Community Memorial Hospital

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observations made during the survey, lack of quality control (QC) records, review of the Cardinal Health human chorionic gonadotropin (HCG) Combo test kit package insert, and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 3:30 pm on 09/23/2022, the laboratory failed to perform a negative and positive control at least each day of patient testing for one out of one lot number of Cardinal Health HCG Combo test kit (lot number HCG1112034, expiration 2023-10-31). The findings include: 1. Observations made during a tour of the laboratory revealed that the laboratory uses the Cardinal Health HCG Combo test kit to perform serum HCG qualitative patient testing. 2. At the time of the survey, the laboratory had in use Cardinal Health HCG Combo kit lot number HCG1112034 (expiration 2023-10-31). 3. The HCG Combo kit package insert stated that for serum testing, federal, state, and local guidelines should be followed. 4. At the time of the survey, personnel identifier #1 confirmed that the laboratory had not performed controls on the Cardinal Health HCG Combo kit lot number HCG1112034 (expiration 2023-10-31). 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 review of proficiency records and reports, the laboratory failed to successfully participate in a proficiency testing program for the analyte, lactate dehydrogenase (LDH), for two consecutive proficiency testing events: 2021 event 3 and 2022 event 1 (refer to D2096). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing 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 reports and records, the laboratory failed to achieve satisfactory performance for the analyte, lactate dehydrogenase (LDH), for two consecutive testing events for unsuccessful participation. The laboratory received unsatisfactory performance scores of zero for 2021 testing event 3 and 2022 testing event 1. -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on observations made during the survey, review of Vidas 30 calibration records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 12:00 pm on 10/14/2020, the laboratory failed to retain the thyroid stimulating hormone (TSH) Vidas 30 calibration records for a minimum of two years for 19 out of 21 months (1/1/2019 - 9/30/2020). The findings include: 1. The laboratory retained the Vidas 30 calibrations in the analyzer, and had TSH calibrations from 8/12/20, 8/28/20, 9/14/20 and 9/30/20. 2. The laboratory did not realize the Vidas only stored the last four calibrations. 3. At the time of the survey, the laboratory did not have any calibrations prior to 8/12/20. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 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 -- 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of proficiency records and reports, the laboratory fails to successfully participate in a proficiency testing program for the analyte, partial pressure of oxygen (PO2), for two consecutive proficiency testing events: 2019 events 1 and 2 (refer to D2096). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- consecutive testing 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 reports and records, the laboratory failed to achieve satisfactory performance for the analyte, partial pressure of oxygen (PO2), for two consecutive testing events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 60% for 2019 testing events 1 and 2. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of proficiency testing records and confirmed by laboratory personnel identifier #6 (refer to the Laboratory Personnel Report) at approximately 10:30 am on 08/08/2018, the laboratory failed to enroll in an approved proficiency testing program for the analytes: blood gas pH, blood gas partial pressure of oxygen (PO2), and blood gas carbon dioxide partial pressure (PCO2). The laboratory did not enroll in an approved proficiency testing program for 2018. D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of patient compatibility records, the MTS Anti-Human Globulin 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 -- Anti-IgG manufacturer's package insert, and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 3:00 pm on 08/08/2018, the laboratory failed to meet immunohematology requirements for ensuring the laboratory performs compatibility testing following 21 CFR 606.151(a) through (e) as specified in D5551. 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 review of proficiency testing (PT) records and confirmed by laboratory personnel identifier #6 (refer to the Laboratory Personnel Report) at approximately 10: 50 am on 08/08/2018, the laboratory failed to perform a self evaluation when it received a score of zero for one out of six testing events (2017 event 1) in 2016 and 2017. The findings include: 1. For 2017 testing event 1, the laboratory received a score of zero for failure to submit the PT results before the submission deadline for the following analytes: blood gas pH, blood gas partial pressure of oxygen (PO2), and blood gas carbon dioxide partial pressure (PCO2). 2. At the time of the survey, the laboratory did not have records indicating it had performed a self-evaluation for the failed PT scores. D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of patient compatibility records, the MTS Anti-Human Globulin Anti-IgG manufacturer's package insert, and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 3:00 pm on 08/08/2018, the laboratory failed to perform compatibility testing using procedures that demonstrate incompatibility between the donor's cell type and the recipient's serum or plasma type for seven out of seven units of blood having compatibility testing performed from 02/06/2018- 02/19/2018. The findings include: 1. The laboratory performed compatibility testing on the following dates: *02/06/2018- two units of blood *02/09/2018- three units of blood *02/19/2018- two units of blood 2. -- 2 of 3 -- The laboratory performed the compatibility testing using MTS Anti-Human Globulin Anti-IgG gel cards. 4. The "Limitations of the Procedure" section of the manufacturer's package insert for the MTS Anti-Human Globulin Anti-IgG gel cards stated, "There is the potential for IgM antibodies to react in this test. Some patient antibodies that are IgM in nature may react with corresponding antigens in the upper portion of the microtube and be trapped in the top portion of the gel at the time of centrifugation resulting in a positive reaction." 5. At the time of the survey, the laboratory did not perform compatibility testing using a method that specifically demonstrated incompatibility for IgM antibodies between the donor's cell type and the recipient's serum or plasma from 02/06/2018- 02/19/2018. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require