Illinois Urologic Health Surgeons

Summary Statement of Deficiencies D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, laboratory records, lack of documentation, and interview with the laboratory director (LD); the laboratory failed to document dermatopathology immunohistochemical (IHC) stain positive and negative reactivity for four of four patient test reports reviewed from 2023 through the date of survey, 04/17/2025. Findings include: 1. Review of laboratory policies and procedure revealed the policy, "Complete Overview", which stated, under "SUBJECT: Quality Control Stains", "Immunohistochemical stains will all be interpreted with the use of positive control stains and a negative control tissue stain." 2. Review of patient testing logs for IHC staining found no documentation of negative reactivity, only positive reactivity was documented for four of four patient test reports reviewed with IHC stains p63, CK34betaE12, and racemase from 2023 through the date of survey, 04/17/2025. Report Date: Case #: IHC QC documentation: 11/10/2023 PLS23-05510 Positive only 12/14/2023 PLS23-06200 Positive only 01/31/2024 PLS24-00374 Positive only 04/30/2024 PLS24-02528 Positive only 3. Interview with the LD on 04/17/2025, at 2:45 pm, confirmed the laboratory failed to document dermatopathology IHC stain positive and negative reactivity for four of four patient test reports reviewed from 2023 through the date of survey, 04/17/2025. 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 interview with the Laboratory Director/Technical Supervisor, the laboratory failed to establish written policies and procedures to assess the competency of the Technical Supervisor and the Laboratory Supervisor. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to describe the laboratory process for assessing the competency of the Technical Supervisor and the Laboratory Supervisor. 2. During an interview on July 19, 2023 at 9:30 AM, these findings were confirmed with the Laboratory Director/Technical Supervisor. 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 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 -- 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, statistical records and interview with the Laboratory Director/Technical Supervisor, the laboratory failed to establish written policies and procedures for the evaluation and comparison of three of three non-gynecologic cytology statistics. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for an annual evaluation and comparison of three of three non-gynecologic cytology statistics documented by the laboratory. Statistics include: -Number of non- gynecologic cytology cases examined -Number of non-gynecologic specimens processed by specimen type -Number of non-gynecologic cases reported by diagnosis, including the number reported as unsatisfactory 2. During an interview on July 19, 2023 at 9:00 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. -- 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 review of laboratory policies and procedures, laboratory records and interviews it was determined the laboratory failed to reassess and document a workload limit for the Laboratory Director/Technical Supervisor (refer to D5637 and D5647); failed to establish policies and procedures to ensure that the laboratory would maintain records of the total hours spent examining slides (refer to D5645); and failed to establish policies and procedures to ensure test reports contained narrative descriptive nomenclature (refer to D5657). The cumulative effect of these systemic problems resulted in the laboratory's inability to ensure the accuracy and reliability of patient test results in the subspecialty of Cytology. 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 it was determined that the laboratory failed to follow a written policy and procedure to reassess a maximum workload limit at least every six months for one 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 5 -- one Laboratory Director/Technical Supervisors in 2019 and to the date of the survey 2020. Findings include: 1. The laboratory failed to follow the written policy and procedure WORKLOAD LIMITS which stated: "The workload limit will be reassessed at least every six months and any changes implemented." 2. The Survey Team requested and the laboratory failed to provide documentation of a workload reassessment for the Laboratory Director/Technical Supervisor in 2019 and 2020. 3. During interviews on November 16, 2020 at 10:15 AM and November 18, 2020 at 10: 20 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, laboratory records and interviews it was determined that the laboratory failed to establish written policies and procedures to ensure that the laboratory would maintain records of the total number of hours one of one Laboratory Director/Technical Supervisors spent examining slides irrespective of site, during each 24-hour period in 2019 and 2020 to the date of the survey. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to detail how records would be maintained of the total number of hours the Laboratory Director/Technical Supervisor spent examining slides during each 24-hour period, irrespective of site. 2. The Survey Team requested and the Laboratory Director/Technical Supervisor failed to provide records to document the total number of hours spent examining slides at FACILITY A (CLIA #12D0431110) from January through December 2019. a. Laboratory records titled DAILY DIAGNOSIS LOG 2019 failed to include the time spent examining slides on 71 of 71 days from January through December 2019. Dates include: -January 8, 10, 13, 15, 21, 27, 31 -February 4, 10, 17, 19, 24, 25 -March 3, 10, 11, 13, 17, 22, 31 - April 7, 8, 14, 21, 25, 28 -May 12, 13, 16, 22, 26, 27 -June 2, 10, 13, 16, 18, 23, 24, 30 -July 7, 15, 22, 29, 31 -August 6, 10, 15, 20, 25, 26, 31 -September 9, 15, 23, 28, 29, 30 -October 6, 13, 19, 22, 31 -November 3, 9, 17, 24, 30 -December 9, 15, 26 b. Laboratory records titled DAILY DIAGNOSIS LOG 2020 failed to include the time spent examining slides on 63 of 63 days from January through October 2020. Dates include: -January 1, 5, 6, 13, 15, 20, 27, 30 -February 3, 9, 15, 23, 29 -March 8, 15, 21, 22, 29 -April 6, 8, 11, 15, 19, 20, 26 -May 10, 15, 16, 25, 31 -June 7, 14, 15, 19, 28, 31 -July 5, 12, 15, 20, 26, 31 -August 9, 11, 16, 19, 23, 30, 31 -September 6, 7, 13, 17, 20, 23, 25 -October 4, 5, 11, 12, 18, 25, 28 c. During an interview on November 16, 2020 at 10:15 AM the Laboratory Director/Technical Supervisor stated "I used to record the hours but I stopped." 