HLT-48-08-00023-A Childhood Lead Poisoning Screening and Follow-up
5/6/09 N.Y. St. Reg. HLT-48-08-00023-A
NEW YORK STATE REGISTER
VOLUME XXXI, ISSUE 18
May 06, 2009
RULE MAKING ACTIVITIES
DEPARTMENT OF HEALTH
NOTICE OF ADOPTION
I.D No. HLT-48-08-00023-A
Filing No. 381
Filing Date. Apr. 17, 2009
Effective Date. Jun. 20, 2009
Childhood Lead Poisoning Screening and Follow-up
PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:
Action taken:
Amendment of Subparts 67-1 and 67-3 of Title 10 NYCRR.
Statutory authority:
Public Health Law, section 206
Subject:
Childhood Lead Poisoning Screening and Follow-up.
Purpose:
Expand follow-up for children with elevated blood lead levels; authorize point-of-care laboratory testing and require reporting.
Text of final rule:
Subdivisions (c) through (h) of Section 67-1.1 are renumbered to be subdivisions (d) through (i), respectively.
A new Subdivision (c) of Section 67-1.1 is added to read as follows:
67-1.1(c) "Child" shall refer to an individual from birth to less than eighteen years, unless otherwise specified.
Paragraphs (5) through (10) of subdivision (a) of Section 67-1.2 are renumbered to be paragraphs (6) through (11), respectively.
Section 67-1.2(a) is amended to add a new paragraph (5) below, and existing paragraphs (5), (8), (9) and (10) are renumbered as (6), (9), (10) and (11), respectively and are amended to read as follows:
67-1.2(a)(5) Results of blood lead analysis performed in a health care practitioner's office pursuant to Public Health Law Section 579(1) that is certified by the Centers for Medicare and Medicaid Services under regulations implementing the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) must be reported to the Commissioner of Health and to the local health officer in whose jurisdiction the subject of the test resides. Such results shall be reported within fourteen business days of the date of analysis and on such forms as prescribed by the Commissioner of Health. Such reports must include the subject's name, date of birth, race, gender, address, county of residence, type of sample (venous or fingerstick) and blood lead level; the health care practitioner ordering the test, facility identifiers, the date of sample collection, and the date of analysis.
67-1.2(a)[(5)](6) Each primary health care provider who screens a child for elevated blood lead levels shall explain the blood lead test results and [give a certificate] provide documentation of lead screening to the parent or guardian of the child or other person authorized to consent for the medical care of the child.
67-1.2(a)[(8)](9) Primary health care providers shall confirm blood lead levels equal to or greater than [15] 10 micrograms per deciliter of whole blood obtained on a [fingerstick] capillary specimen from a child using a venous blood sample.
67-1.2(a)[(9)](10) For each child who has a confirmed blood lead level equal to or greater than [20]15 micrograms per deciliter of whole blood, primary health care providers shall provide or make reasonable efforts to ensure the provision of a complete diagnostic evaluation; medical treatment, if necessary; and referral to the appropriate local or State health unit for environmental management. A complete diagnostic evaluation shall include at a minimum: a detailed lead exposure assessment, a nutritional assessment including iron status, and a developmental screening.
67-1.2(a)[(10)](11) Primary health care providers shall communicate and coordinate as appropriate with local health units to ensure that each child with an elevated blood lead level receives appropriate follow-up, as prescribed above in paragraphs [(5)](6) through [(9)](10) of this Section.
Paragraphs (1) and (3) of subdivision (b) of Section 67-1.2 are amended to read as follows:
67-1.2(b)(1) A health care provider that provides services to a child who is at least 6 months of age but under 6 years of age and who is not the child's ongoing primary care provider, such as a hospital inpatient facility, an emergency service if the child's condition permits, or other facility or practitioner which provides services to the child on a one-time or walk-in basis, shall inquire if the child has been appropriately assessed and screened for elevated blood lead levels in accordance with the schedule prescribed in paragraphs (1) and (3) of [this] subdivision 67-1.2(a).
