TITLE 25.HEALTH SERVICES

Part 1. DEPARTMENT OF STATE HEALTH SERVICES

Chapter 157. EMERGENCY MEDICAL CARE

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 §§157.14, 157.33, 157.34, and 157.40 and new §§157.14, 157.33, 157.34, and 157.40, concerning the requirements for first responder organizations, certification, recertification and paramedic licensure. New §157.14 and §157.34 are adopted with changes to the proposed text as published in the April 14, 2006, issue of the Texas Register (31 TexReg 3160). The repeal of §§157.14, 157.33, 157.34, 157.40 and new §157.33 and §157.40 are adopted without changes and, therefore, the sections will not be republished.

BACKGROUND AND PURPOSE

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 157.14, 157.33, 157.34 and 157.40 have been reviewed and the department has determined that reasons for adopting the sections continue to exist because rules on this subject are needed.

Revisions of these sections were necessary to comply with the mandatory four-year rule review. Additionally, the repealed and new sections reflect consensus achieved by the stakeholder group (Governor's EMS and Trauma Advisory Council) and department staff. These sections also reflect organizational changes in the department mandated by House Bill 2292 of the 78th Texas Legislature, Regular Session, 2003.

SECTION-BY-SECTION SUMMARY

The decision to repeal §§157.14, 157.33, 157.34 and 157.40 and adopt new §§157.14, 157.33, 157.34 and 157.40 was due to extensive formatting changes and changes within the rules to make these sections more uniform.

New §157.14 strengthens regulation of First Responder Organizations using certified or licensed Emergency Medical Services (EMS) personnel to provide prehospital emergency medical care. Under new §157.14, the organizations will be required to be licensed, have medical direction, and work cooperatively with the EMS Providers who transport the patients.

New §157.33 provides clarification to the rules, allows more flexibility to candidates for EMS certification, including those coming from other states or other health care disciplines, and parallels requirements that candidates must meet to be eligible for taking the credentialing exam with the National Testing Service.

New §157.34 provides clarification to the rules, allows more flexibility to candidates completing EMS recertification requirements, and provides an option for candidates with inactive certifications or certifications that have lapsed for more than one year.

New §157.40 provides clarification to the rules, allows more flexibility to candidates for EMS paramedic licensure, parallels requirements that candidates must meet to be eligible for taking the credentialing exam with the National Testing Service, and provides an option for candidates with inactive licensure or a license that has lapsed for more than one year.

COMMENTS

The department, on behalf of the commission, has reviewed and prepared responses to comments received regarding the proposed rules during the comment period, which the commission has reviewed and accepts. The commenter was an individual representing the City of Arlington, Texas. The commenter was not against the rules; however, suggested recommendations for changes to new §157.14 as discussed in the summary of comments. The department, on behalf of the commission, did not receive any public comments regarding the other proposed rules during the comment period.

Comment: Concerning §157.14(c)(3) and §157.14(d)(4), the commenter recommended changing "who" to "that". The result is "Applicants that meet all the requirements shall be issued an FRO license". The word "that" should be used because "applicants" refers to organizations rather than persons.

Response: The commission agrees and has revised the sentence to read: "Applicants that meet all the requirements shall be issued an FRO license".

Comment: Concerning §157.14(e)(9)(B), the commenter recommended changing "condition upon arrival at the scene" to "...patient's condition when first contacted by FRO personnel..." The language published in the Texas Register requires the patient report to include the patient's condition upon the patient's arrival at the scene rather than upon the FRO's arrival at the scene. Further, because all patients cannot always be immediately located as soon as the first FRO personnel arrive, the requirement should be to report the patient's condition when contact is first made with the patient.

The commenter also recommended changing "EMS staff" to "FRO personnel who provided care to the patient". "EMS staff is vague and could refer to FRO or ambulance personnel". With these changes, the following sentence results: "the report shall document, at a minimum, the patient's name, the patient's condition when first contacted by FRO personnel; the prehospital care provided, the dispatch time; scene arrival time; and the identification of the FRO personnel who provided care to the patient".

Response: The commission agrees and has revised the sentence to read: "the report shall document, at a minimum, the patient's name, the patient's condition when first contacted by FRO personnel; the prehospital care provided, the dispatch time; scene arrival time; and the identification of the FRO personnel who provided care to the patient".

The following changes were made as a result of staff comments:

Change: Concerning §157.14, a correction to the reference of "paragraph" and "subsection" for proper Texas Register formatting was made to subsections (c)(1)(F) and (d)(2)(F) and (G) of the section.

Change: Concerning §157.34(b)(4)(B), a title "Recertification Course" was added to the top of the chart; §157.34(d)(3), the word "the" was added in the last sentence to read "a total of two times the fee shall be necessary"; §157.34(e)(2), second sentence, added the words "times the" after the number "1-1/2" to state "a total of 1-1/2 times the fee shall be necessary"; and §157.34(e)(3), second sentence, the word "the" was added after the word "times" to read "a total of two times the fee shall be necessary".

LEGAL CERTIFICATION

The Department of State Health Services, General Counsel, Cathy Campbell, 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 B. EMERGENCY MEDICAL SERVICES PROVIDER LICENSES

25 TAC §157.14

STATUTORY AUTHORITY

The adopted repeal is authorized by Health and Safety Code, §12.0111, which requires the department to charge fees for issuing or renewing a license; §773.050(e) which authorizes the department to adopt minimum standards of first responder organizations; §773.050(b) and §773.0495 which authorize the department to adopt minimum standards for certified and licensed EMS personnel; 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. The review of the sections 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 August 11, 2006.

TRD-200604196

Cathy Campbell

General Counsel

Department of State Health Services

Effective date: August 31, 2006

Proposal publication date: April 14, 2006

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


25 TAC §157.14

STATUTORY AUTHORITY

The adopted new section is authorized by Health and Safety Code, §12.0111, which requires the department to charge fees for issuing or renewing a license; §773.050(e) which authorizes the department to adopt minimum standards of first responder organizations; §773.050(b) and §773.0495 which authorize the department to adopt minimum standards for certified and licensed EMS personnel; 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. The review of the sections implements Government Code, §2001.039.

