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 observation and interview, the lab did not ensure that biohazard and chemical waste was properly disposed. Findings: 1. At 9:00 am a paper waste basket observed by the surveyor, located within the testing area of the lab, contained a pair of blue latex gloves used during lab testing; and 2. Lab staff confirmed that the waste basket containing the gloves was not to be used as a biohazard and chemical waste container and the gloves should be disposed of in the red waste container situated at lab entrance. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the procedure manual and interview with testing person, the laboratory did not ensure that there were written policies and procedures for monitoring the unacceptable urine specimens that are received into the laboratory to monitor, assess and, when indicated, correct problems identified in the postanalytic Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- systems. Findings: 1. According to the testing person the laboratory has a specimen rejection log for documenting unacceptable specimens received from the satellite offices. The testing person will document the information on the specimen rejection log. Then email the satellite office that the test was canceled due to leakage or some other rejection criteria. 2. Review of the procedure manual showed that no approved instructions were provided for documenting unacceptable specimens on a log and emailing the satellite office about the cancellation of the testing. 3. During the survey on 09/17/2018 at 3:00 PM the testing person confirmed that there were no defined policies and procedures for documenting unacceptable specimens on a log and emailing the satellite office about the cancellation of the testing. 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 the procedure manual and interview with the testing person, the laboratory did not establish written procedures for the transportation of the toxicology specimens from the satellite offices to the main laboratory. Findings: 1. According to the testing person the urine samples are picked by the laboratory director and transported to the main laboratory. 2. Review of the procedure manual showed that no instructions were provided to the satellite offices that included- patient preparation; specimen collection; specimen labeling, including patient name or unique patient identifier; specimen storage and preservation; and conditions for specimen transportation. 3. During the survey on 09/17/2018 at 3:00 PM the testing person confirmed that there were no defined policies and procedures for the satellite offices to follow when collecting and transporting urine samples to the main laboratory. 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 observation and interview with lab staff, the toxicology lab did not have a written service manual describing the lab services to the user. Findings: 1. It was observed that the lab did not have a client services manual describing the tests offered, also including description of test methods performed by the lab, ordering instructions, collection instructions, transport instructions and storage instructions; and 2. During interview with lab staff on the day of survey, it was confirmed that the lab did not have a client services manual. D5403 PROCEDURE MANUAL -- 2 of 6 -- 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)