North Carolina Baptist Hospital Pathology Lab

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, microscopic review of specimen slides and interviews the laboratory failed to establish and follow written policies and procedures to assess the competency of the Technical Supervisors and Cytotechnologists (refer to D5209); failed to follow two written policies and procedures (refer to D5401); failed to follow 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), adenocarcinoma, or malignant neoplasms with available histopathology (refer to D5623); failed to establish and follow written policies and procedures to review prior gynecologic cases and identify cases with a more significant lesion (refer to D5625); failed to establish and follow written policies and procedures for an annual statistical evaluation of the required laboratory statistics (refer to D5629); failed to establish and follow written policies and procedures to reassess a maximum workload limit at least every six months for the Cytotechnologists (refer to D5637); and failed to establish written policies and procedures to ensure workload limits for the Cytotechnologists would be prorated when examining slides in less than an eight-hour work day (refer to D5641). D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must 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 8 -- and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: A. Based on review of laboratory policies and procedures, lack of competency assessment records and interview the laboratory failed to establish and follow written policies and procedures to assess the competency of the Technical Supervisors. The laboratory failed to assess the competency of six of six Technical Supervisors in 2022, 2023 and January 1, 2024 to the date of the survey in 2024. 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 six of six Technical Supervisors in 2022, 2023 and January 1, 2024 to the date of the survey in 2024. Technical Supervisors include: -Technical Supervisor A -Technical Supervisor B -Technical Supervisor C -Technical Supervisor D -Technical Supervisor E -Technical Supervisor F 3. During an interview on April 10, 2024 at 12:00 PM, these findings were confirmed with the Laboratory Director, Cytology Manager and Director of Quality, Safety and Accreditation. B. Based on review of laboratory policies and procedures, competency assessment records and interviews the laboratory failed to follow written policies and procedures to assess the competency of seven of seven Cytotechnologists in 2022. Findings include: 1. The laboratory failed to follow the procedure PERSONNEL FILE, CONTINUING EDUCATION, TRAINING AND COMPETENCY, which stated: "For new hires competency assessment will be performed semiannually (first assessment within seven months from initiation of testing) and second assessment no later than 12 months from the start of testing during the first year, and annually thereafter." 2. The Survey Team requested and the laboratory failed to provide competency assessment records for seven of seven Cytotechnologists in 2022. Cytotechnologists include: -Cytology Manager - Cytotechnologist A -Cytotechnologist B -Cytotechnologist C -Cytotechnologist D - Cytotechnologist E -Cytotechnologist F 3. During an interview on April 9, 2024 at 1: 40 PM, the Cytology Manager stated "I was a little late doing them." 4. During an interview on April 10, 2024 at 12:00 PM, these findings were confirmed with the Laboratory Director, Cytology Manager and Director of Quality, Safety and Accreditation. 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 57 laboratory policies and procedures, laboratory records and interviews the laboratory failed to follow two written policies and procedures. Findings include: 1. The laboratory failed to follow the procedure ADDENDUM OR AMENDMENT TO A SIGNED-OUT CASE IN AP BEAKER PROCEDURE, which stated: "In the Correction History Component, enter ".amend" to insert the amended smart phrase that will indicate to the person getting a new report what has been -- 2 of 8 -- changed." a. The Survey Team reviewed five corrected final test reports from December 2023 and January 2024. Two of five corrected final test reports failed to indicate the report was a corrected final test report. Refer to D5821 2. The laboratory failed to follow the procedure PERSONNEL FILE, CONTINUING EDUCATION, TRAINING AND COMPETENCY, which stated: "For new hires competency assessment will be performed semiannually (first assessment within seven months from initiation of testing) and second assessment no later than 12 months from the start of testing during the first year, and annually thereafter." a. The Survey Team requested and the laboratory failed to provide competency assessment records for two of three Staff in 2022. Staff includes: -Staff A -Staff B b. During an interview on April 9, 2024 at 1:40 PM, the Cytology Manager stated "I was a little late doing them." 3. During an interview on April 10, 2024 at 12:00 PM, these findings were confirmed with the Laboratory Director, Cytology Manager and Director of Quality, Safety and Accreditation. 