§157.14.Requirements for a First Responder Organization License.

(a) A First Responder Organization (FRO) is a group or association of certified emergency medical services personnel that works in cooperation with a licensed emergency medical services provider to:

(1) routinely respond to medical emergency situations;

(2) utilize personnel who are emergency medical services (EMS) certified by the Texas Department of State Health Services (department); and

(3) provide on-scene patient care to the ill and injured and does not transport patients.

(b) Individuals or organizations meeting the description in subsection (a) of this section must comply with the requirements outlined in this section including submission of an application for a license.

(c) Application requirements for an FRO affiliated with a licensed EMS Provider.

(1) A Basic Life Support (BLS) or Advanced Life Support (ALS) First Responder Organization affiliated with a Texas licensed EMS Provider must apply for an FRO license by submitting a completed application to the department. A complete application consists of the following:

(A) provider license application form;

(B) personnel list including social security number or EMS personnel identification (ID) number and certification/licensure level;

(C) description and map of the service area;

(D) staffing plan including days of the week and hours of the day the FRO will be available for response;

(E) written affiliation agreement with the primary licensed EMS provider in the service area. The primary licensed EMS provider must provide a letter attesting that the following items have been reviewed and approved by the director and medical director of the EMS provider:

(i) level(s) of certification/licensure of FRO personnel providing care;

(ii) response, dispatch and treatment protocols including an equipment and supply list approved by the medical director of the licensed EMS provider;

(iii) description of how the FRO receives notification of calls;

(iv) patient care reporting procedures;

(v) process for the assessment of care provided by the FRO personnel;

(vi) response code policies for FRO personnel;

(vii) on-scene chain-of-command policies;

(viii) policies regarding FRO personnel canceling en route EMS units;

(ix) policies regarding FRO personnel accompanying patients in EMS providers vehicles including when FRO personnel hold the highest certification or licensure on the scene; and

(x) patient confidentiality.

(F) It is not necessary to submit the individual items in subparagraph (E)(i) - (x) of this paragraph with the application, if each is referenced in the affiliation agreement. All items listed in this paragraph must be immediately available for review by department personnel upon request during unannounced site visits or complaint investigations.

(2) Any FRO which is, or has a contract with, an entity such as a business, corporation or department and whose first responder employees or members are compensated by that entity for providing first responder service shall pay a nonrefundable $60 application fee. If the license is issued for less than 12 months, the nonrefundable fee shall be $30. The FRO personnel described in this paragraph are not exempt from the payment of certification or license application fees.

(3) Applicants that meet all the requirements shall be issued an FRO license. The license may be valid for up to 2 years, but may be issued for less than 2 years for administrative purposes.

(4) Although not required, the FRO license application may be submitted with the license application of the affiliated EMS provider. The FRO is responsible for submitting fees, if applicable.

(5) An affiliation agreement between a licensed EMS provider and a licensed FRO does not automatically imply any legal liability beyond the agreements listed in paragraph (1)(E) of this subsection.

(6) A violation of statute or rule by an FRO will not implicate the affiliated EMS provider unless both organizations are involved in the violation. Likewise, a violation of statute or rule by an affiliated EMS provider does not implicate the FRO unless both organizations are involved in the violation.

(d) Application requirements for an FRO not affiliated with a licensed EMS provider.

(1) A BLS first responder organization not affiliated with a licensed EMS provider may apply for an FRO License by submitting a completed application to the department. A complete application consists of the following:

(A) application form;

(B) personnel list including social security number or personnel ID number and certification/licensure level;

(C) description and map of the service area;

(D) staffing plan including days of the week and hours of the day the FRO will be available for response;

(E) response, dispatch and treatment protocols including an equipment and supply list approved by the FRO medical director;

(F) letter of recognition from the primary licensed 911 EMS Provider or from the highest elected city/county official in the service area and a written explanation why the EMS provider will not enter into an agreement with the FRO;

(G) description of how the FRO receives notification of calls; and

(H) process for the assessment of care provided by the FRO personnel.

(I) The application for a FRO license will be considered incomplete if any items listed in subparagraphs (A) - (H) of this paragraph are not enclosed with the application.

(J) All items listed in subparagraphs (A) - (H) of this paragraph must be immediately available for review by department personnel if requested during unannounced site visits or complaint investigations.

(2) An ALS first responder organization not affiliated with a licensed EMS provider may apply for an FRO License by submitting a completed application to the department. A complete application consists of the following:

(A) application form;

(B) personnel list including social security number or personnel ID number and certification/licensure level;

(C) description and map of the service area; and

(D) staffing plan including days of the week and hours of the day the FRO will be available for response.

(E) The FRO shall have an agreement with all licensed EMS providers and their medical directors who routinely transport patients treated by the FRO's personnel. Each agreement shall be approved by the person responsible for the FRO, director and medical director of each licensed EMS provider. At a minimum, the agreements shall address:

(i) the level(s) of certification/licensure of FRO personnel providing care;

(ii) the response, dispatch and treatment protocols including an equipment and supply list approved by the FRO medical director and a letter of approval from the medical director(s) of the licensed transporting providers with whom the FRO has agreements;

(iii) a description of how the FRO receives notification of calls;

(iv) patient care reporting procedures;

(v) a process for the assessment of care provided by FRO personnel;

(vi) response code policies for FRO personnel;

(vii) on-scene chain-of-command policies;

(viii) policies regarding FRO personnel canceling en route EMS units;

(ix) policies regarding FRO personnel accompanying patients in provider's vehicles including when FRO personnel hold the highest certification or licensure on the scene; and

(x) patient confidentiality.

(F) The application for a FRO license is incomplete if any items listed in this paragraph are not enclosed with the application.

