Clinical Laboratory Evaluation Program - In the News
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, 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, 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
National Medical Laboratory Professionals Week in New York State, April 19 - 25, 2009
Governor Paterson proclaims National Medical Laboratory Professionals Week, recognizing the contributions of clinical laboratories to the well-being of New Yorkers.
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 addition, 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.
December 2004 - Submission Guidelines
The Submission Guidelines have been updated and this Adobe Reader compatible form can now be completed online. The completed form should then ideally be forwarded as an attachment to CLEP@health.state.ny.us with the rest of the validation package. CLEP has set up a paperless review/archiving process, with a quicker turnaround time for laboratories that send their validation packages as email attachments. Electronic submissions are not mandatory, but the processing time will also be shortened if all mailed submissions contain only one sided and letter sized (8 x 11 inches) pages.
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