Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on January 16, 2020. Pediatric Care Group PA clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 College of American Pathologists (CAP) proficiency testing (PT) records and interview, the laboratory failed to have all testing personnel rotate through the testing of proficiency testing (PT) samples for 5 (2018 1st and 2nd, and 2019 1st, 2nd and 3rd) out of 6 events (2018 1st, 2nd and 3rd, and 2019 1st, 2nd and 3rd). Findings: Review of the CAP PT attestation form showed that Testing Personnel A performed all the PT for 2018 (1st, 2nd) and 2019 (1st, 2nd, 3rd). Review of the CMS-209 form title, "Laboratory Personnel Report (CLIA)" that was signed and dated by the Laboratory Director on 1/15/20, listed 5 testing personnel. Review of competency evaluations showed that there were 2 current employees (A and B) and 3 to 4 former employees who worked in the laboratory in 2018. Review of competency evaluations for 2019 showed that all 5 current employees (A, B, C D, and E) had competency evaluations. During an interview on 1/16/19 at 9:57 AM, the Laboratory Consultant stated that PT for 2018 (1st, 2nd) and 2019 (1st, 2nd, 3rd) was performed by Testing Personnel A and that they should have rotated testing personnel. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to retain at least two years of records for laboratory room temperature and humidity logs for 1 (June 2019) out of 24 months reviewed, and the laboratory refrigerator temperature for 1 (November 2019) out of 24 months reviewed. Findings: Review of the "Room Temperature /Humidity Log" revealed that the laboratory was missing the records for June 2019. Review of the "Temperature Log for Refrigerator - Fahrenheit" revealed that the laboratory was missing the records for November 2019. During an interview on 1/16 /20 at 11:28 PM, the Laboratory Consultant acknowledged they were unable to locate the missing documentation. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory's quality assessment program failed to monitor and evaluate the overall quality of the general laboratory system and correct identified deficiencies. Findings: Cross Reference D5221 Based on College of American Pathologists (CAP) proficiency testing (PT) records and interview, the laboratory failed to document