Sterling Urgent Care

Summary Statement of Deficiencies 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 review of proficiency testing (PT) records, the CMS (Centers for Medicare and Medicaid Services) 209 Laboratory Personnel Report, and personnel records, and staff interview, the laboratory failed to rotate testing personnel performing API (American Proficiency Institute) endocrinology and hematology PT for 8 of 8 proficiency testing events reviewed from September 2021 through December 2022. The findings were: 1. Review of the 8 API proficiency testing events performed from September 2021 through December 2022 showed no evidence TP #1 had been included. 2. Review of the CMS 209 Laboratory Personnel Report, dated 1/14/23, showed testing personnel (TP) #1 was listed as performing moderate complexity testing. Review of the personnel records for TP #1 showed an initial competency assessment had been completed on 9/2/21. Interview with TP #1 on 1/23/23 at 3:59 PM revealed she had not been included in the proficiency testing rotation. 3. Interview with the laboratory manager on 1/23/23 at 4 PM confirmed TP #1 had not participated in the proficiency testing events. D5020 ENDOCRINOLOGY CFR(s): 493.1212 If the laboratory provides services in the subspecialty of Endocrinology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. 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 -- This CONDITION is not met as evidenced by: Based on observation, review of the laboratory's quality control (QC) records, individualized quality control plan (IQCP), and patient testing log, and staff interview, the laboratory failed to ensure QC was performed and was acceptable prior to testing patient samples for 2 consecutive survey cycles; 9/7/21 and 1/23/23 (D5461). 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 review of proficiency testing records, lack of documentation, and staff interview, the laboratory failed to review and evaluate proficiency testing results for 2 of 9 testing events from September 2021 through December 2022. The findings were: 1. Review of the American Proficiency Institute (API) proficiency testing (PT) report failed to include documentation the laboratory had evaluated test scores of less than 100%. The following concerns were identified: a. Review of the 2021 API hematology event #3 PT results showed the laboratory scored an 80% on MCV (mean corpuscular volume) and the lymphocyte count. There was no documentation the laboratory had investigated the reason for the 80% score. b. Review of the 2022 API hematology event #2 showed the laboratory scored an 80% on hemoglobin. There was no documentation the laboratory had investigated the reason for the 80% score. 2. Interview with the laboratory manager on 1/23/23 at 3:52 PM confirmed the laboratory had failed to evaluate the reason for the 80% scores on the proficiency testing events. D5461 CONTROL PROCEDURES CFR(s): 493.1256(d)(6)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Perform control material testing as specified in this paragraph before resuming patient testing when a complete change of reagents is introduced; major preventive maintenance is performed; or any critical part that may influence test performance is replaced. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation, review of the laboratory's quality control (QC) records, individualized quality control plan (IQCP), and patient testing log, and staff interview, the laboratory failed to ensure QC was performed and was acceptable prior to testing and reporting patient results for 1 of 4 analytes (PSA) performed on the FREND immunoassay analyzer. The laboratory performed approximately 50 PSA patient tests per year. The findings were: 1. Review of the laboratory's QC records showed QC was performed on PSA (prostate-specific antigen) lot #301022 on 9/23/22 and level one had failed. A note on the QC log sheet stated "No patients ran til control out of range resolved." There was no evidence the failed QC was resolved or QC had been performed on lot #301022 following the 9/23/22 failure. 2. Review of the patient testing log showed 3 patient tests, using PSA lot #301022, were performed and -- 2 of 3 -- reported; patient #1 on 12/7/22, patient #2 on 12/13/22, and patient #3 on 1/10/23. 3. Observation of the laboratory's reagent storage refrigerator on 1/23/23 at 5:15 PM showed two unopened PSA lot #301022 reagent packages were intermingled in a box with PSA lot #301025. 4. Review of the FREND analyzer IQCP, last reviewed by the laboratory director on 4/4/22, showed QC will be performed monthly, with the change in test lots, or with each new shipment, whichever comes first. 5. Interview with the laboratory director and TP #1 on 1/23/23 at 5:30 PM confirmed PSA lot #301022 should not have been used for patient testing. THIS IS A REPEAT DEFICIENCY, last cited on 9/7/21. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of personnel files, review of the CMS (Centers for Medicare and Medicaid Services) 209 Laboratory Personnel Report, lack of documentation, and staff interview, the technical consultant failed to complete a competency assessment for 1 of 1 testing personnel (TP #1) after one year of performing patient testing. The findings were: 1. Review of the personnel file for TP #1 showed a date of hire of July 2021, an initial competency assessment was completed on 9/2/21, and a 6-month competency assessment was completed on 4/4/22. There was no evidence a competency assessment had been completed after TP #1 had performed one year of patient testing. 2. Interview with the laboratory manager on 1/23/23 at 4 PM confirmed the competency assessment had not been completed. -- 3 of 3 --

