Narmc Internal Medicine

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Through review of the laboratory procedure for performing complete blood cell (CBC) analysis, and interview with laboratory staff, the laboratory director did not document approval and date of approval of the change in procedure from performing CBC analysis on the Beckman Coulter AcT Diff 2 hematology analyzer to performing CBC analysis on the Sysmex XN 330 hematology analyzer. Findings follow: A) Review of the laboratory's policy and procedure manual revealed the procedure for "Operation of the Beckman Coulter AcT Diff 2", the wording "Beckman Coulter AcT Diff 2" was crossed out and "Sysmex XN 330" was hand-written in replacement without a date of change or signature of approval. B) In an interview on 8/10/26 at 12: 45 p.m., the laboratory staff member (number 2 on the form CMS 209) stated that the Sysmex XN 330 hematology had been used for performing CBC analysis since March 2024 and confirmed that the date and identity of the person making the change in the manual was not present. D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) (e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). This STANDARD is not met as evidenced by: Based upon observations made during a tour of the laboratory, review of American 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 -- Proficiency Testing Institute (API) reports, review of the laboratory procedure manual, and interview with laboratory staff, the laboratory did not document the date of discontinuance of performing complete blood cell counts (CBC) on the Beckman Coulter AcT Diff 2 hematology analyzer. Findings follow: A) During a tour of the laboratory on 8/10/26 at 11:15 a.m., a Sysmex XN 330 hematology analyzer was observed in the testing area with no other analyzer or method for performing CBC observed. B) Review of API proficiency testing result reports for the 1st event in 2025, the 2nd event in 2025, the 3rd event in 2025, and the 1st event in 2026, revealed that the laboratory reported the method for performing CBC analysis was the Sysmex XN 330 hematology analyzer. C) Review of the laboratory policy and procedure manual revealed that procedures for operating the Beckman Coulter AcT Diff 2 analyzer were in the procedure manual without documentation of discontinuance or date of discontinuance. D) In an interview on 7/10/26 at 12:45 p.m., the laboratory staff member ( number 2 on the form CMS 209) stated that CBC analysis was discontinued being performed on the Beckman Coulter AcT Diff 2 analyzer and was performed on the Sysmex XN 330 analyzer beginning March of 2024, and confirmed that the date of discontinuance was not documented on the procedure for the operation of the Beckman Coulter AcT Diff 2 analyzer. -- 2 of 2 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Through a review of the "Coulter AcT Diff Operator's Manual", the laboratory's procedure manual, the instrument data log for February 2023, patient CBC reports, and the

Summary Statement of Deficiencies D0000 NARMC Internal Medicine Laboratory is in compliance with the applicable Standards and conditions of 42 CFR Part 493, Laboratory Requirements. The following standard level deficiency was cited on current survey: D5417: CFR 493.1252(d) - The laboratory failed ensure that supplies that had exceeded their expiration date were not available for use. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Through observation, and interview it was determined that the laboratory had five of five 5.0 ml. BD PPT Plsma blood collection tubes available for use that had exceeded their expiration date. Findings follow: A. In a tour of the laboratory on 9/4/18 at approximately 3:45 PM, 5 BD PPT Plsma blood collection tubes lot # 6279755 with an expiration date of 2017-10-31 were observed on a phlebotomy tray. B. In an interview on 5/4/18 at approximately 3:45 PM, the technical consultant identified as number 2 on the CMS 209 form and testing personnel identified as number 3 on the CMS 209 form confirmed that the items identified above had exceeded their expiration dates and were available for use. 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 --