Community Memorial Healthcare

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on the lack of proficiency testing (PT) attestation forms from the provider American Proficiency Institute (API) performed from 1/1/2025 to 12/31/25 and interview with the technical consultant #5 (TC#5), the laboratory failed to Attest /Evaluate on fourevents that proficiency testing samples were handled in the same manner as patient samples and evaluate the results. Findings: 1. Request was made for the API attestation forms from 1/1/2025 to 12/31/25 for three events. No fully signed attestation documents were provided at the time of survey for the following: a. 2025 Chemistry - Misc Verification - 2nd Event b. 2025 Immunology/Immunohematology - 3rd Event c. 2025 Microbiology - 3rd Event 2. Request was made for the API Evaluation forms from 1/1/2025 to 12/31/25 for one event. No fully evaluation documents were provided at the time of survey for 2025 Immunology /Immunohematology - 3rd Event. 3. Interview with the TC#5 on 1/6/2026 at 10:00 a. m. confirmed, the laboratory failed to attest on three attestation and evaluation events that proficiency testing samples were handled in the same manner as patient samples and results were evaluated. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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 review of the bioMerieux Vitek2 and Biofire Filmarray Torch (BCID2, RP 2.1, ME panel) microbiology instrument procedures, lack of comparison records and interview, the laboratory failed to evaluate and define the relationship between microbiology organism identification results using different methodologies and instruments twice annually. Findings include: 1. Review of sixteen microbiology organisms: Enterococcus faecalis, Enterococcus faecium, Listeria monocytongenes, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunisis, Strepococcus agalactiae (Group B), Streptococcus pneumoniae, Streptococcus pyogenes (Group A), Pseudomonas aeruginosa, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group and Proteus spp. showed they are performed with two methods: bioMerieux Vitek2 and Biofire Filmarray Torch (BCID2, RP 2.1, ME panel) a. No procedure was available on how to evaluate and define the relationship between the microbiology organism identification results twice annually. b. No comparison testing records performed twice annually from April 14, 2022 to December 19, 2023 were made available at the time of survey. 3. Interview with the technical consultant # 5 on December 19, 2023 at 13:20 p.m. confirmed the laboratory failed to evaluate and define the relationship twice annually between the bioMerieux Vitek2 and Biofire Filmarray Torch (BCID2, RP 2.1, ME panel) microbiology identification method procedures. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on the review of proficiency testing (PT) records and phone interview with the Laboratory Manager on 1/6/2023 at 9:30 a.m., the laboratory failed to successfully participate in PT from College of American Pathologists (CAP) under the specialties: 1. Routine Chemistry for the regulated analytes: a. 0245 Routine Chemistry b. 0315 pH Blood Gas c. 0335 pCO2 Blood Gas 2. See D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing (PT) from the provider CAP for Chemistry, and phone interview, the laboratory failed to achieve an acceptable score of 80% or higher for two of three consecutive testing events for the regulated analytes 0245 Routine Chemistry, pH Blood Gas and pCO2 Blood Gas Findings: 1. Review of CAP PT scores for 2022 revealed the following performance scores for 0245 Routine Chemistry: a. Second testing event 2022 revealed a score of 66%. b. Third testing event 2022 revealed a score of 66% 2. Review of CAP PT scores for 2022 revealed the following performance scores for 0315 pH Blood Gas: a. Second testing event 2022 revealed a score of 60%. b. Third testing event 2022 revealed a score of 60% 3. Review of CAP PT scores for 2022 revealed the following performance scores for 0335 pCO2 Blood Gas: a. Second testing event 2022 revealed a score of 40%. b. Third testing event 2022 revealed a score of 60% 4. Phone interview with the lab manager on January 6, 2022 at 9:30 a.m. confirmed, the laboratory failed to achieve an acceptable score of 80% or higher for two of three consecutive testing events for the regulated analytes Routine Chemistry, pH Blood Gas and pCO2 Blood Gas. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of performance verification documentation for the Ortho Clinical Diagnostics Vitros 5600 chemistry analyzer, non-waived test list and interview, the laboratory failed to verify the reference intervals (normal values) were appropriate for the laboratory's patient population prior to reporting patient test results. Findings: 1. Review of the verification documentation of the Ortho Clinical Diagnostics Vitros 5600 chemistry analyzer, S/N 56004074, revealed the laboratory performed an instrument verification in July 2021. The laboratory started reporting patient test results in August 2021 2. The KS-CLIA-PS01, non-waived test list provided at the time of survey, listed 48 analytes as performed on the Ortho Clinical Diagnostics Vitros 5600. Annual test volumes for the 48 analytes listed as 143,379 tests. 