This course addresses the laboratory personnel requirements as stipulated by the CLIA '88 regulations. Condition: Laboratories performing moderate complexity testing; laboratory director. The technical supervisor of cytology may perform the duties of the cytology general supervisor or delegate the responsibilities to an individual qualified under 493.1469. 493.1453 Condition: Laboratories performing high complexity testing; clinical consultant. O`t The contents of an appropriate job description and recommended provision to employee are outlined, along with Performance evaluation processes, including recommended components. Refer to A Guide to the Evaluation of Educational Experience in the Armed Services. (ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (A) Have earned a high school diploma or equivalent; and, (B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. (e) The general supervisor requirement is met in histopathology, oral pathology, dermatopathology, and ophthalmic pathology because all tests and examinations, must be performed: (1) In histopathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(l)(1); (2) In dermatopathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(l) or (2); (3) In ophthalmic pathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(1)(3); and. The FDA is responsible for determining the complexity level of various tests. 493.1491 Technologist qualifications on or before February 28, 1992. Q1. (a) Each supervisor possesses a current license as a laboratory supervisor issued by the State, if such licensing exists; and, (1) Who qualifies as a laboratory director under 493.1406(b)(1), (2), (4), or (5) is also qualified as a general supervisor; therefore, depending upon the size and functions of the laboratory, the laboratory director may also serve as the laboratory supervisor; or, (i) Is a physician or has earned a doctoral degree from an accredited institution with a major in one of the chemical, physical, or biological sciences; and, (ii) Subsequent to graduation, has had at least 2 years of experience in one of the laboratory specialties in a laboratory; or, (i) Holds a master's degree from an accredited institution with a major in one of the chemical, physical, or biological sciences; and, (ii) Subsequent to graduation has had at least 4 years of pertinent full-time laboratory experience of which not less than 2 years have been spent working in the designated specialty in a laboratory; or, (i) Is qualified as a laboratory technologist under 493.1491; and, (ii) After qualifying as a laboratory technologist, has had at least 6 years of pertinent full-time laboratory experience of which not less than 2 years have been spent working in the designated laboratory specialty in a laboratory; or. (a) The technical consultant must possess a current license issued by the State in which the laboratory is located, if such licensing is required. is available with paragraph structure matching the official CFR (ii) Exception. As a The qualifications of the individual (s) who can perform test and maintenance direct observations for the competence assessment on non-waived testing personnel are defined by CLIA regulations and CMS guidance. This contact form is only for website help or website suggestions. Laboratory and Point-of-Care Testing Personnel - Evidence of user convenience only and is not intended to alter agency intent Organization and Purpose Final. Condition: Laboratories performing PPM procedures; testing personnel. Centers for Medicare & Medicaid Services, Department of Health and Human Services. (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 mycobacteriology. 493.1423 D6069: Standard; Testing personnel qualifications: Comprehensive Accreditation Manual for Hospitals (CAMH Update 2, September 2012 effective January 1, 2013). What laboratories must do to comply with CLIA depends on the nature and complexity of the tests they perform. (ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology. 493.1406 Standard; Laboratory director qualifications on or before February 28, 1992. Each individual performing moderate complexity testing must (a) Possess a current license issued by the State in which the laboratory is located, if such licensing is required; and (b) Meet one of the following requirements: (1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a . 493.1441 Condition: Laboratories performing high complexity testing; laboratory director. Rationale for Personnel Competency CLIA survey experience indicates many problems caused by personnel errors. Condition: Laboratories performing high complexity testing; testing personnel. 493.1461 Standard: General supervisor qualifications. Regulation Y or existing codification. 