Tennessee Urology Associates Pllc

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: . Based on laboratory observation, a review of patient test reports, laboratory records, and interviews with the laboratory director and manager, the laboratory failed to verify the accuracy of histopathology twice annually in 2023, 2024, and through the survey date in 2025 (08.26.2025). The findings include: 1. Observation of the laboratory on 08.26.2025 at 10:10 a.m. revealed equipment used for processing and staining tissue for slide interpretation for histopathology procedures. Subsequent observation of the laboratory director's office on 08.26.2025 at 11:45 a.m. revealed a microscope for slide interpretation for histopathology. 2. Review of patient test reports revealed the following histopathology slide interpretations: -Patient PR23- 00936 on 12.04.2023 -Patient PR24-01223 on 11.18.2024 -Patient PR25-00250 on 03.11.2025 3. A review of the laboratory's records revealed that it did not verify the accuracy of histopathology slide interpretation twice annually in 2023 and 2024 and had not performed it in 2025 through the survey date, 08.26.2025. 4. Interviews with the laboratory manager on 08.26.2025 at 11:10 a.m. and with the laboratory director on 08.26.2025 at 11:50 a.m. confirmed the above survey 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 1 --

Summary Statement of Deficiencies 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: Based on review of laboratory policies and procedures, laboratory records and interview with the Laboratory Director/Technical Supervisor the laboratory failed to follow written policies and procedures for an annual statistical evaluation of three of three required nongynecologic laboratory statistics for January through June 2024. Findings include: 1. The laboratory failed to follow the procedure CYTOLOGY LABORATORY STATISTICS, which stated: "PRICIPLE CFR 493.1274 require laboratories performing cytological examination to provide written policies and procedures for the evaluation and comparison of three of three nongynecologic cytology statistics." "POLICY The laboratory manager of Tennessee Urology Associates (TUA) laboratory is required to gather the following statistics monthly with sign off review by the laboratory director. - Total number of nongynecologic cytology cases examined. - Number of nongynecologic specimens processed by Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- specimen type. - Number of nongynecologic cases reported by diagnosis, including the number reported as nondiagnostic." 2. The laboratory provided statistics for three of three required annual nongynecologic laboratory statistics for January through June 2024. The laboratory also provided the number of cytology cases documented as reviewed by the Laboratory Director/Technical Supervisor for January through June 2024. The Survey Team compared the statistics with the number of cases documented as reviewed by the Laboratory Director/Technical Supervisor and identified inconsistencies in the numbers. a. The statistics provided for the total number of monthly cytology cases examined did not correspond to the number of cases documented as reviewed to include: -January 2024 statistic = 21 versus number reviewed 160 -February 2024 statistic = 31 versus number reviewed 214 -March 2024 statistic = 27 versus number reviewed 215 -April 2024 statistic = 48 versus number reviewed 230 -May 2024 statistic = 46 versus number reviewed 175 -June 2024 statistic = 37 versus number reviewed 216 b. The statistics provided for the number of specimens processed by specimen type did not correspond to the number of cases documented as reviewed to include: -January 2024 statistic = 21 versus number reviewed 160 -February 2024 statistic = 31 versus number reviewed 214 -March 2024 statistic = 27 versus number reviewed 215 -April 2024 statistic = 48 versus number reviewed 230 -May 2024 statistic = 46 versus number reviewed 175 -June 2024 statistic = 37 versus number reviewed 216 c. The statistics provided for the number of patient cases reported by diagnosis (including the number reported as unsatisfactory for diagnostic interpretation) did not correspond with the actual number of cytology cases documented as reviewed to include: -January 2024 -No diagnostic categories documented -The number of cases documented as reviewed;160 -February 2024 - - Negative for Malignancy; 22 -Nondiagnostic; 3 -Atypical Urothelial cells suspicious for urothelial neoplasm; 3 -Negative limited; 1 -Atypical Urothelial cells, inconclusive; 1 -Atypical; 1 -The number of cases documented as reviewed; 214 - March 2024- -Negative for Malignancy; 10 -Nondiagnostic; 5 -Atypical Urothelial cells suspicious for urothelial neoplasm; 5 -Negative limited; 5 -Atypical Urothelial cells, inconclusive; 1 -Atypical urothelial cells suspicious for high grade malignancy; 1 -The number of cases documented as reviewe; 215 -April 2024- -Negative for Malignancy; 25 -Nondiagnostic; 7 -Atypical Urothelial cells suspicious for urothelial neoplasm; 5 -Negative limited; 7 -Atypical Urothelial cells, inconclusive; 1 -Atypical urothelial cells suspicious for low grade urothelial malignancy; 2 -Negative for high grade malignancy; 1 -Atypical urothelial cells, inconclusive; 1 -The number of cases documented as reviewed; 230 -May 2024- -Negative for Malignancy; 34 - Nondiagnostic; 4 -Atypical Urothelial cells suspicious for urothelial neoplasm; 6 - Negative limited; 4 -The number of cases documented as reviewed; 175 -June 2024- - Negative for Malignancy; 26 -Nondiagnostic; 4 -Atypical Urothelial cells suspicious for urothelial neoplasm; 4 -Negative limited; 3 -The number of cases documented as reviewed; 216 3. During an interview on August 14, 2024 at 9:15 AM the laboratory's inaccurate statistics were confirmed with the Laboratory Director/Technical Supervisor. 