Olivia Hospital & Clinic

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 proficiency testing (PT) scores from the American Proficiency Institute (API), the laboratory failed to successfully participate in Compatibility Testing PT under the specialty of Immunohematology in 2022 and 2023. Findings are as follows: 1. The laboratory failed to participate in the 2nd Immunohematology testing event in 2022 which resulted in a score of 0% for all analytes. See D2178 2. The laboratory failed to achieve satisfactory performance for Compatibility Testing in two out of three consecutive testing events in 2022 and 2023, constituting unsuccessful participation for the analyte. D2181 . 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 -- D2178 COMPATIBILITY TESTING CFR(s): 493.863(c) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. 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 participate in the 2nd Immunohematology testing event in 2022 which resulted in a score of 0% for all analytes. Findings are as follows: 1. The API Performance Summary and Comparative Evaluation PT report from the 2022 2nd Immunohematology testing event was reviewed on June 12, 2023. 2. The report indicated the laboratory received a 0% score for failure to participate in PT for all Immunohematology analytes, including Compatibility Testing. . 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 (PT) 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 participation for the analyte. Findings are as follows: 1. API Performance Summary and Comparative Evaluation PT reports from the 2022 Immunohematology 2nd Event and the 2023 Immunohematology 1st Event were reviewed on June 12, 2023. 2. The reports indicated the laboratory had unsatisfactory performance for Compatibility Testing in two out of three consecutive events, leading to unsuccessful participation. Unsatisfactory PT performance for Compatibility Testing was obtained in the following events: Event Score -2022 2nd event 0% -2023 1st event 80% . D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: . Based on review of proficiency testing reports from the American Proficiency Institute, the Laboratory Director failed to provide overall management and direction in accordance with 493.1455 of this subpart. Findings are as follows: 1. The Laboratory Director failed to ensure proficiency testing (PT) results were returned to the PT provider within the established timeframe. See D6090 . D6090 LABORATORY DIRECTOR RESPONSIBILITIES -- 2 of 3 -- CFR(s): 493.1445(e)(4)(ii) The laboratory director must ensure the results are returned within the timeframes established by the proficiency testing program. 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 Director failed to ensure PT results were returned to API within the established timeframe. Findings are as follows: 1. The API Performance Summary and Comparative Evaluation PT report from the 2022 2nd Immunohematology testing event was reviewed on June 12, 2023. 2. The report indicated the laboratory failed to participate in the event which resulted in a 0% score for all analytes. -- 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 a review of Center for Medicare and Medicaid Services reports and American Proficiency Institute proficiency testing reports, the laboratory failed to successfully participate in proficiency testing (PT) in 2022 for Albumin (ALB) under the specialty of Chemistry. Findings include: 1. The laboratory failed to attain PT scores for ALB testing of at least 80 percent in two events in 2022. See D2087 2. The laboratory failed to attain an ALB PT score of at least 80 percent in two out of three consecutive PT events. See D2096 . D2087 ROUTINE CHEMISTRY 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): 493.841(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 (CMS) reports and American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to attain satisfactory PT scores for Albumin (ALB) testing. Findings are as follows: 1. The laboratory failed to attain PT scores for ALB testing of at least 80 percent in two events in 2022. Scores less than 80 percent resulted in unsatisfactory performance for the analyte. 2. CMS CASPER Report 0155D and API PT reports listed the following unsatisfactory ALB scores. - 2022 2nd event: 20% - 2022 3rd event: 0% . D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 (CMS) reports and American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to achieve successful PT performance for Albumin (ALB) testing. Findings are as follows: 1. The laboratory failed to attain satisfactory ALB PT scores in two out of three consecutive PT events. Two out of three consecutive unsatisfactory PT scores for the same analyte constituted unsuccessful performance. 2. CMS CASPER Report 0155D and API PT reports listed the following unsatisfactory ALB scores. - 2022 2nd event: 20% - 2022 3rd event: 0% -- 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 observation, document review, and interview with laboratory personnel, the laboratory failed to retain Hematology quality control records and Chemistry analyzer maintenance records for at least 2 years. Findings are as follows: The laboratory performed Chemistry and Hematology testing as confirmed by the Senior Laboratory Manager (SLM) and Testing Personnel 4 (TP4) during a tour of the laboratory at 10:05 a.m. on 12/07/22. A. Chemistry 1. An Abbott Architect ci4100 chemistry analyzer was observed as present and available for use during the tour of the laboratory. 