Summary:
Summary Statement of Deficiencies D0000 The Deer River Health Care Center laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F. R. part 493) upon completion of the validation survey performed on May 8, 2024. The following standard-level deficiencies were cited: 493.801 Enrollment and testing of samples 493.1252 Test systems, equipment, instruments, reagents, materials, and supplies . 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 document review and interview with laboratory personnel, the Laboratory Director (LD) or designee failed to attest to the integration of proficiency testing samples into the routine patient workload on five of twenty occasions in 2022 and 2023. In addition, Testing Personnel (TP) failed to do the same on four of twenty occasions in the same time period. Findings are as follows: 1. The laboratory performed Microbiology, Diagnostic Immunology, Chemistry, Hematology, and Immunohematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory beginning at 8:05 a.m. on 05/08/24. 2. The Laboratory performed proficiency testing using the American Proficiency Institute (API) in 2022 and 2023. 3. The Proficiency Testing Policy found in the laboratory's electronic procedure manual did not include LD and TP attestation signature requirements. 4. The Laboratory Director failed to sign the attestation statement for five of twenty PT events reviewed from 2022 and 2023. See below. APT event 2022 Chemistry core - 2 2023 Chemistry core - 3 2023 Hematology -2 2023 Hematology -3 2023 Microbiology -3 5. The TP failed to sign the attestation statement for four of twenty 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 -- PT events reviewed from 2022 and 2023. See below. API event 2023 Chemistry core - 3 2023 Hematology -2 2023 Hematology -3 2023 Microbiology -3 6. In an interview at 11:45 a.m. on 05/08/24, the GS confirmed the above finding. . 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: . Based on observation and interview with laboratory personnel, the laboratory failed to ensure a fungal microscopic examination solution was not used for patient testing after the expiration date had been exceeded in 2024. Findings are as follows: 1. The laboratory performed fungal microscopic examinations under the Microbiology specialty as confirmed by the General Supervisor (GS) during a tour of the laboratory beginning at 8:05 a.m. on 05/08/24. 2. The following fungal microscopic testing materials were observed as present and available for use during a tour of the laboratory: Olympus CX-41 microscope Potassium Hydroxide (KOH) solution BD BBL 10% KOH Reagent Droppers Lot #: B01E333M Expiration Date: 03/31/24 3. The GS confirmed the expiration date had been exceeded during the tour of the laboratory. 4. The laboratory performed one fungal microscopic examination in the time period of 04/01/24 through 05/08/24 as indicated in an internal report generated by the GS on date of survey. 5. In an interview at 12:40 p.m. on 05/08/24, the GS confirmed the above finding. . -- 2 of 2 --