Summary:
Summary Statement of Deficiencies D0000 A complaint survey was completed on May 24, 2019. On June 7, 2019 , 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 Technical Supervisor- 42 CFR 493.1447 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 it was determined that the laboratory failed to establish written policies and procedures to ensure optimum patient specimen integrity (refer to D5203); failed to establish written policies and procedures for a program to determine the causes of discrepancies between the cytology diagnosis and the histopathology diagnosis (refer to D5623); failed to establish written policies and procedures for the review of all prior negative gynecologic specimens for each patient with a current high-grade squamous intraepithelial lesion (HSIL) or malignancy (refer to D5625); failed to establish written policies and procedures for the annual evaluation and comparison of six of six laboratory statistics, and failed to document three of six required annual statistics (refer to D5629); failed to establish written policies and procedures to ensure that unsatisfactory gynecologic cytology slide preparations were identified and reported as unsatisfactory, and failed to identify and report five gynecologic cytology cases as being "Unsatisfactory for Interpretation" (refer to D5655); and failed to establish written policies and procedures for the nomenclature used for reporting 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 -- gynecologic cytology test results (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, laboratory records, specimen slides and interview it was determined that the laboratory failed to establish written policies and procedures to ensure the accurate specimen description of patient's specimens. The laboratory failed to ensure that the number of slides and the method of slide preparation was accurately reported for five of 62 random non-gynecologic specimens from January 2019 to March 2019. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to ensure that the total number and type of slide preparation is accurately documented for each specimen. 2. The Survey Team reviewed 62 non-gynecologic final test reports and the corresponding slides from January 2019 to March 2019. The Survey Team observed that five of the 62 specimens provided by the laboratory, were not the same as the specimen description that was documented on the final test reports. Specimen descriptions include: -NM19-0002 Report: ThinPrep and Cell Block Specimen: ThinPrep, Cell Block Two Diff Quik stained Cytospin slides -NM19- 00004 Report: ThinPrep and Cell Block Specimen: ThinPrep and Cell Block Two Diff Quik stained Cytospin slides -NM19-00037 Report: ThinPrep and Cell Block Specimen: ThinPrep and Cell Block One Diff Quik stained Cytospin slide -NM19- 00024 Report: ThinPrep and Cell Block Specimen: ThinPrep and Cell Block Two Diff Quik stained Cytospin slides -NM19-00076 Report: ThinPrep and Cell Block 1 Diff Quik Smear Specimen: ThinPrep and Cell Block 1 Diff Quik stained Cytospin slide 3. The Laboratory Director and Staff A confirmed these findings during an interview on 5/22/19 at 10:00 AM. 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, glass slide preparations 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. D5403 PROCEDURE MANUAL -- 2 of 12 -- 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)