TITLE health-services

Part I. Texas Department of Health

Chapter 73. Laboratories

The Texas Department of Health (department), by majority vote of the Texas Board of Health (board) on February 8, 1998, enters this order finally adopting the repeal of existing §§73.22, 73.31, and 73.41 and new §§73.22, 73.23, and 73.24, concerning fees for laboratory testing services; the sale of laboratory services; and the certification of drinking water, milk and shellfish laboratories. Fees are adopted for newborn screening; blood lead testing; milk, drinking water and shellfish laboratory certification; radiation control testing; and bottled water analysis. Sections 73.22 and 73.24 are adopted with changes to the proposed text as published in the December 5, 1997, issue of the Texas Register (22 TexReg 11933). Section 73.23 and the repealed sections are adopted without changes, and therefore the section and the repeals will not be republished.

The General Appropriations Act of the 75th Legislature requires the department to review all fees within its authority and set fees to recover the cost of providing services to the extent feasible. (Article II, Department of Health, page II-41, Rider 40). In addition to the department's specific directive, Article IX, General Provisions of the General Appropriations Act, directs all agencies to review all fees that each administers and adjust rates as necessary to recover the costs of providing services (page IX-87, Rider 76). State law also requires that fees for public health services, including laboratory services, be established by rule.

The repealed sections have not been substantially revised since their initial adoption a number of years ago. Changes in technological capabilities, economic conditions and social expectation required their reevaluation. Repeal of the existing sections allows for reorganization and clarification through adoption of the new sections. Section 73.22 is repealed because the relationship between the department and local public health laboratories has changed over the years and is no longer the relationship described in that section. In addition, such laboratories will now be charged a fee for certification of the laboratory, which was not allowed under repealed §73.22. Fees in repealed §§73.31 and 73.41 are now in adopted new §73.22. Certification procedures in repealed §73.41 are revised and now in adopted new §73.24.

The demand for laboratory services is expected to increase in the future. Maintaining state of the art technology to respond to unforeseen circumstances will require continued investment in the infrastructure. The adopted fees may be used to invest in that infrastructure to ensure the department's ability to meet and counter emerging threats to the health of Texans.

The adopted fees are only for a limited number of laboratory services. The remaining laboratory services will continue to be provided without adoption of a fee. The adopted fees will not limit public access to services.

The department adopts a fee for newborn screening test kits in §73.22. These tests are required by state law in the Health and Safety Code, Chapter 33 and by department rules in 25 Texas Administrative Code, Chapter 37, §§37.51-37.69 (relating to Newborn Screening Program). The tests analyze blood specimens for treatable disorders, such as phenylketonuria and hypothyroidism. A test kit is the department-designed collection device, demographic information form, and envelope used to submit a newborn's blood specimen for testing by the department's Bureau of Laboratories. Each newborn must have a series of two testing cycles. The department will provide test kits for Medicaid-eligible and charity care newborns at no cost to the provider of services (hospitals, midwives, physicians, clinics, and birthing centers). The department will provide test kits for all other newborns for a fee paid by the provider. The fee shall be determined by the department to be an amount to recover reasonable costs of providing newborn screening testing services and shall not exceed $20 per test kit. At this time the department anticipates setting the fee at $13.75 for fiscal year 1998. Fees for the test kits will be implemented on March 1, 1998; however, use of the test kits will not be required until June 1, 1998.

A fee is adopted for blood lead testing in §73.22. The department currently provides blood lead testing for children enrolled in the Texas Health Steps program and is paid based on vouchers submitted to that program. This process will continue. Adoption of this fee will allow the department to extend needed low-cost testing services to low-income children and families not currently qualified for the Texas Health Steps or Medicaid programs. In addition, state law requires the department to perform blood lead testing at the request of a physician who suspects that a person has been harmed by exposure to lead. The new blood lead testing fee would be assessed to physicians who request testing. At this time the department anticipates setting the fee at $5.20 for fiscal year 1998.

The adopted rules include fees to recover the laboratory testing costs associated with surveillance, investigation, and monitoring of nuclear power plants and other entities which handle radioactive materials. The laboratory currently tests water, soil and other environmental samples for radioactivity to ensure that the public health is not endangered. The adopted rule will place the responsibility for payment of these costs on the regulated industry. The rules set fee caps for these tests. The fee amounts for fiscal year 1998 are available from the Texas Department of Health, Bureau of Laboratories, 1100 West 49th Street, Austin, TX 78756, (512) 458-7318, FAX (512) 458-7294.

The department certifies drinking water, milk and shellfish laboratories pursuant to federal and state laws and regulations. Certification of laboratories by the department is intended to ensure that certified laboratories are competent to test drinking water, milk and shellfish samples. The department also performs proficiency testing for certified and non-certified milk laboratories. Proficiency testing is a process designed to introduce unknown samples into a laboratory for analysis, providing a practical way for the laboratory to demonstrate its capability. The rules adopt fees to allow the department to recover certain costs associated with certification of laboratories and proficiency testing. These fees will be paid annually by laboratories receiving certification or proficiency testing services. The rules also adopt procedures for obtaining certification.

The department currently tests bottled water and drinking water systems for contaminants specified in the federal Safe Drinking Water Act. Fees for testing drinking water systems are assessed to owners of those systems, individuals submitting drinking water samples, and public agencies requesting testing of sampling. These fees are now adopted in new §73.22. In addition, new fees for testing bottled water samples are adopted. These fees will be paid by the bottled water manufacturing industry. The rules set fee caps for these tests. The fee amounts for fiscal year 1998 are available from the Texas Department of Health, Bureau of Laboratories, 1100 West 49th Street, Austin, TX 78756, (512) 458-7318, FAX (512) 458-7294.

The Health and Safety Code, §12.020 (HB 2389, passed by the 75th Legislature), authorizes the department to enter into a contract for the sale or provision of laboratory services with federal, state, or local governmental entities, or freestanding public health clinics owned or controlled by a nonprofit organization, inside or outside the state, and to establish charges for such services by rule. The adopted rule will allow the department to implement the provisions of HB 2389.

Changes made to the proposed text result from comments received. The details of the changes are described in the summary of comments that follow. Following each comment is the department's response and any resulting change(s).

Comment: Concerning §73.22(c)(1), laboratory certification, one commenter asked that a fee of $100 per day and travel expenses be paid to the department to perform assessment of drinking water chemistry laboratories. Currently drinking water chemistry laboratories are required to retain the services of a third party assessment organization in order to apply for certification from the department.

Response. No fee was proposed because the department does not currently perform assessments of drinking water chemistry laboratories. The department performs assessments only for drinking water microbiology laboratories. The cost to perform drinking water chemistry laboratory assessments would be much higher than $100 per day, and the laboratory cannot at this time implement this service due to budget constraints. No change was made because of this comment.

Comment: Concerning §73.22(c)(1), laboratory certification, one commenter pointed out that there are actually two types of milk antibiotic laboratories, one of which is certified and one which is not. The commenter pointed out that quality assurance and certification requirements by the department are much greater than for the non-certified laboratory, which is not required to perform annual proficiency testing supplied by the department.

Response: This rule applies only to certified laboratories. The department has no authority over non-certified laboratories. No change was made because of this comment.

Comment: Concerning §73.22(c)(1), laboratory certification, one commenter pointed out that both commercial and noncommercial drinking water bacteriology laboratories are certified by the department, but the commercial laboratories are required to undergo third-party assessment. The commenter suggested the fee structure be reassessed to compensate for this difference.

Response: The department's fee will help fund program inspection of the laboratories by department personnel on an unannounced basis. Assessments are done by the department for noncommercial drinking water bacteriology laboratories. The department may explore extending its assessment program to commercial drinking water bacteriology laboratories within the State of Texas to alleviate the cost incurred by the laboratories for third-party assessment. No change was made because of this comment.

Comment: Concerning §73.22(c)(1), laboratory certification, one commenter pointed out that the reference to milk proficiency testing by noncertified laboratories actually means fully certified laboratories outside the state which subscribe to the Texas split milk sample program as a necessary part of their state's certification program, but for which their state offers no split milk sample program.

