Community Memorial Hospital

Summary Statement of Deficiencies D0000 . The Community 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 an off-site proficiency testing referral complaint investigation performed on July 24, 2025. The following condition-level deficiency was cited: 493.801 Enrollment and testing of samples . D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory engaged in proficiency testing referral in 2025. Findings are as follows: 1. The laboratory engaged in inter-laboratory communication regarding five hematology proficiency testing (PT) samples prior to the PT event submission deadline in February 2025. See D2012 2. The laboratory improperly submitted five hematology proficiency testing (PT) samples to another laboratory prior to the PT event submission deadline in February 2025. See D2013 . D2012 TESTING OF PROFICIENCY TESTING SAMPLES (b)(4) Laboratories that perform tests on proficiency testing samples must not engage 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 -- in any inter-laboratory communications pertaining to the results of proficiency testing sample(s) until after the date by which the laboratory must report proficiency testing results to the program for the testing event in which the samples were sent. Laboratories with multiple testing sites or separate locations must not participate in any communications or discussions across sites/locations concerning proficiency testing sample results until after the date by which the laboratory must report proficiency testing results to the program. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory engaged in inter-laboratory communication regarding five hematology proficiency testing (PT) samples prior to the PT event submission deadline in February 2025. Findings are as follows: 1. The Community Memorial Hospital laboratory (Lab A) performed proficiency testing using the College of American Pathologists (CAP) proficiency testing provider. 2. Sysmex XP-300 hematology test reports and additional documentation found in another laboratory's (Lab B) 2025 CAP Proficiency Test manual indicated Lab A sent five CAP hematology PT package FH9- A 2025 samples to Lab B on 02/11/25. See D2013 3. The result submission deadline for the FH9-A PT 2025 package was 02/12/25 as indicated on the CAP FH9-A Hematology Automated Differential Survey Result Form provided by General Supervisor 2. 4. The laboratory prohibited inter-laboratory communication pertaining to PT testing events as established in the Proficiency Testing Process procedure located in the Laboratory Quality Manual. 5. General Supervisor 2 (GS2) at Lab A was also Technical Consultant 2 at Lab B. GS2 was aware of the FH9-A PT 2025 results obtained for the five samples at Lab A when she brought the samples to Lab B for testing on 02/11/25. This constitutes inter-laboratory communication. 6. In an interview at 12:20 p.m. on 07/08/25, GS1 and GS2 confirmed the above finding. . D2013 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(4) (b)(5) The laboratory must not send proficiency testing samples or portions of proficiency testing samples to another laboratory for any analysis for which it is certified to perform in its own laboratory. Any laboratory that CMS determines intentionally referred a proficiency testing sample to another laboratory for analysis may have its certification revoked for at least one year. If CMS determines that a proficiency testing sample was referred to another laboratory for analysis, but the requested testing was limited to reflex, distributive, or confirmatory testing that, if the sample were a patient specimen, would have been in full conformance with written, legally accurate and adequate standard operating procedures for the laboratory's testing of patient specimens, and if the proficiency testing referral is not a repeat proficiency testing referral, CMS will consider the referral to be improper and subject to alternative sanctions in accordance with 493.1804(c), but not intentional. Any laboratory that receives a proficiency testing sample from another laboratory for testing must notify CMS of the receipt of that sample regardless of whether the referral was made for reflex or confirmatory testing, or any other reason. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory improperly submitted five hematology proficiency testing (PT) samples to another laboratory prior to the PT event submission deadline in February 2025. Findings are -- 2 of 3 -- as follows: 1. The Community Memorial Hospital laboratory (Lab A) performed proficiency testing using the College of American Pathologists (CAP) proficiency testing provider. 2. Sysmex XP-300 hematology analyzer test reports and additional PT documentation found in another laboratory's (Lab B) 2025 CAP Proficiency Test manual indicated Lab A sent five CAP hematology PT package FH9-A 2025 samples to Lab B on 02/11/25. Five test reports dated 02/11/25 for samples #1, #2, FH9-03, FH9-04, FH9-05 found at Lab B included handwritten documentation "FH9-A Hospital XN survey run at clinic". In addition, hand written documentation on Lab B's CAP FH13-A 2025 evaluation report dated 3/20/25 indicated "FH9-A survey from the hospital was run at clinic to compare Sysmex to Sysmex and study done". 3. The result submission deadline for the FH9-A PT 2025 package was 02/12/25 as indicated on the CAP FH9-A Hematology Automated Differential Survey Result Form provided by General Supervisor 2 (GS2). 4. The laboratory prohibited inter-laboratory communication pertaining to PT testing events as established in the Proficiency Testing Process procedure located in the Laboratory Quality Manual. 5. In an interview at 12:20 p.m. on 07/08/25, GS1 and GS2 confirmed the above finding. . -- 3 of 3 --

Summary Statement of Deficiencies D0000 The Community 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 proficiency testing desk review survey performed on January 15, 2025. The following condition-level deficiencies were cited: 493.303 Successful Participation The following standard-level deficiencies were cited: 493.851 Hematology . 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) reports from the Center for Medicare and Medicaid Services (CMS) and the College of Pathologists (CAP), the laboratory 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 -- failed to successfully participate in Partial Thromboplastin Time (PTT) PT under the specialty of Hematology in 2024. Findings are as follows: 1. The CMS CASPER Report 0155D and the 2024 CAP CGL-B Coagulation Evaluation and 2024 CAP CGL-C Coagulation Evaluation were reviewed on January 15, 2025. The reports indicated the laboratory failed to achieve satisfactory performance for PTT in two of three consecutive testing events from 2024 resulting in unsuccessful performance. See D2130. . D2130 HEMATOLOGY CFR(s): 493.851(f) (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 review of proficiency testing (PT) reports from the Center for Medicare and Medicaid Services (CMS) and the College of American Pathologists (CAP), the laboratory failed to acheive successful PT performance for Partial Thromboplastin Time (PTT) testing in two of three consecutive PT events in 2024. Findings include: 1. The CMS CASPER Report 0153D, reviewed on January 15, 2024 indicated the laboratory failed to obtain a successful PTT score of at least 80 percent in two of three consecutive testing events in 2024. 2. The 2024 CAP CGL-B Coagulation Evaluation and 2024 CAP CGL-C Coagulation Evaluation confirmed the laboratory failed to obtain a PTT score of at least 80 percent in two of three consecutive testing events in 2024. See below. 2024 2nd event 20% 2024 3rd event 0% . -- 2 of 2 --

Summary Statement of Deficiencies D0000 The Community 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 July 31, 2024 and August 1, 2024. The following standard-level deficiencies were cited: 493.1253 Establishment and verification of performance specifications 493.1256 Control Procedures 493.1445 Laboratory director responsibilities 493.1451 Technical supervisor responsibilities . 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 11 of 11 Chemistry reportable ranges obtained during one of three performance verifications (PV) completed in 2024 were adopted by the laboratory. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by General Supervisor 2 (GS2) during a tour of the laboratory at 12:40 p.m. on 07/31/24. 2. A Siemens Healthineers RAPIDPoint 500e Blood Gas System was observed as present and available for use during the tour of the laboratory. The laboratory began using this analyzer to perform testing on 06/03/24. 3. PV activities were completed in April 2024 as indicted in records found in the RP500e Validation /Training manual. The Laboratory Director approved the PV on 07/29/24. 