Summary:
Summary Statement of Deficiencies D5018 URINALYSIS CFR(s): 493.1211 If the laboratory provides services in the subspecialty of Urinalysis, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on surveyor review of the Urinalysis Procedure Manual (UPM) and Work Records, lack of the Urine Microscopic Quality Control (QC) records and interview with the Technical Consultant (TC), the laboratory failed to meet the requirements of pre analytic, analytic and post analytic Urinalysis test procedures. The findings include: 1. The laboratory did not follow UPM procedures. Refer to D 5401 # 4 and (b) 2. The laboratory did not have manufacturer's procedure. Refer to D 5411(a) and (b) 3. The laboratory did not perform maintenance. Refer to D 5433 4. The laboratory did not run QC. Refer to D 5449 5. The laboratory did not report results accurately. Refer to D 5801 6. The laboratory did not report test name. Refer to D 5805 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 lack of the Manufactures Package Insert (MPI) and interview with the Technical Consultant (TC), the laboratory failed to have written policy and procedure Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- on maintaining an optimum integrity of a patients' specimens for tests performed on the Beckman Coulter DxI 600 chemistry analyzer from 12/20/17 to the date of the survey. The TC confirmed on 5/23/19 at 1:30 pm that the laboratory did not have a procedure for maintaining an integrity of patient samples. 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 surveyor review of the Competency Assessment (CA) records and interview with the Technical Supervisor (TS), the laboratory failed to evaluate competency accurately on two of two TP in 2018. The findings include: 1. The CA was not performed on each test method performed by testing personnel. 2. There were no records to substaniate how assessment was performedand what records were reviewed. 3. The TC confirmed on 5/23/19 at 11:00 am that CA was not done correctly. 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 Requisition (TR), Laboratory Information System (LIS) and interview with the Technical Supervisor (TS), the laboratory failed to ensure that information from TR was transcribed accurately into the LIS for all tests from12/20 /17 to the date of the survey. The TS confirmed on 5/23/19nat 10:15 am that the laboratory did not ensure information was transcribed accurately. 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: a) Based on surveyor review of the Procedure Manual (PM), Laboratory's Records and interview with the Technical Consultant (TC) and Testing Personnel (TP), the laboratory personnel failed to follow all of the following procedures from 12/20 17 to the date of survey. The findings include: 1. The 'Laboratory Information System' procedure, step # 11, stated 'The interfaced results is verfied for accuracy bi-annually by random selection of five pateitns results' but the laboratory verified only once with -- 2 of 9 -- less than five patients. 2. The 'Quality System Management' procedure, step # 8 stated "Assessment and Audits" reviewed once a month but there was no documented evidence that it was followed. 3. The 'New Reagent Lot Confirmation of Acceptability' procedure. step # 7 stated 'to perform lot to lot verification before new lot of reagent is put in use' but the laboartory did not follow Hemoglobin A1C test performed on the BioRad D 10 analyzer and for qualitative tests. 4. The 'Microscopic Examination' procedure, step # 4 stated to centrifuge the urine specimen @ 2000 rpm for five minutes but TP # 2 listed on CMS form 209 stated on the day of survey that she centrifuges for 15 minute @ around 3400 rpm. 5. The TC and TP comfirmed on 5 /23/19 at 1:30 pm that all above procedures were not followed. b) Based on surveyor review of ichem VELOCITY Operator Manual (OM) and interview with the Testing Personnel (TP), the laboratory failed to follow OM Urine Strips vial stability instructions to perform Urinalysis tests from 12/20/17 to the date of survey. The finding includes: 1. The OM stated open vial of strips stability was for five days but there was no new expiration date on the bottle of strips and TP # 2 listed in CMS form 209 stated she was not aware that it was good for only five days. 20464 c) Based on surveyor review of the Procedure Manual, and interview with Technical Consultant (TC), the laboratory failed to follow "Calibration Procedures & Calibration Verifications" (CPCV) procedure for chemistry test from 12/20/17 to the date of the survey. The findings include: 1. The PM stated "Linearity studies are performed twice a year and also when new assays are introduced to the test menu and after major maintenance.". 2. There was no evidence that linearity studies were performed on the Beckman coulter AU 680 and Unicel DxI 600 analyzers twice a year. 3. The TC confirmed on 5/23/19 at 11:40 am that the CPCV procedure was not followed. 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)