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Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on October 23, 2020. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on document review and an interview with the practice administrator, the laboratory director failed to review and evaluate Medical Laboratory Evaluation (MLE) proficiency test (PT) results as required by Clinical Laboratory Improvement Amendments. Findings include: 1. Review of MLE PT documents revealed the laboratory director failed to review and evaluate KOH Slide PT results of 2018 MLE - M3 Event, 2019 MLE-M1 Event, 2019 MLE-M2 Event and 2019 MLE-M3. 2. An interview with the practice administrator on 10/23/2020, in the break room at approximately 01:40 p.m., confirmed and verified that (MLE) PT results forms were not reviewed and signed by the laboratory director. 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 document review and an interview with the practice administrator, the lab 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 -- failed to document

Summary Statement of Deficiencies D0000 An initial Clinical Laboratory Improvement Amendments (CLIA) survey was completed on July 3, 2018. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 3, D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on laboratory document review and staff interview, the laboratory failed to establish and follow written policies and procedures to assess testing personnel (TP) competency. Findings include: 1. Laboratory document review revealed the laboratory failed to establish and follow written policies and procedures, using the 6-procedure requirements, to assess TP competency. 2. An interview with the office manager in the laboratory area on 7/3/18 at approximately 12:30 p.m. confirmed written policies and procedures to assess TP competency were unavailable at the time of survey D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on laboratory document review and staff interview, the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and correct problems as required. Findings include: 1. Laboratory document review revealed the laboratory failed to establish and follow written policies and procedures to monitor, assess, and correct problems in all phases of laboratory testing. 2. An interview with the office manager in the laboratory area on July 3, 2018, at approximately 12:30 p.m. confirmed there was not a laboratory quality assessment policy and procedure available at the time of survey. 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 review of laboratory documents and staff interview, the laboratory failed to provide a policy and procedure manual (SOP) for all tests, assays, and examinations performed by the laboratory. Findings include: 1. Laboratory document review revealed the laboratory failed to provide an SOP for the following tests, assays, and examinations: Potassium Hydroxide (KOH) testing. 2. An interview with the office manager on 7/3/18 in the laboratory area at approximately 12:30 p.m. confirmed a laboratory SOP was not available at the time of survey. 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)