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: -- 2 of 3 -- Based on review of laboratory policies and procedures, lack of workload limit reassessment records and interview with the Laboratory Director/Technical Supervisor 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 Laboratory Director/Technical Supervisor. The laboratory failed to provide records of a workload limit reasessment for the Laboratory Director /Technical Supervisor 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 Laboratory Director /Technical Supervisor would reassess a maximum workload limit for the Laboratory Director/Technical Supervisor at least every six months and adjust when necessary. The laboratory failed to provide written policies and procedures to detail what performance criteria would be reviewed as part of a workload reassessment. 2. The Survey Team requested and the laboratory failed to provide documentation the Laboratory Director/Technical Supervisor reassessed a maximum workload limit for the Laboratory Director/Technical Supervisor in 2022, 2023 and January 1, 2024 to the date of the survey in 2024. 3. During an interview on August 13, 2024 at 11:35 AM these findings were confirmed with the Laboratory Director/Technical Supervisor. 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 written policies and procedures, lack of workload limit reassessment records and interview with the Laboratory Director/Technical Supervisor, the Technical Supervisor failed to reassess the workload limits at least every six months for one of one Laboratory Director/Technical Supervisor in 2022, 2023 and January 1, 2024 to the date of the survey in 2024. Findings include: 1. The Survey Team requested and Technical Supervisor failed to provide records of a workload reassessment at least every six months for one of one Laboratory Director /Technical Supervisor in 2022, 2023 and January 1, 2024 to the date of the survey in 2024. (Refer to D5637) 2. During an interview on August 13, 2024 at 11:35 AM, these findings were confirmed with the Laboratory Director/Technical Supervisor. 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. -- 3 of 3 --

Summary Statement of Deficiencies 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, the laboratory failed to establish written policies and procedures to assess the competency of the Laboratory Director/Technical Supervisor. The laboratory failed to assess the competency of one of one Laboratory Director/Technical Supervisor 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 to assess the competency of the Laboratory Director/Technical Supervisor. 2. The Survey Team requested and the laboratory failed to provide documentation of competency assessment for one of one Laboratory Director /Technical Supervisor in 2021, 2022 and to the date of the survey in 2023. Laboratory Director/Technical Supervisor includes: -Laboratory Director/Technical Supervisor 3. During an interview on March 22, 2023 at 8:32 AM, the Laboratory Director /Technical Supervisor confirmed these findings. 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 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 -- 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 D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: =================================== Based on a complaint survey investigation, the lab director failed to fulfill his duty to provide overall management and direction for moderately complex laboratory testing in accordance with $493.1407; for specimen collection/handling errors whenever significant deviations from the laboratory's policies were identified and documented (Refer to D6024). =================================== D6024 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(7) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(7) Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance specifications are identified, This STANDARD is not met as evidenced by: =================================== Based on complaint survey Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- investigation with review of the laboratory's policy and procedure for moderately complex specimen collection and handling and QA (Quality Assurance) Indicator Reports for April 1, 2019 - August 24, 2020 and interviews with 5 testing/processing personnel, laboratory manager and laboratory director, it was determined 101 specimen collection/handling errors were received from clinical sites with no documentation of remedial actions to improve and monitor error rate based on policy /procedures. The findings include: 1. A review of the laboratory's policy and procedure for specimen collection and handling revealed it had not been followed for remedial action and moniroting of errors sent from clinical sites for moderately complex laboratory testing specimens. (reference attached Laboratory Collection and Specimen Handling Guide). 