Wvu Medicine Thomas Hosp Ob & Gyn Ii

Summary Statement of Deficiencies D0000 An announced, on site, routine recertification survey was conducted at Bassam N Shamma MD PLLC on February 22, 2022, by the West Virginia Office of Laboratory Services. The laboratory was surveyed to assess compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies are explained below. D2025 BACTERIOLOGY CFR(s): 493.823(c) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to submit the results of American Proficiency Institute (API) Microbiology 2020 2nd proficiency testing (PT) event before the deadline. Findings: 1. Review of API records identified an unsatisfactory score of 0% (Failure to Participate) for the analyte #0005 Bacteriology. 2. An interview with testing personnel (TP1), on 2/22/2022 at approximately 10:20 AM, confirmed the results for API 2020 2nd PT event were not submitted before the deadline. 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. 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 -- This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview the laboratory failed to document the evaluation of unsatisfactory and unacceptable scores for one of three American Proficiency Institute (API) proficiency testing (PT) events in 2020 and one of three events in 2021. Findings: 1. Review of API records identified the following scores in Bacteriology: 2nd event 2020= 0% (failure to participate) 3rd event 2021= 80% (unacceptable response for specimen VP-15) 2. No documentation of an investigation or

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of laboratory personnel files, written policies and procedures, and an interview with Testing Personnel 1 (TP1), the laboratory failed to assess the annual competency of laboratory personnel for 2018 and 2019. Findings: 1. The written laboratory policy/procedure states " Personnel must be evaluated by the Technical Consultant at least semi-annually during the first year of employment. Thereafter, testing personnel are evaluated yearly." 2. No documentation of an annual employee competency for TP1 could be located for 2018 and 2019. 3. An interview with TP1, on 12/3/19 at approximately 1:00 PM, confirmed the findings. 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. 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 -- This STANDARD is not met as evidenced by: Based on a tour of the laboratory and an interview with Testing Personnel 1 (TP1), the laboratory failed to accurately monitor the condition (2) temperature essential for proper test system operation. Findings: 1. A tour of the laboratory identified the use of the BD Affirm III test system. The manufacturer instructions state "When performing this test the temperature of the testing environment must be 22 to 28 degrees Celsius." 2. A tour of the laboratory identified the use of a NIST calibrated thermometer to monitor the environmental temperature but no documentation of that monitoring could be located. 3. An interview with TP1, on 12/3/19 at approximately 2:00 PM, confirmed the findings. TP1 stated that she did not know she needed to document the daily room temperature of the lab, but that the thermometers had alarms to notify when temperatures were out of range. -- 2 of 2 --

Summary Statement of Deficiencies No Tags No deficiency details available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --