Adopted Sections An agency may take final action on a section 30 days after a proposal has been published in the Texas Register. The section becomes effective 20 days after the agency files the correct document with the Texas Register, unless a later date is specified or unless a federal statute or regulation requires implementation of the action on shorter notice. If an agency adopts the section without any changes to the proposed text, only the preamble of the notice and statement of legal authority will be published. If an agency adopts the section with changes to the proposed text, the proposal will be republished with the changes. TITLE 25. HEALTH SERVICES Part I. Texas Department of Health Chapter 73. Laboratories Fees for Drinking Water Systems 25 TAC sec.73.41 The Texas Department of Health (department) adopts an amendment to sec.73.41, without changes to the proposed text as published in the April 2, 1993, issue of the Texas Register (18 TexReg 2186). The section concerns fees for services for drinking water systems. The amendment will permit the recovery of actual costs for the provision of chemical and bacteriological testing by the department's laboratory. This testing must be done for compliance purposes under the requirements of 31 TAC sec.sec.290.1-290.19, the Safe Drinking Water Act, and the primary drinking water regulations promulgated thereunder as found in Title 40, Code of Federal Regulation, sec.141. The jurisdiction and regulation of water quality in public drinking water supplies rests with the Texas Water Commission. The department's laboratory is certified by the federal Environmental Protection Agency for performing the chemical and bacteriological services or for certifying other laboratories under the Safe Drinking Water Act, thus providing analytical services to the regulated community with the Texas Water Commission making determinations as to the number, type, and frequency of laboratory tests to be done. The only comment came from the Texas Water Commission, recommending a change of the word "bacteriological" wherever it appears in the rule to the broader term "microbiological". This is an appropriate change but should await a future adjustment since the term "bacteriological" occurs in subsections not addressed by this amendment. The amendment is adopted under the Health and Safety Code, sec.12.031 and sec.12.032, which provides the Board of Health (board) with the authority to adopt rules concerning fees for public health services; and sec.12.001, which provides the board with authority to adopt rules to implement every duty imposed by law on the board, the department, and the commissioner of health. sec.73.41. Fees for Services for Drinking Water Systems. (a) Services concerning bacteriological testing. (1) (No change.) (2) The department will charge a fee to recover the actual cost of providing bacteriological testing at the department's laboratory in Austin. Such fee is published at least annually with the State Purchasing and General Services Commission and may be obtained from the Bureau of Laboratories. (3)-(5) (No change.) (b) (No change.) (c) Services concerning chemical testing. (1) (No change.) (2) The department will charge fees to cover its actual costs for chemical testing. Such fees are published at least annually with the State Purchasing and General Services Commission and may be obtained from the Bureau of Laboratories. (3)-(4) (No change.) This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on May 24, 1993 TRD-9323386 Robert A. MacLean, M.D. Deputy Director Texas Department of Health Effective date: June 14, 1993 Proposal publication date: April 2, 1993 For further information, please call: (512) 458-7236 Chapter 98. HIV and STD Control Subchapter C. Texas HIV Medication Program General Provisions 25 TAC sec.98.104, sec.98.105 The Texas Department of Health (department) adopts amendments to existing sec.98.104 and sec.98.105, concerning the Texas HIV Medication Program, without changes to the text as published in the March 30, 1993 issue of the Texas Register (18 TexReg 2116) and as republished in correction in the April 2, 1993 issue of the Texas Register. The sections implement the provisions of the "Communicable Disease Prevention and Control Act," Health and Safety Code, Chapter 85.063, Subchapter C, concerning the Texas HIV Medication Program. The program assists hospital districts, local health departments, public or nonprofit hospitals and clinics, nonprofit community organizations, and HIV infected individuals in the purchase of medications approved by the board that have been shown to be effective in reducing hospitalizations due to HIV related conditions. Generally, the sections cover eligibility for participation and medication coverage. The amendments expand coverage of the program to include atovaquone for eligible participants and adds language to make the two sections uniform. Atovaquone will be used as an oral treatment for acute mild to moderate Pneumocystis carinii Pneumonia (PCP) in patients who are intolerant to trimethoprim-sulfamethoxazole (SMZ-TMP) to reduce the hospitalization and decline of the general health of the HIV infected persons on this program. No comments were received on the proposed amendments. The amendments are adopted under the Health and Safety Code, sec.85.063, which provides the Texas Board of Health with the authority to adopt rules concerning a Texas HIV Medication Program, and the Health and Safety Code, sec.12.001, which provides the Texas Board of Health with the authority to adopt rules for the performance of every duty imposed by law on the Texas Board of Health, the Texas Department of Health, and the Commissioner of Health. sec.98.104. Medication Coverage. The following medications will be provided to each eligible participant. (1) Zidovudine capsules must be provided in increments of 100 not to exceed 400 capsules per month. Zidovudine syrup must be provided in eight- ounce bottles. (2) Pentamidine for inhalation solution must be provided in one 300 mg. vial per month. (3) Sulfamethoxazole-trimethoprim (DS) tablets must be provided in increments of 100 tablets for a maximum of 200 per month. Sulfamethoxazole-trimethoprim suspension must be provided in bottles of 480 ml. (4) Didanosine tablets must be provided in increments of 60 tablets not to exceed 120 tablets per month. (5) Fluconazole must be provided in increments of 30 tablets not to exceed 120 tablets in 3 months. (6) Erythropoietin is provided through the Texas HIV Medication Program for children younger than 18 years of age. Adults and children that meet the financial and drug specific criteria will be eligible to receive this drug under the Ortho Biotech program. (7) Immune Globulin Intravenous (Human) will be provided in 2.5 and 5 gm. vials. (8) Texas HIV Medication Program will reimburse the Tuberculosis Elimination Division for the following listed drugs used to treat atypical mycobacterial infections in individuals that are HIV infected: (A) Amikacin-1 g vial; (B) Capreomycin-1 g vial; (C) Ciprofloxacin-750 mg. tablets; (D) Cycloserine-250 mg. capsules; (E) Ethambutol-100 mg. tablets; (F) Ethambutol-400 mg. tablets; (G) Ethionamide-250 mg. tablets; (H) Isoniazid (INH) syrup; (I) Isoniazid (INH)-100 mg. tablets; (J) Isoniazid (INH)-300 mg. tablets; (K) Kanamycin-1 g vial; (L) Pyrazinamide-500 mg. tablets; (M) Pyridoxine (Vit.B-6)-50 mg. tablets; (N) Rifampin-300 mg. /Isoniazid (INH) 150 mg. capsules; (O) Rifampin-300 mg. capsules; (P) Sodium P.A.S. tablets; and (Q) Streptomycin-5 g. (9) Acyclovir capsules must be provided in increments of 100, not to exceed 200 per month. Acyclovir suspension must be provided in 473 ml. bottles of 200 mg./5ml., not to exceed 2 bottles per month. Acyclovir powder for injection must be provided in 500 mg. vials, not to exceed 2-10 ml. vials per month. (10) Zalcitabine tablets must be provided in increments of 100 not to exceed 100 tablets per month. (11) IV Pentamidine must be provided in 300 mg. vials not to exceed 14 vials per course of therapy (one vial per day for 14 days). (12) Interferon-Alpha must be provided in commercially available vials not to exceed 450 million units per month. (13) Amphotericin-B must be provided in 50 mg. vials not to exceed 40 per month. (14) Atovaquone must be provided in increments of 200 tablets not to exceed 200 tablets per 21 day treatment therapy following each diagnosis. sec.98.105. Drug Specific Eligibility Criteria. A person is eligible for: (1)-(9) (No change.) (10) Interferon-Alpha for the treatment of disseminated Kaposi's sarcoma in HIV infected persons with T-cell counts over 500. The total amount to be expended on this drug is $122,600. The requesting physician must complete a form to be returned to the program which will allow the program to evaluate the benefits of providing this medication; (11) Amphotericin-B for the treatment of patients with progressive, and potentially fatal disseminated fungal infections. The total amount to be expended on this drug is $46,200. The requesting physician must complete a form to be returned to the program which will allow the program to evaluate the benefits of providing this medication; and (12) Atovaquone for the oral treatment of acute mild to moderate Pneumocystis carinii Pneumonia (PCP) in patients who are intolerant to trimethoprim- sulfamethoxazole (TMP-SMX). This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on May 24, 1993. TRD-9323387 Robert A. MacLean, M.D. Deputy Commisioner Texas Department of Health Effective date: June 14, 1993 Proposal publication date: March 30, 1993 For further information, please call: (512) 458-7236 Chapter 115. Home Health Care Agencies Licensing and Regulation 25 TAC sec.sec.115.2, 115.6-115.8, 115.10, 115.13- 115.15, 115. 17, 115.19 The Texas Department of Health (department) adopts amendments to sec.sec.115.2, 115.6-115.8, 115.10, 115.13-115.15, 115.17, and 115. 