4. The 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 -- laboratory's Overall Quality System Design policy found in the Laboratory Quality Manual indicated the reportable range must be adjusted to that which can be proven on Community Memorial Hospital's analyzers. 5. The upper and/or lower reportable range limits adopted by the laboratory for 11 of 11 analytes did not reflect the actual reportable range values obtained by the laboratory during the PV as indicated in Performance Summary documents found in the RP500e Validation/Training manual . See below. Analyte Obtained Adopted pH 6.709-7.718 6.500-7.800 Carbon Dioxide 15.7-159.9 5.0-200.0 Oxygen 45.4-523.3 10.0-700.0 Sodium 110.7-171.3 100.0-200.0 Potassium 1.42-11.46 0.50-15.00 Chloride 73.0-126.0 65.0-140.0 Glucose 25.7-686.3 20.0-750.0 Lactate 4.41-177.21 1.60-270.30 Total Hemoglobin 5.0-21.2 2.0-25.0 Total Carbon Dioxide 4.3-32.1 5.0-50.0 Urea Nitrogen 4.0-108.0 3.0-120.0 6. In an interview on 08/01/24 at 12:50 p.m. and 1:15 p.m., GS2 confirmed the above finding and indicated the manufacturer's analytical measuring range for the analytes had been adopted. . D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (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 document Hematology quality control procedures performed to evaluate stain for intended reactivity each day of use from August 2022 through July 2024. Findings are as follows: 1. The laboratory performed manual differential blood smear testing under the specialty of Hematology as confirmed by General Supervisor 2 (GS2) during a tour of the laboratory at 12:40 p.m. on 07/31/24. 2. Manual differential stains and a Zeiss Axiolab 5 microscope used to perform manual differentials were observed as present and available for use during the tour. 3. The Manual Differential on Peripheral Blood procedure found in the Hematology Dept Procedures manual included direction to determine overall staining quality but did not include direction to document this activity for manual differentials. 4. Hematology testing for patient MRN# xxx591, which included a manual differential performed on 01/31/23, was reviewed on date of survey. Documentation of acceptable stain intended reactivity was not found for the day of patient testing. The laboratory was unable to provide the missing documentation upon request. 5. In an interview at 4:05 p.m on 08/01/24, GS2 confirmed the above finding and stated the laboratory did not document the quality of staining when performing a manual differential. . 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the Laboratory Director failed to ensure all testing personnel were evaluated for test procedure competency as required. Findings are as follows: 1. The laboratory was cited for non- performance of initial competency evaluations during the three previous surveys conducted on 08/10/22, 11/05/20, and 07/18/18. 2. Initial competency evaluations were found incomplete on date of current survey, 07/31/24, for three of six new testing personnel hired in 2023. See D6120. 3. In an interview at 3:55 p.m. on 07/31 /24, General Supervisor 2 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 observation, document review, and interview with laboratory personnel, the Technical Supervisor failed to ensure initial competency assessment for three of six new testing personnel was performed and documented in 2023. Findings are as follows: 1. The laboratory performed Microbiology, Chemistry, and Hematology testing as confirmed by General Supervisor 2 (GS2) during a tour of the laboratory at 12:40 p.m. on 07/31/24. 2. The following test systems and test kits were observed as present and available for use during the tour: Alcor miniiSED ESR analyzer Qiagen Amnisure ROM Test kit Abbott BinaxNOW Streptococcus pneumoniae test kit Abbott BinaxNOW Legionella test kit OSOM hCG Combo Test kit 3. Initial competency assessment was required for new testing personnel as established in the Competency Assessment procedure found in the Laboratory Quality Manual. 4. Initial competency assessment documentation for the Alcor MiniiSED analyzer was not found during review of personnel records for the following testing personnel (TP): TP6, TP7, TP8. Initial competency assessment documentation for the Amnisure, Streptococcus pneumoniae, Legionella, and hCG test kits was not found during review of personnel records for TP8. 5. The laboratory was unable to provide the missing competency assessment records upon request. 6. In an interview at 3:55 p.m. on 07/31/24, GS2 confirmed the above finding. 7. This issue was previously cited during the 08/10/22, 11/05/20, and 07/18/18 surveys. See D6103 . -- 3 of 3 --

