Clinical Laboratory Evaluation Program - In the News
Requirement for full validation of laboratory-developed H1N1 molecular assays
Under the public health emergency declaration at both state and federal levels, following the outbreak of influenza A 2009/H1N1, the Clinical Laboratory Evaluation Program (CLEP) issued expedited guidelines with reduced validation requirements for Emergency Use Authorization (EUA) of laboratory-developed (based on CDC protocol) H1N1 NAAT assays for NYS CLEP-permitted laboratories holding permits in general virology. Permitted laboratories were also subsequently allowed to add (by "Add Analyte" notification) commercialized H1N1 assays (kits) approved by FDA for use under the public health EUA, listed as: In Vitro Diagnostics (IVDs) at this FDA website.
We now advise that all federal and state emergency declarations are scheduled to expire on June 23, 2010 unless specific criteria are met for further extension. Upon expiry, approvals issued under EUA must be withdrawn, since we will no longer be considered to be under a state of emergency. Therefore, please be advised that after June 23, 2010, all laboratory-developed molecular tests (and tests not yet FDA-cleared/approved) molecular tests for H1N1 on specimens originating in New York State under previous EUA will require written assay-specific approval from CLEP following complete validation and submission of SOPM and full (unabbreviated) validation. The laboratory's independent validation should be in accordance with the Submission Guidelines for Nucleic Acid Amplification Tests for Infectious Agents.
We appreciate that this may present difficulties to some laboratories. It has been the subject of much discussion at both state and federal meetings,and is a decision that has been made after lengthy consideration of options. Note that the FDA has recognized that a significant number of laboratories have purchased and are still using EUA tests for the detection of 2009 H1N1 virus, and has given written notification of its intention to exercise enforcement discretion regarding the use of such devices if they were already in laboratories inventories prior to April 23rd 2010. In keeping with this FDA policy, the Clinical Laboratory Evaluation Program of NYS will exercise similar flexibility in the use of EUA detection devices for stocks already in laboratory inventories prior to April 23rd 2010. We continue to monitor federal guidelines and requirements, and any changes will be shared promptly to permitted laboratories. For laboratories wishing to pursue full validation of laboratory-developed (non-FDA-approved) H1N1 molecular assays, but requiring further assistance with validation materials or procedures, you are encouraged to contact clepval@health.state.ny.us or the Laboratory of Viral Diseases at 518-474-4177.
Changes to Breath Alcohol Testing and Ignition Interlocks
An amendment to 10NYCRR Part 59 Regulation filed an emergency action effective 04/23/10 includes significant changes to the oversight of the chemical analysis of a person's blood, urine, saliva or breath for alcohol content and to sections that address iginition interlock devices.
Revised Laboratory Standards for Safety
Comment Period Open Until May 31, 2010
Proposed Safety Standards were distributed to all laboratories by e-mail on November 12, 2009. Eighty-eight comments pertaining to 16 of the 18 standards were received from 27 facilities, organizations and individuals. Some of the comments indicated that changes were needed and the writers have seen a need to increase the stringency of two of the standards. In addition, the section concerning the infectious agent control program was rearranged. It now begins with the requirements for a risk assessment, followed by the standards addressing laboratory design, then the standards for safety practices.
Given these changes, on April 16, 2010 we distributed revised Safety Standards for additional comments. Comments on the revisions are due by May 31, 2010. There are minimal changes to Safety Standard 1 from the original proposed, which requires laboratories to conduct an infectious agent risk assessment and to develop and implement a biosafety program. The expected adoption date of the revised standards will be August 1, 2010. As of that date we will be expecting laboratories to have their risk assessments in progress.
Responses to the comments received to the proposed standards distributed in November 2009 have been formulated. Also available is a crosswalk from the current to the proposed and the revised standards. Questions and comments can be addressed to Beth Johansen at 518-402-2975, 518-485-5378 or bej01@health.state.ny.us.
