Wt Medical Associates Dba West Tennessee Medical

Summary Statement of Deficiencies 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 review of the laboratory's proficiency testing records and staff interview, the laboratory director and testing personnel failed to sign attestation statements for three of nine events in 2019 and 2020. The findings include: 1. Review of the laboratory's proficiency testing records revealed the following: no signature of the laboratory director on the attestation page for proficiency testing events 19 event three, and 2020 events two and three; no testing personnel signatures on the attestation page for proficiency testing events 2019 event three. 2. Interview with the lead testing person on 10/14/2021 at approximately 1pm confirmed proficiency testing attestations were not signed by the lab director and testing personnel for three of nine PT events reviewed in 2019 and 2020. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) 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 review of quality control records and interview with the lead testing person, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- the laboratory failed to retain control assay sheets for six of fifteen control lots reviewed. The findings include: 1. Review of the laboratory's quality control records revealed lot numbers 069500, 079500 and 089500 in use on 03.08.2021; lot numbers 068100, 078100, and 088100 in use on 09.22.2021. No quality control assay sheets for the six lot numbers were retained. 2. Interview on 10/14/2021 at 1pm with the lead testing person confirmed the laboratory failed to retain control assay sheets for six of fifteen lots in 2021. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D2127 HEMATOLOGY CFR(s): 493.851(d) 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 observation of the laboratory, review of the 2017 proficiency testing records and interview with testing personnel number one, the laboratory failed to return the proficiency testing results to the proficiency testing program before the due date. The findings include: 1) Observation of the laboratory on August 6, 2018 at 1:15 p.m. revealed the Beckman Coulter ACT diff 2 complete blood count (CBC) instrument (serial number BB01204) in use for patient testing. 2) Review of the 2017 event three proficiency testing records revealed "exception code [41] Results for this kit were received past the due date". 3) Interview on August 6, 2018 at 4:00 p.m. with testing personnel number one confirmed the 2017 event three proficiency testing results were sent to the proficiency testing program past the due date. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; 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 observation of the laboratory, review of the 2018 verification of performance specifications records, and interview with testing personnel number one, the laboratory director failed to ensure the verification of performance specification records were reviewed and the reportable limits were determined, prior to patient testing, in 2018. The findings include: 1) Observation of the laboratory on August 6, 2018 at at 1:15 p.m. revealed the Beckman Coulter ACT diff 2 complete blood count (CBC) instrument (serial number BB01204) in use for patient testing. 2) Review of the 2018 verification of performance specification records for the CBC instrument revealed installation was performed April 19, 2018, with no laboratory director signature of approval and no instrument reportable limits determined and approved, prior to patient testing. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the 2018 proficiency testing records and interview with testing personnel number one, the laboratory director failed to ensure the laboratory was enrolled in the proficiency testing program for the complete blood count in 2018 event one. The findings include: 1) Observation of the laboratory on August 6, 2018 at at 1:15 p.m. revealed the Beckman Coulter ACT diff 2 complete blood count (CBC) instrument (serial number BB01204) in use for patient testing. 2) Review of the 2018 proficiency testing records revealed no scores for the 2018 event one. 3) Interview on August 6, 2018 at 2:00 p.m. with testing personnel number one confirmed the laboratory director failed to ensure the laboratory was enroll in proficiency testing for 2018 event one. -- 2 of 2 --