Summary Statement of Deficiencies 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 minimum quality control activities required for a Hematology test system on 88 of 96 days of testing in 2022. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by General Supervisor 1 (GS1) during a tour of the laboratory at 8:10 a.m. on 08/10/22. 2. A Quidel Triage Meter was observed as present and available for use during the tour. GS1 stated the D- Dimer assay was implemented on this system on 03/29/22. 3. Quality control (QC) testing with two levels of control material was required with each new lot and shipment and every 30 days as indicated in the Triage D-Dimer procedure located in the Chemistry Procedures manual. 4. The laboratory's Triage Liquid QC form indicated QC was performed on the following dates: 03/28/22 (prior to implementation) 04/07/22 05/07/22 05/16/22 06/15/22 06/22/22 07/22/22 08/09/22 5. An Individual Quality Control Plan (IQCP) to reduce the frequency of QC performance from 2 levels of control material each day of patient testing was not found in laboratory documents. The laboratory was unable to provide an IQCP upon request. 6. The Lab Specimen Log provided by the laboratory indicated 162 patients received D-Dimer testing without daily QC from 03/29/22 to 08/10/22. See below. 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 -- March 2022 - 5 patients Testing occurred without daily QC on March 29, 30, and 31 April 2022- 56 patients Tested without daily QC on April 1, 2, 3, 4, 5, 6, 8, 10, 12, 13, 14, 16, 17, 18, 20, 21, 22, 24, 25, 26, 27, 28, 29, 30 May 2022 - 40 patients Tested occurred without daily QC on May 3, 4, 5, 6, 8, 9, 10, 11, 13, 14, 15, 17, 18, 19, 20, 21, 23, 24, 25, 26, 29, 30 June 2022 - 31 patients Testing occurred without daily QC on June 1, 2, 6, 8, 9, 11, 12, 14, 16, 17, 18, 20, 21, 23, 24, 27, 28, 29, 30 July 2022 - 24 patients Testing occurred without daily QC on July 1, 2, 4, 5, 7, 8, 9, 10, 11, 13, 16, 19, 20, 21, 23, 27 August 2022 - 6 patients Testing occurred without daily QC on August 1, 3, 6, 8 7. In an interview at 3:55 p.m. on 08/10/22, GS1 confirmed the above finding. . D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to follow an established policy to verify the accuracy of test results manually entered into the electronic medical record in 2021. Findings are as follows: 1. The laboratory performed Microbiology, Chemistry, Hematology, and Immunohematology testing as confirmed by General Supervisor 1 (GS1) during a tour of the laboratory at 8:10 a.m. on 08/10/22. Test results were interfaced and also manually entered into the electronic medical record. 2. Review of nine manual test result entries was required annually as established in the QA - Audit Process procedure and Audit Checklist located in the QA Manual. 3. Documentation of manual test result entry review from 2021 was not found in laboratory records. The laboratory was unable to provide the missing documentation for this time period upon request. 4. In an interview at 3:55 p.m. on 08/10/22, GS1 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 all testing personnel were evaluated for test procedure competency as required. Findings are as follows: 1. The laboratory was cited for non- performance of initial competency evaluations during the two previous surveys conducted on 11/05/20 and 07/18/18. 2. Initial competency evaluations were found incomplete on date of current survey, 08/10/22, for five of six new testing personnel hired in 2021 and 2022. See D6120. 3. The laboratory was cited for non-performance -- 2 of 4 -- of semi-annual competency evaluations during the previous survey conducted on 11 /05/20. 4. A semi-annual competency evaluation was found incomplete on date of current survey, 08/10/22, for one of two testing personnel hired in 2021. See D6127. 5. In an interview at 10:55 a.m. on 08/10/22, General Supervisor 1 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 observation, document review, and interview with laboratory personnel, the Technical Supervisor failed to ensure initial training for five of six new testing personnel was performed and documented in 2021 and 2022. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by General Supervisor 1 (GS1) during a tour of the laboratory at 8:10 a.m. on 08/10/22. 