decorations are flame-resistant as demonstrated by passing both the small and large-scale tests of NFPA 701, Standard Methods of Fire Tests for Flame-Resistant Textiles and Films, 1999 Edition, as required by NFPA 101, §18-7.5, and a signed letter or statement corroborating the installation of the product in the project;

(I) a written plan of correction signed by the ASC owner/operator for any deficiencies noted during the final inspection; and

(J) any other documentation or information required or requested due to the type of the project.

(2) Temporary occupancy approval

(A) If, during the final inspection, the inspector finds only a few minor deficiencies that do not jeopardize patient health, safety and welfare, the inspector may grant temporary approval for occupancy by staff only contingent upon the documents listed in paragraph (1)(A) - (E) of this subsection being provided to and approved by the inspector at the time of the final inspection. The inspector shall issue a completed signed final architectural inspection form as testament for temporary approval for occupancy by staff only. The ASC shall complete the licensing process and receive a license before patients may be admitted or treated.

(B) Temporary approval for occupancy allows the ASC owner/operator to occupy the project. However, the ASC owner/operator shall submit the documents required in paragraph (1)(F) - (J) of this subsection before the project receives final approval.

(3) Final approval. Upon its receipt and acceptance of the documents required in paragraph (1) of this subsection, the department shall issue written final approval of the project.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on May 29, 2009.

TRD-200902091

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: June 18, 2009

Proposal publication date: December 5, 2008

For further information, please call: (512) 458-7111 x6972