The Texas Department of Health (department) adopts amendments to §§117.1 - 117.3, 117.32 - 117.34, 117.41, 117.43 - 117.45, 117.65, and 117.81; the repeal of §§117.11 - 117.16 and 117.82 - 117.85; and new §§117.11 - 117.17, 117.46, and 117.82-117.86 concerning the licensing of end stage renal disease (ESRD) facilities. Amended §§117.2, 117.34, 117.43 - 117.44, and 117.65, and new §§117.12 - 117.14, 117.16, 117.84 - 117.86 are adopted with changes to the text as proposed in the October 30, 1998, issue of the Texas Register (23 TexReg, 11043). Repealed §§117.11 - 117.16 and §§117.82 - 117.85, amended §§117.1, 117.3, 117.32 - 117.33, 117.41, 117.45, 117.81, and new §§117.11, 117.15, 117.17, 117.46, and 117.82 - 117.83 are adopted without change and will not be republished.

The sections cover the general provisions; application and issuance of a license; minimum standards for design and space, equipment, water treatment, reuse, and sanitary and hygienic conditions; minimum standards for patient care and treatment; provisions for dialysis technicians; and corrective action plan and enforcement provisions.

The sections represent the development of new language to address problems and areas of concern identified by the ESRD Task Force which was established in accordance with the General Appropriations Act, Rider 53, 1997. Rider 53 mandated the 12-member task force to review the implementation of ESRD facility licensing rules in order to identify problems and recommend changes; review survey outcomes and costs associated with administering the ESRD licensing program; and clarify the function of a licensed vocational nurse in an ESRD facility. Serving on the ESRD Task Force are two patient representatives and one representative from each of the following constituencies: ESRD Network of Texas, Inc.; renal dietitians; registered nurses; physicians; social workers; licensed vocational nurses; ESRD facility administrators; mechanical technicians; patient care technicians; and the department.

Subchapter A, §§117.1 - 117.3, establishes the general provisions for ESRD facilities. Section 117.1 states the purpose of the rules. The amendment to §117.1 adds subsection (d) to clarify that a license is required for an ESRD facility which is not exempt from licensure under the Health and Safety Code, §251.012. Section 117.2 defines words and terms used throughout the rules. The definitions are numbered in compliance with Texas Register format requirements (1 TAC §91.1, effective February 17, 1998). New definitions are added for "administrator," "affiliate," "change of ownership," "corrective action plan," "health care facility," "hospital," "manager," "monitor," "notarized copy(ies)," "patient," "quality," "quality assurance," "quality management," and "working day." The definition of "applicant" was amended to clarify that this is the person in whose name the license is issued. The definitions of "licensed vocational nurse" and "registered nurse" were amended to specify the statutes under which these nurses are licensed. In response to a comment and to conform with the Board of Nurse Examiners rules (22 TAC §217.12(d)), the definition of "charge nurse" was deleted. Section 117.3 clarifies the calculation of a renewal license fee and increases the change of ownership license fee for some facilities from $1,000 to $1,500 and decreases the fee from $2,000 to $1,500 for other facilities. Currently, a new facility owner is required to pay a $1,000 license fee if the survey is waived prior to issuing a license to the new owner or a $2,000 license fee if a survey is not waived. The amendment to the rule eliminates the $1,000 and $2,000 license fees and requires a flat $1,500 fee for all applications for a change of ownership regardless of whether a survey is done. In 1997 and 1998, approximately 16 facilities per year filed for a change of ownership. Approximately one-half of these facilities were surveyed prior to receiving a new license in the new owner's name.

New Subchapter B, §§117.11 - 117.17, replaces existing §§117.11 - 117.16, and establishes the application procedures and provisions for issuance of a license. The sections were rewritten to provide clarity and consistency with requirements for other facilities licensed by the department, and to remove language applicable only to the first year of this licensing program. The following is a summary of changes to these sections.

New §117.11 contains language in existing §§117.11 and 117.12 while defining requirements for the various types of licenses issued by the department. This section contains provisions applicable to any applicant for any type of license.

New §117.12 concerning application and issuance of temporary initial license and first annual license contains language currently in §§117.11 and 117.12 to describe the requirements for applications for a temporary initial license and the first annual license. The new section requires additional information to be included on the license application to be consistent with requirements for other facilities licensed by the department and reorganizes the application requirements to clarify the steps of the review process.

New §117.13 concerning application and issuance of annual renewal license replaces existing §117.12 and retains much of the requirements in existing §117.12. Some of these requirements were reorganized to provide the reader with a better understanding of the renewal process and the department's expectations.

New §117.14 concerning change of ownership or services replaces existing §117.13 and was expanded to include requirements for a change in services provided by a facility. For the purpose of this section, a change in service includes a facility closure; construction, renovation, or modification of a facility's physical plant; a change in a facility's telephone number or mailing address; an increase in the number of dialysis stations in a facility; and the provision of a new service (e.g., peritoneal dialysis). In addition, the new section contains requirements for the department in responding to a facility's request for an increase in dialysis stations or services.

New §117.15 concerning time periods for processing and issuing a license replaces existing §117.14. The text in the new section is unchanged from current §117.14.

New §117.16 concerning inspections replaces existing §117.15. The new section reorganizes existing inspection provisions; describes in more detail the department's expectations from a facility before and during an inspection; outlines the different types of inspections by the department; outlines in detail the inspection procedure and the department's evaluation of compliance; and provides a facility with procedures for challenging a deficiency cited by the department, including time frames imposed upon the department in responding to such a challenge.

New §117.17 covers optional plan review and inspection and replaces existing 117.16. The text in the new section is unchanged from existing §117.16, except that the text in subsection (b) was changed for better readability.

Subchapter C, §§117.32 - 117.34, establishes the minimum standards for equipment, water treatment, reuse, and sanitary and hygienic conditions. The sections were amended as follows.

Section 117.32 covers the minimum standards for equipment. The amendment adds a requirement that all equipment be operated in conformance to manufacturer's specifications and a requirement that at least one back-up dialysis machine be completely operational during a facility's hours of treatment.

Section 117.33 covers the minimum standards for water treatment and reuse. The amendment clarifies that water treatment components that could affect the quality of the product water must not be located after the quality monitor sensing cell, and requires the appointment of a medical director for a centralized reprocessing facility.

Section 117.34 covers the minimum standards for sanitary conditions and hygienic practices. The amendment clarifies provisions relating to the hepatitis B screening of patients. The amendments include new language applicable to a patient new to dialysis or returning to a facility after extended hospitalization or absence of 30 days or longer. Currently, the department requires patients to be screened for hepatitis B surface antigen (HBsAg) one month prior to or at the time of admission. New language in subsection (d)(2)(B)(i) allows the facility to admit a patient who has a known anti-HBs status of at least 10 milli-international units per milliliter within the previous 12 months, without requiring current HBsAg screening. New language in subsection (d)(2)(C)(iv) conforms to the new language in subsection (d)(2)(B)(i). This language recognizes the increase in provision of the hepatitis vaccine to dialysis patients and the resultant reduced need for hepatitis screening and is consistent with current federal Centers for Disease Control guidelines.

Subchapter D, §§117.41 and 117.43 - 117.46, establishes the minimum standards for patient care and treatment. The sections were amended as follows.

Section 117.41 covers minimum standards for quality assurance for patient care by establishing specific quality assurance system requirements for facilities. Currently, the department requires a facility to adopt, implement, and enforce a quality assurance program based on the May 8, 1996, edition of the Criteria and Standards, Dialysis Facility Quality Management Program as published by the ESRD Network of Texas, Inc. The ESRD Task Force and the department chose to incorporate these criteria and standards in the rules for the convenience of the renal community. The criteria and standards text in the rule was modified from the ESRD Network of Texas, Inc. document to conform to Texas Register form and style and to integrate with current rule requirements not included in the ESRD Network of Texas, Inc. document and with the organization of the section. Subsections (e) and (f) were deleted and the language from these subsections was moved to new §117.46.

Section 117.43 covers minimum standards for the provision and coordination of treatment and services. The amendments add new language relating to patient rights; emergency preparedness; medication storage and administration; nursing services; medical services; temporary admissions; audits of billing; student health care professionals; and complaint resolution. The amendments to subsection (a) relating to patient rights imposes a 30 calendar day advance notice for patient discharge or transfer except in cases where the patient presents an immediate risk to others; provides for a patient's protection from abuse, neglect, or exploitation; and excepts correctional institutions from including the 1-800 number in information provided to patients in these facilities. The amendment to subsection (c) relating to emergency preparedness adds a requirement that each facility staff member be able to demonstrate their role or responsibility to implement the facility's disaster preparedness plan. The amendment to subsection (c) also requires each facility to have an emergency lighting system which provides enough lighting to safely discontinue treatments and allow safe evacuation; to maintain and test battery pack systems quarterly; to post a phone number listing specific to the facility equipment and locale to assist staff in contacting mechanical and technical support in the event of an emergency; and to install, test, and maintain back-up generators (if used by a facility) in accordance with the National Fire Protection Association 110, Standard for Emergency Standby Power Systems. The amendment to subsection (d) relating to medication storage and administration allows a health care professional to receive a physician's verbal or telephone orders for the care or treatment provided by that health care professional (e.g., the dietitian may receive verbal orders for dietary services). The amendment to subsection (e) prohibits the nurse functioning in the charge role from being included in the staff to patient ratio during treatment of eight or more patients; reorganizes the subsection; and allows a registered nurse who is not the charge nurse to initiate the initial nursing assessment. The amendment to subsection (j) clarifies that physician visits must occur at the facility during a patient's treatment time; requires that home patients be seen by the physician at least every three months; and defines what the record for these visits must reflect; and specifies the information which must be included in orders for peritoneal dialysis treatment. New subsection (l) provides requirements admissions of transient patients and patients who are normally treated in another local facility, and describes the exchange of treatment information between the referring and receiving facilities. Current subsections (l) - (n) are renumbered as new subsections (m)-(o). New subsection (p) requires facilities to develop, implement, and enforce a compliance policy for monitoring state or federal funds. New subsection (q) provides conditions under which student health care professionals may provide care in a facility. New subsection (r) requires a facility to adopt, implement, and enforce procedures for resolving complaints relevant to quality of care or services.

Section 117.44 covers minimum standards for qualifications of staff. The amendment adds new language to subsection (c) relating to nursing staff and to subsection (e) relating to social services staff, and adds new subsection (f) relating to technical staff. The amendment to subsection (c) adds language to paragraph (3) to list qualifications which would allow an LVN to function in the charge role and delineates differences between an LVN and an RN functioning in this role. The amendment also deletes paragraph (3)(D) relating to the expiration of the paragraph. New subsection (f) describes the required qualifications for all technical staff ( technical supervisory staff, water treatment staff, equipment maintenance and repair staff, and reprocessing staff).

