Sterling Urgent Care Of Wyoming

Summary Statement of Deficiencies 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. This CONDITION is not met as evidenced by: Based on review of the laboratory's quality control (QC) records, the FREND immunoassay instrument manufacturer's instructions for use, individualized quality control plan, the 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; 1/26/22 and 1/31/24 (D5445). D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (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 patient test records, review of 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's individualized quality control plan (IQCP), and staff interview, the laboratory failed to ensure QC was performed with every new lot number, every 30 days, or with each new shipment of TSH (thyroid stimulating hormone), FT4 (free thyroxine) and testosterone testing cartridges prior to testing patient samples for 12 of 28 patient test records reviewed between 11/16/23 and 1/27/24 (72 days). This failure affected 9 of 16 patients (#1, #2, #3, #4, #5, #6, #7, #8, #9). The laboratory performed approximately 300 endocrinology patient tests on the FREND instrument annually. The findings were: 1. Review of patient #1's laboratory results showed a FT4 was performed using lot #413001 and a testosterone was performed using lot #353004 on 12/6/23. Review of the "Frend FT4 Monthly External QC" record showed QC was last performed on lot #413001 on 7/31/23. Review of the "Frend Testosterone Monthly External QC" record showed no evidence QC had been performed on testosterone lot #353004 prior to patient testing. 2. Review of patient #2's laboratory results showed a testosterone was performed using lot #353004 on 12/6/23. Review of the "Frend Testosterone Monthly External QC" record showed no evidence QC had been performed on testosterone lot #353004 prior to patient testing. 3. Review of patient #3's laboratory results showed a FT4 was performed using lot #413001 on 12/9/23. Review of the "Frend FT4 Monthly External QC" record showed QC was last performed on lot #413001 on 7/31/23. 4. Review of patient #4's laboratory results showed a FT4 was performed using lot #413001 on 12/14/23. Review of the "Frend FT4 Monthly External QC" record showed QC was last performed on lot #413001 on 7/31/23. 5. Review of patient #5's laboratory results showed a FT4 was performed using lot #413001 on 12/14/23. Review of the "Frend FT4 Monthly External QC" record showed QC was last performed on lot #413001 on 7/31/23. 6. Review of patient #6's laboratory results showed a TSH was performed using lot #403014 on 12 /29/23. Review of the "Frend TSH Monthly External QC" record showed no evidence QC had been performed on TSH lot #403014 prior to patient testing. 7. Review of patient #7's laboratory results showed a TSH was performed using lot #403014 on 1/19 /24. Review of the "Frend TSH Monthly External QC" record showed no evidence QC had been performed on TSH lot #403014 prior to patient testing. 8. Review of patient #8's laboratory results showed a TSH was performed on lot #403014 and a testosterone was performed on lot #353001 on 1/20/24. Review of the "Frend TSH Monthly External QC" record showed no evidence QC had been performed on TSH lot #403014 prior to patient testing. Review of the "Frend Testosterone Monthly External QC" record showed QC was last performed on lot #353001 on 11/17/23. 9. Review of patient #9's laboratory results showed a TSH was performed on lot #403014 and a FT4 was performed using lot #413003 on 1/22/24. Review of the "Frend TSH Monthly External QC" record showed no evidence QC had been performed on TSH lot #403014 prior to patient testing. Review of the "Frend FT4 Monthly External QC" record showed QC was last performed on lot #413003 on 12/18 /23. 10. 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..." 11. Review of the FREND IQCP, last reviewed by the laboratory director on 3/13/23, showed "... External quality control...the lab performs monthly or with the change in test lots, or with each new shipment, whichever comes first..." 12. Interview with testing personnel #1 on 1/31/24 at 12:04 PM confirmed QC had not been performed with each new lot number, every 30 days, or shipment of the FREND testing cartridges as required. THIS IS A REPEAT DEFICIENCY, last cited on 1/26/22. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) -- 2 of 3 -- (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of quality assessment documentation and staff interview, the laboratory failed to have an ongoing system to monitor, assess, and correct problems in the analytic system which assesses quality control (QC). This failure resulted in deficiencies cited at D5445 for two consecutive survey cycles (2022, 2024). The findings were: 1. Review of the laboratory manager's random patient record quality assessment review showed no evidence QC for the subspecialty of endocrinology was monitored to ensure the laboratory's "Individualized Quality Control Plan" was followed. 