Summary:
Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the federal proficiency testing (PT) data report and review of the comparative evaluation summary from the College of American Pathologists (CAP) PT program, the laboratory failed to successfully participate in the CAP PT program for chemistry testing (D2096). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 17 -- 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 review of the federal proficiency testing (PT) data report and review of the comparative evaluation summary from the College of American Pathologists (CAP) PT program, the laboratory failed to achieve satisfactory performance for the same analyte in two or three consecutive chemistry testing events. The following analytes were noted as failed in the CAP 2020 2nd and 3rd events and the CAP 2021 1st event. Findings: 1. Chloride PT resulted in 40% for the CAP 2020 3rd event and 0% for the 2021 1st event. 2. Total protein PT resulted in 0% for both the CAP 2020 3rd and 2021 1st events. 3. Blood urea nitrogen (BUN) PT resulted in 20% for the CAP 2020 3rd event and 0% for the 2021 1st event. 4. Glucose PT resulted in 40% for the CAP 2020 2nd event, 20% for the 2020 3rd event and 0% for the 2021 1st event. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and the PT procedure and interview with the technical supervisor (TS), the laboratory failed to self-evaluate PT results that were not graded by the College of American Pathologists (CAP) PT program. Findings: 1. Proficiency testing records for 2020 and 2021 were requested via email on 01/07/2021 at 6:14 pm and received via email from the technical supervisor on 03/30/2021 at 10:10 pm. 2. The CAP PT program provided multiple codes when they did not grade a PT result including "[11] = Unable to analyze (documentation to be provided by laboratory)", "[20] = Response was not formally graded due to insufficient peer group data. Please see the participant summary for additional information", "[26] = Educational challenge", "[28] = Response qualified with a greater than or less than sign; unable to quantitate", and "[30] = Scientific committee decision." 3. The following PT samples were not graded by the CAP PT program and were given one of the codes listed above for the reason why. 4. In the chemistry 2019 2nd event (C-B 2019), three of five PT samples for high-density lipoprotein (HDL) and all five PT samples for alanine transaminase (ALT), alkaline phosphatase, aspartate aminotransferase (AST), cortisol, ferritin, and free triiodothyronine (T3) were not graded by the CAP PT program (HDL code [30] and all others code [20]). 5. In the chemistry 2019 3rd event (C-C 2019), all five PT samples for alkaline phosphatase, AST, cortisol, and ferritin were not graded by the CAP PT program (all code [20]). 6. In the chemistry 2020 1st event (C-A 2020), all five PT samples for ALT, alkaline phosphatase, AST, cortisol, free T3, free thyroxine, thyroid stimulating hormone, and ferritin were not graded by the CAP PT program (all code [20]). 7. In the chemistry 2020 2nd event (C-B 2020), all five PT samples for ALT, alkaline phosphatase, AST, cortisol, free T3, free thyroxine, thyroid stimulating hormone, and ferritin were not graded by the CAP PT program (all code [20]). 8. In -- 2 of 17 -- the chemistry 2020 3rd event (C-C 2020), all five PT samples for alkaline phosphatase, AST, thyroid stimulating hormone, ferritin, ALT, free T3, free thyroxine, cortisol, and low-density lipoprotein (LDL) were not graded by the CAP PT program (cortisol code [11] and all others code [20]). 9. In the ligand-general 2019 1st event (K-A 2019), all five PT samples for cortisol and all three PT samples for folate and free T3 were not graded by the CAP PT program (all code [20]). 10. In the ligand-general 2019 2nd event (K-B 2019), all five PT samples for cortisol and all three PT samples for folate and free T3 were not graded by the CAP PT program (all code [20]). 11. In the ligand-general 2019 3rd event (K-C 2019), all three PT samples for folate, free T3, and vitamin B-12 were not graded by the CAP PT program (all code [20]). 12. In the ligand-general 2020 1st event (K-A 2020), one of two PT samples for prostate specific antigen; one of five PT samples for cortisol; and all three PT samples for folate, free T3, and vitamin B-12 were not graded by the CAP PT program (prostate specific antigen code [22] and all others code [20]). 13. In the ligand-general 2020 2nd event (K-B 2020), one of five PT samples for cortisol; one of three PT samples for ferritin; and all three PT samples for folate, free T3, and vitamin B-12 were not graded by the CAP PT program (all code [20]). 