Lake View Memorial Hospital

Summary Statement of Deficiencies D0000 . The Lake View Memorial Hospital laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the recertification survey performed on March 13,2023. The following standard-level deficiencies were cited: 493.1105 Retention requirements 493.1251 Procedure manual 493.1256 Control procedures 493.1445 Laboratory director responsibilities 493.1451 Technical supervisor responsibilities . D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to retain analytic testing records records from 2023 for at least 2 years. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:05 a.m. on 03/13/25. 2. Two Siemens Dimension EXL 200 chemistry analyzers and an Abbott i-STAT device were observed as present and available for use during the tour. 3. Comparison of duplicate methods was required twice annually as established in the Quality Program Laboratory procedure. 4. Comparison documentation of test results between these duplicate methods from 2023 was not found during review of laboratory records. The laboratory was unable to provide documentation of test comparisons from 2023 upon request due to an electronic data issue. 5. In an Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- interview at 6:05 p.m. on 03/13/25, the GS confirmed the above finding. 6. The laboratory was given an opportunity to obtain the missing data within five days of the survey. The laboratory did not provide the data by 03/18/25. . D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to review proficiency testing (PT) results and take

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, document review and interview with laboratory personnel, the laboratory failed to evaluate the relationship between test results obtained from the Hematology analyzer and a manual testing method, and between two different Chemistry analyzers, at least twice annually. Findings are as follows: A. Hematology 1. The laboratory performed Hematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 7:05 a.m., on 07/01/21. 2. A Sysmex XL - 450 hematology analyzer was observed as present and available for use during the tour. The GS indicated the laboratory performed and reported both automated and manual White Blood Cell (WBC) differential testing. 3. The Sysmex XL - 450 / Complete Blood Count procedure, located in the on-line policy and procedure manual, did not include a requirement to compare WBC automated and manual differential testing twice annually. Twice annual comparisons of these test methods was not found in laboratory records. The laboratory was unable to provide comparison records upon request. 4. In an interview at 11:15 a.m., on 07/01/21, the GS confirmed the above finding. B. Chemistry 1. The laboratory performed Chemistry testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 7:05 a.m., on 07/01/21. 2. A Siemens Healthineers Dimension EXL chemistry analyzer, and an Abbott i-STAT chemistry analyzer, were observed as present and available for use during the tour. The GS indicated the laboratory performed and reported basic metabolic chemistry panels (BMP) by both methods. 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 2 -- The i-STAT and Dimension EXL procedures, both located in the on-line policy and procedure manual, did not include a requirement to compare BMP testing twice annually. Twice annual comparisons of these test methods was not found in laboratory records. The laboratory was unable to provide comparison records upon request. 4. In an interview at 11:15 a.m., on 07/01/21, the GS confirmed the above finding. . 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 a reference interval was consistent between a Chemistry procedure and a patient test report. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 7:05 a.m., on 07/01/21. 2. A Siemens Healthineers Dimension EXL chemistry analyzer was observed as present and available for use during the tour. 3. A reference interval listed in the Siemens Dimension EXL System Electrolytes (Na, K, Cl) procedure, located in the on-line policy and procedure manual, was not consistent with that included on a patient test report reviewed on date of survey, as indicated below. Patient - adult male, aged 86 yrs, tested on 8/04/20 Test: Chloride Procedure 96 - 107 mmol/L Report 98 - 107 mmol/L 4. In an interview at 2:45 p.m., on 7/01/21, the GS confirmed the above finding. . D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the technical consultant (TC) failed to ensure 5 of 5 testing personnel were evaluated for test procedure competency in all specialties in 2019 and 2020. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 7:05 a.m., on 07/01/21. 2. A Vital Diagnostics Excyte Mini Erythrocyte Sedimentation Rate (ESR) analyzer was observed as present and available for use during the tour. 3. In an interview at 8:25 a.m., on 7/01/21, the GS confirmed that the laboratory performed Post Vasectomy Semen Analysis testing. 4. Competency assessments for the above test methods were not included in the Competency Evaluation procedure, or forms completed in 2019 and 2020 for 5 of 5 testing personnel. 5. The laboratory was unable to provide the missing evaluations upon request. 