Cordova Community Medical Center

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 a lack of documentation and an interview with the laboratory director, the laboratory failed to verify the performance specifications for accuracy, precision, reportable range, and reference range for the Protime (PT)/INR test on the Abbott i- STAT, Serial Number 43707, in use on 2/27/2023, prior to testing patient samples. Findings include: 1. A request was made to review the verification of performance specifications for the PT/INR test on the Abbott i-STAT analyzer and documentation could not be provided. 2. An interview conducted on 9/26/2024 at 3:00 PM with the laboratory director confirmed the laboratory did not have the verification studies for accuracy, precision, reportable range, and reference range for PT/INR on the Abbott i- STAT. 3. The laboratory reports performing approximately six (6) PT/INRs annually. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. 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 observation of digital thermometers, lack of documentation, and an interview with Testing Person 1 (TP1), the laboratory failed to verify the accuracy of four (4) of four (4) thermometers used by the laboratory to monitor the temperature of the refrigerators and freezer used to store patient samples and test reagents, within the timeframe defined by the manufacturer. Findings include: 1. The Sensoscientific digital thermometers (serial numbers SRS7-36810, SRS7-36811, SRS7-36841, SRS7- 36801) used in the laboratory's refrigerators and freezer had calibration due dates of 3 /10/2022. 2. A request was made to review the documentation verifying the accuracy of the Sensoscientific thermometers, and documentation could not be provided. 3. The testing person 1 confirmed these findings by interview on 9/26/2024 at 3:00 PM. 4. The laboratory reports performing 11,196 tests annually. -- 2 of 2 --

Summary Statement of Deficiencies 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, consultant competency. This STANDARD is not met as evidenced by: Based on review of the CMS-209 personnel form, competency assessments, and interview with the technical consultant (TC), the laboratory failed to have a policy or procedure to document the competency assessment of the technical consultant. Findings include: 1. The laboratory's CMS-209 personnel form identified one individual who was identified as technical consultant (TC) as well as testing personnel. 2. There were no written policies/procedures to assess competency for the technical consultant. 3. The laboratory reports performing 14,313 patient samples annually. 4. The technical consultant confirmed these findings in an interview on 11/8 /22 at 3:45 PM. D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) 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)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or 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 2 -- review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of the CMS-209 laboratory personnel report form, laboratory policies and procedures, and interview with the technical consultant on 11/8/2022 the laboratory director failed to specify in writing, the responsibilities and duties of the technical consultant. Findings include: 1. The laboratory's CMS-209 personnel form identified one individual who was identified as technical consultant (TC) as well as testing personnel. 2. The policy # LAB 202, Delegation of Laboratory Responsibilities, did not include technical consultant responsibilities. 3. The laboratory reports performing 14,313 patient samples annually. 4. The technical consultant confirmed these findings in an interview on 11/8/22 at 3:45 PM. -- 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 an off-site desk review of the laboratory's 2021 and 2022 American Proficieny Institute (API) evaluation of proficiency testing (PT) records and a telephone interview with the laboratory director on May 6, 2022, it was determined that the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for Protime in two (2) out of three (3) Hematology testing events resulting in unsuccessful PT performance. See 2130 D2130 HEMATOLOGY CFR(s): 493.851(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 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 an off-site desk review of the laboratory's 2021 and 2022 American Proficiency Institute (API) proficiency testing (PT) records, and a telephone interview with the laboratory director on May 6, 2022 it was determined that the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for Protime in two (2) out of three (3) Hematology testing events. Findings include: 1. Desk review of the laboratory's 2021 and 2022 API PT records revealed Protome scores of less than eighty percent for the following Hematology events: API Hematology/Coagulation 2022 1st event -score of 60%, API Hematology/Coagulation 2021 3rd event -score of 60%, 2. ln a telephone interview with the laboratory director on 5/6/2022, it was confirmed that the laboratory was unsuccessful in the PT events listed above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory is in substantial compliance with the CMS Interim Final Rule (CMS- 3401-IFC) on Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE) effective August 25, 2020. No deficiencies were cited. 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 review of the laboratory's 2019 American Proficiency Institute (API) proficiency testing (PT) records and an interview with the technical consultant, the laboratory failed to maintain and provide the PT provider's participant results and document their review for nine of fourteen PT events. Findings include: 1. The proficiency records for 2019 did not include the participant results or review for these surveys: a. 2019 1st event: Chemistry Core and Chemistry Miscellaneous participant reports missing b. 2019 2nd event: Chemistry Core, Chemistry Miscellaneous, Hematology/Coagulation, Immunology, and Microbiology participant reports missing c. 2019 3rd event: Chemistry Core, Immunology, and Microbiology participant reports missing 2. The laboratory performs approximately 6,600 Chemistry tests, 2,550 Hematology tests, and 3,700 Microbiology tests annually. 3. The technical 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 -- consultant confirmed the participants reports were missing and had not been reviewed, on 5/5/21 at 11:30 am. 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 review of laboratory blood transfusion policies, and interview with the technical consultant, the laboratory did not have a procedure for the completion of patient testing, including cross-matches, following emergency transfusions. Findings include: 1. The laboratory's policy # LAB 104 entitled 'Transfusion of O negative, Uncrossmatched Blood' did not include instructions for obtaining the subsequent completion patient testing including cross-matches following emergency transfusions. 2. The laboratory performs approximately one emergency transfusion event per year. 3. The technical consultant confirmed these findings on 5/5/21 at 11:30 am. D3035 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(ii) In addition, the laboratory must retain immunohematology records, blood and blood product records, and transfusion records as specified in 21 CFR 606.160(b)(3)(ii), (b) (3)(iv), (b)(3)(v), and (d). This STANDARD is not met as evidenced by: Based on a review of immunohematology patient results and interview with technical consultant, the laboratory failed to maintain records of subsequent completion of cross-matches in two of two emergency transfusions reviewed. Findings include: 1. A review of two of two emergency transfusions (patient #BB966674 on transfused on 10 /31/20 and patient #BB966669 on transfused on 2/27/19) did not contain compatibility records between the recipient and donor blood units. 2. The laboratory performs approximately one emergency transfusion event per year. 3. The technical consultant confirmed these findings on 5/5/21 at 11:30 am. 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: -- 2 of 5 -- Based on review of the Sysmex XP-300 Hematology analyzer verification records from November 2018, and an interview with the technical consultant, the laboratory failed to verify the manufacturer's specifications for precision of complete blood analytes. Findings include: 1. The laboratory had no records showing precision was assessed for red blood cell counts, white blood cell counts, hemoglobin, hematocrit, platelet counts, and differential as part of the verification prior to patient testing. 2. The laboratory began using the Sysmex XP-300 for testing patients on 11/21/18. 3. The laboratory performs approximately 2,250 hematology tests annually. 4. The technical consultant confirmed these findings on 5/5/21 at 11:30 am. 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 quality control review of the Cepheid GeneXpert SARS-CoV-2 assay from July 2020 to survey date, and an interview with the technical consultant, the laboratory did not test, at a minimum two levels of external quality control (QC) material to assess the test performance of the SARS-CoV-2 assay each day of patient testing. Findings include: 1. Quality control records for Cepheid GeneXpert SARS- CoV-2 showed external positive and negative controls were not performed each day of patient testing. 2. The laboratory performs approximately 2,500 SARS-CoV-2 annually. 3. The technical consultant confirmed these findings on 5/5/21 at 11:30 am. D5781