2. Analyzer maintenance was required by the manufacturer and was driven by onboard software. 3. Architect maintenance reports from October 2021 were not found on date of survey, 12/08/22. The laboratory was given five days to provide the missing documents. 4. In an interview at 2:30 p.m. on 12/08/22, TP4 confirmed the above finding. 5. In an email received at 10:35 a.m. on 12/15/22, the SLM indicated the requested Architect analyzer maintenance records were not available. B. Hematology 1. A Beckman Coulter DxH600 hematology analyzer was observed as present and available for use during the tour of the laboratory. 2. Quality Control (QC) testing was performed daily as established in the Beckman Coulter DxH600 procedure found in C360, the laboratory's electronic procedure software. 3. QC records from July through September 2021 were not found on date of survey, 12 /08/22. 4. In an interview at 12:15 p.m. on 12/08/22, TP4 confirmed the above finding. TP4 indicated QC records were retained in the analyzer and the analyzer held only one year of data. . 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 -- 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 observation, document review, and interview with laboratory personnel, the laboratory failed to ensure 22 of 41 Chemistry reportable ranges and 3 of 3 Hematology (Coagulation) reportable ranges obtained during performance verification (PV) activities completed in 2021 and 2022 were adopted by the laboratory. Findings are as follows: The laboratory performed Chemistry and Hematology testing as confirmed by the Senior Laboratory Manager (SLM) and Testing Personnel 4 (TP4) during a tour of the laboratory at 10:05 a.m. on 12/07/22. A. Chemistry 1. An Abbott Architect ci4100 chemistry analyzer was observed as present and available for use during the tour of the laboratory. The laboratory began using this analyzer to perform testing in September 2021 as confirmed by the TP4 during the tour. 2. PV activities were completed in August 2021 as indicated in laboratory records found in the Integration Binder IACC ilsr65222 and Integration Binder IACC c403018 manuals. The Laboratory Director approved the PV on 08/30/21. 3. The upper and/or lower reportable range limits adopted by the laboratory for 22 of 41 analytes did not reflect the actual reportable range values obtained by the laboratory during the PV as indicated in the PV documents, the Abbott Immunoassay Reportable and Reference Range Summary, and Abbott Clinical Chemistry Reportable and Reference Range Summary. See below. Analyte PV Adopted Procalcitonin 0.0-96.17 0.05-100 Acetaminophen 0.37-275.4 3-337 Albumin 0.6-9.3 0.4-6.0 ALT 8.8-3409.4 10-4000 AST 4.5-3862.6 5-4000 Bili, Total 0.01-17.3 0.1-22.0 Calcium 0.02-17.9 1.0-24.0 Creatine Kinase 10.9-4306.6 10-4000 Chloride 54.4-142.0 55-145 CrEnz 0.19-35.04 0.1-35 ETOH 0.0001-0.427 0.01-0.6 Potassium 1.1-9.6 1.0-9.5 Lactic Acid 0.01-9.81 0.2-13.4 Magnesium 0.0-7.1 0.7-8.5 Sodium 107.8-189.9 105-180 Salicylate 0.29- 71.8 5-90 Total Protein 1.1-12.7 1-17 Triglyceride 11.3-1336.6 5-1350 Uric Acid 0.003-22.1 1-28 HDL 0.0-129.9 5-145 Urine Protein 0.13-81.5 1-200 Urea 3.8-117.4 5-120 4. In an interview at 10:20 a.m. on 12/08/22, the SLM confirmed the above finding. B. Hematology 1. A Stago Satellite coagulation analyzer was observed as present and available for use during the tour of the laboratory. The laboratory began using this analyzer to perform the following tests in May 2022 as indicated by TP4 during the tour. Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT) D-Dimer (DD) 2. PV activities on the Satellite analyzer were completed in May 2022 as indicated in laboratory records found in the Satellite Validation manual. The Laboratory Director approved the PV on 05/13/22. 3. The PT, aPTT, and DD lower and/or upper reportable range limits adopted by the laboratory did not reflect the actual reportable range values obtained by the laboratory during the PV as indicated in the PV documents. See below. Analyte PV Adopted PT 13.0->100 10- 100 aPTT 28.4->180 20-180 DD 0.38-18.49 0.27-20 4. In an interview at 9:05 a.m. on 12/08/22, the SLM confirmed the above finding. . D5431 MAINTENANCE AND FUNCTION CHECKS -- 2 of 6 -- CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: . Based on observation, document review and interview with laboratory personnel, the laboratory failed to ensure function checks for a Chemistry analyzer were performed and documented as required in 2021 and 2022. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the Senior Laboratory Manager (SLM) and Testing Personnel 4 (TP4) during a tour of the laboratory at 10: 05 a.m. on 12/07/22. 2. An i-STAT analyzer was observed as present and available for use during the tour. The laboratory used the i-STAT analyzer for Blood Gas testing and as a back-up method for Basic Metabolic Panel and Creatinine testing. 3. Twice annual verification of the i-STAT thermal probe was required as established in the Abbott i-STAT Analyzer procedure found in the C360 procedure program. 