Center For Urologic Care Of Berks Cnty

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted by the Pennsylvania State Agency for Center for Urologic Care of Berks County on 12/16/2025. The laboratory was found out of compliance with the following conditions: 493.1250 Condition: Analytic Systems D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) (b) The laboratory must verify the accuracy of the following: (b)(1) Any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing (PT) records and interview with the Chief Executive officer (CEO), the laboratory failed to verify the accuracy of the PT results obtained for 3 of 3 API Microbiology testing events in 2024. Findings Include: 1. On the day of survey, 12/16/2025 at 10:39 am., review of the laboratory's API PT records revealed that the laboratory did not verify the accuracy for the following analytes that were not scored by the PT agency due to non-consensus for 3 of 3 API PT events performed in 2024: - API 2024 (1st event): Not Graded Bio-Rad CFX/ Resistance Gene: CTX-M; UTI-02, UTI-03 Bio-Rad CFX/ Resistance Gene:dfrA; UTI-02, UTI-03 Bio-Rad CFX/ Resistance Gene:KPC; UTI- 02, UTI-03 Bio-Rad CFX/ Resistance Gene:mecA; UTI-01, UTI-02; UTI-03; UTI-04; UTI-05 Bio-Rad CFX/ Resistance Gene:NDM; UTI-02, UTI-03 Bio-Rad CFX/ Resistance Gene:qnr; UTI-02, UTI-03 Bio-Rad CFX/ Resistance Gene:sul; UTI-02, UTI-03 Bio-Rad CFX/ Resistance Gene:vanA; UTI-01, UTI-02; UTI-03; UTI-04; UTI-05 Bio-Rad CFX/ Resistance Gene:vanB; UTI-01, UTI-02; UTI-03; UTI-04; UTI-05 - API 2024 (2nd event): Not Graded Bio-Rad CFX/ Resistance Gene: NDM; UTI-06, UTI-07; UTI-09; UTI-10 Bio-Rad CFX/ Resistance Gene: qnr; UTI-06, UTI- 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 -- 08; UTI-09; UTI-10 Bio-Rad CFX/ Resistance Gene: sul; UTI-06, UTI-07; UTI-09; UTI-10 Bio-Rad CFX/ Resistance Gene: vanA; UTI-06, UTI-07; uti-08; UTI-09; UTI- 10 Bio-Rad CFX/ Resistance Gene: vanB; UTI-06, UTI-07; UTI-08; UTI-09; UTI-10 - API 2024 (3rd event):Not Graded Bio-Rad CFX/ Resistance Gene: CTX-M; UTI-11, UTI-13; UTI-14; UTI-15 Bio-Rad CFX/ Resistance Gene:dfrA; UTI-11, UTI-13; UTI- 14; UTI-15 Bio-Rad CFX/ Resistance Gene:KPC; UTI-11, UTI-13; UTI-14; UTI-15 Bio-Rad CFX/ Resistance Gene:mecA; UTI-11, UTI-12; UTI-13; UTI-14; UTI-15 Bio-Rad CFX/ Resistance Gene:NDM; UTI-11, UTI-13; UTI-14; UTI-15 Bio-Rad CFX/ Resistance Gene:qnr; UTI-11, UTI-13; UTI-14; UTI-15 Bio-Rad CFX/ Resistance Gene:sul; UTI-11, UTI-13; UTI-14; UTI-15 Bio-Rad CFX/ Resistance Gene:vanA; UTI-12; UTI-13; UTI-14; Bio-Rad CFX/ Resistance Gene:vanB; UTI-11, UTI-12; UTI-13; UTI-14 2. The API Proficiency Testing performance Evaluation form stated, " Laboratories are responsible for documenting and performing

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing (PT) records and interview with the Chief Executive Officer (CEO), the laboratory director (LD)/designee and testing personnel (TP) failed to attest to the routine integration of samples into the patient workload for 3 of 3 Microbiology PT events performed in 2023. Findings include: 1. On the day of survey, 03/19/2024 at 11:02 am., review of the laboratory's API PT records revealed the following attestation statements were not signed by the LD/designee or TP: 2023 Microbiology 1st, 2nd, and 3rd events - Bacteriology UTI panel: Bio-Rad CFX Molecular Bacti-Urine/Molecular Resistance Genes-Urine 2. The CEO confirmed the findings above on 03/19/2024 at 1:00 pm. *Repeat Deficiency 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 lack of documentation and interview with the Chief Executive Officer 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 -- (CEO), the laboratory failed to establish and follow a procedure to assess the competency of 1 of 1 clinical consultant (CC) for their consultant responsibilities in 2022 and 2023. Findings include: 1. On the day of survey, 3/19/2024 at 9:16 am, the laboratory failed to provide a policy that stated how to assess the competency for 1 of 1 CC (CMS 209 personnel #2) for their consultant responsibilities in 2022 and 2023. 2. The laboratory could not provide documentation of CC competency assessment for 2022 and 2023. 3. The CEO confirmed the findings above on 3/19/2024 at 1:00pm. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing (PT) records and interview with the Chief Executive Officer (CEO), the laboratory failed to verify the accuracy of the PT results obtained for 3 of 3 API Microbiology testing events in 2023. Findings Include: 1. On the day of survey, 03/19/2024 at 11:02 am., review of the laboratory's API Microbiology PT records revealed that the laboratory did not verify the accuracy for the following analytes (Molecular resistance genes) that were not graded by the PT agency in 2023: 1st event: UTI Panel Molecular Resistance Genes-Urine (UTI-01 through UTI-05) - Class A Beta-lactamase (CTX-M Group 1), (KPC) - Trimethoprim (dFrA) - Oxacillin (mecA) - Fluoroquinolone (qnr) - Sulfonamide (sul) - Vancomycin A & B (vanA, vanB) 2nd event: - CTX-M Group 1, KPC, dFrA, qnr and sul (UTI-07, UTI-09) - mecA (UTI-06 through UTI-10) - vanA and vanB (UTI-06, UTI-08 through UTI-10) 3rd event: - CTX-M Group 1 and KPC (UTI-12 through UTI-14) - dFrA and sul (UTI-12 through UTI-15) - mecA (UTI-11 through UTI-15) - qnr (UTI-12, UTI-13) - vanA and vanB (UTI-11, UTI-12, UTI-14) 2. The API Proficiency Testing performance Evaluation form states "Laboratories are responsible for documenting and performing