Response: The department's intent is to charge laboratories outside the state for the laboratory split milk sample program. The department did not intend to extend this program to uncertified laboratories, either outside or inside the state, but only used the term noncertified to mean that they were not certified by the Texas milk laboratory certification program. Section 73.22(c)(1)(E) has been changed to clarify that the laboratories are non-Texas certified.

Comment: Concerning §73.22(c)(1) and §73.24(c)(6), one commenter pointed out that the frequency of laboratory certification fee assessment was not stated.

Response: Fee assessment is an administration function which is performed on an annual basis. Sections 73.22(c)(1) and 73.24(c)(6) have been clarified to require the fee annually.

Comment: Concerning §73.22(c)(3) and (d), one commenter suggested administrative location of the department's entire newborn screening program within the laboratory and to include all the program costs in the fee.

Response: Administrative relocation of the newborn screening program is not addressed in these rules. The department will examine the advantages and disadvantages of locating the follow-up program within the laboratory. Any subsequent laboratory fee increase associated with such a move will be considered following the department's analysis. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter asked whether the newborn screening fee would almost totally pay for the new laboratory building and if not, asked what percentage would be paid for by other fees.

Response: The department has always planned to fund the new laboratory building from three primary sources: (1) revenues generated from public health service fees; (2) indirect costs recovered from the federal government, and (3) lease cost savings. The legislature has appropriated funds from the first two sources. Lease cost savings will not be appropriated until the new building is completed. It is anticipated that the fees generated by each of the public health service fee sources will fluctuate from year-to-year. Additionally, fees may be adjusted from time-to-time based on costs and new fees implemented as new services are provided. The department anticipates that public health service fees will continue to play an increasingly important role in the daily operation of department programs and services and in the construction of the new laboratory facility. No change was made because of this comment.

*Comment: Concerning §73.22(c)(3) and (d), one commenter indicated that most of the 41 states that currently charge for newborn screening bill the patient or insurer directly, but the department's rules charge the health care provider attending the newborn.

Response: The department disagrees. The department canvassed all 41 programs in 1997, and at least 27 of those states charge the primary health care provider directly. The department reviewed a number of proposals in selecting the current plan, and believes this plan to be the most equitable. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter acknowledged the efforts of the department to encourage third party payers to reimburse for laboratory newborn screening, but pointed out over 50% of insured Texans are covered under the Employee Retirement Income Security Act (ERISA) law, which is exempt from state regulation, and questioned what assurance the department has been offered that the employers using an ERISA plan have agreed to reimburse for the screening test kits.

Response: The department believes that newborn laboratory services will be covered under the broad guarantee of maternity and newborn services furnished to most employees by both insurance and ERISA plans. No specific assurances from individual employers have been received although benefit plans which act as insurers and as third party administrators of ERISA plans were contacted and indicated that they expected to cover the costs of the test kits. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter pointed out that in the current managed care marketplace, it is standard practice for health maintenance organizations (HMO) to capitate the cost of primary care services, and asked what assurances have been received from HMO's in Texas that capitation rates will be increased to cover the additional expenses of the newborn screening fees.

Response: The department spoke to several HMO medical directors or their staffs regarding this question, and was informed that the responding HMO's would reimburse health care providers as an additional unanticipated expense until such time as capitation contracts were renegotiated. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter indicated that many insurers take 60 to 120 days to reimburse physician claims, and further pointed out that the policy of requiring payment for newborn screening testing kits may force physicians to change their practice behavior for economic reasons, such as by referring patients to public health clinics for the newborn screening, thus having the effect of restricting patient access because of the increased inconvenience to the newborn's parents.

Response: The department believes the low cost for this service will not be a deterrent to continued provision of services. In order to provide some flexibility to accommodate the time it takes for insurers to pay claims, the department has revised the requirement that payment is due within 30 days in §73.22(d)(8) to read payment is due within 120 days. Based on discussions with the medical community, this will allow providers to order a supply of test kits and receive most insurance reimbursement before payment is due to the department.

Comment: Concerning §73.22(c)(3) and (d), one commenter asked how the department currently monitors compliance, and asked how it would be monitored in the future.

Response: The department does not understand the term "compliance" as used by this commenter. If the commenter is discussing monitoring of compliance of payment, the department uses a standard accounts receivable system, with which payment is reconciled against receivables on a monthly basis. If the commenter is questioning monitoring of the second newborn laboratory screening, the current system is a manual system in which second samples are monitored based on aberrant findings of the first sample. It is anticipated that an automated computer monitoring system will be brought on line at the earliest opportunity to facilitate monitoring for second samples. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter urged that as soon as the new laboratory/office facility is paid for, newborn screening fee funds be redirected into the care of children, specifically follow up, treatment, prescriptions and nutritional supplements, because, for example, many families cannot afford low-protein food products, which are necessary to manage a special needs child with phenylketonuria.

Response: The department believes that follow up and treatment of special needs children is a worthy use of such funds. Use of fee funds would be contingent upon statutory authority being available at that time and necessary appropriation of the funds. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter suggested the definition of charity care newborn should be based on the lack of insurance coverage or a government reimbursement source for the newborn, and not the health care provider assessment of whether the patient's family can afford to pay for the testing.

Response: The department has revised the definition of charity care newborn in §73.22(d)(6) to say that a charity care newborn is a patient who is not insured and is not covered or eligible to be covered by Medicaid or any other government program for newborn screening services.

Comment: Concerning §73.22(c)(3) and (d), one commenter suggested the definition of charity care newborn be changed to include patients who lose their insurance coverage between the first and second laboratory screening.

Response: The department has revised the definition of charity care newborn to reference lack of insurance or a government reimbursement source for the newborn. The provider will need to make the assessment of a patient's insurance status at the time the patient is seen. The status may change between the first and second screen. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter suggested, with regard to charity care newborn, the definition be expanded to include newborns with families who are willing to pay minimal amounts for newborn care.

Response: The department has revised the definition to reference lack of insurance or a reimbursement source as the criteria. Families willing to pay some amount but without insurance or a reimbursement source will be able to use free test kits. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter pointed out that providers will incur other costs in addition to the newborn laboratory screening fee charged by the department for non-Medicaid and non-charity care newborns, such as income screening, fee collection, and third party billing.

Response: The department acknowledges that there are expenses associated with claims to third party payers. However, claims are already made to third party payers for clinical care services, and the department encourages health care providers to consolidate their claims for newborn laboratory screening test kits with claims for well baby clinic visits and other services. The department takes no position regarding the management of the provider's office or the amount the provider will charge the patient or the third party payer. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter pointed out that the demand for newborn screening services at local health departments could increase if private providers decide the administrative burden associated with the rules change is excessive.

Response: The department believes the administrative burden associated with implementation of a newborn screening fee in the primary care practitioners office will not significantly affect the public health delivery system. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter, a large public health system, commented that a liberal application of the charity care definition as applied to the newborn screening fee rule would minimize the impact, then pointed out the provision appears broad enough to encompass virtually all their clientele.

Response: The department's definition of charity care newborn is not intended to limit access to newborn screening services by any part of the population. The department believes the revised definition, as it stands, is sufficiently broad to encompass certain portions of non-Medicaid newborns. The department understands that some providers will have a larger volume of charity care newborns than other providers due to the nature of their practice. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), several commenters indicated the newborn screening fee to be greater than insurance companies will reimburse.

Response: Third party payers with whom the department has spoken have indicated a willingness to reimburse providers for the laboratory service. The department believes that a fee uniformly assessed to health care providers will be more likely to be reimbursed, because it is an actual increment to the cost of service for the health care provider. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), several commenters expressed general support for a newborn screening fee, but were concerned that implementation of a fee to support laboratory testing alone, without consideration of the entire newborn screening program, including follow-up and provision of dietary and pharmaceutical support for families, would lead to the deterioration of the newborn screening program or inadequate follow-up care. One commenter thought that to proceed with the newborn screening fee rules places determination of methods to finance construction of a physical plant (a new laboratory/office building) ahead of any planning or consideration of the medical issues and impact on the newborn screening program and the people affected. The commenter asked that the newborn screening fee be withdrawn until there is a reasonable solution found for implementing a system, identified through a comprehensive assessment and inclusive decision-making process that best serves and protects Texas newborns and their families.