4. Thermal probe check documentation from 2021 and 2022 was not found in laboratory records. The laboratory was unable to provide this documentation upon request. 5. In an interview at 3:00 p.m. on 12/08/22, TP4 confirmed the above finding and indicated the thermal probe check had not been performed in 2021 and 2022. . D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) 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 establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to perform and document maintenance and function check activities for general laboratory equipment in 2021 and 2021. Findings are as follows: 1. The laboratory performed Microbiology, Immunology, Chemistry, Hematology, and Immunohematology testing as confirmed by the Senior Laboratory Manager (SLM) and Testing Personnel 4 (TP4) during a tour of the laboratory at 10:05 a.m. on 12/07/22. 2. Thermometers and timers were observed in the laboratory as present and available for use during the tour. 3. Annual thermometer and quarterly timer function checks were required as established in the Preventative Maintenance procedure found in the laboratory's electronic procedure program C360. 4. Thermometer and timer maintenance and function check documentation for 2021 and 2022 was not found during review of laboratory records. The laboratory was given five days to provide the missing documentation. 5. In an interview at 4:15 p.m. on 12/08/22, TP4 confirmed the above findings. 6. In an email received at 10:35 a.m. on 12/15/22, the SLM indicated the requested thermometer and timer function check records were not available. . -- 3 of 6 -- 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 perform quality control (QC) activities as established in a Chemistry Individualized Quality Control Plan (IQCP) for 17 patient specimens tested in 2022. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the Senior Laboratory Manager (SLM) and Testing Personnel 4 (TP4) during a tour of the laboratory at 10:05 a.m. on 12/07/22. 2. A MedToxScan device and Profile V test kits were observed as present and available for use during the tour. 3. QC performance using two levels of control material was required weekly as established in the Drugs of Abuse Screen for Urine Procedure found in the C360 electronic procedure program and in the laboratory's IQCP for the test. 4. The laboratory exceeded the weekly QC performance time interval for 17 patient specimens tested in the time frame reviewed, March through May of 2022, as indicated in laboratory records. See below. QC date QC due QC performed 03/20/22 03/27/22 04/11/22 10 patient specimens were tested between 03/27/22 and 04/10/22 QC date QC due QC performed 04/11/22 04/18/22 04/22/22 7 patient specimens were tested between 04/18/22 and 04/21/22 5. In an interview at 12:55 p.m. on 12/08/22, TP4 confirmed the above finding. . 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 observation, document review, and interview with laboratory personnel, the laboratory failed to follow the Quality Assessment Plan (QAP) for four of four Individualized Quality Control Plans (IQCP) developed by the laboratory. Findings are as follows: 1. The laboratory performed Microbiology and Chemistry testing as confirmed by the Senior Laboratory Manager (SLM) and Testing Personnel 4 (TP4) during a tour of the laboratory at 10:05 a.m. on 12/07/22. 2. The laboratory performed patient specimen testing using the tests or test systems listed below as confirmed by the TP4 during the tour. Molecular testing via Meridian Alethia platform Blood gas via Abbott i-STAT analyzer MedToxScan Profile-V urine drug screen device Meridian Serum hCG test kit 3. The laboratory implemented IQCP's for the above listed tests or test systems to reduce quality control requirements. The QAP for each -- 4 of 6 -- of the IQCP's indicated the IQCP would be reviewed annually. 4. Documentation of 2021 annual IQCP review was not present in laboratory records. The laboratory was unable to provide documentation of IQCP quality assessment review from 2021 upon request. 5. In an interview at 11:45 a.m. on 12/08/19, TP4 confirmed the above finding. . D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the Laboratory Director failed to ensure one of one new testing personnel and two of two tenured testing personnel were evaluated for test procedure competency in 2021 as required. Findings are as follows: 1. The laboratory performed Microbiology, Immunology, Chemistry, Hematology, and Immunohematology testing as confirmed by the Senior Laboratory Manager (SLM) and Testing Personnel 4 (TP4) during a tour of the laboratory at 10:05 a.m. on 12/07/22. 2. The laboratory was cited for non-performance of initial and annual competency evaluations during the previous survey conducted on 04/16/21. 3. An initial competency evaluation was found incomplete on date of current survey, 12/07/22, for one of one new testing personnel hired in 2021. Annual competency evaluations were found incomplete on date of current survey for two of two tenured testing personnel. See D6120. 4. The laboratory was cited for non- performance of semi-annual competency evaluations during the previous survey conducted on 04/16/21. 5. A semi-annual competency evaluation was not found on date of current survey for one of one testing personnel hired in 2021. See D6127. 