Section 117.45 covers minimum standards for clinical records. The amendment reorganizes subsection (e) into paragraphs (1) - (6); clarifies that a facility must obtain and include the information listed in paragraphs (1) - (6) prior to dialyzing a transient patient; adds a requirement for a list of medications and allergies; clarifies that laboratory reports must include screening for hepatitis status; and clarifies that the treatment records provided must be the most current.

New §117.46 concerning reports to the director contains the deleted language in §117.41(e) and (f); changes the time frame for reporting certain occurrences from three working days to ten working days; and requires the use of a department form to report such occurrences.

Subchapter E, §§117.61- 117.65, establishes the minimum standards for dialysis technicians. Section 117.65(b)(1) was amended to prohibit a dialysis technician from discontinuing dialysis via a central catheter, manipulating a central catheter, or performing dressing changes for a central catheter. The prohibition in §117.65(b)(4) was deleted to allow a dialysis technician to perform non-access site venipuncture. The prohibition in §117.65(b)(5) was amended to include "non-access site" before "arterial" to be clear that arterial puncture of a vascular access to perform dialysis is an accepted act for all qualified dialysis technicians.

Subchapter F, §§117.81 - 117.86 establishes enforcement provisions. Section 117.81 concerning corrective action plans was amended to add language to conform to new §§117.82 and 117.83.

New §117.82 - 117.86 is a reorganization of existing §§117.82 - 117.85. New §117.82 concerning voluntary appointment of a temporary manager contains the provisions in existing §117.82(a). New §117.83 concerning involuntary appointment of a temporary manager contains the provisions in existing §117.82(b). New §117.84 concerning disciplinary action contains the provisions in existing §117.83. New §117.85 concerning administrative penalties contains the provisions in existing §117.84. New §117.86 concerning recovery of costs contains the provisions in current §117.85.

The department received written comments and additional comments at the public hearing which the department held in Austin, Texas, on November 18, 1998. The comment period ended on November 30, 1998. The following is a summary of comments received on the proposed rules, the department's responses, and any resulting change(s).

1. COMMENT: Concerning the rules in general, one commenter suggested that the department require that pediatric dialysis patients receive care in a pediatric facility when that option is logistically feasible. The commenter expressed concern that a pediatric patient receiving treatment in an adult facility will be evaluated by adult outcome measures.

1. RESPONSE: While the department would agree that ideally pediatric patients would be treated in pediatric facilities, it is important that care be available for these patients as near to their homes as possible. Requiring all pediatric patients to be cared for in a pediatric facility as a minimum standard would be unduly restrictive. Further, the rules currently contain requirements specific to the care and treatment of the pediatric dialysis patient, without regard to the scope of the treatment facility, to assure minimal safe care for these patients is provided. (see §117.43(e)(6), §117.43(e)(7)(B), and §117.43(j)(2)(B)). In response to the second portion of the comment, the treating facility would have the responsibility to utilize pediatric outcome measures when appropriate and available. No change was made.

2. COMMENT: Concerning the rules in general, one commenter expressed an inability to locate a provision in the rules which clearly defines the scope of the department's licensing authority. The commenter described a scenario in which a hospital provides inpatient acute hemodialysis services to patients admitted to the hospital's skilled nursing facility (SNF) which is designated as an outpatient facility for Medicare certification and reimbursement. The commenter expressed concern that the rules do not clearly define the department's authority to regulate such a scenario.

2. RESPONSE: The department understands the commenter's concern. The state law which provides the department with the authority to adopt licensing rules governing end stage renal disease facilities is located in the Health and Safety Code (HSC), Chapter 251. Language was added to clarify that the licensing rules cover facilities providing routine, repetitive, outpatient dialysis at §117.1(a). The HSC, §251.012 contains specific exemptions from licensure and includes a hospital licensed under HSC, Chapter 241 that provides dialysis only to individuals receiving inpatient services from the hospital. A hospital-based SNF unit is considered an inpatient unit of the hospital regardless of its Medicare reimbursement classification. If a hospital's dialysis services are limited to inpatients of the hospital and its SNF patients, no ESRD facility license is required. No change to the rules was made as a result of the comment.

3. COMMENT: In reference to proposed §117.2(16), renumbered as §117.2(15), concerning dialysis technicians, a commenter stated that the definition for "technician" doesn't address LVNs and assumes LVNs are equivalent to dialysis technicians, without recognizing their additional education and skills.

3. RESPONSE: The department regrets the statutory language did not differentiate unlicensed patient care technicians from LVNs, and recognizes the skills and abilities of the LVNs working in ESRD facilities. These rules include sections which acknowledge these skills and abilities by delineating tasks and functions for the LVN that are beyond the practice of the unlicensed dialysis technician. No change was made.

4. COMMENT: In reference to proposed §117.2(44), renumbered as §117.2(43), concerning definitions, one commenter stated the definition of "progress note" should be sufficiently broad to allow and encourage the use of computer systems.

4. RESPONSE: The department believes that the definition is sufficiently broad to allow the use of electronic formats to maintain progress notes. The definition does not preclude the use of such formats. Electronic signature of clinical records, including progress notes are not prohibited so long as the entries meet the requirement in §117.45(e)(5). No change was made.

5. COMMENT: In reference to proposed §117.2(54), renumbered as §117.2(53), concerning definitions, the Medical Review Board of the ESRD Network of Texas, Inc., suggested that the definition of "working day" be referenced or included wherever the words, "days" or "working days" are included in the document.

5. RESPONSE: The department understands the commenter's concern for clarity. Where practical, the department has defined each reference to "day" as being either "calendar" or "working" throughout the document.

6. COMMENT: In reference to §117.11(c)(3)(A), concerning general requirements for a license, a commenter asked whether the relocation of a facility housed in a modular building (e.g. the building itself would be moved to a different address) would be treated differently than a relocation of a facility to a different building.

6. RESPONSE: The department responds that the license is not transferrable to a different address; the license is issued to a facility at the physical location listed on the license application. In the event the situation described by the commenter occurs, the department would consider waiving the design and space survey of the relocated modular building. No change was made.

7. COMMENT: In reference to §117.13, concerning application and issuance of annual renewal license, one commenter stated "recognizing that both parties have an obligation, it seems to be a burden to make the facility responsible for problems of the department." The commenter did not reference specific provisions of §117.13.

7. RESPONSE: Since the commenter did not reference specific provisions of §117.13, the department can not be sure what problems the commenter is referring to, and therefore cannot respond appropriately. No change was made.

8. COMMENT: In reference to §117.13(f)(2), concerning application and issuance of annual renewal license, one commenter stated that a facility has no mechanism to monitor who has student loans and stated that denying license renewal because of a defaulted student loan is excessive and puts a large number of patients at risk to find alternative care. The commenter added that the requirement jeopardizes the employment of many individuals.

8. RESPONSE: The department understands the commenter's concern, but disagrees that the rule is excessive. The Texas Education Code, §57.491 prohibits the department from renewing a license to a person who is in default on a student loan. The law does not affect any individual employed by a facility unless the individual is the person to whom the ESRD license is issued. Including the student loan provision in the licensing rules serves as a notice regarding the student loan requirement. Deletion of the provision from the rules does not negate the responsibility of the department or the licensee's obligation to comply with the law. Other state licensing authorities (e.g. Texas State Board of Medical Examiners, Texas State Board of Nurse Examiners, Texas State Board of Licensed Vocational Nurse Examiners) are also required to comply with the Texas Education Code's requirements. No change was made.

9. COMMENT: In reference to §117.14(b)(2), concerning change in services, one commenter stated that the provision is too broad and should be restricted to patient care areas and instances where the renovation or modification is not urgent due to safety considerations.

9. RESPONSE: The department disagrees that the provision is overly broad. The rule is not a new requirement and is intended to identify construction projects that must comply with the design and space requirements in §117.31. Notification concerning the project will expedite the department's scheduling of a design and space inspection (if deemed necessary by the department). For clarification purposes, the rule was amended to state the notification time frame is measured in calendar days. No changes were made as a result of the comment.

10. COMMENT: In reference to §117.17(b), optional plan review and inspection, one commenter stated that when a facility is ready to open, the state inspection should be done quickly, that the state can be kept appraised of the construction progress and be prepared to act, and that delay in opening the facility could cause continued hardship to patients and a financial hardship to the facility due to delay in being able to generate income.

10. RESPONSE: The department agrees that an inspection for the purposes of verifying compliance with the design and space requirements in §117.31 should be expeditious. The rule is a current requirement and is presently implemented as suggested by the commenter. No change was made.

11. COMMENT: In reference to §117.32(a), concerning equipment, one commenter stated that it is not always reasonable to operate equipment according to manufacturer's specifications. The commenter stated that when a manufacturer's manual identifies such specifications as "recommendations," it is interpreted that the user may make modifications. The commenter added that discussion with the manufacturer of some equipment indicated that some recommendations are for the manufacturer's protection and not necessarily for patient safety. The commenter suggested flexibility be allowed.

11. RESPONSE: The department agrees that flexibility should be allowed whenever possible. This language was developed by the technical sub-committee of ESRD Network of Texas, Inc. and was endorsed by the ESRD Task Force. The department believes operating equipment in accordance with the manufacturer's specifications provides a minimum level of safety for patients. No change was made.

12. COMMENT: In reference to §117.32(c), concerning equipment, two commenters stated the requirement was confusing. One commenter described a scenario in which there are 44 machines which requires five backup machines. Of these five backup machines, only one would need to be operational. The commenter asked "If one machine fails and the backup is put in use, are we then out of compliance." The commenter stated that a patient's treatment could be delayed several hours safely. The commenter did not state whether all 44 machines are being used during all treatment times. Another commenter requested clarification with regard to the requirement of one operational back-up machine for every eight (8) patients that are dialyzing. The commenter stated that there are some units that have 17 or 18 chairs, and asked if this means that the unit would have to round up on the number of back-up machines.

12. RESPONSE: The department understands the commenters concerns. The department explains that the requirement at §117.32(c) is intended to provide one backup machine for every 10 machines (or portion thereof) in use. Surveyors have found facilities to have the required number of backup machines, but none were ready for use. The intention of this requirement is to assure that at least one functional backup machine is available during patient treatment times. A facility with 44 machines would require five backup machines to be available; and a facility that had 17 machines will be required to have two backup machines available. Machines on the treatment floor not currently in use are considered back-up machines as well as machines stored elsewhere in the facility. Not having an available operational machine should rarely occur; rare occurrences do not routinely constitute a deficient practice unless there are negative patient outcomes. No change was made.

