Arbuckle Memorial Hospital

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and from the proficiency testing provider. The laboratory was found out of compliance with the following CLIA Conditions: 493.803; D2016: Successful Participation 493.1441; D6076: Laboratory Director, High Complexity 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 desk review of proficiency testing scores obtained from the CASPER 0155D report and API (American Proficiency Institute) Performance Summaries and Comparative Evaluation records, the laboratory failed to successfully participate in a 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 -- proficiency testing program for two consecutive testing events for Compatibility Testing, resulting in unsuccessful performance. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) (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 a review of proficiency testing scores obtained from the CASPER 0155D report and API (American Proficiency Institute) Performance Summaries and Comparative Evaluation records, the laboratory failed to achieve satisfactory performance for Compatibility Testing for two consecutive testing events in 2024 and 2025. Findings include: (1) A review of the CASPER 0155D report identified the following unsatisfactory scores for Compatibility Testing: (a) Third 2024 Event - 60% (b) First 2025 Event - 80% (2) A review of the proficiency testing scores from API for 2024 and 2025 confirmed the above findings. 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 a desk review of proficiency testing scores obtained from the CASPER 0155D report and API (American Proficiency Institute) Performance Summaries and Comparative Evaluation records, the laboratory director failed to provide overall management and direction for two consecutive events in 2024 and 2025, resulting in unsuccessful performance. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores obtained from the CASPER 0155D report and API (American Proficiency Institute) Performance Summaries and Comparative Evaluation records, the laboratory director failed to ensure successful performance in an HHS approved proficiency testing program for Compatibility Testing in two consecutive testing events in 2024 and 2025. Refer to D2181. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 08/28,29,30/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director, laboratory manager, testing person #3, chief executive officer, and director of clinical resource during an exit conference performed at the conclusion of the survey. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory director or designee failed to sign proficiency testing attestation statements for six of 17 events reviewed in 2023 and 2024. Findings include: (1) On 08/29/2024, a review of 2023 and 2024 proficiency testing events identified the following for six of 17 events: (a) Second Chemistry Core Event 2023 - The attestation statement had not been signed by the laboratory director or designee; (b) Second Hematology /Coagulation Event 2023 - The attestation statement had not been signed by the laboratory director or designee; (c) Second Immunology/Immunohematology Event 2023 - The attestation statement had not been signed by the laboratory director; (d) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- Second Chemistry Miscellaneous Event 2023 - The attestation statement had not been signed by the laboratory director or designee; (e) Third Hematology/Coagulation Event 2023 -The attestation statement had not been signed by the laboratory director or designee; (f) Third Immunology/Immunohematology Event 2023 - The attestation statement had not been signed by the laboratory director. (2) The findings were reviewed with the laboratory manager who stated on 08/28/2024 at 01:10 pm the attestation statements had not been signed by the laboratory director or designee (as applicable). D3025 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(d) Investigation of transfusion reactions. