Retain all laboratory quality systems assessment records for at least 2 years. Each individual performing PPM procedures must, (a) Possess a current license issued by the State in which the laboratory is located if the licensing is required; and. (2) An individual qualified as a technical supervisor under 493.1449 (b) or (k) who routinely interprets gynecologic slide preparations only after they have been examined by a cytotechnologist can either be tested using a test set that has been screened by a cytotechnologist in the same laboratory or using a test set that has not been screened. (iii) Laboratory personnel are performing the test methods as required for accurate and reliable results; (4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed and that. improvement. (7) Over time, rotate control material testing among all operators who perform the test. Laboratories Performing Provider-Performed Microscopy (PPM) Procedures. (2) For those laboratories receiving payments from the Medicare or Medicaid program, such payments will be suspended on the effective date specified in the notice to the laboratory even if there has been no appeals decision issued. (2) If the laboratory does not correct all deficiencies within 12 months, and a revisit indicates that deficiencies remain, CMS cancels the laboratory's approval for Medicare payment for its services and notifies the laboratory of its intent to suspend, limit, or revoke the laboratory's certificate of compliance, registration certificate, certificate of accreditation, or certificate for PPM procedures. In addition, failure to meet the requirements of this subpart will result in suspension or denial of payments under Medicare and Medicaid in accordance with subpart R of this part. The criteria for acceptable performance are. (b) Perform and document calibration verification procedures. (3) An unsatisfactory testing event score for those subspecialties not graded by analyte (that is, bacteriology, mycobacteriology, virology, parasitology, mycology, blood compatibility, immunohematology, or syphilis serology) for the same subspecialty for two consecutive or two out of three testing events. (ix) The specialty of Clinical Cytogenetics. Committee on Nomenclature and for which reagents are readily available. (ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or, (i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and, (ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or, (i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and. (2) Repeated unsatisfactory overall testing event scores for two consecutive or two out of three testing events for the same specialty or subspecialty. (4) The projected effective date and duration of the proposed sanction or sanctions. (a) The laboratory must retain its records and, as applicable, slides, blocks, and tissues as follows: (1) Test requisitions and authorizations. is available with paragraph structure matching the official CFR (e) Laboratory requirements. patient outcomes. August 30, 2022 | College of American Pathologists Technologist qualifications on or before February 28, 1992. (c) If the laboratory also performs waived tests, compliance with 493.801(a) and (b)(7) and subparts J, K, and M of this part is not applicable to the waived tests. (a) A laboratory issued a certificate must permit CMS or a CMS agent to conduct an inspection to assess the laboratory's compliance with the requirements of this part. SARS-CoV-2 Proficiency | College of American Pathologists Congratulations to ASCP's 40 Under Forty PA Honorees! On April 12, the CMS released additional guidance on the No Surprises Act, including a chart for the Independent Resolution (IDR) Process, FAQs surrounding the new surprise billing requirements, and requirements related to providing good faith estimates. HHS approves only those programs that assess the accuracy of a laboratory's responses in accordance with paragraphs (c) (1) through (5) of this section. (3) The laboratory must determine the D(Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (ii) If CMS or its agent determines that the deficiencies do not pose immediate jeopardy, CMS provides notice at least 15 days before the effective date of the sanction. (6) Test reports. (3) Notify the laboratory that it is not eligible for payment under the Medicare and Medicaid programs. (A EUA allows a company to bring a medical device to the market much faster.) To be approved for proficiency testing in syphilis serology, a program must provide a minimum of five samples per testing event. (ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology. All rights reserved. CMS may withdraw its approval of the accreditation organization or State licensure program, effective 30 days from the date of written notice to the organization or State of this proposed action, if improvements acceptable to CMS have not been made during the probationary period. The referring laboratory must retain or be able to produce an exact duplicate of each testing laboratory's report; and. Human Chorionic gonadotropin (excluding urine pregnancy tests done by visual color comparison categorized as waived tests). Standard; Technical consultant responsibilities. 24, 1995]. (4) Certificate of registration or registration certificate means a certificate issued or reissued before the expiration date, pending an appeal, in accordance with 493.45, that enables the entity to conduct moderate or high complexity laboratory testing or both until the entity is determined to be in compliance through a survey by CMS or its agent; or in accordance with 493.57 to an entity that is accredited by an approved accreditation organization. Specific criteria for these subspecialties are found at 493.923 and 493.927. (2) The laboratory must document, as applicable, that all necessary remedial actions are taken to prevent recurrences of transfusion reactions and that all policies and procedures are reviewed to assure they are adequate to ensure the safety of individuals being transfused. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. (ii) Distribute the samples, using rigorous quality control to assure that samples mimic actual patient specimens when possible and that samples are homogeneous, except for specific subspecialties such as cytology, and will be stable within the time frame for analysis by proficiency testing participants; (2) A scientifically defensible process for determining the correct result for each challenge offered by the program; (3) A program of sufficient annual challenge and with the frequency specified in 493.909 through 493.959 to establish that a laboratory has met minimum performance requirements; (4) The resources needed to provide Statewide or nationwide reports to regulatory agencies on individual's performance for gynecologic cytology and on individual laboratory performance on testing events, cumulative reports and scores for each laboratory or individual, and reports of specific laboratory failures using grading criteria acceptable to HHS. (iii) CMS suspends, limits, or revokes the laboratory's certificate of compliance, registration certificate, certificate of accreditation, or certificate for PPM procedures. The score for a sample in endocrinology is either the score determined under paragraph (c)(2) or (c)(3) of this section. The CAP no longerrecognizes different categories or complexity levels for tissue specimens. (ii) Requires the Secretary to develop and implement a range of such sanctions, including four that are specified in the statute. 7), that provides equivalent quality testing, the laboratory must. Clinical laboratory testsperformed on blood, urine, etc. (2) The resolution is appropriate for the type of tissue or specimen and the type of study required based on the clinical information provided to the laboratory. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. There must be at least three testing events at approximately equal intervals per year. Archives of Pathology & Laboratory Medicine, international laboratories seeking CAP accreditation, Browser and Operating System Requirements. Target 3SD based on the percentage of different types of white blood cells in the samples. (b) Notify HHS no later than 6 months after performing any test or examination within a specialty or subspecialty area that is not included on the laboratory's certificate of compliance, so that compliance with requirements can be determined. (4) Notify each accredited or licensed laboratory within 10 days of CMS's withdrawal of the organization's deeming authority or State's exemption. The CAP will remain engaged with the CMS on this coverage issue. Finally, there was significant interest in the so-called remote testing waiver that was borne from the pandemic. If the laboratory does not use commercial panels, it must maintain a list of individuals for fresh panel bleeding. The laboratory director must be qualified to manage and direct the laboratory personnel and test performance. As part of additional guidance regarding the No Surprises Act, the CMS released a high-level chart that helps determine whether the federal IDR process or the state process applies in a particular state. (b) A laboratory may perform only waived tests, only tests of moderate complexity, only PPM procedures, only tests of high complexity or any combination of these tests. (3) Determine whether the laboratory is performing tests beyond the scope of the certificate held by the laboratory. Standard; Laboratory director qualifications on or before February 28, 1992. (4) Review of ALJ hearing decisions. (l) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of histopathology, the individual functioning as the technical supervisor must. PDF Personnel paradox and more: POC pitfalls - CAP TODAY Regulation Y Microbiology Case Study: A 29 Year Old Man with Fevers andChills, Microbiology Case Study: A 70 Year Old with Altered MentalStatus, Microbiology Case Study: An Unusual Case of HerpesReactivation, Case Studies in Hematology: Hemoglobin S Beta Thalassemia Compound Heterozygosity in a 61 Year OldFemale, Microbiology Case Study: Cryptococcal Meningitis In Immunocompromised Patient. Except as specified in paragraph (b) of this section, a laboratory will be cited as out of compliance with section 353 of the Public Health Service Act unless it, (1) Has a current, unrevoked or unsuspended certificate of waiver, registration certificate, certificate of compliance, certificate for PPM procedures, or certificate of accreditation issued by HHS applicable to the category of examinations or procedures performed by the laboratory; or, (b) Exception. (1) Be accessible to provide on-site, telephone, or electronic consultation to resolve technical problems in accordance with policies and procedures established by the technical supervisor of cytology; (2) Document the slide interpretation results of each gynecologic and nongynecologic cytology case he or she examined or reviewed (as specified under 493.1274(c)); (3) For each 24-hour period, document the total number of slides he or she examined or reviewed in the laboratory as well as the total number of slides examined or reviewed in any other laboratory or for any other employer; and. CAP requirements commonly exceed the standards, bolstering patient care and safety. The samples may be provided through mailed shipments or, at HHS' option, may be provided to HHS or its designee for on-site testing. (i) Have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution; (ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing; and. (b) State inspection results. Neither the CAP nor CMS has ever required anything more than theassociate degree to examine tissues, no matter how complex. (i) Provides for imprisonment or fine for any person convicted of intentional violation of CLIA requirements; (ii) Specifies the administrative hearing and judicial review rights of a laboratory that is sanctioned under CLIA; and. (3) The