3. No documentation for verification of the manufacturer's normal values were available for 48 of 48 analytes at the time of survey. 4. Interview with General Supervisor #1 (GS#1) on 4/13/22 at 1:15 p.m. confirmed, the laboratory failed to verify that the reference intervals (normal values) were appropriate for the laboratory's patient population prior to reporting patient test results. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Review of 2020, 2021 and to date of survey blood bank temperature monitoring records, lack of procedure, lack of alarm check records, and interview, the laboratory failed to regularly inspect the alarm system for the storage of blood products. Findings: 1. Review of monitoring records found 24 hour monitoring system in place with computerized graphs for temperature records. Records reviewed showed acceptable temperatures were maintained. 2. GS #1 stated that the system monitored the temperatures and would send laboratory staff a text alert if the temperature went out of range. 3. Surveyor requested records of high and low alarm checks. GS#1 stated the alarm system was not regularly checked. 4. Surveyor asked for policy for temperature alarm checks. GS#1 stated the laboratory did not have a policy for testing the blood bank storage alarm system. No documentation of an alarm check was provided from 1/10/2020 to 4/13/2022. 5. Interview with GS #1 on 4/13/22 confirmed, the laboratory failed to regularly inspect the alarm system for the storage of blood products. -- 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 a review of proficiency testing (PT) records and staff interview reveals that the laboratory failed to evaluate its proficiency testing results that were not scored by the PT program. Findings: 1. 2019 1st event Chemistry-Miscelleneous PT performance evaluation included 1 ungraded response a. ungraded:MA-02 Microalbumin, semi-qual 2019 2nd event Hematology/Coagulation PT performance evaluation included 5 educational responses a. Educational samples included: Ungraded samples included:ECI 06-10 Blood cell ID 2019 3rd event Microbiology. PT performance included 8 ungraded educational responses a. Educational samples included:Culture ID ES-03 and ES 03- MIC Azithromycin, Cefotaxime, Cetriaxone, Cefuroxime, Clindamycin ,Levofloxacin,vancomycin 2. No evidence of lab investigation and evaluation was available for all three PT testing results at the time of survey. 3. Interview with Technical Supervisor #3 at 1120 am on 01/09/2020 confirmed ungraded/educational results for all three PT surveys were not evaluated or investigated. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. 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 review of instrument type and test settings, reagent package insert, and interview, the laboratory failed to follow manufacturer's instruction for the ISI setting in prothrombin time testing. Findings include: 1. Prothrombin time testing is performed on the ACL Elite using RecombiPlasTin reagent. 2. ACL instrument setting for prothombin time testing showed lot #N0929757, ISI set to 1.020 and patient normal pool of 11.35 sec 3. Lot to lot change study indicated for lot #N0929757, ISI set to 1.020 and geometric mean of patient normal pool of 11.58 sec 4. Interview with GS #1 01/09/2020 @1120AM confirmed the laboratory failed to follow manufacturer's instructions for the resetting of patient normal pool using geometic mean setting in prothrombin time testing for the new lot #N0929757. -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: A review of temperature and humidity logs and interview with staff revealed the laboratory failed to establish a range for the humidity room temperature for the laboratory as the Ruby the hematology analyzer requires and Dimension the Chemistry analyzer failed . The laboratory failed to monitor the freezer temperature range according to manufacture guidelines for the Biorad controls. Findings were as follows: a. Based upon review of manufacture's guide for the Ruby (Hematology analyzers) the laboratory failed to establish the humidity less than 80% and room temperature of 15-30 degrees Celsius. The laboratory failed to define the acceptable humidity range according to the manufacture's range . b. Based upon review of manufacture's guide for the Dimension (chemistry analyzer) for the humidity range 20- 80% room temperature 15-30 degrees Celsius the laboratory failed to define the acceptable ranges. c. Based upon review of freezer temperature Biorad manufacture guidelines require that the Biorad controls are stored >-20 degrees Celsius. The laboratory failed to store the Biorad controls within manufacture guidelines. d. This was confirmed by the Technical Consultant on 02/28/018 at 10::00 hrs D5783