HLT-48-08-00023-P Childhood Lead Poisoning Screening and Follow-Up

11/26/08 N.Y. St. Reg. HLT-48-08-00023-P

NEW YORK STATE REGISTER

VOLUME XXX, ISSUE 48

November 26, 2008

RULE MAKING ACTIVITIES

DEPARTMENT OF HEALTH

PROPOSED RULE MAKING

NO HEARING(S) SCHEDULED

 

I.D No. HLT-48-08-00023-P

Childhood Lead Poisoning Screening and Follow-Up

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

Proposed action:

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:

To expand follow-up for children with elevated blood levels; authorize point-of-care laboratory testing and require reporting.

Text of proposed rule:

Subdivisions (c) through (h) of Section 67-1.1 are renumbered to be subdivisions (d) through (i).

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).

Section 67-1.2(a) is amended to add a new paragraph (5), and newly renumbered paragraphs (6), (9), (10) and (11) 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), 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.

Text of proposed 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, [phone], email: [e-mail]

Data, views or arguments may be submitted to:

Same as above.

Public comment will be received until:

45 days after publication of this notice.

Regulatory Impact Statement

Statutory Authority:

Section 206 (1)(n) of Public Health Law (PHL) authorizes the Commissioner of Health to establish rules and regulations for the protection of the public health against lead poisoning. PHL Section 1370-a authorizes the Department of Health (DOH) to establish a lead poisoning prevention program, including a statewide registry of children with elevated blood lead levels (EBLLs) and regulations for screening and follow-up of children and pregnant women.

Legislative Objectives:

PHL sections 206(1)(n) and 1370-a charge the department with regulating screening, reporting, follow-up and prevention of lead poisoning. This proposal implements that charge by updating regulations to reflect current lead screening technology and practice standards, to update reporting requirements consistent with recent changes in PHL, and to clarify and expand requirements for follow-up of children with lead poisoning.

Needs and Benefits:

In 2006, the Federal Food and Drug Administration (FDA) approved a portable blood lead analyzer that allows for "point-of-care" collection and analysis of blood samples in physician offices and other community practice settings. Current regulations, which require that all blood lead tests be performed by a laboratory approved for toxicology-blood lead under Article 5, Title V of the PHL (i.e. permitted clinical laboratories), and which require reporting of blood lead test results conducted by permitted clinical laboratories to DOH, predate the availability of point-of-care lead test devices and therefore do not recognize blood lead testing or require reporting of results conducted by physician office laboratories (POLs), which are exempt from the New York State clinical laboratory permit requirements of PHL Article 5 Title V, or by registrant laboratories, which register with the Department in accordance with recently-amended PHL Section 579(3). Reporting of all blood lead test results is essential to assure timely follow-up for children with EBLLs and complete surveillance data to guide public health activities. Proposed amendments authorize POLs and registrant laboratories to conduct blood lead testing using devices of complexity appropriate for their level of federal certification, and require reporting of blood lead results performed by these entities to DOH.

Current regulations that require capillary blood lead sample results of greater than 15 mcg/dL to be confirmed using a venous blood sample are inconsistent with current Centers for Disease Control and Prevention (CDC) guidelines and state laboratory standards which require venous confirmation for capillary blood lead results greater than or equal to (>) 10 mcg/dL. Proposed changes update regulations to match these standards.

Current regulations require health care providers (HCPs) to provide a complete diagnostic evaluation, medical management if necessary and referral to the appropriate local or state health department for environmental management for children with blood lead levels (BLLs) > 20 mcg/dL. The dramatic decline in the number of children with BLLs > 20 mcg/dL since 1996 provides the opportunity to use existing resources to expand comprehensive follow-up services to more children by lowering the BLL requiring comprehensive follow-up from 20 to 15 mcg/dL.

While lead poisoning prevention primarily targets children under age six years, all children with EBLLs need follow-up services. Amendments clarify that unless otherwise specified, the term "child" refers to individuals less than 18 years of age, and expand current requirements for immediate reporting of critically elevated blood lead levels for children under age six years by permitted laboratories and HCPs to include all children less than age eighteen. Age-specific requirements for universal and risk-based screening remain unchanged.