2. Telephone interview with the laboratory manager on 1/31/24 at 12:04 PM confirmed the quality assessment review did not include monitoring the quality control of the test cartridges used on the FREND analyzer. -- 3 of 3 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (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 patient test records, review of the laboratory's individualized quality control plan (IQCP), and staff interview, the laboratory failed to ensure QC was performed with every new lot number or shipment of TSH (thyroid stimulating hormone) and FT4 (free thyroxine) testing cartridges prior to testing patient samples for 3 of 13 patient test records reviewed between 5/14 /21 and 11/12/21 (26 weeks). The laboratory performed approximately 13 FT4 and 79 TSH patent tests during that timeframe. The findings were: 1. Review of patient #1's laboratory results showed a TSH was performed using lot #401003 on 6/23/21. Review of the "Frend TSH Monthly External QC" record showed no evidence QC had been performed on TSH lot #401003 prior to patient testing or anytime thereafter. Review of the FREND TSH product insert showed each test kit contained 25 cartridges. 2. Review of patient #1's laboratory results showed a FT4 was performed using lot #410904 on 6/23/21. Review of the "Frend FT4 Monthly External QC" record showed QC was performed on FT4 lot #410904 on 6/25/21. There was no evidence QC had been performed on FT4 lot #410904 prior to patient testing. 3. Review of patient #2's laboratory results showed a FT4 was performed using lot 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 -- #410904 on 5/14/21. Review of the Frend FT4 Monthly External QC record showed QC was performed on FT4 lot #410904 on 6/25/21. There was no evidence QC had been performed on FT4 lot #410904 before it was used for patient testing. 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. Review of the FREND IQCP last reviewed by the laboratory director on 12/13/21 showed "...External quality control...the lab performs monthly or with the change in lot #s whichever comes first." 6. Interview with testing personnel #1 on 1/26/22 at 7:15 PM confirmed QC had not been performed with each new lot number or shipment of the FREND testing cartridges prior to being used for patient testing. -- 2 of 2 --

Summary Statement of Deficiencies 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 patient and quality control records review, lack of documentation, and interview with the laboratory manager, the laboratory failed to retain quality control instrument printouts at least two years for complete blood cell counts (CBC), Thyroid Stimulating Hormone (TSH), Free Thyroxine (FT4), Prostate Specific Antigen (PSA), and Testosterone tests for 4 of 8 test days of quality control performance reviewed. The laboratory performs approximately 400 complete blood cell counts per year and 300 TSH, FT4, PSA, and Testosterone tests per year. Findings include: 1. Quality control records for patient test days: 12/04/2018 for patient #051075 for PSA testing; 03/01/2019 for patient #122495 for TSH and FT4 tests; 07/31/2019 for patient #110682 for CBC testing; and 10/11/2019 for patient #60555 for FT4 and TSH tests failed to have quality control performance instrument printouts retained for at least two years. 2. In an interview with staff on 10/24/2019 at approximately 4:15 P.M., the laboratory manager confirmed he could not locate the instrument printouts to verify quality controls were performed and were within their acceptable ranges. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I 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 3 -- This STANDARD is not met as evidenced by: Based on proficiency testing records review, quality assessment records review, lack of documentation, and interview with staff, the laboratory failed to verify prostate specific antigen (PSA) and testosterone testing at least twice annually from May 2018 when testing began to October 2019. The laboratory tests approximately 2 to 4 tests per month. Findings include: 1. Proficiency testing and quality assessment records review failed to include twice annual verification of PSA and testosterone tests accuracy for 2018. 2. In an interview with staff on 10/24/2019 at approximately 4:30 P.M. the laboratory manager stated the laboratory did not verify PSA and testosterone test's accuracy twice annually for 2018. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on hematology complete blood cell (CBC) counter calibration records review, lack of documentation, and interview with staff, the laboratory failed to follow the manufacturer's instructions to perform instrument calibration every six months for 1 of 3 six month periods over 18 months of testing reviewed. The laboratory performed approximately 1 to 2 CBC tests per day. Findings include: 1. Calibration records review failed to include a calibration performed between 05/08/2018 and 03/27/2019. 