Lakeway Dermatology Associates, Pc

Summary Statement of Deficiencies 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 a review of the laboratory's procedure manual and staff interview, the laboratory failed to establish a written policy for assessing testing personnel competency on the survey date (10.10.2024). The findings include: 1. A review of the laboratory's policy and procedure manual revealed no written policy for testing personnel competency assessments for the surveyor to review on the survey date (10.10.2024). 2. An interview with the Laboratory Director on 10.10.2024 at 10:50 a. m. confirmed thatthe laboratory did not have a written policy for testing personnel competency assessments. 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 observation of the laboratory, review of patient records, lack of documentation, and staff interview, the laboratory failed to verify the accuracy of the Hematoxylin and Eosin (H&E) stain twice a year in 2023. 1. Observation of the laboratory on 10.10.2024 at 8:45 a.m. revealed H&E reagents used for staining tissue removed during dermatology surgical procedures. 2. Patient record review revealed 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 -- the use of H&E stain reported on 02.03.2023 for patient number LDA23-0363 and on 02.06.2023 for patient number LDA23-0403. 3. There was no documentation that the laboratory verified H&E stain for accuracy twice a year in 2023. 4. An interview with the Laboratory Director on 10.10.2024 at 10:50 a.m. confirmed the laboratory did not send H&E slides for twice-a-year verification of accuracy in 2023. 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. This STANDARD is not met as evidenced by: Based on a review of the laboratory procedure manual and staff interview, the laboratory failed to establish a written policy or procedure defining the quality activities used to monitor, assess, and correct problems in the laboratory's testing systems on the survey date (10.10.2024). The findings include: 1. A review of the laboratory procedure manual revealed no policy or procedure defining the laboratory's quality assessment activities used to monitor, assess, and correct problems in the laboratory's testing systems for the surveyor to review on the survey date (10.10.2024). 2. An interview with the Laboratory Director on 10.10.2024 at 10:50 a. m. confirmed the above survey findings. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the Centers for Medicare & Medicaid Services Laboratory Personnel Report (Form CMS-209), review of personnel records, and staff interview, the technical consultant failed to perform an annual competency assessment for one of one testing personnel who performed potassium hydroxide (KOH), scabies, and Tzanck smear patient testing in 2023. The findings include: 1. Observation of the laboratory on 10.10.2024 at 8:45 a.m. revealed a microscope on the counter used for KOH, scabies, and Tzanck smear patient testing. 2. A review of Form CMS-209 revealed one testing personnel (TP) who perform moderately complex patient testing. 3. A review of personnel records revealed no documentation of annual competency assessment for TP3, as listed on Form CMS-209 in 2023. 4. Interview with the Laboratory Director on 10.10.2024 at 10:50 a.m. confirmed the above survey findings. -- 2 of 2 --

Summary Statement of Deficiencies D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: ____________________________________ Based on 3 of 3 testing personnel listed on the CMS-209 form "Laboratory Personnel Report (CLIA)" who perform KOH (potassium hydroxide) testing, lack of policy for monitoring testing personnel performing KOH testing, lack of competency documentation for 3 of 3 testing personnel performing KOH testing and interview with the Laboratory Director, the laboratory director failed to ensure a policy was in place to monitor testing personnel performing KOH testing for 2016, 2017 and 2018. The findings include: 1. Three testing personnel listed on the CMS-209 form who perform KOH testing. 2. Lack of policy for monitoring testing personnel performing KOH testing. 3. Lack of competency documentation for 3 of 3 testing personnel performing KOH testing for 2016, 2017 and 2018. 4. Interview at approximately 12:30 p.m. June 13, 2018 with the Laboratory Director confirmed there was no policy or competency documentation for monitoring 3 of 3 testing personnel listed on CMS-209 form who performed KOH testing since 2016. ____________________________________ 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 --