Pathology Services For Jefferson Regional Mc

Summary Statement of Deficiencies D5619 CYTOLOGY CFR(s): 493.1274(b)(3) (b) Staining. The laboratory must have available and follow written policies and procedures for each of the following, if applicable: (b)(3) Nongynecologic specimens that have a high potential for cross-contamination must be stained separately from other nongynecologic specimens, and the stains must be filtered or changed following staining. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, observation and interviews, the laboratory failed to establish written policies and procedures for identifying nongynecologic specimens with a high potential for cross-contamination and staining them separately from other nongynecologic specimens and filtering or changing the stains following staining 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 for identifying nongynecologic specimens with a high potential for cross-contamination and staining them separately from other nongynecologic specimens and filtering or changing the stains following staining. 2. During an observation of nongynecologic specimen staining on June 6, 2023 at 3:00 PM the Cytology Supervisor stated there were separate staining containers inserted into the automated stainer specifically for nongynecologic specimens but there was no procedure or method used to prevent cross-contamination between these specimens which were stained together. 3. During an interview on June 7, 2023 at 11:10 AM, these findings were confirmed with the Laboratory Director/Technical Supervisor #1. D5655 CYTOLOGY CFR(s): 493.1274(e)(4) (e) Slide examination and reporting. The laboratory must establish and follow written Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- policies and procedures that ensure the following: (e)(4) Unsatisfactory specimens or slide preparations are identified and reported as unsatisfactory. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and interview with the Laboratory Director/Technical Supervisor #1, the laboratory failed to establish written policies and procedures to ensure unsatisfactory slide preparations were identified and reported as unsatisfactory. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures specifying criteria that ensured unsatisfactory slide preparations were identified and reported as unsatisfactory for evaluation. 2. During an interview on June 7, 2023 at 11:10 AM, these findings were confirmed with the Laboratory Director/Technical Supervisor #1. D6115 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(2) The technical supervisor is responsible for verification of the test procedures performed and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on microscopic review of 357 negative gynecologic cytology cases/slides from January 5, 2023 through February 21, 2023 and confirmation by Technical Supervisor #2 on June 6 and 7, 2023 the Technical Supervisor failed to verify the accuracy of three gynecologic cytology tests. 1. G-23-00143 1/23/2023 ThinPrep Pap Test LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion or Malignancy SURVEY TEAM DIAGNOSIS: Low Grade Squamous Intraepithelial Lesion TECHNICAL SUPERVISOR #2 DIAGNOSIS: Low Grade Squamous Intraepithelial Lesion 2. G-23-00402 2/16/2023 ThinPrep Pap Test LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion or Malignancy SURVEY TEAM DIAGNOSIS: Atypical Glandular Cells TECHNICAL SUPERVISOR #2 DIAGNOSIS: Atypical Glandular Cells 3. G-23-00438 2/21/2023 ThinPrep Pap Test LABORATORY DIAGNOSIS: Negative for Intraepithelial Lesion or Malignancy SURVEY TEAM DIAGNOSIS: Low Grade Squamous Intraepithelial Lesion TECHNICAL SUPERVISOR #2 DIAGNOSIS: Low Grade Squamous Intraepithelial Lesion D9999 By agreement between ASCT Services, Inc. and CMS, information provided for CMS's completion of CMS Form 670 are ASCT Services, Inc. averages only. This information is confidential and proprietary to ASCT Services, Inc., is exempt under the Freedom of Information Act (5 U.S.C. 552 et seq.), and shall be used for federal government purposes only. -- 2 of 2 --

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Through a review of the laboratory policy and procedure manual, a review of the Histology Temperature Charts for 2020 and 2021, and interviews with laboratory staff, it was determined the laboratory failed to define an acceptable water bath temperature for the Flotation Water Bath. Survey findings follow: A. The Flotation Bath policy states, "Begin cutting temperature should be 40 to 43 degrees Celsius." B. The "Histology Temperature Chart" includes an acceptable water bath temperature of 36 to 40 degrees Celsius. C. Due to inconsistencies between the acceptable Flotation Bath temperature in the written policy and the acceptable temperature range on the "Histology Temperature Chart" there was no established acceptable temperature for the Flotation Water Bath. D. In an interview at 10:38 on 9/13/2021, laboratory employee #4 (as listed on the form CMS-209) confirmed the inconsistencies in acceptable temperatures for the water bath. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Through a review of the GYN Cytology Quality Assurance Summaries for 2021 and interviews with laboratory staff, it was determined the laboratory failed to document