(G) All items listed in this paragraph must be immediately available for review by department personnel if requested during unannounced site visits or complaint investigations.

(3) Any FRO which is, or has a contract with, an entity such as a business, corporation or department and whose first responder employees or members are compensated by that entity for providing first responder services shall pay a nonrefundable $60 application fee. If the license is issued for less than 12 months, the nonrefundable fee shall be $30. The FRO personnel described in this paragraph are not exempt from the payment of certification and license application fees.

(4) Applicants that meet all the requirements for a license shall be issued an FRO license. The license is issued for 2 years. For administrative purposes, it may be issued for less than 2 years.

(e) Responsibilities of the FRO. During the license period the FRO's responsibilities shall include:

(1) assuring ongoing compliance with the terms of all EMS provider agreement(s);

(2) assuring the existence of and adherence to a quality assurance plan which shall, at a minimum, include:

(A) the standard of patient care and the medical director's protocols;

(B) pharmaceutical storage;

(C) readiness inspections;

(D) preventive maintenance of medical equipment and vehicles owned by the FRO;

(E) policies and procedures;

(F) complaint management; and

(G) patient care reporting and documentation;

(3) ensuring that all medical personnel are currently certified or licensed by the department;

(4) assuring that all personnel on the scene of an emergency are prominently identified by, at least, the last name and the first initial of the first name, the certification or license level and the FRO name. An FRO may utilize an alternative identification system in incident specific situations that pose a potential for danger if the individuals are identified by name;

(5) assuring that all vehicles utilized by FRO personnel carry proof of first responder registration or have the name of the FRO prominently displayed and visible from the outside of the vehicle while on the scene of an emergency;

(6) assuring the confidentiality of all patient information in compliance with all federal and state laws;

(7) developing and adhering to an agreement between the primary transport provider and first responder organization concerning the use of patient refusal forms and documentation for incidents when an informed treatment refusal form cannot be obtained;

(8) developing and adhering to an agreement between the primary transport provider and first responder organization concerning the maintenance of FRO records;

(9) assuring that patient care reports are completed accurately for all patients:

(A) the report shall be accurate, complete and clearly written; and

(B) the report shall document, at a minimum, the patient's name, the patient's condition when first contacted by FRO personnel; the prehospital care provided; the dispatch time; scene arrival time; and the identification of the FRO personnel who provided care to the patient;

(10) assuring that all relevant patient care information is supplied in writing to the licensed EMS provider at the time the patient is transferred to the provider;

(11) assuring that a full written report is provided, upon request, within 1 business day to the transport provider and/or hospital facility where the patient was delivered;

(12) assuring that all requested patient records are made promptly available to the first responder organization's medical director;

(13) assuring that current protocols are available to all certified or licensed personnel;

(14) monitoring and enforcing compliance with all policies;

(15) assuring provisions for the appropriate disposal of medical and/or biohazardous waste materials;

(16) assuring that all documents, reports or information provided to the department are current, accurate and complete;

(17) assuring compliance with all federal and state laws and regulations and all local ordinances, policies and codes at all times;

(18) assuring that the department is notified within 5 business days whenever there is a change:

(A) in the level of service;

(B) in the declared service area;

(C) in the official business mailing address;

(D) in the physical location of the first responder organization;

(E) in the physical location of patient report file storage, to assure that the department has access to these records at all times;

(F) of the administrator;

(G) of the e-mail address; or

(H) of the EMS providers associated with the FRO.

(19) assuring that the department is notified within 1 business day when a change of the medical director has occurred;

(20) assuring the FRO has written operating policies, procedures and medical protocols and provides all medical personnel a copy initially and whenever such policies, procedures and/or medical protocols are changed. A copy of the written operating policies, procedures and medical protocols shall be made available to the department upon request. At a minimum, policies shall adequately address:

(A) personal protective equipment;

(B) immunizations available to personnel;

(C) infection control procedures;

(D) communicable disease exposure;

(E) credentialing of new response personnel before being assigned to respond to emergencies. The credentialing process shall include, at minimum:

(i) a comprehensive orientation session of the FRO's policies and procedures, safety precautions, and quality management process; and

(ii) an internship period in which all new personnel practice under the supervision of, and are evaluated by, another more experienced person, if operationally feasible; and

(F) appropriate documentation of patient care;

(21) assuring that all documents, reports or information provided to the department are current, truthful and correct;

(22) assuring that the department is notified within 1 business day of a collision involving an FRO vehicle responding to a scene or while at the scene of an emergency and resulting in personal injury or death of any person;

(23) maintaining motor vehicle liability insurance as required by the Texas Transportation Code under Subchapter D, §601.071 and §601.072, for all vehicles owned or operated by the FRO;

(24) providing continuous coverage for the service area as defined in the staffing plan; and

(25) responding to requests for assistance from the highest elected official of a political subdivision or from the department during a declared emergency or mass casualty situation.

(f) License renewal.

(1) The department may notify the FRO at least 90 days before the expiration date of the current license at the address shown in the current records of the department. If a notice of expiration is not received, it is the responsibility of the FRO to notify the department and request license renewal application information.

(2) FROs shall submit a completed application and nonrefundable fee, if applicable, and must verify compliance with the requirements of the license.

(g) License denial. A license may be denied for, but not limited to, the following reasons:

(1) failure to meet requirements for an FRO license in accordance with this section;

(2) previous failure to meet the responsibilities of an FRO as described in this section;

(3) falsifying any information, record or document required for an FRO license;

(4) misrepresenting any requirements for an FRO license or renewal of an FRO license;

(5) history of criminal activity while licensed as an FRO;

(6) history of disciplinary action relating to the FRO license; and/or

(7) issuing a check for application for an FRO license which is subsequently returned to the department unpaid.

(h) License revocation criteria. An FRO license may be revoked or suspended for failure to meet the responsibilities of a licensed FRO as described in this section.