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, competency assessment records and interview with the Laboratory Director/Technical Supervisor #1, 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 for two of two Technical Supervisors in 2021, 2022 and January 2023 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 Technical Supervisors. 2. The Survey Team requested and the laboratory failed to provide documentation of competency assessments for two of two Technical Supervisors in 2021, 2022 and January 2023 to the date of the survey in 2023. Technical Supervisors include: -Laboratory Director/Technical Supervisor #1 -Technical Supervisor #2 3. During an interview on December 6, 2023 at 11:15 AM these findings were confirmed by the Laboratory Director/Technical Supervisor #1. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- 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 #1, the laboratory failed to follow it's procedure to assess the accuracy of entering patient information into the laboratory information system from January 2022 to December 2022 and January 2023 to the date of the survey in 2023. Findings include: 1. The laboratory procedure ACCESSIONING ACCURACY REVIEW stated: - Each quarter 10 requisitions received the previous quarter are randomly pulled from the file. - The corresponding reports are printed. - The information on the report and requisition are compared for accuracy and typographical errors. - The discrepancies are reported and discussed at the monthly quality assurance meeting. -

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on American Proficiency Institute (API) proficiency testing (PT) records and interview with the Chief Executive Officer (CEO), the Laboratory Director (LD) failed to sign the API Microbiology attestation statement documents in 2022. Findings include: 1. On the day of survey, 07/07/2022 at 09:44 am, review of API records revealed, the attestation statement documents for bacteriology Events 1 and 2 in 2022 were not signed by the LD. 2. The CEO confirmed the finding above on 07/07/2022 at 12:45 pm. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory policies and interview with the Chief Executive Officer (CEO), the laboratory failed to establish a competency assessment policy to assess the competency for 3 of 3 Technical Supervisors (TS) for their supervisory responsibilities in microbiology from 09/17/2021 to 07/07/2022 Findings include: 1. 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 -- On the day of survey, 07/07/2022 at 08:47 am, the CEO could not provide a competency assessment policy for 3 of 3 TS for their supervisory responsibilities in bacteriology (On the CMS 2019 Personnel #5, #6 and #7) from 09/17/2021 to 07/07 /2022. 2. The CEO could not provide documentation of TS competency for 3 of 3 TS from 09/17/2021 to 07/07/2022. 3. The CEO confirmed the findings above on 07/07 /2022 around 12:45 pm. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the Biorad CFX 96 RT-PCR analyzer validation records and interview with Chief Executive Officer (CEO),the laboratory failed to establish criteria for acceptable performance specifications for the 23 of 23 bacteriology analytes performed on 2 of 2 Biorad CFX 96 RT-PCR analyzers from 08/15/2021 to 07/07/2022. Findings Include: 1. On the day of survey, 07/07/2022 at 09:06 am, review of the 2 of 2 Biorad CFX 96 RT-PCR analyzers validation records revealed, the validation performed on 08/15/2022 did not include the acceptable criteria for performance specifications for precision and accuracy. 2. Review of CMS116 form showed annual testing for bacteriology was 418. 3. The CEO confirmed the finding above on 07/07/2021 around 12:45 pm. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the Chief Executive Officer (CEO), the laboratory failed to evaluate the relationship between 2 of 2 Biorad CFX96 RT-PCR analyzers in February, 2022. Findings: 1. On the day of Survey 07/07/2022 at 11:15 am, The CEO could not provide comparison of test results between 2 of 2 Biorad CFX96 RT-PCR analyzers for bacteriology in February, 2022 2. Review of CMS116 form showed annual testing for bacteriology was 418. 