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as appropriate, to Federal and State authorities. This STANDARD is not met as evidenced by: Based on a review of records, hospital policy, and interview with the clinical laboratory director and nursing director the laboratory failed to ensure written policies were followed for preventing transfusion reactions for one of three patients transfused. Findings include: (1) On 08/28/2024 at 09:30 am, the laboratory manager stated that blood transfusions were performed by nursing staff; (2) On 08/29/2024, a review of the hospital policy titled, "Blood Products Administration" stated all adult patient shall have vital signs taken as follows:" (a) "Prior to the start of the transfusion" (b) "Q 5 minutes there after X 4 after the transfusion is started" (c) "Q 15minutes X 4" (d) "Then Q 30 minutes until transfusion is completed" (e) "Post transfusion" (3) A review of transfusion records for one unit identified the policy had not been followed: (a) Unit #155428 - The unit was started on 03/19/2024 at 04:55 pm and vital signs had not been documented as performed as follows: (i) One 15 minute vital had not been documented between 05:30 pm and 06:00 pm (4) The records were reviewed with the clinical nursing director who stated on 08/30/2024 at 11:30 am, the vital signs had not been documented according to policy. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on interview with the laboratory manager and testing person #6, the laboratory failed to provide written instructions to clients collecting and referring specimens for testing performed in the laboratory. Findings include: (1) On 08/28/2024 at 09:45 pm, the laboratory manager and testing person #6 stated the following testing were performed and specimens were transported to the laboratory from nursing homes and home health care agencies: (a) CBC (complete blood count) testing using the Sysmex XN-550 analyzer; (b) Routine Chemistry testing using the Siemens Dimension EXL with LM and Dimension EXL 200 analyzers. (2) Interview with the laboratory manager and testing person #6 on 08/28/2024 at 11:09 am confirmed the laboratory -- 2 of 8 -- did not provide written instructions (i.e., client service manual) to the clients to explain the laboratory's specimen collection and transportation policies. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of written procedures and interview with the laboratory manager, the laboratory failed to ensure two of three procedures had been approved, signed, and dated by the current laboratory director. Findings include: WET PREP (1) On 08/29 /2024 at 11:20 am, the laboratory manager stated the laboratory performed wet prep procedure to examine the presence of yeasts, Trichomonas vaginalis, and clue cells using vaginal secretion; (2) A review of the procedure titled, "Wet Prep" identified no indication it had been approved, signed, and dated by the current laboratory director; (3) The findings were reviewed with the laboratory manager who stated on 08/29 /2024 at 11:26 am, the procedure had not been signed and dated by the current laboratory director. SERUM HCG (1) On 08/29/2024 at 11:22 am, the laboratory manager stated the laboratory performed qualitative hCG (Human chorionic gonadotropin) testing using serum specimens; (2) A review of the procedure for the serum hCG identified no indication it had been signed and dated as approved by the laboratory director; (3) The findings were reviewed with the laboratory manager who stated on 08/29/2024 at 11:26 am, the procedure had not been signed and dated by the laboratory director. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation and interview with the laboratory manager and testing person #6, the laboratory failed to label three of three containers with the identity, expiration date, and lot number of the contents. Findings include: (1) On 08/28/2024 at 10:40 am, the laboratory manager and testing person #6 stated the laboratory stained peripheral blood smears to perform manual differential testing; (2) Observation on 08 /28/2024 at 10:45 am identified three unlabeled Copeland jars, appearing to contain materials used to stain peripheral blood smears; (3) The findings were reviewed with testing person #6 and the laboratory manager who stated on 08/28/2024 at 11:06 am the Copeland jars contained staining materials had not been labeled with the identity, expiration date, and lot numbers. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) -- 3 of 8 -- Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to ensure expired blood bank reagents were not available for use for one of 15 days of patient testing reviewed from January 2024 through July 2024. Findings include: (1) On 08/29/2024 at at 01:25 pm, the laboratory manager stated Crossmatch testing was performed in the laboratory which included ABO Typing and Antibody Screen testing using the tube method; (2) On 08/30/2024, a review of quality control and patient testing records for 15 days of patient testing performed from 01/29/2024 through 07/27/2024 showed expired reagents had been used for patient testing on 02/03/2024: (a) Immucor Reagent Red Blood Cells A1 and B; lot #111490 with an expiration date 02/02/2024; (b) Immucor Reagent Red Blood Cells PanoScreen I, II, and III; lot #48793 with an expiration date of 02/02/2024. (3) The records were reviewed with the laboratory manager who stated on 08/30/2024 at 11: 10 am, the documentation showed expired reagents had been used on the date of testing. