Caldwell Regional Medical Center

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 from American Proficiency Institute (API), the laboratory failed to successfully participate in PT under the specialty Routine chemistry for the regulated analytes: total bilirubin, pH blood gas, pO2 blood gas, pCO2 blood gas, total cholesterol and total iron. (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 a desk review of proficiency testing (PT) from the provider API 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: total bilirubin, pH blood gas, pO2 blood gas, pCO2 blood gas, total cholesterol and total iron. Findings: 1. Review of API PT scores for 2022 Event 3 revealed a 0% performance scores for total bilirubin, pH blood gas, pO2 blood gas, pCO2 blood gas, total cholesterol and total iron 2. Review of the API PT scores for 2023 Event 1 revealed the following scores: a. Total bilirubin 60% b. pH blood gas 60% c. pO2 blood gas 40% d. pCO2 blood gas 40% e. Total cholesterol 40% f. Total iron 20% 2. Phone interview with the lab manager on 4/4/23at 8:10 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: total bilirubin, pH blood gas, pO2 blood gas, pCO2 blood gas, total cholesterol and total iron. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 a review of proficiency testing (PT) from the provider American Proficiency Institute (API) performed in 2022 and interview with technical consultant and general supervisor revealed that the Laboratory Director or approved designee failed to attest on three events that proficiency testing samples were handled in the same manner as patient samples at time of survey. Findings: 1. Review of the attestation pages for PT from API revealed no signature of the LD or approved designee was present on API 2022 events: a. Hematology / Coagulation 1st Event b. Microbiology 2nd Event c. Immunology / Immunohematology 1st Event 2. Interview with the technical consultant and general supervisor on 11/9/2022 at 10:45 a.m. confirmed, the laboratory director (LD) or approved designee failed to attest on three events that proficiency testing samples were handled in the same manner as patient samples at time of survey. 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 proficiency testing (PT) performance evaluation records from 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 -- the 2022 American Proficiency Institute (API) and interview with the staff, the laboratory failed to evaluate its proficiency testing results for four events at time of survey. Findings: 1. Upon review of the 2022 API PT the following events had no evidence of evaluation was available at the time of survey. a. Hematology / Coagulation - 2nd Event b. Microbiology - 2nd Event c. Immunology / Immunohematology - 1st Event d. Chemisty Miscellaneous - 1st Event 2. Interview with the technical consultant and general supervisor on 11/9/2022 at 10:45 a.m. confirmed, the laboratory had no evidence of evaluations on four events of the 2022 API proficiency testing at time of survey. -- 2 of 2 --

Summary Statement of Deficiencies 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 493.1253. (7) Control procedures. (8)