Current regulations, which refer to a "certificate of lead screening," have caused confusion because there is no specific certificate format that must be utilized. Proposed amendments clarify that a written statement signed by a HCP that documents a child's lead screening status satisfies these requirements.

Recent amendment to PHL Section 576-c requires that all permitted clinical laboratories report all reportable diseases or health conditions electronically, while amendments to PHL Section 579(3) require registrant laboratories to comply with reporting requirements to the same extent and in the same manner as clinical laboratories. Proposed changes require electronic reporting of blood lead results by all clinical laboratories and registrant laboratories, consistent with PHL. Amendments also clarify the existing requirement for transmission of required information when a laboratory refers a blood lead sample to a permitted laboratory for analysis.

Costs:

Costs to the Regulated Entity:

The proposed changes will expand the current requirement for LHDs to coordinate comprehensive services and provide environmental services for children with BLLs > 20 mcg/dL to include children with BLLs 15-19 mcg/dL. This change will assure that more children with lead poisoning receive the most effective interventions to benefit their physical, cognitive and behavioral development. This expansion will initially increase the number of children requiring comprehensive follow-up services from approximately 326 to 786 annually (2005 statewide data, excluding New York City). However, the cost of this increase is offset by the steady decrease in annual incidence that has occurred since current regulations were enacted. The number of children with BLLs > 20 mcg/dL has declined, from 1,113 children in 1996 to 326 children in 2005. Therefore, the total number of children who will require comprehensive follow-up under the proposed changes (786) is significantly less than the number of children requiring comprehensive follow-up under the current regulations in 1996 (1,113) . Preliminary analysis of 2007 data indicates further declines. During this same time period, LHDs have received approximately level grant funding, and in 2007 increased grant funding totaling $400,000 annually was allocated to the ten LHDs outside of New York City with the highest incidence of EBLLs to support expanded environmental lead prevention activities.

The impact of the proposed change is further mitigated by current LHD practices. Environmental management services for 21 partial service counties (counties in which environmental services are provided by state district offices (DOs) rather than the LHD) account for approximately 13% of the projected increase. The New York City Department of Health and Mental Hygiene already provides comprehensive follow-up for all children with EBLLs > 15 mcg/dL. At least 23 other LHDs already provide environmental services to some or all children with EBLLs of 15-19 mcg/dL.

Under the proposed changes, HCPs will be required to confirm capillary blood lead results > 10 mcg/dL in place of the current requirement of >15 mcg/dL. Surveillance data indicate that in practice HCPs are already confirming the vast majority (86%) of capillary blood lead test results 10-14 mcg/dL, consistent with CDC guidelines and state clinical laboratory standards. HCPs also will be required to provide additional follow-up services for children with BLLs 15 - 19 mcg/dL, including detailed lead exposure assessments, developmental screening, and nutritional assessments, equivalent to the services currently required for children with BLLs > 20 mcg/dL.

Under the proposed changes, POLs and registrant laboratories that choose to conduct lead tests will be required to report the results to DOH, consistent with current reporting requirements for clinical laboratories. Registrant laboratories will be required to report in the same manner as clinical laboratories, in accordance with recently amended PHL Section 579(3). POLs may report via paper or electronically; additional systems changes to facilitate more streamlined electronic reporting are being pursued.

Proposed changes clarify that child care providers are required to obtain a written statement signed by a HCP that documents blood lead screening for children enrolling in child care, rather than a specific certificate of blood lead screening referenced in current regulations. The State Office of Children and Family Services has a standard medical form that includes documentation of lead screening, which can be used to meet this requirement.

Costs to State and Local Governments

Costs to the state include provision of environmental management services for approximately 63 additional children annually with BLLs 15-19 mcg/dL residing in 21 partial service counties in which environmental services are provided by DOs. This increase is offset by the steady decline over the past decade in the number of children with BLLs > 20 mcg/dL requiring environmental services, with further decline projected across all EBLL categories. Moreover, DOs serving six of the 21 partial service counties already conduct environmental management for children with BLL 15-19 mcg/dL. It is anticipated that this increased caseload can be absorbed by existing DO staff. Costs to local governments are detailed above as regulated entities.