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on record review and staff interview, the laboratory failed to report 97 of 97 SARS-CoV-2 patient test results, as required, for 25 weeks of testing (3/13/21 to 9/7 /21) reviewed. The findings were: 1. Review of the laboratory's documentation showed 97 SARS-CoV-2 patient tests had been performed using the Access CareStart test system since 3/13/21. There was no evidence the test results had been reported to the State Public Health Laboratory. 2. Interview with testing personnel #1 on 9/7/21 at 4:50 PM confirmed the negative SARS-CoV-2 patient test results had not been reported to the State Public Health Laboratory. In addition, testing personnel #1 stated the positive SARS-CoV-2 patient test results had been reported, however the laboratory was unable to verify the positive results had been transmitted to the State Public Health Laboratory. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the 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 -- laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on lack of documentation and staff interview, the laboratory failed to have a written procedure for reporting SARS-CoV-2 positive and negative test results. The findings were: 1. Review of the laboratory's procedures showed no evidence a policy and procedure had been developed in regard to reporting SARS-CoV-2 positive and negative test results to the appropriate agencies. 2. Interview with testing personnel #1 on 9/7/21 at 4:55 PM confirmed the laboratory did not have a written procedure for reporting SARS-CoV-2 test results. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control (QC) record review, review of the patient testing log, and staff interview, the laboratory failed to perform QC which included a positive and negative control material each day of testing from 6/3/21 to 9/4/21 for the Healgen COVID-19 IgG and IgM antibody test system. This failure affected 10 patient samples. The findings were: 1. Review of the laboratory's QC records showed the laboratory performed a positive and negative control for the Healgen COVID-19 IgG and IgM antibody test system on 2/9/21 for lot number 2006120. Review of the patient testing log showed a patient test was performed on 6/3, 3 on 8/25, 2 on 8/30, 3 on 9/4, and 1 on 9/6. There was no documentation a positive and negative control had been run on each day of patient testing. 2. Interview with testing personnel #2 on 9/7 /21 at 3:10 PM confirmed the laboratory had failed to perform a positive and negative control each day of patient testing. D5461 CONTROL PROCEDURES CFR(s): 493.1256(d)(6)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Perform control material testing as specified in this paragraph before resuming patient testing when a complete change of reagents is introduced; major preventive maintenance is performed; or any critical part that may influence test performance is replaced. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control (QC) record review, review of the FREND immunoassay instrument instructions for use (IFU), review of the patient testing log, review of the laboratory's individualized quality control plan (IQCP), and staff interview, the -- 2 of 3 -- laboratory failed to perform QC with every new lot number or shipment of testing cartridges. The laboratory performed 40 TSH (thyroid stimulating hormone), 15 PSA (prostate-specific antigen), 6 testosterone, and 6 FT4 (free thryroxine) tests from 2/18 /21 to 9/7/21. The findings were: 1. Review of the QC records showed the following concerns: a. On 3/31/21 a low level of QC was performed on PSA lot #309051 and a high level of QC was performed on PSA lot #309053. On 5/3/21 a low and high level of QC was performed on PSA lot #309053. There was no documentation a low level of QC was performed on PSA lot #309053 before it was used for patient testing. b. On 5/3/21 a low and high level of QC was performed on TSH lot #400006. On 5/30/21 a low and high level of QC was performed on TSH lot #400009. There was no documentation QC was performed on TSH lot #400009 before it was used for patient testing. c. On 5/30/21 a low and high level of QC was performed on FT4 lot #410903. On 7/10/21 a low and high level of QC was performed on FT4 lot #410904. There was no documentation QC was performed on FT4 lot #410904 before it was used for patient testing. d. On 5/30/21 a low and high level of QC was performed on testosterone lot #350003. On 7/10/21 a low and high level of QC was performed on testosterone lot #350009. There was no documentation QC was performed on testosterone lot #35009 before it was used for patient testing. 2. Review of the laboratory's patient testing logs showed 2 PSA tests were performed between 3/31 and 5/3; 4 TSH tests were performed between 5/3 and 5/30 and 3 FT4 tests were performed between 5/30 and 7/10. 3. Review of the laboratory's IQCP showed QC on the FREND analyzer was only to be performed monthly. 4. Review of the FREND System IFU showed "If you comply with IQCP 2016, controls for each assay only need to be run on the FREND once every 30 days, every new shipment of cartridges, or every new lot number of cartridges..." 5. Interview with testing personnel #1 on 9/7 /21 at 3:20 PM confirmed QC had not been performed with each new lot number or shipment of the FREND testing cartridges before patient testing. -- 3 of 3 --

