Yosemite Pathology Medical Group Inc

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 it was determined that the laboratory failed to enroll in a CMS-approved cytology PT program for 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 -- gynecologic examination for 2022 and 2023. Findings include: 1. The Survey Team requested and the laboratory failed to provide records of enrollment in an approved cytology PT program for 2022 and 2023. 2. During an interview on June 11, 2024 at 2: 00 PM, when asked if the laboratory had enrolled in an approved cytology PT program for 2022 and 2023, the Compliance Manager replied "no." 3. During a telephone interview on June 11, 2024 at 4:00 PM, these findings were confirmed with the Laboratory Director/Technical Supervisor. 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)

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on the laboratory's physical address, reviews of CLIA Applications (3/01/17, 2 /21/19) and laboratory Pathology Reports and Cytology Reports, and interview with a laboratory person, it was determined that the reports incorrectly stated the laboratory address, failed to specify the Laboratory Director for this CLIA Certificate, and failed to state the name and address of the laboratory performing Grossing. Findings included: a. The CLIA Applications stated the following: 1) Physical Address 2303 Camino Ramon ste 104 San Ramon, CA 94583 2) Laboratory Director Emad Kaabipour, MD b. This CLIA survey on 2/21/19, took place at the aforementioned physical address. c. Twelve out of 12 laboratory reports reviewed from the timeframe May 23, 2018 to February 20, 2019 stated the address as 6001 Norris Canyon Road, San Ramon, CA 94583, and two Medical Directors Emad Kaabipour, MD, and Anthony R Victorio, MD. d. The Pathology Reports included Gross Desciptions of the biopsy samples in terms of number of fragments, color, and measurements, constituting High complexity testing; but failed to disclose the laboratory and address where performed and the responsible Laboratory Director. e. The laboratory person affirmed (2/21/19 at 2pm) the aforementioned address on the reports was incorrect for the professional components of interpreting slides; and that Grossing was performed 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 -- at a different laboratory and physical location that was not clearly stated in the reports. f. Based on the stated annual estimates (Laboratory Testing Declaration, 2/21/19), the laboratory reported potentially 2,169 reports each month, beginning in May 2018. The reliability and quality of laboratory reports could not be assured when addresses were stated incorrectly or not provided, and the Laboratory Directors were not specified. -- 2 of 2 --