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, testing person #3, and testing person #6, the laboratory failed to ensure the manufacturer's instructions were followed for performing maintenance procedures on the OPTI CCA- TS blood gas analyzer during the review period of January 2023 through July 2024. Findings include: (1) On 08/28/2024 at 09:30 am, the laboratory manager and testing person #6 stated the laboratory performed blood gas testing using the OPTI CCA-TS analyzer; (2) A review of the manufacturer's instruction manual titled, "OPTI CCA- TS Procedure Manual", under section 6.3 identified the following required quarterly maintenance procedures: (a) "Perform the tHb calibration (Refer to the calibration section of this procedures)." (3) A review of maintenance logs from January 2023 through July 2024 identified quarterly maintenance had not been documented as performed between 07/23/2023 and 01/27/2024: (4) The records were reviewed with the laboratory director and testing person #3 who stated on 08/30/2024 at 10:36 am, the maintenance procedure had not been documented as performed. 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. -- 4 of 8 -- This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to follow their policy for monitoring the effectiveness of their QCP (Quality Control Plan) for two of three test systems reviewed from January 2023 through the current date. Findings include: D-DIMER (1) On 08/28/2024 at 10:50 am, the laboratory manager stated the following: (a) The laboratory performed D-dimer testing using Alere Triage Meter Pro analyzer; (b) An IQCP (Individualized Quality Control Plans) had been developed for the test system. (2) A review of the IQCP for the test system identified that QA (Quality Assessment) reviews of the QCP (Quality Control Plan) were to be performed on an annual basis; (3) A review of records for the test system from January 2023 through the current date identified no documentation that annual QA reviews had been performed since 01/04/2023; (4) The records were reviewed with the laboratory manager who stated on 08/29/2024 at 01:25 pm, annual QA reviews had not been documented as performed as stated above. PT/INR AND PTT (1) On 08/28/2024 at 10:50 am, the laboratory manager stated the following: (a) The laboratory performed PT/INR (Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) using Hemochron Signature Elite analyzer; (b) An IQCP (Individualized Quality Control Plans) had been developed for the test system. (2) A review of the IQCP for the test system identified that QA (Quality Assessment) reviews of the QCP (Quality Control Plan) were to be performed on an annual basis; (3) A review of records for the test system from January 2023 through the current date identified no documentation that annual QA reviews had been performed since 01/04/2023; (4) The records were reviewed with the laboratory manager who stated on 08/29/2024 at 01:25 pm, annual QA reviews had not been documented as performed as stated above. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager and testing person #6, the laboratory failed to ensure reference intervals were determined as appropriate for the laboratory's patient population for two of two patient reports reviewed. Findings include: (1) On 08/28/2024 at 10:00 am, testing person #6 stated the laboratory performed CBC (complete blood count) testing using the Sysmex XN- 550 analyzer; (2) On 08/29/2024 two patient CBC reports were reviewed - the first report was for an adult female patient with the testing performed on 08/28/2024 at 18: 43 pm; the second report was for an adult male patient with the testing performed on 08/29/2024 at 10:41 am. Both reports included the same reference intervals for the following CBC parameters: (a) Hemoglobin - 11.5 - 17.0 g/dL; (b) Hematocrit - 37.0 - 54.0 %. (3) The reports were reviewed with the laboratory manager who stated on 08 /30/2024 at 10:50 am, the patient reports did not include gender specific reference ranges for hemoglobin and hematocrit. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) -- 5 of 8 -- The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory director failed to attest that, at the time of testing, proficiency testing samples were tested in the same manner as patient specimens as required under Subpart H for five of 17 proficiency testing events reviewed in 2023 and 2024. Findings include: (1) On 08/29/2024, a review of 2023 and 2024 proficiency testing events identified attestation statements had been signed up to seven months after the samples had been tested for five of 17 events reviewed: (a) First Chemistry Miscellaneous Event 2024 - The sample testing had been completed on 05/08/2024 and the attestation statement had not been signed by the laboratory director until 08/26 /2024; (b) First Chemistry Core Event 2024 - The sample testing had been completed on 01/30/2024 and the attestation statement had not been signed by the laboratory director until 08/26/2024; (c) First Hematology/Coagulation Event 2024 - The sample testing had been completed on 03/21/2024 and the attestation statement had not been signed by the laboratory director until 08/24/2024; (d) First Immunology /Immunohematology Event 2024 - The sample testing had been completed on 04/02 /2024 and the attestation statement had not been signed by the laboratory director until 08/26/2024; (e) Second Chemistry Core Event 2024 - The sample testing had been completed on 06/18/2024 and the attestation statement had not been signed by the laboratory director until 08/24/2024. (2) The records were reviewed with the laboratory manager who stated on 08/28/2024 at 01:10 pm the attestation statements had not been signed timely as stated above. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the technical consultant failed to ensure competency evaluations for moderate complexity testing had been performed semiannually during the first year of testing for one of one testing person. Findings include: (1) On 08/28/2024 a review of personnel records for one person hired to perform moderate complexity testing after the previous recertification survey identified the following for one of one person: (a) Testing Person #8 - The initial training was complete on 05/31/2023. There was no evidence a competency evaluation had been performed between 05/31/2023 and 08/24/2024. (2) The records were reviewed with the laboratory manager who stated on 08/30/2024 at 10:10 am, a semiannual competency evaluation had not been performed. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) -- 6 of 8 -- The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the technical consultant failed to ensure personnel performing moderate complexity testing had been evaluated at least annually for six of six persons performing testing during 2022 and to date in 2024. Findings include: (1) On 08/28/2024 a review of personnel records for six persons performing moderate complexity testing during 2022 and to date in 2024 identified no evidence an annual competency evaluation had been performed for six of six testing persons as follows: (a) Testing Person #2 - Between 08 /26/2022 and 08/26/2024 (b) Testing Person #3 - Between 08/26/2022 and 08/24/2024 (c) Testing Person #4 - Between 08/26/2022 and 08/26/2024 (d) Testing Person #5 - Between 08/26/2022 and 08/24/2024 (e) Testing Person #6 - Between 08/26/2022 and 08/26/2024 (f) Testing Person #7 - Between 08/26/2022 and 08/24/2024 (2) The records were reviewed with the laboratory manager who stated on 08/30/2024 at 10: 10 am the annual evaluations had not been performed. 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 a review of records and interview with the laboratory manager, the technical supervisor failed to ensure competency evaluations for high complexity testing had been performed semiannually during the first year of testing for one of one testing person. Findings include: (1) On 08/28/2024 a review of personnel records for one person hired to perform high complexity testing after the previous recertification survey identified the following for one of one person: (a) Testing Person #8 - The initial training was complete on 05/31/2023. There was no evidence a competency evaluation had been performed between 05/31/2023 and 08/24/2024. (2) The records were reviewed with the laboratory manager who stated on 08/30/2024 at 10:10 am, a semiannual competency evaluation had not been performed. Note: High complexity testing included ABO/Rh typing, Antibody Screen, and Compatibility testing. 