19, concerning the licensing and regulation of home health agencies. Sections 115.2, 115.6, 115.8, 115.10, 115.17, and 115.19 are adopted with changes to the proposed text as published in the March 2, 1993, issue of the Texas Register (18 TexReg 1339). Sections 115.7, 115.13, 115.14, and 115.15 are adopted without changes and will not be republished. The amendments add definitions for certified copy, delegation, stable and predictable, and unlicensed person. The amendments also require an agency on or before September 1, 1993, to adopt, implement, and enforce a written policy on disaster preparedness; add provisions to the standards for all agencies (Classes A and B) for the supervision and delegation of tasks by a registered nurse to unlicensed persons; add provisions that require an agency to enforce its operational policies and written agreements with independent contractors; allow an agency to maintain clinical records in the parent agency or in the branch office; include optical disc imaging system as a medium for maintaining clinical records; add a provision requiring the commencement of services within a reasonable period of time based upon a patient's health needs; delete the requirement for a patient care plan when a practitioner orders skilled treatment; change the requirement for approval of a patient treatment plan by a practitioner from 14 days to a "timely" manner; add a requirement that an agency adopt, implement and enforce policies on the time frame of the timely countersignature of a practitioner's verbal orders and policies relating to evidence of coordination of patient care; increase the license fees; add a requirement that an agency investigate complaints made by its patients and document the complaint and the resolution; and allow a branch office to offer fewer, but not different, services than the parent agency. The amendments also reflect the implementation of the Texas Education Code, sec.57.491, amendments to Health and Safety Code, sec.671.001, and Federal Public Law 100-578, Clinical Laboratory Improvement Amendments of 1988. The provisions added by the amendments concern the denial of the renewal of an agency's license if the renewal is prohibited by the Texas Education Code relating to defaults on guaranteed student loans, and pronouncement of death by a registered nurse. The provisions also require an agency to comply with the provisions of the Clinical Laboratory Improvement Amendments of 1988 if the agency provides laboratory services. Further, the amendments update and clarify the standards. The following comments were received concerning the proposed amendments. COMMENT: Concerning sec.115.2, several commenters suggested that the department use the same definition of "delegation" as the Board of Nurse Examiners. RESPONSE: The department agrees and has modified the definition accordingly. COMMENT: Concerning sec.115.2, one commenter stated there was no mention of delegation to a Licensed Vocational Nurse (LVN) in the definition of "delegation." RESPONSE: The department intentionally did not mention LVNs in the definition because a LVN is a licensed individual and the definition of delegation relates to authorizing an unlicensed person to provide nursing services. COMMENT: Two commenters suggested the term "client" be used instead of "patient" in the definitions and rules. RESPONSE: The department disagrees that a term other than patient is necessary. A home health agency is a place of business that provides a home health service in a patient's residence. COMMENT: Concerning sec.115.2, one commenter noted that the word used in the definition of "unlicensed person" should be "complementary" rather than "complimentary." RESPONSE: The department agrees and has made the correction. COMMENT: Concerning sec.115.6, two commenters stated that the addition of language requires department surveys to be unannounced and would result in an unnecessary financial burden on agencies who would be required to ensure that an office be staffed at all times. One of the commenters suggested "within reasonable notice" be substituted for "unannounced." RESPONSE: Upon Board recommendation, the department has deleted the proposed new language. COMMENT: Concerning sec.115.8(m), one commenter suggested deleting the reference to branch offices. The commenter believes that the Clinical Laboratory Improvement Amendments of 1988 will stipulate which offices need to be separately certified. RESPONSE: The department agrees and has deleted the language as the definition of "agency" includes the term "branch office." COMMENT: Concerning sec.115.8(n), numerous commenters took exception to the proposed language for the implementation and enforcement of a written policy or disaster preparedness. The commenters believed the proposed rule was vague and required clarification, definition, and specification. Other commenters considered the requirement to go beyond the capabilities and liabilities of a home health agency. RESPONSE: The department recognizes the commenters concerns and has edited and expanded the language to state the emergency plan need not require the agency to actually evacuate, transport, or triage patients. The term "disaster" was clarified by noting it to be a publicly known natural disaster. The final rule allows agencies until September 1, 1993, to adopt their emergency disaster plan. The plan adopted will complement the local community's resources. During investigations, the department will evaluate only the adoption and enforcement of the emergency plan. COMMENT: Concerning sec.115.8(o) and sec.115.19(d), the department received numerous comments regarding the RN delegation and supervision rules for home health aides and permitted home health medication aides. The comments were basically within the following areas: the RN "may" delegate, not "shall" delegate; the department's rules should defer to or mirror the Board of Nurse Examiners' (BNE) rules for RN delegation and supervision so as not to create conflict and confusion for practicing RNs; the proposed definition for "delegation" should be the same as the definition for "delegation" in the BNE rules; change the terms "clinitest" and "hematest" to generic terms; clarification of RN's employment or contract status as related to the development of written protocols for the instruction and training of unlicensed persons performing nursing tasks in sec.115.8(o)(5)(D)(i); prohibition of therapists providing supervisory visits for home health aides as appropriate under federal Medicare regulations; identifying what patient behaviors the RN could delegate for the home health aide to observe, report and document; and include "equally qualified" in sec.115.8(o)(1) when referring to another RN who supervises an unlicensed person. RESPONSE: The department decided not to adopt the BNE rules by reference, however, the department agrees with the commenters and has mirrored the BNE language by modifying, deleting, and clarifying the specific standards in accordance with the commenters' recommendations. COMMENT: Concerning sec.115.8(o), the department received other comments relative to the RN delegation and supervision rules. The comments were basically within the following areas: clarification of what changes to the baseline data previously established by the RN could be delegated to the home health aide to observe, report, and document; clarification of the transportation provision in sec.115.8(o)(2)(D); and expansion of the language in sec.115.8(o)(2) and sec.115.8(o)(3) to include additional delegable tasks by an RN to an unlicensed person. RESPONSE: The department disagrees that further clarification is necessary for the first two comments. The department also disagrees with the third comment because the proposed language appropriately covers those tasks permitted statutorily by the home health agency licensing Act and the BNE rules for delegation of selected nursing tasks by RNs to unlicensed personnel. COMMENT: One commenter asked the department to clarify the meaning of "equally qualified RN" as used in the BNE rules relating to supervision of delegated tasks to an unlicensed person. RESPONSE: The department has added "equally qualified" to sec.115.8(o)(1) to describe another RN who will make decisions about appropriate levels of supervision. The meaning of "equally qualified" as used in these rules refers only to an RN's capability to supervise the delegated tasks to unlicensed persons; it does not refer to the RN's educational preparation or clinical experience. COMMENT: One commenter requested the department include a rule addressing RN pronouncement of death. RESPONSE: The department has complied with the request by adding subsection sec.115.8(p). COMMENT: One commenter suggested reordering the content of sec.115.10(c)(1) to first list what is required in all records and then list what items will be included as applicable. RESPONSE: The department agrees and has changed the language in sec.115.10(c)(1) according to the suggested format. COMMENT: Concerning sec.115.10(c)(4), one commenter stated that the language should make provisions for a computer record, i.e. one that is paperless but maintained in the computer and accessible to surveyors. RESPONSE: The department agrees and has expanded the language to include optical disc imaging system for records. The new language is consistent with federal regulations for clinical records. COMMENT: Concerning sec.115.10(f), one organization stated some of its members expressed concern that deleting the 72 hours' requirement in sec.115. 