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: Based on review of laboratory policies and procedures, laboratory records and interview the laboratory failed to follow 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 HSIL, adenocarcinoma, or malignant neoplasms with available histopathology. The laboratory failed to determine the cause of discrepancy between gynecologic cytology cases with a diagnosis of HSIL or malignancy and the histopathology diagnosis for one of eight cases in 2023. Findings include: 1. The laboratory failed to follow the procedure CYTO-HISTO CORRELATION STUDIES & CLINICAL FOLLOW-UP, which stated: "Discrepant cases are reviewed by the cytology lab manager or designated senior cytotechnologist and sent, with corresponding biopsies, to the cytology fellow for further review. If no errors are found, documentation thereof will be maintained in a correlation binder." 2. The Survey Team reviewed an untitled document that listed all HSIL and malignant cytology cases and the results of follow-up histopathology for 2023. a. The Survey Team identified eight cytology cases with discrepant histopathology diagnoses. b. The Survey Team reviewed laboratory records titled GYNECOLOGICAL CYTO/HISTO CORRELATION used to document the cause of discrepancy between gynecologic cytology cases with a diagnosis of HSIL or malignancy and the histopathology diagnosis. The laboratory failed to document the cause of discrepancy for one of eight cases in 2023. Case includes: -WFG23-2940 3. During an interview on April 10, 2024 at 12:00 PM, these findings were confirmed with the Laboratory Director, Cytology Manager and Director of Quality, Safety and Accreditation. D5625 CYTOLOGY -- 3 of 8 -- CFR(s): 493.1274(c)(3) (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) (3) For each patient with a current HSIL, adenocarcinoma, or other malignant neoplasm, laboratory review of all normal or negative gynecologic specimens received within the previous 5 years, if available in the laboratory (either on-site or in storage). If significant discrepancies are found that will affect current patient care, the laboratory must notify the patient's physician and issue an amended report. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, microscopic review of specimen slides and interview the laboratory failed to establish and follow written policies and procedures to ensure the search and review of prior negative gynecologic specimens received within the previous five years for each patient with a current HSIL or malignancy was performed. The laboratory failed to document the search for prior negative gynecologic specimens for 87 of 95 HSIL or malignant specimens from 2023. The laboratory failed to identify one of 30 HSIL or malignant specimens as having prior negative specimens, and failed to identify two of 23 prior negative specimens as having a more significant lesion. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to describe the laboratory's process for the search and review of all prior negative gynecologic specimens received within the previous five years, for each patient with a current HSIL or malignancy reported by the laboratory. a. The procedure 5-YEAR RETROSPECTIVE NEGATIVE REVIEW OF CURRENT HGSIL/CANCER failed to describe how the search of current HSIL and malignant specimens would be documented if there were no prior negative specimens. 