6. In an interview at 8:25 a.m. on 7/01/201, the GS confirmed the above finding. -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to retain function check records for an Immunohematology centrifuge for at least 2 years. Findings are as follows: 1. The laboratory performed Immunohematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 11/08/18 at 8:10 a.m. 2. An Ortho MTS ID-Micro Typing System was observed as present and available for use during the tour. 3. The October 2017 "MTS Centrifuge Check Log (day of use)" document was not present in laboratory records on date of survey. The laboratory was unable to provide the missing document upon request. 4. In an interview on 11/08/18 at 4:10 p.m.,the GS indicated the missing function check record could not be located. 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 Chemistry and 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 -- Hematology procedures and patient test reports. Findings are as follows: The laboratory performed Chemistry and Hematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 11/08/18 at 8:10 a.m. A. Chemistry 1. An i-STAT System analyzer was observed as present and available for use during the tour. 2. The reference intervals listed in the manufacturer's Procedure Manual for the i-STAT System were not consistent with those included on the patient test report reviewed on date of survey as indicated below. Patient - adult female tested on 04/28 /18 Analyte* Procedure Report pO2 80-105 80-100 HCO3 22-26 23-27 BE (-)2-(+)3 (- )2-(+)2 O2s 95-98 94-97 3. In an interview on 11/08/18 at 3:30 p.m., the GS confirmed the reference range discrepancy between the procedure and the patient test report. B. Hematology 1. A Sysmex XS-1000i hematology analyzer was observed as present and available for use during the tour. 2. The Mean Platelet Volume (MPV) reference interval listed in the Sysmex XS-1000i Automated Blood Count procedure located in the electronic procedure manual was not consistent with that included on the patient test report reviewed on date of survey. See below. Patient - adult male tested on 07/11/17 Analyte Procedure Report MPV 6.0-11.0 9.1-12.4 3. In an interview on 11/08/18 at 1:55 p.m., Technical Consultant 1 confirmed the reference range discrepancy between the procedure and the patient test report. *Note pO2 - Partial Pressure of Oxygen HCO3 - Bicarbonate BE - Base Excess O2s - Oxygen Saturation D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the technical supervisor failed to ensure 2 of 3 new testing personnel received documented initial training in 2018. Findings are as follows: 1. The laboratory performed Microbiology, Chemistry, Hematology and Immunohematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 11/08/18 at 8:10 a.m. 2. Review of personnel records indicated documentation of initial training in 2018 for Testing Personnel 5 (TP5)was incomplete for the following: Hematology Coagulation, Erythrocyte Sedimentation Rate Body Fluid Microbiology 3. No training documents were found for Testing Personnel 6 (TP6). 4. The laboratory was unable to provide the missing training documents upon request. 5. In an interview on 11/08/18 at 10:15 a. m., the GS stated all testing personnel were working independently in the laboratory and confirmed the above finding for TP6. In an interview at 11:35 a.m., the Nurse Manager confirmed the above finding for TP5. -- 2 of 2 --

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 proficiency testing reports from the American Proficiency Institute, the laboratory failed to successfully participate in proficiency testing for Compatibility Testing under the specialty of Immunohematology. Findings are as follows: D2173 - the laboratory failed to obtain a PT score for Compatibility Testing of at least 100 percent in two testing events D2181 - the laboratory failed to achieve satisfactory performance for Compatibility Testing in two out of three consecutive testing events D2173 COMPATIBILITY TESTING 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 -- CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: . Based on a review of proficiency testing (PT) reports from the American Proficiency Institute (API), the laboratory failed to obtain a PT score for Compatibility Testing of at least 100 percent which resulted in unsatisfactory performance for the analyte. Unsatisfactory PT performance of Compatibility Testing was obtained in the following events. -2017 3rd event 80% -2018 1st event 80% D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory 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 proficiency testing scores from the American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance for Compatibility Testing in two out of three consecutive testing events, constituting unsuccessful performance for the analyte. API results indicated the laboratory had unsatisfactory performance for Compatibility Testing in two out of three consecutive events, leading to unsuccessful performance. Unsatisfactory PT performance of Compatibility Testing was obtained in the following events. -2017 3rd event 80% -2018 1st event 80% -- 2 of 2 --