Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at CSG Dermatology on June 26, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: 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 a review of proficiency testing (PT) records and interviews, the laboratory failed to evaluate Potassium Hydroxide (KOH) Microscopy PT scores of zero (0%) received due to results marked as past due for evaluation on two (2) of 2 events in calendar year 2018. Findings include: 1. Review of the laboratory's 2018 and 2019 College of American Pathology (CAP) clinical microscopy PT documentation, a total of four (4) events, revealed no evaluation or verification of accuracy for: 2018 CM-A: KOH Score 0%- results received past due for evaluation; 2018 CM-B: KOH Score 0% - results received past due for evaluation; a total of 2 of 2 in calendar year 2018 (2 of the 4 events reviewed). The inspector requested to review accuracy evaluation documentation for the events in 2018 outlined above. No additional documentation was available for review. 2. In an interview with the clinical nurse managers, at approximately 11:30 AM, the above findings were confirmed. D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) 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 -- The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records and interviews, the laboratory director failed to ensure the Potassium Hydroxide (KOH) Microscopy PT results for two (2) of 2 events in calendar year 2018 were submitted on time as required by the College of American Pathologists (CAP) program. Findings include: 1. Review of the laboratory's 2018 and 2019 CAP clinical microscopy PT documentation, a total of four (4) events, revealed zero (0%) scores were received due to results received past due: 2018 CM-A: KOH Score 0%; 2018 CM-B: KOH Score 0%; a total of 2 of 2 in calendar year 2018 (2 of the 4 events reviewed). 2. In an interview with the clinical nurse managers, at approximately 11:30 AM, the above findings were confirmed. -- 2 of 2 --