Summary:
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 policies and procedures, record review, observations and interviews it was determined that the laboratory failed to establish policies and procedures for five test processes (refer to D5403); failed to perform gynecologic specimen testing according to the manufacturer's instructions (refer to D5411); failed to test "Diff-Quik"staining materials for intended reactivity and staining characteristics (refer to D5473); failed to follow policies and procedures for the review of prior negative gynecologic specimens from patients with a current high grade lesion (refer to D5625); failed to establish policies and procedures for the evaluation and comparison of six annual statistics and failed to document six required annual statistics (refer to D5629); failed to establish policies and procedures to include the Technical Supervisor's feedback on Cytotechnologists' interpretations when assessing the individual workload limit (refer to D5635); failed to follow policies and procedures to ensure unsatisfactory slide preparations were identified and reported as unsatisfactory (refer to D5655); failed to maintain the identity of the personnel performing comparative reviews of discrepant cytology and histopathology specimens (refer to D5787); and failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and correct problems in the analytic phases of cytology testing (refer to D5791). 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 14 -- 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, laboratory records and interviews it was determined that the laboratory failed to assess the competency of five of five Technical Supervisors that performed microscopic evaluations of cytology specimens in 2018 and to the date of the survey. Findings include: 1. The laboratory failed to follow the policy titled PROFESSIONAL COMPETENCY ASSESSMENT. a. Laboratory records titled PROFESSIONAL COMPETENCY ASSESSMENT did not include assessments or documentation of the items stated in the policy for five of five Technical Supervisors. -Technical Supervisor A -Technical Supervisor B - Technical Supervisor C -Technical Supervisor D -Technical Supervisor E 2. The Survey Team requested and the laboratory failed to provide documentation of competency assessments for five of five Technical Supervisors to reflect microscopic evaluation responsibilities in the analytic phase of testing. 3. During interviews on January 9, 2019 at 2:15 PM and March 5, 2019 at 3:40 PM, the Anatomic Pathology Manager confirmed these findings. 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: Based on review of laboratory policies and procedures, laboratory records and interview it was determined that the laboratory failed to establish written polices and procedures for nongynecologic specimen processing. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to process all types of nongynecologic cytology specimens. a. There were no written policies or procedures for the following types of nongynecologic specimens, which were listed on the laboratory document titled NONGYN/FNA REPORT 01/01/2018 THROUGH 12/21/2018: -Fine Needle Aspiration (FNA); -Bronchial Washing; - Pleural Fluid; -Abdominal Fluid; -Urine; -Sputum; -Miscellaneous Smear; -Breast Discharge; -Anal Rectal; -Bronchial Brushing; -Pneumocystis Carinii Pneumonia Special; -Cell Block; -Nongynecologic (NONGYN) Problem Specimen. 2. During an interview on March 7, 2019 at 3:40 PM, the Anatomic Pathology Manager confimed these findings. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) -- 2 of 14 -- 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)