Proposed Laboratory Standards for Blood Lead
Open For Public Review and Comments Until May 3, 2010
The New York State Department of Health is dedicated to insuring that laboratory services meet performance standards for good patient care. To that end, the Department's clinical laboratory reference system periodically revises laboratory standards and introduces new standards consistent with the technologies in use and practices recommended by professional laboratory agencies. Identification of children exposed to lead remains a key element of our efforts to eliminate childhood lead poisoning in New York State, and screening of children using point-of-care devices is a valuable tool.
The department has found that the requirements outlined in the current laboratory standards for reference methods are burdensome to assays that are primarily intended for point-of-care screening purposes. For example, assays based on single-use, disposable sensors, i.e., screen-printed electrode technology such as the LeadCare II, are designed to be used for screening children at the point of contact using fresh blood.
As announced in the permit reapplication instructions mailed on March 12, 2010 to all laboratories holding or in application for a NYS laboratory permit, we have created the new category of "Toxicology - Blood Lead - Screening Tests Only" for those laboratories that only use point-of-care lead analyzers. We have renamed the previous category to "Toxicology- Blood Lead - Comprehensive" for those laboratories performing reference methods. Laboratories using reference methods based on atomic spectrometry or bench top ASV will continue to follow the existing laboratory standards under "Toxicology - Blood Lead - Comprehensive." Such laboratories may also use point-of care methodology under the "Toxicology - Blood Lead - Comprehensive" permit, although operating under the proposed new blood lead screening standards.
The proposed new blood lead screening standards will require laboratories using point-of-care devices to follow manufacturer's recommendations. In addition, laboratories using these devices will be required to refer all specimens that are elevated to a NY state approved laboratory that uses a reference method for confirmatory testing. For point-of-care devices, elevated is defined as all test results that are 8 micrograms/dL or higher. If there is insufficient sample to refer to the reference laboratory, then a comment will be required on the patient report identifying the need for confirmatory testing.
The proposed standards for "Toxicology - Blood Lead - Screening Tests Only" are now open for public review and we are requesting that you reply with any comments by May 3, 2010. Included are the standards for the Comprehensive category. Standard 3 has been modified to refer to all blood samples rather than just venous specimens and a standard has been added requiring laboratories that perform both reference and screening methods to comply with both sets of standards. Proposed standards and a crosswalk of the current standards to the proposed were sent to all laboratories on March 19, 2010 with a request for review and recommendations to achieve a consensus on effective and practicable standards. Comments are accepted by all interested parties. The standards are available on our website at www.wadsworth.org/labcert/clep/clep.html Comments can be made in writing to the address above or by e-mail to CLEP@health.state.ny.us. Please use the keyword Lead Standards Revision in the subject line.
We look forward to receiving your comments. Questions regarding laboratory standards can be directed to Ms. Beth Johansen at 518-402-4186. Technical questions concerning lead testing can be directed to Dr. Mary Fran Verostek, Assistant Section Head, Blood Lead Reference System at 518-474-4924.
Proposed Laboratory Standards for Safety - comment period has closed
On 11/12/2009 all laboratories were sent a copy of proposed Laboratory Standards for Safety with a request for review and recommendations to achieve a consensus on effective and practicable standards. Comments were accepted by all interested parties through December 21, 2009. A copy of these proposed standards and a crosswalk is available on the Laboratory Standards page.
Lead Standard adopted and effective September 1, 2009
Comments and Responses to the Adopted Lead Standard 11 including a letter from Dr. Richard F. Daines, M.D. can be found here.
Lead Poisoning Prevention Awareness Stressed by Health Commissioner Daines (June 2009)
The Health Department is committed to advancing Governor Paterson's new initiatives to eliminate childhood lead poisoning. The Department has updated lead poisoning prevention regulations and, with your input, drafted a new lead testing standard (Rev. 06/09, 145K PDF), for laboratories holding a permit in Toxicology-Blood Lead to ensure effective communication between health care providers and laboratories when assessing persons for elevated blood lead levels.
For health care providers who perform lead testing at the point of care in office and off-site clinic settings, the Department has compiled a guidance document (Rev. 06/09, 32K PDF), that outlines standards of practice for blood lead screening using waived devices in physician office laboratories (POLs) and registered limited service laboratories. See also the CDC publication on waived testing.
A pamphlet explaining the meaning of blood lead test results is available for copying and distribution to your physician clients and caregivers of children and pregnant women.