Costs to the Department of Health

Costs to the Department are detailed above as costs to the state.

Local Government Mandates:

Current regulations require LHDs to institute measures to identify and track children with EBLLs to assure appropriate follow-up, and to provide environmental management services for children with BLLs > 20 mcg/dL in full-service counties. Proposed changes require expansion of comprehensive services to children with BLLs 15-19 mcg/dL, and clarify that follow-up services are required for all children up to age eighteen years with EBLLs.

Paperwork:

Proposed amendments require no additional forms or reporting systems. Existing forms, reporting systems and policy and procedure manuals may require modifications.

Duplication:

This regulation does not duplicate any existing state or local regulations.

Alternatives:

No viable alternatives to the proposed changes have been identified. Changes to authorize POLs and registrant laboratories to conduct blood lead testing using devices of complexity appropriate for their level of federal certification, and to require reporting of lead test results from these entities, are necessary to reflect new point-of-care technology. Confirming capillary blood lead test results > 10 mcg/dL is necessary to match current federal and state standards. Changes are necessary to clarify the requirement for provision of follow-up services, and prompt reporting of critically elevated BLL results, to assure that all children with lead poisoning regardless of age receive prompt and appropriate follow-up.

Proposed changes will expand environmental management and other comprehensive follow-up services to children with BLLs 15-19 mcg/dL, which exceeds federal standards. The alternative of maintaining the current requirement for these services at BLLs > 20 mcg/dL was rejected in light of the clear evidence of harmful effects of BLLs in this range on children's development and the steady decline in the number of children with EBLLs. Reducing the threshold to 10 mcg/dL was considered as an alternative, but was rejected at this time because it would result in a significant increase (approximately three-fold in New York City and approximately seven-fold outside of New York City, compared to current requirements) in caseload for LHDs and state DOs that is not feasible within existing resources. Lowering the threshold to 15 mcg/dL was selected as a viable approach that will expand comprehensive services to more children with lead poisoning within available resources. The Department will continue to assess the feasibility of further lowering this threshold to 10 mcg/dL in the future.

Federal Standards:

Changes to authorize the appropriate use of blood lead test devices in POLs and registrant laboratories and to require reporting of lead test results by these entities are consistent with approval of portable blood lead test devices by the FDA and CDC. The change to confirm capillary blood lead test results > 10 mcg/dL matches current CDC standards. Expanding comprehensive follow-up services to children with BLLs > 15 mcg/dL exceeds CDC's standard for provision of such services for BLLs > 20 mcg/dL and persistently elevated BLLs 15-19 mcg/dL, but is consistent with CDC's charge to states to eliminate childhood lead poisoning by 2010 through a combination of primary and secondary prevention measures. New York State has the highest number of children with lead poisoning and the highest number of high-risk older housing units nationally, necessitating an aggressive approach to lead elimination. Precedence for lowering the threshold for environmental interventions to 15 mcg/dL has been established in other high-incidence states and municipalities including Chicago, New York City, Baltimore, and Massachusetts.

Compliance Schedule:

The proposed amendments are to be effective 45 days after publication of a notice of adoption in the State Register.

Regulatory Flexibility Analysis

Effect of the Rule:

The proposed amended rule authorizes physician office laboratories (POLs), which are exempt from the New York State clinical laboratory permit requirements of PHL Article 5 Title V, and registrant laboratories, which register with the Department in accordance with recently-amended PHL Section 579(3), to conduct blood lead testing using devices of complexity appropriate for their level of federal certification, and requires reporting of blood lead results performed by POLs and registrant laboratories to DOH. These amendments may impact POLs and registrant laboratories that choose to purchase portable point-of-care blood lead analysis devices, including those approved by the Federal Food and Drug Administration as Clinical Laboratory Improvement Amendment (CLIA)-waived devices. These portable analysis devices allow for immediate analysis of a blood lead sample before a patient leaves the provider's office, offering potential for increasing screening rates. The number of providers that are currently using these lead screening devices is very small. As of September 2008, there are approximately 118 providers known to have purchased devices for point-of-care blood lead analysis, including 92 POLs and 26 registrant laboratories. POLs and registrant laboratories will be positively affected by affirmatively authorizing them to conduct lead screening tests, using testing devices of complexity appropriate for their level of federal certification. POLs and registrant laboratories will also be required to report the results of lead tests to the Department, consistent with current reporting requirements for permitted laboratories and, for registrant laboratories, with recent amendments to Public Health Law (PHL) Section 579(3). Currently the Department's Childhood Lead Poisoning Prevention Program conducts outreach to providers known to have acquired these devices to request reporting of results. Of the 59 providers who have been contacted to date, 57 (97%) are already reporting the results to the department on a voluntary basis, thereby greatly mitigating the impact of the proposed requirement in practice. Outreach is in progress to the remaining 59 providers who more recently acquired the lead screening devices, and similar cooperation in reporting of results is anticipated from these providers. The Department's Wadsworth Laboratory will work with registrant laboratories to implement requirements for electronic reporting in accordance with recently amended PHL Sections 576-c and 579(3).

The proposed amendments to expand environmental and other comprehensive follow up services to children with blood lead levels (BLLs) 15-19 mcg/dL may impact local health departments (LHDs) by initially increasing their caseload. Based on the most recent (2005) data, all full-service LHDs (defined as LHDs that directly provide environmental health services) other than New York City will experience some increase in required caseload for environmental management and other associated follow-up services for children with elevated blood lead levels (EBLLs). LHDs in partial service counties, defined as the 21 counties that receive environmental services through State health department district offices (DOs), will experience caseload increases in non-environmental follow-up services only, with minimal impact.

The impact on individual LHD caseload varies by county, based on population size and the local incidence of childhood lead poisoning. Statewide, the proposed expansion will result in an initial increase in the number of children requiring comprehensive follow-up services from approximately 326 to 786 annually based on 2005 data. These figures exclude New York City, which already provides comprehensive services for all children with BLLs > 15 mcg/dL pursuant to local health code. The projected increase in annual caseload by county ranges from zero to approximately 72 cases, with the vast majority of the increase concentrated among eight full-service LHDs that have an average of 20 or more incident cases of children under age six years with BLLs 15-19 mcg/dL annually. However, the cost of this initial increase in caseload is offset by the steady decline in annual incidence that has occurred since the original enactment of Part 67. Between 1996 and 2005, the number and rate of children with EBLLs > 20 mcg/dL has steadily declined, from 1,113 children (5.4% of children tested) in 1996 to 326 children (1.7% of children tested) in 2005 (data are statewide, excluding New York City). Therefore, the total number of children who will require comprehensive follow-up services under the proposed changes (approximately 786 children annually) is significantly less than the number of children requiring those services under the current regulations in 1996 (1,113 children). This steady decline has occurred across all counties. Moreover, preliminary analysis of 2007 data indicates further significant declines in both the number and rate of EBLLs among children. During this same time period as caseloads have significantly declined, LHDs have received approximately level grant funding to support lead poisoning prevention work. In addition, starting in 2007, increased grant funding totaling $400,000 annually was allocated to the ten LHDs outside of New York City with the highest incidence of EBLLs to support expanded environmental lead prevention activities. This group includes all of the eight LHDs noted above that will experience the most significant projected increase in caseload under the proposed regulation change.

As noted above, the New York City Department of Health and Mental Hygiene already provides environmental management for all children with EBLLs > 15 mcg/dL, so the proposed change will not impact their workload. In addition, at least 23 other full-service LHDs already provide environmental follow-up services to some or all children with EBLLs of 15-19 mcg/dL, thereby further mitigating the impact of the proposed regulatory changes. Finally, the 21 partial-service LHDs will experience an increase only in non-environmental follow-up responsibilities, as environmental management services for children in these counties are provided by the state district offices rather than LHDs.

Current regulations require child care providers to obtain a certificate of blood lead screening for each child at least one year of age but under six years of age. The use of specific certificates by health care providers (HCPs) is not mandated by law, and the Department has not used certificates in practice since 1996. The proposed amendments clarify that a written statement signed by a HCP that documents blood lead screening satisfies this requirement. The State Office of Children and Family Services makes available to child care providers a standard medical form that includes documentation of blood lead screening, which can be used to meet this requirement.

