All Rights Reserved, {{app['fromLang']['value']}} -> {{app['toLang']['value']}}, Pronunciation of Clia with 2 audio pronunciations. (vi) A description of the steps taken to monitor the correction of deficiencies. The notice includes the following: (1) The name of the accreditation organization or State licensure program. (2) Meet the requirements of 493.43 and paragraphs (a)(2) and (b)(2) of this section. (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. 24, 1995]. (i) If the laboratory requests a hearing within the time period specified by HHS, the laboratory retains its certificate of compliance or reissued certificate of compliance until a decision is made by an ALJ as provided in subpart R, except when HHS finds that conditions at the laboratory pose an imminent and serious risk to human health. (iv) To collect information regarding the appropriateness of waiver of tests listed in 493.15. Get notified about new Senior jobs in Germany. The program determines the reportable bacteria to be detected by direct antigen techniques or isolation. (c) The laboratory must document all control procedures performed, as specified in this section. Laboratories must pay a fee for the issuance of a registration certificate, certificate for PPM procedures, certificate of waiver, certificate of accreditation, or a certificate of compliance, as applicable. The score for the antigen tests is the number of correct responses divided by the number of samples to be tested for the antigen, multiplied by 100. This content is from the eCFR and may include recent changes applied to the CFR. The laboratory must have an emergency plan for alternate storage. CMS notifies the OIG of any violations under paragraphs (a)(1), (a)(2), (a)(6), and (b) of this section within 30 days of the determination of the violation. (eg: The additional fee is based on the actual resources and time necessary to perform the activities. If CMS reopens an initial or reconsidered determination, CMS gives the prospective laboratory notice of the revised determination in accordance with 498.32 of this chapter. (c) Challenges per testing event. (2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (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. The laboratory must have available and follow written policies and procedures for each of the following, if applicable: (1) All gynecologic slide preparations must be stained using a Papanicolaou or modified Papanicolaou staining method. This content is from the eCFR and is authoritative but unofficial. 42 U.S.C. 7), that provides equivalent quality testing. (b) A laboratory must pay a fee to cover the cost of issuing a revised certificate in any of the following circumstances: (1) The fee for issuing an appropriate revised certificate is based on the cost to issue the revised certificate to the laboratory as follows: (i) If a laboratory with a certificate of waiver wishes to perform tests in addition to those listed in 493.15(c) as waived tests, it must, as set forth in 493.638, pay an additional fee for the appropriate certificate to cover the additional testing. The in-page Table of Contents is available only when multiple sections are being viewed. (c) If the requirements of paragraph (b)(1) or paragraph (b)(2) of this section are not met, the individual functioning as the general supervisor must, (i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; and, (ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing; or, (i) Qualify as testing personnel under 493.1489(b)(2); and, (ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing; or. . (4) Those that isolate and perform identification of all organisms to the species level. (a) Admits as regular student only persons having a certificate of graduation from a school providing secondary education, or the recognized equivalent of such certificate; (b) Is legally authorized within the State to provide a program of education beyond secondary education; (c) Provides an educational program for which it awards a bachelor's degree or provides not less than a 2-year program which is acceptable toward such a degree, or provides an educational program for which it awards a master's or doctoral degree; (d) Is accredited by a nationally recognized accrediting agency or association. (iii) Indirect costs as negotiated by HHS. (2) Laboratory comparison of clinical information, when available, with cytology reports and comparison of all gynecologic cytology reports with a diagnosis of high-grade squamous intraepithelial lesion (HSIL), adenocarcinoma, or other malignant neoplasms with the histopathology report, if available in the laboratory (either on-site or in storage), and determination of the causes of any discrepancies. While the rule does not require laboratories to interpret test reports, this may result in more direct interaction between laboratory professionals and the patient. (d) Revisions to criteria for test categorization and the list of waived tests. (f) Appeal rights. (i) Directs the laboratory to submit to CMS, the State survey agency, or other CMS agent, within 10 calendar days after the notice of the alternative sanction, a list of names and addresses of all physicians, providers, suppliers, and other clients who have used some or all of the services of the laboratory since the last certification inspection or within any other timeframe specified by CMS. Intentional violation means knowing and willful noncompliance with any CLIA condition. (d) Access requirements. (2) The facility must establish and follow policies to ensure positive identification of a blood or blood product beneficiary. (6) Limited specimen handling or processing is required. This content is from the eCFR and may include recent changes applied to the CFR. Ensuring timely correction of deficiencies. HHS approves only those programs that assess the accuracy of a laboratory's response, in accordance with paragraphs (c)(1) through (5) of this section. [57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5234, Jan. 19, 1993]. (b) Meet one of the following requirements: (2) Be a midlevel practitioner, as defined in 493.2, under the supervision of a physician or in independent practice if authorized by the State in which the laboratory is located. Establishment and function of the Clinical Laboratory Improvement Advisory Committee. (ii) Agrees (in return for not having its Medicare approval cancelled immediately) not to charge Medicare beneficiaries or their private insurance carriers for the services for which Medicare payment is suspended. (b) The organization's or State's inspection process to determine the comparability of the full inspection and complaint inspection procedures and requirements to those of CMS, including, but not limited to, inspection frequency and the ability to investigate and respond to complaints against its laboratories. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as appropriate, to Federal and State authorities. HHS may also impose certain alternative sanctions. Cell identification or white blood cell differential, Hematocrit (excluding spun microhematocrit), (1) An approved program for cell identification may vary over time. Grading is based on the number of correct susceptibility responses reported by the laboratory divided by the actual number of correct susceptibility responses determined by the program, multiplied by 100. Proficiency Testing Programs by Specialty and Subspecialty. (ii) Perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. (ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of immunohematology. Other important emerging pathogens (as determined by HHS) and parasites commonly occurring in patient specimens must be included periodically in the program. Get email updates for new Senior jobs in Germany. Standard: Maintenance and function checks. (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. The eCFR is displayed with paragraphs split and indented to follow The appeal rights of laboratories dissatisfied with the imposition of a sanction are set forth in 493.1844. A registration certificate is required for all laboratories seeking a certificate of accreditation, unless the laboratory holds a valid certificate of compliance issued by HHS. Action when deficiencies are not at the condition level. The cytology general supervisor must be qualified to supervise cytology services. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. The program must have provisions for replacement of samples that are lost in transit or are received in a condition that is unacceptable for testing; and. CLIA outlines personnel qualifications based on the laboratory's level of testing complexity. (2) Inspections of the alarm system must be documented. (b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. (b) The laboratory must retain stained slides, specimen blocks, and tissue remnants as specified in 493.1105. There must be at least three testing events at approximately equal intervals per year. (c) The laboratory must document all general laboratory systems quality assessment activities. 57 FR 7185, Feb. 28, 1992, unless otherwise noted. (C) External proficiency testing materials, if available, may be labile. (1) If a facility stores or maintains blood or blood products for transfusion outside of a monitored refrigerator, the facility must ensure the storage conditions, including temperature, are appropriate to prevent deterioration of the blood or blood product. Choosing an item from https://www.labtestingmatters.org/testimonials/really-they-save-life/, https://www.labtestingmatters.org/testimonials/you-the-patient-matter/. Any PPM procedure must be. (a) General rule. (3) To motivate laboratories to comply with CLIA requirements so that they can provide accurate and reliable test results. (B) LSIL-Human papillomavirus (HPV)/mild dysplasia/cervical intraepithelial neoplasia 1 (CIN 1). (c) In cytology, the technical supervisor or the individual qualified under 493.1449(k)(2). (b) The laboratory must have a system to identify and assess patient test results that appear inconsistent with the following relevant criteria, when available: (3) Diagnosis or pertinent clinical data. (3) Whether the same condition level deficiencies have been identified repeatedly. If CMS determines that a laboratory has intentionally referred its proficiency testing samples to another laboratory for analysis, CMS does one of the following: (i) Revokes the laboratory's CLIA certificate for at least 1 year, prohibits the owner and operator from owning or operating a CLIA-certified laboratory for at least 1 year, and may impose a civil money penalty in accordance with 493.1834(d), if CMS determines that, (A) A proficiency testing referral is a repeat proficiency testing referral as defined at 493.2; or. Laboratories have been transformed from a passive clinical service provider to an active partner in patient diagnosis, treatment, and management. (6) The time allowed (at least 10 days) for the laboratory to respond to the notice. This rate includes the cost of contractor support to provide proficiency testing programs to laboratories that do not participate in an approved proficiency testing program, provide specialized assistance in the evaluation of laboratory performance in an approved proficiency testing program, perform assessments of cytology testing laboratories, conduct special studies, bill and collect fees, issue certificates, establish accounting, monitoring and reporting systems, and assist with necessary surveyor training. For qualitative tests, a challenge means the determination of the presence or the absence of an analyte, organism, or substance in a sample. Fee for determination of program compliance. The technical supervisor is not required to be on site at all times testing is performed; however, he or she must be available to the laboratory on an as needed basis to provide supervision as specified in (a) of this section. (b) Complaint inspection. Publication of approval of deeming authority or CLIA exemption. This button displays the currently selected search type. (2) Suspends or limits the CLIA certificate for less than 1 year based on the criteria in 493.1804(d) and imposes alternative sanctions as appropriate, in accordance with 493.1804(c) and (d), 493.1806(c), 493.1807(b), 493.1809 and, in the case of civil money penalties, 493.1834(d), when CMS determines that paragraph (b)(1)(i)(A) or (B) of this section does not apply but that the laboratory obtained test results for the proficiency testing samples from another laboratory on or before the proficiency testing event close date. Title 42 was last amended 7/03/2023. (3) Costs of the State's prorata share of general overhead to develop and implement CLIA. Repeat proficiency testing referral means a second instance in which a proficiency testing sample, or a portion of a sample, is referred, for any reason, to another laboratory for analysis prior to the laboratory's proficiency testing program event cut-off date within the period of time encompassing the two prior survey cycles (including initial certification, recertification, or the equivalent for laboratories surveyed by an approved accreditation organization). Calibration means a process of testing and adjusting an instrument or