Pathologists Bio-Medical Laboratories, Pllc

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 08/28/2024. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. STANDARD LEVEL DEFICIENCIES were cited. D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on review of laboratory's gynecological cytology requisitions, laboratory's policies/procedures and staff interview, the laboratory failed to ensure for 2 of 2 Pap smears' requisitions received from January to August 2024, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy were documented. Findings included: 1. Review of the following 2 of 2 Pap smears' requisitions received from January to August 2024 revealed neither one had documentation of patient's last menstrual period, or indication of whether 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 2 -- patient had a previous abnormal report, treatment, or biopsy. They were: Patient's medical record number: 8590406 Date of requisition: 04/25/2024 Case/accession number: 24-NT-000374; 1110409844 Test ordered: Pap Patient's medical record number: 7835383 Date of requisition: 06/18/2024 Case/accession number: 24-NT- 000519; 1112732108 Test ordered: Pap 2. Review of laboratory's policy "Gynecologic Cytology Screening and Reporting" (last reviewed by laboratory director on 06/11 /2024) revealed: "Each requisition is checked to verify that all required clinical information is present. If any required information is missing, the case is submitted to the exceptions team and a request is entered in the CRM. The exceptions team is responsible for obtaining the information." 3. The laboratory was asked to provide documentation of the exceptions team obtaining the missing information, and no such documentation was available for review prior to survey exit. 4. In an interview on 08 /28/2024 at1315 hours in the office, the facility's Senior Manager of Quality, Safety and Compliance (as indicated on submitted Survey Entrance/Exit document) confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D5625 CYTOLOGY CFR(s): 493.1274(c)(3) (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) (3) For each patient with a current HSIL, adenocarcinoma, or other malignant neoplasm, laboratory review of all normal or negative gynecologic specimens received within the previous 5 years, if available in the laboratory (either on-site or in storage). If significant discrepancies are found that will affect current patient care, the laboratory must notify the patient's physician and issue an amended report. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, documents and interview it was determined that the laboratory failed to establish written policies and procedures for a program for the identification and review of prior negative gynecologic specimens for each patient with a current High Grade Squamous intraepithelial Lesion (HSIL) or malignant neoplasm. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to describe a process for the search and review of all negative gynecologic specimens received within the previous 5 years, for each patient with a current HSIL, or malignant neoplasm reported by the laboratory. 2. During an interview at 11:00 AM on January 23, 2018, the Cytology Supervisor employed at Facility B stated that the review of previous negative gynecologic cases from current HSIL cases was performed at Facility B and there was no procedure for the review program. D5629 CYTOLOGY CFR(s): 493.1274(c)(5) (c) Control procedures. The laboratory must establish and follow written policies and 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 -- 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 review of laboratory policies and procedures, records and interview it was determined that the laboratory failed to establish written policies and procedures for an annual statistical evaluation of six of six required statistics in 2016 and 2017. Findings include: 1. The Survey Team requested and the laboratory failed to provide a written policy and procedure for an annual statistical laboratory evaluation of six required statistics. 2. The Survey Team requested and the laboratory failed to provide an annual statistical evaluation from 2016 or 2017 for the six required statistics. 3. During an interview at 11:15 AM on January 23, 2018, the Cytology Supervisor from Facility B confirmed that there were no written policies and procedures for documenting and evaluating annual statistics. D5655 CYTOLOGY CFR(s): 493.1274(e)(4) (e) Slide examination and reporting. The laboratory must establish and follow written policies and procedures that ensure the following: (e)(4) Unsatisfactory specimens or slide preparations are identified and reported as unsatisfactory. 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 unsatisfactory cytology specimens or slide preparations were identified and reported as unsatisfactory. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to ensure that cytology specimens or slide preparations were identified and reported as unsatisfactory. 2. During an interview at 11:20 AM on January 23, 2018, the Cytology Supervisor from Facility B confirmed that there were no written policies and procedures for identifying cytology specimens or slide preparations as unsatisfactory. 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. -- 2 of 2 --