Associated Pathologist Llc

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on the lack of cytology proficiency testing (PT) enrollment records and interviews the laboratory failed to enroll in an approved PT program for gynecologic examination (refer to D2001). D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(i) The laboratory must-- (1) Notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart. (2)(i) Designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more than one proficiency testing program approved by CMS; This STANDARD is not met as evidenced by: Based on the lack of cytology PT enrollment records and interviews the laboratory failed to enroll in an HHS-approved cytology PT program for gynecologic Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- examination for 2021 and 2022. Findings include: 1. The Survey Team requested and the laboratory failed to provide records of enrollment in an approved cytology PT program for 2021 and 2022. 2. During an interview on April 18, 2023 at 11:05 AM, the Pathology Support Manager stated "we don't have that." 3. During an interview on April 19, 2023 at 10:30 AM, these findings were confirmed with the Laboratory Director/Technical Supervisor A. D5032 CYTOLOGY CFR(s): 493.1221 If the laboratory provides services in the subspecialty of Cytology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1274, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on the lack of laboratory policies and procedures, review of laboratory records and interviews the laboratory failed to establish written policies and procedures to ensure confidentiality of patient information (refer to D5201); failed to establish written policies and procedures to assess the competency of the Technical Supervisors, and failed to assess the competency of eight of eight Technical Supervisors (refer to D5209); failed to ensure a written procedures manual for all cytology tests and examinations performed by the laboratory was available to laboratory personnel (refer to D5401); failed to establish written policies and procedures for six laboratory test processes (refer to D5403); failed to follow manufacturer's instructions to evaluate gynecologic cytology specimens using the Hologic ThinPrep Pap Test (refer to D5411); failed to establish written policies and procedures for a program to compare clinical information with cytology reports and to compare all gynecologic cytology reports with a diagnosis of high-grade squamous intraepithelial lesion (HSIL) or malignant neoplasms with available histopathology, and failed to provide records for a correlative review program to determine the causes of any discrepancies (refer to D5623); failed to establish written policies and procedures for the review of all negative gynecologic specimens received within the previous five years for each patient with a current HSIL or malignancy, and failed to provide records documenting a search and review of prior negative specimens for each patient with a current HSIL or malignancy was performed (refer to D5625); failed to establish written policies and procedures for an annual statistical evaluation of the required gynecologic laboratory statistics, and failed to document the required laboratory statistics for 2021 and 2022 (refer to D5629); failed to establish written policies and procedures to ensure unsatisfactory slide preparations were identified and reported as unsatisfactory (refer to D5655); failed to establish written policies and procedures for the system of narrative descriptive nomenclature used by the laboratory to report cytology test results (refer D5657); and failed to establish written policies and procedures to ensure corrected test reports indicated the basis for the correction on the test report, and failed to indicate the basis for the correction on one of two corrected test reports (refer to D5659). D5201 CONFIDENTIALITY OF PATIENT INFORMATION CFR(s): 493.1231 The laboratory must ensure confidentiality of patient information throughout all phases of the total testing process that are under the laboratory's control. -- 2 of 12 -- This STANDARD is not met as evidenced by: Based on the lack of laboratory policies and procedures and interviews the laboratory failed to establish written policies and procedures to ensure confidentiality of patient information. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to detail how the laboratory would ensure confidentiality of patient information. 2. During an interview on April 17, 2023 at 11:30 AM, the Survey Team reviewed electronic procedures with the Pathology Support Manager. The Pathology Support Manager stated that the procedures were for Facility B (CLIA 44D0934312) and not for the laboratory being surveyed. 3. During an interview on April 19, 2023 at 10:30 AM, these findings were confirmed with the Laboratory Director/Technical Supervisor A. 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 the lack of laboratory policies and procedures, interviews and lack of competency assessment records, the laboratory failed to establish written policies and procedures to assess the competency of the Technical Supervisors. The laboratory failed to assess the competency of eight of eight Technical Supervisors in 2021, 2022 and to the date of the survey in 2023. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to describe the process for assessing the competency of the Technical Supervisors. a. During an interview on April 17, 2023 at 11:30 AM, the Survey Team reviewed electronic procedures with the Pathology Support Manager. The Pathology Support Manager stated that the procedures were for Facility B and not for the laboratory being surveyed. 2. The Survey Team requested and the laboratory failed to provide documentation of competency assessments for eight of eight Technical Supervisors in 2021, 2022 and to the date of the survey in 2023. Technical Supervisors include: - Laboratory Director/Technical Supervisor A -Technical Supervisor B -Technical Supervisor C -Technical Supervisor D -Technical Supervisor E -Technical Supervisor F -Technical Supervisor G -Technical Supervisor H 3. During an interview on April 19, 2023 at 10:30 AM, these findings were confirmed with the Laboratory Director /Technical Supervisor A. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on the lack of a policy and procedures manual and interviews a written procedure manual for all cytology tests and examinations performed by the laboratory -- 3 of 12 -- was not available to laboratory personnel. Findings include: 1. The Survey Team requested and the laboratory failed to provide a written procedures manual for all cytology tests and examinations performed at the laboratory. 2. During an interview on April 17, 2023 at 11:30 AM, the Survey Team reviewed electronic procedures with the Pathology Support Manager. The Pathology Support Manager stated that the procedures were for Facility B and not for the laboratory being surveyed. 3. During an interview on April 19, 2023 at 10:30 AM, these findings were confirmed with the Laboratory Director/Technical Supervisor A. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)