13. COMMENT: Regarding §117.32(c), concerning backup machines, a commenter asked if facilities owned by the same corporate group and located near each other could share backup machines, transporting them between two or more facilities.

13. RESPONSE: The department has set minimum requirements for back up machines to prevent patients missing or having shortened treatments due to equipment failure. The department and the task force agreed that the minimum of one backup machine in each facility for every 10 in use was necessary to assure safety. The minimum number of backup machines must be maintained in each facility. Corporations may provide access to more back up equipment through sharing if desired.

14. COMMENT: In reference to §117.34(d)(2)(B)(i) and (C)(iv), concerning hepatitis B prevention, a commenter asked the definition of "extended hospitalization."

14. RESPONSE: The department intends the "30 days or longer" to apply to both "extended hospitalization" and "absence." No change was made.

15. COMMENT: In reference to §117.34(d)(2)(C)(iv), concerning hepatitis B prevention, one commenter stated that all the commenter's patients are treated as if they are potentially HBsAg positive and that the staff wears protective equipment and uses standard precautions.

15. RESPONSE: The department recognizes the efforts of the commenter in practicing standard precautions. Treatment of HBsAg positive patients requires specific hemodialysis precautions to include barrier garments and discard of dialyzers after single use. This is in addition to standard precautions. No change was made.

16. COMMENT: In reference to §117.41(c)(5), concerning responsibilities of the governing body, one commenter asked how a governing body is defined by these rules, stating that his facility was part of a multi-specialty clinic which has a central governing body, with no specific knowledge related to ESRD. The commenter suggested changing the frequency for the governing body's review and monitoring of quality management activities from "quarterly" to "annually." The commenter stated that the "quarterly details" are better left to individuals knowledgeable in the area of nephrology and dialysis.

16. RESPONSE: The department believes setting a definition of governing body may be restrictive. The facility may establish a local governing body to be responsible for the quality management activities and the day-to-day functioning of the facility. This is frequently the case in large, multi-state corporations which have a national governing body as well as local governing body for each facility; the local governing body would be responsible to report and respond to the central governing body. This arrangement is also seen in some hospital based units, where a unit- based committee is responsible for the required actions, and reports to the hospital's governing body. No change was made.

17. COMMENT: In reference to §117.41(g)(4)(F), concerning quality control and quality improvement mechanisms, a commenter from a hospital-based dialysis facility stated that monitoring mortality by the quality management team and review of individual deaths would better be done by the medical staff and suggested that this activity would easily duplicate the activities of the hospital medical committees or the hospice committees.

17. RESPONSE: The department agrees that a facility's medical staff should be involved in monitoring mortality. The rule does not preclude the monitoring of mortality as suggested by the commenter. However, it is important that such data be shared with core staff members as active participants in quality management activities. The requirements relating to quality management in §117.41 are consistent with the criteria and standards set out by the ESRD Network of Texas, Inc. No change was made.

18. COMMENT: In reference to §117.43(d)(3), relating to receipt of telephone and verbal order, one commenter agreed with the change to allow dietitians to take verbal orders. A second commenter stated that licensed personnel (e.g., nurses and physicians) should be able to take dietary orders and that this provides more timely interventions as the dietitian may not be present in the facility at all times.

18. RESPONSE: The department appreciates the support and agrees that clarification is needed. The rule is not intended to preclude acceptance of dietary orders by nurses or physician assistants. The department has rewritten the language to make this clear which was included in the proposed rule. No change was made.

19. COMMENT: In reference to §117.43(e)(7)(A), one commenter questioned the 4:1 ratio described in the proposal. The commenter stated that facilities with less than eight patients are unlikely to be economically attractive; the rule will "essentially mandate a ratio of two and two-thirds patients per nurse;" and this high level of staffing decreases the attractiveness of providing satellite services.

19. RESPONSE: The department does not agree with the commenter. Patients treated in "satellite" facilities should be provided the same level of care as patients treated in "non-satellite" facilities. The task force unanimously supported the need to make a licensed nurse available at all times during treatment of eight or more patients to coordinate the care of all the patients being treated. When that nurse has her own patient assignment, she is not available to evaluate the patients of the unlicensed staff members or to take indicated action. Staffing for eight patients could be one licensed nurse and two unlicensed dialysis technicians, maintaining the current rations of one licensed nurse to 12 patients (or portion thereof), and one direct care staff to each four patients. No change was made.

20. COMMENT: In reference to §117.43(e)(7)(A), twelve commenters expressed agreement with the exclusion of the charge nurse from the ratio of four patients per licensed nurse or patient care technician per patient shift during the treatment of eight or more patients. The commenters stated that the amendment promotes a safer environment for dialysis patients.

20. RESPONSE: The department appreciates the support and agrees that when eight or more patients are being treated, requiring the "charge nurse" to provide direct patient care places these patients at risk to receive treatment below the minimum standard for safe dialysis.

21. COMMENT: In reference to §117.43(e)(7)(A), nursing services, one commenter from a pediatric facility suggested that the rule be changed to require facilities to base staffing needs on a statistically validated patient dependency classification system. The commenter expressed concern with regard to the adequacy of care the current 4:1 ratio would provide a pediatric patient. The commenter added that staffing requirements for pediatric care comprise a complex matrix that is most easily implemented with a staffing and scheduling system to staff by skill level according to the dependency level of the patient.

21. RESPONSE: The department agrees that a universally accepted dependency or acuity- based system for determining staffing levels in the dialysis setting would be the optimum approach to meet the intent of the requirement. However, based upon current information obtained from the dialysis community at large, no such universally-accepted system has been established for the out-patient dialysis setting. The rules do not preclude the use of such a system if its use meets the minimum rule requirement of a 4:1 ratio for patients weighing more than 20 kilograms. This requirement does not prohibit a facility from using a lower ratio for pediatric patients whose levels of acuity demand more individual care, and these rules specify higher ratios for certain pediatric patients at §117.43(e)(7). No change was made.

22. COMMENT: In reference to §117.43(e)(7)(A), nursing services, two commenters recommended, in the interest of improved patient care and safety, a reduction of the ratio to three patients per licensed nurse or patient care technician. Another commenter stated that the 4:1 ratio described in the rule encourages administrative staff to pressure nursing supervisors to use 4:1 staffing regardless of patient acuity levels. The commenter suggested that staffing levels should be based on either a 3:1 patient to patient care staff ratio or patient acuity.

22. RESPONSE: The department understands the commenter's concern for patient health and safety and recognizes the minimum ratio of four patients per licensed nurse or patient care technician required by these rules may not be adequate in some situations. Facilities are expected to evaluate the needs of the individual patients being treated and adjust staffing to meet these needs. This expectation is reflected at §117.43(e)(7), which requires sufficient staff be on-site to meet the needs of the patients. The Task Force discussed reducing the 4:1 ratio at length and concluded a 3:1 ratio would be overly restrictive and cost prohibitive. The Task Force is committed to evaluating acuity based staffing methods with the possibility of amending this requirement to address staffing based on patient acuity at a later date. The rule does not preclude the use of a 3:1 ratio or patient acuity staffing formulas which meet or exceed the 4:1 rule. No change was made.

23. COMMENT: In reference to §117.43(e)(7)(A), nursing services, one commenter expressed disagreement with taking the charge nurse out of the 4:1 ratio during treatment of eight or more patients. While recognizing that taking the charge nurse out of this ratio might provide additional staff and benefit patients, the commenter wants the freedom to design work teams to improve continuity of care for patients by pairing each RN with a couple of patient care technicians. Each work team would be responsible for a group of patients for up to six months. The commenter implied that no single RN would be designated "charge", and all RN's would participate in staffing at some level while directing the care of their team's patients. Taking the charge nurse out of the ratio when eight or more patients are receiving treatment might limit the financial resources available to implement this system, and would lock nurses into a "dated position." The commenter was concerned that the rule terminology would "stifle innovation and creativity" related to changes which could improve staffing and better meet patient needs.

23. RESPONSE: The department appreciates the commenter's desire to implement innovative and creative ideas to improve staffing, and would encourage the commenter to use this creativity to identify ways to meet this minimum standard and design work teams to provide the desired outcome. The intent of excluding the nurse functioning in the charge role from the 4:1 ratio when eight or more patients are being treated is to provide a greater level of safety by assuring the availability of a licensed nurse to oversee the care of all patients, rather than having this individual absorbed in direct care responsibilities. No change was made.

24. COMMENT: In reference to §117.43(e)(7)(A), nursing services, two commenters supported this rule, but stated there are situations where a nurse does not report to work requiring the charge nurse to care for up to four patients in order to prevent delay or cancellation of patient treatments. The commenter suggested adding provisions for flexibility so that patients can receive timely care. A second commenter requested an exception for emergency situations.

24. RESPONSE: The department agrees that in the scenario described by the first commenter it is important to avoid delay or cancellation of treatment to patients. There should be some backup system to allow for coverage in the event of personnel absenteeism or emergencies, so that such events described by the commenters would be rare. Rare events do not routinely constitute a deficient practice unless there are negative patient outcomes. No change was made.

25. COMMENT: In reference to §117.43(j)(2)(C), medical services for home patients, the Medical Review Board of the ESRD Network of Texas, Inc. suggested deleting the words, "at the facility," in that the delivery of the service rather than the place of delivery is the key element in providing medical services to these patients. Another commenter stated that requiring home patients to be seen at the facility is unduly restrictive, adding that requiring the physician go from his/her office to a facility to see a patient can waste time; that the facility location provides no advantages; and that occasionally, patients make an appointment in the physician's office due to a preference for more privacy.

25. RESPONSE: The department agrees that where medical services are delivered to home patients is not as important as the actual delivery of these services. The department reminds the commenters that home patients will also need to receive the required support services, (nursing, social, and dietary services) and that Medicare certification requirements limit reimbursement for home services to facilities certified to provide these services. The language was amended to delete the specification of location for the physician to see home patients.

26. COMMENT: In reference to §117.43(j)(2)(C), medical services, one commenter requested that the department consider allowing the use of nurse practitioners and physician extenders to substitute for the physician in writing progress notes and in seeing patients in the dialysis facility every two weeks.

26. RESPONSE: The department agrees that nurse practitioners and physician extenders may be very useful in providing care to dialysis patients. The suggestion that these individuals substitute for the physician in seeing patients every two weeks was considered and rejected by the Task Force and by the Medical Review Board of the ESRD Network of Texas. Other than the minimum requirement for the physician to record a progress note at least every six months, the nurse practitioner or physician extender could certainly document the medical progress of the patient. No change was made.

