Clinical Laboratory Evaluation Program - In the News
eCLEP Beta Test on Health Commerce System
December 6 - 31, 2011
The Clinical Laboratory Evaluation Program will be launching a beta test of its web-based clinical laboratory information management tool, eCLEP, on December 6, 2011. Following the beta test, this management tool will initially be used to electronically reapply for a New York State clinical laboratory permit. Further development of this management tool will allow submission of laboratory information changes to be made continuously throughout the year.
Current features will allow staff to:
- make changes to laboratory information such as contact information and hours of operation;
- make changes to laboratory directors and assistant directors, their assigned permit categories of responsibility and their on-site hours;
- add or delete tests to the laboratory´s test menu;
- add or delete permit categories;
- submit laboratory test volume reports for laboratories located in New York State; and
- submit point-of-care testing information for laboratories located in New York State.
The beta testing period will run from December 6, 2011 through January 13, 2012. Laboratories will be allowed data entry access from December 6 through December 31. From January 1, 2012 through January 13, laboratories will only have read-only access to the management tool.
We request that all permitted laboratories become familiar with the eCLEP management tool and practice making changes to the current information on file in our database. This is an opportunity for laboratory staff to provide feedback to the Department regarding this management tool prior to its implementation in the 2012-2013 clinical laboratory permit reapplication period. Please direct all comments regarding this information management tool to CLEP@health.state.ny.us with the subject line of "eCLEP comments".
Please note that all changes made during this beta test using this management tool will not be reflected in the actual laboratory records. Additionally, the information available through the eCLEP management tool was current as of November 7, 2011. Therefore, there may be change notifications received in the interim that have been processed in the actual laboratory records but are not reflected in the eCLEP management tool.
Any actual changes to laboratory information must continue to be submitted on the appropriate forms available on our website www.wadsworth.org/clep during the beta test.
To allow laboratories access to the eCLEP management tool, data entry and data submission privileges will be provided to all individuals who currently hold submit privileges in the Electronic Proficiency Testing Reporting System (EPTRS). For the 2012-2013 permit reapplication period; however, the laboratory director must provide explicit authorization to allow persons other than the laboratory director data entry and data submission privileges. Please complete and return the Document to assign Delegated Submitter status to an existing HCS holder assigning such privileges specifically for eCLEP. This document may be requested by email to CLEP@health.state.ny.us or by phone at 518-485-5378.
Proposed standards in Diagnostic Immunology, Mycobacteriology, and Parasitology
Revision December 2, 2011
Open for Comment until January 15, 2012
Proposed standards in the areas of Diagnostic Immunology, Mycobacteriology, and Parasitology and crosswalks for each section that highlight the proposed change to the current standards and identifies any newly proposed standard(s) are located here.
Proposed non-permitted laboratory policy and algorithm - Open for Comment until September 12, 2011.
New York State Public Health Law (Article 5, Title V, Section 574) and regulations (Part 58-1.10 (g) of 10NYCRR) require that all specimens obtained within New York State be tested by a laboratory that holds a New York State clinical laboratory permit, including test-specific approval when required. Due to the rarity of many diseases, testing for all potential conditions may not be available from permit-holding laboratories or there may be adequate justification for use of a specific laboratory that does not hold a permit. In these cases, the department´s approval must be received prior to submitting a specimen collected in New York State for testing by a non-permitted laboratory or a permitted laboratory that does not hold approval for that particular test. The Clinical Laboratory Evaluation Program (CLEP) administers this process and monitors the volume and frequency of requests. The policy and algorithm is proposed to manage the non-permitted laboratory (NPL) test request process.
The proposed policy and algorithm is open for review and comment. Please respond with comments by September 12, 2011. Comments can be submitted in writing by mail to the Wadsworth Center, N.Y. State Department of Health, Empire State Plaza, P.O. Box 509 Albany, N.Y. 12201-0509, or by e-mail to CLEP@health.state.ny.us. Please use the keywords Management of non-permitted laboratory requests in the subject line.
Revised Safety Standard 12
Adopted August 1, 2011
An additional revision was made to Safety Sustaining Standard of Practice 12: Work Surface Decontamination in response to comments received from laboratories and survey staff. The proposed revision to this standard was open for comment until July 11, 2011. This revision addressed concerns regarding the frequency of decontamination and established a decontamination policy that is in alignment with good laboratory practices.
Revised Microbiology Standards
Adopted May 1, 2011
Proposed Laboratory Standards in the areas of microbiology, bacteriology and virology, were open for comment until 12/15/10. The Microbiology and Microbiology Nucleic Acid Amplification Assays Standards apply to all laboratories holding the permit categories of Bacteriology, Mycology, Mycobacteriology, Parasitology and Virology with the addition of the molecular standards applying to the HIV molecular assays under the permit category of HIV – Viral Identification. The Microbiology Nucleic Acid Amplification Assays Standards are a new set of standards that were developed in response to the large number of microbiology laboratories that have or will be implementing nucleic amplification assays in their laboratory. The Bacteriology Standards apply to all permit subcategories in this area. The Virology Standards apply to those laboratories using cell culture methods for the detection and identification of viral agents.
Comprehensive Test Approval Policy and Submission Guidelines
February 24 or 25 or 28, 2011
The Clinical Laboratory Evaluation Program (CLEP) has revised its requirements for submission of SOPM and method validation materials for review and approval to include additional category-specific guidance and instructions.
