Dermatopathology Partners Pc

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, observation and interviews the laboratory failed to establish written policies and procedures to ensure confidentiality of patient information (refer to D5201); failed to establish and follow written policies and procedures to ensure specimen slides were labeled with a unique patient identifier (refer to D5203); failed to establish written policies and procedures to assess the competency of the Technical Supervisors, and failed to assess the competency of four of four Technical Supervisors (refer to D5209); failed to establish written policies and procedures for 10 laboratory test processes (refer to D5403); failed to ensure that four of 23 written procedures were approved, signed and dated by the Laboratory Director (refer to D5407); failed to follow manufacturer's instructions for the Hologic ThinPrep Pap Test (refer to D5411); failed to establish performance specifications when the laboratory modified the Hologic ThinPrep test system manufacturer's instructions (refer to D5423); failed to ensure that the required maintenance for the Hologic ThinPrep 5000 Processor and Hologic ThinPrep 2000 Processor was performed (refer to D5429); failed to test staining materials for intended reactivity of the Diff-Quick stain (refer to D5473); failed to establish written policies and procedures to define effective measures to prevent cross-contamination between gynecologic and nongynecologic specimens during the staining process (refer to D5617); failed to establish written policies and procedures to identify nongynecologic specimens with a high potential for cross- contamination and stain them separately from other nongynecologic specimens and filter or change the stains following staining (refer to D5619); failed to establish Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 21 -- written policies and procedures for a program to compare clinical information with cytology reports and to compare all gynecologic cytology reports with a diagnosis of high-grade squamous intraepithelial lesion (HSIL) or malignant neoplasms with available histopathology, and failed to provide records for a correlative review program to determine the causes of any discrepancies (refer to D5623); failed to establish written policies and procedures for the review of all negative gynecologic specimens received within the previous five years for each patient with a current HSIL or malignancy, failed to provide records documenting a search and review of prior negative specimens for each patient with a current HSIL or malignancy was performed, and failed to identify one of eleven prior negative specimens as having a more significant lesion (refer to D5625); failed to follow written policies and procedures for an annual statistical evaluation of the required laboratory statistics, and failed to document the required laboratory statistics for 2021 and 2022 (refer to D5629); failed to establish written policies and procedures to ensure unsatisfactory slide preparations were identified and reported as unsatisfactory (refer to D5655); failed to establish written policies and procedures for the system of narrative descriptive nomenclature used by the laboratory to report cytology test results (refer D5657); and failed to ensure final test reports indicated the accurate address of the laboratory where the test was performed (refer to D5805). D5201 CONFIDENTIALITY OF PATIENT INFORMATION CFR(s): 493.1231 The laboratory must ensure confidentiality of patient information throughout all phases of the total testing process that are under the laboratory's control. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and interview with the Laboratory Director/Technical Supervisor A the laboratory failed to establish written policies and procedures to ensure confidentiality of patient information. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to detail how the laboratory would ensure confidentiality of patient information. 2. During an interview on June 5, 2022 at 2:20 PM, these findings were confirmed with the Laboratory Director/Technical Supervisor A. 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: A. Based on review of laboratory policies and procedures, specimen slide preparations and interview with the Laboratory Director/Technical Supervisor A the laboratory failed to follow written policies and procedures to ensure specimen slides were labeled with a unique patient identifier. The laboratory failed to ensure that 63 of 63 specimen slides from 11 patient specimens from May 2023 had specimen slides labeled with a unique patient identifier. Findings include: 1. The laboratory failed to follow the procedure FINE NEEDLE ASPIRATION SPECIMEN PREPARATION, -- 2 of 21 -- which stated: "Write accession number on all containers and slides received." 2. The Survey Team reviewed 63 specimen slides from 11 specimens received from May 2023 for specimen labeling. a. Sixty-three of 63 specimen slides failed to have the accession number written on the frosted end of the slide. Slides include: -F23-000374 (2 direct smears) -F23-000375 (8 direct smears) -F23-000376 (6 direct smears) -F23- 000377 (6 direct smears) -F23-000378 (9 direct smears) -F23-000379 (6 direct smears) -F23-000380 (4 direct smears) -F23-000381 (2 direct smears) -F23-000383 (6 direct smears) -F23-000384 (8 direct smears) -F23-000385 (6 direct smears) 3. During an interview on June 6, 2023 at 3:45 PM, these findings were confirmed with the Laboratory Director/Technical Supervisor A. B. Based on review of laboratory policies and procedures, specimen slide preparations and interview with the Laboratory Director/Technical Supervisor A the laboratory failed to establish written policies and procedures to ensure nongynecologic Hologic ThinPrep specimen slides were labeled with a unique patient identifier. The laboratory failed to ensure that four of four nongynecologic Hologic ThinPrep specimen slides from three patient specimens from May 2023 had specimen slides labeled with a unique patient identifier. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedure to ensure nongynecologic Hologic ThinPrep specimen slides were labeled with a unique patient identifier prior to specimen processing. 2. The Survey Team reviewed four nongynecologic Hologic ThinPrep specimen slides from three specimens from May 2023 for specimen labeling. a. Four of four specimen slides failed to have the accession number written on the frosted end of the slide. Slides include: -F23-000378 (2 ThinPreps) -F23-000380 (1 ThinPrep) - F23-000383 (1 ThinPrep) 3. During an interview on June 6, 2023 at 3:45 PM, these findings were confirmed with the Laboratory Director/Technical Supervisor A. 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 with the Laboratory Director/Technical Supervisor A the laboratory failed to establish written policies and procedures to assess the competency of the Technical Supervisors. The laboratory failed to assess the competency of four of four Technical Supervisors in 2021, 2022 and to the date of the survey in 2023. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to describe the process for assessing the competency of the Technical Supervisors. 2. The Survey Team requested and the laboratory failed to provide documentation of competency assessments for four of four Technical Supervisors in 2021, 2022 and to the date of the survey in 2023. Technical Supervisors include: -Laboratory Director/Technical Supervisor A - Technical Supervisor B -Technical Supervisor C -Technical Supervisor D 3. During an interview on June 5, 2023 at 2:20 PM, these findings were confirmed with the Laboratory Director/Technical Supervisor A. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) -- 3 of 21 -- 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 23 laboratory policies and procedures, stain maintenance records and interviews the laboratory failed to follow one written policy and procedure. Findings include: 1. The laboratory failed to follow the procedure PAPANICOLAOU STAIN PROCEDURE, which stated: "All solutions will be changed after every 820 slides." 2. The Survey Team reviewed stain maintenance records titled THINPREP STAIN MAINTENANCE for 2021, 2022 and to the date of the survey in 2023. The records documented the total number of slides stained and when the stains and solutions were changed. a. During an interview on June 6, 2023 at 1:55 PM, Staff A stated the stain maintenance records were not accurate. The number of slides stained did not include nongynecologic slides that were stained in the same stains and solutions as gynecologic slides. b. The maintenance records failed to document the accurate number of slides stained or if the number of slides stained exceeded 820 slides before the stains and solutions were changed. 3. During an interview on June 6, 2023 at 3:45 PM, these findings were confirmed by 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)

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, record review and interview it was determined that the laboratory failed to establish written policies and procedures to prevent cross-contamination between gynecologic and nongynecologic specimens during staining (refer to D5617); failed to establish written policies and procedures to prevent cross-contamination of nongynecologic specimens having a high potential for cross-contamination during staining (refer to D5619); failed to follow written policies and procedures for an annual statistical evaluation of three of six required statistics for gynecologic specimens in 2016 and 2017 (refer to D5629); failed to establish written policies and procedures for reassessing workload limits for two of two cytotechnologists in 2016, 2017 and to date of the survey in 2018 (refer to D5637); and failed to establish written policies and procedures to ensure that unsatisfactory specimens were identified and reported as unsatisfactory (refer to D5655). 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. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- This STANDARD is not met as evidenced by: Based on the review of laboratory policies and procedures, lack of quality assessment records and interview, it was determined that Facility A failed to establish written policies and procedures for an ongoing mechanism to monitor, assess and correct problems in the preanalytic system for the years 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 monitor the quality of the preanalytic cytology system. 2. The Survey Team requested and the laboratory failed to provide documentation of any quality assessment activities or problems. 3. Cytotechnologist #1 stated during an interview with the Survey Team at 3:35 PM on December 11, 2018 that the laboratory did not have a preanalytic quality assessment program. 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)