test system to establish a correlation between the measurement response and the concentration or amount of the substance that is being measured by the test procedure. site when drafting amendatory language for Federal regulations: The specialty of hematology, for the purpose of proficiency testing, is not subdivided into subspecialties of testing. Reactive (positive) or nonreactive (negative). After CMS withdraws approval of an accreditation organization or State licensure program, CMS may extend the period for an additional 60 days for a laboratory if it determines that the laboratory submitted an application for accreditation to an approved accreditation organization or an application for the appropriate certificate to CMS or a CMS agent before the initial 60-day period ends. (2) Slides may be loaned to proficiency testing programs in lieu of maintaining them for the required time period, provided the laboratory receives written acknowledgment of the receipt of slides by the proficiency testing program and maintains the acknowledgment to document the loan of these slides. (e) Crossmatching. (b) Adverse action based on improper referrals in proficiency testing. Navigate by entering citations or phrases (a) Corrective action policies and procedures must be available and followed as necessary to maintain the laboratory's operation for testing patient specimens in a manner that ensures accurate and reliable patient test results and reports. The laboratory director must be qualified to manage and direct the laboratory personnel and the performance of moderate complexity tests and must be eligible to be an operator of a laboratory within the requirements of subpart R of this part. (4) Use HLA antigen terminology that conforms to the latest report of the World Health Organization (W.H.O.) This subpart sets forth the methodology for determining the amount of the fees for issuing the appropriate certificate, and for determining compliance with the applicable standards of the Public Health Service Act (the PHS Act) and the Federal validation of accredited laboratories and of CLIA-exempt laboratories. 1/1.1 For the types of laboratories specified in paragraph (a) of this section, an annual program must include samples that contain organisms that are representative of the six major groups of bacteria: anaerobes, Enterobacteriaceae, gram-positive bacilli, gram-positive cocci, gram-negative cocci, and miscellaneous gram-negative bacteria, as appropriate. (a) Approved State laboratory programs. (8) Corrective action to take when calibration or control results fail to meet the laboratory's criteria for acceptability. The fee amount is set annually by HHS on a calendar year basis and is based on the category of test complexity, or on the category of test complexity and schedules or ranges of annual laboratory test volume (excluding waived tests and tests performed for quality control, quality assurance, and proficiency testing purposes) and specialties tested, with the amounts of the fees in each schedule being a function of the costs for all aspects of general administration of CLIA as set forth in 493.649 (b) and. 7), that provides equivalent quality testing. (ii) An explanation of CMS's review process on which the final determination is based and a description of the possible actions, as specified in 493.575, that CMS may impose based on the findings from the comparability or validation review. CMS may bring suit in the appropriate U.S. District Court to enjoin continuation of any activity of any laboratory (including a CLIA-exempt laboratory that has been found with deficiencies during a validation survey), if CMS has reason to believe that continuation of the activity would constitute a significant hazard to the public health. (3) Submit the certificate of accreditation fee specified in subpart F of this part. (e) A certificate for PPM procedures is valid for a period of no more than 2 years. (1) Complies with the requirements of 493.43; (2) Agrees to notify HHS or its designee within 30 days of any changes in ownership, name, location, director or technical supervisor (laboratories performing high complexity testing only); (3) Agrees to treat proficiency testing samples in the same manner as it treats patient specimens; and. (See table at (b)(3)(ii)(A) of this section for a description of the response categories.) An example of data being processed may be a unique identifier stored in a cookie. (iii) In addition, have at least 2 years of supervisory laboratory experience in non-waived testing; (6) Be serving as a laboratory director and must have previously qualified or could have qualified as a laboratory director under 493.1406; or. (5) Take appropriate enforcement action against laboratories found by CMS not to be in compliance with requirements equivalent to CLIA requirements. (i) The maximum number of 100 slides is examined in no less than an 8-hour workday; (ii) For the purposes of establishing workload limits for individuals examining slides in less than an 8-hour workday (includes full-time employees with duties other than slide examination and part-time employees), a period of 8 hours is used to prorate the number of slides that may be examined. (b) Each individual performing high complexity testing must. Laboratory information has a profound impact on patient diagnosis. (d) Revisions to criteria and the list of PPM procedures. What is CLIA?. Must be available to provide needed consultation either on-site, by telephone, or electronically. Standard: Specimen submission, handling, and referral. This page is all about Full Form, Long Form, abbreviation, acronym and meaning of the given term CLIA. (a) Program content and frequency of challenge. (Tests performed for quality control, quality assurance, and proficiency testing are excluded from the laboratory's total annual volume). Patient outcomes can also be measured by how well chronic illnesses are managed. (ii) An individual qualified under 493.1449(b) or paragraph (l)(2)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (l)(2)(i)(B) of this section, the responsibility for examination and interpretation of dermatopathology specimens. (m) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of oral pathology, the individual functioning as the technical supervisor must meet one of the following requirements: (i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and, (ii) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or, (2) Be certified in oral pathology by the American Board of Oral Pathology or possess qualifications for such certification; or.
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