67-1.2(b)(3) If screening is performed, the blood lead test result shall be sent to the child's primary care provider or to the local health unit to enable appropriate follow-up in accordance with paragraphs (a)[(5)](6) through [(9)](11) of this section.
Subdivision (a) of Section 67-1.3 is amended to read as follows:
67-1.3(a) All blood lead tests shall be performed by (i) a clinical laboratory approved for toxicology-blood lead under Article 5, Title V of the Public Health Law[.]; (ii) a health care practitioner's office pursuant to Public Health Law Section 579(1) that is certified by the Centers for Medicare and Medicaid Services under regulations implementing the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA); or (iii) an entity exempt from the requirements of Public Health Law Article 5, Title V pursuant to Section 579(3) of that Title, that holds a certificate of registration issued by the department and is authorized to conduct blood lead analyses.
Subdivision (a) of Section 67-1.4 is amended to read as follows:
67-1.4(a) Prior to or within three months of initial enrollment, each child care provider, public and private nursery school and preschool, licensed, certified or approved by any State or local agency shall obtain [a copy of a certificate of] a written statement signed by a health care provider that documents lead screening for any child at least one year of age but under six years of age, and retain such documentation until one year after the child is no longer enrolled.
Subdivision (a) of 67-3.1 is amended to read as follows:
67-3.1(a) For purposes of this Subpart, laboratory shall mean: (i) any laboratory that holds a permit issued in accordance with Public Health Law Article 5, Title V and is authorized to conduct blood lead analyses [.]; or (ii) an entity exempt from the requirements of Public Health Law Article 5, Title V pursuant to Section 579(3) of that Title, that holds a certificate of registration issued by the department and is authorized to conduct blood lead analyses.
Subdivision (d) of Section 67-3.1 is repealed, subdivisions (e) through (h) are renumbered to be subdivisions (d) through (g), respectively and newly renumbered subdivisions (d), (e), and (f) are amended to read as follows:
67-3.1 [(e)](d) [Laboratories that use an electronic system for tracking test results] All laboratories shall report electronically to the Commissioner of Health each blood lead analysis conducted [which]. The report must include the subject's name, date of birth, race, gender, address, county of residence, type of sample (venous or fingerstick)[,] and blood lead level[,]; the [physician] health care practitioner ordering the test, laboratory identifiers, the date the sample was collected and the date of analysis. Reporting pursuant to this subdivision shall be done using an electronic telecommunication system [or floppy disks] consistent with the technical specifications established by the Department.
67-3.1 [(f)](e) Any [clinical] laboratory not permitted in accordance with Public Health Law Article 5, Title V to perform blood lead analysis which accepts a blood lead sample [from a health care provider for referral to a laboratory] and refers the sample elsewhere for analysis shall [insure that the requisition slip includes] transmit to the laboratory performing the analysis all of the information that is required by [subdivisions] subdivision (d) [and (e)] above. [and that this information is transmitted to the laboratory performing the analysis with the blood lead sample.]
67-3.1[(g)](f)(2) In addition to any other reporting required by this Subpart, all [clinical] laboratories shall notify the provider ordering the blood lead test of the results of any analysis in a child [up to 72 months of age] less than eighteen years of age which is equal to or greater than 45 [mg/dl]mcg/dL (micrograms per deciliter) within 24 hours of the analysis.
Subdivision (b) of Section 67-3.2 is amended to read as follows:
67-3.2(b) All health care providers shall notify the health officer having jurisdiction of the occurrence of any blood lead level above 45 [mg/dl]mcg/dL (micrograms per deciliter) in a child [up to 72 months] less than eighteen years of age within 24 hours of having been notified of this result by the testing laboratory.
Final rule as compared with last published rule:
Nonsubstantive changes were made in section 67-3.1(d).
