Calais Community Hospital

Summary Statement of Deficiencies D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) (a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the proficiency testing (PT) data report (CASPER Report 096D), PT graded results from the American Proficiency Institute (API) and interview with General Supervisor #1 (GS1) the laboratory failed to attain a score of at least 100% for the regulated analyte compatibility testing in the specialty of Immunohematology. Findings include: 1. Record review on 9/22/2026 of the CASPER Report 096D, revealed, the laboratory received an unsatisfactory PT score of 60% for the regulated analyte compatibility testing for 2026 Event 2. 2. Record review on 9/22/2026 of the laboratory's 2026 API PT records revealed, unsatisfactory PT score of 60% for the regulated analyte compatibility testing for 2026 Event 2. 3. Staff interview on 9/22 /2026 at 12:15 PM with GS1 confirmed the above findings. 4. The laboratory performs 65 compatibility tests annually in the specialty of Immunohematology. D2179 COMPATIBILITY TESTING CFR(s): 493.863(d) (d)(1) For any unsatisfactory testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unsatisfactory testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. 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 record review and staff interview with General Supervisor #1 (GS1), the laboratory failed to investigate and document

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 consultant 1 (TC1), the laboratory failed to document routine weekly maintenance on the Cephied GeneXpert Microbiology test system. Findings include: 1. Record review of the CMS form 116 on 6/5/2024 revealed the laboratory performs Strep A, T. Vaginalis, C. Difficile/EPI, Gonorrhea, and Chlamydia testing on the Cepheid GeneXpert. 2. Record review of the GeneXpert maintenance logs on 6/5/2024 revealed 5 out of 17 months reviewed to be missing a weekly maintenance log entry. 3. Interview with TC1 on 6/6/2024 at 9: 00am confirmed the above findings. 4. The laboratory perform 2'557 tests annually in the specialty of Microbiology. . D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on staff interviews and record review the laboratory failed to follow their own Quality Assurance Program policy concerning