10(f) may invite agencies to delay seeing patients for periods longer than three days to the detriment of patient health. RESPONSE: The department disagrees because the initial assessment must be conducted prior to or at the time that home health services are initially provided to the patient. The basis for the assessment is for the patient's health needs rather than meeting specific time frames. The department has amended the language to reflect patient health needs. COMMENT: Concerning sec.115.10(f)(1)(A), one commenter stated the proposed language that provides for the patient care plan to be reviewed annually is too long. The commenter believes the plan should be reviewed at least every six months. RESPONSE: The department disagrees as the language allows for the revision of the patient care plan based upon a patient's needs. If the agency wishes to revise their patient care plans within a shorter time frame, it may do so by agency policy. COMMENT: Concerning sec.115.10(f)(1)(B), one commenter questioned since there is no longer a specified time frame for obtaining signed physician orders, is the department going to set limits on what is reasonable or will compliance with an agency's policy be acceptable? RESPONSE: The department's response is that the language allows flexibility based upon the agency's policy. It will be the agency's responsibility and liability to determine a reasonable time frame for signed physician orders. COMMENT: One commenter stated that there is no definition for practitioner and requested clarification of the intent of sec.115.10(f)(1)(B) and how this relates to the nursing care given. RESPONSE: The department's response is that the term for practitioner is defined in the current rules as "a person who is currently licensed in this state as a physician, dentist, or podiatrist." The department believes the commenter's question would be answered with knowledge of this term. COMMENT: One commenter questioned the formatting of sec.115.10(g) as it appeared in the Texas Register. RESPONSE: The department recognizes the error made at the time of publication in the Texas Register and notes the bracket to complete the deleted language be at the end of the last sentence in subsection (g). COMMENT: Concerning sec.115.10(i)(1), one commenter requested clarification as to whether an agency could contract with another agency to provide supervision or only with an individual RN. RESPONSE: The answer to the commenter's question is supervision must be contracted with an individual RN. Nursing supervision is not a service which can be contracted by arrangement with another agency. COMMENT: Concerning sec.115.13(i), one commenter stated the language is not clear and requested clarification as to whether the rule means that any condition not met whether or not it relates to home health aides triggers this action. RESPONSE: The department's response is that federal certification requirements mandate any Medicare condition of participation out of compliance warrants the prohibition of the training and competency evaluation or competency evaluation for home health aides by a certified agency. The prohibited period is 24 consecutive months following the date of non-compliance. COMMENT: Concerning sec.115.10(i)(9), one commenter requested a revision to state "in compliance with the BNE's rules" since no time frame is required in the proposed rules but is required in the BNE rules. RESPONSE: The department disagrees as the supervisory time frame is addressed in sec.115.19(b)(2)(A). COMMENT: One commenter stated if requirements for determining competency are different between Class A and Class B home health agencies, it should be spelled out clearly. The commenter also asked if membership in the Nurse Aide Registry means that the home health agency does not have to perform its own skills and competency testing for Class A and Class B agencies. RESPONSE: The department considers the current language to be specific in differentiating the requirements between Class A and B for home health aide competency evaluation training. The Nurse Aide Registry is a mechanism by which a home health aide may qualify to work in a Class B agency only. COMMENT: Concerning sec.115.14(a), several commenters objected to the increase in the license fee structure. RESPONSE: The department reiterates the justification provided in the preamble of the proposed amendments. The increase in fees is necessary to offset the cost of administering the licensure program which includes the application, survey, technical and quality assurance review processes in the six zone offices and the central office; preparation for Home Health Services Advisory Council meetings, reimbursement of Council members' travel and per diem, and preparation of minutes; preparation of amendments to rules for submission to the Texas Board of Health and to the Texas Register; costs relating to licensure actions against facilities which include costs for depositions, court reporting, attorney's time and travel; costs for administering the home health medication aide program including approval of programs, permitting aides, actions against program and aides, surveyor time and travel; costs of administering the home health training and employee evaluation program including the approval of programs, maintaining lists, files, and database, actions against programs, and surveyor time and travel; and overhead costs for salaries, fringe benefits, office space, communications, supplies, equipment, training, consultants, data processing and other miscellaneous costs. COMMENT: Concerning sec.115.15(a), one commenter suggested the department should require complaints against home health agencies be submitted in writing. RESPONSE: The department disagrees with the commenter as individuals have the right to complain in writing and verbally. Some individuals may only be able to communicate verbally and to limit their ability to register a complaint would infringe on their rights. COMMENT: One commenter requested a clarification of a patient's health care provider as the term is used in sec.115.15(d). RESPONSE: The department clarifies to the commenter a health care provider may be any individual or organization that provides care to the patient. No changes were made to the language. COMMENT: Concerning sec.115.17(f), one commenter noted that the proposed new language conflicts with existing sec.115.17(d)(1). RESPONSE: The department agrees and has deleted sec.115.17(d)(1). COMMENT: Concerning sec.115.17(4), two commenters expressed concern about conflicting statements. It was recommended to change the word "should" to "may" if the agency has an option as to where the records are kept. RESPONSE: The department agrees and has deleted portions of the proposed language. Language has been added to clarify the location of records, the medium of records which may be maintained and the elimination of duplicate records. COMMENT: One commenter questioned what constituted a certified copy in a patient record. RESPONSE: The department refers the commenter to sec.115.2 for the definition of certified copy. The department believes that knowledge of the term should answer the commenter's question. COMMENT: Concerning sec.115.19(b)(2)(A), one commenter stated that "medication regime" should be "medication regimen" instead. RESPONSE: The department agrees and has corrected the error. COMMENT: Concerning sec.115.19(d)(7), two commenters were very concerned about the proposed language which would allow home health medication aides to administer medications or feeding by way of a tube inserted in a cavity in the body. One commenter recommended that the proposed language be deleted. The other commenter recommended additional language be added in the final rules to clearly define the circumstances under which the home health medication aides could perform the task and an educational process that would assure a quality service. RESPONSE: The department recognizes the commenters' concerns and has deleted the proposed language. The current language is consistent with the BNE rules for RN delegation and supervision of tasks. Minor editorial changes were made for clarification purposes. Comments received on the proposed rules during the comment period were from individuals; the Board of Nurse Examiners; Bowie Memorial Hospital; ContinuCare; Guiding Light Health Care, Inc.; Gulf Gate Health Care Agency; Heart of the Hills Hospice; Lee HealthCare; Nurse's House Call; Nurses In Touch Home Health; St. Luke's Episcopal Hospital; Texas Association for Home Care; Texas Hospital Association; and Visiting Nurse Association, Dallas. The commenters were neither for or against the rules in their entirety; however, they raised questions, offered comments for clarification concerns, and made recommendations concerning specific provisions in the rules. The amendments are adopted under the Health and Safety Code, sec.142.012, which provides the Texas Board of Health (board) with the authority to adopt rules to establish and enforce minimum standards for the licensing of home health agencies; and sec.12.001 which provides the board with authority to adopt rules for the performance of every duty imposed by law upon the board, the department, and the commissioner of health. sec.115.2. Definitions. The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise. Certified copy -A sworn affidavit stating that attached copies are true and correct copies of original documents. Delegation-The act of authorizing an unlicensed person to provide nursing services while retaining accountability for the outcome. It does not include situations in which an unlicensed person is directly assisting an registered nurse (RN) by carrying out nursing tasks in the presence of an RN. Registered nurse (RN)-A person who is currently licensed under the laws of this state as a registered nurse. Stable and predictable -A situation where the patient's clinical and behavioral status and nursing care needs are determined by the RN to be nonfluctuating and consistent, including hospice settings where the patient's deteriorating condition is expected. This term does not include any situation where the patient's clinical and behavioral status is changing and where frequent reassessment by an RN is needed. Unlicensed person -An individual who is not licensed as a health care provider and who functions in a complementary or assistive role to the RN in providing direct patient care or carrying out common nursing functions. The term includes, but is not limited to, home health aides, medication aides permitted by the department, and other individuals providing personal care or assistance in health services. sec.115.6. Inspections. (a) An on-site inspection shall determine if the requirements of the statute and this chapter are being met. The department or its authorized representatives may enter the premises of a license applicant or license holder at reasonable times to make an inspection incidental to the issuance of a license, and at other times as it considers necessary to insure compliance with the statute and the rules adopted under the statute. A standard-by-standard evaluation is required before the initial annual license is issued unless waived at the discretion of the department. At the discretion of the department, an on-site inspection may be conducted for renewal of a license or issuance of a branch office license. (b)-(f) (No change.) sec.115.8. Standards for All Agencies (Classes A and B). (a)-(l) (No change.) (m) An agency that provides laboratory services must meet the requirements of