Summary Statement of Deficiencies D5623 CYTOLOGY CFR(s): 493.1274(c)(2) (c) Control procedures. The laboratory must establish and follow written policies and procedures for a program designed to detect errors in the performance of cytologic examinations and the reporting of results. The program must include the following: (c) (2) Laboratory comparison of clinical information, when available, with cytology reports and comparison of all gynecologic cytology reports with a diagnosis of high- grade squamous intraepithelial lesion (HSIL), adenocarcinoma, or other malignant neoplasms with the histopathology report, if available in the laboratory (either on-site or in storage), and determination of the causes of any discrepancies. This STANDARD is not met as evidenced by: THIS IS A NEW STANDARD-LEVEL DEFICIENCY BASED ON THE REVISIT SURVEY COMPLETED ON NOVEMBER 10, 2020. Based on review of laboratory policies and procedures, laboratory records and interviews it was determined that the laboratory failed to follow written policies and procedures to determine the cause of discrepancies between the cytology diagnosis and the histopathology diagnosis for four of four cases from January 1, 2020 to the date of the survey. Findings include: 1. The laboratory failed to follow the procedure titled CYTOLOGY-HISTOLOGY CORRELATION which stated "Discrepancies are defined as "major" for being two degrees of difference...For major discrepancies, the cases are reviewed in search of an explanation...A record of GYN cytology-histology correlation is kept in file." 2. The Survey Team requested and the laboratory failed to provide documentation of case reviews for four of four cytology cases from January 1, 2020 to the date of the survey. Cytology cases include: -G-20-00595 -G-20-00999 -G-20-01004 -G-20-01199 3. During interviews on November 9, 2020 at 1:41 PM and November 10, 2020 at 8:45 AM, these findings were confirmed by the Laboratory Director/Technical Supervisor A and Technical Supervisor B. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- D6166 CYTOTECHNOLOGIST RESPONSIBILITIES CFR(s): 493.1485(b) The cytotechnologist is responsible for documenting, for each 24-hour period, the total number of slides examined or reviewed in the laboratory as well as the total number of slides examined or reviewed in any other laboratory or for any other employer. This STANDARD is not met as evidenced by: THIS IS A NEW STANDARD-LEVEL DEFICIENCY BASED ON THE REVISIT SURVEY COMPLETED ON NOVEMBER 10, 2020. Based on review of laboratory records it was determined that one of one Cytotechnologist failed to document the total number of slides examined for 10 of 75 days spent examining slides in 2020. Findings include: 1. The Survey Team reviewed "Cytotechnologist Daily Workload" logs for 2020. One of one Cytotechnologist failed to document 84 slides examined for 10 of 75 days spent examining slides in 2020. Dates include: -May 20 Cases include: - G-20-00793, one slide -G-20-00794, one slide -G-20-00795, one slide -G-20-00796, one slide -G-20-00797, one slide -G-20-00798, one slide -May 22 Cases include: -G- 20-00809, one slide -G-20-00810, one slide -G-20-00811, one slide -G-20-00812, one slide -G-20-00813, one slide -G-20-00814, one slide -G-20-00815, one slide -G-20- 00816, one slide -G-20-00817, one slide -G-20-00818, one slide -G-20-00819, one slide -G-20-00820, one slide -June 4 Cases include: -G-20-00913, one slide -G-20- 00914, one slide -G-20-00915, one slide -G-20-00916, one slide -G-20-00917, one slide -G-20-00918, one slide -G-20-00919, one slide -G-20-00920, one slide -G-20- 00921, one slide -G-20-00922, one slide -G-20-00923, one slide -G-20-00924, one slide -July 16 Cases include: -G-20-01241, one slide -G-20-01242, one slide -G-20- 01243, one slide -G-20-01244, one slide -G-20-01245, one slide -G-20-01246, one slide -G-20-01247, one slide -G-20-01248, one slide -G-20-01249, one slide -G-20- 01250, one slide -G-20-01251, one slide -G-20-01252, one slide -G-20-01253, one slide -G-20-01254, one slide -G-20-01255, one slide -G-20-01256, one slide -G-20- 01257, one slide -G-20-01258, one slide -August 24 Cases include: -G-20-01549, one slide -August 25 Cases include: -G-20-01550, one slide -G-20-01551, one slide -G-20- 01552, one slide -G-20-01553, one slide -G-20-01554, one slide -G-20-01555, one slide -G-20-01556, one slide -G-20-01557, one slide -G-20-01558, one slide -G-20- 01559, one slide -G-20-01560, one slide -G-20-01561, one slide -G-20-01562, one slide -G-20-01563, one slide -G-20-01564, one slide -G-20-01565, one slide -G-20- 01566, one slide -G-20-01567, one slide -G-20-01568, one slide -G-20-01569, one slide -G-20-01570, one slide -August 28 Cases include: -G-20-01596, one slide -G-20- 01597, one slide -August 29 Cases include: -G-20-01599, one slide -G-20-01600, one slide -August 31 Cases include: -G-20-01601, one slide -G-20-01602, one slide -G-20- 01603, one slide -G-20-01604, one slide -G-20-01605, one slide -G-20-01606, one slide -September 9 Cases include: -G-20-01667, one slide -G-20-01668, one slide -G- 20-01669, one slide -G-20-01670, one slide -- 2 of 2 --