27. COMMENT: In reference to 117.43(j)(2)(C), medical services, one commenter stated that physicians being able to see patients in satellite facilities every two weeks is problematical: patients on the early shift may have already completed their treatment and left the facility before the physician arrives. The commenter suggested the rules allow such patients to be seen in the physician's office, or for the physician to simply review the patient record in the facility every two weeks and see the patient only if there are issues.

27. RESPONSE: The department recognizes providing medical care to facilities distant from the physician's office may be challenging. Each facility is seen as a distinct entity, and every patient must be provided the minimum level of care required in these rules. The physician member and alternate for the task force supported the requirement that each patient be seen by a physician every two weeks as the minimum for safe medical care. No change was made to the rule.

28. COMMENT: In reference to §117.43(j)(2)(E)(i), orders for hemodialysis treatment, one commenter stated the requirement should be for length of treatment rather than for treatment time and the dialysate bath should also be specified in the requirement.

28. RESPONSE: The department agrees and has changed the language as suggested.

29. COMMENT: In reference to §117.43(l)(1), temporary admissions, one commenter stated the rule was confusing. The commenter asked how a physician becomes a member of the staff of the referring and the receiving facilities, stating that dozens of patients from distant parts of the country are cared for each year and that some of these patients just show up at the facility for treatment. The commenter also asked if care to these patients is to be denied.

29. RESPONSE: The department understands the commenter's concern and denial of care is not suggested by the rule. The rule applies to situations in which a patient is dialyzed in another local facility. A "local facility" is one which is in the same geographical area as the patient's "home" facility. The intent of the rule is to facilitate treatment of patients in an associated facility which is open longer hours than the patient's "home" facility. Language was added at §117.43(l)(2) to describe requirements for a facility to treat transient patients (those from distant facilities), the situation described by the commenter.

30. COMMENT: In reference to §117.43(l)(4), renumbered as §117.43(l)(1)(D), temporary admissions, one commenter stated that it takes one to two days for a laboratory to report hepatitis B status, so the commenter's facility treats these patients using appropriate precautions. The commenter stated that not treating these patients could be hazardous to their health and since the commenter's facility is hospital-based, not providing treatment could be construed as denial of emergency care.

30. RESPONSE: The department understands the commenter's concern. The rule is not intended to deny treatment to patients, and is not meant to preclude treatment if a patient's hepatitis B status cannot be established. Language was added at §117.43(l)(1)(E) to clarify that, if the patient's hepatitis status is unknown, the patient must be undergo treatment as if the HBsAg test results were potentially positive, except that such a patient shall not be treated in the HBsAg isolation room, area, or machine.

31. COMMENT: Regarding §117.43(p), relating to audits of billing, a commenter reported billing is not done in their facility, as all billing is done by a central office, and asked if the facility could be exempt from this requirement.

31. RESPONSE: The department recognizes that many corporate owned facilities will have billing performed at a central location, however, a central system does not relieve the individual facility from the responsibility of assuring that this process is done accurately and not fraudulently. Because the health care community is familiar with the requirements of a compliance policy, the department has added the word "compliance" to describe the policy required by this rule.

32. COMMENT: In reference to proposed §117.43(q)(2), student health care professionals, one commenter stated that his hospital-based facility frequently provides orientation for nursing students (RNs and LVNs) which includes teaching about dialysis, dialysis machines, and health and safety issues. The commenter stated that this information cannot be provided by the students' instructors since they are not familiar with dialysis. The commenter added that the proposed rule is overly restrictive and could lead to less understanding of dialysis by students rather than more.

32. RESPONSE: The department agrees this rule could be interpreted too stringently, and has deleted the requirement and renumbered the remaining paragraphs.

33. COMMENT: In reference to §117.43(r), complaint resolution, a commenter inquired what constitutes a complaint, stating that some patients complain that they need to run a longer time in order to achieve their target clearance, and in some cases, a patient's comments may be dismissed as "insignificant," or "general expressions of unhappiness which should fall below the threshold of formal response."

33. RESPONSE: The department agrees that it may be difficult to identify true complaints. The rule is specific to a complaint resolution system that addresses quality of care or services or staff and intends to relate to complaints describing conditions (clinical or sociological) which may be detrimental to achieving quality. Facilities may need to develop guidelines to direct staff in evaluating the significance of patient comments. A single comment regarding delays in treatment, for example, may not need to be documented, while repeated comments alleging unfair treatment would need to be recorded and addressed. The department has clarified the language in an attempt to assist facilities in this task.

34. COMMENT: In reference to §117.44(c)(3)(A), nursing staff qualifications, one commenter stated that the rule is in conflict with the requirement in the rules and regulations governing professional nurse education, licensure, and practice, Title 22, Texas Administrative Code (TAC), §217.12(d) relating to designations for registered nurse/titles deemed misleading. The commenter added that the rules and regulations governing vocational nursing practice do not contain provisions allowing a licensed vocational nurse (LVN) to practice as a charge nurse. The commenter concluded that if an RN assigned charge nurse duties to an LVN, the RN would be in violation of Title 22, Texas Administrative Code (TAC), §217.13(10) relating to unprofessional conduct.

34. RESPONSE: The department agrees that the rule conflicts with 22 TAC §217.12(d) and has changed the language to conform to the regulations adopted by the State Board of Nurse Examiners. The department consulted with the Board of Nurse Examiners and has changed the language used to describe the licensed nurse who is the primary person responsible for coordinating the care for a shift of patients from "charge nurse" to "the licensed nurse functioning in the charge role" throughout the rules. The department does not agree that the RN would be in violation of 22 TAC §217.13(10) by assigning a qualified LVN to function in the charge role as specified in these rules, but has added language at §117.44(c)(3) to clearly delineate requirements which would allow an LVN to function in the charge role, and to differentiate the responsibilities for an RN versus an LVN functioning in this role.

35. COMMENT: In reference to §117.44(c), qualifications of nursing staff, one commenter stated that licensed vocational nurses (LVNs) should not be allowed to continue to perform charge nurse responsibilities.

35. RESPONSE: The department does not agree that qualified LVNs should not be allowed to continue to perform charge responsibilities. After consulting with the Board of Nurse Examiners, language was added at §117.44(c)(3) to detail the conditions under which an LVN may function in the charge role.

36. COMMENT: In reference to §117.44(c), qualifications of nursing staff, a commenter stated that LVNs do not possess the depth of knowledge necessary for the decision making required of a charge nurse and expressed no knowledge of a certification examination which ensures this knowledge has been gained. Another commenter stated that the certification exams available to LVNs do not qualify an LVN to perform charge duties.

36. RESPONSE: The department recognizes the differences in the scope of practice of an RN versus an LVN and has addressed these differences at §177.44(c). The department has determined that information provided the task force regarding a specific certification exam to confirm the proficiency of an LVN in the charge role was incorrect and has deleted that proposed language. The department consulted with the Board of Nephrology Nurses and Technician Exam and determined LVN's are being allowed to take the Certified Hemodialysis Nurse exam effective January 1, 1999. On the request and with the input of the ESRD task force, language was added to allow licensed vocational nurses with two years hemodialysis experience to obtain certification as a hemodialysis nurse by a nationally recognized board, complete a facility based competency program and demonstrate competency in the charge role as a substitute for the two years experience as a charge nurse prior to September 1, 1996.

37. COMMENT: In reference to §117.44(e)(1), qualifications for social work staff, the Medical Review Board of the ESRD Network of Texas, Inc. and another commenter suggested deleting the words, "and have one year experience in social services." The commenters expressed concern that such a requirement would overly restrict the availability of master's prepared social workers and added that since the requirement does not provide for clinical or nephrology expertise, the potential risk of losing social workers from the available pool outweighs any perceived benefit.

37. RESPONSE: The department agrees that the requirement is overly restrictive and has deleted the words as suggested.

38. COMMENT: In reference to §117.44(e)(1), social services staff, one commenter expressed concern about the requirement that social workers be degreed at the master's level and suggested that services of a bachelor level social worker under the supervision of a master's degree social worker could perform many tasks which do not require a master's degree (e.g., arranging transient treatments, competing drug and travel requests).

38. RESPONSE: The department agrees that many social services do not require the expertise of a master's prepared social worker. The rule provision, which is currently in effect, does not preclude a bachelor's level social worker from providing discrete social services, such as those listed by the commenter, under the supervision of a master's prepared social worker. No change was made.

39. COMMENT: In reference to §117.44(f), technical staff, one commenter applauded the addition of minimum qualification standards for all technical staff, including water treatment, equipment, maintenance, and reprocessing staff.

39. RESPONSE: The department appreciates the support and agrees that establishing minimum qualifications for technical staff is important to patient safety. No change was made.

40. COMMENT: In reference to §117.44(f), technical staff training, a commenter inquired whether there will be a minimum number of hours required for technical training.

40. RESPONSE: The department has not specified a minimum number of hours for the training outlined for technical staff. Each facility would be expected to tailor this training to the individual's learning needs to assure minimum competency at the completion of the training program. No change was made.

41. COMMENT: Concerning §117.44(f)(1), relating to education requirements for technical staff, one commenter asked if these requirements applied to staff who perform reprocessing of hemodialyzers.

41. RESPONSE: The department has specified the education requirements apply to all technical staff to include staff who perform reprocessing of hemodialyzers. The language was amended to clarify this requirement.

42. COMMENT: In reference to §117.44(f)(1)(A)(i), relating to education requirements for technical staff, a commenter asked if there would be a "grandfather" clause to allow individuals with years of experience to continue working in the technical area of dialysis even though they do not have a high school diploma.

42. RESPONSE: The department appreciates the comment's question, agrees that a "grandfather clause" should be included, and has added language which waives the requirement for a high school diploma or equivalent for technical staff employed by the facility for two or more years prior to the effective date of these rules.

43. COMMENT: In reference to §117.44(f)(1)(A)(ii)(II), relating to training or experience for technical staff, one commenter stated that the curriculum components listed in §117.62 (relating to training curricula and instructors for dialysis technicians) contain an "unnecessary level of medical detail for persons who do not have direct patient care responsibility." Another commenter asked whether candidates for technical positions must have two years experience.

43. RESPONSE: The department agrees that the language at §117.44(f)(1)(A)(ii)(I)-(IV) was confusing. Completion of the dialysis technician training program is one option to fulfill the training or education requirements for technical staff, two years experience is another option. The department has modified the language to clarify this as a list of options for training and experience.

44. COMMENT: In reference to §117.44(f)(1)(C), technical staff, one commenter stated that a technician's skill is best known by observing work performance. The commenter added that trying to develop a test and determine its reliability and validity is beyond the capability of most facilities.