2. A review of the QA indicator reports for April 1, 2019 - August 24, 2020 revealed 101 specimen collection/handling errors were documented from clinical collection sites without remedial action and monitoring to reduce the rate of errors as follows: a. 3 specimen labeling discrepancies b. 14 hemolyzed specimens c. 84 patient test requisition information errors 3. Upon interviews with 5 testing /processing personnel, laboratory manager and laboratory director at survey conclusion at approximately 3:00pm, 8/19/2020 it was confirmed there were significant deviations from the laboratory's established specimen collection/handling policies from clinical specimen collection sites with no remedial actions taken to improve and monitor the error rate for the 16-month period between 2019 and 2020. =================================== D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: =================================== Based on a complaint survey investigation, the laboratory director failed to fulfill his duty to provide overall management and direction for high complexity laboratory testing in accordance with $493.1445; for specimen collection/handling errors whenever significant deviations from the laboratory's policies were identified and documented (Refer to D6094). =================================== D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: =================================== Based on complaint survey investigation with review of the laboratory's policy and procedure for specimen collection and handling of high complexity testing specimens and QA (Quality Assurance) Indicator Reports for April 1, 2019 - August 24, 2020 and interviews with 5 testing/processing personnel, laboratory manager and laboratory director, it was determined the quality assessment program failed to be maintained as 28 specimen -- 2 of 3 -- collection/handling errors were received from clinical sites with no documentation of remedial actions to improve and monitor error rate based on policy/procedures. The findings include: 1. A review of the laboratory's policy and procedure for specimen collection/handling revealed it had not been followed for remedial action and monitoring of errors sent from clinical sites for high complexity laboratory testing specimens. (reference attached Laboratory Collection and Specimen Handling Guide). 2. A review of the QA indicator reports for April 1, 2019 - August 24, 2020 revealed 28 specimen collection/handling errors were documented from clinical collection sites without remedial action and monitoring to reduce the rate of errors as follows: a. 1 specimen with only one patient identifier b. 9 urine specimen containers leaking resulting in illegible patient identification c. 2 patient specimen containers with no patient tissue d. 4 tissue specimens with improper fixative e. 3 specimens with no patient test requisition f. 7 specimen labeling discrepancies g. 2 patient specimens double labeled (2 different patients' names) 3. Upon interviews with 5 testing /processing personnel, laboratory manager and laboratory director at survey conclusion at approximately 3:00pm, 8/19/2020 it was confirmed there were significant deviations from the laboratory's established specimen collection/handling policies from clinical specimen collection sites with no remedial actions taken to improve and monitor the error rate for the 16-month period between 2019 and 2020. =================================== -- 3 of 3 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: ==================================== Based on review of temperature logs from July to December 2018 for the oven used in Molecular testing and the Refrigerator used for storage of Clinical Laboratory reagents and interviews with the Molecular Testing Supervisor and the Clinical Laboratory Supervisor, the laboratory failed to maintain temperatures consistent with the procedural and manufacturer's requirements. The findings include: 1. Review of temperature logs for the oven used in Molecular Testing revealed 12 days between 7/27/18 and 8/16/18 out of range low and 10 days between 9/2/18 and 10/21/18 out of range high. 2. Review of temperature logs for the Clinical Laboratory Refrigerator revealed 26 days between 8/1/18 and 12 /06/18 out of range low. 3. Interviews with the Molecular Testing Supervisor and the Clinical Laboratory Supervisor at approximately 3:00 p.m. June 20th, 2019 confirmed the laboratory failed to maintain temperatures consistant with the procedural and manufacurer's requirements from July to December 2018. ===================================== Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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 an interview it was determined that the laboratory failed to establish written policies and procedures to assess the competency of one of one Laboratory Director/Technical Supervisors in 2016, 2017 and 2018 to the date of the survey. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for the competency assessment of one of one Laboratory Director /Technical Supervisors. 2. The Survey Team requested and the laboratory failed to provide documentation of competency assessment for one of one Laboratory Director /Technical Supervisors in 2016, 2017 and 2018 to the date of the survey. 3. During an interview on January 16, 2018 at 11:35 AM the Laboratory Director/Technical Supervisor confirmed that there were no written policies and procedures for competency assessments of the Laboratory Director/Technical Supervisor. D5309 TEST REQUEST CFR(s): 493.1241(e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. 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 review of final test reports and corresponding test requisitions and interview it was determined that the laboratory failed to ensure that the specimen source and patient gender was transcribed accurately into the Laboratory Information System (LIS) for five of thirty specimens sampled from January through October 2017 Findings include: 1. The Survey Team compared thirty final test reports with corresponding test requisitions. Cases reviewed included U17-00090, U17-00092 through U17-00100, U17-05141 through U17-05150 and U17-05081 through U17- 05090. a. Four of the thirty final test reports had an incorrect specimen source transcribed into the LIS. Reports include: U17-00094 U17-00095 U17-00096 U17- 05147 b. One of thirty final test reports had an incorrect patient gender transcribed into the LIS. Report includes: U17-05087 2. During an interview on January 18, 2018 at 10:00 AM, the Laboratory Director/Technical Supervisor confirmed these findings. 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: Based on review of laboratory policies and procedures, laboratory records and interview it was determined that the laboratory failed to establish written policies and procedures for an annual statistical evaluation of three of three required statistics for nongynecologic cytology specimens in 2016 and 2017. Findings include: 1. The Survey Team requested and the laboratory failed to provide a written policy and procedure for an annual statistical laboratory evaluation of three required statistics for the nongynecologic specimens: a. The number of cytology cases examined; b. The number of specimens processed by specimen type; c. The number of patient cases reported by diagnosis, to include unsatisfactory. 2. The Survey Team requested and the laboratory failed to provide an annual statistical evaluation from 2016 and 2017 for the three required statistics. 3. During an interview on January 16, 2018 at 11:35 AM the Laboratory Director/Technical Supervisor confirmed that there were no written policies and procedures for documenting and evaluating annual statistics. D5633 CYTOLOGY CFR(s): 493.1274(d)(1) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(1) The technical supervisor establishes a maximum workload limit for each individual who performs primary screening. -- 2 of 6 -- 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 policies and procedures to ensure that a maximum workload limit was established by the Laboratory Director/Technical Supervisor. There was no workload limit established for one of one Laboratory Director/Technical Supervisors when performing primary evaluation of cytology specimen slide preparations in 2016, 2017 and 2018 to the date of the survey. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to ensure that a maximum workload limit was established by the Laboratory Director/Technical Supervisor for the Laboratory Director/Technical Supervisor. 2. The Survey Team requested and the laboratory failed to provide an established maximum workload limit for the Laboratory Director/Technical Supervisor for 2016, 2017 and 2018 to the date of the survey. 3. During an interview on January 16, 2018 at 11:35 AM the Laboratory Director/Technical Supervisor confirmed that there were no written policies and procedures for the establishment of maximum workload limits for the Laboratory Director/Technical Supervisor. 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 and interview it was determined that the laboratory failed to establish written policies and procedures to ensure that one of one Laboratory Director/Technical Supervisor's workload limits were reassessed at least every six months and adjusted when necessary in 2016, 2017 and 2018 to the date of the survey. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies or procedures to ensure that a workload limit reassessment for the Laboratory Director/Technical Supervisor would occur every 6 months. 2. The Survey Team requested and the laboratory failed to provide records that the Laboratory Director/Technical Supervisor reassessed a maximum workload limit for the Laboratory Director/Technical Supervisor every six months in 2016, 2017 and 2018 to the date of the survey. 