(i) For all applications and renewal applications, the department is authorized to collect subscription and convenience fees, in amounts determined by the Texas Online Authority to recover costs associated with application and renewal application processing through Texas Online.

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 August 11, 2006.

TRD-200604197

Cathy Campbell

General Counsel

Department of State Health Services

Effective date: August 31, 2006

Proposal publication date: April 14, 2006

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


Subchapter C. EMERGENCY MEDICAL SERVICES TRAINING AND COURSE APPROVAL

25 TAC §§157.33, 157.34, 157.40

STATUTORY AUTHORITY

The adopted repeals are authorized by Health and Safety Code, §12.0111, which requires the department to charge fees for issuing or renewing a license; §773.050(e) which authorizes the department to adopt minimum standards of first responder organizations; §773.050(b) and §773.0495 which authorize the department to adopt minimum standards for certified and licensed EMS personnel; 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. The review of the sections 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 August 11, 2006.

TRD-200604198

Cathy Campbell

General Counsel

Department of State Health Services

Effective date: August 31, 2006

Proposal publication date: April 14, 2006

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


25 TAC §§157.33, 157.34, 157.40

STATUTORY AUTHORITY

The adopted new sections are authorized by Health and Safety Code, §12.0111, which requires the department to charge fees for issuing or renewing a license; §773.050(e) which authorizes the department to adopt minimum standards of first responder organizations; §773.050(b) and §773.0495 which authorize the department to adopt minimum standards for certified and licensed EMS personnel; 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. The review of the sections implements Government Code, §2001.039.

§157.34.Recertification.

(a) Recertification requirements.

(1) Not later than the 30th day before the date a person's certificate is scheduled to expire, the Department of State Health Services (department) may send to the person a notice of expiration at the address shown in the current records of the department.

(2) If a certificant has not received a notice of expiration from the department 30 days prior to the expiration, it is the duty of the certificant to notify the department and to request an application for recertification or download an application from the Internet.

(3) To maintain certification status without a lapse, an applicant shall submit a completed application for recertification and shall meet all requirements for renewal of the current certification prior to the expiration date of the current certificate, but no earlier than one year prior to the expiration date.

(4) The certificant shall submit the following non-refundable fees as applicable:

(A) $60 for Emergency Care Attendant (ECA) or Emergency Medical Technician (EMT);

(B) $90 for EMT-Intermediate (EMT-I) or EMT-Paramedic (EMT-P); and

(C) EMS volunteer--no fee. However, if such an individual receives compensation during the certification period, the exemption ceases and the individual shall pay a prorated fee to the department based on the number of years remaining in the certification period when employment begins. The non-refundable fee for ECA or EMT certification shall be $15 per each year remaining in the certification. The non-refundable fee for EMT-I or EMT-P shall be $22.50 per each year remaining in the certification. Any portion of a year will count as a full year.

(5) Recertification by voluntary downgrade. An individual who holds a Texas EMS certification or paramedic license may renew at a lower level by meeting the requirements of this subsection. The applicant must meet the requirements for the lower level of certification requested as described in subsection (b) or (f) of this section. On the date the downgrade is final, the previous higher level of certification becomes invalid. To regain the original higher level of certification, the candidate shall meet the late recertification requirements outlined in subsection (f) of this section, within one year after the expiration date.

(6) A certificate is not transferable.

(7) Military personnel. A person certified by the department who is deployed in support of military, security, or other action by the United Nations Security Council, a national emergency declared by the president of the United States, or a declaration of war by the United States Congress is eligible for recertification under timely recertification requirements from the person's date of demobilization until one calendar year after the date of demobilization but will not be certified during that period.

(A) In addition to requirements described in this subsection, the candidate shall submit a copy of deployment and demobilization orders.

(B) The four-year certification will commence on issue date of the certificate.

(C) If all requirements are not completed within one year after date of demobilization, the candidate must meet the requirements of late recertification within one additional year, as described in subsection (f) of this section.

(b) Recertification options. Upon submission of a completed application for recertification, the applicant shall commit to, and recertify through one of the options described in paragraphs (1)-(5) of this subsection.

(1) Option 1--Written Examination Recertification Process.

(A) The applicant shall pass the National Registry assessment exam. An overall score of 70 is considered to be passing.

(B) If the applicant fails the examination for recertification, the applicant may attempt two retests of the examination after:

(i) submitting a retest application for each attempt at any eligible level; and

(ii) submitting a non-refundable retest fee of $30 for each attempt.

(C) For each subsequent retest attempt, an applicant may apply for and retest at a lower level by complying with paragraph (1)(B) of this subsection, if applicable.

(D) An applicant who selects option 1 and attempts the exam but does not pass the National Registry assessment examination may not gain recertification by any other option and shall not qualify for inactive certification addressed in §157.33(h) of this title (relating to Certification) or subsection (e) or (f) of this section.

(E) An applicant who does not pass the third attempt at the National Registry assessment examination:

(i) shall successfully complete a Formal Recertification Course as described in paragraph (4) of this subsection; and

(ii) shall submit a course completion certificate of the Formal recertification course, reflecting that the course was completed after the 2nd retest failure; and

(iii) shall pass the National Registry assessment examination in accordance with the provisions in subparagraphs (A) - (D) of this paragraph.

(iv) shall not qualify for more than a total of six attempts at the exam, in any combination of levels attempted.

(F) The certification status of an applicant who does not successfully complete the examination recertification process as described in paragraph (1)(A) - (E) of this subsection shall expire on the date of the current certificate.

(i) The applicant will have until 90 days after expiration date of the current certificate to submit the application, pay the renewal fee of 1-1/2 times the amount described in subsection (a)(4) of this section and successfully complete the examination recertification process. If the applicant has already submitted an application and fee prior to the expiration of the certificate, another application will not be required, but an additional one-half fee shall be necessary. If applicable, the retest process, including appropriate retest applications and fees, may continue during the 90-day period.

