Down East Community Hospital

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies 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 lack of documentation and interview with Technical Supervisor #1 (TS1), the laboratory failed to document routine maintenance and function checks on the Cobas/Roche e411 analyzer. Findings include: 1. Record review of the testing list on 4 /11/2023 at 10:00 AM revealed the laboratory performs Chemistry testing on the Cobas/Roche e411. 2. Record review of the laboratory e411 maintenance logs from January 2022 - March 2023 on 4/11/2023 revealed the weekly maintenance, "Clean incubator and aspiration station" and "Clean sipper probe", not documented 6 times. 3. Interview with TS1 on 4/11/2023 at 10:AM revealed that the testing personnel had failed to document the weekly maintenance. 4. The laboratory performs 248,797 tests per year under the Chemistry specialty. 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: 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 -- Based on record review and staff interview, the laboratory failed to evaluate the competency of all testing personnel (TP). Findings include: 1. Record review on 4/11 /2023 of the laboratory's 2022 and 2023 TP competency records revealed 2 of 8 TP missing an annual competency. 2. Staff interview with the Technical Supervisor on 4 /11/2023 at 9:30AM confirmed the above findings. 3. The laboratory performs 280,675 test annually. -- 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 review of the proficiency testing (PT) data report (Casper Report 155D) and PT graded results from the American Proficiency Institute (API), the laboratory failed to successfully participate for the regulated analyte Bacteriology. Refer to D2028. D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) desk review, the laboratory failed to successfully achieve a score of 80 percent (%) in two of three testing events for the subspecialty of Bacteriology. Findings include: 1. Record review on 9/20/2022 of the Center for Medicare & Medicaid Services (CMS) CASPER 0155D report revealed the laboratory obtained unsatisfactory scores for two of three consecutive PT events for analyte 0005 Bacteriology as follows: a. 2021 - Event 3 - 78% b. 2022 - Event 1 - 100% c. 2022 - Event 2 - 78% 2. Record review on 9/20/2022 of the American Proficiency Institute PT program results for the 2021 Bacteriology Survey event 3 and the 2022 survey event 2 revealed the laboratory obtained unsatisfactory scores in two of three consecutive PT events as evidenced below. a. 2021 - Event 3 - 78% b. 2022 - Event 2 - 78% 3. Interview correspondence on 9/19/2022 with the laboratory manager confirmed the above findings. 4. The laboratory performs 1,804 tests annually in the specialty of Microbiology. -- 2 of 2 --