2. Qiagen AmniSure ROM test kits were present and available for use during the tour. 3. Initial training was required for new testing personnel as established in the Laboratory Competency Testing procedure found in the General Lab Procedures manual. 4. Initial training documentation for the AmniSure ROM test was not found during review of the New Employee Training Checklists for the following testing personnel (TP): TP5, TP7, TP8, TP9, TP11. 5. The laboratory was unable to provide the missing training records upon request. 6. In an interview at 10:52 am., GS1 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 observation, document review, and interview with laboratory personnel, the Technical Supervisor failed to assess competency at least semi-annually during the first year of patient specimen testing for one of two testing personnel hired in 2021. Findings are as follows: 1. The laboratory performed Microbiology, Chemistry, and Hematology testing as confirmed by General Supervisor 1 (GS1) during a tour of the laboratory at 8:10 a.m. on 08/10/22. 2. The Sysmex XN-1000 and Alcor Mini iSed analyzers and Qiagen AmniSure ROM, BinaxNOW S. pneumoniae, BinaxNOW Legionella manual test kits and microscopes were present and available for use during the tour. 3. Competency evaluations were required semi-annually for new testing personnel as established in the Laboratory Competency Testing procedure found in the General Lab Procedures manual. 4. Initial training was performed and documented for Testing Personnel 5 (TP5) in June through August 2021 as indicated in laboratory records. 5. Semi-annual competency assessment documentation for TP5 was not -- 3 of 4 -- found for the following tests and test systems: Microbiology - BinaxNOW S. pneumoniae, BinaxNOW Legionella Chemistry - Microscopic urinalysis Hematology - Sysmex XN-1000 and Alcor Mini iSed analyzers, Qiagen AmniSure ROM, microscopic manual differential 6. The laboratory was unable to provide the missing documents upon request. 7. In an interview at 10:54 a.m. on 08/10/22, GS1 confirmed the above finding. . D6128 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 annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the Technical Supervisor failed to assess competency at least annually for three of three tenured Microbiology testing personnel in 2021. Findings are as follows: 1. The laboratory performed Microbiology testing as confirmed by General Supervisor 1 (GS1) during a tour of the laboratory at 8:10 a.m. on 08/10/22. 2. Giardia, Cryptosporidium, and C. Diff Quik Chek test kits were present and available for use during the tour. 3. Annual competency assessments were required for all testing personnel (TP) as established in the Laboratory Competency Testing procedure found in the General Lab manual. 4. Annual competency assessment documentation for the above tests was not found during review of 2021 laboratory records for the following TP: GS2, TP2, TP6. 5. The laboratory was unable to provide the missing records upon request. 6. In an interview at 10:55 am. on 08/10/22, GS1 confirmed the above finding. . -- 4 of 4 --

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records 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 proficiency testing (PT) records for at least 2 years. Findings are as follows: 1. The laboratory performed Chemistry & Hematology testing as confirmed by the General Supervisor 1 (GS1) during a tour of the laboratory on 11/04/20 at 10: 05 a.m. 2. The laboratory performed PT using the College of American Pathologists (CAP) provider. 3. The following PT documentation was not present in laboratory records on date of survey. The laboratory was unable to provide these documents upon request. Event: Urine Drug Testing (UDS-C 2018) Missing Item(s): Attestation Statement Event: Hematology / Auto Diff (FH9-A 2019) Missing Item(s): Lab results, Attestation Statement & Laboratory Director Review Event: Cerebrospinal Fluid Chemistry (M-A 2019) Missing Item(s): Lab results, Attestation Statement & Laboratory Director Review 4. In an interview on 11/05/20 at 8:15 a.m., GS1 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: . Based on document review and interview with laboratory personnel, the laboratory failed to investigate an unacceptable Chemistry proficiency testing (PT) result for 1 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 -- analyte in 2020. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the General Supervisor 1 (GS1) during a tour of the laboratory on 11/04/20 at 10:05 a.m. 2. The laboratory performed PT using the College of American Pathologists (CAP) provider.. 3. The laboratory received an unacceptable PO2* result on Specimen AQ-06 in the CAP Blood Gases (AQ-B 2020) event. 4. Investigation of unacceptable PT results was required as established in the Proficiency Testing Process procedure located in the laboratory's Quality Assurance manual. 5. 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. 6. In an interview on 11/05/20 at 8:15 a.m., GS1 confirmed the above findings. *PO2 = Partial pressure of oxygen . D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of five 2018, five 2019, and seven 2020 proficiency testing (PT) scores when the PT program did not obtain the agreement required for scoring. Findings are as follows: 1. The laboratory performed Immunology, Chemistry, Toxicology, and Urinalysis testing as confirmed by the General Supervisor 1 (GS1) during a tour of the laboratory on 11/04/20 at 10:05 a.m. 2. The laboratory performed PT using the College of American Pathologists (CAP) provider. 3. The following results were not graded by CAP due to lack of consensus. See below. Event: Diagnostic Immunology (S-C 2018) Sample ID: CRP-05 Analyte: C Reactive Peptide Event: Diagnostic Immunology (S-C 2018) Sample ID: HCG-13 Analyte: Qualitative Serum HCG* Event: Procalcitonin (PCT-B 2018) Sample ID: PCT-06 Analyte: Procalcitonin Event: Diagnostic Immunology (S-B 2018) Sample ID: CRP-03 Analyte: C Reactive Peptide Event: Clinical Microscopy (CM-B 2018) Sample ID: USP-04 Analyte: Urine Sediment ID Event: General Chemistry / TDM* (C-A 2019) Sample ID: CHM-01 thru CHM-05 Analyte: Alkaline Phosphatase Event: General Chemistry / TDM* (C-A 2020) Sample ID: CHM-01 thru CHM-05 Analyte: Alkaline Phosphatase Event: Urine Drug Testing (UDS-B 2020) Sample ID: UDS-07 Analyte: Benzodiazapine Group Event: Plasma Cardiac Markers (PCARM-A 2020) Sample ID: PCAR-09 Analyte: Troponin - I 4. The CAP report referred the laboratory to the expected result data summary for evaluation of the non-graded test results. The data summary for the above analytes were not present in laboratory records. Evaluation of the non-graded results were not found in laboratory records. The laboratory was unable to provide an evaluation of the non-graded results upon request. 5. In an interview on 11/05/20 at 8:15 a.m., GS1 confirmed the above findings. * HCG = Human Chorionic Gonadotropin TDM = Therapeutic Drug Monitoring . D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations -- 2 of 5 -- 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 Microbiology Individualized Quality Control Plan (IQCP) in 1 of 12 months reviewed . Findings are as follows: 1. The laboratory performed Microbiology testing as confirmed by the General Supervisor 1 (GS1) during a tour of the laboratory on 11/04 /20 at 10:05 a.m. 2. An Abbott Binax NOW analyzer was observed as present and available for use during the tour of the laboratory. Legionella Antigen testing was performed on this analyzer. 3. Legionella Antigen Quality Control (QC) performance was required with each new lot number and/or new shipment as established in the laboratory's IQCP for the test. 4. Documentation on the Patient Testing Log for the Legionella Antigen test indicated that QC was not performed with the change in reagents from lot # 093663 (Exp date: 7/28/19) to lot # 100099 (Expiration date: 4/28 /20) on 1/21/19. 5. In an interview on 11/05/20 at 10:15 a.m., GS1 confirmed the above findings. . 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 and define the relationship between test results obtained from different Chemistry analyzers at least twice annually in 2020. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the General Supervisor 1 (GS1) during a tour of the laboratory on 11/04/20 at 10:05 a.m. 2. Siemens RAPIDPoint 500 and EPOC blood gas analyzers were observed and available for use during the tour of the laboratory. 3. GS1 indicated the laboratory used the EPOC blood gas analyzer for back up testing to the RAPIDPoint 500. 4. A system to evaluate and define the relationship between test results obtained from different analyzers or methodologies at least twice annually was established in the Method Comparison procedure located in the General Lab Procedures manual. Documentation of such an evaluation in 2020 for the blood gas analyzers was not found during review of laboratory records. The laboratory was unable to provide these documents upon request. 