Lab Rx Llc

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of sample shipping stability studies and interview with the technical supervisor (TS) and laboratory director (LD), the laboratory failed to evaluate the potential impact on patient results for drug analytes that did not meet the acceptability criteria for shipping stability for urine drug confirmation testing. Findings: 1. The laboratory performed a shipping stability study that mimicked the ambient shipping conditions that patient samples underwent during transport to the laboratory. 2. The "Ambient Sample Shipping Stability Summary" (summary) stated that "2 negative samples and 6 positive samples" spiked with known concentrations of 58 drug analytes were tested. 3. The acceptability limits were defined as "A minimum of 75% (6/8) of the lab result comparisons for each analyte should be within +/- 25.0%." 4. Two drug analytes did not meet the acceptability requirements. Bupropion had three of eight samples (62.5%) test outside the acceptability limits and Lorazepam had five of eight samples (37.5%) test outside the acceptability limits. 5. The summary stated "The study verifies that ambient sample transport temperature is acceptable for the indicated analytes with the exception of bupropion and lorazepam." 6. There was no indication of the potential impact on or the

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation in the toxicology laboratory and interview with the testing personnel, the laboratory did not have the required eyewash solution in the area where the testing occurred. Findings: 1. The laboratory is required to implement safety policies and procedures to ensure safety in the testing personnel. The Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA) provide guidelines for laboratory safety. 2. The area where the testing personnel prepare solutions and perform toxicology testing was toured during the survey. Observation of the testing area showed that there was an eyewash station secured to the wall but there was no eyewash solution containers in the wall station to aid in flushing out the eyes of the testing personnel if they were to have been splashed with any chemicals used in preparing the stock solution, calibrators and quality control materials. 3. During the survey on 01/15/2020 at 1:30 PM the testing personnel confirmed that the eyewash station did not contain the required eyewash solution in the area where the testing was being performed. D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- This STANDARD is not met as evidenced by: Based on record review and interview with the technical supervisor (TS), the laboratory did not retain a copy of the original test report for 2 years. Findings: 1. The TS was asked to retrieve original test reports from after the previous survey conducted on 08/01/2018. 2. According to the TS the new laboratory information system (LIS) was installed in January through February 2019. All the patient test results prior to January 2019 were archived on the old LIS and are not accessible at this time. 3. During the exit survey on 01/31/2020 at 12:30 PM the TS confirmed that laboratory records did not include the documentation of the original test results prior to January 2019. 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)

Summary Statement of Deficiencies 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 review of competency assessments, interview with the laboratory director, and the testing person, the laboratory did not perform competency assessments on the technical supervisor (TS) Findings: 1. The laboratory begin patient testing in May 2017. The laboratory did not perform an assessment of the TS competency for performing testing on the Liquid Chromatology Mass Spectrophotometer analyzer. 2. The laboratory director and the testing person stated that they were unsure if the TS needed a competency assessment performed. 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)