Bridger Valley Urgent Care

Summary Statement of Deficiencies 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 1 of 11 testing events from January 2022 through December 2023. 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 2022 API Hematology Event #3 PT results showed the laboratory scored an 80% on the platelet count. There was no documentation the laboratory had evaluated the proficiency testing results. 2. Interview with the laboratory director on 1/31/24 at 5:50 PM confirmed the laboratory had failed to evaluate the reason for the 80% score. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of proficiency testing records, lack of documentation, and staff 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 -- interview, the laboratory failed to have a system in place for reviewing proficiency test results that received an artificial score of 100% due to lack of peer group data or due to a lack of consensus for 3 of 11 American Proficiency Institute (API) proficiency testing events reviewed from January 2022 through December 2023. The findings were: 1. Review of the 2022 API Microbiology Event #3 and the 2023 API Microbiology Event #1 proficiency testing results showed the laboratory scored an artificial score of 100% on the detection of Influenza A on the BioFire FilmArray analyzer due to a lack of peer group data. There was no documentation the laboratory had performed a self-evaluation. 2. Review of the 2023 API Hematology Event #1 proficiency testing results showed the laboratory scored an artificial score of 100% on the lymphocyte count performed on the Beckman Coulter DxH 520 analyzer due to a lack of consensus. There was no documentation the laboratory had performed a self- evaluation. 3. Interview with the laboratory director on 1/31/24 at 5:50 PM confirmed an evaluation of the proficiency testing results had not been completed. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on observation, review of manufacturer's instructions, and staff interview, the laboratory failed to ensure 2 of 5 (Henry Schein One-Step + Ultra Mono, Henry Schein One Step + H. pylori) waived testing kits were not used beyond their expiration date. The findings were: 1. Observation on 1/31/24 at 3:15 PM showed a Henry Schein One-Step + Ultra Mono kit had an expiration date of 11/30/23 and a Henry Schein One-Step + H. pylori kit had an expiration date of 5/31/23 and were available for patient testing. 2. Interview with the laboratory director on 1/31/24 at 3: 48 PM confirmed the test kits were expired. Further, the laboratory director revealed the H. pylori kit was used for patient testing on 1/27/24 and the Mono kit was used for patient testing on 12/23/23 and 1/9/24. 3. Review of the One Step + H. pylori Rapid Test Device manufacturer's instructions showed the kit was stable until the expiration date when stored as directed. 4. Review of the One Step + Ultra Mono Test Kit manufacturer's instructions showed "Do not use the Test Sticks or reagents after their expiration dates." 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 -- 2 of 3 -- having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of documentation, policy and procedure review, and staff interview, the laboratory failed to verify the statistical parameters of quality control material prior to use for 1 of 1 test system (Hematology) reviewed. The findings were: 1. There was no documentation the laboratory had verified new lot numbers of quality control material prior to being used on the Beckman Coulter DxH 520 hematology analyzer. 2. Review of the policy and procedure "Beckman DxH 520 Complete Blood Count with WBC Differential", effective 5/2022, showed "Assay values on a new lot of control should be confirmed before the new lot is put into routine use." 3. Interview with the laboratory director on 1/31/24 at 5:19 PM confirmed the statistical parameters of the quality control materials had not been verified before use. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 the Individualized Quality Control Plan (IQCP) for 1 of 2 years (2023) reviewed. The findings were: 1. Review of an "Annual IQCP Quality Assessment" for the BioFire Film Array showed it was last completed by the laboratory director on 4/7/22. 2. Interview with the laboratory director on 1/31/24 at 6: 23 PM confirmed there was no further documentation. -- 3 of 3 --

