Meeker Memorial Hospital

Summary Statement of Deficiencies D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or 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 observation, record review, and an interview with laboratory personnel, the laboratory failed to define and evaluate the acceptable relationship between two Hematology analyzers and two Chemistry testing methods at least twice annually in 2021 and 2022. Findings are as follows: 1. The laboratory performed Hematology and Chemistry testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 9:45 a.m. on January 18, 2023. 2. The following Hematology and Chemistry instruments were observed and present and available for use during the tour: One Beckman Coulter DxH 600 Hematology analyzer - primary method One Beckman Coulter DxH 520 Hematology analyzer - back up method One Roche Cobas c6000 Chemistry analyzer - primary method One iSTAT Chem 8+ Chemistry analyzer - back up method 3. A twice annual process for comparison of test results obtained from multiple non-waived methods was not found in the laboratory's procedure manual. 4. Comparison of test results obtained from the two Hematology and two Chemistry methods was not found in laboratory records from 2021 and 2022. The laboratory was unable to provide documentation of test comparisons upon request. 5. In an interview at 10:17 a.m. on January 18, 2023, the Technical Consultant confirmed the laboratory was not evaluating the relationship between the two Hematology and two Chemistry methods at least twice annually. . 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 --

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 a review of Center for Medicare and Medicaid Services (CMS) reports and American Proficiency Institute (API) proficiency testing reports, the laboratory failed to successfully participate in proficiency testing (PT) in 2020 for Human Chorionic Gonadotropin (HCG) and Endocrinology. Findings include: 1. The CMS CASPER Report 0155D and API PT Performance Summary, reviewed on November 25, 2020, indicated the the laboratory failed to successfully participate in HCG and Endocrinology PT testing in two testing events in 2020. See D2098 and D2099. Unsatisfactory PT performance in HCG was obtained in the following events: -2020 3rd event 40% -2020 1st event 40% Unsatisfactory PT performance in Endocrinology 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 -- was obtained in the following events: -2020 3rd event 70% -2020 1st event 70% 2. The CMS CASPER Report 0155D and API PT Performance Summary indicated the laboratory failed to obtain successful HCG and Endocrinology PT scores in two out of three consecutive testing events in 2020. See D2107 and D2108. . D2098 ENDOCRINOLOGY CFR(s): 493.843(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: . Based on a review of Center for Medicare and Medicaid Services reports and American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to attain satisfactory PT scores for Human Chorionic Gonadotropin (HCG) testing. Findings are as follows: 1. The laboratory failed to attain PT scores for HCG testing of at least 80 percent in two testing events. Scores less than 80 percent resulted in unsatisfactory performance for the analyte. 2. API PT reports listed the following unsatisfactory HCG scores: - 2020 3rd event: 40% - 2020 1st event: 40% . D2099 ENDOCRINOLOGY CFR(s): 493.843(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: . Based on a review of Center for Medicare and Medicaid Services reports and American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to attain satisfactory PT scores for Endocrinology testing. Findings are as follows: 1. The laboratory failed to attain an overall testing event score in Endocrinology of at least 80 percent in two testing events. Scores less than 80 percent resulted in unsatisfactory performance for the specialty. 2. API PT reports listed the following unsatisfactory Endocrinology events: - 2020 3rd event: 70% - 2020 1st event: 70% . D2107 ENDOCRINOLOGY CFR(s): 493.843(f) 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 a review of Center for Medicare and Medicaid Services reports and American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to achieve successful PT performance for Human Chorionic Gonadotropin (HCG) testing. Findings are as follows: 1. The laboratory failed to attain satisfactory HCG PT scores in two out of three consecutive PT events. Two out of three consecutive unsatisfactory PT scores for the same analyte constituted unsuccessful -- 2 of 3 -- performance. 2. API PT reports listed the following unsatisfactory HCG scores: - 2020 3rd event: 40% - 2020 1st event: 40% . D2108 ENDOCRINOLOGY CFR(s): 493.843(g) Failure to achieve an overall testing event score of satisfactory performance for 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 a review of Center for Medicare and Medicaid Services reports and American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to achieve successful PT performance in Endocrinology testing. Findings are as follows: 1. The laboratory failed to achieve a satisfactory overall testing event score in Endocrinology in two out of three consecutive PT events. Two out of three consecutive unsatisfactory PT scores in the same specialty constituted unsuccessful performance. 2. API PT reports listed the following unsatisfactory Endocrinology events: - 2020 3rd event: 70% - 2020 1st event: 70% -- 3 of 3 --