Text of rule and any required statements and analyses may be obtained from:
Katherine Ceroalo, DOH, Bureau of House Counsel, Regulatory Affairs Unit, Room 2438, ESP, Tower Building, Albany, NY 12237, (518) 473-7488, email: regsqna@health.state.ny.us
Revised Regulatory Impact Statement
Changes made to the last published rule do not necessitate revision to the previously published RIS.
Revised Regulatory Flexibility Analysis
Changes made to the last published rule do not necessitate revision to the previously published RFA.
Revised Rural Area Flexibility Analysis
Changes made to the last published rule do not necessitate revision to the previously published RAFA.
Revised Job Impact Statement
Changes made to the last published rule do not necessitate revision to the previously published JIS.
Assessment of Public Comment
Four public comments were submitted to the NYS Department of Health ("DOH," "The Department") in response to this proposed regulation from: the Coalition to End Lead Poisoning in New York State ("The Coalition"); the New York State Association of County Health Officials ("NYSACHO"); the Westchester County Executive; and the New York City Department of Health and Mental Hygiene ("NYCDOHMH").
The Coalition expressed support for the proposed amendment to reduce the blood lead level (BLL) threshold that triggers comprehensive follow-up services from 20 mcg/dL to 15 mcg/dL, noting that "intervention at this lower level will mean that fewer New York children will be further poisoned. Moreover, earlier intervention will benefit other children in the home who have been or would be exposed to lead paint dust in the absence of an investigation and appropriate remedial action." The Coalition also urged that the Department consider further reducing this threshold to 10 mcg/dL. As noted in the Coalition's comment, the Governor and DOH have committed to undertaking a review to assess further lowering this threshold; this review is currently in progress. Expanding the criteria for these services to 10 mcg/dL was considered as an alternative in developing these proposed regulations, but was rejected at this time because it would result in a significant increase in caseload that is not feasible within existing resources and because of the need to further assess scientific literature regarding the effectiveness of expanding this model of intervention to children with BLLs of 10-14 mcg/dL.
The Coalition also included in its comment two additional recommendations that are not directly related to the proposed amendments. First, the Coalition recommended that the state do more to increase blood lead testing rates among children and pregnant women. Provisions of the proposed regulation that authorize appropriate lead testing within private physician office laboratories (POLs) and limited service clinic laboratories, and that require reporting of lead test results from these laboratories, are aimed at supporting office-based testing using portable lead testing technology as a means of reducing known barriers to lead testing and increasing testing rates. Other provisions governing requirements for universal and targeted blood lead testing of children and pregnant women are found elsewhere in Part 67, and are not the subject of the proposed change. However, it may be noted that DOH conducts a number of strategies to improve blood lead testing, including a variety of population-based and targeted education, outreach, quality improvement and systems-based activities in collaboration with local health departments (LHDs), hospital-based regional lead resource centers, managed care plans, and other partners. A specific proposal to amend the public health law to authorize linkage of the department's childhood immunization and blood lead data systems was included in the proposed executive budget for 2009. If enacted, this data systems linkage will provide important new information tools to health care providers, insurers, LHDs and DOH to support improved practice and enforcement of blood lead testing requirements.
Second, the Coalition recommended that regulations related to reporting of blood lead test results from laboratories and health care practitioners should require that Medicaid identifier numbers be included on blood lead laboratory reports to provide an additional tool to monitor compliance with state and federal requirements for blood lead testing of children enrolled in Medicaid. While this is not the subject of the proposed rule, DOH will consider this recommendation as part of an assessment of additional potential regulations related to laboratory reporting of blood lead tests. The Coalition concludes its comment by re-stating its support for the proposed amendment to reduce the trigger for comprehensive public health interventions from 20 mcg/dL to 15 mcg/dL.
The Westchester County Executive and NYSACHO, while stating strong support for the goals of preventing and eliminating childhood lead poisoning, noted several concerns regarding the impact of the proposed regulations. Each concern is summarized below, followed by the DOH response. Closely related comments have been grouped together for purposes of summary and response.