2. The Survey Team requested and the laboratory failed to provide records of the search and review of prior negative gynecologic specimens received within the previous five years, for each patient with a current HSIL or malignancy reported by the laboratory. The laboratory failed to document the search for prior negative gynecologic specimens for 87 of 95 HSIL or malignant specimens from 2023. Specimens include: - WFG23-00085 -WFG23-00161 -WFG23-00238 -WFG23-00249 -WFG23-00415 - WFG23-00579 -WFG23-00599 -WFG23-00634 -WFG23-00738 -WFG23-00770 - WFG23-00789 -WFG23-00965 -WFG23-01107 -WFG23-01280 -WFG23-01562 - WFG23-01677 -WFG23-01705 -WFG23-02006 -WFG23-02056 -WFG23-02110 - WFG23-02366 -WFG23-02674 -WFG23-02746 -WFG23-03430 -WFG23-03490 - WFG23-04096 -WFG23-04137 -WFG23-04381 -WFG23-04783 -WFG23-04832 - WFG23-05663 -WFG23-06067 -WFG23-06221 -WFG23-06432 -WFG23-06804 - WFG23-07337 -WFG23-07429 -WFG23-07558 -WFG23-07588 -WFG23-07672 - WFG23-07714 -WFG23-08024 -WFG23-08032 -WFG23-08206 -WFG23-08628 - WFG23-08681 -WFG23-08805 -WFG23-09227 -WFG23-09539 -WFG23-09759 - WFG23-09949 -WFG23-10462 -WFG23-10654 -WFG23-10882 -WFG23-10901 - WFG23-11056 -WFG23-11911 -WFG23-12036 -WFG23-12082 -WFG23-12092 - WFG23-12222 -WFG23-12311 -WFG23-12876 -WFG23-13556 -WFG23-13597 - WFG23-13699 -WFG23-13832 -WFG23-13876 -WFG23-13935 -WFG23-14393 - WFG23-14430 -WFG23-14755 -WFG23-15163 -WFG23-15177 -WFG23-15202 - WFG23-15401 -WFG23-15436 -WFG23-15498 -WFG23-16078 -WFG23-11767 - WFG23-16314 -WFG23-16477 -WFG23-16527 -WFG23-16594 -WFG23-16656 - WFG23-16740 -WFG23-16790 a. The Survey Team reviewed a sample of 30 HSIL or malignant specimens from 2023 and identified one of the 30 HSIL or malignant -- 4 of 8 -- specimens that had one prior negative specimen the laboratory failed to identify. Specimen includes: -WFG23-00599 3. The Survey Team identified and Technical Supervisor A confirmed on April 10, 2024 the laboratory failed to identify two of 23 prior negative gynecologic cases as having a more significant lesion than was originally reported. Prior negative cases include: -P20-11650 -P20-17584 4. During an interview on April 10, 2024 at 12:00 PM, these findings were confirmed with the Laboratory Director, Cytology Manager and Director of Quality, Safety and Accreditation. D5629 CYTOLOGY CFR(s): 493.1274(c)(5) (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) (5) An annual statistical laboratory evaluation of the number of - (c)(5)(i) Cytology cases examined; (c)(5)(ii) Specimens processed by specimen type; (c)(5)(iii) Patient cases reported by diagnosis (including the number reported as unsatisfactory for diagnostic interpretation); (c)(5)(iv) Gynecologic cases with a diagnosis of HSIL, adenocarcinoma, or other malignant neoplasm for which histology results were available for comparison; (c)(5)(v) Gynecologic cases where cytology and histology are discrepant; and (c)(5)(vi) Gynecologic cases where any rescreen of a normal or negative specimen results in reclassification as low-grade squamous intraepithelial lesion (LSIL), HSIL, adenocarcinoma, or other malignant neoplasms. This STANDARD is not met as evidenced by: A. Based on review of laboratory policies and procedures and interview the laboratory failed to establish written policies and procedures for an annual statistical evaluation of two of six required gynecologic laboratory statistics. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for an annual statistical evaluation of two of six required gynecologic statistics. Statistics include: -The number of gynecologic cases with a diagnosis of HSIL, adenocarcinoma, or other malignant neoplasm for which histology results were available for comparison -The number of gynecologic cases where cytology and histology are discrepant 2. During an interview on April 10, 2024 at 12:00 PM, these findings were confirmed with the Laboratory Director, Cytology Manager and Director of Quality, Safety and Accreditation. B. Based on review of laboratory policies and procedures, laboratory statistical records and interview the laboratory failed to follow written policies and procedures for the evaluation and comparison of two of three nongynecologic cytology statistics. The laboratory failed to document two of three required annual nongynecologic statistics for 2022 and 2023. Findings include: 1. The laboratory failed to follow the procedure STATISTICAL REPORTS POLICY, which stated: "Statistical data is analyzed for the following:" "Number of specimens processed by specimen type" "Volume of patient cases reported by diagnoses, including number or cases reported as unsatisfactory for diagnosis" 2. The Survey Team requested and the laboratory failed to provide records of two of three required annual nongynecologic statistics for 2022 and 2023. Statistics include: - Number of specimens processed by specimen type -Number of patient cases reported by diagnosis (including the number reported as unsatisfactory for diagnostic interpretation) 3. During an interview on April 8, 2024 at 4:20 PM, these findings were confirmed with the Laboratory Director, Cytology Manager and Director of Quality, Safety and Accreditation. -- 5 of 8 -- D5637 CYTOLOGY CFR(s): 493.1274(d)(1)(ii) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(1)(ii) Each individual's workload limit is reassessed at least every 6 months and adjusted when necessary. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records and interviews the laboratory failed to establish and follow written policies and procedures to reassess and adjust when necessary, a maximum workload limit at least every six months for the Cytotechnologists. The laboratory failed to ensure the Technical Supervisor reassessed the maximum workload limits at least every six months for seven of seven Cytotechnologists in 2022, 2023 and January 1, 2024 to the date of the survey in 2024. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to detail how the Technical Supervisor would reassess a maximum workload limit for the Cytotechnologists at least every six months and adjust when necessary. a. The procedure WORKLOAD SURVEILLANCE CYTOTECHNOLOGIST failed to state when the Technical Supervisor would reassess workload limits for the Cytotechnologists. 2. The Survey Team requested workload reassessment records titled CYTOTECHNOLOGIST PRODUCTIVITY EVALUATION AND COMPETENCY ASSESSMENT for 2022, 2023 and January 1, 2024 to the date of the survey in 2024. a. The laboratory provided workload assessment records for the period of June 2023 through December 31, 2023 for seven of seven Cytotechnologists. The Technical Supervisor failed to reassess the workload limit for the period until March 13, 2024. Cytotechnologists include: - Cytology Manager -Cytotechnologist A -Cytotechnologist B -Cytotechnologist C - Cytotechnologist D -Cytotechnologist E -Cytotechnologist F b. The laboratory failed to provide workload reassessment records for January 2022 through December 2022 and January 2023 through June 2023 for seven of seven Cytotechnologists. Cytotechnologists include: -Cytology Manager -Cytotechnologist A -Cytotechnologist B -Cytotechnologist C -Cytotechnologist D -Cytotechnologist E -Cytotechnologist F c. During an interview on April 9, 2024 at 1:40 PM, the Cytology Manager confirmed workload limits were not reassessed at least every six months in 2022, 2023 and January 1, 2024 to the date of the survey in 2024. 3. During an interview on April 10, 2024 at 12:00 PM, these findings were confirmed with the Laboratory Director, Cytology Manager and Director of Quality, Safety and Accreditation. D5641 CYTOLOGY CFR(s): 493.1274(d)(2)(ii) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(2)(ii) For the purposes of establishing workload limits for individuals examining slides in less than an 8-hour workday (includes full-time employees with duties other than slide examination and part-time employees), a period of 8 hours is used to prorate the number of slides that may be examined. The formula-- Number of hours examining slides X 100 / 8 is used to determine maximum slide volume to be examined; This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and interview the laboratory -- 6 of 8 -- failed to establish written policies and procedures to ensure workload limits for the Cytotechnologists would be prorated when examining slides in less than an eight-hour work day. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to prorate workload limits for the Cytotechnologists when examining slides in less than an eight-hour day, or with duties other than examining cytology specimen slides. 2. During an interview on April 8, 2024 at 4:20 PM, these findings were confirmed with the Laboratory Director, Cytology Manager and Director of Quality, Safety and Accreditation. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 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: Based on review of laboratory policies and procedures, laboratory records, microscopic review of specimen slides and interviews the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and correct problems identified in the analytic cytology systems. The laboratory failed to document analytic quality assessment activities during 2022, 2023 and January 1, 2024 to the date of the survey in 2024. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for an ongoing program to monitor, assess and correct problems identified in the analytic cytology systems. 