Summary:
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, lack of laboratory records and interview it was determined that the laboratory failed to establish written policies and procedures to ensure individual maximum workload limits were established for the Laboratory Director/Technical Supervisor. The laboratory failed to ensure workload limits were established for the one of one Laboratory Director/Technical Supervisor who performed primary screening of nongynecologic cytology specimens in 2020 and 2021. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to ensure the Technical Supervisor established individual maximum workload limits for the Laboratory Director/Technical Supervisor who performed primary screening of nongynecologic cytology specimens. 2. The Survey Team requested and the laboratory failed to provide individual maximum workload limits for one of one Laboratory Director/Technical Supervisor in 2020 and 2021. Technical Supervisor includes: -Laboratory Director/Technical Supervisor 3. During an interview on March 7, 2022 at 1:00 PM, these findings were confirmed with the Laboratory Director/Technical Supervisor. D5637 CYTOLOGY CFR(s): 493.1274(d)(1)(ii) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the following: (d)(1)(ii) Each individual's workload limit is reassessed at least every 6 months and adjusted when necessary. 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 -- 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 workload limits were reassessed and adjusted when necessary at least every six months for the Laboratory Director/Technical Supervisor. The laboratory failed to ensure workload limits were reassessed for the one of one Laboratory Director/Technical Supervisor in 2020 and 2021. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to detail how the Laboratory Director/Technical Supervisor's workload limits would be reassessed at least every six months and adjusted when necessary. 2. The Survey Team requested and the laboratory failed to provide records of a workload reassessment at least every six months for one of one Laboratory Director/Technical Supervisor in 2020 and 2021. Technical Supervisor includes: -Laboratory Director /Technical Supervisor 3. During an interview on March 7 at 1:00 PM, these findings were confirmed with the Laboratory Director/Technical Supervisor. 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 and interview it was determined that the laboratory failed to establish written policies and procedures to ensure that the workload limits for the Laboratory Director/Technical Supervisor would be prorated when examining slides in less than eight hours. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to prorate the workload limits for the Laboratory Director/Technical Supervisor when examining slides in less than an eight-hour day. 2. During an interview on March 7, 2022 at 1:00 PM, these findings were confirmed with the Laboratory Director/Technical Supervisor. D6130 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(c)(2)(3) (c) In cytology, the technical supervisor or the individual qualified under 493.1449(k) (2)-- (c)(2) Must establish the workload limit for each individual examining slides and (c)(3) Must reassess the workload limit for each individual examining slides at least every 6 months and adjust as necessary. This STANDARD is not met as evidenced by: Based on review of written policies and procedures, lack of laboratory records and interview it was determined that the Technical Supervisor failed to establish an -- 2 of 3 -- individual workload limit and failed to reassess workload limits at least every six months for one of one Laboratory Director/Technical Supervisor who performed primary slide examinations in 2020 and 2021. Cross refer to D5633 and D5637. Findings include: 1. The Survey Team requested and the Laboratory Director /Technical Supervisor failed to provide documentation that the Technical Supervisor established a maximum workload limit for one of one Technical Supervisors who performed primary slide examinations in 2020 and 2021. Technical Supervisor includes: - Laboratory Director/Technical Supervisor 2. The Survey Team requested and the Laboratory Director/Technical Supervisor failed to provide documentation that the Technical Supervisor reassessed a workload limit at least every six months for one of one Technical Supervisor who performed primary slide examinations in 2020 and 2021. Technical Supervisor includes: - Laboratory Director/Technical Supervisor 3. During an interview on March 7, 2022 at 1:00 PM, these findings were confirmed with the Laboratory Director/Technical Supervisor. D9999 By agreement between ASCT Services, Inc. and CMS, information provided for CMS's completion of CMS Form 670 are ASCT Services, Inc. averages only. This information is confidential and proprietary to ASCT Services, Inc., is exempt under the Freedom of Information Act (5 U.S.C. 552 et seq.), and shall be used for federal government purposes only. -- 3 of 3 --