Advanced Pathology

Summary Statement of Deficiencies 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 and interview with Laboratory Director/Technical Supervisor #1, the laboratory failed to establish and follow written policies and procedures to establish an individual maximum workload limit for each Technical Supervisor who performed primary examnation of non-gynecologic cytology specimens. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to detail how the Technical Supervisor would establish maximum workload limits for Technical Supervisors who performed primary examination of non-gynecologic cytology specimens. 2. During an interview on March 27, 2024 at 10:30 AM these findings were confirmed by Laboratory Director/Technical Supervisor #1. D5637 CYTOLOGY CFR(s): 493.1274(d)(1)(ii) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(1)(ii) Each individual's workload limit is reassessed at least every 6 months and adjusted when necessary. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and interview with Laboratory Director/Technical Supervisor #1, the laboratory failed to establish and follow written 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 -- policies and procedures to reassess and adjust when necessary, a maximum workload limit at least every six months for the Technical Supervisors who performed primary screening of non-gynecologic cytology specimens. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to detail how the Technical Supervisor would reassess a maximum workload limit for Technical Superviors at least every six months and adjust when necessary. 2. During an interview on March 27, 2024 at 10:30 AM these findings were confirmed by Laboratory Director/Technical Supervisor #1. 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 interview with the Laboratory Director/Technical Supervisor #1, the laboratory failed to establish and follow written policies and procedures to ensure that workload limits for the Technical Supervisors would be prorated when examining slides in less than an eight-hour work day. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to prorate workload limits for the Technical Supervisors when examining slides in less than an eight-hour day, or with duties other than examining cytology specimen slides. 2. The Survey Team requested and the laboratory failed to provide documentation of prorated workload limits for two of two Technical Supervisors when examining slides in less than eight hours. Technical Supervisors include: - Laboratory Director/Technical Supervisor #1 - Technical Supervisor #2 3. During an interview on March 27, 2024 at 10:30 AM these findings were confirmed by Laboratory Director/Technical Supervisor #1. 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 and interview with Laboratory Director/Technical Supervisor #1, the Laboratory Director failed to ensure written policies and procedures were established to assess, monitor and maintain the competency of Laboratory Assistants who conducted preanalytic and postanalytic phases of cytology testing. Findings include: 1. The Survey Team requested and the -- 2 of 3 -- Laboratory Director failed to provide written policies and procedures to assess, monitor and maintain the competency of Laboratory Assistants who conducted preanalytic and postanalytic phases of cytology testing. a. The Survey Team requested and the Laboratory Director failed to provide documentation of competency assessments for two of two Laboratory Assistants in January through December 2023 and January 2024 to the date of the survey in 2024. . Laboratory Assistants include: - Laboratory Assistant #1 - Laboratory Assistant #2 2. During an interview on March 27, 2024 at 10:30 AM these findings were confirmed by Laboratory Director /Technical Supervisor #1. 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 interview with Laboratory Director /Technical Suervisor #1, the Technical Supervisor failed to establish and reassess a maximum workload limit for two of two Technical Supervisors in January through December 2023 and January 2024 to the date of the survey in 2024. Findings include: 1. The Technical Supervisor failed to provide documentation that the Technical Supervisor established a maximum workload limit for two of two Technical Supervisors who performed primary non-gynecologic cytology slide examinations in January through December 2023 and January 2024 to the date of the survey in 2024. Refer to D5633 and D5647 Technical Supervisors include: - Laboratory Director /Technical Supervisor #1 - Technical Supervisor #2 2. The Technical Supervisor failed to provide documentation that the Technical Supervisor reassessed a workload limit at least every six months for two of two Technical Supervisors who performed primary non-gynecologic cytology slide examinations in January through December 2023 and January 2024 to the date of the survey in 2024. Refer to D5637 and D5647 Technical Supervisors include: - Laboratory Director/Technical Supervisor #1 - Technical Supervisor #2 3. During an interview on March 27, 2024 at 10:30 AM these findings were confirmed by Laboratory Director/Technical Supervisor #1. D9999 By agreement between ASCT Services, Inc. and CMS, information provided for CMS's completion of CMS Form 670 are ASCT Services, Inc. averages only. This information is confidential and proprietary to ASCT Services, Inc., is exempt under the Freedom of Information Act (5 U.S.C. 552 et seq.), and shall be used for federal government purposes only. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 06/28/2023. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the laboratory director at the conclusion of the survey. 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 and interview with the histology supervisor, the laboratory failed to ensure expired supplies were not available for use. Findings include: (1) Observation of the laboratory on 06/28/2023 at 10:27 am, identified the following expired reagent that appeared to be available for use: (a) Mercedes Scientific Silver Nitrate Solution (0.2%) - lot #61961 with an expiration date of 12/2022. (2) Interview with the histology supervisor on 06/28/202 at 10:30 a.m. confirmed the Silver Nitrate Solution was used for special stains and was available for 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 1 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 03/24/2021. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director, histotechnician, and laboratory assitant at the conclusion of the survey. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of manufacturer's instructions, observation, and interview with the histotechnician, the laboratory failed to ensure the Sakura Tissue-TEK SCA and coverslipped slides had been stored as required by the manufacturer. Findings include: (1) On 03/24/2021 at 10:00 am, the histotechnician stated the following to the surveyors: (a) The laboratory performed processing, staining, and microscopic examination of histopathology and non-gynecologic specimens; (b) The Sakura Tissue-Tek SCA coverslipper was an automated instrument used to coverslip the specimens that were mounted on microscope slides, using a resin coated film instead of cover glass and liquid mounting media. (2) On 03/24/2021 at 11:20 am, surveyor #1 observed the following and the histotechnician stated: (a) The Sakura Tissue-Tek was housed in a separate room denoted as room 2; (b) The coverslipped slides (after slide interpretation) were stored in the hall area outside of the processing room. (3) Surveyor #1 reviewed the manufacturer's environmental instructions contained in the 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 -- "Operating Manual" for the Sakura Tissue-Tek coverslipper with the following identified: (a) Under the heading "Environmental Factors" on page 2.1, the manufacturer required the analyzer be stored at a relative humidity of 30-70%; (b) Under the heading "Storage of Coverslipped Slides" on page 3.3, the manufacturer required the coverslipped slides be stored at a relative humidity of less than 50% and a temperature of 19-25 degrees Celsius (67-77 degrees Fahrenheit). (4) Surveyor #1 reviewed the manufacturer's storage requirements with the histotechnician, who stated to surveyor #1 on 03/24/2021 at 12:30 pm, the laboratory did not monitor the humidity of the room where the Sakura Tissue-Tek was stored and did not monitor the temperature and humidity in the area where the coverslipped slides were stored. 39088 Based on a review of manufacturer's instructions, observation, and interview with the histotechnician, the laboratory failed to ensure the Cell Solutions F50 had been stored as required by the manufacturer. Findings include: (1) On 03/24/2021 at 10:00 am, the histotechnician stated the following to the surveyors: (a) The laboratory performed processing, staining, and microscopic examination of histopathology and non-gynecologic specimens. (2) On 03/24/2021 at 10:15 am, surveyor # 2 observed the following and the histotechnician stated: (a) The Cell Solutions F50, used in specimen slide preparation, was housed in room 1. (3) Surveyor #2 reviewed the manufacturer's environmental instructions contained in the "Operating Manual" with the following identified: (a) Cell Solutions F50 - Under the heading "Equipment Specifications " on page 2-1, the manufacturer required the Cell Solutions F50 be stored at a relative humidity of 30-80%. (4) Surveyor #2 reviewed the manufacturer's storage requirements with the histotechnician, who stated to surveyor #2 on 03/24 /2021 at 12:45 pm, the laboratory did not monitor the humidity of the room where the equipment was stored. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the histotechnician, the laboratory failed to perform maintenance procedures as required by the manufacturer for 52 of 52 weeks. Findings include: (1) On 03/24/2021 at 10:00 am, the histotechnician stated the following to the surveyors: (a) The laboratory performed processing, staining, and microscopic examination of histopathology and non-gynecologic specimens. (2) Surveyor #2 reviewed the Leica ASP 300S Tissue Processor manufacturer's weekly maintenance requirements located in Section 7.3 "Preventative maintenance schedule" of the Operator's Manual, which required the following maintenance: (a) Weekly (i) Lubricate reagent bottle "O" rings and check for damage. (ii) Inspect and, if necessary, clean retort lid seal. (iii) Inspect and, if necessary, clean wax bath lid seal. (iv) Inspect and, if necessary, clean wax bath strainers. (v) Inspect wax bath air vent and, if necessary, clear. (vi) Inspect and empty condensate bottle. Clear inlet holes if necessary. (3) Surveyor #2 then reviewed records from January 2020 through December 2020 with the following identified: (a) There was no documentation to prove the weekly maintenance had been performed. (4) Surveyor #2 reviewed the findings with the histotechnician. The histotechnician stated on 03/24/2021 at 12:55 pm the weekly maintenance had not been documented as indicated above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The initial certification survey was performed 07/17/19. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director, laboratory supervisor, and histotechnician at the conclusion of the survey. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory supervisor, histotechnician, and the laboratory director, the laboratory failed to perform maintenance procedures as defined by the manufacturer, with at least the frequency required by the manufacturer. Findings include: (1) At the beginning of the survey, the laboratory director stated to the surveyor, the laboratory performed non-gynecologic cytology testing on samples submitted for processing, staining, microscopic examination and interpretation for diagnosis. Examples of samples types received for testing included the following: (a) Body fluids-pleural, ascites, synovial, urine (b) Fine needle aspirates (c) Brushings/washings-bronchial, esophageal, pelvic, abdominal (d) Sparsley cellular fluids-Cerebral spinal fluid, bladder washings (2) The laboratory director stated to the surveyor low volume samples and fluids with low numbers of cellular components, were concentrated by centrifugation using the CytoTek Centrifuge. The surveyor reviewed the manufacturer's instructions for the cytocentrifuge. The manufacturer required the following maintenance procedures: (a) Daily Maintenance: (i) "Wipe the external instrument surfaces with a clean cloth moistened with neutral detergent. Pat dry any excessively moist areas;" (ii) "Wipe the motor bowl vigorously with a cloth wet with 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 -- disinfecting solution. Then, clean the rotor bowl by wiping with a clean cloth moistened with neutral detergent. Disconnect the drain hose at the rear of the instrument, and place a drain pan under the drain port of the instrument. Thoroughly rinse the rotor bowl with clear water. Completely dry the rotor bowl with clean, lint- free cloths;" (iii) "CAUTION: Do not use excessive quantities of fluid when cleaning the rotor bowl, as V-rings are not intended to provide a leak-proof seal." (b) Periodic Maintenance: (i) "At least once weekly, clean the rotor. It can be soaked in a chlorhexidene hydrochloride solution (5%) or a sodium hypochlorite solution (5% or less), then soaked in a neutral detergent solution. Complete the cleansing by rinsing with clear water, then drying thoroughly;" (ii) "CAUTION: If infectious specimens have been processed, the rotor must be autoclaved at a temperature of 250 degrees F (121 degrees C)." (ii) "Examine lid for seal cracks or signs of deterioration. Replace the seal if cracks or fatigue is evident. See Section 6 for service information." (c) 3- month Maintenance: (i) "Remove the V-ring and grease (with the Super Lube grease) the skirt (the bottom edge of the V-ring);" (ii) "Lift the lip of the lid seal packing, wipe with a cloth wet with disinfection solution as required to remove dirt. To prevent lodging of dirt in the gaps after cleaning, apply grease (SuperLube) to the edge of the guard bowl." (3) The surveyor then reviewed maintenance records from 01/01/18 through 05/31/19. There was no documentation the manufacturer's required maintenance procedures listed above had been performed on the CytoTek centrifuge; (4) The surveyor reviewed the manufacturer's maintenance requirements with the laboratory supervisor and the histotechnician and asked if the daily, weekly, and 3- month maintenance procedures had been performed as required. The laboratory supervisor and the histotechnician stated to the surveyor the manufacturer's maintenance procedures listed above had not been performed. -- 2 of 2 --