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 proficiency testing records and staff interview, the laboratory director and testing personnel failed to attest to the routine integration of proficiency tests into the patient workload using the laboratory's routine methods for 1 of 5 (American Proficiency Institute (API) microbiology event 1) proficiency testing events reviewed from December 2020 through April 2022). The findings were: 1. Review of the proficiency testing records failed to include the attestation statements signed by the laboratory director and the testing personnel for API 2022 microbiology event 1. 2. Interview with the laboratory director on 4/11/22 at 5:30 PM confirmed the attestation statements were not available. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of the Medonic hematology analyzer calibration records, review of the manufacturer's instructions, and staff interview, the laboratory failed to ensure the Medonic manufacturer's operator's manual was followed and calibrations were 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 -- performed every 6 months for two survey cycles conducted on 11/9/20 and 4/11/22. Refer to D5411. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of the manufacturer's operator's manual, review of calibration records, and staff interview, the laboratory failed to follow the Medonic complete blood count (CBC) instrument manufacturer's instructions to perform instrument calibration once every six months for 17 months of testing reviewed. The laboratory performed approximately 1400 CBCs annually. The findings were: 1. Review of the Medonic hematology calibration records showed the last calibration was performed on 5/15/21. There was no evidence a calibration had been performed in November 2021 or anytime thereafter. 2. Review of the Medonic operator's manual section 7 page 59 recommended calibration be performed every 6 months. The manufacturer's training manual instructions on page 18 stated calibration frequency was every 6 months or by local regulatory requirements. 3. Interview with the laboratory director on 4/11/22 at 3: 55 PM confirmed the Medonic hematology analyzer had not been calibrated as required. THIS IS A REPEAT DEFICIENCY, last cited on 11/9/21. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(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)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on review of the Medonic hematology analyzer manufacturer's instructions, review of the Medonic instrument calibration records, and staff interview, the laboratory director failed to ensure testing personnel followed the manufacturer's instructions to calibrate the instrument every 6 months. The laboratory performed approximately 1400 complete blood counts per year. Refer to D5411. -- 2 of 2 --

Summary Statement of Deficiencies D5405 PROCEDURE MANUAL CFR(s): 493.1251(c) Manufacturer's test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory. This STANDARD is not met as evidenced by: . Based on lack of documentation, operator's manual review, and confirmation by staff, the laboratory failed to add 3 of 12 required elements to the manufacturer's operator's manuals for 2 of 2 moderately complex test systems reviewed, Medonic blood cell counter and Biofire Respiratory Panel 2.1, (include instructions for entering test results into the patient's test record, identificaton of the testing person performing the test, and what to do when the test system is inoperable). The laboratory performed 0-3 Complete Blood Counts (CBC) tests per day and 5 to 10 Biofire Respiratory panel tests per day. Findings include: 1. The laboratory used the Medonic operator's manual as the procedure manual for CBC testing and the Biofire Respiratory operator's manual for the laboratory procedure manuals. 2. The operator's manuals did not include the method for transcribing CBC tests into the patient's test record or saving the instrument printouts for the transcribed results. Biofire Respiratory Panel 2.1 operator's manual failed to include instructions for entering the instrument printouts into the patient's test record, identification of the test person performing the test, and what testing personnel are to do when the test systems are inoperable. 3. In an interview conducted on 11/09/2020 at approximately 3:50 P.M., staff confirmed the procedure manual lacked the laboratory specific information for CBC and Biofire Respiratory Panel 2.1 tests. . D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) 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 -- Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: . Based on lack of documentation, manufacturer's operator's manual review, and confirmation by staff, the laboratory failed to follow Medonic complete blood count instrument manufacturer's instructions to perform instrument calibrations once every six months for two of two years of testing reviewed, November 2018 to November 2020. The laboratory performed from 0 to 3 complete blood counts per day. Findings include: 1. The laboratory failed to record the dates and retain the calibration record for complete blood cell counts performed on the Medonic cell counting instrument from November 9, 2018 to November 9, 2020. 