Dermatology And Cosmetic Physicians, Sc

Summary Statement of Deficiencies 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 surveyor review of laboratory records, observation in the laboratory, and interview with the laboratory director, the laboratory did not have documentation showing twice annual verification of accuracy of Mohs interpretations in one of the last two years. Findings include: 1. Review of laboratory records showed the laboratory sent Mohs cases to a dermatopathologist for accuracy verification. The forms used to document the evaluations showed the laboratory sent samples for evaluation on January 25, and July 12, 2023. Further review showed no documented results of accuracy verification for Mohs interpretations in 2024. 2. Review of the laboratory's

Summary Statement of Deficiencies 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 surveyor review of laboratory records and interview with the laboratory director, the laboratory did not verify the accuracy of Mohs interpretations twice annually in 2022. Findings include: 1. Review of laboratory records showed the laboratory sent three Mohs cases to a second laboratory for accuracy verification on June 16, 2022. Further review showed no other documentation of accuracy verification for Mohs slides in 2022. 2. Interview with the laboratory director on April 20, 2022, at 11:35 AM confirmed the laboratory did not verify the accuracy of Mohs interpretations twice annually in 2022. This is a repeat deficiency from June 30, 2021. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on surveyor review of accuracy verification records and interview with the laboratory director, the laboratory did not document the evaluation and subsequent

Summary Statement of Deficiencies 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 surveyor review of laboratory records and interview with the laboratory director, the laboratory last verified the accuracy of Mohs slide interpretation in January 2020. Findings include: 1. Review of laboratory records show the laboratory sent three cases to a second laboratory for accuracy verification in January 2020. No other documentation of accuracy verification of Mohs interpretation is evident. 2. Interview with the laboratory director on June 30, 2021 at 2:00 PM confirmed the laboratory did not verify the accuracy of Mohs interpretations twice annually since January 2020. D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on surveyor review of previous survey records and Mohs maps from June 2021 and interview with the laboratory director, the laboratory had not documented the time it receives specimens on the Mohs maps for 16 of 17 cases reviewed. Findings include: 1. This is a repeat deficiency previously cited on September 19, 2019. The

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor observation of slides, review of laboratory records, and interview with the laboratory director, the laboratory did not retain documentation identifying what stains and reagents the laboratory used for slide preparation since July 2, 2019. Findings include: 1. Observation of slides on September 19, 2019 at 1:45 PM from Mohs procedures from July 2, 2019 through August 6, 2019 showed irregular staining of the tissue samples. 2. Review of laboratory records showed no record of the type, lot number, or expiration date of the stains, mounting media, or coverslip media the laboratory used for slide preparation and staining. 3. During interview with the laboratory director on September 19, 2019 at 2:00 PM the director confirmed the laboratory did not retain records to identify the stains and other reagents used in slide preparation and staining since testing began on July 2, 2019. D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the laboratory director, the laboratory had not documented the time of receipt of Mohs specimens in the laboratory. Findings include: 1. Review of Mohs maps and the Mohs specimen log 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 -- showed no indication of the time the laboratory received tissue specimens for Mohs testing. 2. Interview with the laboratory director on September 19, 2019 at 2:00 PM confirmed the laboratory did not document the time of specimen receipt for Mohs specimens. 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 surveyor review of laboratory procedures and interview with the laboratory director, the laboratory did not have a procedure for the performance of KOH (potassium hydroxide) testing. Findings include: 1. Review of procedures showed no evidence of a procedure for KOH testing. 2. Interview with the laboratory director on September 19, 2019 at 1:00 PM confirmed the director performed KOH testing on patient specimens and confirmed the laboratory had not developed a procedure for KOH testing. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the 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 surveyor review of laboratory procedures and records, observation of specimen slides and interview with the laboratory director, the director had not developed a quality assessment program to ensure the quality of laboratory services and to identify failures in quality as they occur. Findings include: 1. Review of laboratory procedures showed no evidence of a documented quality assessment program. 2. Comparison of laboratory records and observation of Mohs slides on September 19, 2019 at 1:00 PM for Case One (see F-2-62552 Statement of Deficiencies Identifier Key) showed the Mohs log and slides identified the tumor type as SCC (Squamous Cell Carcinoma). The Mohs map for Case One identified the tumor type as BCC (Basal Cell Carcinoma). 3. Observation of specimen slides on September 19, 2019 at 1:00 PM showed slides from July 2019 exhibited irregular staining of the specimens. No documented record of evaluation or resolution of the problem was available. 4. Interview with the laboratory director on September 19, 2019 at 2:00 PM confirmed the identified quality issues and confirmed the director had not established a quality assessment program to ensure the quality of laboratory services and identify failures in quality as they occur. -- 2 of 2 --