Response: The department agrees with support for the fee, but disagrees with the remainder of the comment. The commenters are interested in additional department funding for follow-up care, which is one of a number of service components associated with screening newborns for heritable diseases. Each component has individual fiscal support requirements. Federal and state funding for the laboratory has declined significantly in recent years, necessitating new funding in order to continue the laboratory portion of newborn screening. This fee will provide such funding. However, this fee mechanism cannot currently be used to provide support to parts of the program other than the laboratory, because the state law allows fee rules only for services provided by the department and the current General Appropriations Act limits the use of the new fees to laboratory-related purposes. Because of such limitations, the department did not consider expanding the scope of the new fees beyond the recovery of laboratory-related costs. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter stated that the impact of the newborn screening fee as designed goes beyond raising funds for a new laboratory building; it can seriously impair a family's efforts to raise a special needs child. The commenter acknowledged that funds for universal screening, aggressive follow-up by trained caseworkers and a community of specialists that provides services and consultations throughout the state have diminished. The commenter was concerned that the rules establish fees to build a laboratory facility to diagnose disease but provide no support to use that knowledge to educate and prevent the medical and financial consequences of those disorders.

Response: This commenter expressed no objection to the fee itself, but objected because the fee did not cover comprehensive funding of non-laboratory follow-up services. Currently, there exists no authority within state law to assess a fee for services not provided by the department or to create and use a fund for follow-up services. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter asked how the newborn screening fee applies to Title V newborns.

Response: Newborns qualified for Title V services must have a test kit purchased by the provider. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter representing a public health clinic asked if a newborn were Medicaid-eligible, but no application for Medicaid enrollment had been made, would the provider have to pay for the newborn's screening test kit.

Response: The free test kit may be used for Medicaid-eligible newborns even if the newborn is not yet enrolled in the Medicaid program. The department's experience is that providers take a very aggressive posture in enrolling newborns for Medicaid in order to recover their costs. Otherwise, if the provider determines that the newborn has no access to a third-party reimbursement plan, the newborn will fit under the definition of charity care. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter asked if the provider type (i.e., health department clinic) affects the number of charity care kits that provider could order without investigation by the department into the accuracy of the number.

Response: The department understands that a larger percentage of charity care newborns will be referred to health department clinics and does not anticipate questioning the higher number of charity care kits. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter from the midwifery community suggested that an explanatory sheet be provided in English and Spanish to explain the fee and the purpose so parents could better understand the need for the testing.

Response: The department agrees that it is appropriate to provide educational information for parents to explain the nature and purpose of the testing. This suggestion has been referred to the Bureau of Women's Health. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter calculated that newborn screening fees will cover 70% of the cost to the laboratory for the laboratory portion of the newborn screening program, and asked if the funds currently appropriated to the laboratory by the legislature for newborn screening would be used by the department for other purposes and if those purposes would benefit the laboratory or the newborn screening program.

Response: No funds are specifically appropriated by the legislature for newborn screening laboratory services. Laboratory testing has been funded by a blend of state and federal funds. However, both sources of funding have decreased in the previous years and the cost of the program has been borne by shifting appropriated funds from other portions of the laboratory to cover newborn screening costs. This practice can no longer be supported. In addition, any expenditure is subject to appropriation from the state legislature which is already set in this biennium. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter raised a question about whether the newborn screening fee included the cost of bond debt service for the new laboratory/office building, and asked if the cost of debt retirement fit the definition of "reasonable service costs."

Response: Bond debt service was included in the calculation of the fee, and is reasonably included in service costs as a portion of overhead. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter asked if the newborn screening fees will improve access to newborn screening in Texas or will improve the health of the newborns from whose insurance companies providers will be reimbursed.

Response: The department believes the implementation of this fee will ensure the continued availability of the laboratory newborn screening program in the state, thus ensuring continued availability of testing to all newborns. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter asked if the newborn screening fee will decrease the cost of the newborn screening program to the taxpayers of Texas.

Response: The total cost to operate the newborn screening program will not be affected by the laboratory fees. Because the laboratory costs of the program will be shifted to those who use the program, the laboratory will not require additional funding. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter asked if their offices and physician-owned laboratories would be expected to file insurance claims to receive payment for specimen acquisition and test result interpretation. The commenter further asked how many forms to order and what Current Procedural Terminology (CPT codes) to use for filing insurance claims.

Response: Providers may file any appropriate insurance claims for newborn screening sampling. Providers should order forms to ensure that they have a sufficient supply, yet not lose inventory due to expiration of the forms (the forms are medical devices and expire in two years). The rules do not govern the use of CPT codes, but the department will provide technical assistance to providers. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter indicated surprise that the laboratory had provided newborn screening and other laboratory expenses for free for so long, and had expected a fee much earlier. The commenter had been pleased with the quality of services for 30 years, and the fact that laboratory personnel had always responded in a professional and very timely way. The commenter requested the CPT codes for newborn screening.

Response: The rules do not govern the use of CPT codes which were sent to the commenter. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter asked if it was fair for parents of newborns or their insurers to bear the burden of cost for the proposed infrastructure improvements.

Response: Infrastructure improvements include improvements in diagnostic technology, computer systems and software, skills and physical facilities including a new laboratory/office building. The cost for these improvements has been spread over several areas. Newborn screening represents the single largest segment of the laboratory operational cost and workload, and the amount of overhead this fee bears is proportionate to the workload it generates. Other fees and federal funding sources have borne the cost of newborn screening laboratory operations in the past. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), two commenters pointed out that the sale of laboratory test kits limits the opportunity for privatization of newborn screening laboratory services. The possibility of a fee support system makes this testing attractive to private laboratories. One commenter urged creating this opportunity within the fee structure. The other questioned how the department would justify selling a form if privatization occurred when the commenter believed the actual cost of the test kit to be well below one dollar.

Response: Historically, this program has provided an excellent service to the parents and medical community of the state at a very low cost. Currently, all testing is provided by the department, so selling the test kit is a straightforward method of funding the services. It is not known if this fee will have an effect on private laboratories' desire to conduct newborn screening. However, state law requires the department to maintain a newborn screening laboratory, requiring funding for the laboratory whether or not private laboratories choose to seek certification. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter asked how an approved private laboratory would receive compensation from Medicaid for providing newborn testing services.

Response: At this time, there are no approved private laboratories. Medicaid reimbursement calculations are determined in accordance with the applicable federal and state laws and regulations. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter asked the meaning of "infrastructure improvements" mentioned in the proposed preamble.

Response: Laboratory infrastructure improvements include improvements in diagnostic technology, computer systems and software, skills and physical structures, including the new laboratory /office building. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), several commenters asked if the newborn screening fee will result in improved care or service for the target population of newborns.

Response: Decreases in funding sources have required the implementation of this fee in order to maintain the newborn screening laboratory program. Because of restrictions in authorization, it was not intended that the fee address improvements in care or services, other than laboratory services, at this time. The department believes that this funding source will allow improved laboratory service through improvements in technology and data management systems and a new facility. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter asked how an HMO to whom a patient reports for a follow-up screen receives Medicaid reimbursement for specimen collection and result interpretation.

Response: HMO providers with Medicaid patients will be furnished free newborn screening test kits by the department for those patients. Specimen collection and result interpretations performed by a Medicaid managed care provider are covered under the managed care capitation rate. The newborn screening fee has no direct effect on this relationship. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter asked the estimated impact to the private physician or hospital for maintaining appropriate inventories of forms for paying, nonpaying and Medicaid patients, and asked how the health care provider is expected to recover these expenses.

Response: The department believes that the health care provider will include the cost of this and similar supply items in overhead and make decisions about how frequently to order test kits based on individual business practices. Managing a practice requires mechanisms to maintain appropriate inventories of supplies and appropriate billing procedures. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter asked how Medicaid is to be billed and if Medicaid has approved a method of billing.

Response: The department will provide test kits free of charge to providers for their Medicaid-eligible newborns, and the department will continue to charge Medicaid. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter asked the definition of a Medicaid- eligible newborn. The commenter pointed out that a newborn is not a Medicaid recipient at the time of birth, and requested the department rely on the newborn's mother's Medicaid status.

Response: The department agrees that the intent of the rule is to assume the Medicaid status of the mother for the newborn. The department has added a definition of a Medicaid-eligible newborn to §73.22(d)(6).

Comment: Concerning §73.22(c)(3) and (d), one commenter asked if the department was working to ensure that full coverage of the newborn screening fee will be allowed under reimbursement plans with private insurers so that families of patients do not incur the additional expense.

Response: The department is concerned as well about coverage of laboratory services by private insurers. The department intends to educate insurers about the new fee and the legal requirements for newborn screening. A department survey of private insurers and managed care organizations indicates they will reimburse physicians and hospitals for the cost of the test kits. No change was made because of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter asked if patients will face additional costs as charges to cover unused inventories of newborn screening test kits are added to hospital and physician administrative expenses.

Response: The department anticipates that unused inventory will be minimal, since providers will decide how many test kits to order. No change was made because of the comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter asked what mechanism the department intends to use to monitor abuse of the ordering system, and if the costs of monitoring for abuse have been included in the proposed fees.

Response: The department expects health care professionals will respond based upon their historical and anticipated patient mix. If a disproportionate share of free forms is ordered, laboratory staff will work directly with the health care provider involved. No change was made as a result of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter asked what the estimated impact to the department will be of maintaining a payment system for over 650,000 specimens annually.

Response: The billing mechanism will result in very little change to the current newborn screening process. The department expects little additional workload as a result of the billing system, since the laboratory already ships newborn screening forms and maintains an active billing system. The only additional work will be invoicing health care providers for test kits. No change was made as a result of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter asked how many pay cycles billing records will be maintained by the department.

Response: The department will maintain records for a minimum of two years. No change was made as a result of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter asked what the penalty will be for providers who do not pay the newborn screening laboratory test kit fee, and what the impact will be of nonpayment to the infants being screened by that provider.

Response: The department intends to use standard state billing practices regarding the payment of the fees. Providers will be able to recover costs from third-party payers or receive no-cost forms, which should encourage them to provide the service. No change was made as a result of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter noted that a number of submitters of newborn screening samples currently use the department's remote data entry system, which the commenter believed reduced costs for clerical services to the department. The commenter believed that other states have shown that by discounting the newborn screening fee for electronic data transfer system users, staff could be reassigned or eliminated as electronic entry efficiency increases.

Response: The department believes that while expanded use of a remote data entry system could reduce some costs, additional automated data system support would be required. The current system must be maintained for providers who choose not to use the remote data entry system, and for times when the electronic system is not operational. The department will continue to support benefits of increased automation for all services. Currently, of the 3,500 health care providers who ordered newborn screening forms from the department in 1997, approximately 20 use the electronic system. No change was made as a result of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter asked how adherence to the state-mandated second screen will be monitored, and what actions will be taken.

Response: The department has begun an extensive educational campaign for health care providers to reinforce the need for the second screen. The department will continue to monitor second screens to ensure they continue to be performed. No change was made as a result of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter noted that serum and whole blood samples are currently analyzed by the department at no charge as a follow up and monitor for the newborn screening program, and asked if they would continue to be free of charge, or if third party payers and Medicaid would support these metabolic tests.

Response: The department has not proposed fees for laboratory services for confirmatory diagnosis and patient management, and intends to continue to fund these services at this time. No change was made as a result of this comment.

Comment: Concerning §73.22(c)(3) and (d), two commenters asked if results of early screenings were inconclusive, such as with children on antibiotics, whether additional tests would incur additional charges, or if followup test kits would be provided free of charge.

Response: As with other tests that must be performed repetitively to ensure adequate care for the newborn, the cost of testing does not diminish on repetitive testing. Therefore, second and subsequent test kits will be sold on the same basis as the first test kit. Section 73.22(d)(2) has been revised to recognize that additional screenings may be necessary.

Comment: Concerning §73.22(c)(3) and (d), one commenter asked the difference in the fee assessed to a Medicaid patient versus a full pay patient, whether that same percentage of difference will be incorporated in all laboratory charges, and if not, why not.

Response: No fee may be assessed to a Medicaid patient pursuant to federal law. Test kits for Medicaid-eligible newborns will be provided at no cost to the provider. Currently, the department bills Medicaid $7.72 per screen for Medicaid-eligible newborns. Inclusion of capital costs and bond interest will raise the Medicaid reimbursement rate to approximately $13 in 2000 and succeeding years. The department will bill providers for non-Medicaid-eligible, non-charity care newborns at the rate of $13.75. This principle of cost recovery will also apply to other fees for which both Medicaid and third-party reimbursement are appropriate. No change was made as a result of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter asked if the newborn screening fee is the only fee assessed prior to the service being rendered.

Response: With the exception of laboratory certification fees, this is the only fee assessed prior to the performance of a service. The department reviewed the advantages and disadvantages of billing for test kits versus billing after performance of services, and found the administrative cost to be significantly less when the former mechanism was used. No change was made as a result of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter asked what the impact would be if another test were added to the current battery, and if the laboratory recovered its expenses through the laboratory testing fee, how would follow up support costs be covered.

Response: The rule allows the laboratory to raise this fee up to $20. If a new test were incorporated into the testing battery, existence of a laboratory fee rule which allows for small increases in funding would streamline the implementation of a new test. For costs greater than $20, the rule would need to be amended. The department would fund approved follow-up support from resources other than the laboratory fee. No change was made as a result of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter asked what the impact would be of a change by the laboratory to seven-day service when no additional funds are available to support the needed follow-up by the Bureau of Children's Health.

Response: The laboratory currently operates on a six-day work week. Emergency needs are addressed on a case by case basis. No proposal has been made to expand the work week to seven days. If the work week were expanded in the laboratory, the Bureau of Children's Health would be on call to handle emergencies as they are now. No change was made as a result of this comment.

Comment: Concerning §73.22(c)(3) and (d), two commenters questioned whether the newborn screening fee would result in better care for newborns in the state.

Response: The department does not expect the fee to change the quality of care for newborns. The fee provides a funding mechanism to continue newborn screening by the laboratory. Because of this funding source, it is expected that improvements will be made in newborn screening testing which the laboratory previously has not been able to fund. No change was made as a result of this comment.

Comment: Concerning §73.22(c)(3) and (d), one commenter felt that to increase the newborn screening cost from a free service to $14 was a dramatic increase, and suggested an incremental increase, starting with $5 or $10.

Response: The General Appropriations Act requires the department to set fees to recover the cost of providing services to the extent feasible. No change was made because of this comment.

Comment: Concerning §73.22(c)(4)(B)(ii), on commenter recommended changing the wording to clarify that the total recoverable metals digestion is required if turbidity equals or exceeds one nephelometric turbidity unit (NTU), since the United States Environmental Protection Agency (EPA) recommends digestion above one NTU, but does not recommend it below one NTU, and does not address the situation where the turbidity is one NTU exactly.

Response: The department believes that in the rare circumstance where a drinking water sample turbidity is exactly one NTU, the more conservative scientific approach should be applied. Thus, the language has been changed to say that digestion would be performed only if turbidity equals or exceeds one NTU.

Comment: Concerning §73.24(b)(2), one commenter requested clarification of the definition of "certification" to indicate that certification does not mean or imply that the department certifies results of analyses produced by the certified laboratory.

Response: The department agrees and has changed the language of the rule accordingly.

Comment: Concerning §73.24(c)(4), one commenter asked if it was the department's intention to accept drinking water samples from individuals for chemical analysis.

Response: It is currently the policy of the department not to solicit or encourage submission of drinking water samples from individuals, such as those who have private wells on their property. However, the situation often arises where justification exists for analysis of private samples. In those instances, the rules will allow the department to charge for the cost of analysis. No change was made because of the comment.

Comment: Concerning §73.24(e), one commenter requested laboratory assessment by the department on a triennial rather than a biennial basis, since the minimum inspection requirement by the EPA is on a triennial basis.

Response: The department does not agree with the commenter. The EPA schedule is a minimum standard, and biennial assessment helps to ensure quality services. However, the department agrees with the approach of requiring triennial inspections for third-party assessed laboratories, because it is the department's policy to continue the practice of unannounced visits to laboratories assessed by third parties. No change was made as a result of this comment.

Comment: Concerning §73.24(e), a commenter asked if the rule limits laboratory assessments by the department to a biennial schedule.

Response: The department believes it is in the interest of public health to conduct laboratory assessments on no less than a biennial basis, and to allow unannounced inspections. Therefore the language has been changed to reflect that assessments may be made on at least a biennial basis.

Comment: Concerning §73.24(f), one commenter suggested mirroring the EPA's position on submission of laboratory analyses on proficiency samples which were not performed in the submitting laboratory by revoking the laboratory's certification for all analysis parameters for three years.

Response: The department agrees and has added language to that effect in §73.24(f)(5).

Comment: Concerning §73.24(f)(3), one commenter wished to clarify the 90 day period specified in the rule. Ninety days is the maximum period allowed for correction of major deficiencies under the Safe Drinking Water Act. The Food and Drug Administration allows 45 days for correction for some major deficiencies and 60 days for others. The laboratory certification officer must make the determination using the appropriate guidance at the time the determination of a major deficiency is made.

Response: Clarifying language has been added to indicate that corrective action must take place in 90 days or less, depending on the regulatory authority under which the certification takes place.

Comment: Concerning §73.24(f)(4), one commenter wished to clarify that the term "due process" was confusing. The commenter indicated that a laboratory may continue operation until due process is given even though it was operating in a manner inconsistent with good laboratory practice and may jeopardize public health by doing so.

Response: The rule as passed indicates due process will be afforded to a laboratory whose certification is revoked or suspended. Revocation or suspension of the laboratory certification bars the laboratory from processing milk, water or shellfish samples under the federal regulatory authority until the revocation or suspension is removed. No change was made because of this comment.

The comments on the proposed rules received by the department during the comment period were submitted by the Texas Genetics Network Newborn Screening Subcommittee, Interagency Council for Genetic Services, Texas Hospital Association, Sickle Cell Disease Association of America, Inc. (Texas State Chapter), University of Texas Southwestern Medical School Department of Pediatrics, and department staff. The commenters were neither for nor against the rules in their entirety; however, they raised questions, offered comments for clarification purposes, objected to portions of the rules, and suggested clarifying language concerning specific provisions in the rules.

The effective date of the repeal and new sections is March 1, 1998.

Training and Certification

25 TAC §73.22

The repeal is adopted under the Health and Safety Code, §§12.031, 12.032, and 12.034, which provide the board with the authority to adopt rules relating to public health services fees for laboratory services; §12.020, which provides the department with the authority to establish charges by rule for the sale of specific laboratory services; §§33.002 and 33.011, which provide the board and department with authority to adopt rules to carry out the newborn screening program and to prescribe screening test procedures; §§81.004 and 81.006, which provide the board with the authority to adopt rules and to seek and receive fees for the purpose of identifying communicable diseases; §161.101, which provides the department with the authority to charge for certain blood lead tests requested by a physician who suspects that a person has been harmed by exposure to lead; Texas Civil Statutes, Article 4512i, §19A, which provides the department with authority to charge a newborn screening fee to midwives; and Health and Safety Code, §12.001, which provides the board with the authority to adopt rules to implement every duty imposed by law on the board, the department, and the commissioner of health.

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

Filed with the Office of the Secretary of State on February 9, 1998.

General Counsel

Texas Department of Health

Effective date: March 1, 1998

Proposal publication date: December 5, 1997

For further information, please call: (512) 458-7236

Chapter 73. Laboratories

25 TAC §§73.22, 73.23, 73.24

The new sections are adopted under the Health and Safety Code, §§12.031, 12.032, and 12.034, which provide the board with the authority to adopt rules relating to public health services fees for laboratory services; §12.020, which provides the department with the authority to establish charges by rule for the sale of specific laboratory services; §§33.002 and 33.011, which provide the board and department with authority to adopt rules to carry out the newborn screening program and to prescribe screening test procedures; §§81.004 and 81.006, which provide the board with the authority to adopt rules and to seek and receive fees for the purpose of identifying communicable diseases; §161.101, which provides the department with the authority to charge for certain blood lead tests requested by a physician who suspects that a person has been harmed by exposure to lead; Texas Civil Statutes, Article 4512i, §19A, which provides the department with authority to charge a newborn screening fee to midwives; and Health and Safety Code, §12.001, which provides the board with the authority to adopt rules to implement every duty imposed by law on the board, the department, and the commissioner of health.

§73.22.Fees.

Purpose. This section establishes fees pursuant to the Health and Safety Code, §§12.031, 12.032, and 12.034 for laboratory services provided by the Bureau of Laboratories (bureau) of the Texas Department of Health (department). The fees will enable the department to offset costs incurred when delivering certain laboratory services.

General. Services are offered at the discretion of the department subject to laws and rules in effect at the time of the request for services.

The fees assessed are intended to recover the reasonable service costs and shall not exceed the costs of providing the service as determined by the department.

Each fee for which a maximum cap is set within this section shall be calculated annually by department staff in accordance with paragraph (1) of this subsection.

A schedule of all fees will be available upon request from the Texas Department of Health, Bureau of Laboratories, 1100 West 49th Street, Austin, Texas 78756, (512) 458-7318.

The department will determine whether a fee must be paid with submission of the specimen or whether the department will bill later for the fee unless stated otherwise in this section.

The submission of specimens to the department shall be in compliance with the bureau's Manual of Reference Services and other written instructions established by the bureau.

The manual outlines clinical and scientific standards, procedures and requirements of the department.

Failure to submit a specimen as required may result in the department's refusal to perform the requested services.

The manual and other written instructions may be obtained upon request from the Texas Department of Health, Bureau of Laboratories, 1100 West 49th Street, Austin, Texas 78756, (512) 458-7318.

Failure to pay a fee in a timely manner may result in the department's refusal to accept specimens or samples until the fee is paid.

A fee paid is nonrefundable.

The annual fees for certification of milk, drinking water and shellfish laboratories and proficiency testing for milk laboratories are as follows:

antibiotic milk laboratories - $250;

water bacteriology laboratories - $250;

milk industry laboratories - $400;

full service milk laboratories - $500;

milk proficiency testing (non-Texas certified laboratories) - $250;

water chemistry laboratories - $250; and

shellfish laboratory - $500.

The fee for testing blood for the presence of lead shall not exceed $10 per test.

The fee for a newborn screening test kit shall not exceed $20 per test kit.

The fees for testing of bottled water, drinking water systems, drinking water fountains in day care centers or schools, or individual home drinking water systems shall not exceed the following amounts:

tests for minerals and physical properties:

chloride -$22.50;

fluoride -$22.50;

sulfate - $22.50;

total dissolved solids - $37.50;

turbidity -$24;

total organic carbon, water - $53;

chlorate - $75;

chlorite - $75;

nitrate and nitrite - $27;

routine water (minerals panel) - $180; and

tests for trace metals:

all metals panel: Al, Sb, As, Ba, Be, Cd, Cr, Cu, Fe, Pb, Mn, Hg, Ni, Se, Ag, Th, Zn- $357;

total recoverable metals digestion (performed only if turbidity equals or exceeds 1 NTU) - $36;

antimony - $22;

ICP metals panel: Ba, Cr, Cu, Fe, Mn, Ag, Zn, Al, Ni, Be - $165;

selenium - $22;

single ICP metal - $22; and

thallium - $22;

tests for organics:

volatile organic compounds, including trihalomethanes - $180;

ethylene dibromide (EDB) and dibromochloropropane (DBCP) - $192;

carbamate insecticides - $246;

chlorophenoxy herbicides - $270;

polychlorinated biphenyl and chlorinated insecticides - $280;

polyaromatic hydrocarbons (PHA), phthalates - $354;

endothall - $439;

glyphosate - $208;

haloacetic acids (EPA method 552) - $370;

haloacetonitriles (EPA method 551) - $231;

insecticides, drinking water (EPA method 505) - $225;

organophosphate insecticides, drinking water (EPA method 507) - $340;

polychlorinated biphenyls (PCB), drinking water (EPA method 508A) - $360; and

trihalomethanes, drinking water (EPA method 502.2) - $82;

radiochemical testing:

gross alpha and beta - $111;

total alpha emitting radium - $87;

radium 226 - $100;

radium 228 - $84;

uranium isotopes - $93; and

bacteriological examination for coliforms - $20; and

miscellaneous drinking water chemistry procedures - $96 per hour.