6. In an interview at 3:20 p.m. on 12/07/22, the SLM confirmed the above finding. . 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 comprehensive initial training for one of one new testing personnel (TP) and comprehensive annual competency assessment for two of two tenured TP was performed and documented in 2021. Findings are as follows: 1. The laboratory performed Microbiology, Immunology, Chemistry, Hematology, and Immunohematology testing as confirmed by the Senior Laboratory Manager (SLM) -- 5 of 6 -- and Testing Personnel 4 (TP4) during a tour of the laboratory at 10:05 a.m. on 12/07 /22. 2. The following tests were performed by the laboratory in 2021 as indicated by TP4 during the tour: Molecular testing via Alethia platform (MOL) Chemistry via AU480 platform (CHEM) Blood gas via i-STAT platform (BG) MedToxScan Profile- V urine drug screen (UDS) Hematology via DxH600 platform (CBC) Manual differential (Diff) Coagulation via CA-600 platform (COAG) Immunohematology (IH) KOH microscopic examination (KOH) Vaginal wet preparation examination (VWP) Urine Sediment examination (US) Post vasectomy semen analysis (PV) Amnisure ROM (ROM) Serum hCG (hCG) 3. Personnel competency evaluation was required after training and annually as established in the New Hire Lab Orientation procedure and Competency Assessment Policy found in the C360 electronic procedure program. 4. Comprehensive initial training documentation was not found during review of TP6's personnel records as listed below. Training records not found CHEM, BG, UDS, US, PV, COAG, IH 5. Comprehensive annual competency assessments were not found during review of personnel records for the following testing personnel: TP4 and TP10. See below Test TP missing training records MOL TP4, TP10 UDS TP4, TP10 CBC TP10 Diff TP4, TP10 COAG TP10 IH TP4, TP10 KOH TP4, TP10 VWP TP4, TP10 US TP4, TP10 PV TP4, TP10 ROM TP10 hCG TP10 6. The laboratory was unable to provide the missing training records and missing competency assessment documents upon request. 7. In an interview at 3:20 p. m. on 12/07/22, the SLM confirmed the above finding. . D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: . Based document review and interview with laboratory personnel, the Technical Supervisor failed to complete a competency assessment at least semi-annually during the first year of patient specimen testing for one of one testing personnel hired in 2021. Findings are as follows: 1. The laboratory performed Microbiology, Immunology, Chemistry, Hematology, and Immunohematology testing as confirmed by the Senior Laboratory Manager (SLM) and Testing Personnel 4 (TP4) during a tour of the laboratory at 10:05 a.m. on 12/07/22. 2. The following non-waived test systems, analyzers, devices, and test kits were in use in 2021 as indicated by TP4 during the tour: Meridian Alethia molecular platform Beckman Coulter AU480 chemistry analyzer Beckman Coulter Access 2 chemistry analyzer Abbott i-STAT device MedToxScan Profile-V urine drug screen analyzer Beckman Coulter DxH600 hematology analyzer Sysmex CA-600 coagulation analyzer Quidel Triage Meter Meridian Alethia molecular platform Grifols Immunohematology test system Microscopes for microscopic examinations Amnisure ROM test kit Serum hCG test kit 3. Personnel competency evaluation was required six months after hire as established in the New Hire Lab Orientation procedure and Competency Assessment Policy found in the C360 procedure program. 4. Initial training was performed and documented for TP6 in April through July 2021 as indicated in personnel records. Training was not documented for seven tests and/or test systems. See D6120 5. Semi- annual competency assessment documentation for TP6 was not found in personnel records. 6. The laboratory was unable to provide the missing documents upon request. 7. In an interview at 3:20 p.m. on 12/07/22, the SLM confirmed the above finding. . -- 6 of 6 --

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 reports and American Proficiency Institute (API) proficiency testing reports, the laboratory failed to successfully participate in proficiency testing (PT) in 2021 for Compatibility Testing under the specialty of Immunohematology. Findings include: 1. The CASPER Report 0155D, reviewed on July 1, 2021, indicated the the laboratory failed to successfully participate in Compatibility Testing in 2021. Unsatisfactory PT performance in Compatibility Testing was obtained in the following events as verified with API proficiency testing reports. -2020 3rd event 80% -2021 1st event 80% 2. The CASPER Report 0155D indicated the laboratory failed to obtain a Compatibility 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 -- Testing PT score of at least 100 percent in two out of three consecutive testing events in 2020 and 2021. See D2173 and D2181 D2173 COMPATIBILITY TESTING 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 in Compatibility Testing of at least 100 percent which resulted in unsatisfactory performance. Unsatisfactory PT performance of Compatibility Testing was obtained in the following events. -2020 3rd event 80% -2021 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 participation for the analyte. API results indicated the laboratory had unsatisfactory performance for Compatibility Testing in two out of three consecutive events, leading to unsuccessful participation. Unsatisfactory PT performance of Compatibility Testing was obtained in the following events. -2020 3rd event 80% -2021 1st event 80% -- 2 of 2 --

