North Platte Valley Medical Center

Summary Statement of Deficiencies 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 personnel files, review of the Centers for Medicare and Medicaid Services 209 Laboratory Personnel Report, lack of documentation, review of policy and procedure, and staff interview, the general supervisor failed to complete a 6- month competency assessment for 1 of 2 testing personnel (TP #1) reviewed. The findings were: 1. Review of the personnel file for TP #1 showed she was hired on 2/2 /24 and an initial competency assessment had been completed; however, there was no documentation a 6-month competency assessment had been performed. 2. Interview with the general supervisor on 3/5/25 at 4:35 PM revealed she had assumed the position of general supervisor in October of 2024. The 6-month competency assessment for TP #1 could not be located. 3. Review of the Personnel Requirements policy and procedure, last reviewed by the laboratory director on 1/3/22, showed "General Supervisor will conduct employee competency evaluations. An employee will be assessed every 6 months for the first year of their employment and annually every year thereafter." D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) 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 -- (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(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 new test method verification study review, lack of documentation, and staff interview, the laboratory failed to ensure the verification studies were complete for 1 of 2 (Medtox urine drug screen) test system prior to patient testing. The laboratory performed approximately 108 Medtox urine drug screens per year. The findings were: 1. Review of the laboratory's documentation showed no evidence a verification study for the Medtox urine drug screen test system had been completed prior to patient testing. 2. Interview with the general supervisor on 3/6/25 at 8 AM revealed she had assumed the position of the general supervisor in October 2024. The general supervisor was unable to locate the verification study; however, was able to determine patient testing began on 8/16/23. Interview with the laboratory director on 3/6/25 at 9: 04 AM revealed he recalled a verification study being performed; however, was unable to locate the documentation. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on observation, review of the laboratory's documentation, and staff interview, the laboratory failed to perform function checks on each piece of equipment /instrument it uses to ensure accurate and reliable test reporting for 1 of 2 years (2024). The findings were: 1. Review of the immunohematology documentation showed the serologic centrifuge for immediate agglutination was to be calibrated annually. The method outlining the procedure was signed by the laboratory director on 6/28/23. The procedure stated it was last completed in June of 2023. There was no evidence the procedure had been completed in 2024. 2. Review of the immunohematology documentation showed the serologic centrifuge for washing and antiglobulin testing was to be calibrated annually. The method outlining the procedure was signed by the laboratory director on 6/28/23. The procedure stated it was last completed in June of 2023. There was no evidence the procedure had been completed in 2024. 3. Observation of the laboratory on 3/6/25 showed 4 pipettes were available for patient testing. Each pipette was labeled with a sticker which stated service was due on 6/27/23. 4. Review of the laboratory's documentation showed no evidence the timers or thermometers had been checked for accuracy. 5. Interview with the general supervisor on 3/6/25 at 11:43 AM confirmed no further documentation was available. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) (d)(3)(ii) Each qualitative procedure, include a negative and positive control material; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on lack of documentation and staff interview, the laboratory failed to perform a positive and negative control each day of patient testing for the Medtox urine drug screen test system. This failure affected approximately 108 patient tests. The findings were: 1. Review of the laboratory's quality control records showed no documentation external quality control had been performed on the Medtox urine drug screen test system. 2. Interview with the general supervisor on 3/6/25 at 10:26 AM revealed she had assumed the position of general supervisor in October of 2024. The general supervisor revealed she had recently identified the failure and had ordered external quality control. Further, the general supervisor was able to determine patient testing started on 8/16/23. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood shall be stored in a clean and orderly environment in a manner to prevent mix-ups. Expired blood must not be in the routine inventory. Unacceptable units must be segregated from routine inventory. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. This STANDARD is not met as evidenced by: Based on observation, staff interview, review of the laboratory's immunohematology documentation, and policy and procedure review, the laboratory failed to ensure the audible alarm was inspected and functioning appropriately for 1 of 2 years reviewed (2024). The findings were: 1. Observation of the blood product storage refrigerator showed 1 unit of O positive and 1 unit of O negative packed red blood cells were available for patient use. 2. Review of the laboratory's immunohematology verification study showed it was completed on 5/25/23 and signed by the laboratory director on 5/30/23. 