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 observation, record review, and interview with the Laboratory Director (LD), the laboratory failed to verify the accuracy of its quantitative urine toxicology testing for 1 (2022) of 2 years reviewed. Findings include: 1. The surveyor observed the laboratory was enrolled with American Proficiency Institute program for 2 events in 2021. 2. When queried on 3/14/2023 at 9:54 am, the LD stated the laboratory failed to enroll or perform twice a year verification of accuracy for the following analytes: a. Amphetamines b. Benzodiazepines c. Buprenorphine d. Cocaine Metabolites e. Methadone f. Opiates g. Oxycodone 3. An interview on 3/14/2023 at 9:54 am, the LD confirmed the laboratory failed to perform and document twice annual verification of accuracy for the above analytes in 2022. D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: . Based on record review and interview with the Laboratory Director (LD), the laboratory failed to provide test reports maintained as part of the patients' electronic medical record (EMR) for 3 (Patients #1, #2, and #3) of 10 patient test reports reviewed. Findings include: 1. A record review of the laboratory's "Patient Report" for 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 -- the toxicology testing revealed for 3 of 10 patient charts reviewed, the final report was not available as part of the patient's EMR for the following: a. Patient #1 tested on 9 /26/2021. b. Patient #2 tested on 11/20/2021. c. Patient #3 tested on 1/16/2022. 2. An interview on 3/14/2023 at 11:00 am, the LD confirmed the laboratory did not maintain patient tests results as part of the patients' charts for the patients listed above. -- 2 of 2 --