Summary:
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, lack of laboratory records and interview it was determined the laboratory failed to establish written policies and procedures to assess the competency of Technical Supervisors. The laboratory failed to assess the competency of three of three Technical Supervisors in 2020 and to the date of the survey in 2021. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to assess the competency of the Technical Supervisors. 2. The Survey Team requested and the laboratory failed to provide documentation of competency assessments for three of three Technical Supervisors in 2020 and to the date of the survey in 2021. Technical Supervisors include: -Laboratory Director/Technical Supervisor A -Technical Supervisor B - Technical Supervisor C 3. During an interview on October 27, 2021 at 3:30 PM, the Laboratory Director/Technical Supervisor A 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: 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 -- Based on review of laboratory policies and procedures and interview it was determined the laboratory failed to establish written policies and procedures to ensure individual maximum workload limits were established for three of three Technical Supervisors. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to ensure that individual maximum workload limits were established for the three of three Technical Supervisors who performed examinations of cytology specimens. 2. During an interview on October 26, 2021 at 4:30 PM, the Laboratory Director/Technical Supervisor A 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 and interview it was determined 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 three of three Technical Supervisors. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to detail how three of three Technical Supervisor's workload limits would be reassessed and adjusted when necessary. 2. During an interview on October 26, 2021 at 4:30 PM, the Laboratory Director/Technical Supervisor A confirmed these findings. D5647 CYTOLOGY CFR(s): 493.1274(d)(4) (d) Workload limits.The laboratory must establish and follow written policies and procedures that ensure the following: (d)(4) Records are available to document the workload limit for each individual. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and interview it was determined the laboratory failed to establish written policies and procedures to ensure records were available to document the workload limit for three of three Technical Supervisors who performed the examinations of cytology specimens. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to document the workload limit for three of three Technical Supervisors who performed the examinations of cytology specimens. 2. During an interview on October 26, 2021 at 4:30 PM, the Laboratory Director/Technical Supervisor A 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 -- 2 of 3 -- every 6 months and adjust as necessary. This STANDARD is not met as evidenced by: Based on the lack of laboratory records and interview it was determined the Technical Supervisor failed to establish individual workload limits and to reassess the workload limits at least every six months for three of three Technical Supervisors who performed examinations of cytology specimen slides in 2019, 2020 and January 2021 to the date of the survey on October 26, 2021. Findings include: 1. The Survey Team requested and the Laboratory Director/Technical Supervisor A failed to provide documentation that the Technical Supervisor established a maximum workload limit for three of three Technical Supervisors who performed examinations of cytology specimen slides in 2019, 2020 and January 2021 to the date of the survey on October 26, 2021. Technical Supervisors include: -Laboratory Director/Technical Supervisor A -Technical Supervisor B -Technical Supervisor C 2. The Survey Team requested and the Laboratory Director/Technical Supervisor A failed to provide records of a workload reassessment at least every six months for three of three Technical Supervisors who performed examinations of cytology specimen slides in 2019, 2020 and January 2021 to the date of the survey on October 26, 2021. Technical Supervisors include: -Laboratory Director/Technical Supervisor A -Technical Supervisor B -Technical Supervisor C 3. During an interview on October 26, 2021 at 4:30 PM, the Laboratory Director/Technical Supervisor A confirmed these findings. 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 --