6. In an interview on 11/05/20 at 10:15 a.m., GS1 confirmed the above findings. . D5807 TEST REPORT -- 3 of 5 -- 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 1 (GS1) during a tour of the laboratory on 11/04/20 at 10:05 a.m. 2. A Siemens Dimension EXL chemistry analyzer was observed and available for use during the tour of the laboratory. 3. The Phosphorus reference intervals listed in the Siemens Dimension EXL Phosphorus procedure, located in the Chemistry Procedure Manual, were not consistent with those included on a patient test report reviewed on date of survey, as indicated below. Patient: Adult female, aged 75 years, tested on 3/23/19 Procedure: 2.5 - 4.9 mg/dl Patient Report: 2.6 - 4.7 mg/dl 4. In an interview on 11/05 /20 at 10:15 a.m., GS1 confirmed the above findings. . 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 10 of 10 testing personnel (TP) received competency assessments for three test procedures performed in 2019. Findings are as follows: 1. The laboratory performed Immunology and Microbiology testing as confirmed by the General Supervisor 1 (GS1) during a tour of the laboratory on 11/04/20 at 10:05 a.m. 2. Competency assessment documents for 10 of 10 fully trained TP in 2019 did not include an evaluation of the following tests: Legionella Antigen Streptococcus Pneumoniae Antigen Fetal Rupture of Membranes 3. The laboratory was unable to provide the missing competency assessments upon request. 4. In an interview at 11:25 a.m. on 11/04/20, GS1 confirmed the above findings. . 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: -- 4 of 5 -- . Based on document review and interview with laboratory personnel, the Technical Supervisor failed to ensure 3 of 5 new testing personnel received a competency evaluation at least semiannually during the first year of patient specimen testing. Findings are as follows: 1. The laboratory performed Chemistry, Toxicology, Hematology, Urinalysis, Microbiology, Parasitology, Immunology, and Immunohematology testing as confirmed by the General Supervisor 1 (GS1) during a tour of the laboratory on 11/04/20 at 10:05 a.m. 2. New Testing Personnel (TP) were hired with the following start dates: TP Hire Date TP7 3/26/19 TP9 5/21/19 TP14 10/2 /18 3. Documentation of the semiannual competency assessment for all tests in the noted specialties were not found for TP7, TP9 and TP14 during review of laboratory personnel records. The laboratory was unable to provide the missing semiannual competency assessments upon request. 4. In an interview at 11:25 a.m. on 11/04/20, GS1 confirmed the above findings. -- 5 of 5 --

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 College of American Pathologists (CAP) proficiency testing reports, the laboratory failed to successfully participate in proficiency testing (PT) in 2019/2020 for Compatibility Testing under the specialty of Immunohematology. Findings include: 1. The CASPER Report 0155D, reviewed on 10-29-20, indicated the the laboratory failed to successfully participate in Compatibility Testing in 2019/2020. Unsatisfactory PT performance in Compatibility Testing was obtained in the following events. -2019 3rd event 50% -2020 2nd event 60% 2. The CASPER Report 0155D indicated the laboratory failed to obtain a Compatibility Testing PT score of at 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 -- least 100 percent in two out of three consecutive testing events in 2019/2020. 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 College of American Pathologists (CAP), 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. -2019 3rd event 50% -2020 2nd event 60% . 