Summary:
Summary Statement of Deficiencies 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 review of proficiency testing (PT) records from American Proficiency Institute (API), and interview with the laboratory Technical Consultant (TC), the laboratory failed to have signed attestation records for four (4) of eight (8) records in 2024 and four (4) of twelve (12) in 2023. Findings included: 1. A review of 4 of 8 API PT records in 2024 did not include signed attestation records by the Laboratory Director (LD). 2024 Records include: a) 1st event for Microbiology b) 2nd event for Microbiology c) 2nd event for Chemistry d) 2nd event for Hematology 2. A review of 4 of 12 API PT records in 2023 did not include signed attestation records by the Laboratory Director (LD). 2023 Records include: a) 1st event for Chemistry b) 1st event in Coagulation/Hematology c) 2nd event for Microbiology d) 3rd event for Chemistry 3. An interview with the TC on 07/24/2024 at 12:30 pm confirmed that attestations forms were not signed by day of survey. 4. The laboratory reports performing 1934 Bacteriology, Chemistry, Mycology, and Hematology tests annually. D5006 MYCOLOGY CFR(s): 493.1203 If the laboratory provides services in the subspecialty of Mycology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1263, and 493.1281 through 493.1299. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- This CONDITION is not met as evidenced by: Based on observation during the laboratory tour, a lack of verification and maintenance records, and an interview with the Dermatology supervisor, the laboratory failed to establish and follow written policies and procedures to assess personnel competency, failed to twice annually verify the accuracy of the testing of fungal elements using potassium hydroxide (KOH), and failed to perform and document maintenance for the Olympus microscope. See D5209, D5217, D5401, and D5429. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of competency assessment (CA), policies and procedures, and interview with the Technical Consultant (TC), the laboratory failed to establish a CA policy and procedure to assess Testing Personnel (TP) competency. Findings include: 1. Review of CA records for 2023 and 2024 revealed that the TC failed to review and complete CA for three (3) of three (3) Laboratory TP and six (6) of six (6) Point of Care TP. See D6046. 2. Request for policies and procedures revealed that the laboratory did not have an established policy in place for performing CAs. 3. Interview with the TC on 07/24/2024 at 12:30 pm confirmed that the laboratory did not have a policy and procedure in place. 4. The laboratory reports performing 1934 Bacteriology, Chemistry, Mycology, and Hematology tests annually. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on observation during the laboratory tour, a lack of verification records, and an interview with the Dermatology lead and Technical Consultant (TC), the laboratory failed to have a system for verifying the accuracy of the testing for fungal elements using potassium hydroxide (KOH). Findings include: 1. Laboratory tour revealed an Olympus microscope and KOH reagent used for fungal elements/mycology in the dermatology section of the facility. 2. Review of documentation revealed that the laboratory failed to have any verification records for fungal elements/mycology. 3. Interview with the Dermatology lead on 07/23/2024 at 1:00 pm confirmed that fungal elements/mycology identification is being performed and that there is no documentation of verifying the accuracy of testing. 4. Interview with the TC on 07/23 /2024 at 1:00 pm confirmed that the laboratory was not aware that fungal elements /mycology were being performed at the facility. 5. The laboratory reports performing 30 mycology tests annually. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) -- 2 of 9 -- A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on observation during a laboratory tour, document review, and interview with the Dermatology lead and Technical Consultant (TC), the laboratory failed to have written procedures for fungal element/mycology testing. Findings include: 1. Laboratory tour revealed a microscope used for fungal elements/mycology in the dermatology section of the facility. 2. Document review of Centers for Medicare & Medicaid Services (CMS) Form CMS-116 revealed that the laboratory failed to document mycology non-waived testing. 3. Document request revealed that the laboratory failed to have written procedures for fungal elements/mycology testing. 4. Interview with the Dermatology lead on 07/23/2024 at 1:00 pm confirmed that fungal elements/mycology identification is being performed and no procedures are available. 5. Interview with the TC on 07/23/2024 at 1:00 pm confirmed that the laboratory was not aware that fungal elements/mycology were being performed at the facility. 6. The laboratory reports performing 30 mycology tests annually. 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)