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 document review and interview with laboratory personnel, the laboratory failed to establish and follow a written competency assessment procedure for General Supervisor and Technical Supervisor. Findings are as follows: 1. The laboratory performed Chemistry, Coagulation, Hematology, Immunology, Immunohematology, Microbiology, Parasitology, Urinalysis, Virology and Toxicology testing as by Testing Personnel 1 (TP1) during a tour of the laboratory on 01/16/19 at 10:05 a.m. 2. A competency assessment procedure for General Supervisor and Technical Supervisor was not found during review of laboratory policies and procedures. The laboratory was unable to provide a competency assessment procedure upon request. 3. Competency assessments for the General Supervisor and Technical Supervisor for 2017 and 2018 were not found during review of laboratory records. The laboratory was unable to provide the documentation upon request. 4. In an interview on 01/16/19 at 11:15 am., TP1 confirmed the above findings. . 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- . Based on document review and interview with laboratory personnel, the laboratory failed to investigate an unacceptable Endocrinology proficiency testing (PT) result for 1 analyte in 2018. Findings are as follows: 1. The laboratory performed Endocrinology testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory on 01/16/19 at 10:05 a.m. 2. The laboratory performed PT using the American Proficiency Institute (API) as PT provider. 3. The laboratory received an unacceptable PT result from API for the survey event, sample and analyte listed below. Survey Event: 2018 Chemistry Core / 2nd Sample: HCG-10 Analyte: HCG* (Serum Quantitative) 4. An investigation of the unacceptable PT result was not found during review of laboratory records. The laboratory was unable to provide investigation documentation upon request. 5. In an interview on 01/16/19 at 12:30 p. m., TP1 confirmed the above findings. * HCG = human chorionic gonadotropin . D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of non-graded proficiency testing (PT) results. Findings are as follows: 1. The laboratory performed Chemistry, Toxicology and Hematology testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory on 01/16/19 at 10:05 a.m. 2. The laboratory performed PT using the American Proficiency Institute (API) as PT provider. 3. The laboratory received non-graded results from API due to no consensus for the survey events, samples and analytes listed below. Event: 2017 Chemistry Core / 2nd Sample ID: CM-07 Test: Troponin I Event: 2017 Chemistry Misc / 2nd Sample ID: IA-04 & IA-06 Test: Folate Event: 2018 Chemistry Misc / 1st Sample ID: UDS-02 Test: Urine Drug Screen / Opiates Event: 2018 Hematology / Coagulation / 1st Sample ID: CYS-02 Test: Body Fluid Crystals 4. An evaluation of the non-graded PT results was not found during review of laboratory records. The laboratory was unable to provide evaluations upon request. 5. In an interview on 01/16/19 at 12:30 p.m., TP1 confirmed the above findings. . D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on observation, document review and interview with laboratory personnel, the laboratory failed to to establish and follow a procedure for the ongoing monitoring of -- 2 of 4 -- the effectiveness of 3 Individualized Quality Control Plans (IQCP). Findings are as follows: A. Chemistry - Arterial Blood Gases (ABG's) 1. The laboratory performed Chemistry testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory on 01/16/19 at 10:05 a.m. 2. An Abbott i-Stat analyzer was observed as present and available for use during the tour of the laboratory. 3. An Individualized Quality Control Plan (IQCP) to reduce the frequency of QC performance from each day of patient testing for ABG's (established March, 2015) was located in the IQCP Manual. 4. An annual review of the ABG IQCP for 2017 and 2018 was not found in laboratory records. The laboratory was unable to provide the documentation upon request. 5. In an interview on 1/17/19 at 10:05 am., TP1 confirmed the above findings. B. Chemistry - Microalbumin (M/Alb) 1. The laboratory performed Chemistry testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory on 01/16/19 at 10:05 a.m. 2. An Alere Affinion analyzer was observed as present and available for use during the tour of the laboratory. 3. An Individualized Quality Control Plan (IQCP) to reduce the frequency of QC performance from each day of patient testing for M/Alb (established August, 2015) was located in the IQCP Manual. 4. An annual review of the M/Alb IQCP for 2017 and 2018 was not found in laboratory records. The laboratory was unable to provide the documentation upon request. 5. In an interview on 1/17/19 at 10:05 am., TP1 confirmed the above findings. C. Immunology - Amniosure 1. The laboratory performed Immunology testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory on 01/16/19 at 10:05 a.m. 2. Qiagen Amniosure Rupture of Fetal Membranes (ROM) test kits were observed as present and available for use during the tour of the laboratory. 3. An Individualized Quality Control Plan (IQCP) to reduce the frequency of QC performance from each day of patient testing for the Amniosure test kits (established September, 2015) was located in the IQCP Manual. 4. An annual review of the Amniosure IQCP for 2017 and 2018 was not found in laboratory records. The laboratory was unable to provide the documentation upon request. 5. In an interview on 1/17/19 at 10:05 am., TP1 confirmed the above findings. . D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: . Based on observation, document review and interview with laboratory personnel, the laboratory failed to ensure reference intervals were consistent between a Chemistry procedure and a patient test report. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory on 01/16/19 at 10:05 a.m. 2. A Roche C6000 immunoassay analyzer was observed as present and available for use during the tour. 3. The reference interval for Vitamin B12 listed in procedures was not consistent with those on the patient test report (Male - 66 years, Date performed = 2-16-18) reviewed on date of survey as indicated below: Procedure: Roche Cobas Vitamin B12 Application Sheet Version = 2016-07, v7.0 Reference Range: 211 - 946 Procedure: Roche Cobas Vitamin B12 II Instruction for Use (IFU) Version = 2017-04, v1.0 English Reference Range: 22 - 1245 Patient Report Reference Range: 213 - 816 4. In an interview on 1 /17/19 at 9:15 am., TP1 confirmed the above findings. . -- 3 of 4 -- D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that 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 observation, document review and interview with laboratory personnel, the laboratory failed to provide documentation of review and approval by the laboratory director of Performance Verification results prior to implementation of a revised Chemistry test method. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by Testing Personnel 1 (TP1) during a tour of the laboratory on 01/16/19 at 10:05 a.m. 2. A Roche C6000 immunoassay analyzer was observed as present and available for use during the tour. 3. A Performance Verification (PV) data binder (established July, 2017) with precision and accuracy verification for a revised Vitamin B12 test method on the Roche C6000 immunoassay analyzer analyzer was found during review of laboratory records. 4. The Laboratory Director (LD) failed to sign and date the documents found in the Performance Verification (PV) data binder . 5. In an interview on 1/17/19 at 9:15 am., TP1 confirmed the above findings. . -- 4 of 4 --