Summary:
Summary Statement of Deficiencies 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 surveyor review of the Procedure Manual (PM) and interview with the Laboratory Consultant (LC), the laboratory failed to establish a detailed procedure for Biannual Assessment (BA) on the date of survey. The findings include: 1. There was no BA procedure in the PM. 2. The LC confirmed on 9/6/23 at 12:15 pm that the laboratory did not have a BA procedure. D5309 TEST REQUEST CFR(s): 493.1241(e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. This STANDARD is not met as evidenced by: Based on review of Test Reports (TR), Electronic Medical Records (EMR) and interview with the Laboratory Consultant (LC), the laboratory failed to ensure that information from TR was manually transcribed accurately into the EMR for all tests on that date of survey. The LC confirmed on 9/6/23 at 11:15 am that the laboratory did not ensure information was manually transcribed accurately. 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 -- 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: A) Base on survey review of the Techincal Processing of the Specimen Report (TPSR) and interview with the Laboratory Consultant (LC) the laboratory failed to follow written policies and procedures for Specimen processing the findings include: 1. The TPSR stated "Slide preparation", "One Slide was stained with Diff Quick for adequacy evaluation". 2. The LC stated "we do not use or have Diff Quick" 3. The LC confirmed on 9/6/23 that the laboratory failed to follow the aforementioned procedure. B) Base on survey review of the TPSR and interview with the LC the laboratory failed to establish written policies and procedures for Specimen referral on the date of survey. The findings include: 1. The TPSR stated "More of the sample was then taken, to prepare another slide by cell block method. This was stained with H&E stain." 2. The LC stated "H&E staining is performed by a reference laboratory." 3. The LC confined on 9/6/23 at 11:40 am that the laboratory failed to establish written policies and procedures for Specimen referral. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the Laboratory Consultant (LC), the laboratory failed to follow their policy for "Centrifuges", "Microscopes", "Laboraotry Test Reports" and "Monitor Post- Analytical Key Indicators" on the date of survey. The findings include: 1. The PM stated under "Centrifuges", "The number of revolutions per minute (RPM) and the time of centrifugation must be checked annually". 2. The PM stated under "Microscopes" "All microscopes would be cleaned and aligned annually." 3. The PM stated under "Monitor Post-Analytical Key Indicators", "Indicators are monitor through the Laboratory Director an Medical Director monthly review of patient case results and resulting reports when necessary, average TAT, incidence reports and the annual review of patient filing system, computer SOP, and file and specimen storage capacity." 4. The PM stated under "Laboratory Test Reports" , "Final reports must (have): 5. date of receipt of specimen in the laboratory","7. Specimen source", " 5. There was no documented evidence that the aforementioned procedures were performed. 6. The LC confirmed on 9/6/23 at 12:30 pm that the laboratory failed to follow the aforementioned procedures. -- 2 of 6 -- 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)