Ut Medical Group, Inc

Summary Statement of Deficiencies D0000 A complaint survey was completed on April 9, 2024. The laboratory was found NOT to be in compliance with the following 42 CFR PART 493, Requirements for Laboratories. The complaint was substantiated. The laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: CFR 493.801 Condition: Enrollment and testing of samples CFR 493.1441 Condition: Laboratories performing high complexity testing; laboratory director D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on observation of the laboratory, review of the laboratory's College of American Pathologists (CAP) proficiency testing (PT) records, and staff interview, the laboratory failed to ensure that proficiency testing (PT) samples were not referred to another laboratory for analysis. (Refer to D2013). D2013 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(4) The laboratory must not send proficiency testing samples or portions of proficiency 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 -- testing samples to another laboratory for any analysis for which it is certified to perform in its own laboratory. Any laboratory that CMS determines intentionally referred a proficiency testing sample to another laboratory for analysis may have its certification revoked for at least one year. If CMS determines that a proficiency testing sample was referred to another laboratory for analysis, but the requested testing was limited to reflex, distributive, or confirmatory testing that, if the sample were a patient specimen, would have been in full conformance with written, legally accurate and adequate standard operating procedures for the laboratory's testing of patient specimens, and if the proficiency testing referral is not a repeat proficiency testing referral, CMS will consider the referral to be improper and subject to alternative sanctions in accordance with 493.1804(c), but not intentional. Any laboratory that receives a proficiency testing sample from another laboratory for testing must notify CMS of the receipt of that sample regardless of whether the referral was made for reflex or confirmatory testing, or any other reason. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of proficiency testing records, and staff interviews, the laboratory failed to ensure Sudden Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) proficiency testing samples were not sent to another laboratory for analysis for four of four testing events. The findings include: 1. Observation of the laboratory on 4/09/24 at 10:00 am revealed no testing for SARS- CoV-2 was being performed. 2. A review of the laboratory's College of American Pathologists (CAP) PT records revealed the laboratory was enrolled in SARS-CoV-2 testing. The PT results printouts displayed the name, address and CLIA number for another laboratory (44D2090400). Attestation statements were signed by testing personnel working at CLIA number 44D2090400 for the following events: 2022 event two: COV2-04, COV2-05, COV2-06 2023 event one: COV2-01, COV2-02, COV2-03 2023 event two: COV2-04, COV2-05, COV2-06 2024 event one: COV2-01, COV2- 02, COV2-03 3. Interview with the quality manager and lead histotech on 04/09/24 at 4:30 pm confirmed the following: The SARS-CoV-2 samples enrolled under CLIA 44D2091956 were performed by the laboratory with CLIA number 44D2090400. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of laboratory policy, lack of records, and staff interviews, the laboratory failed to follow the safety procedure for monitoring Xylene exposure for personnel in 2023 and 2024. The findings include: 1. Observation of the laboratory on 04/09/2024 at 10:15 am revealed a container labeled "Xylene" on the counter in the frozen section room. During the observation, testing persons nine and ten stated exposure to Xylene was not monitored. 2. A review of the laboratory policy titled " Formaldehyde and Xylene Monitoring" revealed "Vapors are monitored by badges worn by employees" and that badges are evaluated by an outside agency. 3. Documentation for Xylene badge monitoring was not available on the date -- 2 of 5 -- of the survey (04/09/2024). 4. Interview on 04/09/2024 at 3:45 pm with the pathology manager confirmed the laboratory failed to follow the procedure for monitoring employee exposure to Xylene in 2023 and 2024. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation of the laboratory, patient test record review, and staff interview the laboratory used Hematoxylin stain after the manufacturer expiration date in 2024. The findings include: 1. Observation of the laboratory on 04/09/2024 at 10:45 am revealed Hematoxylin stain (lot 158304) stored in the laboratory with an expiration date of 03/31/2024. During observation, testing person nine stated the expired Hematoxylin was being used to stain tissue in frozen section procedures. 2. A review of patient test records revealed the laboratory used the expired Hematoxylin for patient SH24-1058 reported on 04/01/2024. 3. Interview on 04/09/2024 at 3:45 pm with the pathology manager confirmed the laboratory used expired Hematoxylin stain in 2024 for patient testing. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of patient frozen section reports, lack of records, and staff interviews, the laboratory failed to document Hematoxylin and Eosin (H&E) stain quality for staining performed in the "Frozen Section" room for one of one dates reviewed in 2024. The findings include: 1. Laboratory observations were performed on 04/09/2024 at 10:45 am. Observation of the section of the laboratory referred to as the "Frozen Section" room revealed H&E stains used for staining tissues removed during surgical procedures. Also observed was a microscope used for evaluation of the tissue after staining. During observations, testing person nine stated that H&E stain quality was not documented for the slides that were processed in the "Frozen Section" room. 2. A review of patient frozen section reports revealed patient SH24-1058 reported on 04/01/2024. Documentation of H&E stain quality was not available on the date of the survey (04/09/2024). 3. Interview on 04/09 /2024 at 3:45 pm with the pathology manager confirmed the laboratory failed to document H&E stain quality for patient testing in the "Frozen Section" room of the laboratory. D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) -- 3 of 5 -- (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on observation of the laboratory, lack of records, and staff interviews, the laboratory failed to retain records of stain lot numbers, dates in use, and stain quality assessment documentation when shipments were received or lot numbers changed for reagents and stains used the "Frozen Section" room of the laboratory in 2023 and 2024. The findings include: 1. Observation of the laboratory on 04/09/2024 at 10:45 am revealed H&E stains and other chemicals used for processing patient tissue removed during surgical procedures. During the observation, testing person nine stated that the laboratory did not retain records of stain and reagent lot numbers or documentation of stain quality when lot numbers change. 2. Interview on 04/09/2024 at 3:45 pm with the pathology manager confirmed the laboratory failed to retain records of lot numbers, dates in use, and stain quality assessment or reagents used in the "Frozen Section" room of the laboratory in 2023 and 2024. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of final patient test reports and staff interviews, the laboratory failed to ensure the correct address of the facility that performed the professional component of patient testing was included on the final patient test report (13 of 13 reports reviewed) in 2023 and 2024. The findings include: 1. A review of final patient test reports revealed the following reports that did not include the correct address of the facility that performed the professional component of patient testing: SHBM23-3 reported on 01/17/2023 SH23-668 reported on 03/14/2023 SH23-991 reported on 04 /14/2023 SH23-2258 reported on 08/04/2023 SH23-2719 reported on 09/13/2023 CH23-457 reported on 12/12/2023 CH24-17 reported on 01/25/2024 CH24-73 reported on 03/12/2024 SH24-1026 reported on 04/02/2024 CH24-104 reported on 04 /02/2024 SH24-913 reported on 04/03/2024 CH24-106 reported on 04/04/2024 SH24- 1058 reported on 04/05/2024 2. Interview on 04/09/2024 at 3:45 pm with the pathology manager confirmed the laboratory failed to ensure the correct address of the facility where the professional component of patient testing was performed was included on the final patient test report in 2023 and 2024. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 -- 4 of 5 -- 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 review of the laboratory's CAP PT records and staff interview, the Laboratory Director failed to provide overall management and direction of the laboratory. (Refer to D6089) D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's CAP PT records, and staff interview, the Laboratory Director failed to ensure SARS-CoV-2 proficiency testing samples were not sent to another laboratory for analysis for four of four PT events. (Refer to D2013) -- 5 of 5 --

Summary Statement of Deficiencies D0000 A complaint survey was completed on April 9, 2024. The laboratory was found NOT to be in compliance with the following 42 CFR PART 493, Requirements for Laboratories. The complaint was substantiated. The laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: CFR 493.801 Condition: Enrollment and testing of samples CFR 493.1441 Condition: Laboratories performing high complexity testing; laboratory director D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on observation of the laboratory, review of the laboratory's College of American Pathologists (CAP) proficiency testing (PT) records, and staff interview, the laboratory failed to ensure that proficiency testing (PT) samples were not referred to another laboratory for analysis. (Refer to D2013). D2013 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(4) The laboratory must not send proficiency testing samples or portions of proficiency 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 -- testing samples to another laboratory for any analysis for which it is certified to perform in its own laboratory. Any laboratory that CMS determines intentionally referred a proficiency testing sample to another laboratory for analysis may have its certification revoked for at least one year. If CMS determines that a proficiency testing sample was referred to another laboratory for analysis, but the requested testing was limited to reflex, distributive, or confirmatory testing that, if the sample were a patient specimen, would have been in full conformance with written, legally accurate and adequate standard operating procedures for the laboratory's testing of patient specimens, and if the proficiency testing referral is not a repeat proficiency testing referral, CMS will consider the referral to be improper and subject to alternative sanctions in accordance with 493.1804(c), but not intentional. Any laboratory that receives a proficiency testing sample from another laboratory for testing must notify CMS of the receipt of that sample regardless of whether the referral was made for reflex or confirmatory testing, or any other reason. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of proficiency testing records, and staff interviews, the laboratory failed to ensure Sudden Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) proficiency testing samples were not sent to another laboratory for analysis for four of four testing events. The findings include: 1. Observation of the laboratory on 4/09/24 at 10:00 am revealed no testing for SARS- CoV-2 was being performed. 2. A review of the laboratory's College of American Pathologists (CAP) PT records revealed the laboratory was enrolled in SARS-CoV-2 testing. The PT results printouts displayed the name, address and CLIA number for another laboratory (44D2090400). Attestation statements were signed by testing personnel working at CLIA number 44D2090400 for the following events: 2022 event two: COV2-04, COV2-05, COV2-06 2023 event one: COV2-01, COV2-02, COV2-03 2023 event two: COV2-04, COV2-05, COV2-06 2024 event one: COV2-01, COV2- 02, COV2-03 3. Interview with the quality manager and lead histotech on 04/09/24 at 4:30 pm confirmed the following: The SARS-CoV-2 samples enrolled under CLIA 44D2091956 were performed by the laboratory with CLIA number 44D2090400. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of laboratory policy, lack of records, and staff interviews, the laboratory failed to follow the safety procedure for monitoring Xylene exposure for personnel in 2023 and 2024. The findings include: 1. Observation of the laboratory on 04/09/2024 at 10:15 am revealed a container labeled "Xylene" on the counter in the frozen section room. During the observation, testing persons nine and ten stated exposure to Xylene was not monitored. 2. A review of the laboratory policy titled " Formaldehyde and Xylene Monitoring" revealed "Vapors are monitored by badges worn by employees" and that badges are evaluated by an outside agency. 3. Documentation for Xylene badge monitoring was not available on the date -- 2 of 5 -- of the survey (04/09/2024). 4. Interview on 04/09/2024 at 3:45 pm with the pathology manager confirmed the laboratory failed to follow the procedure for monitoring employee exposure to Xylene in 2023 and 2024. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation of the laboratory, patient test record review, and staff interview the laboratory used Hematoxylin stain after the manufacturer expiration date in 2024. The findings include: 1. Observation of the laboratory on 04/09/2024 at 10:45 am revealed Hematoxylin stain (lot 158304) stored in the laboratory with an expiration date of 03/31/2024. During observation, testing person nine stated the expired Hematoxylin was being used to stain tissue in frozen section procedures. 2. A review of patient test records revealed the laboratory used the expired Hematoxylin for patient SH24-1058 reported on 04/01/2024. 3. Interview on 04/09/2024 at 3:45 pm with the pathology manager confirmed the laboratory used expired Hematoxylin stain in 2024 for patient testing. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of patient frozen section reports, lack of records, and staff interviews, the laboratory failed to document Hematoxylin and Eosin (H&E) stain quality for staining performed in the "Frozen Section" room for one of one dates reviewed in 2024. The findings include: 1. Laboratory observations were performed on 04/09/2024 at 10:45 am. Observation of the section of the laboratory referred to as the "Frozen Section" room revealed H&E stains used for staining tissues removed during surgical procedures. Also observed was a microscope used for evaluation of the tissue after staining. During observations, testing person nine stated that H&E stain quality was not documented for the slides that were processed in the "Frozen Section" room. 2. A review of patient frozen section reports revealed patient SH24-1058 reported on 04/01/2024. Documentation of H&E stain quality was not available on the date of the survey (04/09/2024). 3. Interview on 04/09 /2024 at 3:45 pm with the pathology manager confirmed the laboratory failed to document H&E stain quality for patient testing in the "Frozen Section" room of the laboratory. D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) -- 3 of 5 -- (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on observation of the laboratory, lack of records, and staff interviews, the laboratory failed to retain records of stain lot numbers, dates in use, and stain quality assessment documentation when shipments were received or lot numbers changed for reagents and stains used the "Frozen Section" room of the laboratory in 2023 and 2024. The findings include: 1. Observation of the laboratory on 04/09/2024 at 10:45 am revealed H&E stains and other chemicals used for processing patient tissue removed during surgical procedures. During the observation, testing person nine stated that the laboratory did not retain records of stain and reagent lot numbers or documentation of stain quality when lot numbers change. 