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: -- 7 of 8 -- Based on a review of records and interview with the laboratory manager, the technical supervisor failed to ensure personnel performing high complexity testing had been evaluated at least annually for six of six persons performing testing during 2022 and to date in 2024. Findings include: (1) On 08/28/2024 a review of personnel records for six persons performing high complexity testing during 2022 and to date in 2024 identified no evidence an annual competency evaluation had been performed for six of six testing persons as follows: (a) Testing Person #2 - Between 08/26/2022 and 08/26 /2024 (b) Testing Person #3 - Between 08/26/2022 and 08/24/2024 (c) Testing Person #4 - Between 08/26/2022 and 08/26/2024 (d) Testing Person #5 - Between 08/26/2022 and 08/24/2024 (e) Testing Person #6 - Between 08/26/2022 and 08/26/2024 (f) Testing Person #7 - Between 08/26/2022 and 08/24/2024 (2) The records were reviewed with the laboratory manager who stated on 08/30/2024 at 10:10 am the annual evaluations had not been performed. Note: High complexity testing included ABO/Rh typing, Antibody Screen, and Compatibility testing. -- 8 of 8 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 11/07,08,09,10/2022, The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director, incoming laboratory director, assistant to the laboratory director, and laboratory manager during an exit conference performed at the conclusion of the survey. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory director failed to sign a proficiency testing attestation statement for one of five Immunohematology events. Findings include: (1) On 11/07/2022, a review of the 2021 and 2022 Immunohematology proficiency testing records identified the following for one of five events: (a) First 2022 Immunology/Immunohematology Event - The attestation statement had not been signed by the laboratory director. (2) The findings were reviewed with the laboratory manager who stated on 11/08/2022 at 11:07 am the attestation statement had not been signed by the laboratory director. 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 -- D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on a review of policies and interview with the laboratory manager, the laboratory failed to ensure one of three policies had been approved, signed, and dated by the current laboratory director. Findings include: (1) On 11/07/2022 at , the laboratory manager stated the following: (a) Neisseria gonorrhoeae and Chlamydia trachomatis testing were performed using the Cepheid Gene Xpert analyzer effective 03/19/2021; (b) An IQCP (Individualized Quality Control Plan) had been developed for the test system. (2) On 11/08/2022, a review of the IQCP identified the QCP (Quality Control Plan) for the test system had not been approved, signed, and dated by the current laboratory director; (3) The records were reviewed with the laboratory manager who stated on 11/08/2022 at 01:32 pm, the QCP for the above test system had not been approved, signed, and dated by the current laboratory director. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory manager, the laboratory failed to follow the manufacturer's instructions for performing maintenance procedures for one of three analyzers reviewed. Findings include: (1) On 11/07/2022 at 10:40 am, the laboratory manager stated Albumin, Alcohol, Alkaline Phosphatase, ALT (Alanine Aminotransferase), Amylase, AST (Aspartate Aminotransferase), BUN (Blood, Urea, Nitrogen), Calcium, CK (Creatine Kinase), Creatinine, Chloride, CO2, Glucose, Lipase, Magnesium, Myoglobin, Phosphorus, Troponin I, Potassium, Sodium, Total Bilirubin, Total Cholesterol, and Total Protein testing were performed on the Siemens Dimension EXL 200 as the STAT analyzer effective 06/24/2022; (2) On 11/09/2022, a review of the "Siemens Dimension Operator's Guide" Chapter 7 titled, "Maintenance" stated the following maintenance requirements: (a) Weekly (i) Clean HM Wash Probes and R2 Reagent Probes (b) Monthly (i) Clean Clot Check Drain on the IMT Port (ii) Replace IMT Pump Tubing (iii) Clean IMT System (iv) Replace Instrument Air filter (v) Stylette HM Wash Probes (vi) Replace HM Pump Heads on Wash Stations (vii) Clean R2 and R3 Drains (3) A review of maintenance records contained in the SQS (Strategic Quality Support System) identified no documentation of the weekly and monthly maintenance procedures during the review period of July 2022 through October 2022; (4) The findings were reviewed with the laboratory manager who stated on 11/09 /2022 at 02:59 pm that although the maintenance procedures had been performed, the tasks had not been built into SQS for the procedures to be documented as performed. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) -- 2 of 4 -- 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 a review of records and interview with the laboratory manager, the laboratory failed to perform quality control as stated in the IQCP for Neisseria gonorrhoeae and Chlamydia trachomatis testing for four of 18 months reviewed. Findings include: (1) On 11/07/2022 at 10:05 am, the laboratory manager stated the following: (a) Neisseria gonorrhoeae and Chlamydia trachomatis testing were performed using the Cepheid Gene Xpert analyzer beginning 03/19/2021; (b) Positive and negative QC (Quality Control) materials were tested monthly, according to the laboratory IQCP (Individualized Quality Control Plan). (2) On 11/08/2022, a review of QC records from June 2021 through the current date identified no documentation to prove QC had been performed as stated in the QCP (Quality Control Plan) for four of 18 months reviewed. QC had not been performed between: (a) 06/31/2021 and 08/05 /2021 (b) 12/17/2021 and 02/02/2022 (c) 03/21/2022 and 05/20/2022 (d) 05/20/2022 and 07/08/2022 (3) The records were reviewed with the laboratory manager who stated on 11/08/22 at 01:45 pm, QC had not been performed as shown above. 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 a review of records and interview with the laboratory manager, the laboratory failed to have a system that twice a year evaluated and defined the relationship between test results for Blood Gas testing performed using two test methods. Findings include: (1) On 11/07/2022 at 10:20 am, the laboratory manager stated Blood Gas (pH, pCO2, pO2) testing was performed using the Nova Stat Profile Prime + analyzer as the primary method and the Opti CCA-TS analyzer as the backup method; (2) On 11/08/2022, a review of records from January 2022 through the current date identified no records to prove the relationship between the different test methods had been evaluated during the review period; (3) Interview with the laboratory manager on 11/08/2022 at 02:15 pm confirmed the relationship between the test methods had not been evaluated. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) -- 3 of 4 -- (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 a review of records and interview with the laboratory manager, the laboratory failed to follow their policy for monitoring the effectiveness of their QCP for two of two test systems. Findings include: (1) On 11/07/2022 at 10:30 am, the laboratory manager stated the following: (a) D-dimer testing was performed using the Alere Triage Meter Pro analyzer; (b) PT/INR(Prothrombin Time/International Normalized Ratio) and PTT (Partial Thromboplastin Time) testing were performed using the Hemochron Signature Elite analyzer; (c) IQCP's (Individualized Quality Control Plans) had been developed for the test systems. (2) On 11/08/2022, a review of the IQCP's identified that QA (Quality Assessment) reviews of the QCP (Quality Control Plans) were to be performed on an annual basis; (3) A review of records for the test systems during 2020 and to date in 2022 revealed the IQCP's had been approved on 12/11/2020. There was no documentation QA reviews had been performed during the review period of January 2021 and to date in 2022; (4) The records were reviewed with the laboratory manager who stated on 11/08/2022 at 01: 29 pm, annual QA reviews had not been documented as performed. 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 a review of records and interview with the laboratory manager, the technical supervisor failed to ensure that persons performing high complexity testing had been evaluated semiannually during the first year of testing for two of two testing persons. Findings include: (1) On 11/07/2022, a review of personnel records identified the following: (a) Testing Person #4 - The Blood Bank initial training had been completed on 12/06/2021. There was no evidence a semiannual evaluation had been performed to date; (b) Testing Person #6 - The Blood Bank initial training had been completed on 12/06/2021. There was no evidence a semiannual evaluation had been performed to date. (2) The records were reviewed with the laboratory manager who stated on 11 /07/2022 at 01:20 pm there were no records to prove the above persons had been evaluated semiannually. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 12/01,02,03/2020. The laboratory was found out of compliance with the following CLIA regulations: 493.1447; D6108: Technical Supervisor The findings were reviewed with the laboratory director, Chief Nursing Officer, laboratory manager, hospital administrator, and the laboratory consultants during an exit conference performed at the conclusion of the survey. 