Summary:
Summary Statement of Deficiencies D0000 Based on an announced validation inspection, the laboratory was found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies, the CMS 209 form, personnel records, the laboratory's AAB (American Association of Bioanalysts) proficiency testing results, and staff interview, it was revealed that the laboratory failed to ensure that proficiency testing samples were analyzed by personnel who routinely performed patient testing in the laboratory for ten of ten proficiency testing events in 2021 and 2022. Findings include: 1. A review of the laboratory's policy titled 'Quality Management' revealed the following: "Proficiency Testing - All testing personnel within the laboratory, as well as applicable personnel other department(s) shall be included in the pool of personnel required to complete the testing on Proficiency specimens. Personnel shall complete testing on Proficiency specimens on a rotating basis as staffing allows." 2. A review of the laboratory's CMS 209 form revealed 4 testing personnel performing moderate complexity testing. 3. A review of the laboratory's personnel records revealed 2 of 4 testing personnel were hired prior to 2021: Testing person #2 Hire date: 3/2019 Testing person #3 Hire date: 8/2014 4. A review of the laboratory's AAB proficiency testing records from 2021 and 2022 revealed the laboratory participated in the following 10 testing events: - Chemistry Q2 2021 - Comprehensive Chemistry (second event) - Chemistry Q2 2021 - Fertility Endocrinology (second event) - Chemistry Q3 2021 - Comprehensive Chemistry Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- (third event) - Chemistry Q3 2021 - Fertility Endocrinology (third event) - Chemistry Q1 2022 - Comprehensive Chemistry (first event) - Chemistry Q1 2022 - Fertility Endocrinology (first event) - Chemistry Q2 2022 - Comprehensive Chemistry (second event) - Chemistry Q2 2022 - Fertility Endocrinology (second event) - Chemistry Q3 2022 - Comprehensive Chemistry (third event) - Chemistry Q3 2022 - Fertility Endocrinology (third event) 5. Further review of the proficiency testing events from 2021 and 2022 revealed all 10 events were tested by Testing person #3. 6. An interview with the technical supervisor (as indicated on the CMS 209 form) on 5/24 /23 at 5:10 p.m. in the patient lounge, after review of the records, confirmed the above findings. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies, the laboratory's American Association of Bioanalysts (AAB) proficiency testing records from 2022, and staff interview, it was revealed that the laboratory failed to have documentation of reviewing and evaluating the proficiency testing results for two of eight events in 2022. Findings include: 1. A review of the laboratory's policy titled 'Quality Management' revealed the following: "Investigation of Results When AAB send back the test results, check if the testing results are within acceptable range. If all results are within acceptable range, have the lab director review the results, sign and date the reports and then file the report in the PT files. If any result is out of acceptable range, contact lab director and an evaluation must be performed." 2. A review of the laboratory's AAB proficiency testing records from 2022 revealed the laboratory failed to have documentation of reviewing and evaluating the proficiency testing results for the following 2 events: - Embryology, Andrology & Fetal S2 2022 (second event) - Chemistry Q3 2022 Fertility Endocrinology (second event) 3. An interview with the technical supervisor (as indicated on the CMS 209 form) on 5/24/23 at 5:10 p.m. in the patient lounge, after review of the records, confirmed the above findings. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of the laboratory's American Association of Bioanalysts (AAB) proficiency testing records from 2021 and 2022, and staff interview, it was revealed that the laboratory failed to have documentation of verifying the accuracy of analytes that were 'not graded' by the proficiency testing program for two of four proficiency testing events in 2021 and 2022. Findings include: 1. A review of the laboratory's American Association of Bionanlysts proficiency testing results from 2021 and 2022 revealed the following analytes were scored as 'not graded' and had a '?' next to the reported value: Embryology, Andrology & Fetal S2 2021 (second event) - Sperm -- 2 of 10 -- Mobility Sample #2 Reported value: 44 Acceptable range: 16 - 40 Embryology, Andrology & Fetal S1 2022 (first event) - Sperm Cell ID sample #3 Reported value: Normal Acceptable response: Abnormal head AAB defines that "? = This score may not truly evaluate performance for this specimen which was not graded because of lack of participant consensus. You need to review this result to make sure that you can defend your response as accurate. Generally, if your result is within the given acceptable range, at minimum a documented QA/QC review is required. If you are outside the given acceptable range, you either need to justify why this range is not appropriate or treat this as a miss requiring