Summary Statement of Deficiencies 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 one 2019 non-graded proficiency testing (PT) result for a regulated analyte when the PT program did not obtain the agreement required for scoring. Findings are as follows: 1. The laboratory performed Microbiology testing as confirmed by the General Supervisor during a tour of the laboratory at 1:05 p.m. on 04 /15/21. 2. The laboratory performed PT using the American Proficiency Institute (API) PT provider. 3. One Microbiology result from the first 2019 Microbiology PT event was not graded by API. See below. Sample ID Test UR-01 MIC/Cefuroxime 4. The API report referred the laboratory to the expected result data summary for evaluation of the non-graded test result. The data summary for the above analyte was not present in laboratory records. Evaluation of the non-graded result was not found in laboratory records. 5. Investigation of non-graded PT results was required as established in the laboratory's Proficiency Testing Procedure. The laboratory was unable to provide an evaluation of the non-graded result upon request. 6. In an interview at 4:30 p.m. on 04/15/21, the Technical Consultant confirmed the above finding. . 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 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 -- (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 document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of one 2019 non-graded proficiency testing (PT) result for a non-regulated analyte when the PT program did not obtain the agreement required for scoring. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the General Supervisor during a tour of the laboratory at 1:05 p.m. on 04/15/21. 2. The laboratory performed PT using the American Proficiency Institute (API) provider. 3. One Hematology result from the third 2019 Hematology PT event was not graded by API due to lack of consensus. See below. Sample ID Analyte COU-12 Nucleated Red Blood Cells 4. The API report referred the laboratory to the expected result data summary for evaluation of the non- graded test result. The data summary for the above analyte was not present in laboratory records. Evaluation of the non-graded result was not found in laboratory records. 5. Investigation of non-graded PT results was required as established in the laboratory's Proficiency Testing Procedure. The laboratory was unable to provide an evaluation of the non-graded result upon request. 6. In an interview at 4:30 p.m. on 04 /15/21, the Technical Consultant confirmed the above finding. . 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 perform quality control (QC) activities as established in a Toxicology Individualized Quality Control Plan (IQCP) in 1 of 24 weeks reviewed . Findings are as follows: 1. The laboratory performed Toxicology testing as confirmed by the General Supervisor during a tour of the laboratory at 1:05 p.m. on 04/15/21. 2. A MedToxScan toxicology analyzer was observed as present and available for use during the tour. 3. MedToxScan QC performance was required weekly as established in the Profile-V Medtox Scan Drugs of Abuse procedure and in the laboratory's IQCP for the test, both found in laboratory procedure manuals. 4. The laboratory exceeded the weekly time interval for QC performance in 1 of 24 weeks reviewed; April - September 2020. The omission potentially affected 1 patient (Pt)test result. See below. QC date Pt test date Days elapsed 03/30/20 04/07/21 8 5. In an interview at 1:25 p.m. on 04/16/21, the Technical Consultant confirmed the above finding. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) -- 2 of 4 -- (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 (TS) failed to ensure 3 of 3 new testing personnel (TP) received documented training for 2 of 13 testing platforms in use by the laboratory. In addition, the TS failed to ensure of 6 of 6 TP in 2019 and 4 of 6 TP in 2020 received documented annual competency assessments for all test procedures performed under the Microbiology, Immunology, Chemistry, Hematology, and Immunohematology specialties. Findings are as follows: A. Training 1. The laboratory performed Urine Drug Screens and Microscopic Examinations (Urine Sediment, Manual White Blood Cell Differential, KOH Wet Preparation and Post Vasectomy) as confirmed by the General Supervisor during a tour of the laboratory at 1:05 p.m. on 04/15/21. 2. Testing personnel 5 (TP5) was hired in June 2019, and TP1 and TP2 were hired in March and May and 2020, respectively, as indicated in laboratory records. 3. The laboratory's New Hire Lab Orientation Policy indicated TP were trained on all policies and procedures prior to testing patient specimens. 4. Initial training documentation for the above tests for TP1, TP2, and TP3 was not found during review of laboratory personnel records. The laboratory was unable to provide the missing document upon request. 