Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: . Based on review of laboratory documents, review of the Centers of Medicare and Medicaid Services (CMS) form 116, and confirmed in interview, the laboratory failed to perform twice annual accuracy in 2020 and 2021 for one of one test: gross examinations. The findings include: 1. Surveyor queried, 2/16/2022 at 1350, for the 2020 and 2021 documentation of twice annual accuracy for the gross examination histopathology testing and none was provided. 2. Review of the CMS form 116, subsection VII. Non-waived testing, lists a estimated annual testing volume of 6,000 for the subspecialty histopathology. 3. In an interview on 2/16/2022 at 1350, in the laboratory office, testing person (TP) 1 confirmed that no twice annual accuracy for gross examinations had been performed in 2020 and 2021. . D6143 GENERAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1461 (a) The general supervisor must possess a current license issued by the State in which the laboratory is located, if such licensing is required; and (b) The general supervisor must be qualified as a-- (b)(1) Laboratory director under 493.1443; or (b)(2) Technical supervisor under 493.1449. (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-- (c)(1)(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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; and (c)(1)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing; or (c)(2)(i) Qualify as testing personnel under 493.1489(b)(2); and (c)(2)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing; or (c)(3)(i) Except as specified in paragraph (3)(ii) of this section, have previously qualified as a general supervisor under 493.1462 on or before February 28, 1992. (c)(3)(ii) Exception. An individual who achieved a satisfactory grade in a proficiency examination for technologist given by HHS between March 1, 1986 and December 31, 1987, qualifies as a general supervisor if he or she meets the requirements of 493. 1462 on or before January 1, 1994. (c)(4) On or before September 1, 1992, have served as a general supervisor of high complexity testing and as of April 24, 1995-- (c) (4)(i) Meet one of the following requirements: (c)(4)(i)(A) Have graduated from a medical laboratory or clinical laboratory training program approved or accredited by the Accrediting Bureau of Health Education Schools (ABHES), the Commission on Allied Health Education Accreditation (CAHEA), or other organization approved by HHS. (c)(4)(i)(B) Be a high school graduate or equivalent and have successfully completed an official U.S. military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician). (c)(4)(ii) Have at least 2 years of clinical laboratory training, or experience, or both, in high complexity testing; or (c) (5) On or before September 1, 1992, have served as a general supervisor of high complexity testing and-- (c)(5)(i) Be a high school graduate or equivalent; and (c)(5) (ii) Have had at least 10 years of laboratory training or experience, or both, in high complexity testing, including at least 6 years of supervisory experience between September 1, 1982 and September 1, 1992. (d) For blood gas analysis, the individual providing general supervision must-- (d)(1) Be qualified under 493.1461(b)(1) or (2), or 493.1461(c); or (d)(2)(i) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; and (d)(2)(ii) Have at least one year of laboratory training or experience, or both, in blood gas analysis; or (d)(3) (i) Have earned an associate degree related to pulmonary function from an accredited institution; and (d)(3)(ii) Have at least two years of training or experience, or both in blood gas analysis. (e) The general supervisor requirement is met in histopathology, oral pathology, dermatopathology, and ophthalmic pathology because all tests and examinations, must be performed: (e)(1) In histopathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(l)(1); (e)(2) In dermatopathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(l) or (2); (e)(3) In ophthalmic pathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(1)(3); and (e)(4) In oral pathology, by an individual who is qualified as a technical supervisor under 493.1449(b) or 493.1449(m). This STANDARD is not met as evidenced by: . Based on review of the Centers of Medicare and Medicaid Services (CMS) form 209, laboratory requisitions, patient final reports, and CMS Form 116, and confirmed in interview, the general supervisor failed to review the gross examination within 24 hours of reporting for eight out of eight patients reviewed from random days in 2021 and 2022. The findings include: 1. Review of the CMS form 209 lists testing person (TP) 1 performing gross examinations testing. TP1 was qualified to perform the high complexity test under regulation 493.1489 but was not qualified as a technical supervisor under regulation 493.1449. 2. Review of laboratory requisitions and patient final reports for random days in 2021 and 2022 had the following eight patients -- 2 of 3 -- grossing performed by TP1 and then reviewed by the general supervisor outside the 24-hour turnaround time required: CCS21-0048: Grossing performed 1/15/2021, review 1/20/2021 CCS21-138: Grossing performed 2/24/2021, review 3/3/2021 CCS21-210 Grossing performed 3/24/2021, review 3/29/2021 CCS21-0981: Grossing performed 12/16/2021, review 12/22/2021 CCS21-1012: grossing performed 12/20 /2021, review 1/4/2022 CCP21-0325: Grossing performed 12/29/2021, review 1/4 /2022 CCS22-005: Grossing performed 1/5/2022, review 1/10/2022 CCS22-0109: Grossing performed 2/3/2022, review 2/9/2022 3. Review of the CMS form 116, subsection VII. Non-waived testing lists an estimated annual testing volume of 6,000 for the subspecialty histopathology. 4. In an interview on 2/16/2022 at 14:30 hours in the laboratory office, testing person 1 confirmed that grossing examination reports were not reviewed by the general supervisor within a 24 hour period. . -- 3 of 3 --