Federal Public Law 100-578, Clinical Laboratory Improvement Amendments of 1988 (CLIA 1988). CLIA 1988 applies to all agencies with laboratories that examine human specimens for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. (n) On or before September 1, 1993, an agency shall adopt, implement, and enforce a written policy for publicly known natural disaster preparedness for patients receiving home health services. The written policy shall include a plan for the reasonable mechanism for triaging patients, the notification of appropriate personnel and patients in the event of a disaster if possible, the identification of appropriate community resources, and the identification of possible evacuation procedures. The plan need not require that the agency actually evacuate, transport, or triage the patients. (o) A registered nurse (RN) may delegate nursing tasks to unlicensed persons and shall provide supervision of all nursing tasks delegated to unlicensed persons in accordance with this subsection. (1) When the RN delegates nursing tasks to an unlicensed person, the RN or another equally qualified RN (for the purposes of supervision of an unlicensed person) shall be available in person or by telecommunication and shall make decisions about appropriate levels of supervision as follows. (A) In situations where nursing care is provided in the patient's residence and the RN is required to assess, plan, intervene, and evaluate the patient's unstable and unpredictable condition and need for skilled nursing services, the RN shall be responsible for the nursing care rendered and shall make supervisory visits at least every two weeks. The RN shall assess the services provided by the unlicensed person to the patient to determine whether health care goals and orders are being met. (B) In situations where the patient is stable and predictable, the RN shall make supervisory visits when, in consultation with the patient, and when appropriate, family and significant others, the RN determines it is necessary to assure that safe and effective services are provided. The ability or desire of the patient to participate in the supervision of the care provided by the unlicensed person should be considered when establishing the frequency of supervisory visits. (C) The degree of supervision shall be determined after a documented evaluation of appropriate factors including, but not limited to: (i) the stability of the condition of the patient; (ii) the training and capability of the unlicensed person to whom the nursing task is delegated; (iii) the nature of the nursing task being delegated; and (iv) the proximity and availability of the RN to the unlicensed person when the nursing task will be performed. (2) The RN delegating nursing tasks to unlicensed persons shall comply with the following requirements. (A) The RN must make an assessment of the patient's nursing care needs. The RN should, when the patient's condition allows, consult with the patient to identify the patient's nursing needs prior to delegating nursing tasks. (B) The nursing task must be one that a reasonable and prudent RN would find is within the scope of sound nursing judgment to delegate. (C) The nursing task must be one that, in the opinion of the delegating RN, can be properly and safely performed by the unlicensed person involved without jeopardizing the patient's welfare. The RN delegates nursing tasks based on the needs of the client and the knowledge and skills of the individual selected to perform such tasks. (D) The nursing task must not require the unlicensed person to exercise nursing judgment or intervention except in emergency situations. (E) The unlicensed person to whom the nursing task is delegated must be adequately identified. The identification may be by individual or, if appropriate, by training, education, and/or certification of the unlicensed person. (F) The RN shall have either instructed the unlicensed person in the delegated task or verified the unlicensed person's competency to perform the nursing task. (G) The RN shall adequately supervise the performance of the delegated nursing task in accordance with the requirements of this subsection. (H) The RN shall be accountable and responsible for the delegated nursing tasks. (3) The following nursing tasks are within the scope of sound professional nursing practice to be delegated by an RN to an unlicensed person after consideration of the training and capability of the unlicensed person: (A) non-invasive and non-sterile treatments unless otherwise prohibited by this subsection; (B) the collecting, reporting, and documentation of data including, but not limited to: (i) vital signs, height, weight, intake and output, dip stick tests for glucose and dip stick tests for blood results; (ii) changes from baseline data established by the RN; (iii) environmental situations; (iv) patient or family comments relating to the patient's care; and (v) patient behaviors related to the care; (C) ambulation, positioning, and turning; (D) transportation of the patient within a facility; (E) personal hygiene and elimination, including vaginal irrigations and cleansing enemas; (F) feeding, cutting up of food, or placing of meal trays; (G) socialization activities; (H) activities of daily living which include bathing, dressing, grooming, routine hair and skin care, meal preparation, feeding, exercising, toileting, transfer/ambulation, and assistance with self-administered medications; and (I) reinforcement of health teaching planned and/or provided by the registered nurse. (4) The following nursing tasks are not usually within the scope of sound professional nursing practice to delegate and may be delegated by an RN to an unlicensed person only in accordance with paragraph (5) of this subsection: (A) sterile procedures involving a wound or an anatomical site which could potentially become infected; (B) non-sterile procedures, such as dressing or cleansing penetrating wounds and deep burns; (C) invasive procedures such as inserting tubes in a body cavity; and (D) care of broken skin other than minor abrasions or cuts generally classified as requiring only first aid treatment. (5) The nursing tasks listed in paragraph (4) of this subsection may be delegated by an RN to an unlicensed person only: (A) under circumstances where a reasonably prudent RN would find that the delegation does not jeopardize the patient's safety or welfare; (B) if, in the judgment of the RN, the unlicensed person has the appropriate knowledge and skills to perform the nursing task(s) in a safe and effective manner; (C) if the RN delegating the task is directly responsible for the nursing care given to the patient; and (D) if the agency follows a current written protocol for the instruction and training of unlicensed persons performing nursing tasks under this paragraph and the protocol: (i) was developed with input from the registered nurses currently employed or under contract by the agency; (ii) states the manner in which the instruction addresses the complexity of the delegated task; (iii) states the manner in which the unlicensed person demonstrates competency of the delegated task: (iv) states the mechanism for reevaluation of the competency; (v) contains an established mechanism for identifying the unlicensed persons to whom nursing tasks may be delegated under this paragraph; and (vi) recognizes that the final decision as to what nursing tasks can be safely delegated in any specific situation is within the specific scope of the RN's professional judgment. (6) The following nursing tasks are not within the scope of sound professional nursing practice to be delegated by an RN to an unlicensed person: (A) a physical, psychological, or social assessment which requires professional nursing judgment, intervention, referral, or follow-up; (B) the formulation of a treatment plan or patient care plan and evaluation of the patient's response to the care rendered; (C) specific tasks involved in the implementation of the plan of care which require professional nursing judgment or intervention, except in emergencies; (D) the responsibility and accountability for patient health teaching and health counseling which promotes patient education and involves the patient's significant others in accomplishing health goals; and (E) the administration of medications except as permitted by sec.115.19 of this title (relating to Home Health Medication Aides). (p) An agency shall adopt, implement, and enforce a policy on pronouncement of death if that function is carried out by an agency RN. The policy shall be in compliance with the Health and Safety Code, sec.671.001. sec.115.10. Standards for a Class B License. (a) (No change.) (b) Organizational structure and operational policies of the agency must be clearly stated in writing. An agency shall adopt, implement, and enforce its operational policies. It must include the lines of authority and delegation of responsibility down to the patient care level and the services provided. (1) (No change.) (2) Personnel policies are developed in writing, shall be enforced by the agency, and must contain the following: (A)-(F) (No change.) (3) A personnel record shall be maintained on each employee. A personnel record should include, but not be limited to, the following: job description; qualifications; application for employment; verification of license, permits, references, job experience, and educational requirements as appropriate; performance evaluations and disciplinary actions; or letters of commendation. All information should be kept current. In lieu of the job description and qualifications for employment, the personnel record may include a statement signed by the employee that the employee has read the job description and qualifications for the position accepted. The original personnel record must be maintained in the parent agency. (4) If an agency utilizes independent contractors, there shall be a written agreement between such independent contractors (i.e. per hour, per visit) and the agency . The agreement shall be enforced by the agency and clearly designate: (A)-(H) (No change.) (5) (No change.) (c) The agency shall maintain a current roster of patients and have a clinical record for each patient which is maintained according to professional standards. (1) A clinical record shall contain appropriate identifying information; name