Palm Harbor Dermatology Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Palm Harbor Dermatology on 11/12/2024-11/14/2024. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D6063-Moderate Laboraotry Testing Personnel D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of the Laboratory Personnel Report, personnel records, and staff interview, the laboratory failed to verify the educational qualifications for 1 Moderate Complexity Testing Personnel of 2 Moderate Complexity Testing Personnel (TP #B and TP #C). (See D6065) D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of 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 -- Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of the Laboratory Personnel Report, personnel records, and Lab Coordinator interview, the laboratory failed to verify the educational qualifications for 1 Moderate Complexity Testing Personnel of 2 Moderate Complexity Testing Personnel (TP #B and TP #C). Findings included: Review of the Laboratory Personnel Report, signed by the Lab Director on 11/11/2024, revealed two Moderate Testing Personnel (TP #B and TP #C). Review of TP #C''s personnel record showed there was no education available for review or evaluation of the equivalence to a United States Diploma. The Lab Coordinator confirmed on 11/12/2024 at 4:30 pm and via email 11/13/2024 at 5:59 pm, the requested proof of education and evaluation of the equivalence to a United States Diploma for TP #C was not available for review. -- 2 of 2 --

Summary Statement of Deficiencies 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 laboratory record review and interview with the Histotechnologist, the Laboratory Director failed to maintain quality assurance activities. Findings included: During the laboratory record review, it was found that documentation of quality assurance activities were missing from the laboratory records. During an interview on 05/15/2018 at 10:15 AM, the Histotechnologist confirmed that the laboratory was not documenting quality assurance activities. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --