MRD-12-10-00010-A Procedures for Control of Tuberculosis (TB)

5/26/10 N.Y. St. Reg. MRD-12-10-00010-A

NEW YORK STATE REGISTER

VOLUME XXXII, ISSUE 21

May 26, 2010

RULE MAKING ACTIVITIES

OFFICE OF MENTAL RETARDATION AND DEVELOPMENTAL DISABILITIES

NOTICE OF ADOPTION

 

I.D No. MRD-12-10-00010-A

Filing No. 517

Filing Date. May. 11, 2010

Effective Date. Jun. 01, 2010

Procedures for Control of Tuberculosis (TB)

PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:

Action taken:

Repeal of Subpart 635-8 and addition of section 633.14 to Title 14 NYCRR.

Statutory authority:

Mental Hygiene Law, sections 13.07, 13.09(b) and 16.00

Subject:

Procedures for control of tuberculosis (TB).

Purpose:

To conform OMRDD requirements related to the control of TB to current national recommended practices.

Substance of final rule:

• The regulation repeals existing out-of-date OMRDD requirements on the control of tuberculosis (TB) in 14 NYCRR Subpart 635-8 and adds a new Section 633.14 containing updated requirements.

• TB testing. The previous regulation required most service recipients, employees, volunteers and independent contractors to be tested for TB annually. The new regulation requires service recipients, employees, volunteers and independent contractors (excluding those who reside, work or volunteer in a developmental center) to have an initial TB test with a follow-up TB test only if the person is exposed to TB or the person exhibits TB symptoms. For those who live, work or volunteer in a development center, an annual TB test continues to be required.

• Testing technology. The previous regulation only allowed for testing with the purified protein derivative (PPD) Mantoux skin test. The new rule allows for new TB testing techniques.

• Treatment of TB. The previous regulation contained requirements, including isolation rooms at developmental centers, for the treatment of someone with active TB. The newly adopted regulations require people who have active TB be treated by their own healthcare provider in conjunction with the local health department.

• Applicability to non-certified services. The previous regulation applied to developmental centers, certified facilities and non-certified services. The new regulation only applies to developmental centers and certified facilities. Non-certified services are no longer required to comply.

Final rule as compared with last published rule:

Nonsubstantive changes were made in section 633.14(b), (c), (f), (g) and (i)(2).

Text of rule and any required statements and analyses may be obtained from:

Barbara Brundage, Director of Regulatory Affairs, Office of Mental Retardation & Developmental Disabilities, 44 Holland Avenue, Albany, NY 12229, [phone], email: [e-mail]

Additional matter required by statute:

Pursuant to the requirements of SEQRA and 14 NYCRR Part 602, OMRDD has determined that the action described herein will have no effect on the environment, and an E.I.S. is not needed.

Revised Regulatory Impact Statement, Revised Regulatory Flexibility Analysis, Revised Rural Area Flexibility Analysis and Revised Job Impact Statement

In subparagraph 633.14(c)(1)(i), the term “two-step TST” is changed to “two-step PPD,” to be consistent with the definition and usage in the regulation. Technical corrections were also made in the definitions of “contractor” and “service provider.” Other changes have been made to correct punctuation and grammar. These minor changes do not necessitate revision to the previously published Regulatory Impact Statement, Regulatory Flexibility Analysis for Small Businesses and Local Governments, Rural Area Flexibility Analysis or Job Impact Statement.

Assessment of Public Comment

OMRDD received one comment from the NYC Department of Health and Mental Hygiene, one comment from a provider association, and five comments from individuals employed by voluntary providers of services regarding the proposed regulations. The comments and OMRDD’s response to each is as follows:

Comment: The provider association strongly supports the new approach to disease control embodied in the proposed regulation. In particular, the association understands that these new measures will result in greater efficiency of provider financial resources. The CEO of a provider of services also commented that the provider fully supports the proposed regulations. The NYC Department of Health and Mental Hygiene also supports the proposal.