Comment:
The proposed regulations would redefine age and blood lead level criteria, effectively increasing the number of children to be screened and managed. The proposed changes will lower the blood lead level that triggers health department intervention that legally defines lead poisoning from 20 mcg/dL to 15 mcg/dL, and will increase the age of covered children that currently ranges from infants to six year olds to 18 year olds.
Response:
While it is correct that the proposed regulations will expand the BLL criteria that trigger required environmental and other comprehensive interventions from 20 mcg/dL to 15 mcg/dL, the proposed amendments do not change the current definition of lead poisoning or requirements for routine blood lead testing (screening) of children. Current regulations that define an elevated blood lead level (EBLL) as greater than or equal to 10 mcg/dL (Subpart 67-1.1(d)); that define age-specific requirements for universal and targeted blood lead testing of children (Subparts 67-1.2(a)(1) and (3)); and that require LHDs to institute measures to identify and track children with EBLLs to assure appropriate follow-up services are provided (Subpart 67-1.6(f)) remain unchanged. LHDs are already required to track all children with EBLLs; the proposed amendments to 67-1.2(a)(10) will expand the scope of required services for children with BLLs 15-19 mcg/dL to include additional specific services, including complete diagnostic assessments and environmental management, which are currently required for children with BLLs greater than or equal to 20 mcg/dL. The proposed addition to define the term "child" as an individual less than 18 years of age is intended to clarify existing regulations for follow-up of children with EBLLs which, in contrast to the regulations for routine blood lead screening of children under age six years, are not age-specific.
Comment:
During discussions of the proposed changes with DOH, NYSACHO was under the impression that the result would be a guidance document, rather than new regulations.
Response:
Regulation changes are the necessary and sufficient mechanism for expanding the requirement for provision of comprehensive follow-up services to children with BLLs 15-19 mcg/dL. The proposed changes to the definition of "child" are intended to provide clarification that follow-up services are required for all children with EBLLs up to age eighteen years. DOH agrees that additional guidance documents are warranted to assist LHDs in tailoring follow-up services for older children to address individual case histories and sources of lead exposure that are likely to differ from the typical exposure patterns of younger children. NYSACHO has provided extensive substantive input on the development of these draft protocols and guidance documents, which are currently being finalized within DOH for dissemination to LHDs.
Comment:
The proposed regulatory change would result in a substantial program expansion that must be accompanied by an increase in aid to LHDs to handle the added workload that these changes will create. NYSACHO disagrees that an overall statewide decline in the number of lead poisoned children under the age of six has freed up LHD resources sufficient to absorb the significant caseload expansion that is proposed. Some LHDs indicated they will need to increase staffing to comply with the proposed regulations. The proposed programmatic expansion would occur at a time when all LHDs have seen a significant cut in state support for this program, on the heels of years of flat-level funding and an 8% reduction in funding in 2008-09 grant cycle, on top of recent reductions in state aid to localities. Hence NYSACHO finds that the proposed program expansion represents a new unfunded mandate to LHDs.
Response:
DOH does not agree. As described in detail in the Regulatory Impact Statement and other supporting documents accompanying the proposed regulation changes, the number of children who require environmental and other comprehensive follow-up services under current regulations (i.e., a BLL of greater than or equal to 20 mcg/dL) has declined dramatically over the past decade, while evidence of the harmful effects of lead at lower BLLs has grown, thereby providing both the opportunity and imperative to expand services to more children with EBLLs. As one measure of this dramatic decline, in 1996 there were 1,044 children under the age of six years newly identified with BLLs greater than or equal to 20 mcg/dL in New York State excluding New York City; in 2007 (the latest year for which complete statewide data are available), only 263 children were newly identified with BLLs in this range. While changing the BLL criteria for comprehensive follow-up services from 20 mcg/dL to 15 mcg/dL will result in an increase in the number of children requiring such services, the total number of estimated cases requiring these services under the proposed new criteria will still be well below the number of children who required such services under the current criteria a decade ago. Approximately 543 children with BLLs greater than or equal to 15 mcg/dL outside of New York City will require initiation of comprehensive follow-up services in 2009 (projections based on current data). This projected total is less than the 568 new cases of BLLs greater than or equal to 20 mcg/dL that required these services in 1999, and far below the 1,044 new cases that required these services in 1996.
