Summary:
Summary Statement of Deficiencies 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 laboratory records it was determined that the laboratory failed to follow written policies and procedures to ensure three of four Technical Supervisors did not exceed the prorated workload limit of 12.5 slides per hour when examining slides in less than an 8-hour workday during July, August and September 2021. Findings include: 1. The policy CYTOLOGY PRIMARY SCREENING WORKLOAD POLICY stated: "The maximum number of Cytology slides that can be screened by primary screening personnel is defined by the following: 1. No more than 100 slides per 8-hour shift or 24 hour day. 2. No more than 12.5 slides per hour. 3. Cytospin slides can count as 1/2 slide per current regulations. The number of slides screened must be pro-rated based upon the actual hours worked and including other duties. For example, if a primary screener only screens slides for 4 hours, but has other duties for 4 hours, then they could only screen 12.5 slides per hour or 50 slides." 2. The Survey Team reviewed the laboratory document titled "Cytology Log" from 2021. The Laboratory Director/Technical Supervisor A, Technical Supervisor C and Technical Supervisor D who performed primary examination of cytology slides exceeded the prorated workload limit of 12.5 slides per hour. a. Laboratory Director/Technical Supervisor A exceeded prorated workload limits on 10 of 10 days in August and September 2021. Dates include: 8/3 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 -- /21 Time spent examining slides: 12 minutes Number of slides examined: 6 Number of slides allowed: 3 8/4/21 Time spent examining slides: 6 minutes Number of slides examined: 3 Number of slides allowed: 1 8/5/21 Time spent examining slides: 6 minutes Number of slides examined: 3 Number of slides allowed: 1 8/6/21 Time spent examining slides: 6 miutes Number of slides examined: 3 Number of slides allowed: 1 8/31/21 Time spent examining slides: 6 minutes Number of slides examined: 3 Number of slides allowed: 1 9/2/21 Time spent examining slides: 6 minutes Number of slides examined: 3 Number of slides allowed: 1 9/3/21 Time spent examining slides: 6 minutes Number of slides examined: 3 Number of slides allowed: 1 9/15/21 Time spent examining slides: 15 minutes Number of slides examined: 6 Number of slides allowed: 3 9/16/21 Time spent examining slides: 12 minutes Number of slides examined: 6 Number of slides allowed: 3 9/17/21 Time spent examining slides: 6 minutes Number of slides examined: 3 Number of slides allowed: 1 b. Technical Supervisor C exceeded prorated workload limits on 21 of 21 days in July, August and September 2021. Dates include: 7/1/21 Time spent examining slides: 7 minutes Number of slides examined: 3 Number of slides allowed: 1 7/2/21 Time spent examining slides: 9 minutes Number of slides examined: 4 Number of slides allowed: 2 7/12/21 Time spent examining slides: 15 minutes Number of slides examined: 7 Number of slides allowed: 3 7/14/21 Time spent examining slides: 20 minutes Number of slides examined: 8 Number of slides allowed: 4 7/15/21 Time spent examining slides: 28 minutes Number of slides examined: 10 Number of slides allowed: 6 7/16/21 Time spent examining slides: 35 minutes Number of slides examined: 15 Number of slides allowed: 7 7/29/21 Time spent examining slides: 14 minutes Number of slides examined: 6 Number of slides allowed: 3 8/9/21 Time spent examining slides: 20 minutes Number of slides examined: 10 Number of slides allowed: 4 8/12/21 Time spent examining slides: 14 minutes Number of slides examined: 7 Number of slides allowed: 3 8/13/21 Time spent examining slides: 8 minutes Number of slides examined: 4 Number of slides allowed: 2 8/23/21 Time spent examining slides: 8 minutes Number of slides examined: 4 Number of slides allowed: 2 8/24/21 Time spent examining slides: 9 minutes Number of slides examined: 4 Number of slides allowed: 2 8/25/21 Time spent examining slides: 8 minutes Number of slides examined: 4 Number of slides allowed: 2 9/8/21 Time spent examining slides: 15 minutes Number of slides examined: 7 Number of slides allowed: 3 9/9/21 Time spent examining slides: 16 minutes Number of slides examined: 7 Number of slides allowed: 3 9/10/21 Time spent examining slides: 8 minutes Number of slides examined: 4 Number of slides allowed: 2 9/20/21 Time spent examining slides: 10 minutes Number of slides examined: 4 Number of slides allowed: 2 9/21/21 Time spent examining slides: 23 minutes Number of slides examined: 10 Number of slides allowed: 5 9/22/21 Time spent examining slides: 8 minutes Number of slides examined: 4 Number of slides allowed: 2 9/23/21 Time spent examining slides: 6 minutes Number of slides examined: 3 Number of slides allowed: 1 9/30/21 Time spent examining slides: 10 minutes Number of slides examined: 4 Number of slides allowed: 2 c. Technical Supervisor D exceeded prorated workload limits on 2 of 2 days in July 2021. Dates include: 7/20/21 Time spent examining slides: 6 minutes Number of slides examined: 3 Number of slides allowed: 1 7/22/21 Time spent examining slides: 15 minutes Number of slides examined: 6 Number of slides allowed: 3 3. During an interview on October 9, 2021 at 9:20 AM, the Laboratory Director/Technical Supervisor 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 -- 2 of 3 -- 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 --