The fees for testing environmental samples from nuclear power plants and other users or holders of radiation sources shall not exceed the following amounts:

miscellaneous (per hour) Nuclear Chemical Branch - $96;

gross alpha or beta, water - $99;

gross alpha and beta, water - $111;

gamma emitting isotopes, water - $91;

radium-226, water - $100;

alpha spectrum preparation, water- $162;

radium-228, water - $84;

uranium isotopes, water - $93;

thorium isotopes, water - $87;

plutonium, water - $88;

tritium, water - $61;

total alpha emitting radium, water - $87;

radon, water - $81;

strontium-89 or 90, water - $124;

carbon-14, water - $133;

gross alpha or beta, soil - $79;

gross alpha and beta, soil - $100;

gamma emitting isotopes, soil - $138;

alpha spectrum preparation, soil - $151;

radium-226, soil- $133;

radium-228, soil - $108;

uranium isotopes, soil - $84;

thorium isotopes, soil - $87;

plutonium, soil - $88;

tritium, soil -$98;

strontium-89 or 90, soil - $160;

gross alpha or beta, vegetation/tissue - $79;

gross alpha and beta, vegetation/tissue - $109;

gamma emitting isotopes, vegetation/tissue - $135;

alpha Spectrum preparation, vegetation/tissue - $151;

radium-226, vegetation/tissue - $133;

radium-228, vegetation/tissue - $96;

uranium isotopes, vegetation/tissue - $84;

thorium isotopes, vegetation/tissue - $87;

plutonium, vegetation/tissue - $88;

tritium, vegetation/tissue - $97;

strontium-89 or 90, vegetation/tissue - $160;

gross alpha or beta, wipe/filter/cartridge - $48;

gross alpha and beta, wipe/filter/cartridge - $63;

alpha spectrum preparation, wipe/filter/cartridge - $151;

radium-226, wipe/filter/cartridge - $133;

radium-228, wipe/filter/cartridge - $96;

uranium isotopes, wipe/filter/cartridge - $84;

thorium isotopes, wipe/filter/cartridge - $87;

plutonium, wipe/filter/cartridge -$88;

tritium, wipe/filter/cartridge - $61;

strontium-89 or 90, wipe/filter/cartridge - $160;

carbon-14, wipe/filter/cartridge - $142;

gamma emitting isotopes, wipe/filter/cartridge - $78;

asbestos identification - $55;

asbestos fiber counting - $46;

dust identification - $60;

organic chemicals, by group, such as insecticides, herbicides, volatile organic compounds, semi-volatile organic compounds in water or soil/sediment, including routine sample preparation procedures - $542 per group per sample;

metals, per analyte in water or soil/sediment, including routine sample preparation procedures - $77 per analyte per sample; and

inorganic chemicals, per analyte in water or soil/sediment - $105 per analyte per sample.

Newborn screening procedures.

Newborn screening is required by the Health and Safety Code, Chapter 33.

The department through the bureau will provide newborn screening test kits upon written request from a provider of newborn screening. A test kit is the department-designed collection device, demographic information form and envelope used to submit a newborn's blood specimens for screening by the bureau. A separate test kit is required for each screening panel. Each newborn must have two screening panels performed. Additional screening panels may be necessary under certain circumstances. Testing providers include hospitals, birthing centers, physicians, midwives, and clinics.

The department shall accept only its test kit for submission of specimens.

The department will provide test kits for Medicaid-eligible or charity care newborns at no cost to the provider.

The department will provide test kits for all other newborns at a fee as described in subsection (c)(3) of this section.

A Medicaid-eligible newborn is a patient whose mother is a Medicaid recipient or who is otherwise eligible for Medicaid coverage for the newborn-related services. A charity care newborn is a patient who is not insured and is not covered or eligible to be covered for newborn screening services by Medicaid or any other government program.

When a provider requests test kits, the provider must identify the number estimated to be needed for Medicaid-eligible newborns, charity care newborns, and other newborns. The provider's estimates shall be based on the provider's newborn screening services provided in the most recent fiscal or calendar year if the provider has previously provided these services. A provider shall provide further information upon request of the department to verify the appropriateness of the number of test kits provided at no cost.

The department will bill the requesting provider for test kits when the test kits are sent to the provider. Payment is due within 120 days from the provider's receipt of the test kits.

A provider may use the no-cost test kit only for a Medicaid-eligible or charity care newborn.

A provider shall ensure that the identifying and demographic information provided with the test kit is complete and accurate when submitted to the department.

A provider may use the department's previous newborn screening forms until May 31, 1998. Beginning on June 1, 1998, all providers must use the department's new test kits for newborn specimens.

§73.24.Certification of Drinking Water, Milk, and Shellfish Laboratories.

Purpose. This section establishes the procedures for drinking water, milk, and shellfish laboratories to become certified laboratories under federal or state law.

Definitions. The following words and terms, when used in this section, shall have the following meanings unless the text clearly indicates otherwise.

Assessment - A fact-finding process performed either by an approved third party or by the Texas Department of Health (department) in which information and observations are collected and evaluated for the purpose of judging the laboratory's conformance with established certification standards. Assessment includes an onsite inspection.

Certification - An official and legal approval granted by the department to a laboratory, permitting analysis of drinking water, milk, or shellfish samples in accordance with applicable federal and state laws and rules based on the process outlined in this section. Certification means that a certified laboratory has been judged capable of performing the analyses for which it is certified correctly. Certification does not imply or mean that the department certifies the results produced by the certified laboratory.

Certification application.

An applicant laboratory must submit an application for certification directly to the department on a form specified by the department. For drinking water laboratories, the application must be accompanied by evidence of assessment by a department-approved assessor in the category for which certification is requested or assessment by the department if the department performs assessments.

Payment of the appropriate fee for certification under §73.22 of this title (relating to Fees) must accompany the application.

Payment may be by check or money order made payable to the Texas Department of Health.

A laboratory may apply for certification in a single category or any combination of categories from among the following: chemistry-routine inorganics, chemistry-nitrate and nitrite, chemistry-metals, chemistry-lead and copper, chemistry-trihalomethanes, chemistry-volatile organics, chemistry-insecticides and herbicides, chemistry-carbamate insecticides, chemistry - ethylene dibromide (EDB) and dibromochloropropane (DBCP), chemistry-synthetic organics, chemistry-endothal, chemistry-glyphosate, chemistry-diquat, chemistry-radiochemicals, chemistry-asbestos, chemistry-dioxin, drinking water microbiology, milk analysis - antibiotics, milk analysis - raw, milk analysis - full service, or shellfish analysis - full service.

The department shall perform an assessment for each milk and shellfish laboratory applying for certification.

Each certified laboratory must reapply for certification every two years and pay the appropriate certification fee. After initial certification, the laboratory will be assessed the certification fee on an annual basis.

The minimum standards for certification are as specified by the United States Environmental Protection Agency (EPA) applying to drinking water and the United States Food and Drug Administration (FDA) applying to milk and shellfish. These specifications are available for review during normal business hours at the department's Bureau of Laboratories, 1100 West 49th Street, Austin, Texas.

Each applicant laboratory will be evaluated, at a minimum on the following factors: credentials and experience of staff, quality assurance plan, manuals of procedures, performance on evaluation unknowns, equipment, calibrations and standards, methodology, facilities, sample acceptance policies, sample tracking, record keeping, reporting, and results interpretation.

Inspections. The department may conduct inspections of laboratories to ascertain adherence to minimum standards and the effectiveness of the certification system. For laboratories for which the department serves as both the assessing and certification authority, inspections will be conducted on at least a biennial basis.

Withdrawal of certification.

A laboratory must meet all minimum standards, pass all performance evaluation sets, and pass onsite inspection no less than every two years to be certified.

A laboratory that fails to meet requirements by scoring outside the acceptable limits on a set of performance evaluation unknowns, has serious deficiencies at the time of an onsite inspection, fails to notify the department within 30 days of major changes which might impair analytical capability (personnel, equipment, or location), or fails to notify the state or public of certain problems as required by notification regulations may be placed on provisionally certified status.

