Summary:
Summary Statement of Deficiencies D5022 TOXICOLOGY CFR(s): 493.1213 If the laboratory provides services in the subspecialty of Toxicology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on surveyor observation, record review and staff interview, the toxicology laboratory failed to meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. The cumulative effect of these systemic problems resulted in the laboratory's inability to ensure that accuracy and reliability of patient test results. refer to D5209, D5217, D5221, D5291, D5403, D5429, D5441, D5469, D5783, and D5791. 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 record review and staff interview, the laboratory failed to have a policy in place to assess the competency of all laboratory personnel and they were not assessed. Findings include: 1. Record review of the laboratory's competency records on 4/8/19 revealed the following: a. The laboratory did not have policy in place to assess the competency of the clinical consultant (CC), technical supervisor (TS), and general supervisor (GS). b. Competency documentation for the TS and CC was not available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- 2. Staff interview with the laboratory director on 4/8/19 at 11:10 AM confirmed the above findings. 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 record review and staff interview, the laboratory failed to evaluate all non- regulated analytes at least twice annually for confirmatory drug testing on the Sciex Multiquad 5500 instrument in the subspecialty of toxicology. Findings include: 1. Record review of the "College of American Pathologists" (CAP) proficiency testing (PT) summary reports on 4/8/19 revealed the laboratory failed to test all 23 analytes analyzed on the liquid chromatography tandem mass spectrometry (LC/MS/MS) Sciex Multiquad 5500 instrument twice annually in 2017 and 2018. 2. Record review of the laboratory's PT CAP enrollment "Drug Monitoring For Pain" (DMPM) survey program list on 4/8/19 revealed the DMPM PT program list contained all 23 analytes, but not all are sent to the laboratory twice a year. Instead only a mix of the drugs from the list are sent for each survey. 3. Staff interview with the laboratory director on 4/8 /19 at 2:15 PM confirmed the above findings. 4. The laboratory performs 276,000 LC /MS/MS toxicology confirmation 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 record review and staff interview, the laboratory failed to properly investigate unacceptable proficiency test (PT) results and take remedial action to prevent recurrence in the subspecialty of toxicology. Findings include: 1. Record review on 4/8/19 of the laboratory's 2017 and 2018 PT records revealed: a. 2018 Survey Medical Laboratory Evaluations (MLE) 2, AUR-3 Urine Ph, the required response was abnormal. The laboratory submitted a response of normal. 2. Record review on 4/8/19 of the laboratory's investigation for the unacceptable result referenced in 1 above revealed: a. The test was repeated using a new lot of reagent and the results were acceptable. b. The above investigation was incomplete and lacked procedural changes/