2022 - 2023 Times Mojo - All Rights Reserved eCFR :: 42 CFR Part 493 -- Laboratory Requirements If you have questions or comments regarding a published document please This contact form is only for website help or website suggestions. Moderately complex tests are usually those that are available on automated clinical laboratory equipment such as electrolyte profiles, chemistry profiles, complete blood count, urinalysis, urine drug screen, and automated immunoassays. Moderate and High Complexity Personnel AACC recommends that Congress and CMS work together to ensure sufficient numbers of qualified MLS professionals. PDF CLIA Program and Medicare Laboratory Services - HHS.gov 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. Any PPM procedure must be. The four categories of personnel required for a moderate complexity laboratory to meet CLIA accreditation requirements are: A. director, clinical consultant, technical consultant, and testing personnel. (4) Document the number of hours spent examining slides in each 24-hour period. It's a site that collects all the most frequently asked questions and answers, so you don't have to spend hours on searching anywhere else. y'(C-:) &B(v+ >PH2Mpeb6'0 (3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (4) On or before April 24, 1995 be a high school graduate or equivalent and have either, (i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or. (a) The slide interpretation results of each gynecologic and nongynecologic cytology case he or she examined or reviewed (as specified in 493.1274(c)); (b) For each 24-hour period, the total number of slides 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. 0000001504 00000 n (c) The laboratory director must be accessible to the laboratory to provide onsite, telephone or electronic consultation as needed. "Published Edition". The target audience includes individuals who perform testing in waived testing sites (physician offices, nursing facilities, home health agencies, clinics, pharmacies and other non-laboratory sites) throughout the United States. 493.1419 Standard; Clinical consultant responsibilities. Choosing an item from Standard: Technical supervisor responsibilities. trailer What is the difference between waived and non waived testing? 57 FR 7172, Feb. 28, 1992, unless otherwise noted. [57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5235, Jan. 19, 1993]. The laboratory must have a director who meets the qualification requirements of 493.1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. (1) Selection of the test methodology that is appropriate for the clinical use of the test results; (2) Verification of the test procedures performed and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system; (9) Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. (Rq3\/K6qg.ad7 \eRV}-bOp2GK[ 493.1413 Standard; Technical consultant responsibilities. qz ~ E$iR&5Oi28f0w+/8 You can learn more about the process (a) Each individual performs only those high complexity tests that are authorized by the laboratory director and require a degree of skill commensurate with the individual's education, training or experience, and technical abilities. (1) Must be accessible to testing personnel at all times testing is performed to provide on-site, telephone or electronic consultation to resolve technical problems in accordance with policies and procedures established either by the laboratory director or technical supervisor; (2) Is responsible for providing day-to-day supervision of high complexity test performance by a testing personnel qualified under 493.1489; (3) Except as specified in paragraph (c) of this section, must be onsite to provide direct supervision when high complexity testing is performed by any individuals qualified under 493.1489(b)(5); and. What is the minimum education requirement for testing personnel in high complexity testing laboratories? EDUCATION REQUIREMENT - MODERATE COMPLEXITY TESTING REQUIREMENT: Clinical Laboratory Improvement Amendment 1988 (CLIA '88) 493.1423, Subpart M - D6064, D6065, D6066, & D6069. The clinical consultant must be qualified to consult with and render opinions to the laboratory's clients concerning the diagnosis, treatment and management of patient care. (ii) Have had at least one year experience directing or supervising non-waived laboratory testing; (i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; (ii) Have at least one year of laboratory training or experience, or both in non-waived testing; and, (iii) In addition, have at least one year of supervisory laboratory experience in non-waived testing; or. 0000001211 00000 n Xei(7 (wMtSq$dbQxp @h* %vmI1j"e]YWvmW1M7A]a&w?Wg 493.1481 Condition: Laboratories performing high complexity testing; cytotechnologist. 292 0 obj<> endobj (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. Background and more details are available in the eCFR :: 42 CFR 493.1489 -- Standard; Testing personnel qualifications. will also bring you to search results. FAR). The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. startxref 0000003319 00000 n MD, DO, DPM, doctorate, master's or bachelor's degree in lab science and 1 year lab training/experience in high complexity testing. 0000002402 00000 n (This required experience may be met by the substitution of education for experience); or. (3) For tests in ophthalmic pathology, meet one of the following requirements: (B) Must meet one of the following requirements: (2) Be certified by the American Board of Ophthalmology or possess qualifications that are equivalent to those required for such certitication and have successfully completed at least 1 year of formal post-residency fellowship training in ophthalmic pathology; or, (ii) An individual qualified under 493.1449(b) or paragraph (1)(3)(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 (1)(3)(i)(B) of this section, the responsibility for examination and interpretation of ophthalmic specimens; or.