Toxicology - TSMQ Policy Update
October 22, 2010
Laboratories holding a permit in the categories of Clinical and Forensic Toxicology (Initial and Comprehensive) and/or Therapeutic Substance Monitoring/Quantitative Toxicology are no longer required to submit validation materials when adding commercially available tests and LDTs performed in whole blood, plasma, serum, oral fluid, urine or sweat. However, laboratories must continue to notify the Clinical Laboratory Evaluation Program when new tests are added to the laboratory´s menu. Toxicology - TSMQ Policy Update October 2010
Release of Alcohol and Drug Test Results
Laboratories performing toxicology services should be aware of recent changes in New York State Vehicle and Traffic Law (V&TL) provisions for DWI. These provisions establish the legal authority for certain licensed professionals to order laboratory tests for ethanol alcohol, its biomarkers including ethyl glucuronide (EtG), and abused drugs and to use the results in their practice. The Office of Alcohol and Substance Abuse Services (OASAS) has issued clinical guidelines that include test selection available here. Laboratories are not responsible for determining whether a professional ordering such testing is qualified or acting within the circumstances specified in V&TL, however, this guidance is provided to clarify the Department of Health's position on the acceptance of and/or release of the results of alcohol and substance abuse tests to certain professionals. Please note that the Department of Health does not require laboratories to use chain of custody protocols for such testing; testing must be performed under a permit in toxicology (clinical or forensic). Laboratories seeking to add assays, including ethanol biomarkers, to their test menus, must notify the Clinical Laboratory Evaluation Program.
The V&TL requires mandatory abuse and dependency assessment, including testing for alcohol and drugs of abuse, of individuals charged with or convicted of an impaired driving offense. V&TL provides the following persons with the authority to conduct these assessments: licensed mental health counselors; licensed master social workers; licensed clinical social workers; nurse practitioners; physicians; physician assistants; psychiatrists; psychologists and registered nurses. A laboratory performing such testing may accept orders from, and release the results of drug and alcohol tests to; persons licensed by the New York State Education Department in an appropriate health field when such testing is performed within the scope of practice of their professional duties. Nurse practitioners, physicians (including psychiatrists) and physician assistants are already recognized as authorized by law to order and use laboratory tests in their practice; the list of individuals authorized by law to order and receive the results of laboratory tests has been updated to reflect the additional professionals named in V&TL. Note that a court and an attorney are also recognized as an authorized order sources, and would be authorized for testing related to charges of driving while impaired.
The updated list of individuals authorized by law to order and receive the results of laboratory tests is available here.
Laboratory Standards for Safety
Effective November 1, 2010
On August 25, 2010 all laboratories were sent a copy of the Adopted Laboratory Standards for Safety announcing that the standards are effective November 1, 2010. A copy of these adopted standards and the Department's responses to the comments received are available on the Survey Standards page. Questions and comments can be addressed to Beth Johansen at 518-402-2975, 518-485-5378 or bej01@health.state.ny.us.
Changes to HIV Testing Law
On July 30, 2010 Governor Paterson signed Chapter 308 of the Laws of 2010, which authorizes significant changes to HIV testing practices in New York State. We anticipate these changes will increase the number of persons screened for HIV and the number of persons newly diagnosed and linked to care, which may include HIV monitoring tests.
The statute has an effective date of September 1, 2010 and the Department has issued general guidance to the health care community. While the majority of the new provisions will have no direct impact on laboratories, one key change is that HIV test requisition forms submitted to laboratories will no longer need to include medical provider certification that patient consent was obtained.
The general guidance provided to the health care community, including FAQs, information and tools to assist with the initial implementation of the law as well as guidance specific to the impact of the new provisions on laboratory operations has been posted on the Department of Health website. Full implementation of certain sections will take place after regulations have been developed and adopted in final form. Please watch that site for further updates.
Proposed Standards for Blood Lead
Adopted and Effective 07/01/10
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.
As announced in the 2010 permit reapplication instructions, 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.
There were no comments received concerning the proposed Blood Lead Standards that were distributed on March 19, 2010. Therefore the standards covering testing for blood lead are adopted with an effective date of July 1, 2010. The new blood lead categories are reflected on the 2010/2011 clinical laboratory permits. The blood lead screening standards allow laboratories using point-of-care devices to follow manufacturer's operational instructions as minium requirements. Laboratories using these devices are 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 is required on the patient report identifying the need for confirmatory testing. Copies of the Announcement and Adopted standards can be obtained on the On-Site Survey Standards page.
Questions regarding laboratory standards can be directed to Ms. Beth Johansen at 518-402-2975. Technical questions concerning lead testing can be directed to Dr. Mary Fran Verostek, Assistant Section Head, Blood Lead Reference System at 518-474-4924.
Test Approval Update - 07/16/10
The Clinical Laboratory Evaluation Program (CLEP) has changed its "material" requirements for submission of SOPM and method validation material for review and approval.
Options for Point-of-Care Testing in Hospitals - Effective 07/01/10
Hospitals located in New York State have the option to register a single Limited Service Laboratory (LSL) for all waived and practitioner-performed microscopy procedures performed as point-of-care in all units within the hospital (i.e. ancillary practice, delivery room, cardiac catheterization, and nursing floors) that are distinct from and physically located outside of the laboratory(ies) that operate under a full permit. Please note that effective 07/01/10, unlicensed persons discovered to be performing testing other than pursuant to a LSL registration will be referred to the Education Department for investigation. The letter explaining the options for point-of-care testing in hospitals is available for review.
Limited Service Laboratory Guidance for following Standard Practices in Laboratory Medicine - 06/28/10
For sites performing waived and/or provider-performed microscopy procedures under a Limited Service Laboratory Registration, Guidance is available here.
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.
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 09/01/09
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