(ii) If applicant does not apply for and successfully complete the Option 1 recertification process within 90 days following expiration, applicant shall meet requirements of late recertification described in subsection (d)(3) of this section. Another application and a non-refundable renewal fee that is equal to two times the amount designated in subsection (a)(4) of this section shall be required. Successful completion of the late recertification process must be accomplished within one year of expiration.

(iii) A candidate whose certificate has been expired for one year or more may not renew the certificate. The candidate may become certified by complying with the requirements of §157.33(a) or (j) of this title.

(2) Option 2--Continuing Education Recertification Process. The certificant shall attest to accrual of department approved EMS continuing education as specified in §157.38 of this title (relating to Continuing Education).

(3) Option 3--National Registry Recertification Process. The applicant shall attest to and hold current National Registry certification at the time of applying for recertification.

(4) Option 4--Formal Course Recertification Process. The applicant shall attest to successful completion of a department approved recertification course.

(A) The recertification course, as prescribed by the Education and Training Manual, shall be a formal structured interactive training course as approved by the department and conducted within the four-year certification period.

(B) The minimum contact hours required for recertification courses are:

Figure: 25 TAC §157.34(b)(4)(B)

(5) Option 5--CCMP Recertification Process. An applicant affiliated with an EMS provider that has a department-approved Comprehensive Clinical Management Program (CCMP) may be recertified if:

(A) the applicant is currently credentialed in the provider's CCMP;

(B) the applicant has been enrolled in the provider's CCMP for at least six continuous months; and

(C) the applicant submits to the department a signed written statement by the CCMP's medical director, attesting to the applicant's successful participation in and completion of the provider's CCMP.

(6) If a candidate wishes to change options (other than option 1), another application form must be submitted. An additional fee is not required if the candidate completes all requirements within the same time period of the original submission.

(c) After verification by the department of the information submitted by the applicant, that the information is true, correct and complete with regard to the applicant meeting recertification requirements by the certification expiration date, the department shall recertify the applicant for four years, commencing on the day following the expiration date of the most recent certificate. A candidate must verify current certification before staffing an EMS vehicle. Certification may be verified by the applicant's receipt of the official department identification card, by using the department's certification website, or by contacting the department directly.

(d) Late recertification.

(1) The candidate whose certification has expired shall be considered late, non-certified and shall not function in the capacity of an EMS certificant or represent that he is EMS certified until recertification is issued.

(2) A candidate whose certificate has been expired for 90 days or less may renew the certificate by submitting an application accompanied by a non-refundable renewal fee that is equal to 1-1/2 times the normally required application renewal fee for that level as listed in subsection (a)(4) of this section. Applicant shall meet one of the recertification options described in subsection (b)(1) - (5) of this section and submit verification of skills proficiency from an approved education program. If the applicant has already submitted an application and fee, but has not met all of the requirements prior to expiration, another application will not be required, but a total of 1-1/2 times the normally required application renewal fee shall be necessary. The applicant shall be recertified for a period of four years beginning on the date of issuance.

(3) A candidate whose certificate has been expired for more than 90 days but less than one year may renew the certificate by submitting an application accompanied by a non-refundable renewal fee that is equal to two times the normally required application renewal fee as listed in subsection (a)(4) of this section. Applicant shall meet one of the recertification options described in subsection (b)(2) - (6) of this section and submit verification of skills proficiency from an approved education program. If the applicant has already submitted an application and fee, but has not met all of the requirements prior to the 90th day after expiration, another application will not be required, but a total of two times the fee shall be necessary.

(4) The applicant shall be recertified for a period of four years beginning on the date of issuance.

(5) A candidate whose certificate has been expired for one year or more may not renew the certificate. The candidate may become certified by complying with the requirements of §157.33(a) or (j) of this title.

(6) A candidate who was certified in this state, moved to another state, and is currently certified or licensed and has been in practice in the other state for two years preceding the date of application may become certified without reexamination. The candidate may gain recertification by:

(A) submitting to the department a non-refundable fee that is equal to two times the normally required renewal fee for certification as listed in subsection (a)(4) of this section; and

(B) attesting to regular practice of emergency medical care in the other state for the two years preceding the date of application.

(e) Renewal of inactive certification.

(1) To renew inactive certification, an applicant holding inactive certification shall submit an application and the non-refundable fee as described in §157.33(a)(4) of this title. The $30 inactive fee is not required for renewal when renewing inactive certification. A candidate who meets requirements for inactive renewal shall be awarded inactive certification for a period of four years beginning on the first day after the expiration of the previous inactive certification.

(2) A candidate whose inactive certification has been expired for 90 days or less may renew the inactive certification during the 90 day period after expiration of the certification upon submitting a fee of 1-1/2 times the normally required renewal fee as described in subsection (a)(4) of this section. If the applicant has already submitted an application and fee, but has not met all of the requirements prior to expiration, another application will not be required, but a total of 1-1/2 times the fee shall be necessary. The applicant shall be recertified for a period of four years beginning on the date of issuance.

(3) A candidate whose inactive certification has been expired more than 90 days but less than one year may renew the inactive certification upon submitting a fee of two times the normally required renewal fee as described in subsection (a)(4) of this section. If the applicant has already submitted an application and fee, but has not met all of the requirements prior to the 90th day after expiration, another application will not be required, but a total of two times the fee shall be necessary. The applicant shall be recertified for a period of four years beginning on the date of issuance.

(4) A candidate whose inactive certificate has been expired more than one year must regain active certification before reapplying for inactive certification as described in subsection (f) of this section.

(f) Inactive to active certification.

(1) An inactive certificant prior to the expiration of the first four-year inactive certification period may obtain active certification by submitting an application and the non-refundable fee to the department, as described in subsection (a)(4) of this section and by completing one of the following options:

(A) Option 1--meet the normal 4 year continuing education requirement for certification renewal as listed in subsection (b)(2) of this section, submit verification of skills proficiency from an approved education program, and pass the national registry assessment exam.

