Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Riverside King William Medical Center on May 21, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiencies are as follows: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the laboratory's proficiency testing (PT) records and an interview with Laboratory Support Tech, the Laboratory Director (LD) failed to sign three (3) of six (6) PT attestation statements and the testing personnel (TP) failed to sign one (1) of six (6) PT attestation statements from August 2017 to May 2019. Findings include: 1. Review of the American Proficiency Institute (API) records from August 2017 to May 2019 revealed the following: 2017 API Hematology/Coagulation Event 2 attestation signed by TP A, not signed by LD; 2017 API Hematology /Coagulation Event 3 attestation signed by TP A, not signed by LD; 2018 API Hematology Coagulation Event 1 attestation signed by TP A and LD; 2018 API Hematology/Coagulation Event 2 attestation signed by LD, not signed by TP B; 2018 API Hematology/Coagulation Event 3 attestation signed by TP A, not signed by LD; and 2019 API Hematology/Coagulation Event 1 attestation signed by TPA and LD. 3 of 6 attestation statements were not signed by the LD. 1 of 6 attestation statements were not signed by the TP. 2. In an exit interview with the Practice Manager, Laboratory Support Tech, TP A and TP B at approximately 12:45 PM, the Laboratory Support Tech confirmed the above findings. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- 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 the review of the laboratory's proficiency testing (PT) records and interview with the Laboratory Support Tech, the Laboratory Director (LD) failed to review and sign three (3) of six (6) PT event results from August 2017 to May 2019. Findings include: 1. Review of the American Proficiency Institute (API) PT records from August 2017 to May 2019 revealed the following: API 2017 Hematology/Coagulation Event 2 PT results were not reviewed and signed by LD; API 2017 Hematology /Coagulation Event 3 PT results were not reviewed and signed by LD; API 2018 Hematology/Coagulation Event 1 PT results were reviewed and signed by LD; API 2018 Hematology/Coagulation Event 2 PT results were reviewed and signed by LD; API 2018 Hematology/Coagulation Event 3 PT results were not reviewed and signed by LD; API 2019 Hematology/Coagulation Event 1 PT results were reviewed and signed by LD. A total of 3 of 6 PT events were not reviewed and signed by the LD. 2. In an exit interview with the Practice Manager, Laboratory Support Tech, TP A and TP B at approximately 12:45 PM, the Laboratory Support Tech confirmed the above findings. -- 2 of 2 --