2. The Survey Team requested and the laboratory failed to provide documentation of analytic quality assessment activities during 2022, 2023 and January 1, 2024 to the date of the survey in 2024. a. The Survey Team requested and the laboratory failed to provide written policies and procedures for a mechanism to monitor and evaluate the competency of the Technical Supervisors and Cytotechnologists. Refer to D5209 b. The Survey Team requested and the laboratory failed to provide written policies and procedures for a mechanism to monitor and evaluate the program to compare clinical information with cytology reports and to compare all gynecologic cytology reports with a diagnosis of HSIL, adenocarcinoma, or malignant neoplasms with available histopathology. Refer to D5623 c. The Survey Team requested and the laboratory failed to provide written policies and procedures for a mechanism to monitor and evaluate the program to review prior negative gynecologic cases received within the previous five years for each patient with a current diagnosis of HSIL or malignancy and identify cases with a more significant lesion. Refer to D5625 d. The Survey Team requested and the laboratory failed to provide written policies and procedures for a mechanism to monitor and evaluate the annual statistical evaluation of the required laboratory statistics. Refer to D5629 e. The Survey Team requested and the laboratory failed to provide written policies and procedures for a mechanism to monitor and evaluate the reassessment of workload limits at least every six months. Refer to D5637 f. The Survey Team requested and the laboratory failed to provide written policies and procedures for a mechanism to monitor and evaluate corrected final test reports to ensure corrected final test reports indicated the reports were corrected final test reports. Refer to D5821 D5821 TEST REPORT CFR(s): 493.1291(k) -- 7 of 8 -- When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on review of corrected final test reports and interview the laboratory failed to ensure two of five corrected final test reports indicated the reports were corrected final test reports. Findings include: 1. The Survey Team reviewed five corrected final test reports from December 2023 and January 2024. Two of five corrected final test reports failed to indicate the report was a corrected final test report. Reports include: - WFP23-02595 -WFG24-01156 2. During an interview on April 8, 2024 at 4:20 PM, these findings were confirmed with the Laboratory Director, Cytology Manager and Director of Quality, Safety and Accreditation. The Cytology Manager stated that corrected final test reports were supposed to state "Amended Report" on the corrected final test report. D6130 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(c)(2)(3) (c) In cytology, the technical supervisor or the individual qualified under 493.1449(k) (2)-- (c)(2) Must establish the workload limit for each individual examining slides and (c)(3) Must reassess the workload limit for each individual examining slides at least every 6 months and adjust as necessary. This STANDARD is not met as evidenced by: Based on review of workload records and interviews the Technical Supervisor failed to reassess a maximum workload limit at least every six months for seven of seven Cytotechnologists in 2022 and 2023. Findings include: 1. The Technical Supervisor failed to provide documentation the Technical Supervisor reassessed a maximum workload limit at least every six months for seven of seven Cytotechnologists in 2022 and 2023. Refer to D5637 Cytotechnologists include: -Cytology Manager - Cytotechnologist A -Cytotechnologist B -Cytotechnologist C -Cytotechnologist D - Cytotechnologist E -Cytotechnologist F 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. -- 8 of 8 --

Summary Statement of Deficiencies D5641 CYTOLOGY CFR(s): 493.1274(d)(2)(ii) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(2)(ii) For the purposes of establishing workload limits for individuals examining slides in less than an 8-hour workday (includes full-time employees with duties other than slide examination and part-time employees), a period of 8 hours is used to prorate the number of slides that may be examined. The formula-- Number of hours examining slides X 100 / 8 is used to determine maximum slide volume to be examined; This STANDARD is not met as evidenced by: Based on the review of laboratory records and interview it was determined that one of six Cytotechnologists exceeded the prorated workload limit on 2 of 19 days spent examining slides in September 2018 and October 2018. Findings include: 1. The Survey Team reviewed laboratory records titled CYTOTECHNOLOGIST PRODUCTIVITY EVALUATION AND SCREENING COMPETENCY ASSESSMENT for six of six Cytotechnologists dated September 