Over this time period, Article 6 state aid for general public health work to LHDs for lead poisoning prevention activities and Lead Poisoning Prevention Program (LPPP) grant funding have been approximately level. Beginning in 2007, a total of $400,000 in annual funding was redirected from other program activities to increase LPPP grant awards to the ten LHDs outside of New York City with the highest annual incidence of childhood lead poisoning cases to support expanded environmental lead prevention work. Cost of Living Adjustments (COLAs) for lead poisoning prevention activities were awarded to LHDs in 2006, 2007 and 2008, while in 2008 LHD LPPP grants were reduced as part of across the board state spending reductions. The net result of these changes is approximately level funding for most LHD LPPPs, with a net increase in funding to the subset of ten targeted LHDs. Article 6 state aid provides formula-based reimbursement that is responsive to local spending and revenue patterns. In 2007, the base grant reimbursement was increased by ten cents per capita, effectively increasing reimbursement by $100,000 for each county.
The dramatic decline in the number of children who require comprehensive services under the 20 mcg/dL criteria in current regulations provides a clear opportunity to expand services to additional children within existing resources. This conclusion is supported by the growing number of LHDs that have already adopted local protocols for providing comprehensive follow-up services to children with BLLs 15-19 mcg/dL with their current resources. At least ten LHDs already provide comprehensive services to children in this group, including the three LHDs with the highest number of cases (New York City and Monroe and Erie Counties). These ten LHDs together account for nearly two-thirds of the total statewide caseload of children with BLLs 15-19 mcg/dL, and for nearly one-third of the caseload outside of New York City. Moreover, at least 22 additional counties are already providing comprehensive services to a subset of children with BLLs 15-19 mcg/dL, such as children who meet the CDC's definition of persistently elevated 15-19 mcg/dL or children whose health care providers have requested environmental services. While this existing caseload cannot be readily quantified due the varying criteria used by counties, it further mitigates the impact of the proposed change on LHD workloads. The proposed change will make the requirements consistent statewide.
DOH staff have met with NYSACHO staff to discuss these concerns. In response to those discussions, for the upcoming grant year, DOH has made several changes to streamline the annual grant work plans and quarterly reports to reduce the administrative work load for LHD programs, and will offer LHDs appropriate flexibility in prioritizing activities within their annual LPPP grant work plans and budgets, within the parameters of those minimum activities that are required under Public Health Law and regulations. DOH has also agreed to assess potential changes to the methodology that is currently used to distribute funding across LHDs, and this assessment is in process. As noted above, in addition to their LPPP grant funds, LHD will be able to utilize Article 6 state aid funds to support implementation of the proposed changes.
Comment:
Between 1996-2007, LHDs reported an increase in the intensity and acuity of cases. The current caseloads in many LHDs consist of children who remain longer on the caseload and have multiple socioeconomic issues including lack of stable housing, transportation and adult supervision and support.
Response:
DOH does not agree. The most severe childhood lead poisoning cases - those with the highest BLLs of greater than or equal to 45 mcg/dL - have declined significantly since 1996 from 55 to 16 statewide excluding New York City. In response to these comments, DOH performed additional analysis of surveillance data over this period, which demonstrated that the median number of days that children's BLLs remain elevated after initial diagnosis has declined dramatically from 342 days in 1996 to 91 days in 2007. While detailed data on socioeconomic characteristics of children with lead poisoning are not readily available, it is not expected that children with BLLs 15-19 will have significant differences in this regard from children with higher BLLs currently managed by LHDs, nor that these trends would vary significantly across counties. As noted above, at least ten LHDs, including those with the highest annual caseloads, have demonstrated that these services can feasibly be extended to children with BLLs 15-19 even in the context of any changing demographic characteristics of children and families requiring services.
