Los Alamos National Laboratory

Summary Statement of Deficiencies D0000 An initial survey and complaint investigation were conducted onsite 05/11/2021 and 05/12/2021. Remote review of documentation continued 05/17/2021 through 05/21 /2021. Allegations for complaint intake #NM00051786 were substantiated. The laboratory was found to not be in compliance with the following condition: Testing Personnel High Complexity Testing 42 CFR 493.1487 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 the laboratory's policy, personnel competencies, and in interview with laboratory staff, the laboratory failed to establish all requirements in their written policies and procedures to assess competency of all employees. Findings included: 1. Review of the laboratory's policy for "COVID-19 Assay Technician Demonstration of Competency Assessment" (SAM 959.00, approved 03/09/2021) did not include all six components that must be evaluated and documented by a qualified individual, as specified in 493.1451 (b)(8)(i) through (b)(8)(vi): a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; b) Monitoring the recording and reporting of test results; c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; d) Direct observation of performance of instrument maintenance and function checks; e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and f) Assessment of problem solving skills; The laboratory's policy did not include assessing competency for their Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- technical supervisors, general supervisors and clinical consultant. 2. Review of personnel competencies revealed the TS did not ensure all six components were evaluated and documented, as specified in 493.1451 (b)(8)(i) through (b)(8)(vi). Refer to D6127. 3. During an interview on 05/11/2021 at 1:20 pm, General Supervisor - 1 stated the laboratory did not have a policy/procedure for personnel competency prior to 03/09/2021. D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on observation, interview, and record review the laboratory failed to record time of collection in order to ensure specimen integrity after collection as established of 96 out of 96 observed sample collections on 05/12/2021. Findings: 1) In review of SOP 1321.03 in section 3.3.2 step 13 states: "Aliquot specimens immediately per Section 3.5 of this document or store at 4C for up to 72 hours after collection. Batches that cannot be processed within that time will be stored at -70C". 2) Review of OSH- ISH-QTG-032 Title: Quick Take Guide COVID -19 Drive- Through Sample Collection under IV. Sample Donor Screening and Registration step 4 states "Testing sample donors will be scheduled in 30 minute blocks during hours of operation". 3) Section V. Preparation for Sample Collection step 4 states "Process Control will print the schedule from the electronic health record, and place the appropriate labels with the LIMS codes on the spreadsheet once the sample donor arrives which will serve as the key to match results with sample donor". 4) The Quick Take Guide did not include recording of collection time as according to SOP 1321.03 to ensure stability of specimen prior to analysis. 5) Observation of sample collection occurred on 5/12/2021 at 0805 hours at collection site Technical Area 33 (TA 33). A collection kit containing swab, barcoded VTM tube and a duplicate barcode label was taken from the Coleman cooler that contained presorted collection kits. As the patient arrived the duplicate barcode corresponding to the barcode on the VTM tubes was placed next to the name as the patient was verified on a list containing names in an appointment block. 6) In interview with process control personnel at 0835 hours on 5/12/2021 at the process control table it was confirmed that sample collection time was not documented. Collection time was considered to be appointment time. 7) Record review of a random sampling of Cordity final result reports from 12/2020 - 3/2021 under Sample Time, 15 out of 15 records reviewed showed no recorded collection time. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL -- 2 of 12 -- 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 record review, observation, and interview the laboratory failed to monitor and maintain temperature (2-8C) of the refrigerator where collected specimens were stored to ensure sample integrity for 7 of 7 days in 2021 (refrigerator) and for 96 of 96 samples 05/12/2021 (in transport box). Findings: 1) Review of SOP 1321.03 Title: Receipt and Handling of Samples for COVID Testing section 3.4.1 titled Time limitations and long-term storage states "Per CDC guidance on March 26, 2020, specimens can be stored at 2-8C for up to 72 hours after collection. If a delay in extraction is expected, specimens must be stored at -70C or lower." 3a) In observation of accessioning and processing of the collected samples on 5/12/2021 at 0945 hours 96 samples were counted. Transport box labeled 4H2V/X20/S/00USA/M4563 was observed with 4 frozen ice packs. No thermometer was observed inside the box for temperature monitoring. b) Based on interview with TP-6 on 5/12/2021 at 0945 hours in the accessioning area confirmed that temperatures inside the transport boxes are not monitored. 4) Samples were accessioned and divided into 8 bundles with 12 samples each then stored in the refrigerator for aliquoting. A sticker was observed on the refrigerator stating 2-8C. 5) Record review of a random sampling of temperature logs from 12/17/2020 through 5/11/2021 for accessioning area refrigerator (where collected specimens were stored) ID: DF68B08813600724 revealed the following temperatures outside the established acceptable range: Temperature C Time Date 8.55 13:15 5/11/2021 8.64 13:00 5/11/2021 8.7 12:15 4/30/2021 9.19 11:00 4/30/2021 9.92 08:00 4/30/2021 9.62 12:30 4/29/2021 9.53 10:00 4/29/2021 9.5 10:45 4/27/2021 10.38 13:00 4/26/2021 10.59 10:15 4/26/2021 10.65 9:00 4/26/2021 10.02 13:30 4/3 /2021 8.48 11:30 3/19/2021 8.48 13:30 3/19/2021 6) The laboratory failed to maintain required refrigerator temperature to ensure sample integrity. 7) In interview with TP-6 on 5/12/2021 at 1035 hours in the accessioning room the question was asked how often temperatures were monitored for the refrigerator. The response was that temperatures were downloaded and reviewed monthly. 8) The question was then asked "How do you know when the temperature is out of range and what do you do about it?" The response was that someone would notice and call QA. 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 -- 3 of 12 -- 493.1253. (7) Control procedures. (8)