3. Review of the "Blood Bank Alarm Checks" policy, last reviewed by the laboratory director on 8/29/24, showed alarm checks were to be completed monthly to ensure the remote alarms were functioning and personnel responded in a timely manner. The set point of the alarm system was to be validated quarterly. Review of the 2024 log sheet showed the monthly alarm checks were completed in March, May, June, and July. The quarterly checks were completed in March, May, June and July. There was no evidence the blood product storage unit audible alarms had been checked in 2025. 4. Interview with the general supervisor on 3/6/25 at 10:37 AM confirmed no further documentation was available. -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services Casper Report 155, review of the College of American Pathologists evaluation reports, and staff interview, the laboratory failed to achieve satisfactory performance scores on the analyte of creatinine for 2 consecutive events (2024 event #1, 2024 event #2). Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services (CMS) Casper Report 155, review of the CAP (College of American Pathologists) evaluation reports, and staff interview, the laboratory failed to achieve satisfactory performance scores on the analyte of creatinine for 2 consecutive events (2024 event #1, 2024 event #2). The findings were: 1. Review of the CMS Casper 155 report showed the laboratory failed to successfully obtain a passing score for the analyte of creatinine for the following CAP proficiency testing events: a. 2024 event #1 showed the laboratory scored a 20%. b. 2024 event #2 showed the laboratory scored a 60%. 2. Telephone interview with the laboratory director on 8/30/24 at 8 AM confirmed the laboratory had failed 2 consecutive proficiency testing events on the analyte of creatinine. -- 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 testing personnel (TP) and/or the laboratory director (LD) failed to attest to the routine integration of proficiency tests into the patient workload for 4 of 8 AAB (American Association of Bioanalysts) and 6 of 12 CAP (College of American Pathologists) proficiency testing (PT) events reviewed from September 2021 through December 2022. The findings were: 1. Review of the AAB proficiency testing records failed to include the signatures of the testing personnel (TP) and/or the laboratory director (LD) for the following events: a. The 2021 non-chemistry quarter 3 event attestation statement failed to include the signature of the LD on the serology section of the PT event. b. The 2021 chemistry quarter 3 event attestation statements failed to include the signature of the LD on the urinalysis, lipid, ammonia, clinical microscopy, D-dimer, special chemistry, immunochemistry, basic chemistry, and comprehensive chemistry sections of the PT event. In addition, the clinical microscopy attestation statement failed to include the signature of the TP. c. The 2022 chemistry quarter 1 event attestation statements failed to include the signature of the LD on the basic chemistry, clinical microscopy, comprehensive chemistry, immunochemistry, urinalysis, and special chemistry sections of the PT event. In addition, the comprehensive chemistry and urinalysis attestation statements failed to include the signature of the TP. d. The 2022 chemistry quarter 2 event attestation statements failed to include the signature of the LD on the comprehensive chemistry section of the PT event. 2. Review of the CAP proficiency testing records failed to include the signatures of the TP and/or the LD for the following events: a. The 2021 quarter 3 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 -- diagnostic immunology attestation statement failed to include the signature of the LD. b. The 2021 quarter 2 PCT-B attestation statement failed to include the signature of the LD. c. The 2022 quarter 3 CAR-C attestation statement failed to include the signature of the LD. d. The 2022 quarter 1 K-A attestation statement failed to include the signature of the TP and the LD. e. The 2022 quarter 2 K-B attestation statement failed to include the signature of the TP and the LD. f. The 2022 quarter 1 PCT-A records failed to include a copy of the attestation statement. 3. Interview with the general supervisor on 1/25/23 at 9:45 AM confirmed the attestation statements had not been signed. 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 the AAB (American Association of Bioanalysts) and CAP (College of American Pathologists) proficiency testing (PT) records, lack of documentation, and staff interview, the laboratory failed to review and evaluate proficiency testing results for 6 of 20 testing events reviewed from September 2021 to December 2022. The findings were: 1. Review of the AAB and CAP proficiency testing records failed to include documentation the laboratory had evaluated the proficiency testing results. The following concerns were identified: a. Review of the AAB 2021 quarter 3 non-chemistry event showed no documentation the laboratory director (LD) had reviewed the results. b. Review of the AAB 2021 quarter 3 chemistry event showed no documentation the LD had reviewed the results. c. Review of the AAB 2022 quarter 1 chemistry event showed no documentation the LD had reviewed the results. d. Review of the CAP 2021 PCT-B (procalcitonin) event showed no documentation the LD had reviewed the results. e. Review of the CAP 2021 CAR- C (troponin I) event showed no documentation the LD had reviewed the results. f. Review of the CAP 2022 CAR-B (troponin I) event showed no documentation the LD had reviewed the results. 