(B) Option 2--complete a department approved recertification course, and pass the national registry assessment exam.

(2) A certificant who has held inactive certification for more than four years may return to active certification only by completing requirements described in §157.33(a) or (j) of this title.

(g) For all applications and renewal applications, the department is authorized to collect subscription and convenience fees, in amounts determined by the Texas Online Authority, to recover costs associated with application and renewal application processing through Texas Online.

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 August 11, 2006.

TRD-200604199

Cathy Campbell

General Counsel

Department of State Health Services

Effective date: August 31, 2006

Proposal publication date: April 14, 2006

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


Chapter 229. FOOD AND DRUG

Subchapter N. CURRENT GOOD MANUFACTURING PRACTICE AND GOOD WAREHOUSING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD

25 TAC §§229.210 - 229.222

The Executive Commissioner of the Health and Human Services Commission (commission), on behalf of the Department of State Health Services (department), adopts new §229.210 and amendments to §§229.211 - 229.222, concerning the current good manufacturing practice and good warehousing practice in manufacturing, packing or holding of human food. Amendments to §§229.219 and 229.222 are adopted with changes to the proposed text as published in the March 10, 2006, issue of the Texas Register (31 TexReg 1590). New §229.210 and amendments to §§229.211 - 229.218 and 229.220 - 229.221 are adopted without changes and, therefore, the sections will not be republished.

BACKGROUND AND PURPOSE

The new section and amendments are necessary to update current good manufacturing practice and good warehousing practice in manufacturing, packing, or holding human food in regards to food safety during manufacturing and storage and distribution.

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 229.211 - 229.222 have been reviewed and the department has determined the reasons for adopting the sections continue to exist because rules are required by the enabling statute, the department continues to regulate this activity, and persons engaged in the activity are required to comply with the rules.

SECTION-BY-SECTION SUMMARY

A new §229.210, General Provisions, is added to provide clarification on the facilities subject to this subchapter. Amendments to §229.211 include the addition of new definitions. An amendment to §229.212 clarifies the reference of the U.S. Code of Federal Regulations. Section 229.213 is amended to reference employee health. Section 229.214 is amended to clarify what firms are exempt from these rules. Sections 229.215 and 229.220 reflect grammatical revisions. Section 229.216 is amended to clarify language on pest activity, and to include specific language on approved pesticides. Section 229.217 is amended in several subsections to reflect grammatical revisions, suitable water temperature for hand-washing facilities, and clarification on waste and food waste operations. Section 229.218 is amended to provide clarification on the maintenance of instruments. Section 229.219 is amended in several subsections to include a reference for approved source, update the current cold holding temperature requirements for potentially hazardous foods, and to reflect extensive new language on reduced oxygen packaging. Section 229.221 is amended to add language on approved source, to clarify language on pest activity, and to update the current cold holding temperature for potentially hazardous foods. Section 229.222 is amended to clarify enforcement action on emergency orders and penalties.

COMMENTS

The department, on behalf of the commission, did not receive any public comments regarding the proposed rules during the comment period.

The department staff, on behalf of the commission, provided comments and the commission has reviewed and agrees to the following changes that will clarify and improve the accuracy of the sections.

Change: Concerning §229.219(2)(P) and §229.222, typographical, punctuation and grammatical corrections were made.

LEGAL CERTIFICATION

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

STATUTORY AUTHORITY

The adopted new section and amendments are authorized under the Health and Safety Code, §431.241 and §441.003, which provide the department with the authority to adopt necessary regulations pursuant to the enforcement of Chapters 431; 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.

§229.219.Production and Process Controls.

All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of food shall be conducted in accordance with good public health and sanitation principles. Appropriate quality control operations shall be employed to ensure that food is suitable for human consumption and that food-packaging materials are safe and suitable. Overall sanitation of the plant shall be under the supervision of one or more competent individuals assigned responsibility for this function. All reasonable precautions shall be taken to ensure that production procedures do not contribute contamination from any source. Testing procedures shall be used where necessary to identify sanitation failures or possible food contamination by chemicals, microbes, or extraneous materials. All food that has become contaminated to the extent that it is adulterated within the meaning of the Act shall be rejected, or if permissible, treated or processed to eliminate the contamination.

(1) Raw materials and other ingredients.

(A) Food including raw ingredients and finished product shall be obtained from an approved source.

(B) Raw materials and other ingredients shall be inspected and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing into food and shall be stored under conditions that will protect against contamination and minimize deterioration. Raw materials shall be washed or cleaned as necessary to remove soil or other contamination. Water used for washing, rinsing, or conveying food shall be safe and of sanitary quality for its intended use. Water may be reused for washing, rinsing, or conveying food if it does not increase the level of contamination of the food. Containers and carriers of raw materials should be inspected on receipt to ensure that their condition has not contributed to contamination or deterioration of food.

(C) Raw materials and other ingredients shall either: not contain levels of microorganisms that may produce food poisoning or other disease in humans; or they shall be pasteurized or otherwise treated during manufacturing operations so that they no longer contain levels that would cause the product to be adulterated within the meaning of the Act. Compliance with this requirement may be verified by any effective means, including purchasing raw materials and other ingredients under a supplier's guarantee or certification.

(D) Raw materials and other ingredients susceptible to contamination with aflatoxin or other natural toxins shall comply with current Food and Drug Administration regulations, guidelines, and action levels for poisonous or deleterious substances before these materials or ingredients are incorporated into finished food. Compliance with this requirement may be accomplished by purchasing raw materials and other ingredients under a supplier's guarantee or certification, or may be verified by analyzing these materials and ingredients for aflatoxins and other natural toxins.