Comment:
Compounding the reduction in grant funding, DOH has increased grant deliverables over the 1996-2007 period, resulting in an increased workload for LHDs. Examples include increased coordination and training of medical providers; increased data and reporting requirements; and intensified case management and parent education. As a result of these increased deliverables, costs of lead poisoning screening and management have already shifted from the state to local governments.
Response:
DOH does not agree that grant deliverables have increased over this time period. In 2007, with significant input from NYSACHO, the annual grant work plan for LHD LPPPs was revised to more clearly define goals and objectives across existing program areas, and to require LHDs to propose specific, measurable activities to accomplish those objectives. While these improvements may have increased the amount of time required for LHDs to complete their work plan documents, they did not introduce additional mandated deliverables, and in some cases actually served to streamline activities and provide LHDs with additional flexibility in how they would meet objectives. For example, a previous work plan objective that required all LHDs to conduct very time-intensive outreach visits to health care providers to conduct detailed chart reviews and provide tailored feedback was removed in favor of an objective that provides LHDs the flexibility to select effective activities to improve local lead testing rates that best fit their local needs and resources. The minimum required activities outlined in the work plan directly reflect those LHD responsibilities that are required in current regulations (Subpart 67-1.6), and thus do not represent a change. Requirements for case coordination have not been intensified, and in some instances LHDs have discontinued more intensive case coordination strategies, such as frequent nurse home visits, in favor of more administrative tracking measures and communication with primary care providers to encourage delivery of lead testing and follow-up services within a child's medical home. Moreover, as described previously, the number of children with EBLLs requiring any case coordination services has declined dramatically over this time period.
NYSACHO's statement that "costs of lead poisoning screening and management have already shifted from the state to local governments" is unclear. The costs of providing or arranging for lead screening (testing) and management of children with elevated blood lead levels have never been borne directly by NYSDOH. Under New York State Public Health Law and implementing regulations, blood lead screening and testing of children, and medical management of children with EBLLs, is the responsibility of health care providers. LHDs are responsible for instituting measures to identify and track all children with EBLLs to assure that all required follow-up services are provided, and for direct provision of environmental management services for children who meet established BLL criteria, except in "partial service" LHDs that do not have environmental health programs and in which NYSDOH district office staff provide these environmental management services. These basic responsibilities have not changed as a result of modifications to the annual grant work plan or these proposed regulations. Therefore, there has been no "shift" in costs from the state to the local health departments.
As noted above, in response to concerns raised by some LHDs, several changes have been made for the grant project year beginning April 2009 to further streamline the work plan and reporting documents to reduce the administrative work load for LHD programs, and LHDs will continue to have appropriate flexibility in prioritizing activities within their LPPP grant work plans and budgets, within the parameters of those minimum activities that are required under Public Health Law and regulations.
Comment:
Even at its full 100% funding level the state Lead Poisoning Prevention Grant does not cover the complete costs of the local lead poisoning prevention program at the current 20 mcg/dL standard. Any further reduction in this grant or increase in work load by lowering the BLL standard and increasing the age of those covered translates into the imposition of an additional unfunded state mandate.
Response:
This comment does not accurately reflect the purpose of the Lead Poisoning Prevention Program (LPPP) grant funding that is provided by DOH to LHDs. The purpose of these grant funds has always been to enhance the provision of basic local public health services that are required under public health law and regulations, and for which Article VI state aid funds are provided. Grant funds may be used to supplement state aid funds for both minimum required activities as well as additional enhanced activities that are outlined in the annual grant work plan. In accordance with the formula for use of state aid funds, LPPP grant and other grant funds or sources of reimbursement are utilized first, with state aid payment for 36% of remaining eligible expenses. Grant funds should not be viewed as the sole source of funding to support required local lead poisoning prevention activities, and grant deliverables may exceed the minimum requirements outlined in state regulations to reflect additional program or policy priorities as part of the state's broader lead poisoning prevention program.
The NYCDOHMH offered several comments related to proposed changes that address reporting of blood lead test results from private physician office laboratories (POLs). Each comment is summarized below, followed by the DOH response.