Current regulations require permitted laboratories to report to the HCP ordering the test any blood lead test results > 45 mcg/dL within 24 hours for children up to 72 months of age, and require HCPs to report blood lead test results > 45 mcg/dL for children up to 72 months of age to the LHD within 24 hours of receiving the report. The proposed amendments require that blood lead test reports for any child less than age 18 years with a result > 45 mcg/dL be reported by permitted laboratories and health care providers, respectively. The impact of this change is minimal, as the total number of children between 6 and 18 years of age with BLLs greater than or equal to 45 mcg/dL is small; in 2005, only 12 children age six to eighteen years were identified with BLLs > 45 mcg/dL in New York State, including New York City.

Compliance Requirements:

The proposed changes will not extend regulatory oversight to any parties not presently regulated. Under the proposed amendments, POLs and registrant laboratories that choose to conduct lead screening tests will be required to report the results to the Department of Health. As noted, in practice the majority of providers conducting such testing are already reporting to the Department on a voluntary basis. POLs can report via paper records or electronically to offer flexibility to the provider; additional systems changes to facilitate even more streamlined electronic reporting are being pursued. Registrant laboratories will be required to report to the department electronically in the same manner as clinical laboratories, in accordance with recently amended PHL Section 579(3). Permitted laboratories and HCPs will be required to report blood lead test results for any child up to age 18 years with a result > 45 mcg/dL within 24 hours, consistent with current requirements for reporting of such results for children up to age six years.

LHDs may need to make changes to their existing protocols or forms to expand actions currently provided for children with BLLs > 20 mcg/dL to children with BLLs 15-19 mcg/dL, and to update their standard policy and procedure manuals.

Professional Services:

It is not expected that regulated parties will require additional professional services to comply with these regulations. LHDs already have the professional staffing and expertise needed to comply with the requirements. As noted, the initial increase in environmental management caseload for LHDs is offset by the significant decline in the number of children requiring environmental management over the past ten years, in the context of approximately level grant funding. In addition, the ten counties with the highest projected increase in caseload received increased annual grant funding beginning in 2007 to support additional environmental prevention activities. LHDs may request to use grant funds to hire additional staff, or services may be provided by existing staff.

Compliance Costs:

POLs and registrant laboratories that choose to conduct blood lead testing using testing devices of complexity appropriate for their level of federal certification may need to develop or modify standard policy and procedure manuals and will be required to submit reports of test results to the Department, thus incurring minimal costs. Reporting by POLs may be done via paper reports or electronically; additional systems changes to facilitate even more streamlined electronic reporting are being pursued. Registrant laboratories will be required to report to the department electronically in the same manner as clinical laboratories, in accordance with recently amended PHL Section 579(3). LHDs may need to modify policy and procedure manuals and accompanying protocols for management of children with BLLs 15-19 mcg/dL.

Economic and Technological Feasibility:

The proposed changes present no significant economic or technical difficulties for laboratories, HCPs, or child care providers. The increase in caseload for LHDs presents no significant technical difficulties, as LHDs have necessary experience and expertise to provide these services, and are economically feasible within current funding levels in light of the significant and continued decline in the number of children requiring comprehensive follow-up services under current regulations.

Minimizing Adverse Impact:

The proposed amendments were developed with the goal of minimizing burdens on regulated parties including the approaches suggested in SAPA Section 202-b(1). Performance rather than design standards have been applied to have appropriate flexibility for meeting requirements for reporting and provision of follow-up services. The revised BLL threshold for required environmental follow-up services was established with specific consideration for economic and technical feasibility within the context of existing resources and current practices, in favor of other proposals considered that would require significant additional resources to implement. Exemption from proposed requirements is not feasible as it would create unfair disparities in provision of services for at-risk children.

Small Business and Local Government Participation:

The proposed changes have been discussed with and comments solicited from affected parties, including the New York State Association of County Health Officials (NYSACHO) and the New York State Advisory Council on Lead Poisoning Prevention, which includes representatives from other state agencies and diverse public groups with a vested interest in lead poisoning prevention including local government, medical organizations, parents, community groups, industry and others. Recommended changes have been incorporated, as appropriate, based on comments received as a result of these discussions.