5. In an interview at 3:30 p.m. on 04/15/21, the Technical Consultant confirmed the above finding. B. Annual Competency Assessments 1. The laboratory performed Microbiology, Immunology, Chemistry, Hematology, and Immunohematology as confirmed by the GS during a tour of the laboratory 1:05 p.m. on 04/15/21. 2. The laboratory's Competency Assessment Procedure indicated TP were evaluated annually for competency in all tests performed. The Annual Employee Competencies document, found in the procedure and used to record TP competency, included the six required elements for competency evaluation as indicated at 493.1451. 3. The single page Annual Employee Competencies document was completed for each TP in 2019 and 2020 to cover the entirety of testing performed by the laboratory. The document did not provide evidence that each area of testing was evaluated during the annual competency assessments. 4. In an interview at 3:30 p.m. on 04/15/21, the Technical Consultant confirmed the above finding. . D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the Technical Supervisor failed to ensure 3 of 3 new testing personnel (TP) were evaluated for competency in 12 of 13 testing platforms in use by the laboratory at least semiannually during the first year of patient specimen testing. Findings are as follows: -- 3 of 4 -- 1. The laboratory performed Microbiology, Immunology, Chemistry, Hematology, and Immunohematology as confirmed by the General Supervisor during a tour of the laboratory at 1:05 p.m. on 04/15/21. 2. TP5 was hired in June 2019, and TP1 and TP2 were hired in March and May and 2020, respectively, as indicated in laboratory records. 3. The laboratory's New Hire Lab Orientation Policy indicated TP were evaluated for competency in all testing areas semi-annually during the first year of patient testing. The 6 Month Post Hire Competencies: Tech document, found in personnel records and used to record the semi-annual competency, included a separate line for listed departments with an area to record competency in each. The document did not include the six required competency elements indicated at 493.1451. 4. The single page 6 Month Post Hire Competencies: Tech document was completed for TP5 in 2019 and TP1 and TP2 in 2020 to cover the entirety of testing performed by the laboratory. The document did not provide evidence that the evaluation of each area of testing included the six required competency elements. Acceptable semi-annual coagulation competency assessment for TP5, TP1, and TP2 were found. 5. In an interview at 3:30 p.m. on 04/15/21, the Technical Consultant confirmed the above finding. . -- 4 of 4 --

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 reports and proficiency testing reports from the American Proficiency Institute (API) proficiency testing (PT) provider, the laboratory failed to successfully participate in PT for the following analytes under the specialty of Chemistry: ALT (SGPT) * Alkaline Phosphatase Amylase Total Cholesterol Total Creatine Kinase Creatinine Glucose Blood Urea Nitrogen Uric Acid Findings are as follows: 1. The laboratory failed to submit Chemistry PT results to API prior to the submission deadline. See D2093 2. The laboratory failed to achieve successful performance for Chemistry testing. See D2087 3. The laboratory failed to achieve successful performance for Chemistry 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 -- testing in two of three consecutive events. See D2096 * ALT = alanine aminotransferase . D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 proficiency testing (PT) reports from the American Proficiency Institute (API), the laboratory failed to obtain a PT score of at least 80 percent for testing of the following analytes: ALT (SGPT) * Alkaline Phosphatase Amylase Total Cholesterol Total Creatine Kinase Creatinine Glucose Blood Urea Nitrogen Uric Acid which resulted in unsatisfactory performance for each of these analytes. Unsatisfactory PT performance of testing for each of these analytes was obtained in the following event: - 2019 Chemistry / Core / 3rd event ALT (SGPT) 60% Alkaline Phosphatase 60% Amylase 60% Total Cholesterol 60% Total Creatine Kinase 60% Creatinine 60% Glucose 60% Blood Urea Nitrogen 60% Uric Acid 60% * ALT = alanine aminotransferase . D2093 ROUTINE CHEMISTRY CFR(s): 493.841(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. 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 submit Chemistry PT results to API prior to the submission deadline. Findings are as follows: The laboratory failed to submit PT results for each of the following analytes: ALT (SGPT) * Alkaline Phosphatase Amylase Total Cholesterol Total Creatine Kinase Creatinine Glucose Blood Urea Nitrogen Uric Acid for the 2019 Chemistry / Core / 1st event. Failure to participate in the testing event resulted in a score of 0% and unsatisfactory performance for each of the analytes listed above. * ALT = alanine aminotransferase . D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 proficiency testing (PT) reports from the American Proficiency Institute (API) provider, the laboratory failed to achieve successful performance for testing of the following analytes: ALT (SGPT) * Alkaline Phosphatase Amylase Total Cholesterol Total Creatine Kinase Creatinine Glucose Blood Urea Nitrogen Uric Acid -- 2 of 3 -- in two out of three consecutive PT events. Findings are as follows: The laboratory failed testing