laboratory must maintain records of the total number of slides examined by each individual during each 24-hour period and the number of hours spent examining slides in the 24-hour period irrespective of the site or laboratory. Standard; PPM laboratory director responsibilities. (2) Costs incurred for investigations of complaints against the State's CLIA-exempt laboratories if the complaint is substantiated. The facility must have a transfusion service agreement reviewed and approved by the responsible party(ies) that govern the procurement, transfer, and availability of blood and blood products. (o) If the laboratory performs tests in the specialty of histocompatibility, the individual functioning as the technical supervisor must either. and biohazard requirements are followed. All Rights Reserved. Unless otherwise stated, this includes test systems exempt from FDA premarket clearance or approval. This contact form is only for website help or website suggestions. CMS computes the total penalty amount after the laboratory's compliance is verified or CMS suspends, limits, or revokes the laboratory's CLIA certificate but in no event before, (i) The 60 day period for requesting a hearing has expired without a request or the laboratory has explicitly waived its right to a hearing; or. (a) Types of services offered by laboratories. (3) Notice of imposition of a principal sanction following the imposition of an alternative sanction. (d) Revisions to criteria for test categorization and the list of waived tests. (1) If CMS imposes onsite monitoring, the sanction continues until CMS determines that the laboratory has the capability to ensure compliance with all condition level requirements. (2) The State's representations and to assess the State's compliance with its own policies and procedures, including verification of State enforcement actions taken on the basis of validation inspections performed by CMS or a CMS agent. (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (v) Schedule E. The laboratory performs more than 25,000 but not more than 50,000 laboratory tests annually. Laboratories are not required to verify or establish performance specifications for any test system used by the laboratory before April 24, 2003. It implements sections 1861(e) and (j), the sentence following section 1861(s)(13), and 1902(a)(9) of the Social Security Act, and section 353 of the Public Health Service Act, as amended by section 2 of the Taking Essential Steps for Testing Act of 2012. If CMS has reason to believe that continuation of the activities of any laboratory, including a State-exempt laboratory, would constitute a significant hazard to the public health, CMS may bring suit in a U.S. District Court to enjoin continuation of the specific activity that is causing the hazard or to enjoin the continued operation of the laboratory if CMS deems it necessary. (5) The relationship of one deficiency or group of deficiencies to other deficiencies. (3) The rationale for the proposed sanction or sanctions. Doctoral degree in chemical, physical, biological or clinical laboratory science with: a. [57 FR 7185, Feb. 28, 1992, as amended at 58 FR 5237, Jan. 19, 1993; 60 FR 20051, Apr. Facility Administration for Nonwaived Testing. Log in to e-LAB Solutions Suite Enter Proficiency Testing Results See your Performance Analytics Dashboard The laboratory must establish and follow written policies and procedures for a program designed to detect errors in the performance of cytologic examinations and the reporting of results. To determine the accuracy of a laboratory's response for unexpected antibody detection and antibody identification, a program must compare the laboratory's response for each analyte with the response that reflects agreement of either 95 percent of ten or more referee laboratories or 95 percent or more of all participating laboratories. (4) Be serving as a laboratory director and must have previously qualified or could have qualified as a laboratory director under regulations at 42 CFR 493.1415, published March 14, 1990 at 55 FR 9538, on or before February 28, 1992; or, (5) On or before February 28, 1992, be qualified under State law to direct a laboratory in the State in which the laboratory is located; or. (ii) The laboratory withdraws any prior refusal to allow a validation inspection. (12) Any facility-specific data, upon request by CMS, which includes, but is not limited to, the following: (i) PT results that constitute unsuccessful participation in a CMS-approved PT program. (LogOut/ The importance of having qualified personnel to perform laboratory testing is magnified during a disease pandemic where each positive or negative result has public as well as patient concerns. (a) Laboratory tests are categorized as one of the following: (2) Tests of moderate complexity, including the subcategory of PPM procedures. If the laboratory provides services in the subspecialty of Histopathology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1273, and 493.1281 through 493.1299. (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.). Based on this notification, CMS may take an adverse action against a laboratory that fails to participate successfully in an approved PT program. For individuals qualified under 493.1489(b)(5), who were performing high complexity testing on or before January 19, 1993, the requirements of paragraph (a)(3) of this section are not effective, provided that all high complexity testing performed by the individual in the absence of a general supervisor is reviewed within 24 hours by a general supervisor qualified under 493.1461. (2) If such proof of accreditation is not supplied within this timeframe, the laboratory must meet, or continue to meet, the requirements of 493.49. (b) If the findings of a revisit indicate that a laboratory has not eliminated the jeopardy, CMS suspends or limits the laboratory's CLIA certificate no earlier than 5 days after the date of notice of suspension or limitation.