Jordan Valley Community Health Center

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the 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 review of blood bank procedures, and interview with the technical supervisor (TS) #2, the laboratory failed to provide a procedure for checking patient history in blood bank. Findings: 1. Review of blood bank procedures showed no procedure for checking patient history prior to performing blood bank procedures. 2. Interview with the TS #2 on May 24, 2023 at 9:30 AM confirmed the laboratory failed to provide a blood bank procedure for checking patient history. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of Cepheid GeneXpert quality control (QC), Diesse Mini cube sedrate QC, and interview with technical supervisor (TS) #2, the laboratory director (LD) failed to ensure that the quality assessment programs are established and maintained. Findings: 1. Review of the Cepheid GeneXpert QC for sars COVID-19, influenza, respiratory syncytial virus, chlamydia, gonorrhea, and trichomonas showed 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 -- no QC review to ensure appropriate QC results and to identify failures in quality as they occur. 2. Review of Diesse Mini cube sedrate QC showed no QC review to ensure appropriate QC results and to identify failures in quality as they occur. 3. Interview with the TS #2 on May 24, 2023 at 10:00 AM confirmed the LD failed to ensure that the quality assessment programs are established and maintained. D6095 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(6) The laboratory director must ensure the establishment and maintenance of acceptable levels of analytical performance for each test system. This STANDARD is not met as evidenced by: Based on observation of immunohematology testing area and interview with the technical supervisor (TS) #2, the laboratory director (LD) failed to ensure the establishment and maintenance of acceptable levels of analytical performance for each test system. Findings: 1. Observation of immunohematology testing area showed while performing approximately 5 blood bank type and screening tests the testing personnel was also performing approximately 15 rapid plasma reagin (RPR) tests simultaneously. 2. Interview with TS #2 on May 24, 2023 at 10:30 AM confirmed the LD failed to ensure the establishment and maintenance of acceptable levels of analytical performance for immunohematology and RPR testing. -- 2 of 2 --

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 observation of refrigerator reagents, refrigerator temperature logs and interview with the general supervisor (GS), the laboratory failed to follow manufacturer's instructions for storing Vitros 5600 calibrators for 14 of 132 days. Findings: 1. Observation of the laboratory refrigerator showed six boxes of chloride calibrators lot # 4010-0739-8746 expiration date 11/1/22 storage requirements 2 to 8 degrees Celsius, six boxes of albumin calibrators lot # 0932-3377-8388 expiration date 10/1/22 storage requirements 2 to 8 degrees Celsius and six boxes of calcium calibrators lot # 0349-0606-7120 expiration date 9/1/22 storage requirements 2 to 8 degrees Celsius. 2. Review of 2021 refrigerator temperature logs showed on 5/14, 5 /20, 5/25, 5/27, 5/28, 6/4, 6/7, 6/10, 6/21, 7/1, 7/2, 7/8, 7/9, 7/12 the refrigerator temperature was not within 2 to 8 degrees Celsius. 3. Interview with the GS on July 20, 2021 at 10:30 AM confirmed the laboratory failed to follow manufacturer's storage requirements for Vitros 5600 calibrators. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system 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 -- must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of performance verification procedures for the Ortho Diagnostics workstation, ABO, Rh, antibody screen and interview with the general supervisor (GS) the laboratory failed to verify accuracy and precision before reporting patient test results. Findings: 1. Review of performance verification procedures for the Ortho Diagnostics workstation, ABO, Rh and antibody screen showed the laboratory failed to verify accuracy and precision. 2. Interview with the GS on July 20, 2021 at 10:30 AM confirmed the laboratory failed to ensure performance verification procedures were adequate before reporting patient test results. 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 review of "Sysmex XN-550 CLSI" procedure, 2019/2020 calibration records for the Sysmex XN-550 hematology analyzer and interview with the general supervisor (GS), the laboratory failed to follow manufacturer's recommended frequency of every six months for calibration of the hematology analyzer in 2019 /2020. Findings: 1. Review of the"Sysmex XN-550 CLSI" procedure states "The laboratory must verify calibration every six months or on an "as-needed" basis to ensure accuracy of system." 2. Review of 2019, 2020 and 2021 calibration records for the Sysmex XN-550 hematology analyzer showed the laboratory failed to perform a calibration for the Sysmex XN-550 following manufacturer's recommended frequency of every six months in 2019/2020 for the analytes: white blood cell, red blood cell, hemoglobin, hematocrit and platelet. 3. Interview with the GS on July 20, 2021 at 10: 00 AM confirmed the laboratory failed to follow manufacturer's recommended frequency of every six months for calibration of the Sysmex XN-550 hematology analyzer in 2019/2020. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or -- 2 of 3 -- instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of Medtox Scan analyzers and interview with the general supervisor (GS), the laboratory failed to evaluate and define a relationship between test results using the same type of instrument twice a year for 2019, 2020 and to date July 20, 2021. Findings: 1. Review of Medtox Scan drug testing analyzers #1 and #2 for analytes: cannabinoids, phencyclidine, cocaine, methamphetamine, opiates, amphetamine, benzodiazepines, tricyclic antidepressants, methadone, barbiturates, oxycodone, propoxyphene, and buprenorphine showed no documentation of evaluation between test results using the same type of instrument twice a year for 2019, 2020 and to date July 20, 2021. 2. Interview with the GS on July 20, 2021 at 10: 00 AM confirmed the laboratory failed to evaluate and define a relationship between test results using the same type of instrument twice a year for 2019, 2020 and to date July 20, 2021. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies 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 Rapid Plasma Reagin (RPR) procedure, maintenance and interview with the laboratory director on October 22, 2018 at 12:15 PM confirmed the laboratory failed to follow manufacturers instructions and check rotation on rotor, needle accuracy and timer for RPR's each day of patient testing from September 2017 to date. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --