Forefront Dermatology, Sc Dba Advanced Dermatology

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. The condition not met was: 493.1487 D6168 Condition: Laboratories performing high complexity testing; testing personnel Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representatives were given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor observation of manufacturer labeling, and confirmed in interview of facility personnel, the laboratory failed to ensure expired items were not available for use in patient testing. The findings were: 1. This is a repeat deficiency from the survey dated January 25, 2017. 2. Surveyor observation at 13:15 hours in the laboratory during the initial tour of the laboratory found the following expired items located in the flammable cabinet: a. Eosin (Lot 049298): expiration date: 10-2018 b. Scott Tap Water Substitute (Lot 1730005): expiration date: 11-01-2018 3. In an interview with the practice manager at 15:10 hours in the hallway on December 13, 2018, the findings were confirmed. 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. 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 -- This STANDARD is not met as evidenced by: Based on patient final reports and confirmed in interview of facility personnel, the laboratory failed to include the facility's name and address on patient final reports. The findings were: 1. On December 13, 2018 at 13:40 hours in the practice manager's office 5 random cases from 2017 and 2018 were requested for review. The original pathology report, slides, final Mohs report, and the Mohs maps were requested. The documentation provided included the original pathology report, slides, and the Mohs maps. The histotechnologist confirmed that the Mohs map was the final Mohs report. 2. Review of the 5 of 5 cases revealed the final report did not include the name of the facility or the facility's address. 3. An interview with the practice manager at 14:50 hours in the office confirmed the findings. -- 2 of 2 --