Response: OMRDD appreciates the support for these regulations.

Comment: The NYC Department of Health and Mental Hygiene (DOHMH) suggested modifying the definition of TB testing to read as follows: "Screening for tuberculosis infection with any approved test to detect M. tuberculosis infection, such as the tuberculin skin test (TST), or one of the whole blood interferon-gamma release assays (IGRAs) approved by the United States Food and Drug Administration (FDA)."

Response: The definition in the proposed regulation specified that tests must be "currently approved by the United States Food and Drug Administration (FDA) and/or recommended by the Centers for Disease Control (CDC) for that purpose." OMRDD disagrees with identifying specific currently-approved tests as examples, since in the future approval for a particular test may withdrawn by the FDA or the test may no longer be recommended by CDC. The definition is unchanged in the final regulation.

Comment: NYCDOHMH also suggested modifying the definition of "two-step PPD" to include the following: "If an IGRA test is used for screening, there is no need to perform a two-step baseline."

Response: OMRDD does not disagree with the accuracy of the statement. However, OMRDD does not consider it necessary to add the statement to the cited definition, since an IGRA test is not a type of PPD and there is no two-step IGRA testing. The definition is unchanged in the final regulation.

Comment: A medical director of a voluntary provider asked whether 2-step PPD testing is required.

Response: The proposed regulations require TB testing but do not specify the type of testing that is required. Other TB tests may be utilized, such as a blood assay test (e.g. Quantiferon Gold). The regulations at 633.14(e)(2) do specify that if an initial TST is performed, it shall be conducted employing a two-step PPD unless the person has documented evidence of a TST within the last twelve months.

Comment: The medical director also suggested the inclusion of a provision for individuals for whom TB testing cannot be done secondary to behavior issues.

Response: OMRDD has not added the suggested provision. OMRDD agrees that in limited circumstances it may be undesirable to require a TB test for individuals with challenging behaviors. However, it has been OMRDD's experience that many individuals who have challenging behaviors can successfully be screened with a PPD, especially when it is a one-time requirement. In addition, in some cases the physician can order a blood assay test for such individuals when other blood work is being done. OMRDD is concerned that the addition of a specific exemption for individuals on the basis of their challenging behaviors could be interpreted to exempt any person who has a behavior management plan, or who in any way acts like they may not "like" a TB test.

OMRDD considers that the proposed regulatory language already accommodates those limited circumstances when it is undesirable to require a TB test on the basis of challenging behaviors. Paragraph 633.14(d)(2) states:

"A statement by a physician, nurse practitioner or physician's assistant of contraindication shall be acceptable as long as the statement includes:

(i) a recommendation as to when and if testing would be appropriate at a designated point in the future; and

(ii) how the party will be evaluated for active pulmonary tuberculosis in the interim."

OMRDD has not included a definition of the term "contraindication" to accommodate a diverse range of possible issues that would make doing a TB test contraindicated. Basically, if in the opinion of the practitioner, the risks of TB testing outweigh the benefits, the individual may be exempted so long as the practitioner statement includes the required elements.

Comment: The deputy executive director, on behalf of a provider agency, characterized the proposed regulation as a "good step forward." The individual specifically stated that extending the use of other TB testing technologies was excellent as is the requirement limiting testing in many circumstances to the initial testing. The clinical and HR staff of the same provider were concerned with the total removal of ongoing testing except in the case of someone with symptoms or with an exposure occurrence. They were concerned that staff may not reliably report an exposure situation. In addition, they observed that TB symptoms may be mimicked by other respiratory infections or conditions such as bronchial disturbances and smokers' cough, which might cloud the decision-making for the agency concerned with identifying a specific TB symptom. They are considering leaving in place 3 year or 5 year testing requirements.