for the analytes listed above in two out of three consecutive PT events. Two out of three consecutive PT failures for the same analyte constitutes unsuccessful performance. PT reports from API showed the following unsatisfactory scores for each of the analytes listed above. - 2019 Chemistry / Core / 1st event: 0% - 2019 Chemistry / Core / 3rd event: 60% * ALT = alanine aminotransferase . . -- 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 a review of Center for Medicare and Medicaid Services reports and proficiency testing reports from the American Proficiency Institute (API) proficiency testing (PT) provider, the laboratory failed to successfully participate in PT for the following analytes under the specialty of Hematology. - Cell Identification or White Blood Cell Differential - Erythrocyte Count - Hematocrit - Hemoglobin - Leukocyte Count - Platelet Count - Partial Thromboplastin Time - Prothrombin Time Findings are as follows: 1. The laboratory failed to submit Hematology PT results to API prior to the submission deadline. See D2127 2. The laboratory failed to achieve successful performance for Hematology testing. See D2130 3. The laboratory failed to achieve 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 -- successful performance for Hematology testing in two consecutive events. See D2131 . D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. 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 participate in the 3rd Hematology/Coagulation testing event in 2018 and 1st Hematology/Coagulation testing event in 2019, which resulted in a score of 0 for all analytes on each event. Findings are as follows: 1. Review of PT results from API revealed that the laboratory failed to participate in the 3rd Hematology/Coagulation testing event in 2018 and 1st Hematology/Coagulation testing event in 2019. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 proficiency testing (PT) reports from the American Proficiency Institute (API), the laboratory failed to achieve successful performance for Hematology testing for multiple analytes. Findings are as follows: The laboratory failed Hematology testing for the following analytes in two consecutive PT events: - Cell Identification or White Blood Cell Differential - Erythrocyte Count - Hematocrit - Hemoglobin - Leukocyte Count - Platelet Count - Partial Thromboplastin Time - Prothrombin Time Two consecutive PT failures for the same analyte constitutes unsuccessful performance. PT reports from API listed the following unsatisfactory scores for each of the analytes listed above. - 2018 Hematology/Coagulation 3rd event: 0% - 2019 Hematology/Coagulation 1st event: 0% D2131 HEMATOLOGY CFR(s): 493.851(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 proficiency testing (PT) scores from the American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance for multiple Hematology analytes in two consecutive testing events, constituting unsuccessful performance for each analyte. Review of results from API revealed that the laboratory had unsatisfactory performance for the following Hematology analytes in two -- 2 of 3 -- consecutive PT events, leading to unsuccessful performance. - Cell Identification or White Blood Cell Differential - Erythrocyte Count - Hematocrit - Hemoglobin - Leukocyte Count - Platelet Count - Partial Thromboplastin Time - Prothrombin Time Unsatisfactory PT performance for each of the analytes listed above was obtained in the following events. - 2018 Hematology/Coagulation 3rd event: 0% - 2019 Hematology/Coagulation 1st event: 0% . -- 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 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 for pCO2* testing, under the specialty of Chemistry. Findings are as follows: D2087 - the laboratory failed to obtain a PT score of at least 80 percent for pCO2 testing. D2093 - the laboratory failed to summit PT results prior to the submission deadline. D2096 - the laboratory failed to achieve satisfactory analyte PT performance for pCO2 testing in two out of three consecutive events. *Note pCO2 - Partial pressure of Carbon Dioxide . 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 -- D2087 ROUTINE CHEMISTRY CFR(s): 493.841(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 proficiency testing (PT) reports from the American Proficiency Institute (API), the laboratory failed to obtain a PT score for pCO2 testing of at least 80 percent which resulted in unsatisfactory performance for the analyte. Unsatisfactory PT performance of pCO2 testing was obtained in the following events: - 2018 Chemistry / Core / 2nd event: 40% . D2093 ROUTINE CHEMISTRY CFR(s): 493.841(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. 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 submit Chemistry PT results to API prior to the submission deadline. Findings are as follows: The laboratory failed to submit PT results for all analytes, including pCO2, for the 2019 Chemistry / Core / 1st event. Failure to participate in the testing event resulted in unsatisfactory performance for pCO2. . D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 proficiency testing (PT) reports from the American Proficiency Institute (API) provider, the laboratory failed to achieve successful performance for pCO2 testing in two out of three consecutive PT events. Findings are as follows: The laboratory failed pCO2 testing in two out of three consecutive PT events. Two out of three consecutive PT failures for the same analyte constitutes unsuccessful performance. PT reports from API listed the following unsatisfactory pO2 scores. - 2018 Chemistry / Core / 2nd event: 40% - 2019 Chemistry / Core / 1st event: 0% -- 2 of 2 --