(E) Raw materials, other ingredients, and rework susceptible to contamination with pests, undesirable microorganisms, or material shall comply with applicable Food and Drug Administration regulations, guidelines, and defect action levels for natural or unavoidable defects if a manufacturer wishes to use the materials in manufacturing food. Compliance with this requirement may be verified by any effective means, including purchasing the materials under a supplier's guarantee or certification, or examination of these materials for contamination.

(F) Raw materials, other ingredients, and rework shall be held in bulk, or in containers designed and constructed so as to protect against contamination and shall be held at a temperature and relative humidity and in a manner to prevent the food from becoming adulterated within the meaning of the Act. Material scheduled for rework shall be identified as such.

(G) Frozen raw materials and other frozen ingredients shall be kept frozen. If thawing is required prior to use, it shall be done in a manner that prevents the raw materials and other ingredients from becoming adulterated within the meaning of the Act.

(H) Liquid or dry raw materials and other ingredients received and stored in bulk form shall be held in a manner that protects against contamination.

(2) Manufacturing operations.

(A) Equipment and utensils and finished food containers shall be maintained in an acceptable condition through appropriate cleaning and sanitizing. As necessary, equipment shall be taken apart for thorough cleaning.

(B) All food manufacturing, including packaging and storage, shall be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, or for the contamination of food. Compliance with this requirement may be accomplished by careful monitoring of physical factors such as time, temperature, humidity, a w , pH, pressure, flow rate, and manufacturing operations such as freezing, dehydration, heat processing, acidification, and refrigeration to ensure that mechanical breakdowns, time delays, temperature fluctuations, and other factors do not contribute to the decomposition or contamination of food.

(C) The internal temperature of potentially hazardous foods during transport and storage shall be maintained at or below 41 degrees Fahrenheit as appropriate for the food using methods, that include refrigeration, pre-chilled insulated coolers, dry ice, or storage on ice made from potable water. The method used must maintain the required temperature for the entire length of time the food is in transport or storage.

(i) Frozen foods shall be kept frozen at all times.

(ii) Shell eggs, after initial packing, must be transported and stored at a temperature of 45 degrees Fahrenheit or less. If the United States Department of Agriculture and the U.S. Food and Drug Administration determine by law that a lower temperature must be maintained, the lower temperature shall prevail.

(iii) The temperature of molluscan shellfish from the harvester through the original shellfish dealer shall be maintained in accordance with §§241.58-241.60 of this title (relating to Molluscan Shellfish). Raw molluscan shellfish shall be adequately iced or refrigerated at 45 degrees Fahrenheit or less during all subsequent distribution, storage, processing, and sale.

(iv) Hot foods shall be maintained at 135 degrees Fahrenheit (60 degrees Celsius) or above.

(v) Acid or acidified foods shall be heat treated to destroy mesophilic microorganisms when those foods are to be held in hermetically sealed containers at ambient temperatures.

(D) Measures such as sterilizing, irradiating, pasteurizing, freezing, refrigerating, controlling pH or controlling a w that are taken to destroy or prevent the growth of undesirable microorganisms, particularly those of public health significance, must be adequate under the conditions of manufacture, handling, and distribution to prevent food from being adulterated within the meaning of the Act.

(E) Work-in-process shall be handled in a manner that protects against contamination.

(F) Effective measures shall be taken to protect finished food from contamination by raw materials, other ingredients, or refuse. When raw materials, other ingredients, or refuse are unprotected, they shall not be handled simultaneously in a receiving, loading, or shipping area if that handling could result in contaminated food. Food transported by conveyor shall be protected against contamination as necessary.

(G) Equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-process, rework, or food shall be constructed, handled, and maintained during manufacturing or storage in a manner that protects against contamination.

(H) Effective measures shall be taken to protect against the inclusion of metal or other extraneous material in food. Compliance with this requirement may be accomplished by using sieves, traps, magnets, electronic metal detectors, or other suitable effective means.

(I) Food, raw materials, and other ingredients that are adulterated within the meaning of the act shall be disposed of in a manner that protects against the contamination of other food. If the adulterated food is capable of being reconditioned, it shall be reconditioned using a method that has been proven to be effective or it shall be reexamined and confirmed to be safe within the meaning of the Act before being incorporated into other food.

(J) Mechanical manufacturing steps such as washing, peeling, trimming, cutting, sorting and inspecting, mashing, dewatering, cooling, shredding, extruding, drying, whipping, defatting, soaking, tempering, and forming shall be performed so as to protect food against contamination. Compliance with this requirement may be accomplished by providing adequate physical protection of food from contaminants that may drip, drain, or be drawn into the food. Protection may be provided by cleaning and sanitizing all food-contact surfaces, and by using time and temperature controls at and between each manufacturing step.

(K) Heat blanching, when required in the preparation of food, should be effected by heating the food to the required temperature, holding it at this temperature for the required time, and then either rapidly cooling the food or passing it to subsequent manufacturing without delay. Thermophilic growth and contamination in blanchers should be minimized by the use of sufficient operating temperatures and by periodic cleaning. Where the blanched food is washed prior to filling, water used shall be safe and of sanitary quality for its intended use.

(L) Batters, breading, sauces, gravies, dressings, and other similar preparations shall be treated or maintained in such a manner that they are protected against contamination. Compliance with this requirement may be accomplished by any effective means, including one or more of the following:

(i) using ingredients free of contamination;

(ii) employing adequate heat processes where applicable;

(iii) using proper time and temperature controls;

(iv) providing adequate physical protection of components from contaminants that may drip, drain, or be drawn into them;

(v) cooling to a sufficient temperature during manufacturing; or

(vi) disposing of batters at appropriate intervals to protect against the growth of microorganisms.

(M) Filling, assembling, packaging, and other operations shall be performed in such a way that the food is protected against contamination. Compliance with this requirement may be accomplished by any effective means, including:

(i) use of a quality control operation in which the control points are identified and controlled during manufacturing;

(ii) proper cleaning and sanitizing of all food-contact surfaces and food containers;

(iii) using materials for food containers and food-packaging materials that are safe and suitable for their intended use;

(iv) providing physical protection from contamination, particularly airborne contamination; and

(v) using sanitary handling procedures.

