Summary:
Summary Statement of Deficiencies D3027 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(1) Test requisitions and authorizations. Retain records of test requisitions and test authorizations, including the patient's chart or medical record if used as the test requisition or authorization, for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor's review of pathology & cytology test reports and an interview with the pathologist/laboratory director, the laboratory failed to retain test requisitions /courier logs for patients' pathology & urine cytology specimens, sent to the technical component laboratory with each set of samples. FINDINGS: 1. This Physician Office Laboratory (POL) is using a technical component/professional component (TC/PC) split for histopathology and cytology specimens. 2. The laboratory director /pathologist on August 1, 2018 at approximately 1:30 PM confirmed the surveyor's findings that the laboratory failed to retain test requisitions/courier logs for patients' pathology & urine cytology specimens, sent to the technical component laboratory with each set of samples from March 1, 2017 through October 20, 2017. D3029 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(2) Test procedures. Retain a copy of each test procedure for at least 2 years after a procedure has been discontinued. Each test procedure must include the dates of initial use and discontinuance. This STANDARD is not met as evidenced by: Based on a lack of the histology and cytology procedure manuals and an interview with the current laboratory director/pathologist, the laboratory failed to retain 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 6 -- histology and cytology procedure manuals from the previous pathologist /laboratory director implemented in June 2015 through October 17, 2017. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on lack of Quality Control (QC) records for stain quality and reactivity for the histology & cytology slides & FISH images, and an interview with the current laboratory director/pathologist, the laboratory failed to retain copies of the previous pathologist QC records for stains used for both histology & cytology and FISH images from March 1, 2017 through October 17, 2017. FINDINGS: The laboratory director/pathologist, confirmed on August 1, 2018 at approximately 1:45 PM, that the laboratory failed to retain copies of the previous pathologist QC records for stains used for both histology & cytology slides and FISH images from March 1, 2017 through October 17, 2017. D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. This STANDARD is not met as evidenced by: Based on a lack of the histology and cytology Quality Assessment (QA)/Quality Improvement Plan (QIP) records and an interview with the current laboratory director /pathologist, the laboratory failed to retain the QA/QIP records for the calendar year 2017. FINDINGS: The laboratory director/pathologist confirmed on August 1, 2018 at approximately 1:00 PM, the surveyor's findings that the laboratory failed to retain the QA/QIP records to include a review of the following records and documentation: twice yearly verification for the histology, cytology and FISH images; quality control documentation for the stains; workload work sheets; workload assessment records; maintenance records for the microscope; and annual statistical evaluation documentation for cytology cases that were examined and reported during the calendar year 2017. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. -- 2 of 6 -- This STANDARD is not met as evidenced by: Based on surveyor's review of the histology/cytology procedure manual, lack of EastGene Laboratories service/reference manual and confirmed in an interview with the current laboratory director/pathologist, the laboratory failed to establish written procedures for specimen collection for urine cytology, specimen transportation and specimen referral. FINDINGS: The current laboratory director/pathologist confirmed on August 1, 2018 at approximately 2:00 PM, the surveyor's findings that the laboratory failed to establish written procedures for specimen collection for urine cytology, specimen transportation and specimen referral. The laboratory failed to: a. retain a service/reference manual for East Gene Laboratories to ensure that the histology and urine cytology specimens are collected according to the reference laboratory requirements for preparation of the slides and FISH images. b. establish a log sheet for both offices to ensure that the specimens are transported in a timely manner to the reference laboratory. c. establish a method for tracking the specimens sent from both office locations to the reference laboratory. 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's review of the cytology procedure manual and interview with the pathologist/laboratory director, the laboratory failed to establish written policies and procedures for a program to evaluate and compare the laboratory statistics annually to detect errors in the performance of cytological examinations and reporting results. FINDINGS: The pathologist/laboratory director confirmed on August 1, 2018 at approximately 1:30 PM, that the laboratory failed to establish written policies and procedures for a program designed to detect errors in the performance of cytological examinations and the reporting of results annually. D5631 CYTOLOGY CFR(s): 493.1274(c)(6) (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) (6) An evaluation of the case reviews of each individual examining slides against the laboratory's overall statistical values, documentation of any discrepancies, including reasons for the deviation, and, if appropriate,