44. RESPONSE: The department understands resources are available in the renal community to include prepared tests in the areas of water, reuse, and mechanical support for dialysis. Just as facilities utilized commercial curricula (available without charge) for their dialysis technician training programs, they may use such available curricula, which include prepared tests, for this requirement. No change was made.

45. COMMENT: In reference to §117.44(f)(2), training required for the technical staff, one commenter indicated that the requirements for "chief technician" (technical supervisor) may conflict with the commenter's hospital-based organizational hierarchy. The commenter stated that the chief technician for the ESRD facility is responsible for the facility's mechanical and water treatment systems, while significant preventive maintenance and repair of dialysis machines are performed by the hospital's biomedical engineering department staff, who report to their own supervisor.

45. RESPONSE: The department understands the commenter's concern but believes there is sufficient flexibility in the language of this requirement to allow it to "fit" his hospital-based program. Facilities may arrange for some services, such as preventative maintenance, to be provided by an outside source or by a department in a hospital. The work done by that outside entity would be reported to the facility; the chief technician would be responsible for reviewing those reports and bringing any problem identified to the attention of the facility's quality assurance committee. No change was made.

46. COMMENT: In reference to §117.44(f)(3)(B)(iii), technical staff, confirmation of the ability to distinguish all primary colors, a commenter asked why the person responsible for water testing needs to distinguish all primary colors.

46. RESPONSE: The department is aware that several of the tests required to assure safety in the treatment water and in reuse procedures are based on color changes when reagents are added. A person who could not distinguish all primary colors would not be capable of accurately performing and reading these tests. No change was made.

47. COMMENT: In reference to §117.44(f)(4)(B)(iii), equipment maintenance and repair staff, one commenter from a hospital-based facility stated that the facility's technical supervisor is not responsible for building maintenance and suggested provisions for these situations.

47. RESPONSE: The department recognizes facilities may meet these requirements in various ways. Facility staff responsibilities for building maintenance may be as minimal as knowing whom (from the hospital building maintenance personnel) to call for building maintenance issues, or as complex as having the capability to effect maintenance and repair of the physical plant. The department believes that the rule is sufficiently flexible and made no change.

48. COMMENT: In reference to §117.45(e), clinical records for transient patients, one commenter expressed agreement that most transient visits are scheduled and the facility has received all the information specified in the rule. The commenter stated that the rule should accommodate situations when patients present to the facility requiring emergency services. The commenter added that the nephrologist is capable of evaluating a patient and developing a plan of treatment, including dialysis orders.

48. RESPONSE: The department agrees that the nephrologist is capable of evaluating a transient patient and developing a plan of treatment, including dialysis orders, when the patient presents unannounced. Language was added at §117.43(l)(2) to clarify and to allow for treatment of transient patients who present unannounced. No change was made to §117.45(e).

49. COMMENT: In reference to §117.46, report to the director, one commenter stated that clotted vascular access is a frequent occurrence and that the facility handles this by hospitalizing the patient (sometimes on an outpatient basis). The commenter asked if the department really wanted a formal report on every patient who was hospitalized for a clotted vascular access.

49. RESPONSE: The rule requiring reports to the director is currently in effect at §117.41(e) and (f), except that the proposed language in §117.46 relaxes the reporting time from three working days to ten working days. In response to the commenter's question, if the clotting occurred as a result of treatment and required hospital care, it should be reported. If the access was clotted when the patient was presented to the dialysis facility for treatment, this occurrence would not need to be reported. No change was made.

50. COMMENT: In reference to §117.65(b)(1), prohibited acts for dialysis technicians who are not licensed vocational nurses, a commenter asked why dressing changes for central catheters are now prohibited.

50. RESPONSE: The department and the task force are aware of the high infection rate for central catheters and determined restricting the performance of dressing changes to licensed nurses would provide a definite time to assess the catheter insertion site, increasing the potential an infection would be recognized early to allow treatment. No change was made.

51. COMMENT: In reference to §117.65(b)(1), prohibited acts, a commenter stated that the language regarding the prohibited acts for unlicensed dialysis technicians was not clear as to whether the technician could return the patient's blood, and expressed concern that unlicensed technicians would not be allowed to do this task for patients who were unstable.

51. RESPONSE: The department does not agree that the language is unclear. No reference is made to the interdialysis care; the acts prohibited are the connection, manipulation, and disconnection of the catheter, not the administration of fluid (e.g. to return the patient's blood) through the catheter. No change was made.

The commenters included representatives from the following: W.W. Wise Memorial Dialysis Center, Harlingen; Collom and Carney Clinic Association, Texarkana; the Medical Review Board of the ESRD Network of Texas, Inc., Dallas; Scott and White Hospital, Temple; Total Renal Care, San Antonio; Texas Children's Hospital Renal Dialysis Center, Houston; University of Texas Medical Branch at Galveston; Austin Diagnostic Clinic, Austin; and several registered nurses working in dialysis. The commenters were generally in favor of the rules as proposed, but expressed concerns, asked questions, and made recommendations for change.

In addition to the changes the department made as a result of comments received, the department is making the following changes due to staff comments to clarify the intent and improve the accuracy of the sections.

1. CHANGE: Concerning §117.12(a), the department corrected the cross reference to requirements relating to the application and issuance of an annual renewal license. The cross reference was erroneously listed as §117.13; it was changed to refer to subsection (h).

2. CHANGE: Concerning §117.12(c)(1), the department deleted the extraneous words, "to the," between the phrases "...of this subsection..." and "...within six months from the mailing date...."

3. CHANGE: Concerning §117.13(b)(2) and §117.13(g), sentence structure was modified for clarification purposes.

4. CHANGE: Concerning §117.13(f), the department deleted the words "propose to" for clarity.

5. CHANGE: Concerning §117.13(f)(3), the department added language to clarify that the department may deny the issuance of an annual renewal license if information in §117.12(c)(3)(S) and (T) is discovered by the department.

6. CHANGE: Concerning §117.16(c)(4)(C)(vi)(IV), the reference to "clause (ii) or (iii) of this subparagraph" was corrected to read "subclause (II) or (III) of this clause."

7. CHANGE: Concerning §117.43(a)(15), patient's rights in respect to a complaint mechanism, the department made a change as a result of conversations with the management of the dialysis facilities located in correctional institutions and research by the legal staff of the department. This requirement was amended to exempt correctional institutions from including the 1-800 number in information provided to patients in these facilities as inmates have limited phone access and other grievance mechanisms exist within the Texas Department of Criminal Justice.

8. CHANGE: Concerning §117.43(e)(10), the term "nursing assessment" was changed to "patient evaluation" for clarification.

9. CHANGE: Concerning §117.65(b)(4), this requirement was amended to include "non-access site" before "arterial" to be clear that arterial puncture of a vascular access to perform dialysis is an accepted act for all qualified dialysis technicians.

Subchapter A. General Provisions

Subchapter F. Advisory Committee

Subchapter A. Control of Radiation

The Texas Department of Health (department) adopts the repeal of existing §289.112 without changes and new §289.205 concerning hearing and enforcement procedures with changes to the proposed text as published in the December 4, 1998, issue of the Texas Register (23 TexReg 12118), as a result of comments received during the 30-day comment period. The repeal of §289.112 is adopted without changes and therefore will not be republished.

The General Appropriations Act, House Bill 1, Article IX, Rider 167, passed by the 75th Legislature, 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). Section 289.112 has been reviewed and the department has determined that the reasons for adopting the section continue to exist; however, a new section was proposed. The department published a Notice of Intention to Review for §289.112 as required by Rider 167 in the Texas Register (23 TexReg 10504) on October 9, 1998. No comments were received by the department on this section.

The repealed section adopts by reference Part 13, titled "Hearing and Enforcement Procedures" of the Texas Regulations for Control of Radiation (TRCR). The new section incorporates language from TRCR Part 13 that has been rewritten into Texas Register format and includes the addition and revision of several subsections of the section. The repeal and new section are part of the renumbering phase in the process of rewriting the department's radiation rules in Texas Register format. The new section reflects the renumbering.

The new section includes new language describing the process for hearings on denials of applications. Clarifying language is added concerning modifications, revocations or suspensions of licenses; certificates of registration, accreditation of mammography facilities; and industrial radiographer certification. The language for issuing, renewing, and amending licenses to process materials resulting in byproduct material or dispose of byproduct material and to process radioactive waste is revised to clarify noticing and hearing requirements. New language on severity levels for mammography violations is included to reflect current requirements, while examples of severity levels of violations are deleted. Other minor grammatical changes are made to the section for clarification.

The department is making the following changes due to staff comments to clarify the intent and improve the accuracy of the section.

Change: Concerning §289.205(b)(16), the department deleted the words "suffering" and "who" and added the words "that the person has suffered" after the word "demonstrates" to make the language consistent with that of the Texas Radiation Control Act.

Change: Concerning §289.205(c)(2), the department deleted the word "requestor" as it did not provide clarification to this paragraph.

Change: Concerning §289.205(c)(2)(B), the department reworded the subparagraph for clarification and moved it to subparagraph (A), as it is part of what must be contained in a request for hearing. The subsequent subparagraph is renumbered. Change is reflected in §289.205(c)(2)(A)(v).

Change: Concerning §289.205(d)(1), the department corrected the reference to the Texas Radiation Control Act from §401.003(B) to §401.003(3)(B).

Change: Concerning §289.205(d)(2)(B)(i), the department added wording requiring a licensee to "cause notice of the proposed action to be published and," to the beginning of the clause to clarify that this is the responsibility of the licensee.

Change: Concerning §289.205(d)(3)(B), the department deleted the words, "a statement regarding the" to be grammatically correct.

Change: Concerning §289.205(e)(1)(B)(i), the department added wording requiring a licensee to "cause notice to be published and," to the beginning of the clause to clarify that this is the responsibility of the licensee.

Change: Concerning §289.205(e)(3), the department deleted "a" and added the word "the" and deleted the words "certain as" from the second sentence to provide clarification.

Change: Concerning §289.205(e)(3)(F), the department added the words "service by" after "The return of" to clarify the intent of the subparagraph.

Change: Concerning §289.205(e)(3)(G), the department deleted the words "return receipt requested," and added the words "addressed to the last known address," following the words "certified mail" for consistency throughout the section on requirements for certified mail.

Change: Concerning §289.205(f)(3), the department added wording requiring a licensee to "cause notice to be published and" to clarify that this is the responsibility of the licensee.

Change: Concerning §289.205(g), the department deleted the words "license, certificate of registration," after "Revocation of," and the words "or industrial radiographer certification for fraud, misrepresentation, or mistake," after "mammography facilities." The requirements concerning revocation of licenses, certificates of registration and industrial radiographer certifications are delineated in subsection (i). Subsection (g) will only address revocation of mammography facility accreditations.