(N) Food such as, but not limited to, dry mixes, nuts, intermediate moisture food, and dehydrated food, that relies on the control of a w for preventing the growth of undesirable microorganisms shall be processed to and maintained at a safe moisture level. Compliance with this requirement may be accomplished by any effective means, including employment of one or more of the following practices:

(i) monitoring the a w of food;

(ii) controlling the soluble solids-water ratio in finished food; and

(iii) protecting finished food from moisture pickup, by use of a moisture barrier or by other means, so that the a w of the food does not increase to an unsafe level.

(O) Acid food, acidified food, and similar food that relies principally on the control of pH for preventing the growth of undesirable microorganisms shall be monitored and maintained at a pH of 4.6 or below. Compliance with this requirement may be accomplished by any effective means, including employment of one or both of the following practices:

(i) monitoring the pH of raw materials, food in process, and finished food; and

(ii) controlling the amount of acid or acidified food added to low-acid food.

(P) Reduced oxygen packaging. Manufacturers performing reduced oxygen packaging:

(i) shall maintain Standard Operating Procedures (SOPs) that:

(I) limit the shelf life of foods to not more than 14 calendar days from the date the food is packaged to the date the food is consumed or the original manufacturer's "sell by" or "use by" date, whichever comes first, except as described in clause (vi) of this subparagraph;

(II) describe how the packages shall be prominently and conspicuously labeled on the principal display panel in bold type on a contrasting background, with instructions to:

(-a-) "use by" and provide a date that is within 14 calendar days of packaging or provide a date as allowed by clause (v) of this subparagraph; and

(-b-) keep the food refrigerated at 41 degrees Fahrenheit or below;

(III) require employees that contact foods with bare hands to wash hands properly or utilize proper utensils;

(IV) designate raw food and ready to eat food areas and place physical barriers or effective methods that minimize the risk of cross-contamination between raw foods and ready-to-eat foods and restrict access to the food processing equipment to personnel who are trained to operate the equipment and understand the risks of cross-contamination;

(V) describe cleaning and sanitization procedures for food-contact surfaces; and

(VI) describe the training program that ensures that the individual responsible for the reduced oxygen packaging operation understands the:

(-a-) concepts required for safe operation;

(-b-) equipment and facility; and

(-c-) procedures specified in clauses (i)(II)-(V) and (iii)-(vii) of this subparagraph;

(ii) shall maintain records that document employee training. Records documenting training must be maintained for at least one year after the employee leaves the company or is moved to other duties that do not include vacuum packaging. The records must be available at the packaging facility or corporate offices for review by the regulatory authority;

(iii) shall maintain food processing records for at least one year from the time the food is packed. The records must be available at the facility or corporate offices for review by the regulatory authority. The records must contain the following information:

(I) the identity of the food that is packaged;

(II) the date the food was packaged; and

(III) the name of the operator performing the food packaging;

(iv) shall limit the types of foods that are packaged to a food that does not support the growth of Clostridium botulinum because it complies with one of the following:

(I) has a water activity (a w ) of 0.91 or less;

(II) has a hydrogen ion concentration (pH) of 4.6 or less;

(III) is a meat or poultry product cured at a food processing plant regulated by the U.S. Department of Agriculture or the department, and is received in an intact package; or

(IV) is a food with a high level of competing organisms such as raw meat or poultry;

(v) food products, other than those specified in clause (iv) of this subparagraph may be vacuum packaged if the firm provides written documentation of product testing such as shelf life studies of the product under the same storage and packaging conditions or scientific studies of the product which must be the same species, market form, packaging, and holding conditions that prove the reduced oxygen packaged product will not support the growth of Clostridium botulinum ;

(vi) the shelf life of a vacuum packaged product may be extended past the 14 day shelf life limit as specified in clause (i)(I) of this subparagraph if the firm provides written documentation of product testing such as shelf life studies of the product under the same storage and packaging conditions or scientific studies of the product which must be the same species, market form, packaging, and holding conditions that prove the extended shelf life of the reduced oxygen packaged product will not support the growth of Clostridium botulinum, Listeria and Salmonella ; and

(vii) fish shall not be packaged in reduced oxygen packaging unless the fish is frozen before, during, and after packaging unless the firm is subject to §§229.121-229.129 of this title (relating to Seafood HACCP).

(Q) Unshelled pecans shall be thoroughly cleaned to remove foreign matter before cracking. After cleaning, unshelled pecans shall be sanitized.

(R) When ice is used in contact with food, it shall be made from water that is safe and of adequate sanitary quality, and shall be used only if it has been manufactured in accordance with current good manufacturing practice as outlined in this part.

(S) Food-manufacturing areas and equipment used for manufacturing human food should not be used to manufacture nonhuman food-grade animal feed or inedible products, unless there is no reasonable possibility for the contamination of the human food.

§229.222.Enforcement.

(a) Criminal penalties as provided in Health and Safety Code, §431.059 may be assessed for violations of these sections.

(b) Civil penalties as provided in Health and Safety Code, §431.0585 may be assessed for violations of these sections.

(c) Administrative penalties as provided in Health and Safety Code, §431.054, §431.055, §431.056, §431.057, §431.058, and in §229.261 of this title (relating to Assessment of Administrative Penalties), may be assessed for violation of these sections. If the person charged with the violation does not request a hearing, the Commissioner of the Department of State Health Services (Commissioner) or the Commissioner's designee may assess a penalty after determining that a violation has occurred and the amount of the penalty.

(d) Emergency orders as provided in Health and Safety Code, §431.045 may be issued by the Commissioner or the Commissioner's designee.

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 August 11, 2006.

TRD-200604195

Cathy Campbell

General Counsel

Department of State Health Services

Effective date: August 31, 2006

Proposal publication date: March 10, 2006

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