Mercyone Dubuque Laboratory

Summary Statement of Deficiencies 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. This CONDITION is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interviews the laboratory failed to ensure one of two Technical Supervisors received the required morphology certification to perform diagnostic interpretations of Becton Dickinson (BD) SurePath Pap Tests (refer to D5411); failed to establish and follow written policies and procedures for the establishment and reassessment of individual workload limits (refer to D5633 and D5637); failed to establish and follow written policies and procedures to ensure the laboratory maintained records of the total number of slides examined and the total number of hours spent examining slides per 24-hour period (refer to D5645); failed to establish and follow written policies and procedures to document workload limits (refer to D5647); and failed to ensure test reports indicated the name of the laboratory where the test was performed (refer to D5805). 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- Based on review of laboratory policies and procedures, lack of laboratory records and interview the laboratory failed to follow written policies and procedures to assess the competency of the Technical Supervisors. The laboratory failed to assess the competency of two of two Technical Supervisors in 2020, 2021 and to the date of the survey in 2022. Findings include: 1. The laboratory failed to follow the procedure COMPETENCY ASSESSMENT, which stated: "Competency Assessment is performed on an annual basis." 2. The Survey Team requested and the laboratory failed to provide documentation of competency assessments for two of two Technical Supervisors in 2020, 2021 and to the date of the survey in 2022. Technical Supervisors include: -Laboratory Director/Technical Supervisor A -Technical Supervisor B 3. During an interview on September 13, 2022 at 8:20 AM, these findings were confirmed with the Laboratory Director/Technical Supervisor A. 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, lack of laboratory records and interviews the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in the general laboratory systems. The laboratory failed to document general laboratory quality assessment activities in 2020, 2021 and to the date of the survey in 2022. Cross refer to D5209 Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for an ongoing program to monitor, assess and correct problems identified in the general laboratory systems. 2. The Survey Team requested and the laboratory failed to provide documentation of general laboratory quality assessment activities in 2020, 2021 and to the date of the survey in 2022. a. The laboratory failed to document a system for monitoring and evaluating the competency of the Technical Supervisors. (Refer to D5209) 3. During an interview on September 13, 2022 at 11:05 AM, these findings were confirmed with the Laboratory Director/Technical Supervisor A and the Pathology Support Services Supervisor. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of laboratory records and interview the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in the preanalytic cytology systems. The laboratory failed to document preanalytic quality assessment activities in 2020, 2021 and to the date of the survey in 2022. Findings include: 1. The Survey Team requested and the laboratory failed to provide written -- 2 of 12 -- policies and procedures for an ongoing program to monitor, assess and correct problems identified in the preanalytic cytology systems. 2. The Survey Team requested and the laboratory failed to provide documentation of preanalytic quality assessment activities in 2020, 2021 and to the date of the survey in 2022. 3. During an interview on September 13, 2022 at 11:05 AM, these findings were confirmed with the Laboratory Director/Technical Supervisor A and the Pathology Support Services Supervisor. 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 review of 28 laboratory policies and procedures, laboratory records and interviews the laboratory failed to follow two written policies and procedures. Cross refer to D5805 Findings include: 1. The laboratory failed to follow the procedure CYTOLOGY REPORT FORMAT POLICY, which stated: "Copath cytopathology report format:" "Name and address of laboratory location where the test was performed (required element)." a. The Survey Team reviewed consecutive final test reports from June 2022 (range reviewed: GY22-3510 through GY22-3569). Seven of 60 final test reports failed to indicate the name of the laboratory where the test was performed. (Refer to D5805) 2. The laboratory failed to follow the procedure QUALITY, CYTOLOGY CAP PREPAREDNESS, which stated: "Semiannually, all hospital based fine-needle aspiration specimens will be reviewed for cytology /histology correlation, the results of which will be included in the annual anatomic pathology QC summary." a. The Survey Team requested and the laboratory failed to provide cytology/histology correlation records of fine-needle aspiration specimens for 2020, 2021 and to the date of the survey in 2022. b. During an interview on September 13, 2022 at 3:30 PM, these findings were confirmed with the Laboratory Director/Technical Supervisor A. 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)