of practitioner; treatment plan (which shall include as applicable medication, dietary, treatment, and activities orders) or a patient care plan; clinical and progress notes (clinical notes are written the day service is rendered and incorporated no less often than weekly); medication sheet; and record of supervisory visits. The following shall be included if applicable: medication administration record; record of patient care conference; written statements regarding consumer complaints; acknowledgement of receipt of a copy of the Human Resources Code, Chapter 102, Rights of the Elderly; patient request for and acknowledgement of home health medication aides; and discharge summary. All entries shall be signed and dated by the person making the entry and/or supervisory personnel as is necessary. (2) Records shall be retained for five years and safeguarded against loss and unofficial use. The agency shall have written procedures which are enforced governing the use and removal of records and the release of information. (3) (No change.) (4) The original, microfilmed, optical disc imaging system, or certified copy of the clinical record shall be maintained at the parent or the branch office, as appropriate. If the clinical record is microfilmed, the microfilm and the equipment needed to read the record must be accessible at the time of the on- site inspection of the home health agency. (d) (No change.) (e) The agency must have a written contingency plan which is implemented in the event of dissolution for continuity of patient care. All records shall be retained even if the agency discontinues operations. (f) The agency shall accept a patient for health services on the basis of a reasonable expectation that the patient's medical, nursing, and social needs can be met adequately in the patient's residence. The agency shall commence providing home health services to a patient within a reasonable time from acceptance of the patient. The commencement of home health services shall be based on the patient's health service needs. (1) An initial assessment shall be performed in the patient's residence by the appropriate health care professional prior to or at the time that home health services are initially provided to the patient. The assessment shall determine whether the agency has the ability to provide the necessary services in the home. (A) If a practitioner has not ordered skilled care for a patient, then the appropriate health care professional shall prepare a patient care plan. The patient care plan shall be developed after consultation with the patient and/or the patient's family and shall include potential services to be rendered; the frequency of visits and/or hours of service; the assignment of health care personnel; and identified problems, method of intervention, and date of resolution. The patient care plan is revised as necessary, but it shall be reviewed and updated by all appropriate staff members involved in patient care at least annually. (B) If a practitioner orders skilled treatment, then the appropriate health care professional shall prepare a treatment plan. The treatment plan must be signed and approved by a practitioner in a timely manner. The plan of treatment shall be developed in conjunction with agency staff and shall cover all pertinent diagnoses, including mental status, types of services and equipment required, frequency of visits at the time of admission, prognoses, functional limitations, activities permitted, nutritional requirements, medications and treatments, any safety measures to protect against injury, and any other appropriate items. The treatment plan shall be revised as necessary, but it shall be reviewed and updated at least every six months. An agency shall adopt, implement, and enforce a policy on the time frame for the timely countersignature of a practitioners' verbal orders. (2) The agency will inform the patient and/or his family in writing of the terms of their agreement for services and obtain an acknowledgement of receipt of the agreement. The agency shall comply with the terms of the agreement. The agreement shall include, but not be limited to, the following: (A)-(D) (No change.) (g) A clinical record or minutes of care conferences shall show that effective interchange, reporting, and coordination of patient care occurs. An agency shall adopt, implement, and enforce a policy on documentation of coordination of patient care. (h) (No change.) (i) An agency shall provide at least one health service. All services shall be rendered and supervised by qualified personnel. (1) If nursing service is provided, a registered nurse shall be employed by or under contract with the agency to provide services and/or supervision. The administrator shall designate a registered nurse to serve as an alternate. (2)-(6) (No change.) (7) If home health aide service is provided, a home health aide shall be employed by or under contract with the agency to provide home health aide services; and a registered nurse shall be employed by or under contract with the agency to perform the initial assessment, prepare the patient care plan, as appropriate, and supervise the home health aide. (8) (No change.) (9) If home health medication aide services are provided, a home health medication aide shall be employed by the agency to provide home health medication aide services, and a registered nurse shall be employed by or under contract with the agency to perform the initial assessment; prepare the patient care plan; establish the medication sheet, medication record, and medication aide assignment sheet; and supervise the home health medication aide. sec.115.17. Branch Offices. (a)-(c) (No change.) (d) A person who holds a Class B agency license who applies for a branch office license shall meet the following requirements for the branch office. (1) On-site supervision will be conducted by the parent agency of the branch office at least monthly. More frequent supervision may be required considering the size of the service area and the scope of approved services provided by the parent agency. Supervision will be provided by the administrator and/or appropriate licensed professional personnel. The supervisory visits must be documented and include the date of the visit; the content of the consultation; the individuals in attendance; and the recommendations of the staff. (2) Original personnel files are to be kept in the parent agency. (3) The original, microfilmed, optical disc imaging system, or certified copy of the clinical records for each patient may be kept at the branch or parent agency, as determined by the agency. Duplicate records are not required. (4) Branch office clinical records shall be accessible and readily retrievable for inspection by the department. (e) (No change.) (f) A branch office may offer fewer health services than the parent office but may not offer health services that are not also offered by the parent agency. sec.115.19. Home Health Medication Aides. (a) (No change.) (b) Required actions. (1) The registered nurse (RN) shall be knowledgeable regarding the rules of the Texas Department of Health governing home health medication aides and shall assure that the home health medication aide is in compliance with the statute. (2) A permit holder must: (A) function under the supervision of a registered nurse; the RN shall make a supervisory visit while the medication aide is in the patient's residence at least weekly or when any change in medication regimen is ordered if the patient is not stable and predictable or the patient's medication changes; (B) function in accordance with applicable law and this chapter relating to administration of medication and operation of the home health agency; (C) comply with department rules applicable to personnel used in a home health agency; and (D) comply with this section and sec.115.13 of this title (relating to Home Health Aides; Training Course; Duties) if the person will be used as a home health aide and a home health medication aide. (c) (No change.) (d) Prohibited actions. Permit holders shall not: (1)-(6) (No change.) (7) administer medications or feedings by way of a tube inserted in a cavity of the body; (8)-(16) (No change.) (e) -(j) (No change.) (k) Determination of eligibility. The department shall receive and approve or disapprove all applications. Notices of application approval, disapproval or deficiency shall be in accordance with subsection (q) of this section. (1) (No change.) (2) If, after review, the department determines that the application should not be approved, the director shall give the applicant written notice of the reason for the proposed decision and of the opportunity for a formal hearing in accordance with subsection (r) of this section. (l)-(p) (No change.) (q) Processing procedures. The department shall comply with the following procedures in processing applications of home health medication aide permits and renewal of permits. (1)-(2) (No change.) (3) In the event an application is not processed in the time period stated in subsection (a) of this section, the applicant has the right to request reimbursement of all fees paid in that particular application process. Request for reimbursement shall be made to the director of the Home Health Medication Aide Permit Program. If the director of the Home Health Medication Aide Permit Program does not agree that the time period has been violated or finds that good cause existed for exceeding the time period, the request will be denied. (4) (No change.) (5) If a request for reimbursement under paragraph (3) of this subsection is denied by the director of the Home Health Medication Aide Permit Program, the applicant may appeal to the commissioner of the department for a timely resolution of any dispute arising from a violation of the time periods. The applicant shall give written notice to the commissioner at the address of the department that he or she request full reimbursement of all fees paid because his or her application was not processed within the applicable time period. The director of the Home Health Medication Aide Permit Program shall submit a written report of the facts related to the processing of the application and of any good cause for exceeding the applicable time period. The commissioner shall provide written notice of the commissioner's decision to the applicant and