Failure on two consecutive performance evaluation sets or failure to correct major deficiencies following onsite inspection may result in the withdrawal of certification. The correction action must take place within the time frames set by the appropriate federal regulatory authority, which are 90 days or less.

Certification may be suspended or revoked immediately if the standards of the EPA or FDA require suspension or revocation, or if continued operation of the laboratory will jeopardize public health. Due process will be afforded to the laboratory whose certification is revoked or suspended.

Certification shall be revoked for a laboratory which submits as its own work the results for analysis of any performance evaluation sample which was analyzed by a different laboratory. The laboratory may not reapply for certification for a period of not less than three years.

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

Filed with the Office of the Secretary of State on February 9, 1998.

General Counsel

Texas Department of Health

Effective date: March 1, 1998

Proposal publication date: December 5, 1997

For further information, please call: (512) 458-7236

Exposure to Lead

25 TAC §73.31

The repeal is adopted under the Health and Safety Code, §§12.031, 12.032, and 12.034, which provide the board with the authority to adopt rules relating to public health services fees for laboratory services; §12.020, which provides the department with the authority to establish charges by rule for the sale of specific laboratory services; §§33.002 and 33.011, which provide the board and department with authority to adopt rules to carry out the newborn screening program and to prescribe screening test procedures; §§81.004 and 81.006, which provide the board with the authority to adopt rules and to seek and receive fees for the purpose of identifying communicable diseases; §161.101, which provides the department with the authority to charge for certain blood lead tests requested by a physician who suspects that a person has been harmed by exposure to lead; Texas Civil Statutes, Article 4512i, §19A, which provides the department with authority to charge a newborn screening fee to midwives; and Health and Safety Code, §12.001, which provides the board with the authority to adopt rules to implement every duty imposed by law on the board, the department, and the commissioner of health

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

Filed with the Office of the Secretary of State on February 9, 1998.

General Counsel

Texas Department of Health

Effective date: March 1, 1998

Proposal publication date: December 5, 1997

For further information, please call: (512) 458-7236

Fees for Drinking Water Systems

25 TAC §73.41

The repeal is adopted under the Health and Safety Code, §§12.031, 12.032, and 12.034, which provide the board with the authority to adopt rules relating to public health services fees for laboratory services; §12.020, which provides the department with the authority to establish charges by rule for the sale of specific laboratory services; §§33.002 and 33.011, which provide the board and department with authority to adopt rules to carry out the newborn screening program and to prescribe screening test procedures; §§81.004 and 81.006, which provide the board with the authority to adopt rules and to seek and receive fees for the purpose of identifying communicable diseases; §161.101, which provides the department with the authority to charge for certain blood lead tests requested by a physician who suspects that a person has been harmed by exposure to lead; Texas Civil Statutes, Article 4512i, §19A, which provides the department with authority to charge a newborn screening fee to midwives; and Health and Safety Code, §12.001, which provides the board with the authority to adopt rules to implement every duty imposed by law on the board, the department, and the commissioner of health.

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

Filed with the Office of the Secretary of State on February 9, 1998.

General Counsel

Texas Department of Health

Effective date: March 1, 1998

Proposal publication date: December 5, 1997

For further information, please call: (512) 458-7236

Chapter 99. Occupational Conditions Reporting

25 TAC §99.1

The Texas Department of Health (department), by majority vote of the Texas Board of Health (board) on February 8, 1998, enters this order finally adopting an amendment to §99.1, concerning occupational condition reporting with changes to the proposed text as published in the September 26, 1997, issue of the Texas Register (22 TexReg 9600), as a result of comments received during the 30 day comment period.

This amendment will lower the blood lead reporting level mandated by the Occupational Condition Reporting Act from 40 micrograms of lead per deciliter of blood (40 µg/dL) to 25 µg/dL. This lower level is consistent with the level recommended by the Centers for Disease Control and Prevention's Healthy People 2000: National Health Promotion and Disease Prevention Objectives, and will allow the department to track progress on meeting the Healthy People 2000 objectives for Texas.

This amendment replaces the word "disease" with "condition" throughout the rule to be consistent with Chapter 245 (House Bill 2311), adopted by the 75th Legislature (1997). Next, this amendment will lower the blood lead reporting level from 40 micrograms of lead per deciliter of blood (40 µg/dL) to 25 µg/dL. The amendment also adds a division name and a mailing address.

The following comments were received concerning the proposed sections. Following each comment is the department's response and any resulting change(s). A minor editorial change was made for clarification purposes.

COMMENT: Concerning §99.1(b)(5), the definition of occupational conditions, one commenter recommended deleting the word "and" between "diseases" and "abnormal health conditions" and replacing it with a comma. Also, the word "conditions" in the last line of the definition should be replaced with the word "exposures" to be consistent with the statute.

RESPONSE: The department agrees with the commenter, and has made the requested changes.

COMMENT: Concerning §99.1(b)(6), definition of reportable occupational condition, one commenter recommended replacing the "or" between "disease" and "condition" with a comma and to add "or laboratory finding" between "condition" and "for" to more precisely conform to the statute, which defines "reportable condition" in Section 84.002(3) of the Texas Health and Safety Code.

RESPONSE: The department agrees with the commenter, and has made the requested changes. COMMENT: Concerning §99.1(c)(5), reports from outside the jurisdiction of the local health authority, one commenter recommended deleting the word "disease" in the third line of the paragraph (as published in the Texas Register ). Since the definition of "occupational condition" includes diseases the commenter felt the inclusion of the word "disease" would be redundant.

RESPONSE: The department agrees with the commenter, and has deleted the work "disease" as requested. Also, the word "or" between condition and [disease] has been deleted for clarification purposes.

Comments were received Brown McCarroll & Oaks Hartline. This is a law firm that represents a number of industrial clients that are involved in metal processing and that may have employees who are exposed to lead in the workplace. Their comments dealt with grammar and vocabulary changes in three sections of the proposed rule.

The amendment is adopted under the Health and Safety Code, Chapter 84 of the Health and Safety Code §84.003, which requires the board to adopt rules necessary to implement the reporting of elevated blood lead levels; and §12.001 which allows the board to adopt rules for the performance of every duty imposed by law on the Texas Board of Health, the Texas Department of Health and the Commissioner of Health.

§99.1.General Provisions.

Purpose. This section implements the Texas Occupational Conditions Reporting Act, Health and Safety Code, Chapter 84, House Bill 2091, 69th Legislature, 1985, which authorizes the Texas Board of Health to adopt rules concerning the reporting and control of occupational conditions.

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

Case - A person in whom an occupational condition is diagnosed by a physician based upon clinical evaluation, interpretation of laboratory and/or roentgenographic findings, and an appropriate occupational history.

Occupational conditions - Those diseases, abnormal health conditions or laboratory findings that are caused by or are related to exposures in the workplace.

Reportable occupational condition - Any occupational disease, condition or laboratory finding for which an official report is required. See subsection (d) of this section.

Report of occupational condition - The notification to the appropriate authority of the occurrence of a specific occupational disease in a human, including all information required by the procedures established by the Board of Health.

Suspected case - A case in which an occupational condition is suspected, but the final diagnosis is not yet made.

Reporting requirements.

It is the duty of every physician holding a license to practice in the State of Texas to report promptly to the local health authority each patient she or he shall examine and who has or is suspected of having any reportable occupational condition. The local health authority may authorize a staff member to transmit reports.

It is the duty of every person who is in charge of a clinical or hospital laboratory, blood bank, mobile unit, or other facility in which a laboratory examination of any specimen derived from a human body yields microscopical, cultural, serological, chemical, or other evidence suggestive of a reportable condition to report promptly that information to the local health authority.

The local health authority shall collect the reports and transmit the information at weekly intervals to the Noncommunicable Disease Epidemiology and Toxicology Division, Bureau of Epidemiology, Texas Department of Health, 1100 W. 49th Street, Austin, Texas 78756. Transmission may be made by mail, courier, or electronic transfer.

If by mail or courier, the reports shall be placed in a sealed envelope addressed to the attention of the Noncommunicable Disease Epidemiology and Toxicology Division, Bureau of Epidemiology, Texas Department of Health, 1100 W. 49th Street, Austin, Texas 78756, and marked "Confidential Medical Records."