Comment:
The proposed regulation fails to take into account that NYCDOHMH regulates the reporting of blood lead results to DOHMH. In order for their to be no uncertainty as to the reporting scheme for New York City residents, DOHMH believes it is critical that the regulations are clear that they do not affect the required reporting already set form in the New York City Health code, which requires that a person or entity who orders or performs blood lead tests but does not submit the specimen to a clinical laboratory for analysis shall report results of less than 10 mcg/dL to the Department within five business days, or within 24 hours if the BLL is greater than or equal to 10 mcg/dL. NYCDOHMH suggests that the proposed Subpart 67-1.5(a)(5) be amended by inserting this language: "Nothwithstanding anything contained herein, results of blood lead analysis performed on New York City residents shall be reported to the New York City Department of Health and Mental Hygiene in the manner and form required by the New York City Health Code."
Response:
The proposed regulations do not change or limit New York City's current local requirements for reporting. Because New York City's local requirements for reporting within five days (or within 24 hours, for elevated results) are within the state's proposed 14-day reporting period, compliance with New York City's code constitutes compliance with the proposed state requirement. The Department will take steps to clearly inform health care providers and laboratories of this.
Comment:
NYCDOHMH questioned why the substance of proposed Subpart 67-1.2(a)(5) is in Subpart 67-1, noting that it would be more consistent with the existing structure of the lead regulations if the substance of this section is codified in Subpart 67-3, which governs the reporting of blood lead levels.
Response:
NYSDOH does not agree. The proposed amendment in question adds a new requirement that private physician office laboratories (POLs) that conduct blood lead testing report the results to the department. In drafting these regulations, placing this amendment in Subpart 67-3 was considered but rejected for two key reasons. First, although POLs are a type of laboratory, as private physician practices they are more likely to consult regulations aimed at lead testing and follow-up by health care providers (found in 67-1) than reporting of blood lead levels by laboratories (found in 67-3). Second, as defined in Subdivision (a) of 67-3.1, the requirements for reporting contained in Subpart 67-3 specifically pertain to permitted laboratories, including clinical laboratories and "limited service" registrant laboratories but exclusive of POLs, which are exempted from Title V of the Public Health Law. It was determined that to accommodate requirements of reporting by POLs, Subpart 67-3 would need to be significantly restructured, resulting in unnecessary loss of clarity.
Comment:
There are various references made in the proposed amendments to "pursuant to Public Health Law Section 579(1)," which addresses entities and providers who are exempt from Title V of the Public Health Law, for example laboratories operated by a physician who performs laboratory tests solely as an adjunct to the treatment of his or her own patients. We are unclear as to the appropriateness of the reference to PHL Section 579(1) when used in the proposed amendments, and believe it would be sufficient and clearer to omit the reference to PHL.
Response:
The purpose of the specific reference to PHL Section 579(1) is to accurately define a Physician Office Laboratory (POL), the entity to which the new requirements in question apply. Although it may be possible to define POLs without this reference, in drafting these regulations DOH determined that for clarity it is preferable to retain the specific reference to that law.
Comment:
For purposes of consistency we would suggest that instead of referring to "health care practitioner's office," reference be made to "health care provider," since that is the term generally used in 10 NYCRR Subparts 67-1 and 67-3 wherein "health care provider" is defined to include health care practitioner.
Response:
The term "health care provider," as defined in Subpart 67-1.1, includes both individual health care practitioners as well as facilities licensed pursuant to Article 28 of the Public Health Law. The term "practitioner" is used in this amendment because it refers more specifically to individual private practitioners who operate POLs, and does not include Article 28 facilities.
In addition to these comments, a minor non-substantive change has been made to the amended Subpart 67-3.1(d) to clarify methods for electronic reporting. The reference to "floppy disks" as a method of electronic reporting has been removed because in accordance with current public health law all permitted laboratories must report through the department's electronic telecommunications system and floppy disks are no longer used for reporting by any laboratory.