the director of the Home Health Medication Aide Permit Program. An appeal shall be decided in the applicant's favor if the applicable time period was exceeded and good cause was not established. If the appeal is decided in favor of the applicant, full reimbursement of all fees paid in that particular application process shall be made. (6) (No change.) (r) Denial, suspension, or revocation. (1)-(3) (No change.) (4) If the director for the Home Health Medication Aide Permit Program proposes to deny, suspend, or revoke a home health medication aide permit or to rescind a home health medication aide program approval, the Director shall notify the permit holder or home health medication aide program by certified mail, return receipt requested, of the reasons for the proposed action and offer the permit holder or home health medication aide program an opportunity for a hearing. (A) (No change.) (B) The request must be in writing and submitted to the Director, Home Health Medication Aide Permit Program, Health Facility Licensure and Certification Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756. (C) (No change.) (5)-(9) (No change.) This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on May 26, 1993. TRD-9323449 Robert A. MacLean, M.D. Deputy Commissioner Texas Department of Health Effective date: July 1, 1993 Proposal publication date: March 2, 1993 For further information, please call: (512) 458-7236 Chapter 289. Radiation Control Texas Regulations for Control of Radiation 25 TAC sec.289.127 The Texas Department of Health (department) adopts sec.289.127, without changes to the proposed text as published in the February 26, 1993, issue of the Texas Register (18 TexReg 1245) and with changes to the material the section adopts by reference. The section adopts by reference Part 46 of the Texas Regulations for Control of Radiation (TRCR) titled, "Licensing of Naturally Occurring Radioactive Material (NORM)." NORM which is present in most soils and minerals is not to be regulated. However, there are certain processes that concentrate NORM to levels far above those existing as background radiation and above which similar radioactive material classified as source or byproduct material is regulated. Concentrated NORM can increase risk from direct exposure, increased radon concentration, inhalation, and ingestion. Part 46 contains sections which address worker protection; exemptions of materials that pose insignificant risk; release criteria for equipment for unrestricted use; activities to be included under a general license and provisions for use of the general license; and activities requiring a specific license and regulations concerning specific licensure. Several wording changes were made to Part 46 to further clarify the intent of the section and to provide consistency with other sections of the TRCR. The words "equal to or greater than" were added to 46.4(a)(1)(ii)(a) and (b) to clarify the intended range for the radon emanation rate. The wording in 46.4(a) (2) was changed to "Materials in the recycling process contaminated with scale or..." for further clarification of the intent of the section. The wording in 46.10(b), 46.20(b), and footnote "g" of Appendix 46-A was expanded to clarify that the surface contamination levels in Appendix 46-A are not intended for equipment or land. Also, the wording in Appendix 46-A, footnote "a", was clarified to eliminate confusion. The first two words of 46.2 were deleted and replaced with "The rules in this part..." for clarification and consistency with other sections of the TRCR. Throughout the section, the term "U.S. Nuclear Regulatory Commission" was shortened to "Commission" to reflect the definition in TRCR Part 11 and for consistency throughout the TRCR. The wording in 46.40 was changed to reflect the current wording concerning reciprocity in TRCR Part 41, "Licensing of Radioactive Material" for consistency throughout the TRCR. In addition, the department reformatted 46.4(a)(1)(iii) the same as 46.4 (a)(1)(i) and (ii) to address soil and media other than soil. Section 46.20(b) (2) was deleted because the described activities should be licensed under TRCR Part 44, "Licensing of Radioactive Waste Storage and Processing Facilities." The words "disposing of" in 46.22(b)(2)(iv) were changed to "managing" to more accurately reflect the authority of the department. Appendix 46-A, footnote "b" was modified to delete the reference to 46.5 and to add gamma radiation to the types of radiation to be detected. The following comments were received concerning the proposed amendment. Comment. Six commenters expressed support of the proposed amendment. Response. The department acknowledged their support. Comment. Two commenters questioned why the maximum reciprocity period is specified as one year. One of the commenters also asked whether a specific licensee in another Agreement State entering Texas under reciprocity would be granted a general license or be given a letter authorizing work in Texas under the specific license issued by another Agreement State. Response. The department's response is to change the wording in 46.40 to reflect the current wording concerning reciprocity in TRCR Part 41. This provides consistency in the reciprocity time period. A company working in Texas under reciprocity is granted a general license to conduct the activities authorized in a licensing document from another Licensing State or Agreement State. Comment. Three commenters expressed concern about the exemption level of 50 microroentgens per hour including background for equipment containing NORM. Their concerns were that the background in some places in the state is that high and that equipment may be exempt when surveyed in one area and not exempt if surveyed in another due to the background radiation levels. Response. The department's response is that the background radiation levels in Texas range from two to ten microroentgens per hour, as determined by the results of the department's statewide monitoring program. Even with varying geographical conditions across the state, the 50 microroentgens per hour exemption level allows a sufficient safety margin, including background. Based upon the types of industry in Texas and the large volume of equipment that could contain NORM, it is more practical to allow a sufficient safety margin and thus eliminate the variability in attempts to characterize background. The department made no change to the section as a result of the comments. Comment. One commenter noted the absence of a specific license fee for NORM and for reciprocity. Response. The department's response is that schedules of annual fees for all categories of radioactive material licenses and certificates of registration are contained in TRCR Part 12, "Fees for Certificates of Registration, Radioactive Material(s) Licenses, Emergency Planning and Implementation, and Other Regulatory Services." The department made no change to the section as a result of the comment. Comment. One commenter noted that the first sentence of 46.1 states that the section establishes radiation protection standards for the possession, use, transfer, transport and/or storage of NORM, yet stated that the section does not contain standards for transport and/or storage. The commenter also noted that the last sentence of this section states that the requirements of the section "...are in addition to and not in substitution for other applicable requirements of Parts 11, 12, 13, 21, 22, and 41 of these rules." The commenter stated that in certain cases, such as with the soil contamination limits established in 21.108, these other parts appear to conflict with provisions of Part 46. Response. The department's response to those comments are as follows: Provisions for storage and/or transport are addressed under the general license section in 46.10 or the specific license section in 46.20, therefore the wording in 46.1 is appropriate. The department made no change to the rule as a result of the first comment. The department agrees with the commenter's second point and changed the wording in 21.108 (which is also a proposed rule) to read, "Except for the requirements in Part 46 of these rules and notwithstanding..." Comment. A commenter suggested that the first paragraph of 46.2 begin with the same words as the second paragraph so it is clear that only Part 46 rules are being referenced. Response. The department agrees and has changed the section as per the commenter's suggestion. Comment. One commenter suggested defining "transfer" as the "exchange of ownership." Response. The department's response is that as used throughout the TRCR, "transfer" does not necessarily mean "exchange of ownership." It can also indicate change of possession or location but not ownership. The department made no change to the rule as a result of the comment. Comment. Three commenters recommended that the exemptions in 46.4 not refer to radon emanation rates because they are difficult and expensive to measure in the field and because a report concluded that radon emanation rates from soil and oilfield waste materials containing 30 picocuries per gram of radium-226 will not exceed 20 picocuries per meter squared per second. One commenter stated that if the department decided to retain the radon emanation rates in rule, the department should develop a list of specific types of NORM known to have low emanation rates. Further, if the department does not develop such a list, the commenter believes that the department should incorporate into Part 46, with opportunity for public comment, specific methodology for measurement of radon emanation. Response. The department's response is that the department does intend to develop a regulatory guide to accompany Part 46 which will include a list of types of NORM that, because of physical characteristics, are known not to exceed the 20 picocuries per meter squared per second emanation rate. The department made no change to the section as a result of the comment. Comment. Three commenters stated that the language in 46.4(a)(1)(ii) should refer to radon emamantion rates equal to or greater than 20 picocuries per meter squared per second. Response. The department agrees has made the change as per the commenters' suggestion. Comment. One commenter suggested that the phrase "media other than soil" in 46.4 be revised or defined so it is