Minneola District Hospital

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 College of American Pathologists (CAP) and phone interview, the laboratory failed to successfully participate in PT for the analyte: 0595 Thyroxine (T4) for two consecutive proficiency testing events: 2022 Event 3 and 2023 Event 1 (refer to D2107). D2107 ENDOCRINOLOGY CFR(s): 493.843(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) records from the CMS report 0155D and phone interview, the laboratory failed to achieve satisfactory performance in PT for the regulated analyte 0595 Thyroxine (T4) for two consecutive testing events. Findings: 1. A review of proficiency testing records from the PT provider College of American Pathologists (CAP) Proficiency Testing for the regulated analyte 0595 Thyroxine (T4) revealed the following performance scores for the periods indicated: 2. Third testing event, 2022 revealed a score 0% 3. First testing event, 2023 revealed a score of 0% 4. Phone interview on May 4, 2023 at 2:45 p.m. confirmed, the laboratory failed to achieve satisfactory performance in PT for the regulatd analyte Thyroxine (T4) for two consecutive testing events. -- 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)

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the laboratory's 2019 American Proficiency Institute (API) Proficiency Testing (PT) documentation, CMS-209 form and interview with Technical Consultant (TC) #1, the laboratory failed to document proficiency testing evaluation and verification activities for the specialties of immunohematology by qualified personnel for 2019. Findings: 1. Review of the laboratory's 2019 APT PT documentation for immunohematolgy lacked documentation for evaluation and verification activities by qualfied personnel. a. Two of two Immunohematology PT Performance Evaluations for 2019 include compatibility testing, which is high complexity. b. Two of two Immunohematology PT Performance Evaluations for 2019 were signed by TC #1 only. TC #1 does not meet the qualifications for Technical Supervisor in this specialty. 2. CMS-209 form lists TC #1 for immunohematology, moderate complexity. 3. Interview on January 7, 2020 at 1:00 p.m.with TC #1 confirmed, the laboratory failed to document proficiency testing evaluation and verification activities for the specialties of immunohematology by qualified personnel for 2019. 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 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 -- 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)

Summary Statement of Deficiencies 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 interview with Technical Supervisor #2 and the review of the package inserts and patient test logs, the laboratory failed to perform external quality control (QC) for moderate complexity testing for Serum HCG. Finding: 1. Review of patient logs showed that external quality control was not performed each day of patient testing on 5/1/2018, 5/14/2018, 7/27/2018, 8/22/2018, 9/6/2018 2. No IQCP has been completed to allow the lab to reduce the frequency of QC for SERUM HCG. The interview occurred on 10/10/2018 @1007. 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 --