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 a review of records and interview with the laboratory manager, the laboratory failed to retain patient records for at least 2 years. Findings include: (1) On 12/01/2020 at 10:45 am, the laboratory manager stated to surveyor #2 CBC (Complete Blood Count) testing was performed using the Horiba ABX Pentra XL80; (2) On 12 /01/2020, surveyor #2 reviewed patient testing records with the following identified: (a) Records between 07/01/2019 through 12/24/2019 were not available. (3) Surveyor #2 asked the laboratory manager if patient records between 07/01/2019 through 12/24 /2019 could be located; (4) The laboratory manager stated to surveyor #2 the patient testing records between 07/01/2019 through 12/24/2019 for CBC testing could not be located. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 16 -- consultant competency. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to have a written technical consultant and general supervisor competency policy based on the job responsibilities as listed in Subpart M. Findings include: (1) On 12/01/2020 surveyor #2 reviewed personnel records for competency assessments performed during 2019 and 2020. There was no evidence competencies had been performed for the technical consultant and general supervisor based on job responsibilities; (2) Surveyor #2 asked the laboratory manager if a written policy to evaluate the technical consultant and general supervisor, based on job responsibilities, was available and if competencies had been performed during the review period. The laboratory manager stated to surveyor #2 on 12/01/2020 at 12:35 pm, a policy to evaluate the technical consultant and general supervisor based on job responsibilities had not been written; and competencies had not been performed. 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 a review of records and interview with the laboratory manager, the laboratory failed to thoroughly review and evaluate proficiency testing results for 2 of 22 events. Findings include: BIAS (1) On 12/01/2020, surveyor #2 reviewed 2019 and 2020 proficiency testing records. The following biases (the biases were identified using the SDI (Standard Deviation Index) values assigned by the proficiency testing program) were identified: (a) 2019 Chemistry Core First Event (i) Total Iron - 5 of 5 results exhibited a negative bias (aa) CH-01 - SDI -2.8 (bb) CH-02 - SDI -2.6 (cc) CH- 03 - SDI -2.9 (dd) CH-04 - SDI -2.2 (ee) CH-05 - SDI -2.4 (b) 2019 Hematology First Event (i) White Blood Cell - 4 of 5 exhibited a negative bias (aa) PNT-01 - SDI -3.1 (bb) PNT-02 - SDI -2.8 (cc) PNT-03 - SDI -2.0 (dd) PNT-05 - SDI -3.7 (2) Surveyor #2 reviewed the above findings with laboratory manager who stated on 12/01/2020 at 12:40 pm, the biases had not been thoroughly addressed. FAILURES (1) On 12/01 /2020, surveyor #2 reviewed 2019 and 2020 proficiency testing records. The following was identified: (a) 2019 Chemistry Core First Event (i) TIBC (Total Iron Binding Capacity) - The laboratory received a score of 80% (failed 1 of 5 results for sample CH-10). There was no evidence that

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database. 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 desk review of proficiency testing scores, the laboratory failed to successfully participate in a proficiency testing program for the subspecialty of Compatibility Testing. Findings include: (1) The laboratory failed to achieve satisfactory performance for two consecutive testing events for Compatbility Testing. Refer to D2179 and 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 2 -- D2179 COMPATIBILITY TESTING CFR(s): 493.863(d) (1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unsatisfactory testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing scores, the laboratory failed to achieve successful performance for Compatibility Testing. Findings include: (1) The laboratory failed to achieve satisfactory performance on the second event in 2019 and the third event in 2019. Refer to D2181. NOTE: The only acceptable

Summary Statement of Deficiencies D0000 The survey was performed on 07/30/18 - 08/01/18. The laboratory was found to be in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director, technical consultant, and the hospital admininistrator at the conclusion of the survey D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of records, written policy and procedure, and interview with the technical consultant, the laboratory failed to follow its written policy and procedure. Findings include: (1) On the first day of the survey, the technical consultant stated to the surveyor the laboratory performed microscopic urinalysis testing and reported the presence of WBC's (White Blood Cells), RBC's (Red Blood Cells), Epithelial Cells, Clue Cells, and bacteria; (2) On the third day of the survey, the surveyor reviewed the laboratory's written policy and procedure for microscopic urinalysis. The policy