Change: Concerning §289.205(g)(1), the department deleted the words, "A license, certificate of registration," from the beginning of the paragraph. The words, ", or industrial radiographer certification" after the words "mammography facility" were deleted. The requirements concerning revocation of licenses, certificates of registration and industrial radiographer certifications are delineated in subsection (i). The words, "for any of the following:" were added to refer to new subparagraphs (A), (B), and (C). The words, "on the grounds of fraud, misrepresentation, or mistake" were deleted because the intent of the words is more clearly specified in new subparagraphs (A), (B), and (C).

Change: Concerning new §289.205(g)(1)(A), (B), and (C), the department added these subparagraphs to delineate the reasons that an accreditation of mammography facility may be revoked.

Change: Concerning §289.205(g)(2), the department deleted the words, "a license, certificate of registration," "or industrial radiographer certification," "licensee/registrant" "/certified industrial radiographer," and "license, certificate of registration," from the first sentence. The words, "licensee, registrant," and ",or industrial certified radiographer" were deleted from the last sentence. The requirements concerning revocation of licenses, certificates of registration, and industrial radiographer certifications are delineated in subsection (i).

Change: Concerning §289.205(g)(3), the department added a paragraph delineating the requirements for requesting a hearing for revocation of a mammography facility accreditation.

Change: Concerning §289.205(i), the department deleted the words "accredited mammography facilities," ",and accreditation of mammography facilities," "accreditation of a mammography facility," "accredited mammography facility," and "mammography facility accreditation," throughout the subsection as this subsection addresses compliance procedures that do not pertain to accredited mammography facilities. Requirements concerning revocations for mammography facilities are addressed in subsection (g).

Change: Concerning §289.205(l)(3), the department corrected the references from subsection (i)(6) to subsection (i)(8) and subsection (i)(7) to subsection (i)(9).

Change: Concerning §289.205(l)(4), the department corrected the reference from subsection (i)(7) to subsection (i)(9).

Change: Concerning §289.205(m)(6), the department deleted the words "return receipt requested." and added the words "addressed to the last known address." following the words "certified mail" for consistency throughout the section on requirements for certified mail.

Change: Concerning §289.205(n)(3), the department changed the heading to "Hearing location." from "Place of hearing." for clarification.

The following comments were received concerning the proposed section. Following each comment is the department's response and any resulting change(s).

Comment: Concerning §289.205(c)(5), the commenter questioned if this is to allow the agency to schedule a hearing in the expectation of potentially receiving a request from an affected person? The commenter stated that if so, this is a good change as it will allow the agency to expedite the hearing process in the event a request is received; however, the agency should not be able to request a hearing on its own initiative as it already has made its determination.

Response: The department has the authority to hold a hearing even if a hearing is not requested by the licensee. No change was made as a result of the comment.

Comment: Concerning §289.205(i), the commenter suggested restructuring this section for clarity as subsection (i)(8) modifies subsection (i)(2), after being procedurally referenced in subsection (i)(5). The commenter stated that it doesn't make sense unless you read the entire section and then have to interpret the cross-connections, as everything is the same rank (e.g., the things the agency can do; why they can do it; how they must do it).

Response: Section 289.205(i)(8) also modifies subsection (i)(3) and subsection (i)(7). No change was made as a result of the comment.

The commenter is a representative from International Isotopes, Inc. The commenter was generally favorable of the rule as proposed; however, the commenter had questions or specific concerns, and offered suggestions for changes to the proposal as discussed in the summary of the comments.

Subchapter C. Texas Regulations for Control of Radiation

The Texas Department of Health (department) adopts the repeal of existing §289.115 without changes and new §289.255 concerning radiation safety requirements and licensing and registration procedures for industrial radiography with changes to the proposed text as published in the December 4, 1998, issue of the Texas Register (23 TexReg 12126), as a result of comments received during the 30-day comment period. The repeal of §289.115 is adopted without changes and therefore will not be republished.

The General Appropriations Act, House Bill 1, Article IX, Rider 167, passed by the 75th Legislature, 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). Section 289.115 has been reviewed and the department has determined that the reasons for adopting the section continue to exist; however, a new section was proposed. The department published a Notice of Intention to Review for §289.115 as required by Rider 167 in the Texas Register (23 TexReg 9079) on September 4, 1998. No comments were received by the department on this section.

The repealed section adopts by reference Part 31, titled "Radiation Safety Requirements and Licensing and Registration Procedures For Industrial Radiography" of the Texas Regulations for Control of Radiation. The new section incorporates language from Part 31 that has been rewritten into Texas Register format and includes addition and revision of several subsections of the section. The repeal and new section are part of the renumbering phase in the process of rewriting the department's radiation rules in the Texas Register format. The new section reflects the renumbering.

The revision incorporates industrial radiography training requirements that are items of compatibility with the United States Nuclear Regulatory Commission (NRC) and as an agreement state, Texas must adopt them. Additional options for personnel monitoring are added. The fee for industrial radiographer certification is raised to reflect a more accurate cost recovery by the department. References to other sections of this chapter are clarified to reflect the Texas Register format. Other minor grammatical changes are made to the section for clarification.

The department is making the following changes due to staff comments to clarify the intent and improve the accuracy of the section.

Change: Concerning §289.255(c)(15), the department deleted this sentence and formulated two new sentences to more clearly state the intent of the definition.

Change: Concerning §289.255(c)(19), the department replaced the word "control" with "drive" for consistency with the term "drive cable" throughout the section.

Change: Concerning §289.255(d)(1), the department deleted the reference "and (7)(A)" because this reference was redundant as §289.255(b)(3) already required registration.

Change: Concerning §289.255(d)(4), in the first sentence, the department replaced the word "subsection" with "section" to state the correct reference intended by this paragraph and added the references "(b)(3) and (5), (j)" before the reference "(m)(1)(A)" to ensure that all the necessary exemptions were addressed. The department also deleted the reference "and (7)(A)" at the end of the first sentence since it was unnecessary and deleted the second sentence since it restated what was already included in §289.255(m)(1)(A).

Change: Concerning §289.255(e), the department restructured the second sentence by deleting the phrase "in accordance with subsection (w)(1) of this section" at the end of the sentence and added the phrase "in accordance with subsection (w)(1) of this section," after the word "records" for clarification of the intent of the subsection.

Change: Concerning §289.255(f)(1), the department changed the "§289.202(f)" reference to "§289.202(p)(1) and (2)" because "§289.202(f)" was an incorrect reference.

Change: Concerning §289.255(h)(1)(E), the department deleted this subparagraph to avoid duplication of records by licensees and registrants as they are already required to maintain these records in accordance with §289.255(j)(2) and (6).

Change: Concerning §289.255(h)(2), the department changed the form number from "255-2" to "255-U" to more accurately reflect the form numbering system used throughout the section.

Change: Concerning §289.255(i)(1), the department deleted the words "of use" and replaced them with "before using equipment," to clarify the intent of the paragraph.

Change: Concerning §289.255(i)(2)(A), in the last sentence, the department added the words "inspection and maintenance" after the word "This" to specify which program the subparagraph addresses.

Change: Concerning §289.255(k)(2)(B), the department deleted the word "control" before the word "drive" for consistency with the term "drive cable" throughout the section.

Change: Concerning §289.255(m)(1), the department replaced the words "a current" with "the original or a copy of an" and added to the end of the sentence the phrase "or a certification ID card" to allow for various options of proof of radiographer trainee status.

Change: Concerning §289.255(m)(2)(A)(ii)(I), the department replaced the word "radiographer" before the words "trainee status card" with "legible" to emphasize that the document must be capable of being read.

Change: Concerning §289.255(m)(2)(A)(ii)(III), the department replaced the word "x rays" with "x-ray machines" to more clearly state the intent of the subclause.

Change: Concerning §289.255(m)(2)(A)(ii)(V), the department changed the form number from "255-OOS" to "255-OS" to more accurately reflect the form numbering system used throughout the section.

Change: Concerning §289.255(m)(2)(A)(iv), the department changed the "(p)(1)" reference to "(p)(2)" because "(p)(1)" was an incorrect reference.

Change: Concerning new §289.255(m)(3)(B), the department added this subparagraph that specifically lists the responsibilities of the radiographer trainer regarding the supervision of radiographer trainees to clarify the intent of this subsection. As a result of adding this subparagraph, the proposed §289.255(m)(3) text was renumbered to allow for the addition of the new subparagraph and comply with the Texas Register format. Change is reflected in renumbered (m)(3)(A)-(B).

Change: Concerning §289.255(m)(4), the department added the word "industrial" before "radiography" for consistency throughout the section.

Change: Concerning §289.255(m)(4)(B)(ii), the department deleted the reference "(2)(A)(ii) and (iii)", added "(2)(A)(iii)" after the phrase "paragraph (1)(A) and", and added the phrase "subsection (n)(1)(B) of this section" to state the correct references intended by this clause.

Change: Concerning §289.255(m)(4)(C)(xv), the department changed the references "(u)(4)(A)-(D)" to "(u)(4)(A)-(C)" and "(v)(7)(A)-(D)" to "(v)(7)(A)-(C)" to state the correct references intended by this clause.

Change: Concerning §289.255(o)(1)(C), the department added the words "for examination" after the word "application" to specify the application to be submitted as intended by this subparagraph.

Change: Concerning §289.255(o)(2)(D), the department deleted the first sentence because it was redundant.

Change: Concerning §289.255(o)(2)(F), the department replaced the word "have" with "present" to more clearly state the intent of this subparagraph.

Change: Concerning §289.255(p)(1), the department changed the form number from "255-OOS" to "255-OS" to more accurately reflect the form numbering system used throughout the section.

Change: Concerning §289.255(p)(1)(B), the department added the words "for radiographer certification" after the word "application" to specify the application to be submitted as intended by this subparagraph.

Change: Concerning §289.255(q)(2), the department deleted the words "When performing" before the word "industrial" and replaced this phrase with the word "During" so the sentence reads better.

Change: Concerning §289.255(q)(2)(A)(i), the department deleted this clause and replaced it with "an individual monitoring device that meets the requirements of §289.202(p)(3) of this title" so as not to limit licensees and registrants to current available individual monitoring devices but to allow for new technologies in personnel monitoring.

Change: Concerning §289.255(q)(2)(G), in the first sentence, the department replaced the words "film badge, TLD, or OSL" with "monitoring device" so as not to limit licensees and registrants to current available individual monitoring devices but to allow for new technologies in personnel monitoring.

Change: Concerning §289.255(q)(2)(H), the department replaced the words "film badge, TLD, or OSL" with "individual monitoring device" so as not to limit licensees and registrants to current available individual monitoring devices but to allow for new technologies in personnel monitoring.

