Star Valley Health - Alpine Clinic

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of proficiency testing documentation, policy and procedure review, review of patient testing worksheets, and staff interview, the laboratory failed to enroll in an approved proficiency testing program for the regulated manual identification of blood cells. The laboratory performed approximately 217 complete blood counts from 7/2/24 to 9/18/24 of which a manual identification of blood cells was performed on 22 patient samples. The findings were: 1. Review of the 2024 American Proficiency Institute hematology/coagulation proficiency testing records showed the laboratory was enrolled in an automated complete blood count with a white blood cell differential program; however, had failed to enroll in a program to evaluate the manual method for identifying blood cells. 2. Review of the "Hematology-Manual Differential Procedure" and the "Hematology-Uniform Grading of Blood Smears" procedure showed an effective date of 8/2022 and were revised 9/2024. 3. Review of the patient testing worksheets from 7/2/24 to 9/18/14 showed a manual identification of blood cells was performed on 22 patients. 4. Interview with the technical consultant on 9/18/24 at 2:34 PM confirmed the laboratory had failed to enroll in a proficiency testing program for manually identifying blood cells. 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 -- 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 interview, the laboratory failed to have a system in place for reviewing proficiency testing results that received an artificial score of 100% for 2 of 6 American Proficiency Institute (API) proficiency testing events reviewed from September 2022 through August 2024. The findings were: 1. Review of the 2023 API Hematology /Coagulation Event #1 showed the laboratory was given an artificial score of 100% on DxH-04 (lymphocyte count) due to no consensus. There was no documentation a self- evaluation of the results had been completed. 2. Review of the 2023 API Hematology /Coagulation Event #3 showed the laboratory was given an artificial score of 100% on DxH-11 and DxH-14 (lymphocytes) due to no consensus. There was no documentation a self-evaluation of the results had been completed. 3. Interview with the technical consultant on 9/18/24 at 1:35 PM confirmed the non-graded samples had not been evaluated. -- 2 of 2 --

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, lack of documentation, and staff interview, the individual testing the proficiency testing samples and the laboratory director failed to attest to the routine integration of the American Proficiency Institute (API) proficiency tests into the patient workload for 5 of 5 proficiency testing events reviewed from January 2021 to September 2022. The findings were: 1. Review of the proficiency testing records showed the following concerns related to the proficiency testing attestation statements: a. Review of the 2021 API Hematology Event #1 record showed the attestation statement had not been signed by the laboratory director until 9 /13/22. b. The laboratory was unable to locate the attestation statement for 2021 API Hematology Event #2. c. Review of the 2021 API Hematology Event #3 record showed no evidence of a signed attestation statement. d. Review of the 2022 API Hematology Event #1 record showed the attestation statement had not been signed by the laboratory director. e. Review of the 2022 API Hematology Event #2 record showed no evidence of a signed attestation statement. 2. Interview with technical consultant #1 on 9/15/22 at 10 AM confirmed no further documentation was available. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of proficiency testing records and staff interview, the laboratory failed to maintain a copy of each step in the testing and reporting of the API (American Proficiency Institute) proficiency samples for 5 of 5 proficiency testing events reviewed from January 2021 to September 2022. The findings were: 1. Review of the proficiency testing records showed no evidence of the following documentation: a. 2021 API Hematology Event #1 was missing the instrument printouts of the testing results, the attestation statement signed by the laboratory director, and the performance review form. b. 2021 API Hematology Event #2 was missing all of the required documentation. c. 2021 API Hematology Event #3 was missing the attestation statement, the instrument printouts of the testing results, and the submission forms. d. 2022 API Hematology Event #1 was missing the attestation statement signed by the laboratory director. e. 2022 API Hematology Event #2 was missing all of the required documentation. 2. Interview with technical consultant #1 on 9/15/22 at 10 AM confirmed no further documentation was available. 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 the CMS (Centers for Medicare and Medicaid Services) 209 Laboratory Personnel Report, review of personnel records, policy and procedure review, and staff interview, the laboratory failed to ensure the technical consultants' (TC #1, TC #2, TC #3) competency assessments had been completed for 2 of 2 years reviewed (2020, 2021). The findings were: 1. Review of the CMS 209 Laboratory Personnel Report showed 3 laboratory personnel were listed as technical consultants. 