Summary:
Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on lack of documentation and interview with staff, the laboratory failed to enroll in an approved proficiency testing program for prothrombin time testing performed using a plasma specimen and the addition of Calcium Chloride on the Coagusence instrument which is a modification of the waived method that uses whole blood without additional reagents. Modification changes the categorization to High Complexity. Findings include: 1. The laboratory failed to document proficiently testing enrollment confirmation for prothrombin time testing of a non-waived test method. 2. In an interview with staff on 05/21/2019 at approximately 3:00 P.M. the laboratory manager stated they did not have confirmation of Proficiency testing enrollment prior to 05/21/2019 for prothrombin tests performed on the Congusence instrument using Calcium Chloride with a plasma specimen. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Based on proficiency testing records review, lack of documentation, and interview with staff, the laboratory failed to verify they could accurately and precisely report quantitative drug concentrations at the stated cut off limits for 47 of 47 drugs included in the laboratory test menu. The laboratory lacked documentation of verification they could accurately detect the presence of (Alprozolam, Aminoclonazapam, Butalbital, Carisopodol, Clonazepam, Diazepam, Nordiazepam, Hydroxyalprazolam, Meprobamate, Oxazepam, Temazepam, Desmethyltapentadol, Desmethlytramadol, EDDP, Fentanyl, Meperidine, Methandone, Naloxone, Naltrexone, Norbuprenorphine, Norfentanyl,Normeperidine, Propoxypene, Tapentadol, Tramadol, EXTC, PCP, Methamphetamine, Cocaine, Benzodiazepine, Barbiturates, Amphetamines, Oxycodone, 6AM, MDEA, Despramine, Doxepam, Cyclobenzapine, Tizadine, Morphine, Oxymorphine, Noroxycodone, Norhydrocodone, Hydroxycodone, Oxymorphone, and Codeine) drugs using the accepted cut off concentrations for their presence or absence at least twice annually from July 2017 to May 2019. The laboratory performed approximately 100,000 drug analysis concentrations for the presence or absence of drugs of abuse and prescribed drugs per year. Findings include: 1. Proficiency test records review failed to include twice annual verification the laboratory could accurately measure the presence of the listed drugs by quantitative methods.. Proficiency records reviewed failed to include the laboratory confirmed their concentration of drugs measured twice annually. 2. In an interview with staff on 05/22/2019 at approximately 12:00 Noon staff confirmed the proficiency program included a selected set of drugs in each of 2 CAP (DMPM module) events sent per year included a presence or absence drug screen and concentration confirmation for approximately 47 drugs listed above for confirmation of drug presence through screening and quantitation and the concentration. 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)