clear that it refers to solids and semi- solids, not to fluids such as produced water. Response. The department's response is that produced waters are specifically addressed in 46.4(f) and therefore the term "media other than soil" needs no further clarification. The department made no change to the section as a result of the comment. Comment. One commenter noted that 46.4(a)(1)(iii) establishes 150 picocuries per gram as the exemption level for radionuclides other than radium-226 and radium-228, but does not include a quantity or area over which the concentration is to be measured, such as exists for soil contaminated with radium. Response. The department agrees and has changed the section to address other NORM radionuclides in soil and in media other than soil. Comment. Two commenters stated that 46.4(a)(2) should be revised to clarify that the exemption applies to the recycling of materials which are contaminated with scale or residue, rather than the direct recycling of scale or residue material. One of the commenters suggested the following wording: "Materials in the recycling process contaminated with scale or residue not otherwise..." Response. The department agrees and has changed the section as per the commenter's suggestion. Comment. One commenter stated that under 46.4(a)(1)(i)(a) and (b), NORM- contaminated materials should also be exempt from the requirements of the section if the materials contain or are contaminated at a concentration greater than 30 picocuries per gram of radium-226 or radium-228, and if the materials in question also meet air and water (including radon and leaching) pathway exemptions such as the state of Oregon's Gamma Pathway Exemption Interpretive Rule OAR 345-50-035 and OAR 345-50-036, in order to demonstrate no significant risk. The commenter concluded that a variety of criteria, such as computer modeling or a direct ratio of radon half lives, can be used to obtain a higher exemption level for radium-228, which would maintain acceptable safety standards, yet reflect the lower exposure hazard as compared with radium-226. Response. The department's response is that there is not yet sufficient data currently in existence from actual surveying and sampling to warrant an exempt concentration greater than 30 picocuries per gram for radium-226 or radium-228. The 30 picocurie per gram exemption level already takes into account the lower radon emanation rates from types of NORM which have crystalline or glassified physical form. Also, the commenter cites Oregon rules and the department would prefer to use data specific to the environment in Texas, since the concentrations of radium-226 and radium-228 in NORM appear to differ with differing geographic regions. The department made no change to the section as a result of the comment. Comment. One commenter suggested that the rules define to what energies meters should be calibrated. As an example, the commenter cited meter readings which vary depending on whether a meter is calibrated to a radium-226 source or a cesium-137 source. The commenter suggested cesium-137 be made the standard source. Response. The department's response is that the current requirements for survey instruments to be calibrated at energies appropriate for the licensee's use adequately addresses the appropriate energies. The department made no change to the section as a result of the comment. Comment. Four commenters expressed confusion concerning the applicability of the exemption for equipment in 46.4(a)(2) and Appendix 46-A. One commenter suggested that 46.10(b) be revised to clarify that Appendix 46-A does not apply to facilities and equipment which are exempt under 46.4, as follows: "Facilities and equipment not otherwise exempted under the provisions of 46.4 which are contaminated with NORM..." Response. The department agrees and has expanded the wording in 46.10(b), 46.20(b), and Appendix 46-A, footnote "g" to clarify that the surface contamination levels in Appendix 46-A are not intended for equipment or land. Equipment and land is exempt if below the radiation levels in 46.4, and if they must be decontaminated for release for unrestricted use, they must be decontaminated such that the radiation levels do not exceed those in 46.4. Comment. Three commenters noted that 46.10(b) could be interpreted to mean that a contractor under the control and supervision of a general licensee cannot remove NORM-contaminated material from equipment, facilities, or land controlled by the general licensee. The commenters stated that the wording of the section should be changed to allow general licensees and contractors working for general licensees to decontaminate during the course of routine maintenance. Response. The department's response is that the intent of the section is that contractors performing activities specified in 46.20 be specifically licensed. The department made no change to the section as a result of the comments. Comment. A commenter stated that general licensees or contractors of a general licensee should be allowed to perform disposal operations such as downhole disposal (in a Class II well) on the general licensee's property. Response. The department's response is that the authority to regulate the disposal of radioactive substances was transferred to the Texas Water Commission (TWC) on March 1, l992. Downhole disposal and any other disposal options must be authorized by TWC. The department made no change to the section as a result of the comment. Comment. One commenter stated that 46.11 could be interpreted to imply that Part 46 general licensees are only obligated to comply with those sections of Part 21 specifically listed in 46.11 and asked for clarification. Response. The department's response is that the intent of the section is to require general licensees to comply with the specific sections of Part 21 listed in 46.11 and with all of Part 22. The department made no change to the section as a result of the comment. Comment. One commenter expressed concern over the deletion of the authorization for disposal of pumpable NORM into a Class II permitted well and stated that this option should be adopted into the TWC regulations on NORM disposal. The commenter also asked whether movement of NORM waste from facility to facility, when both facilities are owned by the same general license or company, constitutes "transfer." Response. The department's response is that since the authority to regulate the disposal of radioactive substances was transferred to TWC, downhole disposal and any other disposal must be authorized by TWC. The department will forward the commenter's concerns to TWC. Section 46.10(b) allows for the transfer of NORM from one general licensee to another general licensee under certain conditions. The department made no change to the section as a result of the comment. Comment. A commenter stated that the authority to regulate the transfer of waste for disposal is under the TWC and recommended that 46.11 not address alternative methods of disposal but leave those to the TWC to address in pending regulations. The commenter also stated that it is not clear how provisions of Part 21 will apply to recording and manifesting NORM transfers and disposal and suggested the TWC address these issues in their regulations. Response. The department's response is that TWC has jurisdiction over disposal of radioactive substances. TWC would therefore have the responsibility for licensing a disposal site or specifying disposal options. Management and transfer of wastes prior to actual disposal is under the authority of the department. The requirements for recording and manifesting waste transfers are specified in Part 21, which TWC has also adopted by reference. The department made no change to the section as a result of the comments. Comment. A commenter suggested that the language in the first sentence of 46.20(b) be expanded to include a reference to contaminated land, since land is mentioned in 46.20(b)(1). Response. The department agrees and has changed the section as per the commenter's suggestion. Comment. One commenter noted that 46.22(b)(2)(iv) requires that an applicant for a specific license address the methods of disposing of NORM removed from contaminated equipment and facilities. In many cases, the specific licensee will be employed to remove NORM from equipment but not to dispose of it. The owner or operator of the equipment will be responsible for selecting an authorized disposal method, subject to TWC regulations and that method of disposal may not have been determined at the time the equipment is being decontaminated by the specific licensee. Response. The department agrees and has changed the words "disposing of" in 46.22(b)(2)(iv) to "managing" to more accurately reflect the intent of the section. Comment. One commenter stated that the first sentence of 46.40 should be reworded as follows to correct the misapplication of the term "these rules," which carries specific meaning as it is defined in Part 11: "Subject to the following conditions, any..." Response. The department agrees and has changed the section to reflect the commenter's suggestion. Comment. Four commenters expressed confusion over footnote a of Appendix 46-A and how the levels in the appendix apply to alpha and beta radiations. Response. The department agrees and has simplified the wording of footnote "a". The average limit of 5,000 disintegrations per minute per 100 square centimeters applies to both alpha and beta radiations, not 5,000 for one type and an additional 5,000 for the other. Comment. Two commenters questioned the apparent conflict between footnote b of Appendix 46-A and 46.5 and the absence of gamma radiation since it is the type of radiation routinely detected by NORM surveys. Response. The department agrees and has modified the section to delete the reference to 46.5 and to add gamma radiation. Comment. One commenter asked whether a specific licensee in another Agreement State working in Texas under reciprocity would be responsible for submitting financial security to Texas. Response. The department's response is that 46.50 specifically states that financial security must be posted by a licensee or applicant for licensure under 46.22. Companies working in Texas under reciprocity are not licensed pursuant to 46.22. The requirements of 46.50 thus do not apply to out-of-state