3. The CEO confirmed the above finding on 07/07/2022 at 12:45 pm. -- 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 that the laboratory failed to ensure written policies and procedures were approved, signed and dated by the Laboratory Director (refer to D5407); failed to establish policies and procedures for the annual evaluation and comparison of three of three laboratory statistics (refer to D5629); failed to establish and reassess a workload limit for six of six Technical Supervisors (refer to D5633, D5637); failed to follow written policies and procedures to ensure that the laboratory would maintain records of the total number of hours spent examining slides (refer to D5645); and failed to establish written policies and procedures to ensure that unsatisfactory cytology slide preparations were identified and reported as unsatisfactory (refer to D5655). The cumulative effect of these systemic problems resulted in the laboratory's inability to ensure the accuracy and reliability of patient test results in the subspecialty of Cytology. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. 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 21 laboratory policies and procedures and interview it was determined that the laboratory failed to ensure that 21 of 21 written procedures were approved, signed and dated by the Laboratory Director prior to the start of the survey on October 28, 2019. Findings include: 1. The Laboratory Director failed to sign and date 21 laboratory procedures prior to the date of the survey. Procedures include: - ACCESSIONING ACCURACY REVIEW - COMMUNICATIONS - PERSONNEL COMPETENCY - COMPLAINT INVESTIGATIONS - EQUIPMENT, REAGENTS, SUPPLIES - GENERAL QUALITY ASSURANCE PLAN - HOW TO SCREEN A SLIDE - LABELING OF CYTOLOGY SLIDES - EQUIPMENT MAINTENANCE - PAPANICOLAOU STAINING - PATHOLOGISTS STATISTICS - PATIENT CONFIDENTIALITY POLICIES - TESTS RESULTS - PROCEDURE MANUALS - REPORTING OF TEST RESULTS - SAFETY QC - SPECIMEN IDENTIFICATION AND INTEGRITY - DAILY CONTROL SLIDES - SPECIMEN SUBMISSION AND HANDLING - CYTOLOGY PROCESSING (THINPREP) - WORKLOAD LIMIT FOR CYTOLOGY SCREENING 2. During an interview on October 30, 2019 at 9:30 AM the Chief Operating Officer 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 a written policy and procedure and maintain statistics for an annual evaluation of three required statistics for nongynecologic cases during the years 2017 and 2018. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for an annual evaluation of the following three required annual statistics: 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 (including the number reported as unsatisfactory for diagnostic interpretation). 2. The Survey Team requested and the laboratory failed to provide documentation of the three annual nongynecologic statistics during the years 2017 and 2018. 3. During an interview on October 29, 2019 at 11:15 AM the Chief Operating Officer confirmed these findings. D5633 CYTOLOGY CFR(s): 493.1274(d)(1) (d) Workload limits. The laboratory must establish and follow written policies and -- 2 of 6 -- procedures that ensure the following: (d)(1) The technical supervisor establishes a maximum workload limit for each individual who performs primary screening. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of laboratory records and interview it was determined that the laboratory failed to establish written policies and procedures to ensure that a maximum individual workload limit was established for six of six Technical Supervisors when performing primary evaluation of cytology specimen slide preparations in 2017, 2018 and to the date of the survey in 2019. Findings include: 1. The Survey Team requested and the laboratory failed to provide, written policies and procedures to ensure that a maximum individual workload limit was established by the Technical Supervisor for the six of six Technical Supervisors. 2. The Survey Team requested and the laboratory failed to provide documentation of an established individual workload limit for six of six Technical Supervisors for 2017, 2018 and to the date of the survey in 2019. Technical Supervisors include: -Technical Supervisor #1 -Technical Supervisor #2 -Technical Supervisor #3 -Technical Supervisor #4 -Technical Supervisor #5 -Technical Supervisor #6 3. During an interview on October 29, 2019 at 3:10 PM the Chief Operating Officer confirmed these findings. 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, lack of laboratory records and interview it was determined that the laboratory failed to establish written policies and procedures to ensure that the workload limits for six of six Technical Supervisors were reassessed at least every six months during the years 2017 and 2018, and to the date of the survey in 2019. Findings include: 1. The Survey Team requested and the laboratory failed to provide a written policy and procedure for the reassessment of workload limits at least every six months for six of six Technical Supervisors. 