2. Interview on 04/09/2024 at 3:45 pm with the pathology manager confirmed the laboratory failed to retain records of lot numbers, dates in use, and stain quality assessment or reagents used in the "Frozen Section" room of the laboratory in 2023 and 2024. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of final patient test reports and staff interviews, the laboratory failed to ensure the correct address of the facility that performed the professional component of patient testing was included on the final patient test report (13 of 13 reports reviewed) in 2023 and 2024. The findings include: 1. A review of final patient test reports revealed the following reports that did not include the correct address of the facility that performed the professional component of patient testing: SHBM23-3 reported on 01/17/2023 SH23-668 reported on 03/14/2023 SH23-991 reported on 04 /14/2023 SH23-2258 reported on 08/04/2023 SH23-2719 reported on 09/13/2023 CH23-457 reported on 12/12/2023 CH24-17 reported on 01/25/2024 CH24-73 reported on 03/12/2024 SH24-1026 reported on 04/02/2024 CH24-104 reported on 04 /02/2024 SH24-913 reported on 04/03/2024 CH24-106 reported on 04/04/2024 SH24- 1058 reported on 04/05/2024 2. Interview on 04/09/2024 at 3:45 pm with the pathology manager confirmed the laboratory failed to ensure the correct address of the facility where the professional component of patient testing was performed was included on the final patient test report in 2023 and 2024. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 -- 4 of 5 -- 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 review of the laboratory's CAP PT records and staff interview, the Laboratory Director failed to provide overall management and direction of the laboratory. (Refer to D6089) D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's CAP PT records, and staff interview, the Laboratory Director failed to ensure SARS-CoV-2 proficiency testing samples were not sent to another laboratory for analysis for four of four PT events. (Refer to D2013) -- 5 of 5 --

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, lack of laboratory records and interviews the laboratory failed to establish written policies and procedures for an annual statistical evaluation for three of three nongynecologic cytology statistics (refer to D5629); failed to establish written policies and procedures for the establishment, reassessment and documentation of individual workload limits (refer to D5633, D5637 and D5647); failed to establish written policies and procedures to ensure that the workload limit would be prorated when examining slides in less than eight hours (refer to D5641); failed to establish written policies and procedures to ensure the laboratory maintained records of the total number of slides examined and the total number of hours spent examining slides per 24-hour period (refer to D5645) and failed to establish written policies and procedures to ensure unsatisfactory nongynecologic slide preparations were identified and reported as unsatisfactory (refer to D5655). 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 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 -- 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, lack of nongynecologic cytology statistic records and an interview with the Pathology Manager it was determined that the laboratory failed to establish written policies and procedures for an annual statistical evaluation for three of three required nongynecologic cytology statistics. The laboratory failed to document three of three required nongynecologic statistics for 2021 and 2022. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for an annual statistical evaluation for three of three required nongynecologic cytology statistics. Statistics include: -The number of cytology cases examined -The number of specimens processed by specimen type -The number of patient cases reported by diagnosis, including the number reported as unsatisfactory 2. The Survey Team requested and the laboratory failed to provide the three of three required nongynecologic cytology statistics for 2021 and 2022. Statistics include: -The number of cases examined -The number of specimens processed by specimen type -The number of patient cases reported by diagnosis, including the number reported as unsatisfactory 3. During an interview on March 21, 2023 at 12:15 PM, the Pathology Manager confirmed these findings. 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. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of workload limit records and interviews the laboratory failed to establish written policies and procedures to ensure Technical Supervisor A established maximum workload limits for seven of seven Technical Supervisors who performed primary screening of nongynecologic cytology specimens. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to ensure Technical Supervisor A established maximum workload limits for seven of seven Technical Supervisors who performed primary screening of nongynecologic cytology specimens. 2. During interviews on March 20, 2023 at 4:00 PM with Technical Supervisor B and on March 21, 2023 at 12:15 PM with the Pathology Manager these findings were confirmed. D5637 CYTOLOGY CFR(s): 493.1274(d)(1)(ii) -- 2 of 7 -- (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 individual workload limit records and interviews the laboratory failed to establish written policies and procedures to reassess and adjust, when necessary, a maximum workload limit at least every six months for seven of seven Technical Supervisors. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to describe how Technical Supervisor A would reassess and adjust a maximum workload limit for seven of seven Technical Supervisors at least every six months and adjust when necessary. 2. During interviews on March 20, 2023 at 4:00 PM with Technical Supervisor B and on March 21, 2023 at 12:15 PM with the Pathology Manager these findings were confirmed. 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, lack of workload limit records and interviews the laboratory failed to establish written policies and procedures to ensure that the workload limit for seven of seven Technical Supervisors would be prorated when examining slides in less than eight hours. The laboratory failed to prorate workload limits for seven of seven Technical Supervisors 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 prorate the workload limits for seven of seven Technical Supervisors when examining slides in less than an eight-hour day. 2. The Survey Team requested and the laboratory failed to provide documentation of prorated workload limits for seven of seven Technical Supervisors when examining slides in less than eight hours. Technical Supervisors include: -Laboratory Director/Technical Supervisor A -Technical Supervisor B - Technical Supervisor C -Technical Supervisor D -Technical Supervisor E -Technical Supervisor F -Technical Supervisor G 3. During interviews on March 20, 2023 at 4:00 PM with Technical Supervisor B and on March 21, 2023 at 12:15 PM with the Pathology Manager these findings were confirmed. 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 -- 3 of 7 -- 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, lack of workload limit records and interviews the laboratory failed to establish written policies and procedures to ensure the laboratory maintained records of the total number of slides examined per 24-hour period and the number of hours spent examining slides per 24-hour period. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to ensure that the laboratory maintained records of the total number of slides examined per 24-hour period and the number of hours spent examining slides per 24-hour period. 2. During interviews on March 20, 2023 at 4:00 PM with Technical Supervisor B and on March 21, 2023 at 12:15 PM with the Pathology Manager these findings were confirmed. 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 workload limit records and interviews the laboratory failed to establish written policies and procedures to ensure records were available to document the workload limit for seven of seven Technical Supervisors 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 ensure records were available to document the workload limit for the Technical Supervisors. 2. The Survey Team requested and the laboratory failed to provide records of an established maximum workload limit for seven of seven Technical Supervisors in 2021, 2022 and to the date of the survey in 2023. Technical Supervisors include: - Laboratory Director/Technical Supervisor A - Technical Supervisor B -Technical Supervisor C -Technical Supervisor D -Technical Supervisor E -Technical Supervisor F -Technical Supervisor G 3. During interviews on March 20, 2023 at 4:00 PM with Technical Supervisor B and on March 21, 2023 at 12:15 PM with the Pathology Manager these findings were confirmed. 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 interviews it was determined that the laboratory failed to establish written policies and procedures to ensure unsatisfactory nonngynecologic cytology slide preparations were identified and reported as unsatisfactory. Findings include: 1. The Survey Team requested and the -- 4 of 7 -- laboratory failed to provide written policies and procedures to ensure that unsatisfactory nongynecologic cytology slide preparations were identified and reported as unsatisfactory for evaluation. 2. During interviews on March 20, 2023 at 4: 00 PM with Technical Supervisor B and on March 21, 2023 at 12:15 PM with the Pathology Manager these findings were confirmed. 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 review of laboratory policies and procedures, lack of laboratory records and interviews 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 ensure that quality control programs were established and maintained to assure the quality of cytology testing and identify failures in quality as they occur (refer to D6093); failed to ensure quality assessment programs were established to assure the quality of cytology services and identify failures in quality as they occur (refer to D6094) and failed to follow written policies and procedures to assess the competency of seven Technical Supervisors, and when necessary identify methods to improve the skills of the Technical Supervisors (refer to D6103). D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control 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 review of laboratory policies and procedures, lack of cytology quality control records and interviews it was determined that the Laboratory Director failed to ensure that quality control programs were established and maintained to assure the quality of cytology testing and identify failures in quality as they occur in 2021, 2022 and to the date of the survey in 2023. Findings include: 1. The Laboratory Director failed to ensure written policies and procedures for quality control programs were established and maintained for cytology. 2. The Laboratory Director failed to ensure records were maintained for a quality control program in cytology for 2021, 2022 and to the date of the survey in 2023. 3. During interviews on March 20, 2023 at 4:00 PM with Technical Supervisor B and on March 21, 2023 at 12:15 PM with the Pathology Manager these findings were confirmed. 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. -- 5 of 7 -- This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of quality assessment activity records and interview with the Pathology Manager it was determined that the Laboratory Director failed to ensure quality assessment programs were established to assure the quality of cytology services and identify failures in quality as they occur in 2021, 2022 and to the date of the survey in 2023. Findings include: 1. The Laboratory Director failed to ensure written policies and procedures were established for a quality assessment program for all phases of cytology testing. 2. The Laboratory Director failed to ensure records were maintained for a quality assessment program in cytology for 2021, 2022 and to the date of the survey in 2023. 3. During an interview on March 21, 2023 at 12:15 PM, the Pathology Manager confirmed these findings. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. 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 Pathology Manager, the Laboratory Director failed to follow written policies and procedures to assess the competency of the Technical Supervisors. The Laboratory Director failed to assess the competency of seven of seven Technical Supervisors in 2021, 2022 and to the date of the survey in 2023. Findings include: 1. The Laboratory Director failed to ensure the procedure COMPETENCY ASSESSMENT was followed. The policy stated: "To define the elements of competency test for laboratory testing personnel and to describe the incorporation of these elements into the annual performance evaluation process." 2. The Laboratory Director failed to provide documentation of competency assessments of seven of seven Technical Supervisors in 2021, 2022 and to the date of the survey in 2023. Technical Supervisors include: -Laboratory Director/Technical Supervisor A - Technical Supervisor B -Technical Supervisor C -Technical Supervisor D -Technical Supervisor E -Technical Supervisor F -Technical Supervisor G 3. During an interview on March 22, 2023 at 11:00 AM, the Pathology Manager 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 the lack of workload limit records and interviews Technical Supervisor A -- 6 of 7 -- failed to establish a maximum workload limit and reassess workload limits at least every six months for seven of seven Technical Supervisors, who performed primary cytology slide examinations in 2021, 2022 and to the date of the survey in 2023. Cross refer to D5633 and D5637 Findings include: 1. The Survey Team requested and the laboratory failed to provide records that Technical Supervisor A established a maximum workload limit for seven of seven Technical Supervisors who performed primary cytology slide examinations in 2021, 2022 and to the date of the survey in 2023. (refer to 5633) Technical Supervisors include: -Laboratory Director/Technical Supervisor A -Technical Supervisor B -Technical Supervisor C -Technical Supervisor D -Technical Supervisor E -Technical Supervisor F -Technical Supervisor G 2. The Survey Team requested and the laboratory failed to provide records that Technical Supervisor A reassessed a workload limit at least every six months for seven of seven Technical Supervisors who performed primary cytology slide examinations in 2021, 2022 and to the date of the survey in 2023. (refer to 5637) Technical Supervisor includes: -Laboratory Director/Technical Supervisor A -Technical Supervisor B - Technical Supervisor C -Technical Supervisor D -Technical Supervisor E -Technical Supervisor F -Technical Supervisor G 3. During interviews on March 20, 2023 at 4:00 PM with Technical Supervisor B and on March 21, 2023 at 12:15 PM with the Pathology Manager these findings were confirmed. 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 the lack of cytology workload records and interviews it was determined that seven of seven Technical Supervisor performing primary screening of nongynecologic cytology specimen slides failed to document the number of slides screened and the number of hours devoted to screening slides during each 24-hour period in 2021, 2022 and to the date of the survey in 2023. Cross refer to D5645 Findings include: 1. The Survey Team requested and the laboratory failed to provide records of the total number of slides screened and the total number of hours seven of seven Technical Supervisors devoted to screening cytology specimen slides during each 24-hour period in 2021, 2022 and to the date of the survey in 2023. (refer to D5645) Technical Supervisor includes: -Laboratory Director/Technical Supervisor A -Technical Supervisor B -Technical Supervisor C -Technical Supervisor D -Technical Supervisor E -Technical Supervisor F -Technical Supervisor G 2. During interviews on March 20, 2023 at 4:00 PM with Technical Supervisor B and on March 21, 2023 at 12:15 PM with the Pathology Manager these findings were confirmed. 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. -- 7 of 7 --