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 College of American Pathologists (CAP), the laboratory failed to achieve satisfactory performance for Compatibility Testing in two out of three consecutive testing events, constituting unsuccessful participation for the analyte. CAP 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. -2019 3rd event 50% -2020 2nd event 60% . -- 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 Center for Medicare and Medicaid Services reports, College of American Pathologists (CAP) proficiency testing reports, and email communication with the Technical Consultant, the laboratory failed to successfully participate in proficiency testing (PT) for Prothrombin Time (ProX) testing under the specialty of Hematology. Findings are as follows: D2123 - the laboratory failed to obtain a PT score of at least 80 percent for Prothrombin Time (ProX) testing. D2127 - the laboratory failed to submit PT results for the CAP GCL-A 2019 testing event . D2130 - the laboratory failed to achieve successful PT performance for Prothrombin Time (ProX) testing in two consecutive PT 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 2 -- D2121 HEMATOLOGY CFR(s): 493.851(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 review of proficiency testing (PT) reports from the College of American Pathologists (CAP), the laboratory failed to obtain a PT score for Prothrombin Time (ProX) of at least 80 percent which resulted in unsatisfactory performance for the analyte. Unsatisfactory PT performance of Prothrombin Time (ProX) was obtained in the following CAP events. - GCL-A 2019 0% - GCL-B 2019 0% D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: . Based on a review of proficiency testing (PT) reports from the College of American Pathologists (CAP) provider, the laboratory failed to participate in one PT event for Prothrombin Time (ProX) testing. Findings are as follows: The laboratory failed to participate in Prothrombin Time (ProX) PT for the GCL-A 2019 event . Failure to participate in the testing event resulted in unsatisfactory performance for the analyte. 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 review of proficiency testing (PT) reports from the College of American Pathologists (CAP), the laboratory failed to achieve successful PT performance for Prothrombin Time (ProX) testing in two consecutive PT events. Findings are as follows: The laboratory received unsatisfactory scores for Prothrombin Time (ProX) testing in two consecutive PT events. Two consecutive PT failures for the same analyte constitutes unsuccessful performance. PT reports from CAP listed the following unsatisfactory Prothrombin Time (ProX) scores. - GCL-A 2019 0% - GCL- B 2019 0% . -- 2 of 2 --

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 establish a system to evaluate and define the relationship between test results obtained from different analyzers or methodologies at least twice annually. Findings are as follows: 1. The laboratory performed Chemistry (Toxicology) and Hematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 07/18/18 at 8:05 a.m. 2. The following items were observed and available for use during the tour of the laboratory. -Two MEDTOXScan Drugs of Abuse Test System toxicology analyzers -Sysmex XT-4000i hematology analyzer with automated differentials -Stain set up for manual differentials 3. The GS indicated the laboratory used the following test system for Chemistry and Hematology back up testing. -epoc Blood Analysis System 4. The laboratory's procedure manuals did not include a system to define and evaluate the relationship between test results obtained from different test methodologies or analyzers at least twice annually. Documentation of such an evaluation was not found during review of laboratory records. 5. In an interview on 07/18/18 at 5:00 p.m., the GS confirmed the laboratory did not have a system in place to evaluate the relationship between test results obtained from different analyzers or methodologies. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) 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 -- (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 testing personnel (TP)received competency assessments for all test procedures performed in 2016 and 2017. Findings are as follows: 1. The laboratory performed Microbiology, Chemistry, and Hematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 07/18/18 at 8:05 a. m. 2. Competency assessment documents for 9 of 9 TP in 2016 and 10 of 10 TP in 2017 did not include a complete evaluation of the following items. Analyzers - bioMerieux Vidas -MEDTOXScan -Biosite Triage Microscopic Examinations - Potassium Hydroxide -Vaginal wet preparations -Manual Differentials Kit tests - Amnisure Rupture of Fetal Membranes -OSOM hCG serum pregnancy test 3. The laboratory was unable to provide the missing competency documents upon request. 4. In an interview on 07/18/18 at 10:30 a.m., the GS confirmed a complete evaluation of the above items was not included in the 2016 and 2017 competency assessments. -- 2 of 2 --