2. The manufacturer provided instructions to calibrate the Poch i 100 cell counting instrument once every six months in the operator's manual and on each calibration work sheet calibration certificate with the next calibration due date. 3. In an interview conducted on 10/24/2019 at approximately 3:45 P.M., the laboratory manager confirmed the laboratory failed to perform a calibration due in November 2018. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must -- 2 of 3 -- document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control (QC) records review, lack of documentation, and interview with the laboratory manager, the laboratory failed to verify commercial quality control ranges for complete blood cell for approximately 4 lot numbers of hematology controls. The laboratory performed approximately 2 to 5 complete blood cell tests per day. Findings include: 1. Quality control records review failed to include documentation the laboratory verified new lot numbers of Hematology quality control verifying the laboratory could recover values within the manufacturer's stated ranges at the time the controls are placed in use. 2. In an interview with the laboratory manager on 10/24/2019 at approximately 4:00 P.M., the laboratory manager stated the laboratory did not document they verified new lot numbers of complete blood count quality controls ranges were acceptable (within the manufacturer's stated ranges) comparing the new lot number of controls to the stated values when they started new lot numbers. -- 3 of 3 --

Summary Statement of Deficiencies D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: Based on new testing verification studies review, lack of documentation, and interview with staff, the laboratory failed to verify the accuracy, precision, and reportable range for 1 of 4 tests performed on the Nano Entek FREND instrument, Free Thyroxine. The laboratory tested one patient over 3 months of testing reviewed from May to August 2018. Findings include: 1. New test verification studies failed to include documentation the laboratory verified Free Thyroxine accuracy, precision, and reportable range prior to testing a patient on 08/20/2018 reporting a result of 1.62. 2. In an interview conducted on 08/21/2018 at approximately 8:00 P.M., staff confirmed the verification documentation for Free Thyroxine was not present. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) 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 2 -- laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control records review, lack of documentation, and confirmation by staff, the laboratory quality control procedures for non-waived routine chemistry and endocrinology testing failed to include a method to monitor over time the accuracy and precision for 4 of 4 tests performed, Free Thyroxine (FT4), Thyroid Stimulating Hormone (TSH), Prostate Specific Antigen (PSA), and Testosterone (Testo). The laboratory performed approximately 1 to 3 tests per month. Findings include: 1. The laboratory Individual Quality Control Plan for FT4, TSH, PSA, and Testo failed to include a method to monitor weekly performance of one level of quality control over time. 2. In an interview with staff on 08/21/2018 at approximately 7:15 P.M., staff confirmed the laboratory had not yet set up a method to monitor quality control for the 4 moderate complexity chemistry tests performed over time to monitor shifts and trends that may affect patient test results. 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; This STANDARD is not met as evidenced by: Based on new tests verification studies review, lack of documentation, and interview with staff, the director failed to document verification procedures used were adequate to determine accuracy and precision for 1 of 4 new tests - Free Thyroxine (FT4) performed on the Nano Entek FREND instrument and failed to sign and date as approved the verification studies for 3 of 4 tests met the manufacturer's specifications for accuracy, precision, and reportable ranges for Thyroid Stimulating Hormone (TSH), Prostate Specific Antigen (PSA), and Testosterone (Testo). The laboratory tested and reported Free T4 for 1 patient since opening of the laboratory in May of 2018 and tested and reported approximately 8 to 12 results for TSH, PSA, and Testosterone. Findings include: 1. New test verification studies for Free Thyroxine testing failed to include accuracy and precision studies. 2. New test verification studies review failed to include documentation the director approved verification studies for TSH, PSA, and Testo. 3. In an interview conducted on 08/21/2108 at approximately 8:15 p.m., staff confirmed the director had not approved, by signing and dating, the 05/09/2018 study results. -- 2 of 2 --