2. Review of the personnel files for TC #1, TC #2, and TC #3 showed no evidence a competency assessment had been completed for the position of technical consultant as required. 3. Review of the policy and procedure provided by the laboratory showed it was a shared document from the laboratory's parent organization, was not unique to the laboratory, and had not been approved by the laboratory director. 4. Interview with TC #1 on 9/15/22 at 11:44 AM confirmed the laboratory did not have a policy and procedure related to competency assessments and the required competency assessments had not been completed. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) -- 2 of 6 -- Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on procedure manual review, lack of documentation, review of the Beckman Coulter DxH 520 new instrument verification study, and staff interview, the laboratory director failed to approve 1 of 1 procedure manual (Beckman DxH 520 Complete Blood Count with WBC Differential) reviewed. The findings were: 1. Review of the Beckman Coulter DxH 520 new instrument verification study showed the laboratory director had approved the study on 2/9/22. 2. Review of the Beckman Coulter DxH 520 Complete Blood Count with WBC Differential policy and procedure, effective 9/2022, had not been signed and dated as approved by the laboratory director. 3. Interview with technical consultant #1 on 9/15/22 at 10:26 AM confirmed the procedure manual had not been signed by the laboratory director. 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 Beckman Coulter DxH 520 manufacturer's instructions for use (IFU), review of patient testing records, and staff interview, the laboratory failed to follow the manufacturer's instructions and review and resolve any instrument flags prior to reporting patient results for 12 of 14 (#32658, #320591, #318643, #311164, #309970, #309968, #309033, #308245, #307781, #305914, #301970, #300089) patient tests reports with flagged analytes reviewed from 2/25/22 to 9/14/22. The findings were: 1. Review of the instrument printouts of patient testing showed the following concerns: a. Review of patient #326258, dated 9/14/22, showed a flag for platelet debris. There was no evidence the patient sample had been reviewed prior to the reporting of patient results. b. Review of patient #320591, dated 8/5/22, showed a flag for suspect differential. There was no evidence the patient sample had been reviewed prior to the reporting of patient results. c. Review of patient #318643, dated 7 /22/22, showed a flag for suspect differential. There was no evidence the patient sample had been reviewed prior to the reporting of patient results. d. Review of patient #311164, dated 6/3/22, showed a flag for suspect differential. There was no evidence the patient sample had been reviewed prior to the reporting of patient results. e. Review of patient #309970, dated 5/25/22, showed flags for abnormal differential, cellular interference, and suspect differential. There was no evidence the patient sample had been reviewed prior to the reporting of patient results. f. Review of patient #309968, dated 5/25/22, showed flags for abnormal differential, suspect differential, and MO/NE (monocyte/neutrophil) overlap. There was no evidence the patient sample had been reviewed prior to the reporting of patient results. g. Review of patient #309033, dated 5/15/22, showed a flag for platelet debris. There was no evidence the patient sample had been reviewed prior to the reporting of patient results. h. Review of patient #308245, 5/11/22, showed a flag of platelet debris. There was no evidence the patient sample had been reviewed prior to the reporting of patient results. i. Review of patient #307781, dated 5/8/22, showed a flag for platelet debris. There was -- 3 of 6 -- no evidence the patient sample had been reviewed prior to the reporting of patient results. j. Review of patient #305914, dated 4/22/22, showed a flag for suspect differential. There was no evidence the patient sample had been reviewed prior to the reporting of patient results. k. Review of patient #301970, dated 3/15/22, showed a flag for platelet debris. There was no evidence the patient sample had been reviewed prior to the reporting of patient results. l. Review of patient #300089, dated 2/25/22, showed a flag for platelet debris. There was no evidence the patient sample had been reviewed prior to the reporting of patient results. 2. Interview with technical consultant #1 on 9/15/22 at 10:27 AM confirmed the flagged patient specimens had not been evaluated for accuracy prior to reporting the results. 3. Review of the Beckman Coulter DxH 520 manufacturer's IFU showed "Flags IMPORTANT Beckman Coulter recommends that you review all flags according to your laboratory's protocol before reporting any results." 4. Review of the Beckman DxH 520 Complete Blood Count with WBC differential showed "...Reporting Patient Results...Any patient results that are flagged by the analyzer must be reviewed and all flags need to be resolved prior to reporting patient results...If flags or other results (sic) issues cannot be resolved, specimens should be sent to the main lab for testing on primary hematology analyzer." 