Urology Associates, Llc

Summary Statement of Deficiencies D0000 A complaint survey was completed on February 14, 2020. On February 24, 2020, it was determined that Immediate Jeopardy (IJ) existed for the following Condition- level deficiencies: Cytology: 42 CFR 493.1221 Laboratory Director: 42 CFR 493.1441 Laboratory Techincal Supervisor: 42 CFR 493.1447 D3013 FACILITIES CFR(s): 493.1101(e) Records and, as applicable, slides, blocks, and tissues must be maintained and stored under conditions that ensure proper preservation. This STANDARD is not met as evidenced by: Based on observation and interview it was determined that eight of 223 urine cytology cases were not maintained and stored with the glass slide preparations intact. Findings include: 1. Eight of 223 urine cytology cases in a slide file drawer labeled "C19-00041 through C19-00263" were observed with broken glass slide preparations which were not repaired. Case #: # of Slides Broken in Case: -C19-00139 2 of 2 -C19-00151 1 of 2 -C19-00188 2 of 2 -C19-00189 2 of 2 -C19-00190 2 of 2 -C19-00191 2 of 2 -C19- 00192 2 of 2 -C19-00206 1 of 2 2. During an interview on February 12, 2020 at 11:15 AM Histotechnologist A confirmed the slides were broken and stated "I didn't do that. I would never file them that way." D5032 CYTOLOGY CFR(s): 493.1221 If the laboratory provides services in the subspecialty of Cytology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1274, and 493.1281 through 493.1299. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 16 -- This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, glass slide preparations, observation and interviews it was determined the laboratory failed to establish policies and procedures (refer to D5403); failed to perform the NuView System testing on urine cytology specimens according to the manufacturer's instructions (refer to D5411); failed to ensure the NuPrep solution was not used beyond the expiration date (refer to D5417); failed to establish performance specifications when the laboratory modified the NuView Test System manufacturer's instructions with an alternate method of processing urine cytology specimens (refer to D5423); failed to test Papanicolaou staining materials for intended reactivity each day of use (refer to D5473); failed to establish policies and procedures for the annual evaluation and comparison of three of three laboratory statistics (refer to D5629); failed to establish and reassess a workload limit for one of one Laboratory Director /Technical Supervisor (refer to D5633, D5637); failed to establish policies and procedures to ensure the workload limit for one of one Laboratory Director/Technical Supervisor would be prorated to determine the number of slides that may be examined (refer to D5641); failed to establish policies and procedures to ensure that the laboratory would maintain records of the total number of slides examined and hours spent examining slides (refer to D5645); failed to establish policies and procedures to ensure that unsatisfactory urine cytology slide preparations were identified and reported as unsatisfactory (refer to D5655); and failed to establish policies and procedures to ensure urine cytology test reports contained narrative descriptive nomenclature (refer to D5657). The cumulative effect of these systemic problems resulted in the laboratory's inability to ensure the accuracy and reliability of patient test results in the subspecialty of Cytology. 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 review of laboratory policies and procedures, observation, interview and review of glass slide preparations it was determined that the laboratory failed to follow written policies and procedures to ensure positive patient identification during specimen processing, staining and reporting of test results. Findings include: 1. The laboratory failed to follow the procedure SPECIMEN HANDLING PROCEDURE: PREANALYTIC SYSTEM which stated: "10. Write the accession number on the requisition and on the matching tissue container. 11. This number will be the permanent identifying number for this tissue. (Cytology will be a C series). 12. Label 'C-year-case number' for cytology." 2. During observation of specimen processing on January 28, 2020 at 8:45 AM, Histotechnologist A failed to label three of three specimen containers and corresponding specimen slides with the complete patient identifier accession number. Cases include: Accession #: # Written on Specimen: - C20-000047 47 -C20-000048 48 -C20-000049 49 a. During further observation it was determined that the laboratory failed to label five of five previously processed specimen centrifuge tubes with the complete patient identifier accession number. Cases include: Accession #: # Written on Specimen: -C20-000038 38 -C20-000039 39 -C20-000040 40 -C20-000041 41 -C20-000042 42 b. During an interview on January -- 2 of 16 -- 28, 2020 at 10:00 AM, Histotechnologist A stated that the slide label with the complete patient identifier accession number was not placed on the specimen slide until after the slide staining process. 3. During microscopic review of urine cytology case #C19-000170 it was observed that one of three slides in the case was not labeled with the complete patient identifier accession number. The slide was labeled as "170." and did not have an attached slide label with a patient identifier accession number. 4. During microscopic review of urine cytology case #C18-00359 it was observed that two of two slide labels in the case did not have the complete patient identifier accession number. The slide was labeled as "C-00359." 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 laboratory policies and procedures, lack of competency assessment records and interview it was determined that the laboratory failed to establish written policies and procedures to assess the competency of one of one Laboratory Director/Technical Supervisor who performed cytology testing and reporting of test results in 2018, 2019 and to the date of the survey in 2020. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to assess the competency of the Laboratory Director /Technical Supervisor who performed cytology testing. 2. The Survey Team requested and the laboratory failed to provide documentation of competency assessments for the Laboratory Director/Technical Supervisor in 2018, 2019 and to the date of the survey in 2020. 3. During an interview on January 28, 2020 at 2:40 PM, the Laboratory Director/Technical Supervisor confirmed these findings. 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 laboratory policies and procedures, laboratory records and interview it was determined that the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in the general laboratory systems. Cross refer to D5203 and D5209 Findings include: 1. The laboratory failed to follow the procedure QUALITY ASSURANCE PLAN: PRE-ANALYTIC which stated: "Exception Criteria: The patients unique ID number does not match the ID number on the specimen container or slide. Responsible Staff: The specimen processor compares the test requisition form with the container and/or slide. Any inconsistencies shall be recorded in the Remedial Action Log and worked up as problems." 2. The Survey Team reviewed the QUALITY ASSURANCE LOG from 2019. a. The laboratory failed to record any -- 3 of 16 -- discrepancies between the test requisition and the corresponding cytology specimen slides on 13 cases in 2019, as part of the quality assessment preanalytic review program. b. The Survey Team reviewed the same cytology cases to check for completeness of the patients unique identification number on the slides. Thirteen of 13 cases did not have the complete patient identification number written on the slide, prior to the application of the slide label. Cases include: -C19-00003 -C19-00082 - C19-00120 -C19-00139 -C19-00168 -C19-00249 -C19-00264 -C19-00277 -C19- 00318 -C19-00449 -C19-00516 -C19-00588 -C19-00633 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)