2. The Survey Team requested and the laboratory failed to provide documentation of a reassessed workload limit for six of six Technical Supervisors during the years 2017 and 2018 and to the date of the survey in 2019. Technical Supervisors include: - Technical Supervisor #1 -Technical Supervisor #2 -Technical Supervisor #3 - Technical Supervisor #4 -Technical Supervisor #5 -Technical Supervisor #6 3. During an interview on October 30, 2019 at 9:30 AM the Chief Operating Officer 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. -- 3 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 follow policies and procedures. The laboratory did not maintain records of the total number of hours spent examining slides in each 24-hour period for six of six Technical Supervisors in August, September and to the date of the survey in October 2019. Findings include: 1. The laboratory failed to follow the procedure WORKLOAD LIMIT FOR NON- GYNECOLOGICAL CYTOLOGY SCREENING which stated "A workload log will be kept for each work period detailing the number of hours spent examining cytology slides and the total number of slides examined." 2. The Survey Team reviewed the CYTOLOGY WORKLOAD LOG for August, September and to the date of the survey in October, 2019. The CYTOLOGY WORKLOAD LOG included slides examined by the six Technical Supervisors. Thirty eight of 38 days had no record of the time spent examining slides. Technical Supervisors with no record of time spent examining slides include: -Technical Supervisor #1 -August 6, 2019 -September 6, 2019 -September 13, 2019 -October 1, 2019 -Technical Supervisor #2 -August 7, 2019 -August 14, 2019 -August 21, 2019 -August 28, 2019 -September 25, 2019 - October 2, 2019 -October 9, 2019 -October 16, 2019 -October 24, 2019 -Technical Supervisor #3 -August 2, 2019 -August 22, 2019 -September 10, 2019 -September 19, 2019 -September 24, 2019 -October 3, 2019 -October 10, 2019 -October 17, 2019 - Technical Supervisor #4 -August 9, 2019 -September 17, 2019 -September 26, 2019 - October 4, 2019 -October 11, 2019 -Technical Supervisor #5 -August 29, 2019 - September 4, 2019 -September 11, 2019 -September 18, 2019 -October 15, 2019 - October 23, 2019 -Technical Supervisor #6 -August 30, 2019 -September 5, 2019 - September 12, 2019 -October 8, 2019 -October 22, 2019 -October 25, 2019 3. During an interview on October 29, 2019 at 9:40 AM the Chief Operating Officer confirmed these findings. D5655 CYTOLOGY CFR(s): 493.1274(e)(4) (e) Slide examination and reporting. The laboratory must establish and follow written policies and procedures that ensure the following: (e)(4) Unsatisfactory specimens or slide preparations are identified and reported as unsatisfactory. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and interview it was determined that the laboratory failed to establish written policies and procedures to ensure that unsatisfactory nongynecologic slide preparations were identified and reported as unsatisfactory. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to ensure that unsatisfactory nongynecologic cytology slide preparations were identified and reported as unsatisfactory. 2. During an interview on October 29, 2019 at 3:10 PM the Chief Operating Officer confirmed that the laboratory did not have a policy and procedure specifying the criteria for an unsatisfactory nongynecologic slide. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. -- 4 of 6 -- 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 review of laboratory policies and procedures, laboratory records and interviews it was determined that the laboratory failed to have a Laboratory Director who provides overall management and direction in accordance with 493.1445 of this subpart. The Laboratory Director failed to fulfill the responsibility for the overall operation of the laboratory and failed to ensure compliance and oversight with applicable regulations (refer to D6079). The cumulative effect of these systemic problems 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, to include assuring compliance with the applicable regulations and ensuring that all the duties of the Laboratory Director were performed. Cross refer to D5407, D5629, D5633, D5637, D5645 and D5655 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 procedures, lack of laboratory records and interview it was determined that the Technical Supervisor failed to establish and reassess individual workloads limits for six of six Technical Supervisors.during the years 2017 and 2018 and to the date of the survey in 2019. Cross refer to D5633 and D5637 D6133 TECHNICAL SUPERVISOR RESPONSIBILITIES -- 5 of 6 -- 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 procedures, laboratory records and interview it was determined that six of six Technical Supervisors failed to document the number of hours spent examining slides during each 24-hour period in August, September and to the date of the survey in October 2019. 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 --