2. Interview with the general supervisor on 1/25/23 at 9:45 AM confirmed the PT records did not show documentation of the LD's review of the results. 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 test results that received an artificial score of 100% due to lack of peer group data for 6 of 20 AAB (American Association of Bioanalysts) and CAP (College of American Pathologists) proficiency testing events reviewed from September 2021 to December -- 2 of 3 -- 2022. This failure affected the analytes of troponin I, ammonia, lipase, and D-dimer. The laboratory performed approximately 10 troponin I, 2 ammonia, 8 lipase, and 10 D- dimer patients tests annually. The findings were: 1. Review of the CAP proficiency testing evaluation forms showed the laboratory received an artificial score of 100% on the analyte of troponin I on the CAP 2021 CAR-C event, the CAP 2022 CAR-A event, and the CAP 2022 CAR-C event due to a lack of peer group data. There was no documentation the laboratory had performed a self-evaluation. 2. Review of the AAB proficiency testing evaluation forms showed the laboratory received an artificial score of 100% on the analyte of ammonia on the AAB 2022 quarter #1, quarter #2, and quarter #3 due to a lack of peer group data. There was no documentation the laboratory had performed a self-evaluation. 3. Review of the AAB 2022 quarter #2 proficiency testing evaluation form showed the laboratory received an artificial score of 100% on the analyte of lipase due to a lack of peer group data. There was no documentation the laboratory had performed a self-evaluation. 4. Review of the AAB 2022 quarter #3 proficiency testing evaluation form showed the laboratory received an artificial score of 100% on the analyte of D-dimer due to a lack of peer group data. There was no documentation the laboratory had performed a self-evaluation. 5. Interview with the general supervisor on 1/25/23 at 9:45 AM confirmed an evaluation of the proficiency testing results had not been performed to ensure the accuracy of the analytes. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on observation, review of the Beckman Coulter Allegra X-30R centrifuge manufacturer's instructions for use, and staff interview, the laboratory failed to define a function check protocol to ensure system performance for 1 of 1 centrifuge (Beckman Coulter Allegra X-30R). The findings were: 1. Observation on 1/24/23 at 1: 45 PM showed the laboratory used a Beckman Coulter Allegra X-30R centrifuge to separate blood components for patient testing. 2. Review of the Beckman Coulter Allegra X-30R centrifuge manufacturer's instructions for use showed no function check protocols were provided by the manufacturer. 3. There was no documentation the laboratory had defined a function check and maintenance protocol. 4. Interview with the general supervisor on 1/24/23 at 1:57 PM confirmed function checks on the centrifuge had not been performed. -- 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 the laboratory's COVID-19 patient testing log, review of policy and procedure, and staff interview, the laboratory failed to report 233 SARS-CoV-2 negative test results, as required, for 15 weeks of testing (5/24/21 to 9/8/21) reviewed. The findings were: 1. Review of the laboratory's COVID-19 patient testing log showed 308 SARS-CoV-2 patient tests were performed using the Abbott Binax Now test system from 5/24/21 to 9/8/21. There was no evidence the 233 negative patient test results had been reported to the State Public Health Laboratory. 2. Review of the procedure titled "Abbot Binax Now Covid-19" showed "Positive results must be reported to the State of Wyoming Public Health Department." 3. Interview with the laboratory manager on 9/9/21 at 1:40 PM confirmed the negative patient test results were not reported to the State Public Health Laboratory. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper 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 -- 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 estimated it would perform approximately 15,095 tests annually. The findings were: 1. Review of the daily environmental log showed the humidity level in the lab was not monitored. 2. Review of the Beckman Coulter manufacturer's instructions showed the following environmental requirements: a. The Access 2, AU480, and IQ200 required the relative humidity to be maintained between 20% and 80%. b. The DxH900 required the relative humidity to be less than 70%. 3. Interview with the laboratory manager on 9/9 /21 at 9:15 AM confirmed the laboratory did not measure, monitor, or record relative humidity. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system 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 new instrumentation and new test method verification study review, and staff interview, the laboratory failed to verify the accuracy for 4 of 4 new Beckman Coulter analyzers (AU480, Access 2, DxH900, IQ200) prior to patient testing. The laboratory estimated 10,160 routine chemistry tests, 3700 hematology tests, 675 endocrinology tests, 550 urinalysis tests, and 10 general immunology tests would be performed annually. The findings were: 1. Review of the laboratory's new instrument verification study for the Beckman Coulter AU480 (chemistry analyzer), the Beckman Coulter Access 2 immunoassay analyzer), the Beckman Coulter DxH900 (hematology analyzer), and the Beckman Coulter IQ200 (urinalysis analyzer) failed to show the performance specification of accuracy had been verified by the laboratory prior to patient testing on 5/4/21. 2. Interview with the laboratory manager on 9/9/21 at 10 AM confirmed the laboratory had not verified accuracy prior to testing patient samples. 