Summary Statement of Deficiencies D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to ensure that an Individualized Quality Control Plan (IQCP) was reviewed annually. Findings are as follows: 1. The laboratory performed Serum Qualitative HCG* under the specialty of Immunology as confirmed by the General Supervisor (GS) during a tour of the laboratory on 12/27/18 at 8:05 a.m. 2. QC performance for Serum Qualitative HCG* was established in the Mono / Serum HCG Individualized Quality Control Plan (IQCP), dated 5/4/2016. 3. Annual reviews for 2017 and 2018 of the IQCP for Serum Qualitative HCG* were not found in laboratory records. The laboratory was unable to provide the documents upon request. 4. In an interview on 12 /27/18 at 3:30 p.m., the GS confirmed the above findings. * HCG = Human chorionic gonadotropin . 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. 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 -- This STANDARD is not met as evidenced by: . Based on 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 new Immunology test method. Findings are as follows: 1. The laboratory performed Immunology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 12/27/18 at 8:05 a.m. 2. The Qiagen AmniSure Rupture of Fetal Membrane test kit was observed as present and available for use during the tour of the laboratory. 3. A Performance Verification (PV) report with verification of accuracy, performed 8/17 /2017, was found during review of laboratory records. 4. The Laboratory Director (LD) failed to sign and date the Performance Verification (PV) report. 5. In an interview on 12/27/18 at 3:00 p.m., the GS confirmed the above findings. . -- 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 D2178 - the laboratory failed to participate in the 3rd Immunohematology testing event in 2017 D2181 - the laboratory failed to achieve satisfactory performance for Compatibility Testing in two out of three consecutive testing events 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 -- D2173 COMPATIBILITY TESTING 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 in Compatibility Testing of at least 100 percent which resulted in unsatisfactory performance. Unsatisfactory PT performance of Compatibility Testing was obtained in the following events. -2017 3rd event 0% -2017 1st event 60% D2178 COMPATIBILITY TESTING CFR(s): 493.863(c) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: . Based on a review of proficiency testing (PT) reports from the American Proficiency Institute (API) and email communication with the General Supervisor (GS), the laboratory failed to participate in the 3rd Immunohematology testing event in 2017 which resulted in a score of 0 for all analytes. Findings are as follows: 1. Review of PT results from API revealed that the laboratory failed to participate in the 3rd Immunohematology testing event of 2017. 2. In an email communication on 02/28/18 at 9:47 a.m, the GS confirmed that laboratory failed to submit the results on-time for this event and indicated they had self-graded their obtained results and would have received a score of 100%. 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 reports from the American Proficiency Institute (API), the laboratory failed to achieve satisfactory results in Compatibility Testing in two out of three consecutive testing events, constituting unsuccessful performance for the analyte. API results indicated the laboratory had obtained unsatisfactory results 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 0% -2017 1st event 60% D6076 LABORATORY DIRECTOR CFR(s): 493.1441 -- 2 of 3 -- The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: . Based on a review of proficiency testing reports from the American Proficiency Institute and email communication with the General Supervisor, the Laboratory Director failed to provide overall management and direction in accordance with 493.1455 of this subpart. Findings are as follows: The Laboratory Director failed to ensure PT results were returned to the PT provider within the established timeframe. See D6090 D6090 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(ii) The laboratory director must ensure the results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: . Based on a review of proficiency testing (PT) reports from the American Proficiency Institute (API) and email communication with the General Supervisor (GS), the Laboratory Director failed to ensure PT results were returned to API within the established timeframe. Findings are as follows: 1. The laboratory failed to return their 2017 3rd event Immunohematology PT results to API prior to the submission deadline. 2. In an email communication on 02/28/18 at 9:47 a.m, the GS confirmed that laboratory failed to submit the results on-time for this event and indicated they had self-graded their obtained results and would have received a score of 100%. -- 3 of 3 --