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. This STANDARD is not met as evidenced by: Based on review of the laboratory's environmental records, review of manufacturer's instructions, and staff interview, the laboratory failed to monitor humidity in the testing and reagent storage areas. The laboratory performed approximately 200 complete blood cell counts per year. The findings were: 1. Review of the daily environmental log showed the humidity level in the laboratory was not monitored. 2. Review of the Beckman Coulter DxH 520 manufacturer's instructions showed the analyzer met performance claims when operated at a maximum of 80% relative humidity (non-condensing) at 89.6 degrees Fahrenheit. 3. Interview with technical consultant #1 on 9/15/22 at 11:42 AM confirmed the humidity of the laboratory had not been monitored. 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 -- 4 of 6 -- 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 document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of documentation 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. Interview with technical consultant #1 at 10:27 AM 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 lack of documentation, review of patient test records, and staff interview, the laboratory failed to have a written policy and procedure for identifying and correcting problems identified in the analytic phase of testing. The findings were: 1. Review of patient test records showed 12 patient test reports had been flagged for review by the Beckman Coulter DxH 520 hematology analyzer and reported to the provider prior to resolution of the flagged analytes. 2. There was no evidence the laboratory had developed a policy and procedure for ensuring the quality of patient test results during the analytic phase of testing. 3. Interview with technical consultant (TC) #1 and TC #2 on 9/15/22 at 11:49 AM revealed the final patient test results were reviewed from a remote location, however the instrument printouts had not been reviewed to ensure the results had not been flagged by the analyzer. In addition, the technical consultants confirmed a quality assessment policy and procedure had not been developed. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. -- 5 of 6 -- This STANDARD is not met as evidenced by: Based on review of patient test reports and staff interview, the laboratory failed to ensure the patient test report included the name and address of the laboratory location where the test was performed. The laboratory performed approximately 200 complete blood cell counts per year. The findings were: 1. Review of the test report for patient #309968, dated 5/25/22, showed the location of the testing laboratory was incorrect. 2. Interview with technical consultant #1 on 9/15/22 at 11 AM confirmed the patient test report failed to include the correct name and address of the location the test was performed. -- 6 of 6 --

Summary Statement of Deficiencies 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 lack of documentation, review of the manufacturer's operator's manual, and staff interview, the laboratory failed to follow the Beckman Coulter AC*T manufacturer's instructions to perform instrument calibrations once every 6 months for 2 of 2 years of testing reviewed (May 2019 to May 2021). In addition the laboratory failed to review flagged analytes on the analyzer printout for 5 of 15 (#18693, #193711, #198257, # 203832, #236484) hematology samples reviewed. The laboratory performed approximately 200 complete blood counts per year. The findings were: 1. Review of the laboratory's hematology records failed to include evidence the hematology analyzer had been calibrated from 5/1/19 through 5/4/21. The laboratory failed to record the date of the calibrations and retain the calibration records. 2. Review of the AC*T instrument for patient test #18693, #193711, #198257, # 203832, and #236484 showed results for platelets were flagged with an asterisk. There was no documentation the sample had been reviewed for accuracy. 3. Review of the Beckman Coulter AC*T operator's manual showed "Instrument calibration or calibration check should be done every 6 months and after major repairs". In addition the operator's manual showed on page A-15 a result value coded with an asterisk required review. 4. Interview with the technical consultant and general supervisor on 5/4/21 at 12:10 PM confirmed the calibration records could not be located. Further, they confirmed the manufacturer required patient's blood sample results be reviewed if the results were flagged with an asterisk, which had not been done, and a procedure should be implemented. 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 -- D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on the lack of documentation, review of the Beckman Coulter AC*T operator's manual, and staff interview, the facility failed to follow the AC*T manufacturer's instructions to perform preventative maintenance as required. The laboratory tested approximately 200 hematology samples per year. The findings were: 1. Review of the Beckman Coulter AC*T operator's manual showed the instrument required the diluent filters and peristaltic pump tubing be replaced every 12,000 cycles. 2. Review of the laboratory's records failed to include pump and filter maintenance documentation for 2 years of records reviewed. 3. Interview with the technical consultant and general supervisor on 5/4/21 at 12:10 PM revealed the laboratory did not have a preventative maintenance contract with the manufacturer and provided the service internally. Further they confirmed the laboratory did not have documentation of when the maintenance was last performed. D5789 TEST RECORDS CFR(s): 493.1283(b) Records of patient testing including, if applicable, instrument printouts, must be retained. This STANDARD is not met as evidenced by: Based on patient test record review, lack of documentation, and staff interview, the laboratory failed to retain the Beckman Coulter AC*T instrument printouts for patient testing that were transcribed into the patient's test record for 1 of 15 (#236484) complete blood counts (CBCs) reviewed. The laboratory performed approximately 200 CBCs per year. The findings were: 1. Review of patient test report #236484 showed a result of 231,000 platelets per microliter of blood and a monocyte result of 4.8 %. Further review showed these results were a corrected values from a previously reported result of 24,000 platelets per microliter of blood and a monocyte result of 10.4%. Review of the instrument's printout showed a result of 242,000 platelets per microliter and a monocyte result of 10.4%. 2. Interview with the technical consultant and general supervisor on 5/4/21 at 12:10 PM revealed the results of the CBC were manually entered into the computer system and the error was discovered during a quality assessment review. The instrument printout for the corrected values could not be located to verify the reported result of 231,000 platelets per microliter or the monocyte result of 4.8%. D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if -- 2 of 3 -- applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on patient test record review, lack of documentation, and staff interview, the laboratory failed to ensure the original copy of a corrected patient test report was maintained for 1 of 1 corrected test reports reviewed (#236484). The laboratory performed approximately 200 complete blood counts (CBCs) per year. The findings were: 1. Review of patient test report #236484 showed the original CBC test report dated 11/12/20 had been amended to include the corrected values for platelets and monocytes. There was no documentation of the original test report with the inaccurate test results. 2. Interview on 5/4/21 at 12:10 PM with the technical consultant and general supervisor confirmed the original test report was not available and understood the need to keep both the original and corrected versions of the test report. -- 3 of 3 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on manufacturer's specifications review, lack of documentation, and interview with staff, the laboratory failed to monitor and document the ambient temperature for performing complete blood counts (CBC) using the AcT 5 instrument to be consistent with the manufacturer's instructions. Findings include: 1. The manufacturer stated the operating temperature for performing CBC testing is from 16 to 34 degrees C (60-93 degrees F). 2. The laboratory failed to document they monitored the room temperature prior to reporting patient specimens for 1 of 1 patient (159299) tested on 10/19/2018. 3. In an interview with staff on 10/22/2018 at approximately 4:15 P.M. staff stated they did not monitor or record the room temperature where CBC testing was performed. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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 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 -- director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on procedure manual review, lack of documentation, and interview with the laboratory manager, the director failed to ensure the laboratory established a quality assessment plan for general laboratory, pre-analytic, analytic, and post-analytic portions of complete blood cell count testing. The laboratory performs approximately 1 test per week. Findings include: 1. The laboratory procedure manual failed to include a quality assurance plan that includes the items the laboratory reviews, the frequency of review, and the method they use to document the review of general laboratory tasks (ex. proficiency testing review, testing personnel competency procedure performance, and complaint documentation and resolution); Pre-analytic quality assessment (ex. Specimen collection, patient identification verification, specimen labeling, storage, and transportation) performance; analytic quality assessment (ex. review of quality control, instrument preventive maintenance, reagent replacement and test record logs) performance; and post-analytic quality assessment, (ex. test report accuracy review) performance. 2. The laboratory lacked documentation of quality assessment plans or a method for documentation. 3. In an interview with the laboratory manager on 10/22/2018 at approximately 4:20 P.M. staff confirmed the laboratory did not have a written quality assessment plan for general laboratory, pre-analytic, analytic and post-analytic portions of the complete blood count testing process. -- 2 of 2 --