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 -- 2 of 3 -- 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 review of the instrumentation method verification records, lack of documentation, and staff interview, the laboratory director failed to evaluate and approve the results of the reportable range and precision verification studies and ensure the accuracy of each new analyzer prior to testing patient samples for 4 of 4 new analyzers (Access 2, AU480, DxH900, IQ200). The laboratory estimated it would perform approximately 15,095 tests annually. The findings were: 1. Review of the laboratory's new instrument verification study for the Beckman Coulter AU480 (chemistry analyzer), the Beckman Coulter Access 2 (immunoassay analyzer), the Beckman Coulter DxH900 (hematology analyzer), and the Beckman Coulter IQ200 (urinalysis analyzer) failed to show the performance specification of accuracy had been verified by the laboratory prior to patient testing on 5/4/21. 2. Review of the method verification records for the Beckman Coulter Access2, AU480, DxH900, and IQ200 showed the performance specifications for reportable range and precision had been verified, however the laboratory director had not signed the report as approved. 3. Interview with the laboratory manager on 9/9/21 at 10 AM confirmed the new instrument verification studies had not been signed by the laboratory director and the accuracy studies 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 the laboratory's COVID-19 patient testing log, review of policy and procedure, and staff interview, the laboratory failed to report 233 SARS-CoV-2 negative test results, as required, for 15 weeks of testing (5/24/21 to 9/8/21) reviewed. The findings were: 1. Review of the laboratory's COVID-19 patient testing log showed 308 SARS-CoV-2 patient tests were performed using the Abbott Binax Now test system from 5/24/21 to 9/8/21. There was no evidence the 233 negative patient test results had been reported to the State Public Health Laboratory. 2. Review of the procedure titled "Abbot Binax Now Covid-19" showed "Positive results must be reported to the State of Wyoming Public Health Department." 3. Interview with the laboratory manager on 9/9/21 at 1:40 PM confirmed the negative patient test results were not reported to the State Public Health Laboratory. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper 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 -- 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 estimated it would perform approximately 15,095 tests annually. The findings were: 1. Review of the daily environmental log showed the humidity level in the lab was not monitored. 2. Review of the Beckman Coulter manufacturer's instructions showed the following environmental requirements: a. The Access 2, AU480, and IQ200 required the relative humidity to be maintained between 20% and 80%. b. The DxH900 required the relative humidity to be less than 70%. 3. Interview with the laboratory manager on 9/9 /21 at 9:15 AM confirmed the laboratory did not measure, monitor, or record relative humidity. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system 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 new instrumentation and new test method verification study review, and staff interview, the laboratory failed to verify the accuracy for 4 of 4 new Beckman Coulter analyzers (AU480, Access 2, DxH900, IQ200) prior to patient testing. The laboratory estimated 10,160 routine chemistry tests, 3700 hematology tests, 675 endocrinology tests, 550 urinalysis tests, and 10 general immunology tests would be performed annually. The findings were: 1. Review of the laboratory's new instrument verification study for the Beckman Coulter AU480 (chemistry analyzer), the Beckman Coulter Access 2 immunoassay analyzer), the Beckman Coulter DxH900 (hematology analyzer), and the Beckman Coulter IQ200 (urinalysis analyzer) failed to show the performance specification of accuracy had been verified by the laboratory prior to patient testing on 5/4/21. 2. Interview with the laboratory manager on 9/9/21 at 10 AM confirmed the laboratory had not verified accuracy prior to testing patient samples. 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 -- 2 of 3 -- 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 review of the instrumentation method verification records, lack of documentation, and staff interview, the laboratory director failed to evaluate and approve the results of the reportable range and precision verification studies and ensure the accuracy of each new analyzer prior to testing patient samples for 4 of 4 new analyzers (Access 2, AU480, DxH900, IQ200). The laboratory estimated it would perform approximately 15,095 tests annually. The findings were: 1. Review of the laboratory's new instrument verification study for the Beckman Coulter AU480 (chemistry analyzer), the Beckman Coulter Access 2 (immunoassay analyzer), the Beckman Coulter DxH900 (hematology analyzer), and the Beckman Coulter IQ200 (urinalysis analyzer) failed to show the performance specification of accuracy had been verified by the laboratory prior to patient testing on 5/4/21. 2. Review of the method verification records for the Beckman Coulter Access2, AU480, DxH900, and IQ200 showed the performance specifications for reportable range and precision had been verified, however the laboratory director had not signed the report as approved. 3. Interview with the laboratory manager on 9/9/21 at 10 AM confirmed the new instrument verification studies had not been signed by the laboratory director and the accuracy studies had not been completed. -- 3 of 3 --