Thank you for your assistance in implementing recent changes, and for your ongoing role in the identification and management of childhood lead poisoning in New York State. If you have any questions or would like additional information, please contact the New York State Lead Poisoning Prevention Program at (518)-402-5706, the Physician Office Laboratory Evaluation Program at (518) 485-5352, or the Clinical Laboratory Evaluation Program at (518) 485-5378
Limited Services Laboratories Amendments to Public Health Law
On July 7, 2008, Governor David A. Paterson signed into law an amendment (PDF 25K ) to Article 5 Title V of Public Health Law to establish in statute the Department's registration and oversight process for facilities that limit testing to waived and/or provider-performed microscopy procedures. These amendments effectively exempt these sites from the requirement for a permit and director certification, while calling for a quality assurance program, professional oversight of testing, and other processes to ensure reliability of testing in near-patient settings. The new law also exempts individuals performing laboratory testing at such sites from the personnel licensure provisions of Education Law. Registration fees are $200 for an initial registration and $200 for each two year renewal. Registration forms are being updated for the facility type known as Limited Service Laboratories, and staged collection of renewal fees is expected to begin later this year; billing will not be retroactive. Questions can be directed to staff of the Clinical Laboratory Evaluation Program at (518) 485-5378, or by email to CLEP@health.state.ny.us.
Clinical Laboratory Technology Practice Act Amended
In July 2008, Article 165 of the Education Law (the Clinical Laboratory Technology Practice Act) was also amended to add a new profession of certified histological technician, to establish restricted licenses in several laboratory disciplines, and provide expanded opportunities for grandparenting. While the Health Department will continue to certify laboratory directors, qualify laboratory supervisors, and register cytotechnologists, licensure for all other laboratory professionals remains within the State Education Department (SED) under the oversight of the Board of Regents and emergency regulations to implement the changes in Article 165 are scheduled to be considered by the Board of Regents at its meeting on September 15-16, 2008. Questions regarding personnel licensure can be directed to the SED Office of the Professions by email at clinlabd@mail.nysed.gov, or by telephone at 518-474-3817, extension 150. The proposed regulations, which will be available the first week of September, and more information on the new provisions related to laboratory personnel, can be obtained at http://www.op.nysed.gov/home.html.
National Medical Laboratory Professionals Week in New York State, April 20-26, 2008
Governor Paterson proclaims National Medical Laboratory Professionals Week, recognizing the contributions of clinical laboratories to the well-being of New Yorkers.
Article5 Title V Updated
Public Health Law (PDF 41K) has been amended by Chapter 317 of the Laws of 2007 to require electronic reporting and provide clear authority for the Commissioner of Health and local health officials to require clinical laboratories to submit specimens (e.g., sera) or their derivatives (e.g., culture isolates) whenever supplemental testing is necessary to confirm evidence of a disease or health condition otherwise required to be reported. The new provisions became effective July 18, 2007.
Part 70 Regulated Medical Waste
Good Laboratory Practices for Waived Testing Sites - MMWR Publication
Good Laboratory Practices for Waived Testing Sites - Survey Findings from Testing Sites Holding a Certificate of Waiver Under the Clinical Laboratory Improvement Amendments of 1988 and Recommendations for Promoting Quality Testing
Criminal History Record Checks for Phlebotomists
Department regulations that took effect April 1, 2005 mandate the use of criminal history record checks of employed persons involved in direct patient care by operators of residential health care facilities, AIDS home care programs, home care agencies, and other users of clinical laboratory services. The Department's Division of Legal Affairs has recently clarified that these amendments do NOT apply to phlebotomists and laboratory technical personnel sent into a nursing home or home care setting by a clinical laboratory. Such laboratory employees need not be fingerprinted since they are not persons used by the covered provider (i.e, the nursing home) to provide direct care or supervision to patients within the meaning of the regulation.