Change: Concerning §289.255(q)(2)(I), in the first sentence, the department replaced the words "Film badges, TLDs, or OSLs" with "Individual monitoring devices" and in the second and third sentences replaced the words "film badge, TLD, or OSL" with "individual monitoring device" so as not to limit licensees and registrants to current available individual monitoring devices but to allow for new technologies in personnel monitoring.

Change: Concerning §289.255(q)(2)(J), in the first sentence, the department replaced the phrase "a film badge, TLD, or OSL" with "an individual monitoring device" and throughout this subparagraph, replaced the words "film badge, TLD, or OSL" with "individual monitoring device" so as not to limit licensees and registrants to current available individual monitoring devices but to allow for new technologies in personnel monitoring.

Change: Concerning §289.255(q)(4)(A), at the end of the sentence, the department deleted the phrase "prior to use at the start of each work shift" because it was redundant in this subparagraph.

Change: Concerning §289.255(q)(4)(D), at the end of the sentence, the department deleted the phrase "for correct response to radiation" because it was redundant in this subparagraph.

Change: Concerning §289.255(q)(6)(B), the department deleted this subparagraph and replaced it with "Records of the individual monitoring device monitoring results received from the individual monitoring device processor." so as not to limit licensees and registrants to current available individual monitoring devices but to allow for new technologies in personnel monitoring.

Change: Concerning §289.255(t)(1)(B), the department deleted this subparagraph and replaced it with "an individual monitoring device that meets the requirements of §289.202(p)(3) of this title for each worker" so as not to limit licensees and registrants to current available individual monitoring devices but to allow for new technologies in personnel monitoring.

Change: Concerning §289.255(t)(3), the department deleted the word "valid" before the words "trainee status card" to more clearly state the intent of the paragraph and also changed the "(m)(1)(A)" reference to "(m)(1)" to state the correct reference intended by this paragraph.

Change: Concerning §289.255(u)(4)(C), the department replaced the "(n)" reference with "(n)(1)" to state the correct reference intended by this subparagraph.

Change: Concerning §289.255(u)(5), the department deleted the words "and survey records" after the word "surveys" since the records requirements are in another subsection.

Change: Concerning §289.255(u)(5)(C), at the end of the second sentence, the department replaced the "§289.202(n)(3)" reference with "§289.202(n)(1)(B) and (C)" to state the correct reference intended by this subparagraph.

Change: Concerning §289.255(u)(6), the department deleted the phrase "and exemptions" after the word "requirements" since the exemptions are addressed in another subsection.

Change: Concerning §289.255(v)(5)(C)(ii), the department added the phrase ", the NRC," after the word "agency" to accurately state that the NRC is also an authorizing entity as intended by this clause.

Change: Concerning §289.255(v)(7)(C), the department replaced the "(n)" reference with "(n)(1)" to state the correct reference intended by this subparagraph.

Change: Concerning §289.255(v)(8), the department deleted the words "and survey records" after the word "surveys" since the records requirements are in another subsection.

Change: Concerning §289.255(w)(2), in the second sentence, the department added the words "and registrant" after the word "licensee" to accurately state who is responsible for maintaining the records of the calibrations.

Change: Concerning §289.255(w)(3)(A), the department added the words "and registrant" after the word "licensee" to accurately state who is responsible for maintaining the records of the quarterly inventories. The department also deleted the phrase "sealed sources and of" after the word "inventory" and replaced it with "sources of radiation, including" to specify the correct items to be inventoried as intended by this subparagraph.

Change: Concerning §289.255(w)(3)(B), the department deleted the word "sealed" before the word "source" to correctly state the types of radiation to be included in the record as intended by this subparagraph.

Change: Concerning §289.255(w)(4)(A), the department added the words "and registrant" after the word "licensee" to accurately state who is responsible for maintaining the records intended by this subparagraph.

Change: Concerning new §289.255(w)(4)(A)(vi), the department added this clause to address all the necessary equipment intended by this clause.

Change: Concerning §289.255(w)(5), in the first sentence, the department replaced the word "checks" with the word "tests" for consistency in this paragraph. In the second sentence, the department added the words "and registrant" after the word "licensee" to accurately state who is responsible for maintaining the records intended by this subparagraph and also replaced the phrase "until disposal is authorized by the agency" with "for two years from the date of the test" to more accurately reflect the intended record retention period.

Change: Concerning §289.255(w)(7)(B), the department replaced the "(n)" reference with "(n)(1)" to state the correct reference as intended by this subparagraph. At the end of the sentence, the department replaced the phrase "until disposal is authorized by the agency" with "for five years after the record is made" to more accurately reflect the intended record retention period.

Change: Concerning §289.255(w)(8)(A), in the first sentence, the department added the word "pocket" after the word "Direct-reading" and added the phrase "or electronic personal dosimeter" before the word "readings" to reflect consistency of context used in equivalent subsections throughout the section. In the second sentence, the department replaced the words "film badge, TLD, or OSL" with "individual monitoring device" so as not to limit licensees and registrants to current available individual monitoring devices but to allow for new technologies in personnel monitoring. At the end of the second sentence, the department replaced the phrase "until the agency authorizes disposal" with "for agency inspection until disposal is authorized by the agency" for consistency throughout the section.

Change: Concerning §289.255(w)(8)(C), the department replaced the words "film badge, TLD, or OSL" with "individual monitoring device" so as not to limit licensees and registrants to current available individual monitoring devices but to allow for new technologies in personnel monitoring.

Change: Concerning §289.255(w)(8)(D), the department replaced the words "film badges, TLDs, or OSLs" with "individual monitoring devices" so as not to limit licensees and registrants to current available individual monitoring devices but to allow for new technologies in personnel monitoring.

Change: Concerning §289.255(w)(12), in the end of the second sentence, the department replaced the phrase "until the agency authorizes disposal" with "for agency inspection until disposal is authorized by the agency" for consistency throughout the section.

Change: Concerning §289.255(w)(13), the department deleted the phrase "and exemptions" after the word "requirements" since the exemptions are addressed in another subsection and not in this paragraph.

Change: Concerning §289.255(w)(13)(A), at the end of the sentence, the department replaced the phrase "two years after the evaluation" with the phrase "five years from the date of the evaluation" to more accurately reflect the intended record retention period.

Change: Concerning §289.255(w)(13)(B), at the end of the sentence, the department replaced the phrase "until disposal is authorized by the agency" with the phrase "for five years from the date of the test" to more accurately reflect the intended record retention period.

Change: Concerning §289.255(w)(13)(C), at the end of the sentence, the department replaced the phrase "two years after the evaluation" with the phrase "five years from the date of the evaluation" to more accurately reflect the intended record retention period.

Change: Concerning §289.255(w)(14)(B), at the end of the sentence, the department replaced the phrase "until disposal is authorized by the agency" with the phrase "for two years from the date of the test" to more accurately reflect the intended record retention period.

Change: Concerning §289.255(w)(15), the department added a new sentence "Records of utilization logs." to comply with the Texas Register format that requires a lead-in sentence if all other paragraphs within the same subsection contain this. At the end of the proposed first sentence, the department replaced the phrase "until disposal is authorized by the agency" with the phrase "for two years from the date the utilization log is made" to more accurately reflect the intended record retention period.

Change: Concerning proposed §289.255(y)(1)(B)(iii), the department replaced the word "personnel" with "individual" and replaced the word "equipment" with "devices" for consistency throughout the section.

Change: Concerning proposed §289.255(y)(3), the department deleted this paragraph and replaced it with a new revised paragraph to reflect consistency of terminology used throughout the section, to include for: subsection (j), changed the word "Installations" to "Installation Tests;" subsection (m)(1)(A) and (2)(A) and (n), changed the reference "(n)" to "(n)(1);" and subsection (q), changed the name of the record from "Personnel Monitoring" to "Individual Monitoring Devices" and to the record titled "Direct-Reading Dosimeter Readings" added the words "Pocket or Electronic Personal" before the word "Dosimeter." The department also changed the "Record Keeping Time Interval" accordingly to reflect the specific subsection context record retention period, to include for: subsection (h), changed from "until disposal is authorized by the agency" to "2 years;" subsection (j), changed from "until disposal is authorized by the agency" to "2 years;" subsection (m)(1)(A) and (2)(A) and (n), changed from "until disposal is authorized by the agency" to "5 years;" subsection (u)(6)(B), changed from "2 years" to "5 years;" subsection (u)(6)(C)(i), changed from "until disposal is authorized by the agency" to "5 years;" subsection (u)(6)(C)(ii), changed from "until disposal is authorized by the agency" to "5 years;" subsection (u)(6)(C)(iii), changed from "2 years" to "5 years;" and subsection (v)(9)(C), changed from "until disposal is authorized by the agency" to "2 years."

The following comments were received concerning the proposed section. Following each comment is the department's response and any resulting change(s).

Comment: Concerning §289.255 in general, the commenter stated that the new format and numbering are hard to read and follow. He suggested the department highlight/shade the subsection letters and the titles so that the reader can at least see when one subsection starts and ends.

Response: The department is required to use the Texas Register format for the adoption of all rules. When the final printed copy is distributed to all affected licensees and registrants, the revised text will be shaded to make it easy to note the revisions; therefore, the subsection letters and the titles will not be shaded, unless they have been revised. No change was made as a result of the comment.

Comment: Concerning §289.255 in general, the commenter stated that he experienced confusion with the overall readability due to the Texas Administrative Code (TAC) format requirements. The commenter further stated that the new 25 TAC format is hard to read compared to the prior format of the Texas Regulations for Control of Radiation (TRCR). The commenter expressed that this will lead to extra costs and potential errors for those trying their best to read, cross-reference, and ensure compliance to the requirements. He further added that the category headings are hard to find because they are buried in the text.

Response: The department is required to use the Texas Register format for the adoption of all rules. In an attempt to reduce the level of confusion and errors, the department has included a "Cross-Reference" table that provides the old rule numbers and the equivalent new rule subsection numbers. The table is located at the back of all rules that have been converted into the Texas Register format and distributed to licensees and registrants. The table will be provided when this section is adopted and distributed. No change was made as a result of the comment.

Comment: Concerning §289.255(c), the commenter questioned the difference between "lay-barge radiography," "offshore radiography," and "underwater radiography." The commenter stated that he recalled an interpretation by department staff that explained offshore radiography to be performed on water with depth less than six feet.

Response: The department defines the terms in question in §289.255(c)(22), (24), and (52) accordingly. The department has made no official interpretation to explain that "offshore" is meant to be radiography performed in water with depths less than six feet. No change was made as a result of the comment.