3. The Survey Team requested and the Laboratory Director/Technical Supervisor failed to provide records to document the total number of hours spent examining slides at Facility B (CLIA #14D2030411) from January through September 2020. a. Laboratory records titled CYTOTECHNOLOGISTS MONTHLY WORKLOAD LOG and DAILY DIAGNOSIS LOG failed to include the time spent examining slides on 113 of 113 days from January through September 2020. Dates include: -January 2, 3, 6, 8, 9, 13, 14, 15, 16, 17, 20, 21, 22, 23, 24, 27, 29, 30, 31 -February 4, 5, 6, 10, 11, 12, 14, 17, 18, 20, 21, 24, 26, 27 -March 3, 4, 6, 9, -- 2 of 5 -- 10, 11, 12, 13, 17, 20, 26 -April 0 -May 1, 7, 11, 12, 13, 14, 19, 26, 27, 28 -June 1, 2, 3, 8, 11, 12, 16, 17, 18, 19, 24, 25, 26, 30 -July 1, 6, 7, 8, 9, 10, 13, 15, 17, 20, 21, 22, 24, 27, 28, 29, 30 -August 4, 5, 6, 7, 12, 14, 18, 19, 20, 21, 24, 25, 28 -September 1, 2, 4, 8, 9, 14, 15, 16, 17, 18, 21, 23, 28, 29, 30 4. The Survey Team requested and the Laboratory Director/Technical Supervisor failed to provide records to document the total number of hours spent examining slides at Facility C (CLIA #14D0705475) on January through October 2020. a. Laboratory records titled DAILY DIAGNOSIS LOG 2020 failed to include the time spent evaluating slides on 33 of 33 days from January through October 2020. Dates include: -January 15, 16, 21, 26 -February 13 - March 5, 18, 19, 22, 24 -April 0 -May 0 -June 1, 10, 18, 19, 30 -July 12, 20, 26 - August 4, 10, 11, 17, 31 -September 9, 10, 13, 16, 22, 25 -October 15, 16, 20, 25 5. During an interview on November 16, 2020 at 1:15 PM the Laboratory Director /Technical Supervisor stated that the Laboratory Director/Technical Supervisor "evaluates slides at two other locations." When asked by the Survey Team if slides were examined at Facility B or Facility C on the same day slides were examined at FACILITY A the Laboratory Director/Technical Supervisor replied "sometimes, but not often." 6. During interviews on November 16, 2020 at 1:15 PM and November 18, 2020 at 10:20 AM the Laboratory Director/Technical Supervisor confirmed these findings. D5647 CYTOLOGY CFR(s): 493.1274(d)(4) (d) Workload limits.The laboratory must establish and follow written policies and procedures that ensure the following: (d)(4) Records are available to document the workload limit for each individual. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of laboratory records and interviews it was determined that the laboratory failed to establish written policies and procedures to ensure records to document the workload limit for one of one Laboratory Director/Technical Supervisors in 2019 and to the date of the survey in 2020 were available. Cross refer to D5637 Findings include: 1. The Survey Team requested and the laboratory failed to provide records of an established workload limit for the one of one Laboratory Director/Technical Supervisor in 2019 and to the date of the survey in 2020. 2. During interviews on November 16, 2020 at 10:15 AM and November 18, 2020 at 10:20 AM the Laboratory Director/Technical Supervisor confirmed these findings. D5657 CYTOLOGY CFR(s): 493.1274(e)(5) (e) The laboratory must establish and follow written policies and procedures that ensure the following: (e)(5) The report contains narrative descriptive nomenclature for all 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 nongynecologic urine cytology test reports contained narrative descriptive nomenclature. Findings include: 1. The Survey Team requested and the laboratory -- 3 of 5 -- failed to provide written policies and procedures to describe the laboratory's nomenclature system for reporting nongynecologic urine cytology test results. 2. During interviews on November 16, 2020 at 3:45 PM and November 18, 2020 at 10: 20 AM the Laboratory Director/Technical Supervisor confirmed these findings. D5659 CYTOLOGY CFR(s): 493.1274(e)(6) (e) The laboratory must establish and follow written policies and procedures that ensure the following: (e)(6) Corrected reports issued by the laboratory indicate the basis for correction. 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 that corrected reports indicated the basis for the correction on the report. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to ensure corrected reports indicated the basis for the correction on the report. 2. During interviews on November 16, 2020 at 3:45 PM and November 18, 2020 at 10:20 AM the Laboratory Director/Technical Supervisor confirmed these findings. 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 laboratory records and interviews it was determined that the Technical Supervisor failed to reassess workload limits at least every six months for one of one Laboratory Director/Technical Supervisors in 2019 and to the date of the survey in 2020. Cross refer to 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 review of laboratory records and interviews it was determined that one of one Technical Supervisors failed to document the number of hours devoted to screening slides during each 24-hour period in 2019 and to the date of survey in 2020. Cross refer to D5645 -- 4 of 5 -- 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. -- 5 of 5 --