Summary:
Summary Statement of Deficiencies D0000 An onsite recertification survey conducted on February 18, 2026 found the Rhonda S Fogel MD, PC Laboratory in non compliance with the following CONDITIONS with 42 CFR Part 493, Requirements for Laboratories: D2000- 42 C.F.R. 493.801 Condition: Enrollment and Testing of Samples D5400 - 42 C.F.R. 493.1250 Condition: Analytical Systems 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 surveyor review of Bacteriology proficiency testing (PT) records and staff interview conducted on 1/18/2026, the laboratory failed to enroll in a CMS approved proficiency testing (PT) Program for Bacteriology. Findings include: 1 Record review of the laboratory's 2024 and 2025 graded PT results (STAS435) revealed the laboratory used Oneworld Accuracy AccuTest as their PT Program provider for their Streptococcus A Culture testing. 2. Record review of CMS PT data report (CASPER Report 155) printed on 1/17/2026 revealed no results reported to CMS for the analyte 0005 BACTERIOLOGY for 2024 and 2025. 3. Record review of the CMS APPROVED PROFICIENCY TESTING PROGRAMS FOR CLIA listing revealed that Oneworld Accuracy is not a CMS approved PT Program provider. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) (2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1). This STANDARD is not met as evidenced by: Based on record review and interview conducted on 2/18/2026 with the laboratory director (LD), laboratory failed verify the accuracy of their Uricult CLED/EMB testing at least twice annually in 2025. Findings include: 1. Record review of 2024 and 2025 proficiency testing records revealed no documentation that the laboratory verified the accuracy of Uricult CLED/EMB testing in all of 2025. 2. Interview with the LD on 2/18/2026 at 11:10 AM confirmed the findings above. 3. The laboratory reported performing 432 Urine cultures annually. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on record review and interview with the Laboratory Director (LD) on 2/18 /2026, the laboratory failed to review and evaluate proficiency testing (PT) a sample result failure for one of three events in 2024. Findings include: 1. Record review on of 2024 and 2025 proficiency testing (PT) records revealed the following sample failure: a. 2024 AccuTest Bacteriology PT Cycle 2 - 80% Score. Incorrect response Sample E. Laboratory response: negative for Group A Streptococcus. Acceptable result: positive for Group A Streptococcus. 2. Surveyor record review 2024 PT records revealed no evidence of an evaluation, or