William E Freeman Md

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on January 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: D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of the standard operating procedures, the package insert, and staff interview the laboratory failed to read the Dermatophytic Fungi Culture(DTM) results, and the Nickerson Yeast Culture(Nickerson) results within the 14 day incubation time limit. Findings: 1. Based on review of the DTM and Nickerson test log, the laboratory failed to read the result within in the 14 day incubation time limit for testing. April 2018 thru December 2018, the laboratory failed to read 97 DTM results, and 16 Nickererson results within the 14 day incubation time limit, and 5 patients did not have results posted. 2. Staff interview with the Laboratory Director, and staff #2 (CMS 209 form), on January 23, 202, in the upstairs lab, at approximately 3:30 pm., confirmed that the laboratory failed to document results within the 14 day incubation time limit. 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 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 28, 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: D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on Proficiency Testing documentation for the year 2016, 2017 and 2018, and staff interview, the laboratory failed to enroll in a Proficienccy Testing(PT) program for the Potassium Hydrozide Preparation(KOH) and Dematophyte Test Media (DTM) being performed.. Reference: 2001 D2001 ENROLLMENT CFR(s): 493.801(a)(1)(2)(i) The laboratory must-- (1) Notify HHS of the approved program or programs in which it chooses to participate to meet proficiency testing requirements of this subpart. (2)(i) Designate the program(s) to be used for each specialty, subspecialty, and analyte or test to determine compliance with this subpart if the laboratory participates in more 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 -- than one proficiency testing program approved by CMS; This STANDARD is not met as evidenced by: Based on Proficiency Testing documentation for 2016, 2017, and 2018, and staff interview the laboratory failed to enroll in a Proficiency testing program for Potassium Hydroxide Preparation (KOH) and Dermatophyte Test Medium (DTM). Findings: 1. Staff interview with staff # 1 (CMS 209 form) on March 28, 2018, in the Surgical Center Nursing Station, confirmed that the Laboratory did not enroll in a Proficiency program for KOH and DTM testing. -- 2 of 2 --