Summary Statement of Deficiencies D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) The laboratory must retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). The laboratory must retain histopathology slides for at least 10 years from the date of examination. The laboratory must retain pathology specimen blocks for at least 2 years from the date of examination. The laboratory must preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: Based on interviews it was determined that the laboratory failed to retain all cytology slide preparations for at least five years from November 2016 to the date of the survey in 2020. Findings include: 1. During an interview on January 29, 2020 at 10:45 AM the Cytotechnologist stated that Diff Quick stained slides prepared during bronchoscopic fine needle aspiration procedures were discarded into the Sharps box in the bronchoscopy suite if they were interpreted as bloody, scant or nondiagnostic by the Cytotechnologist. a. These slides were not retained as part of the specimen case. 2. During an interview on January 29, 2020 at 11:48 AM the Cytotechnologist stated "I put stars on the diagnostic ones so I know which ones to keep. For bronchs a bunch of them get thrown away because a bunch of them are nothing." The Cytotechnologist stated that Diff Quick stained slide preparations were also discarded in Sharps boxes on thyroid fine needle aspirations prior to 2017 if they were interpreted as bloody, scant or nondiagnostic by the Cytotechnologist during rapid onsite evaluations. 3. During an interview on January 29, 2020 at 1:00 PM the Cytotechnologist stated that slides were also held back in a box and were only forwarded to the Technical Supervisors if they asked for more. If the Technical Supervisors did not request the held back slides they were discarded. a. The Laboratory Director/Technical Supervisor A stated that they would need to instruct the radiologists to refrain from giving them so much material and added "This is not all Cytotechnologist's fault." Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 15 -- 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 it was determined that the laboratory failed to establish written policies and procedures to assess the competency of two of two Technical Supervisors (refer to D5209); failed to ensure that 33 of 33 written laboratory procedures were approved, signed, and dated by the Laboratory Director prior to use (refer to D5407); failed to ensure that all reagents and solutions were labeled to indicate content (refer to D5415); failed to ensure that reagents and solutions were used before the expiration dates (refer to D5417); failed to test Diff Quick staining materials and Papanicolaou staining materials for intended reactivity to ensure predictable staining characteristics (refer to D5473); failed to follow written policies and procedures to establish individual workload limits for one of one Cytotechnologist and two of two Technical Supervisors and to reassess the workload limits at least every six months (refer to D5633 and D5637); failed to ensure that one of one Cytotechnologist did not exceed the prorated workload limit of 12.5 slides per hour (refer to D5641); failed to establish written policies and procedures to ensure that the laboratory maintained records of the number of hours spent examining slides (refer to D5645); and failed to ensure that two of two Technical Supervisors reviewed all nongynecologic preparations (refer to D5653). 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 and interviews it was determined that the laboratory failed to establish written policies and procedures to ensure optimal integrity of a patient specimen to include all slide preparations from the time of collection or receipt of the specimen through completion of testing and reporting of results from November 2016 to the date of the survey in 2020. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to ensure optimal integrity of a patient specimen to include all slide preparations from the time of collection or receipt of the specimen through completion of testing and reporting of results. 2. During an interview on January 29, 2020 at 10:45 AM the Cytotechnologist stated that Diff Quick stained slides prepared during bronchoscopic fine needle aspiration procedures were discarded into the Sharps box in the bronchoscopy suite if they were interpreted as bloody, scant or nondiagnostic by the Cytotechnologist. These slides were not retained as part of the -- 2 of 15 -- patient's specimen case through specimen testing and reporting of results. 3. During an interview on January 29, 2020 at 11:48 AM the Cytotechnologist stated that Diff Quick stained slide preparations were also discarded in Sharps boxes on thyroid fine needle aspirations prior to 2017 if they were interpreted as bloody, scant or nondiagnostic by the Cytotechnologist during rapid onsite evaluations. 4. During an interview on January 29, 2020 at 1:00 PM the Cytotechnologist stated that slides were also held back in a box and only forwarded to the Technical Supervisors if they asked for more. If the Technical Supervisors did not request the held back slides they were discarded. 5. These findings were confirmed by the Cytotechnologist and the Laboratory Director/Technical Supervisor A on January 29, 2020 at 1:00 PM. 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 establish written policies and procedures to assess the competency of two of two Technical Supervisors. 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. Technical Supervisors include: - Laboratory Director/Technical Supervisor A -Technical Supervisor B 2. The Survey Team requested and the laboratory failed to provide records of competency assessment for the Laboratory Director/Technical Supervisor A who performed microscopic evaluations in 2018, 2019 and to the date of the survey in 2020 and for Technical Supervisor B who performed microscopic evaluations from July 2019 to the date of the survey in 2020. 3. During interviews on January 27, 2020 at 10:13 AM and 3:15 PM these findings were confirmed by the Laboratory Director/Technical Supervisor A and the Laboratory Manager. 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)