3. During an interview on January 16, 2018 at 11:35 AM the Laboratory Director/Technical Supervisor confirmed there were no policies or procedures to reassess workload limits. 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; -- 3 of 6 -- This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and interview it was determined that the laboratory failed to establish written policies and procedures to ensure that the workload limit for the Laboratory Director/Technical Supervisor, when examining slides in less than an 8-hour workday, would be prorated using a period of eight hours to determine the number of slides that may be examined in each day for 2016, 2017 and 2018 to the date of the survey. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to ensure the workload limits would be prorated for the Laboratory Director/Technical Supervisor, when examining slides in less than an 8-hour workday or on activities other than primary examinations of cytology slides. 2. During an interview on January 16, 2018 at 11:35 AM the Laboratory Director/Technical Supervisor confirmed these findings. D5645 CYTOLOGY CFR(s): 493.1274(d)(3) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(3) The laboratory must maintain records of the total number of slides examined by each individual during each 24-hour period and the number of hours spent examining slides in the 24-hour period irrespective of the site or laboratory. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and interview, it was determined that the laboratory failed to establish written policies and procedures to ensure that the laboratory would maintain records for the one of one Laboratory Director/Technical Supervisors of the total number of slides examined and the number of hours devoted to examining slides in 2016, 2017 and 2018 to the date of the survey. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to ensure that the laboratory would maintain records of the total number of slides examined and the number of hours devoted to examining slides during each 24-hour period for the Laboratory Director/Technical Supervisor. 2. During an interview on January 16, 2018 at 11:35 AM the Laboratory Director /Technical Supervisor confirmed there were no records maintained of the time spent examining slides in each twenty-four hour period in 2016, 2017 and 2018 to the date of the survey. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: The Laboratory Director failed to fulfill the responsibility for the overall operation of the laboratory and failed to ensure compliance and oversight with applicable -- 4 of 6 -- regulations (refer to D6079). The cumulative effect of these practices resulted in the Laboratory Director's inability to provide overall management and direction of cytology in accordance with 493.1445 of this subpart. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. 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 Director failed to be responsible for the overall operation and administration of the laboratory including assuring compliance with applicable regulations by having cytology procedures and programs established and followed. Cross Refer to D5209, D5309, D5629, D5633, D5637, D5645 and D6115 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 the review of 255 negative non-gynecologic cases from 2017 and confirmation by the Laboratory Director/Technical Supervisor on January 17, 2018 it was determined that the Laboratory Director/Technical Supervisor failed to verify the accuracy of one non-gynecologic cytology test result. Case Includes: 1. U17-00091 January 10, 2017 Urine LABORATORY DIAGNOSIS: Negative for Malignancy SURVEY TEAM DIAGNOSIS: Urothelial Cell Carcinoma LABORATORY DIRECTOR/TECHNICAL SUPERVISOR DIAGNOSIS: Atypical Urothelial Cells Suspicious for High Grade Neoplasia 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. -- 5 of 6 -- 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 Technical Supervisor failed to establish an individual workload limit in 2016, 2017 and 2018 to the date of the survey for the Laboratory Director/Technical Supervisor. The Technical Supervisor also failed to reassess the workload limits at least every six months and make adjustments when necessary in 2016, 2017 and 2018 to the date of the survey for the Laboratory Director /Technical Supervisor. Cross Refer to D5633 and D5637 D6133 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(c)(6) In cytology, the technical supervisor or the individual qualified under 439.1449(k)(2), if responsible for screening cytology slide preparations, must document the number of cytology slides screened in 24 hours and the number of hours devoted during each 24- hour period to screening cytology slides. This STANDARD is not met as evidenced by: Based on interview and lack of laboratory records it was determined that one of one Technical Supervisors failed to document the number of slides screened and the number of hours devoted to screening slides during each 24-hour period for any date in 2016, 2017 or 2018 to the date of the survey. Cross refer to D5645 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. -- 6 of 6 --