4, 2018. This form was used by the laboratory to document workload limits. a. The workload limit for Cytotechnologist #6 was documented as 10 slides/hour. 2. The Survey Team reviewed workload records from September 6, 2018 through October 8, 2018 for six of six Cytotechnologists. a. Cytotechnologist #6 exceeded the prorated number of slides allowed per eight hour workday on 2 of 19 days spent examining slides. Dates include: -DATE - September 6, 2018 -HOURS SCREENING - 2.5 -SLIDES EVALUATED - 33 -SLIDES ALLOWED - 25 -DATE - October 8, 2018 -HOURS SCREENING - 3.5 -SLIDES EVALUATED - 39 -SLIDES ALLOWED - 35 3. The workload records were reviewed and signed/dated by the Laboratory Manager /Cytotechnologist #1. a. The Laboratory Manger/Cytotechnologist #1 stated in an interview on October 22, 2018 at 3:30 PM that the laboratory review failed to identify that Cytotechnologist #6 had exceeded the prorated workload limits. 4. These findings 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 -- were reviewed with and confirmed by the Laboratory Director on October 23, 2018 at 10:15 AM. -- 2 of 2 --

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 the review of written procedures, record review, surveyor interviews, and observation the laboratory failed to follow written procedures to ensure positive identification of patient specimens (refer to D5203); failed to establish written procedures for stain maintenance (refer to D5403); failed to perform and document equipment maintenance defined by the manufacturer (refer to D5429); failed to test Diff Quik staining materials each day of use (refer to D5473); failed to establish written procedures to prevent cross-contamination between gynecologic and non- gynecologic specimens (refer to D5617); failed to establish written procedures to prevent cross contamination between non-gynecologic specimens with a high potential for cross-contamination (refer to D5619); failed to establish written procedures for a review program to include high risk patients (refer to D5621); failed to follow written procedures to document and evaluate one annual statistic (refer to D5629); and failed to follow written procedures to establish and prorate workload limits (refer to D5633 and D5637). 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 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 -- collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on the review of written laboratory procedures, observation of glass slides, and interview it was determined that the laboratory failed to follow the written procedure to ensure the positive identification of eighty-five of eighty-five gynecologic glass slides and twenty-five of twenty-five non-gynecologic glass slides sampled from January 2018. Findings include: 1. The laboratory failed to follow the written procedure titled CYT-C-1 CYTOLOGY SLIDE LABELING. The procedure stated that "two patient identifiers are placed on cytology specimen slides. The two identifiers include the patient name and unique case number assigned by the CoPath system. The number consists of the letter "P" the last two digits of the current year and the number." a. The Survey Team observed the slide labeling on eighty-five randomly selected gynecologic cases (eighty-five slides) and ten randomly selected non-gynecologic cases (twenty-five slides) from January 2018. The slides were not labeled with the complete accession number prior to attaching a permanent patient identification slide label. Gynecologic Cases include: Specimen Specimen Slide Accession #: Labeled as: -P18-44 44 -P18-45 45 -P18-46 46 -P18-47 47 -P18-48 48 - P18-49 49 -P18-50 50 -P18-51 51 -P18-52 52 -P18-53 53 -P18-54 54 -P18-55 55 - P18-56 56 -P18-57 57 -P18-65 65 -P18-66 66 -P18-67 67 -P18-68 68 -P18-69 69 - P18-70 70 -P18-71 71 -P18-72 72 -P18-73 73 -P18-74 74 -P18-75 75 -P18-76 76 - P18-77 77 -P18-78 78 -P18-79 79 -P18-80 80 -P18-81 81 -P18-82 82 -P18-83 83 - P18-84 84 -P18-162 162 -P18-163 163 -P18-164 164 -P18-165 165 -P18-166 166 - P18-167 167 -P18-168 168 -P18-169 169 -P18-170 170 -P18-171 171 -P18-172 172 - P18-219 219 -P18-220 220 -P18-221 221 -P18-222 222 -P18-223 223 -P18-225 225 - P18-226 226 -P18-227 227 -P18-228 228 -P18-229 229 -P18-230 230 -P18-231 231 - P18-279 279 -P18-280 280 -P18-281 281 -P18-282 282 -P18-283 283 -P18-284 284 - P18-285 285 -P18-286 286 -P18-295 295 -P18-296 296 -P18-297 297 -P18-298 298 - P18-299 299 -P18-300 300 -P18-301 301 -P18-302 302 -P18-303 303 -P18-304 304 - P18-305 305 -P18-306 306 -P18-307 307 -P18-308 308 -P18-309 309 -P18-310 310 - P18-311 311 -P18-312 312 -P18-313 313 -P18-314 314 Non-Gynecologic Cases include: Specimen Specimen Slide Accession #: Labeled as: -P18-7 7 1 slide -P18-8 8 3 slides -P18-38 38 2 slides -P18-41 41 7 slides -P18-95 95 4 slides -P18-99 99 1 slide -P18-103 103 2 slides -P18-173 173 1 slide -P18-175 175 2 slides -P18-267 267 2 slides 3. The Laboratory Manager/Cytotechnologist #1 and Laboratory Director confirmed during a survey overview on 6/19/18 at 4:30 PM that the laboratory practice for labeling slides prior to and during processing did not include the prefix and year. 