Rural Area Flexibility Analysis

Types and Estimated Numbers of Rural Areas:

The amended regulation will have a statewide impact, affecting all 44 rural areas in New York State. However, the number of children with elevated blood lead levels (EBLLs) who will require additional follow-up services, including environmental management services, is significantly lower in rural vs. urban counties. Moreover, the expansion of environmental management services will not directly impact local health departments (LHDs) in 21 partial-service rural counties, defined as those counties that receive environmental services through state department of health District Offices (DOs).

Reporting, Recordkeeping and Other Compliance Requirements, and Professional Services:

The proposed changes will not extend regulatory oversight to any parties not presently regulated, and will not impose significant adverse impact on providers or LHDs in rural areas. The proposed amended rule authorizes physician office laboratories (POLs), which are exempt from the New York State clinical laboratory permit requirements of PHL Article 5 Title V, and registrant laboratories, which register with the Department in accordance with recently-amended Public Health Law (PHL) Section 579(3), to conduct blood lead testing using devices of complexity appropriate for their level of federal certification. These changes may impact POLs and registrant laboratories that choose to purchase portable point-of-care blood lead analysis devices, including those approved by the Federal Food and Drug Administration as Clinical Laboratory Improvement Amendment (CLIA)-waived devices. These portable analysis devices allow for immediate analysis of a blood lead sample before a patient leaves the provider's office, offering significant potential for increasing screening rates. The proposed changes also require POLs and registrant laboratories that choose to conduct blood lead testing to report blood lead test results to the Department. POLs currently may report via paper or electronic methods; additional systems changes to facilitate even more streamlined electronic reporting are being pursued. Registrant laboratories will be required to report to the department electronically in the same manner as clinical laboratories, in accordance with recently amended PHL Section 579(3). LHDs in rural counties will be required to expand their coordination of comprehensive follow-up services currently provided to children with blood lead levels (BLLs) > 20 mcg/dL to children with BLLs 15-19 mcg/dL. However, the number of children with BLLs 15-19 mcg/dL in rural counties is significantly lower than in larger urban counties, and environmental management services in 21 partial-service rural counties are provided by state District Offices rather than by the local health departments themselves. It is not anticipated that rural areas will require additional professional services to comply with the proposed changes.

Costs:

Costs associated with modifying policy and procedure manuals and accompanying protocols may be incurred by LHDs, and by POLs and registrant laboratories that choose to conduct blood lead testing. The expansion of comprehensive follow-up services to children with BLLs 15-19 mcg/dL is not expected to create significant costs for LHDs in rural counties. Environmental health services in 21 partial-service rural counties are provided through state district offices, and thus would not incur additional costs for those LHDs. Minimal costs may be associated with provision of expanded educational follow-up services by rural LHDs for children with BLLs in this range, but this increase in caseload for rural counties will be small. In 2005, rural counties identified between 0 and 15 children under age six years annually with EBLLs between 15 and 19 mcg/dL; the majority of rural counties identified fewer than 10 children with BLLs in this range, and 28 rural counties identified three or fewer cases. These numbers are projected to continue to decline over time consistent with statewide and national trends in childhood lead poisoning.

Minimizing Adverse Impact:

The proposed changes would have no significant adverse impact on regulated parties in rural areas. These amendments were developed with the intent to minimize any burden on regulated parties. The revised BLL threshold for required environmental and other comprehensive follow-up services was established with specific consideration for economic and technical feasibility within the context of existing resources and current practices, in favor of other proposals considered that would require significant additional resources to implement.

Rural Area Participation:

The proposed changes have been discussed with and comments solicited from affected parties, including the New York State Association of County Health Officials (NYSACHO) and the New York State Advisory Council on Lead Poisoning Prevention, which includes representatives from other state agencies and diverse public groups with a vested interest in lead poisoning prevention including local government, medical organizations, parents, community groups, industry, and others. Both of these groups include representation from rural areas. Recommended changes have been incorporated, as appropriate, based on comments received as a result of these discussions.

Job Impact Statement

A Job Impact Statement is not included because it is apparent from the nature of the proposed amendment that it will not have a substantial adverse impact on jobs and employment opportunities.