Summary:
Summary Statement of Deficiencies D2075 GENERAL IMMUNOLOGY CFR(s): 493.837(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) testing records, five (5) random patients sampling, and interview with the technical consultant (TC) testing personnel (TP); it was determined that the laboratory failed to attain a score of at least 80 percent of acceptable responses for C- Reactive Protein (CRP) on the third event of 2020 (Q3-2020). The findings included: 1. The API proficiency program gave an unsatisfactory score of 50% for CRP on the third event of 2020 (Q3-2020). 2. Based on the laboratory's annual testing declaration submitted on the day of the survey December 28, 2021, the laboratory discontinued Immunology testing and the number of tests performed during the time the laboratory had unsatisfactory proficiency testing results for CRP was not indicated. 3. The TC and TP confirmed on 12/28/2021 at approximately 11:00 a.m. that the laboratory received the above proficiency score of 50% for CRP on the third event of 2020 described in 1. D2099 ENDOCRINOLOGY CFR(s): 493.843(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on the review of the American Proficiency Institute (API) proficiency testing reports, review of five (5) randomly selected patient result records from 05/14/2020 to 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 -- 12/6/21, and interview with the laboratory's technical consultant (TC) and testing person (TP), the laboratory failed to attain a score of at least 80 percent for Endocrinology for Parathyroid hormone (PTH), and Free T3. The findings included: 1. Analyte Event Score PTH Q2-2020 50% PTH Q3-2020 0% Free T3 Q2-2020 60% 2. The TC and TP confirmed on 12/28/2021 at approximately 10:45a.m. that the laboratory had failed to attain a proficiency score of at least 80 percent for PTH and Free T3. 3. Based on the laboratory's annual test volume declaration signed by the laboratory director on 12/28/2021 the laboratory analyzed and reported approximately 1,403 Endocrinology tests which include PTH and Free T3. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of the American Proficiency Institute (API) proficiency testing repots and interview with the laboratory's technical consultant (TC) and testing person (TP); it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, Thyroid Stimulating Hormone (TSH), resulting in unsuccessful performance. The findings include: 1. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analyte, TSH, as follows: Analyte Q2-2020 Q3- 2020 TSH 50% 0% Q1 = First Testing Event Q2 = Second Testing Event 2. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an subsequent unsuccessful performance for the TSH analyte. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation on the lack of calibrated thermometers in all refrigerators and freezers to verify digital temperature readings and interviews with the technical consultant (TC) and testing personnel (TP); it was determined that the laboratory failed to monitor the temperature of equipment essential for proper storage of reagents and specimens that adversely affect patient test results. The findings included: 1. On the day of the survey, December 28, 2021 based on observation and interview with the TC and TP the laboratory failed to have calibrated thermometers on refrigerators and freezers that verify accurate digital thermometers readings which affect proficiency -- 2 of 3 -- and patients' samples testing. 2. The TC and GS confirmed on 12/28/2021, at approximately 11:30 a.m. that the laboratory has no calibrated thermometers in refrigerators and freezers. 3. Based on the laboratory's submitted testing declaration volume, the laboratory tested and reported approximately 13,835 samples annually. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a review of proficienc testing (PT) records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analyte, PTH the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance. (see D2099 and D2107) D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system; This STANDARD is not met as evidenced by: -- 3 of 3 --