Amended Part 63
Impact On Laboratories
The recent case of multiple drug resistant HIV with apparent rapid progression to AIDS highlighted the need for better ways to track HIV drug resistance in the population. Laboratory reporting of HIV-related testing is necessary to monitor the suppression of HIV by antiretroviral therapy and, thus, the risk of drug resistance. With amendments to Part 63 regulations, effective June 1, 2005, laboratories conducting tests on specimens from New York State residents are required to report HIV resistance test results, non-detectable viral load test results and CD4 test results.
Part 63, as amended effective June 1, 2005, no longer includes two forms (i.e., Informed Consent to Perform an HIV Test; Authorization for the Release of Confidential HIV Related Information), but the forms will continue to be posted on the Department's web site. The new Informed Consent form documents patient authorization for HIV antibody testing and, if HIV-positive, for viral load testing and resistance testing; it also allows pregnant women to consent to more than one test during the same pregnancy.
Laboratories are reminded that the practitioner retains the patient-signed consent form and the practitioner is required by law to certify to the laboratory that informed consent had been obtained. The Department does not require laboratories to demand, or to be in possession of certification prior to performing the ordered HIV tests or releasing results. However, many laboratories have adopted policies that require practitioners to certify on each and every test requisition that they have obtained patients' informed consent. While the Department continues to encourage use of requisitions with dedicated space for practitioner certification, amended Part 63 gives laboratories flexibility to control costs and paperwork attributable to obtaining repetitive certifications. The new consent forms, available for use June 1, 2005 and after, and ensuing certifications are applicable to series of tests, meaning that a one-time certification covers not only antibody screening and confirmatory tests, but also any viral load and resistance testing ordered by the certifying practitioner for that patient. Laboratories may refer to one-time certifications on file rather than solicit repeat certifications, e.g., for a series of viral load analyses.
Education Law Article 165
Clinical Laboratory Technology Practice Act
On January 30, 2005 Governor Pataki signed a bill adding Article 165 to the Education Law, creating the Clinical Laboratory Technology Practice Act. This act establishes licensing requirements through the State Education Department Office of the Professions, for persons who perform clinical testing and related activities in clinical laboratory settings. The act defines the practice of clinical laboratory technology; establishes licensure requirements for clinical laboratory technologists and cytotechnologists; and establishes certification requirements for clinical laboratory technicians. These requirements are now in effect for all individuals practicing in permitted laboratories located in New York State, subject to certain exceptions.
Cytopathology changes
Effective December 29, 2004, 10 NYCRR Subpart 58-1 was amended to establish a mechanism for cytotechnologists using devices approved by the FDA to perform instrumented examinations of gynecologic slides to obtain approval to exceed the current work standard of 80 slides. Cytotechnologists previously approved to examine 96-100 slides may perform instrumented examinations up to the maximum designated in their existing approval; however, in order to exceed a number previously approved when conducting instrumented examinations, a new filing and approval is required. The amendment did not affect the requirement that workload limits be set by the laboratory director for each cytotechnologist on an individual basis.
This amendment to the regulation does not itself establish a new work standard; it provides the Department with the authority to establish a new work standard and it identifies the information that must be submitted to obtain approval. New cytopathology standards have been developed that establish instrument-specific workloads (i.e., the limitation on the actual number of slides that may be examined in a work day).
A form has been developed using the workload figures proposed in these draft technical standards to allow laboratories using instrumented cytology examinations to submit requests for approval for one or more cytotechnologists at this time; however, approvals will not be issued until the draft Technical Standards and specific workload figures are finalized.
If you have any questions concerning the new regulation, you may contact Betty Kusel, Director for Regulatory Affairs, at kusel@wadsworth.org, or by telephone at 518- 485-5357. Questions related to filing an application to exceed the work standard may be directed to Louise Newton at 518-474-6343.
October 2001
October 15, 2001 - For questions on the identification and handling of suspicious mail, please see the U.S. Postal Service website www.usps.com/news/2001/press/pr01_1010tips.htm
October 12, 2001 - Guidance for handling clinical specimens for Bacillus anthracis in the clinical microbiology laboratory (PDF format *).
* The document is available as Adobe Portable Document Format (PDF) files. The Adobe Acrobat Reader software is required to view and print these forms. [ HELP with PDF files.]
Requests for the document in an alternate format can be requested by sending an e-mail note to CLEP@health.state.ny.us