Souza Pathology

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Souza Pathology on July 10, 2025 by the Virginia Department of Health's Office of Licensure and Certification. The inspection also included an offsite follow up interview with the lab director on 7/11/25. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows: D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of procedures, proficiency testing logs, lack of documentation, and interviews, the laboratory failed to perform surgical tissue pathology/histology accuracy checks by peer review twice annually per laboratory policy during calendar year 2024 and up to the date of the recertification inspection (review timeframe: January 10, 2024 to July 10, 2025). Findings include: 1. Review of the laboratory's procedure manual revealed a policy for proficiency testing of surgical surgery histology specimens ("Quality Assurance Peer Review"). The written policy stated "the laboratory will pull random cases (30-50) twice per year for peer review." 2. Review of the laboratory's peer review documentation for calendar year 2024 up to the date of survey on 7/10/25 revealed documentation that surgical pathology tissue split sample testing (forty-five cases) were sent out for peer review on 12/9/24. The inspector requested to review additional peer review that was performed in 2024 and year to date 2025. No additional documentation of peer review was available. 3. The inspector inquired as to the reason peer review cases were not pulled twice annually as outlined in the quality assurance policy. The laboratory director (LD) stated on 7/10 /25 at 4:30 PM, "I realized last week preparing for this CLIA visit that cases were not pulled twice annually. I have scheduled the peer review immediately to validate 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 -- original diagnosis and to comply with CLIA for proficiency standard". 4. An offsite exit interview with the LD on 7/11/25 at 10 AM confirmed the above findings. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services CLIA Laboratory Application for Certification form (CMS 116), policies, proficiency testing (PT) records, lack of documentation, and interviews, the laboratory director (LD) failed to identify quality assessment failures as they occurred for two of three peer review assessments missed during the recertification review (timeframe: 1/10/24 - 7/11/25). *Refer to D5217. Findings include: 1. Review of the CMS 116 report revealed that the LD identified high complexity patient Surgical Pathology Level IV histopathology slide reading with special and immunohistochemical stains performed during the review timeframe of 1/10/24 - 7/11/25. 2. Review of procedures revealed a PT policy for surgical surgery histology specimens slide reading ("Quality Assurance Peer Review"). The policy stated "the laboratory will pull random cases (30-50) twice per year for peer review." 3. Review of the laboratory's PT documentation for calendar year 2024 up to the date of survey on 7/10/25 revealed one event of peer review (dated 12/9/24). The inspector requested to review additional peer review records. No additional documentation for expected peer review performed in June 2024 and June 2025 were available. 4. The inspector inquired regarding records that documented the identification/

Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at Souza Pathology on January 8, 2024 by the Virginia Department of Health's Office of Licensure and Certification. The inspection also included an offsite follow up interview with the lab director on 1/9 /24. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiency cited is as follows: 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 a review of the laboratory's Centers for Medicare and Medicaid Services (CMS) Aspen database and CMS survey 116 form, patient test logs, lack of documentation, and interviews, the laboratory failed to ensure that surgical tissue pathology test reports included the correct performing laboratory name and address for two hundred seven (207) of 207 patient reports as noted during the initial survey on January 8, 2024. Findings include: 1. During pre-survey inspection duties, the inspector noted that the CMS Aspen database listed the laboratory's name and physical facility location as: Souza Pathology (CLIA ID 49D2286784) 335 S. Main Street Chatham, Virginia 24531 Review of the laboratory's submitted CMS 116 form confirmed the above name and address. 2. Review of the laboratory patient test logs revealed 207 histopathology cases. The inspector requested to review the following 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 -- nine randomly selected pathology test results (accession/case numbers) from the test logs: 2024004Q860508, 2024002Q860505, 2024004Q860507, 2024004Q860512, 2024004Q860505, 2024004Q860503, 2024004Q860504, 2024004Q860513, and 2024004Q860501. The inspector's review revealed that the selected patient reports failed to identify the correct performing laboratory name/physical location of the surgical histopathology microscopy evaluation. The inspector noted the report included a footnote "performing labs" with the following information: Laboratory Corporation of America Holdings Component Type - Technical, Professional TW Alexander Drive, Research Triangle Park, NC 27709 CLIA 34D0655205 3. The inspector inquired regarding the performing laboratory footnote outlined above. The laboratory director (LD) confirmed on 1/8/24 at approximately 2:30 PM that all 207 patient case reports (to date) failed to correctly identify the pathology component's performing laboratory name/physical location. 4. A offsite follow up interview with the LD on 1/9/24 at approximately 3:30 PM confirmed the above findings. -- 2 of 2 --