Summary:
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 review of the laboratory's records and interview with Testing Personnel #2 (TP2), the laboratory failed to certify the proper functioning of their fume hood annually. The findings include: 1. Review of the laboratory's records identified no documentation of fume hood maintenance. 2. Review of the laboratory's fume hoods identified that the fume hoods were installed on 08/18/17 and there was no recertification sticker for 2018. 3. On 10/30/18 at approximately 9:15 AM TP2 confirmed the findings. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on laboratory policies and procedures, observation and interview with testing personnel, it was determined that the laboratory did not have a written policy that ensured optimum integrity of a patient's specimen in transit. Findings include: 1. Observed on Oct 30, 2018 at approximately 11AM, the laboratory received a 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 -- shipment of approximately 10 urine specimens sent in transit via UPS which originated from a sole medical provider in Oklahoma. The tests ordered for every patient received were Urinalysis/Microscopy and urine drug screens. 2. The transit time for the urinalysis specimens varied between 2- 5 days which made the specimen integrity questionable. 3. The laboratory personnel stated they test all specimens received and have no time related policy for acceptance of urinalysis specimens. 4. The laboratory specimen collection devices did not appear to contain any preservative additives. 5. The specimen collection tubes where the date of expiration is located was covered by an adhesive label that contained the identity of the patient. The personnel did not check the expiration date on the tube and placed another bar code label on top of the original label. 6. There was no documentation of specimen rejection. 7. There was no documentaion of pre-analytic test method establishment and the impact of transit time on urine specimens for a newly introduced test. 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 personnel competency record review and interview with the testing personnel, the laboratory personnel competency policies did not contain the initial training documentation and assurance of competency prior to performing laboratory testing. Findings include: 1. The laboratory was in the process of documenting the annual personnel competency assessment for Urinalysis/Microscopy, urine drug screens. However, the initial training and competency assessment verification prior to performing patient tests were not found on all 3 testing personnel. 2. On October 30, 2018 at approximately, 2:00PM, the testing personnel stated that they had not had the initial training and competency assessment performed prior to reporting patient testing and were unaware of that portion of the policy. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on review of the policy and procedure manual and interview with testing personnel, the laboratory failed to provide referring clients with written instructions for Urinalysis/Microscopy patient preparation, specimen collection, specimen storage and preservation, and specimen transportation. Findings include: 1. The laboratory Client Handbook signed by the director on 10/15/2018 did not contain written instructions on patient preparation, specimen collection, storage/preservation and timelines for specimen transport to maintain the quality of the Urinalysis/Microscopy specimens. It contained guidelines for urine toxicology, respiratory and blood which were not the types of specimens being tested at the time of the survey. 2. There were no guidelines for urinalysis/microscopy specimen rejection. 3. The inspectors -- 2 of 8 -- observed the receipt and testing of referred Urinalysis/Microscopy specimens that had been collected five days prior to receipt with no cooling packs/preservatives used in transit to preserve urine quality. 4. On 10/30/18 at approximately 11AM, the testing personnel stated that the urine's are not preserved and sometimes the urines arrived with cold packs and sometimes they did not. They only reject samples that are leaking or missing patient information. 5. On 10/30/2018 at approximately 11AM, the testing personnel stated they were not aware of any instructions provided to the Oklahoma originated primary care provider. 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)