Grand Strand Regional Medical Center 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 record review, surveyor interviews and observation the laboratory failed to follow written policies and procedures to ensure optimum integrity of a patient's specimen from the time of slide labeling through completion of testing (refer to D5203); failed to follow written procedures (refer to D5401); failed to establish written procedures for cytology test processes (refer to D5403); failed to perform required instrument maintenance, as specified by the manufacturer (refer to D5429); failed to test staining materials for intended reactivity (refer to D5473); failed to follow written procedures to prevent cross-contamination by staining nongynecologic specimens that have a high potential for cross-contamination separately from other nongynecologic specimens (refer to D5619); failed to establish written procedures to document and evaluate annual statistics (refer to D5629); failed to establish written procedures for the evaluation of individual case reviews against the laboratory's overall statistical values (refer to D5631); failed to establish written procedures for establishing workload limits, reassessing workload limits, prorating workload limits and maintaining workload slides and hours (refer to D5633, D5635, D5637, D5641, D5645); failed to maintain the identity of the personnel who performed comparative reviews of cytology and histopathology specimens, and failed to maintain the date the comparative reviews were performed (refer to D5787). 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- 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, review of specimen slides and interviews it was determined that the laboratory failed to follow written policies and procedures to ensure accurate specimen slide labeling. The laboratory failed to ensure that twenty-nine of thirty patient specimens from January 2018 had specimen slides labeled with accurate patient specimen information. Findings include: 1. The laboratory failed to follow the procedure CY.201 titled NONGENITAL PROCESSING/STAINING SOLUTIONS (signed and dated by the Laboratory Director on 8/14/17) which stated: "Label a thinprep slide for each vial/specimen withCR, the accession number, patient last name, first initial and specimen type." "Non-gyn specimens to include brushings and FNA's must be submitted with patient last name and first initial. A CR plus unique accession number for that specimen will be written in pencil on the slide." 2. The Survey Team reviewed thirty consecutive specimens for accurate specimen labeling. Twenty-nine of thirty cases were not labeled with the full accession accession number. Specimens include: CR18:QV:1 CR18:QV:2 CR18:QV:3 CR18:QV:4 CR18:QV:5 CR18:QV:6 CR18:QV:7 CR18:QV: 8 CR18:QV:9 CR18:QV:11 CR18:QV:12 CR18:QV:13 CR18:QV:14 CR18:QV:15 CR18:QV:16 CR18:QV:17 CR18:QV:18 CR18:QV:19 CR18:QV:20 CR18:QV:21 CR18:QV:22 CR18:QV:23 CR18:QV:24 CR18:QV:25 CR18:QV:26 CR18:QV:27 CR18:QV:28 CR18:QV:29 CR18:QV:30 3. During an interview on 2/27/18 at 8:30 AM, Staff C stated that the full accession number was to be written on specimen slides. Staff C further stated that sometimes fine needle aspiration (FNA) slides were processed without the full accession number being written on the slides and a paper label was placed on the slides after staining. 4. During an interview on 2/27/18 at 3:05 PM, Staff A and Staff B confirmed that specimen slides were not labeled with the full accession number. 5. During an interview on 2/28/18 at 9:10 AM, the Laboratory Director/Technical Supervisor A confirmed these findings. 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 laboratory records, and interview it was determined that the laboratory failed to establish written policies and procedures to assess the competency of two of two Technical Supervisors in 2016, 2017 and to the date of the survey in 2018. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to describe the laboratory's process for assessing the competency of two of two Technical Supervisors. 2. The Survey Team requested and the laboratory failed to provide records of competency assessment for two of two Technical Supervisors who -- 2 of 13 -- performed microscopic evaluations during 2016, 2017 and to the date of the survey in 2018. Technical Supervisors include: Technical Supervisor A Technical Supervisor B 3. During an interview on 2/26/18 at 3:00 PM, the Laboratory Director/Technical Supervisor A 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 and interview it was determined that 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. Cross refer to D5203, D5209 Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for an ongoing mechanism to monitor and assess the quality of the general laboratory system. 2. During an interview on 2/28/18 at 9:10 AM, the Laboratory Director/Technical Supervisor A confirmed these findings. 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 and interview it was determined that the laboratory failed to establish written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in the preanalytic systems. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to monitor the quality of the cytology preanalytic laboratory system. 2. During an interview on 2/28/18 at 9:10 AM, the Laboratory Director/Technical Supervisor A confirmed these findings. 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 fifty-seven laboratory policies and procedures, observation and interviews it was determined that the laboratory failed to follow three written policies -- 3 of 13 -- and procedures. Findings include: 1. The laboratory failed to follow the written procedure CY.00.01 titled REVIEW OF CYTOLOGY PROCEDURE MANUAL (signed and dated by the Laboratory Director on 9/5/13) which stated: "All procedures are reviewed annually by the laboratory director and/ or designee." a. During an interview on 2/27/18 at 3:05 PM, Staff A stated that procedures were reviewed biennially by Staff A and the Laboratory Director/Technical Supervisor A. 2. The laboratory failed to follow the written procedure CY.203.01 titled RICHARD ALLAN CYTOLOGY STAINING (signed and dated by the Laboratory Director on 9/5/13) which stated: "A daily QC check is made on the non-gynecological stain quality and the quality of preparation by the cytotechnologist and pathologist. This is documented in the staining QC book." "Richard Allan Hematoxylin and Richard Allan cytology stain are replaced once a week, usually Friday's and filtered daily." "At the beginning of each day, all solutions must be replaced in this setup." a. The Survey Team reviewed laboratory records titled "NON-GYN CYTOLOGY SETUP & MAINTENANCE" from January 2017 through the date of the survey in 2018. The records did not document when the stains were changed. b. During an interview on 2 /27/18 at 3:05 PM, Staff B stated that the laboratory did not check the staining characteristics of the nongynecologic stains. 3. The laboratory failed to follow the written procedure CY.601.01 titled INSTRUMENT MAINTENANCE, FUNCTION /EVALUATION NIKON ECLIPSE, THINPREP 2000, LABOFUGE 400 (signed and dated by the Laboratory Director on 9/5/13) which described the weekly maintenance to be performed on the centrifuge and the Hologic ThinPrep 2000 Processor. a. During an interview on 2/27/18 at 8:30 AM, Staff C stated that the laboratory did not perform weekly maintenance on the centrifuge or the Hologic ThinPrep 2000 Processor. b. During an interview on 2/27/18 at 3:05 PM, Staff A and Staff B confirmed that the laboratory did not perform weekly maintenance on the centrifuge or the Hologic ThinPrep 2000 Processor. 4. During an interview on 2/28/18 at 9:10 AM, the Laboratory Director/Technical Supervisor A confirmed these findings. 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)