Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 a review of proficiency testing (PT) documentation from the American Proficiency Institiute (API) and an interview with the laboratory manager on 6/18 /2026, the laboratory failed to have testing personnel and the laboratory director attest to the integration of PT samples with routine testing of patient samples in 2026. The findings include: 1. A review of PT records from API for 2026 identified that the laboratory failed to have the laboratory director and testing personnel attest that the PT samples were integrated with patient samples for chemistry event one. 2. A review of PT records from API for 2026 identified that the laboratory failed to have the laboratory director attest that the PT samples were integrated with patient samples for hematology event one. 3. An interview with the laboratory manager on 6/18/2026 at 10:28 am confirmed the above findings. 4. The laboratory reports performing 10,000 tests annually. 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Based on a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, laboratory procedures, training and competency assessment records and an interview with the laboratory manager on 6/18/2026, the laboratory failed to establish and follow a written procedures to assess consultant competency for one (1) of one (1) technical consultant (TC) and competency for all testing performed for one (1) of one (1) testing personnel (TP). The findings include: 1. The CMS 209 identified one (1) technical consultant and one (1) testing personnel. 2. A review of laboratory procedures identified that the laboratory failed to establish a procedure to assess competency of the TC which included the time interval for competency assessments and TP competency for every test procedure. 3. A review of training and competency assessment records identified that the laboratory failed to have competency assessments for one (1) of one (1) TC and six month competency for one (1) of one (1) TP for every test procedure. 4. An interview with the laboratory manager on 6/18 /2026 at 3:10 pm confirmed the above findings. 5. The laboratory reports performing 10,000 tests annually. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) documents from the American Proficiency Institute (API) and an interview with the laboratory manager on 6/18 /2026, the laboratory failed to review and evaluate PT scores that were given an artificial score of 100% for the specialty of chemistry for event one (1) in 2026. The findings include: 1. A review of PT documents from API for the specialty of chemistry for 2026 event one (1) identified that the laboratory failed to evaluate results for samples UDS-01, UDS-02 and UDS-03 for amphetamines, barbiturates, cannabinoids, cocaine, methidone, phencydidine and ethyl glucuronide sample UDS- 02 that were given an artificial score of 100%. 2.. An interview with the laboratory manager on 6/18/2026 at 10:25 am confirmed the above findings. 3. The laboratory reports performing 6,000 chemistry tests annually. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) documents from the American Proficiency Institute (API) and an interview with the laboratory manager on 6/18 /2026, the laboratory failed to review and evaluate PT results that were unacceptable for the specialties of chemistry and hematology event one (1) in 2026. The findings include: 1. A review of PT documents from API for the specialty of chemistry for 2026 event one (1) identified that the laboratory failed to evaluate an unacceptable result for ethyl glucuronide sample ETH-01 and perform a