included instructions for reporting results, as follows: (a) WBC's: Number seen/HPF (per High Power Field) (b) RBC's: Number seen/HPF (c) Epithelial cells: Number seen /HPF (b) Bacteria: 1+ to 4+/HPF (3) The surveyor then reviewed the microscopic urinalysis results for 4 patients and identified the laboratory failed to follow its written policy and procedure for 3 of the 4 patients reports reviewed: (a) Patient #1-Testing performed 02/06/17: (i) Bacteria was reported as "Moderate" (b) Patient #2-Testing performed 12/13/17: (i) Epithelial cells were reported as "Large" (ii) Bacteria was reported as "Large" (c) Patient #3-Testing performed 04/11/18: (i) Epithelial cells were reported as "Rare" (ii) Bacteria was reported as "Large" (4) The surveyor 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 -- reviewed the findings with the technical consultant who stated to the surveyor the laboratory failed to follow its written policy and procedure for reporting microscopic urinalysis results. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the technical consultant, the laboratory failed to ensure expired testing materials were not used. Findings include: (1) On the first day of the survey, the technical consultant stated to the surveyor the laboratory performed Crossmatch testing (i.e. ABO/Rh typing, Antibody Screen testing, and Compatibility testing) using the tube method; (2) On the second day of the survey, the surveyor reviewed Blood Bank QC (Quality Control) and patient testing records from 21 months (November and December 2016; January through December 2017; and January through July 2018) and identified documentation the laboratory used expired testing materials during 7 of the 21 months reviewed (November and December 2016; January, February, and September 2017; and April and May 2018: (a) Reagent Red Blood Cells A1 (Lot #111098), and Reagent Red Blood Cells B (Lot #113098), which were used for ABO serum blood typing, had a manufacturer's expiration date of 10/21/16 and had been used on 11 days of patient testing: 11/01/16, 11/04/16, 11/16/16, 11/17/16, 11/21/16, 11/22/16, 11/24 /16, 11/25/16, 12/05/16, 12/06/16 and 12/15/16 (b) Reagent Red Blood Cells (Panoscreen) I, II, and III, (Lot #33898), which were used for Antibody Screen testing, had a manufacturer's expiration date of 10/21/16 and had been used on 11 days of patient testing: 11/01/16, 11/04/16, 11/16/16, 11/17/16, 11/21/16, 11/22/16, 11 /24/16, 11/25/16, 12/05/16, 12/06/16 and 12/15/16 (c) Check Cells (IgG coated RBC's) (Lot #33888), which were used for Antiglobulin QC testing, had a manufacturer's expiration date of 10/21/16 and had been used on 11 days of patient testing: 11/01/16, 11/04/16, 11/16/16, 11/17/16, 11/21/16, 11/22/16, 11/24/16, 11/25 /16, 12/05/16, 12/06/16 and 12/15/16 (d) Reagent Red Blood Cells B (Lot #113112) had a manufacturer's expiration date of 01/13/17 and had been used on 9 days of patient testing: 01/14/17, 01/21/17, 01/23/17, 01/24/17, 01/28/17, 01/30/17, 01/31/17, 02/01/17, and 02/04/17 (e) Rh Control, (Lot #33888), used for QC of the Rh antiserum, had a manufacturer's expiration date of 09/08/17, and had been used on 1 day of patient testing: 09/12/17 (f) Reagent Red Blood Cells A1 (Lot #111179) and Reagent Red Blood Cells B (Lot #113098), had a manufacturer's expiration date of 04 /06/18, and had been used on 5 days of patient testing: 04/07/18, 04/11/18, 04/12/18, 04/13/18, and 05/02/18 (g) Check Cells (Lot #05119), used for ABO serum blood typing, had a manufacturer's expiration date of 04/06/18, had been used on 5 days of patient testing: 04/07/18, 04/11/18, 04/12/18, 04/13/18, and 05/02/18 (3) The surveyor reviewed the records with the technical consultant who stated to the surveyor, the documentation on the testing records showed expired reagents had been used, as listed above; (4) Examples of patient Crossmatch testing performed when documentation showed the laboratory used expired materials, follow: (a) Patient #4 - Testing performed on 11/01/16 (b) Patient #5 - Testing performed on 11/16/16 (c) Patient #6 - Testing performed on 11/21/16 (d) Patient #7 - Testing performed on 12/05/16 (e) Patient #8 - Testing performed on 12/31/16 (f) Patient #9 - Testing performed on 01/14 -- 2 of 3 -- /17 (g) Patient #10 - Testing performed on 01/28/17 (h) Patient #11 - Testing performed on 01/30/17 (i) Patient #12 - Testing performed on 02/01/17 (j) Patient #13 - Testing performed on 02/04/17 (k) Patient #14 - Testing performed on 09/12/17 (l) Patient #15 - Testing performed on 04/07/18 (m) Patient #16 - Testing performed on 04/13/18 (n) Patient #17 - Testing performed on 05/02/18 -- 3 of 3 --