Comment: Concerning §289.255(c)(38), the commenter questioned if two persons were needed to transport the radioactive source because of the requirements in §289.255(v)(7)(G). The commenter added that this is unnecessary and costly.

Response: Subsection §289.255(v)(7)(G) explains when at least two radiographic personnel are required and that requirement does not include transport of radioactive sources. No change was made as a result of the comment.

Comment: Concerning §289.255(d)(4), the commenter stated that he experienced confusion with the new language in the paragraph and noted that this paragraph states, "Facilities which utilize radiation machines for industrial radiography at permanent radiographic installations only are exempt from the requirements of this subsection except for the requirements of subsections §289.255(m)(1)(A) and (u)(6)(A), (B), (E) and (7)(A). The individual operating radiation machines at permanent radiographic installations must successfully complete a course of at least 40 hours on the applicable subjects..." The commenter expressed that the phrase "this subsection" seemed to mean the entire §289.255. He further stated that no other interpretation logically fit based on positioning of this paragraph and that since his entire operation consisted of a single shielded room x-ray machine, the only requirements of §289.255 that seemed to apply to his operation were the following: §289.255(d)(4) concerning operators required 40 hour training course; §289.255(m)(1)(A) regarding that trainees must possess current trainee status cards; §289.255(u)(6)(A), (B), and (E) concerning annual evaluation of radiation systems; and §289.255(u)(7)(A) that requires radiation machines must be registered.

The commenter further stated that by reading this proposed section, items previously required, but now exempted included the following: §289.255(e)-equipment receipt, transfer, and disposal records; §289.255(f)-radiation survey instruments; §289.255(g)-quarterly inventory; §289.255(h)-utilization logs; §289.255(i)-daily equipment inspection; §289.255(j)-shielded room alarms and entrance controls; §289.255(k)-notification of incidents; §289.255(m)(2), (3), and (4) radiographer, radiographer trainer, RSO certification; §289.255(q)-personnel monitoring control; §289.255(r)-access control; and §289.255(s)-posting.

The commenter added that a lot of change has been made to this section, but that he is not particularly opposed because of the low risk of a well-designed shielded room x-ray unit. The commenter further expressed that if he had misunderstood the intent of the section, then he urged the department to strengthen the language and positioning of this exception in order to ensure that everyone clearly understands.

Response: The department further clarified the paragraph by adding the references "(b)(3) and (5), (j)" before the reference "(m)(1)(A)" in this paragraph to ensure that all the necessary exemptions were addressed. The department also deleted the reference "and (7)(A)" at the end of the first sentence since it was unnecessary and deleted the second sentence since it restated what was already included in §289.255(m)(1)(A).

Comment: Concerning §289.255(h)(1)(B), the commenter stated that the words "and signature" need to be added after the word "name" to meet the NRC compatibility requirements equivalent to 10 Code of Federal Regulations (CFR) 34.71(a)(2).

Response: The department added the suggested language to comply with NRC compatibility requirements equivalent to 10 CFR 34.71(a)(2) because as an agreement state, Texas must adopt this section as comparable to NRC's regulations.

Comment: Concerning §289.255(i)(1)(B), the commenter asked how he is supposed to determine that the survey instrument is responding when using an x-ray machine since the x-ray machine has to be in the "on" position in order to make this determination.

Response: The requirement of this subparagraph is for checks for response to radiation and not intended to require calibration. The department suggests that the licensee or registrant simply perform a battery check of the survey meter to check for response. No change was made as a result of the comment.

Comment: Concerning §289.255(j)(3), the commenter asked how he is supposed to test that the alarm system is operating properly before the installation is used for radiographic operations when the x-ray machine has to be in the "on" position in order to make this determination. The commenter stated that his facility currently possesses a machine with internal machine checks.

Response: The department suggests that the registrant apply to the department for approval of alternative methods for controlling access to high radiation areas in accordance with §289.202(s)(3) as stated in §289.255(j)(1). No change was made as a result of the comment.

Comment: Concerning §289.255(l)(3), the commenter stated that if the enforcement actions did not suspend or revoke the identification (ID) card, then the individual's card should be reciprocally recognized.

Response: The department notes that this paragraph states "Enforcement actions....by an independent certifying entity may be considered when reviewing..." This paragraph does not mean that an individual's card would not be recognized for any type of enforcement action but instead the word "may" is permissive and informs the reader that the department may consider such actions prior to granting reciprocity. No change was made as a result of the comment.

Comment: Concerning §289.255(m)(2)(A)(ii)(IV), the commenter asked what the word "travel" means in this context.

Response: The word "travel" in this context has the same meaning as it would in any other context and that is to transport to and from a point of origin or final destination. This clause provides a list of items that cannot be used to receive credit for the hours of on-the-job training. Travel is included in that list because there is no educational benefit being gained for the person sitting in a vehicle, driver or passenger, "traveling" to a job site. No change was made as a result of the comment.

Comment: Concerning §289.255(m)(3)(B), the commenter suggested the department consider issuing trainer cards rather than taking the time to amend licenses.

Response: This issue will be addressed in a future revision of this section because a revision as suggested by the commenter would incur a fee and there are other departmental resource issues to be considered. No change was made as a result of the comment.

Comment: Concerning §289.255(o), the commenter suggested the department provide an explanation of the procedures for submitting the application and money.

Response: There will be two separate application forms, one for the exam and one for the certification (that involves review of the training documentation). Often, an individual will submit an application for an exam, take the exam, but not complete the required on-the-job training until some time later. In this case, the individual would submit the separate application for certification (and the $100 fee) upon completion of the training. In a situation where an individual has completed the training requirements and applies to take the exam, a single check or money order for the combined fee of $125 may be submitted, but both application forms must be submitted in order for the department to appropriately allocate the fee money. No change was made as a result of the comment.

Comment: Concerning §289.255(o)(1)(B), the commenter expressed that this subsection states a fee of $25 for the exam and §289.255(p) states a fee of $100 for the ID card. The commenter asked if the new cost for the ID card is $125. The commenter asked if someone under reciprocity with an ID card from another agreement state/NRC will have to pay $100 to get a Texas ID card.

Response: A certification ID card is issued upon completion of the requirements for certification. One requirement is to successfully pass the exam and the exam fee is $25. Another requirement is to complete the training requirements. The fee for review of training requirements is $100. Since all requirements must be met before a certification ID card is issued, the total cost is $125. A person granted reciprocity with an ID card from another certifying entity is not required to get a Texas certification ID card. No change was made as a result of the comment.

Comment: Concerning §289.255(p)(1)(A), the commenter asked how the fees were determined and broken down to $100 and $25.

Response: The department calculated the fees by using actual staff time and resource costs assigned to those activities. The department created two separate fees, one for the examination and one for the actual certification to reflect a more accurate cost recovery by the department. The examination cost is normalized over the total number of persons tested while the certification cost considers the staff time required to review the individual's qualifications. The two different fees also allow the department to accurately recover costs when only one component of certification is performed by the department. For example, an individual may take the exam in Texas, but submit training documentation and be certified by another certifying entity. No change was made as a result of the comment.

Comment: Concerning §289.255(q)(2)(G), the commenter asked why the subparagraph requires that the film badge or TLD be turned in for processing if the readings from the electronic personal dosimeter are greater than 200 millirem (2 mSv) as this specific equipment already gives you the dose and dose rate.

Response: The electronic personal dosimeter will give those readings for the day or shift that it is being used, but may not represent the individual's cumulative dose for the time period being monitored by the film badge, TLD, or OSL. This requirement is included in this subparagraph so that the individual performing radiographic operations does not become dependent on the electronic personal dosimeter and alarming ratemeter but instead continues to practice and comply with all requirements that are meant to provide for the radiographic personnel's safety. No change was made as a result of the comment.

Comment: Concerning §289.255(r)(1), the commenter asked why the paragraph requires that the individual maintaining visual surveillance of the operation specifically has to be a radiographer. The commenter suggested the words "a radiographer" be changed to "radiographic personnel."

Response: The department added the suggested language to this paragraph.

Comment: Concerning §289.255(u)(4)(D), the commenter asked in what situation would this subparagraph apply that is different from a situation in which §289.255(u)(4)(E) would apply.

Response: The difference between §289.255(u)(4)(D) and (E) is that §289.255(u)(4)(E) only applies in a one-person operation where an individual is not only the radiographer and the radiation safety officer (RSO), but is also the only individual that performs radiography. The rules permit this in a permanent radiographic installation or with the use of only x-ray machines. No change was made as a result of the comment.

Comment: Concerning §289.255(u)(4)(F), the commenter asked who trains the trainer when one individual serves as RSO, radiographer, and trainer. The commenter stated this subparagraph needed clarification as well as the documentation of this training.

Response: The requirements of this subparagraph do not specify who has to perform the training and therefore the decision of who trains the trainer, when one individual serves as RSO, radiographer, and trainer, is left to the licensee and/or registrant. Records of the annual refresher training are required by §289.255(u)(4)(J) and (v)(7)(L). No change was made as a result of the comment.

Comment: Concerning §289.255(v)(5)(C), the commenter asked why this subparagraph includes depleted uranium (DU) for leak testing. The commenter further questioned why a separate DU leak test must be performed every 12 months if leak testing sources every six months is already required.

Response: The licensee can perform a DU leak test at the same time that leak testing of sources is performed and thus be in compliance with the requirements of this subparagraph. No change was made as a result of the comment.

Comment: Concerning §289.255(v)(7)(F), the commenter asked who trains the trainer when one individual serves as RSO, radiographer, and trainer. The commenter stated this subparagraph needed clarification as well as the documentation of this training.

Response: The requirements of this subparagraph do not specify who has to perform the training and therefore the decision of who trains the trainer, when one individual serves as RSO, radiographer, and trainer, is left to the licensee and/or registrant. Records of the annual refresher training are required by §289.255(u)(4)(J) and (v)(7)(L). No change was made as a result of the comment.

Comment: Concerning §289.255(w)(1)(B)(iv), the commenter questioned what is meant by the word "mass" in this context. The commenter suggested the department clarify this term.

Response: "Mass" in this context means the number of pounds of DU the licensee possesses. No change was made as a result of the comment.

Comment: Concerning §289.255(y)(1)(B)(iii), the commenter stated that his facility has no optically stimulated luminescence devices or electronic personal dosimeters and suggested the department add clarifying language such as "when applicable" or "as applicable" if equipment is not available for use.

Response: The department added the words "as a minimum" to this clause to allow for flexibility when the licensee and/or registrant does not possess all of the different personnel monitoring equipment.

Commenters included representatives from Raytheon TI Systems, Frank Malek and Associates, Sharp Radiation Services, MQS Inspection, and San Jacinto College.

Subchapter C. Texas Regulations for Control of Radiation