2. Operator's manual section 7 page 59 recommended calibration be performed every 6 months. Manufacturer's training manual instructions on page 18 stated calibration frequency was every 6 months or by local regulatory requirements. 3. In an interview conducted on 11/09/2020 at approximately 5:15 P.M., staff confirmed the calibration records for the Medonic cell counting instrument could not be located for testing performed from November 2018 to November 2020. . D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: . Based on complete blood count (CBC) test records review, lack of documentation, and interview with staff, the laboratory test records failed to include the identity of the personnel who performed CBC tests from 11/09/2018 to 11/09/20 for 8 of 11 tests reviewed. Findings include: 1. Patient CBC record review failed to include the identity of the person performing the CBC test for the following 8 of 11 tests reviewed: Patient 093097 collected on 02/15/2019; for patient 101497 collected on 09 /15/2019; patient 100394 collected on 08/27/2019; patient 02081961 collected on 09 /15/2020; patient 10041955 collected on 08/26/2020; patient 020770 collected on 07 /03/2020; patient 031653 collected on 03/13/2020; and patient 031008 collected on 02 /28/2020. 2. In an interview with staff on 11/09/2020 at approximately 4:30 P.M. staff confirmed when the laboratory began transcribing test results into the laboratory information system (LIS) the instrument printouts containing the initials of the person performing the CBC tests were not retained in a manner they could be retrieved. . D5789 TEST RECORDS CFR(s): 493.1283(b) Records of patient testing including, if applicable, instrument printouts, must be -- 2 of 3 -- retained. This STANDARD is not met as evidenced by: . Based on patient test record review, lack of documentation, and interview with staff, the laboratory failed to retain Medonic instrument printouts for patient testing results that were transcribed into the patient's test record for 8 of 12 complete blood counts reviewed. The laboratory performed approximately 0 to 3 complete blood counts (CBC's) per day. Findings include: 1. Patient test records review failed to include instrument printouts for the transcribed complete blood count reports for: Patient 093097 collected on 02/15/2019 for which no mixed cell result was reported (Neutrophils were transcribed into the laboratory information system as 52.3 and Lymphocytes were transcribed as 40.0%, no mixed cell resullts were reported); patient 101497 collected on 09/15/2019; patient 100394 collected on 08/27/2019; patient 020861 collected on 09/15/2019; patient 100455 collected on 08/26/2020; patient 020770 collected on 07/03/2020; patient 031653 collected on 03/13/2020; and patient 031008 collected on 02/28/2020. 2. In an interview conducted with staff on 11 /09/2020 at approximately 4:45 P.M., staff confirmed the record system did not include the scanned instrument printouts for CBC's transcribed into the laboratory information system. . 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 Biofire Respiratory Panel 2.1 test verification documentation, lack of documentation, and interview with staff, the director failed to document test verification of accuracy precision, analytic specificity and analytic sensitivity met the laboratory's performance characteristics specified by the test's manufacturer. Findings include: 1. Biofire Respiratory Panel 2.1 test verification failed to include the director's signature and date of approval. 2. In an interview conducted on 11/09/2020 at approximately 4:00 P.M., staff confirmed the verification studies failed to include the date and signature of the director as approved. -- 3 of 3 --

Summary Statement of Deficiencies 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 proficiency testing record review and confirmation by staff, the laboratory failed to document 3 of 5 American Proficiency Institute (API) proficiency testing events were reviewed for complete blood count, and 3 of 4 American Association of Bioanalysts (AAB) Thyroid Stimulating Hormone (TSH), Free Thyroxine, and Prostate Specific Antigen testing events were reviewed from July 2016 to January 2018. Findings include: 1. Proficiency tests review revealed the laboratory failed to document 3 of 5 American Proficiency Institute (API) proficiency testing events were reviewed for complete blood count, and 3 of 4 American Association of Bioanalysts (AAB) Thyroid Stimulating Hormone (TSH), Free Thyroxine, and Prostate Specific Antigen testing events were reviewed from July 2016 to January 2018. There was no documentation the test results had been reviewed by the personnel responsible for testing to ensure test results were evaluated for bias, accuracy, or if