When an occupational condition is reported to a local health authority, and the person diagnosed as having the condition resides outside his or her area of local health jurisdiction, the local health authority receiving the report shall notify the appropriate local health authority where the person or persons reside. The department shall assist the local health authority in providing such notifications if requested.

List of reportable occupational conditions. Occupational conditions reportable by name, address, age, sex, race/ethnicity, method of diagnosis, and relevant occupation(s) and employer(s) of the case, and identity of the reporter, are: asbestosis, silicosis, blood lead levels at or above 25 micrograms lead/100 milliliters of blood in persons 15 years of age or older, and acute occupational pesticide poisoning.

General control measures for reportable occupational conditions. The commissioner or his or her duly authorized representative shall, as circumstances may require, proceed as follows:

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

Filed with the Office of the Secretary of State on February 9, 1998.

General Counsel

Texas Department of Health

Effective date: March 1, 1998

Proposal publication date: September 26, 1997

For further information, please call: (512) 458-7236

Chapter 119. Health Maintenance Organizations

The Texas Department of Health (department) by majority vote of the Texas Board of Health (board) on February 8, 1998, enters this order finally adopting the repeal of §§119.1 - 119.4, 119.21 - 119.25, 119.51 - 119.56, and 119.71, concerning the regulation of health maintenance organizations (HMOs), without changes to the proposed text as published in the Texas Register on December 5, 1997 (22 TexReg 11952).

Specifically, the sections cover definitions; application, assessments, and fees; examinations; reporting complaints; organization of a health maintenance organization and service area; quality improvement; quality improvement program; quality improvement committee; utilization review; ambulatory health care services; emergency care; inpatient hospital and medical service; diagnostic and therapeutic services; optional services; single health care service; and enforcement.

These rules address the quality of health care services furnished by HMOs to its enrollees under the authority given to the department in the Health Maintenance Organization Act, Texas Insurance Code, Chapter 20A (HMO Act). The department and the Texas Department of Insurance (TDI) jointly regulated HMOs under authority of the HMO Act prior to September 1, 1997. Senate Bill (SB) 385, 75th Texas Legislature, 1997, amended the HMO Act by amending the authority for the regulation of the quality of health care services furnished by HMOs from the department to the TDI, effective September 1, 1997. The bill did not provide for the administrative transfer of department rules to TDI, therefore Chapter 119 is being repealed in its entirety to void the sections promulgated by the Texas Board of Health under the HMO Act. Although the formal adoption of the repeal of these sections will not be effective until sometime in March of 1998, these sections became null and void effective September 1, 1997, because of the amendments in SB 385.

Adoption of the repeal of these sections will formally void sections which are no longer effective because of the amendments in SB 385.

There were no comments received on this proposal during the comment period which ended January 5, 1998.

Subchapter A. General Provisions

25 TAC §§119.1-119.4

The repeals are adopted under the Health and Safety Code, §12.001, which provides the board with the authority to adopt rules to implement every duty imposed by law on the board, the department, and the commissioner of health.

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

Filed with the Office of the Secretary of State on February 9, 1998.

General Counsel

Texas Department of Health

Effective date: March 1, 1998

Proposal publication date: December 5, 1997

For further information, please call: (512) 458-7236

Subchapter B. Organizations and Functions of a Health Maintenance Organization

25 TAC §§119.21-119.25

The repeals are adopted under the Health and Safety Code, §12.001, which provides the board with the authority to adopt rules to implement every duty imposed by law on the board, the department, and the commissioner of health.

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

Filed with the Office of the Secretary of State on February 9, 1998.

General Counsel

Texas Department of Health

Effective date: March 1, 1998

Proposal publication date: December 5, 1997

For further information, please call: (512) 458-7236

Subchapter C. Services

25 TAC §§119.51-119.56

The repeals are adopted under the Health and Safety Code, §12.001, which provides the board with the authority to adopt rules to implement every duty imposed by law on the board, the department, and the commissioner of health.

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

Filed with the Office of the Secretary of State on February 9, 1998.

General Counsel

Texas Department of Health

Effective date: March 1, 1998

Proposal publication date: December 5, 1997

For further information, please call: (512) 458-7236

Subchapter D. Enforcement

25 TAC §119.71

The repeal is adopted under the Health and Safety Code, §12.001, which provides the board with the authority to adopt rules to implement every duty imposed by law on the board, the department, and the commissioner of health.

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

Filed with the Office of the Secretary of State on February 9, 1998.

General Counsel

Texas Department of Health

Effective date: March 1, 1998

Proposal publication date: December 5, 1997

For further information, please call: (512) 458-7236

Chapter 229. Food and Drug

Seafood Safety

25 TAC §§229.121-229.129

The Texas Department of Health (department), by majority vote of the Texas Board of Health (board), on February 8, 1998, enters this order finally adopting new §§229.121 - 229.129, concerning state enforcement of new federal seafood safety regulations. Section 229.124 is adopted with changes to the proposed text as published in the November 7, 1997, issue of the Texas Register (22 TexReg 10881). Sections §§229.121-229.123 and §§229.125-229.129 are adopted without changes, and therefore the sections will not be republished.

The new sections define terms used in the industry's application of fish and fishery products hazard analysis critical control point principals (HACCP), establish rules on current good manufacturing practices, specify the requirements of a HACCP plan, the corrective actions required, requirements for verification that a HACCP plan is adequate, and the specific requirements for record keeping, training, and sanitation control procedures. In addition, the sections specify requirements for processing smoked and smoke-flavored fishery products.

Federal Fish and Fishery Products HACCP regulations contained in Code of Federal Regulations, Title 21, §§123.3 - 123.16 take effect in December 1997. It is estimated that the rules will affect 150 seafood establishments in Texas. Adoption of HACCP in Texas will create uniformity and consistency of seafood safety throughout the entire seafood industry. It will also benefit Texas consumers by ensuring that all Texas seafood meets the same level of safety as seafood in interstate commerce.

No comments were received on the proposal of these rules during the comment period. However, the department is making the following change due to staff comment to clarify the intent and improve the accuracy of the section.

CHANGE: Concerning §229.124(b), the word "plan" has been inserted between the words "Point" and "in accordance."

The new sections are adopted under the Health and Safety Code, §431.241, which provides the department with the authority to adopt necessary regulations pursuant to the enforcement of Chapter 431; and §12.001, which provides the Texas Board of Health (board) with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

§229.124.Corrective Actions.

Whenever a deviation from a critical limit occurs, a processor shall take corrective action either by:

following a corrective action plan that is appropriate for the particular deviation; or

following the procedures in subsection (c) of this section.

Processors may develop written corrective action plans, which become part of their Hazard Analysis Critical Control Point plan in accordance with §229.123(c)(5) of this title (relating to Hazard Analysis and Hazard Analysis Critical Control Point (HACCP) Plan), by which they predetermine the corrective actions that they will take whenever there is a deviation from a critical limit. A corrective action plan that is appropriate for a particular deviation is one that describes the steps to be taken and assigns responsibility for taking those steps, to ensure that:

no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation; and

the cause of the deviation is corrected.

When a deviation from a critical limit occurs and the processor does not have a corrective action plan that is appropriate for that deviation, the processor shall:

segregate and hold the affected product, at least until the requirements of paragraph (2) and (3) of this subsection are met;

perform or obtain a review to determine the acceptability of the affected product for distribution. The review shall be performed by an individual or individuals who have adequate training or experience to perform such a review. Adequate training may or may not include training in accordance with §229.127 of this title (relating to Training);

take corrective action, when necessary, with respect to the affected product to ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation;

take corrective action, when necessary, to correct the cause of the deviation;

perform or obtain timely reassessment by an individual or individuals who have been trained in accordance with §229.127 of this title, to determine whether the HACCP plan needs to be modified to reduce the risk of recurrence of the deviation, and modify the HACCP plan as necessary.

All corrective actions taken in accordance with this section shall be fully documented in records that are subject to verification in accordance with §229.125(a)(3)(B) of this title (relating to Verification) and the record keeping requirements of §229.126 of this title (relating to Records).

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

Filed with the Office of the Secretary of State on February 9, 1998.

General Counsel

Texas Department of Health

Effective date: March 1, 1998

Proposal publication date: November 7, 1997

For further information, please call: (512) 458-7236