14. In the ligand- special 2020 1st event (Y-A 2020), one of three PT samples for estradiol and progesterone; two of four PT samples for testosterone; and all three PT samples for dehydroepiandrosterone (DHEA) sulfate and growth hormone were not graded by the CAP PT program (estradiol code [11], testosterone codes [20] and [26], and all others code [20]). 15. In the drug monitoring for pain management 2019 1st event (DMPM- A 2019), oxymorphone in specimen DMPM-03 was not graded by the CAP PT program (code [20]). 16. In the drug monitoring for pain management 2019 2nd event (DMPM-B 2019), pregabalin in specimen DMPM-05 was not graded by the CAP PT program (code [30]). 17. In all DMPM PT events for 2019 and 2020, none of the educational challenges were graded by the CAP PT program (all code [26]). 18. The laboratory's procedure titled "Proficiency Testing" stated "All ungraded results must be reviewed, and the evaluation documented." 19. The laboratory had no documentation indicating that a self-evaluation was performed for the ungraded PT samples listed above to ensure that the laboratory's results were acceptable. 20. The laboratory was cited for not performing a self-evaluation when alkaline phosphatase, ALT, and AST were not graded by the PT program under tag D2096 on the statement of deficiencies issued for the survey completed on 09/28/2018. The laboratory's allegation of compliance stated a correction date of 11/07/2018. 21. During the on-site survey on 08/17/2021 at 2:30 pm, the TS confirmed that the laboratory did not perform a self-evaluation for PT specimens that were ungraded by the PT provider. 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: I. Based on review of proficiency testing (PT) records and interview with the technical supervisor (TS), the laboratory failed to document that the accuracy of the toxicology screening testing was verified at least twice annually. Findings: 1. Proficiency testing records for 2019 and 2020 were requested via email on 01/07/2021 at 6:14 pm and received via email from the TS on 03/30/2021 at 10:10 pm. 2. The laboratory performed toxicology screening testing using the Mindray BS-480 instrument. 3. The laboratory was enrolled in the College of American Pathologists (CAP) PT program -- 3 of 17 -- for Drug Monitoring for Pain Management (DMPM). 4. The TS stated during a video conference call on 10/25/2021 that the toxicology screening should have been combined with the confirmation testing to perform the CAP DMPM PT. 5. There were no instrument printouts or documentation that toxicology screening was performed using the Mindray BS-480 instrument for the CAP DMPM PT. 6. No documentation was provided to show that the accuracy of the toxicology screening testing performed using the Mindray BS-480 was verified at least twice annually. II. Based on review of the laboratory testing menu and PT records, the laboratory failed to verify the accuracy of all analytes tested on the liquid chromatography tandem mass spectrometry (LC/MS/MS) analyzer for toxicology confirmation testing at least twice annually. Findings: 1. Proficiency testing records for 2019 and 2020 were requested via email on 01/07/2021 at 6:14 pm and received via email from the TS on 03/30/2021 at 10:10 pm. 2. The laboratory performed toxicology confirmation testing using a LC/MS/MS analyzer. 3. The TS provided the surveyors with a document titled "APMI LAB Test Menu" listing all drug analytes performed by the laboratory using the LC/MS/MS analyzer. 4. The laboratory was enrolled in the CAP DMPM PT which sent three PT samples two times a year. Each sample contained a mix of drug analytes that were selected from a master list of drug analytes located in the CAP survey catalog. 5. Not all drug analytes listed on the laboratory's test panel were included in the CAP PT master list of drug analytes. 6. Not all drug analytes listed on the laboratory's test panel that were included in the CAP PT master list of drug analytes were included in the PT samples twice a year. 7. During the on-site survey on 08/17/2021 at 2:30 pm, the TS confirmed that the laboratory was not performing any additional PT to ensure that the accuracy of all drug analytes evaluated by the laboratory was verified at least twice annually. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: I. Based on review of proficiency testing (PT) records and interview with the technical supervisor (TS), the laboratory failed to document the investigation into and