Summary:
Summary Statement of Deficiencies 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 the surveyor's review of the laboratory's College of American Pathologists (CAP) proficiency testing (PT) reports, laboratory records, manual, reports, and an interview with the testing personnel (TP); the laboratory failed to verify the accuracy of all the Toxicology testing it performs at least twice annually, during the years of 2017 and 2018 Findings: 1. The manual states that the laboratory must participate in the CAP-PT program for the toxicology test system in-use to fulfill the twice annual accuracy verification requirement for the follow drugs: opiates, marijuana, cocaine, Benzedrine, and methadone. 2. The CAP-PT documents in the laboratory revealed the following: a). The last CAP-PT event in which the laboratory participated was Event #3 of 2016. b). The laboratory Re-enrolled in the CAP-PT program on 05/21/2018. c). No documentation was provided as evidence that the laboratory chose another method to verify the accuracy of its toxicology testing from the period of January of 2017 to May of 2018.. 4. The laboratory was conducting urine drug screens on patients during the period stated in line 2(c). 5. On a Recertification survey conducted on 05/24/2018 at 12:00 PM, the TP and administrative staff confirmed the above findings. 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 --