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 -- 2 of 12 -- 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 A complaint investigation survey was conducted at the facility February 5-8, 2018. Based on the survey findings, an Immediate Jeopardy situation was identified and the laboratory was notified at approximately 4:20 p.m. The laboratory failed to identify and correct problems in the subspecialty of histopathology. The laboratory failed to ensure the procedure manual was complete for all testing performed. The laboratory failed to ensure equipment and procedures were validated prior to use for patient testing, and failed to perform manufacturers' specified maintenance as required. The laboratory failed to monitor water quality, temperature, and humidity as required. The laboratory failed to perform and document quality control for H&E (hematoxylin and eosin) stains as required, and failed to discard expired supplies. The laboratory director failed to provide overall management and direction for the laboratory. The laboratory director failed to ensure delegated duties were performed as required. The laboratory director failed to ensure testing personnel were trained prior to testing patients, and failed to ensure policies and procedures were established and followed for monitoring testing personnel competency. The laboratory tests approximately 25,000 surgical pathology cases per year. As of 2/8/18, the laboratory had identified 4 cases in which erroneous histopathology test results were reported, resulting in unnecessary treatment for three patients and a delay in diagnosis for a fourth patient. Case reviews are ongoing. Based on the severity of the deficiencies, the Immediate Jeopardy was not abated and the laboratory was placed on a 23 day revocation track. D5028 HISTOPATHOLOGY CFR(s): 493.1219 If the laboratory provides services in the subspecialty of Histopathology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1273, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of policies and procedures, observation, review of 2017 laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- records, and interview with staff 2/5/18 - 2/8/18, the laboratory failed to identify and correct problems identified during the survey in the subspecialty of histopathology. Findings: 1. The laboratory failed to ensure the procedure manual was complete for all testing performed (See D5403). 2. The laboratory failed to monitor water quality, failed to monitor and document temperature and humidity, and failed to establish temperature and humidity ranges that were consistent with manufacturers' requirements (see D5413). 3. The laboratory failed to discard expired supplies (see D5417). 4. The laboratory failed to verify performance specifications for the faxitron PathVision X-Ray Analyzer prior to use in patient testing (see D5421). 5. The laboratory failed to establish performance specifications for the modified stain procedures performed on the Artisan Staining System prior to use in patient testing (see D5423). 6. The laboratory failed to perform and document manufacturers' specified maintenance for histology equipment (see D5429). 7. The laboratory failed to perform and document quality control for H&E (hematoxylin and eosin) stains as required (see D5601). 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 the laboratory's policies and procedures and interview with TP (testing personnel) 2/5/18 - 2/8/18, the laboratory failed to establish policies and procedures for monitoring the competency of testing personnel. Findings: Review of the laboratory's procedure manual for the OR (Operating Room) Pathology laboratory revealed there was no written policy or procedure which described the process for evaluating the competency of testing personnel who perform grossing of pathology specimens, including the elements evaluated, the criteria for acceptability, who is responsible for performing the evaluation, and the