Response: When OMRDD discussed the issue with the New York State Department of Health, it was the strong recommendation of NYSDOH that OMRDD drop routine screening for a much more "targeted" approach. Reviewing data from the last 10 years, OMRDD has been made aware of 4 cases of active pulmonary TB, only one of which was identified by routine screening. This was an individual who had recently migrated from a country where TB is endemic, and was discovered during pre-employment screening. In consultation with NYSDOH and guided by the newest guidelines of the CDC and its Advisory Council for the Elimination of Tuberculosis, OMRDD identified those populations at highest risk. This included persons who:

• have spent time with a person known or suspected to have active TB disease (a.k.a.: known exposure); or

• have symptoms of active TB disease; or

• are recent immigrants from a country where active TB disease is very common; or

• live somewhere in the United States where active TB disease is more common such as a homeless shelter, migrant farm camp, prison or jail; or

• inject illegal drugs; or

• have HIV infection or another condition that weakens the immune system and puts them at high risk for active TB disease.

According to the CDC, because of problems with continued cross-reactions with other mycobacteria, the specificity of the tuberculin test is less when serial skin testing is performed than when a single test is administered. Thus, serial skin-testing programs tend to overestimate the incidence of new TB infection in the tested population. Because of this potential for overestimation of incidence, the CDC recommends that serial skin-testing programs be targeted to populations at high risk for continued exposure to infectious TB.

To operationalize the recommendations, OMRDD and NYSDOH determined that persons who should continue to be routinely screened included:

• Pre-employment/pre-receipt of service for all new employees and individuals

• Developmental center populations as high risk as many of the individuals served in those settings have recently resided in state or county prisons or jails

• Persons with symptoms of active TB disease

• Persons with known exposures to active TB disease

The requirements of the regulation are the minimum standard with which agencies must comply. If agencies wish, they are permitted to require testing of employees and/or individuals in excess of the minimum standard.

Comment: The same deputy executive director commented that on a routine basis they encountered staff and some service recipients and their families who travel abroad annually to visit families in their former homelands. Some of these countries have a different level of public health/medical oversight, and the person can remain there for up to 4 weeks. When they return back and receive services, the agency has become increasingly concerned that perhaps the best course would be to request medical clearance before they return. The agency has not mandated this process unless they are informed that the travelers contracted something when they were away or if symptoms are observed at work or in program.

Response: OMRDD carefully considered this issue during the development of the revised recommendations. However, after consultation with the NYSDOH and CDC, it was determined that this is not community standard of practice, and should not be a requirement of the regulation. Every day thousands of American citizens travel to countries where TB is endemic. Many are returning after many weeks or months of working in those countries, including US military personnel and State Department personnel. Neither CDC, NYSDOH, US Immigration, the US Department of State, the US Military nor any other authority of which OMRDD is aware require that these people be tested for any contagious disease upon their return (unless they have obvious symptoms). There is no epidemiological evidence that these people pose a significant risk, nor is there information that they disproportionately have a higher incidence of TB. Therefore, OMRDD decided against the inclusion of a regulatory requirement for medical clearance in these circumstances. However, if the agency chooses it can impose additional requirements in excess of the regulatory minimum standard.

Comment: A compliance officer of a provider agency commented that in his opinion the NYS Department of Health does not allow LPNs to read PPDs. He suggests deleting LPNs from the list of professionals who can read PPDs in the proposed regulation.

Response: Paragraph 633.14(e)(3) permits LPNs to read, but not interpret PPDs. This is consistent with an opinion of the State Board of Nursing. LPNs are allowed to collect objective data. Measuring the millimeters of induration from a Mantoux skin test is an objective measure. However, determining that the measurement constitutes a "positive" or "negative" is an interpretation of the objective data an can only be done by an RN, NP, PA or MD. Therefore OMRDD is retaining the provision to give providers flexibility in complying with this requirement.

Comment: An employee health nurse of a provider agency requested a clarification of the terms "registry" and "summary" used in the proposed regulations.

Response: OMRDD considers that the regulated parties are already familiar with these terms and the necessary compliance activities associated with these terms, and that further definition or specificity is not needed. OMRDD staff is available to assist regulated parties regarding requests for further clarification.