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on record review and staff interview, the laboratory failed to report 97 of 97 SARS-CoV-2 patient test results, as required, for 25 weeks of testing (3/13/21 to 9/7 /21) reviewed. The findings were: 1. Review of the laboratory's documentation showed 97 SARS-CoV-2 patient tests had been performed using the Access CareStart test system since 3/13/21. There was no evidence the test results had been reported to the State Public Health Laboratory. 2. Interview with testing personnel #1 on 9/7/21 at 4:50 PM confirmed the negative SARS-CoV-2 patient test results had not been reported to the State Public Health Laboratory. In addition, testing personnel #1 stated the positive SARS-CoV-2 patient test results had been reported, however the laboratory was unable to verify the positive results had been transmitted to the State Public Health Laboratory. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the 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 -- laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on lack of documentation and staff interview, the laboratory failed to have a written procedure for reporting SARS-CoV-2 positive and negative test results. The findings were: 1. Review of the laboratory's procedures showed no evidence a policy and procedure had been developed in regard to reporting SARS-CoV-2 positive and negative test results to the appropriate agencies. 2. Interview with testing personnel #1 on 9/7/21 at 4:55 PM confirmed the laboratory did not have a written procedure for reporting SARS-CoV-2 test results. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control (QC) record review, review of the patient testing log, and staff interview, the laboratory failed to perform QC which included a positive and negative control material each day of testing from 6/3/21 to 9/4/21 for the Healgen COVID-19 IgG and IgM antibody test system. This failure affected 10 patient samples. The findings were: 1. Review of the laboratory's QC records showed the laboratory performed a positive and negative control for the Healgen COVID-19 IgG and IgM antibody test system on 2/9/21 for lot number 2006120. Review of the patient testing log showed a patient test was performed on 6/3, 3 on 8/25, 2 on 8/30, 3 on 9/4, and 1 on 9/6. There was no documentation a positive and negative control had been run on each day of patient testing. 2. Interview with testing personnel #2 on 9/7 /21 at 3:10 PM confirmed the laboratory had failed to perform a positive and negative control each day of patient testing. D5461 CONTROL PROCEDURES CFR(s): 493.1256(d)(6)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Perform control material testing as specified in this paragraph before resuming patient testing when a complete change of reagents is introduced; major preventive maintenance is performed; or any critical part that may influence test performance is replaced. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control (QC) record review, review of the FREND immunoassay instrument instructions for use (IFU), review of the patient testing log, review of the laboratory's individualized quality control plan (IQCP), and staff interview, the -- 2 of 3 -- laboratory failed to perform QC with every new lot number or shipment of testing cartridges. The laboratory performed 40 TSH (thyroid stimulating hormone), 15 PSA (prostate-specific antigen), 6 testosterone, and 6 FT4 (free thryroxine) tests from 2/18 /21 to 9/7/21. The findings were: 1. Review of the QC records showed the following concerns: a. On 3/31/21 a low level of QC was performed on PSA lot #309051 and a high level of QC was performed on PSA lot #309053. On 5/3/21 a low and high level of QC was performed on PSA lot #309053. There was no documentation a low level of QC was performed on PSA lot #309053 before it was used for patient testing. b. On 5/3/21 a low and high level of QC was performed on TSH lot #400006. On 5/30/21 a low and high level of QC was performed on TSH lot #400009. There was no documentation QC was performed on TSH lot #400009 before it was used for patient testing. c. On 5/30/21 a low and high level of QC was performed on FT4 lot #410903. On 7/10/21 a low and high level of QC was performed on FT4 lot #410904. There was no documentation QC was performed on FT4 lot #410904 before it was used for patient testing. d. On 5/30/21 a low and high level of QC was performed on testosterone lot #350003. On 7/10/21 a low and high level of QC was performed on testosterone lot #350009. There was no documentation QC was performed on testosterone lot #35009 before it was used for patient testing. 2. Review of the laboratory's patient testing logs showed 2 PSA tests were performed between 3/31 and 5/3; 4 TSH tests were performed between 5/3 and 5/30 and 3 FT4 tests were performed between 5/30 and 7/10. 3. Review of the laboratory's IQCP showed QC on the FREND analyzer was only to be performed monthly. 4. Review of the FREND System IFU showed "If you comply with IQCP 2016, controls for each assay only need to be run on the FREND once every 30 days, every new shipment of cartridges, or every new lot number of cartridges..." 5. Interview with testing personnel #1 on 9/7 /21 at 3:20 PM confirmed QC had not been performed with each new lot number or shipment of the FREND testing cartridges before patient testing. -- 3 of 3 --