Summary:
Summary Statement of Deficiencies 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 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 surveyor review of the Procedure Manual and interview with the Laboratory Director (LD), the laboratory failed to establish a written procedure which included number of cytology cases examined, specimens processed by type and patient cases reported by diagnosis (including the number reported as unsatisfactory for diagnostic interpretation) from 1/23/17 to the date of the survey. The LD confirmed on 12/19/18 at 1:30 pm the laboratory did not have the above procedure. 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. 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 -- This STANDARD is not met as evidenced by: Based on the surveyor review of the Procedure Manual (PM), review of laboratory records, and interview with the Technical Supervisor (TS)/Laboratory Director (LD), the laboratory failed to establish written policies or procedures to ensure that the TS established a maximum workload limit for three of three TS who performed the primary screening of cytology specimens from 1/23/17 to the date of the survey. The TS/LD confirmed on 12/19/18 at 1:45 pm that there were no written procedures to establish individual workload limits and no workload limits established by the TS/LD. 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 the surveyor review of the Procedure Manual (PM), review of laboratory records, and interviews with the Laboratory Director (LD), the laboratory failed to a establish written procedure to ensure that the workload limit is reassessed at least every 6 months and adjusted when necessary from 1/23/17 to the date of the survey. The LD confirmed on 12/19/18 at 1:40 pm the above procedure was not established. D5639 CYTOLOGY CFR(s): 493.1274(d)(2)(i) (d) Workload limits. The laboratory must establish and follow written policies and procedures that ensure the Following: (d)(2) The maximum number of slides examined by an individual in each 24-hour period does not exceed 100 slides (one patient specimen per slide; gynecologic, nongynecologic, or both) irrespective of the site or laboratory. This limit represents an absolute maximum number of slides and must not be employed as an individual's performance target. In addition-- (d)(2)(i) The maximum number of 100 slides is examined in no less than an 8-hour workday; This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual and interview with the Laboratory Director (LD), the laboratory failed to establish a written procedure which ensures the maximum number of slides read in an 8 hour period does not exceed 100 regardless of the location from 1/23/17 to the date of the survey. The LD confirmed on 12/19/18 at 1:15 pm the laboratory did not establish the above procedure. -- 2 of 2 --