licensees working under reciprocity. The department made no change to the section as a result of the comment. Comment. Two commenters recognized that TWC has jurisdiction over the regulation of NORM waste disposal and wished to emphasize to TWC the importance of allowing generators of NORM wastes as many economically feasible options for disposal as possible. Response. The department's response is to acknowledge the commenters' remarks and forward them to TWC. The department made no change to the section as a result of the comments. Comment. Two commenters stated that in Louisiana, specific licensees cannot store NORM waste for their customers for more than 30 days. The commenter stated that the longer the licensees are allowed to store waste for their customers, the better, because 30 days is not long enough to decontaminate, store, manifest, and transport the NORM waste. The commenters suggested that if the department puts limits on the length of storage, that limit should not be less than 90 days and that six months might be more feasible. Response. The department's response is that the proposed section does not limit the length of time a specific license can store NORM waste and the department is not inclined to include a time restriction in the section because of the very limited options currently available for disposal of NORM waste. The department made no change to the section as a result of the comments. Comment. One commenter asked if the exemption levels in the section were based upon protection of the public health and safety by using a dose to the general public and then back-calculating to arrive at the exemption levels. The commenter also wondered if the items in 46.4(c) and (d) were exempted because they fall below the exemption levels in 46.4(a). Response. The department's response is that the exempt concentration levels in 46.4(a) reflect the current soil contamination limits in 21.108(c). These limits were based on the Environmental Protection Agency's soil contamination limits in 40 CFR 192 which were based on exposures from uranium mill tailings piles. Realizing that the radon emanation fraction from many types of NORM is significantly lower than from mill tailings, the 30 picocuries per gram exemption (with the specified radon emanation fraction) was derived from the Appendix 21-A maximum concentration for radium-226 (using grams instead of milliliters). The exemption level in 46.4(a)(1)(i) was analyzed by the department using a computerized program from the U.S. Department of Energy for modeling residual radioactive material. This concentration in soil, averaged over 100 square meters and a depth of 15 centimeters, gives a dose of approximately 100 millirem per year. The items exempted in 46.4(c) and (d) generally fall below the concentrations in 46.4(a). The department made no change to the section as a result of the comment. Comment. One commenter cited experience in Louisiana in which removal of NORM contamination also involved handling of hazardous waste. In Louisiana, handlers of hazardous waste are not allowed to handle NORM waste and vice versa and the commenter asked that this issue be addressed in this section. Response. The department's response is that the department has no jurisdiction over hazardous waste and therefore cannot address such in this section. The department made no change to the section as a result of the comment. Representatives from Pine Street Salvage Company in Abilene, Odessa Metals, Inc. in Odessa, J.L. Proler Iron & Steel Company in Houston, Mayne Machinery Company, Inc. in Waco, TU Electric in Dallas, and Exxon Company, USA in Houston offered comments in support of the proposed amendment. Representatives from Central Environmental, Inc. in Houston, Texas Mid-Continent Oil & Gas Association in Austin, Du Pont Chemicals in Wilmington, Delaware, Exxon Company, USA in Houston, North Texas Oil & Gas Association in Wichita Falls, Nuclear Waste Management, Inc. in Chattanooga, Tennessee, Waste Environmental Services and Technology in Amarillo, NORMCO in Houston, HP Consulting in Houston, Texcor, Inc. in Bracketville, and Oilfield Testers in Kenner, Louisiana presented comments, questions, and suggestions for changes to the proposed amendment as discussed in the summary of comments. A representative from TN Technologies in Round Rock expressed opposition to several sections of the proposed section but declined to specify what sections or reasons for opposition. The amendment is adopted under the Health and Safety Code, Chapter 401, which provides the Board of Health with the authority to adopt rules and guidelines relating to the control of radiation; and sec.12.001, which authorizes the board to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health. sec.289.127. Adoption by Reference. (a) The Texas Department of Health adopts by reference Part 46, "Licensing of Naturally Occurring Radioactive Material (NORM)" of the Department's document titled Texas Regulations for Control of Radiation, as amended in July 1993. (b) The document adopted by reference in this section is indexed and filed in the Bureau of Radiation Control, Texas Department of Health, The Exchange Building, 8407 Wall Street, Austin, Texas 78754 and is available for public inspection during regular working hours. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on May 24, 1993. TRD-9323388 Robert A. MacLean,M.D. Deputy Director Texas Department of Health Effective date: July 1, 1993 Proposal publication date: February 26, 1993 For further information, please call: (512) 458-7236 TITLE 31. NATURAL RESOURCES AND CONSERVATION Part I. General Land Office Chapter 1. Executive Administration Vacancies 31 TAC sec.1.3 The General Land Office adopts an amendment to sec.1.3, concerning fees for reproductive costs and for grants of coastal easements to homeowners' associations, without changes to the proposed text as published in the April 13, 1993, issue of the Texas Register (17 TexReg 2466). Section 1.3 is amended in order to clarify the General Land Office fee schedule and provide for rental rates commensurate with the use of state property. Reproduction rates will be reflective of the cost of the service, and the rental rates for the use of state property will commensurate with the extent of the usage for all users, including homeowners' associations. No comments were received regarding adoption of the amendment. The amendment is adopted under the Natural Resources Code, sec.sec.31.064, 31. 051, and 33.063, which provides the General Land Office with the authority to set and collect fees and make and enforce rules consistent with the law. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on May 25, 1993. TRD-9323404 Garry Mauro Commissioner General Land Office Effective date: June 15, 1993 Proposal publication date: April 13, 1993 For further information, please call: (512) 463-5007 TITLE 37. PUBLIC SAFETY AND CORRECTIONS Part XIII. Texas Commission on Fire Protection Chapter 531. Fire Alarm Rules 37 TAC sec.sec.531.14-531.16, 531.22 The Texas Commission on Fire Protection adopts the repeal of sec.sec.531. 14- 531.16 and 531.22, concerning regulation of the business of inspecting, planning, certifying, leasing, selling, servicing, testing, installing, monitoring, and maintaining fire alarm or fire detection devices and systems, without changes to the proposed text as published in the December 8, 1992, issue of the Texas Register (17 TexReg 8513). The repeal of these rules allows for replacement of obsolete language. The sections adopted for repeal will be replaced by new sections relating to the same subject matter published in the December 8, 1992, issue of the Texas Register (17 TexReg 8513). No comments were received regarding adoption of the repeals. The repeals are adopted under the Insurance Code, Article 5.43-2, sec.4, 4A, and 6, which provides the Texas Commission on Fire Protection with the authority to adopt rules necessary to its administration through the state fire marshal for the protection and preservation of life and property. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on May 24, 1993. TRD-9323432 Jack Woods General Counsel Texas Commission on Fire Protection Effective date: June 16, 1993 Proposal publication date: December 8, 1992 For further information, please call: (512) 873-1700 TITLE 40. SOCIAL SERVICES AND ASSISTANCE Part I. Texas Department of Human Services Chapter 15. Medicaid Eligibility Subchapter E. Income The Texas Department of Human Services (DHS) adopts amendments to sec.15. 475 and sec.15.500, without changes to the proposed text as published in the April 23, 1993, issue of the Texas Register (18 TexReg 2619). The amendments are justified to expand and clarify rules on deeming and to add clarification regarding the preparation of a companion budget. The amendments will function by ensuring the correct and consistent application of the deeming policy and the preparation of companion budgets. The department received no comments regarding adoption of the amendments. 40 TAC sec.15.475 The amendment is adopted under the Human Resources Code, Title 2, Chapters 22 and 32, which provides the department with the authority to administer public and medical assistance programs and under Texas Civil Statutes, Article 4413 (502), sec.16, which provides the Health and Human Services Commission with the authority to administer federal medical assistance funds. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on May 26, 1993. TRD-9323448 Nancy Murphy Section Manager Texas Department of Human Services Effective date: July 1, 1993 Proposal publication date: April 23, 1993 For further information, please call:(512) 450-3844 Subchapter E. Income 40 TAC sec.15.500 The amendment is adopted under the Human Resources Code, Title 2, Chapters 22 and 32, which provides the department with the authority to administer public and medical assistance programs and under Texas Civil Statutes, Article 4413 (502), sec.16, which provides the Health and Human Services Commission with the authority to administer federal medical assis- tance funds. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on May 26, 1993. TRD-9323447 Nancy Murphy Section Manager Texas Department of Human Services Effective date: July 1, 1993 Proposal publication date: April 23, 1993 For further information, please call: (512) 450-3844