Georgetown Dermatologists 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 record review and interview with the Office Manager, the laboratory failed to ensure testing personnel competency was performed for 1 (Testing Personnel #1) of 2 testing personnel listed on Form CMS-209 performing Scabies and Potassium Hydroxide (KOH) preparations. Findings include: 1. A review of the laboratory's Michigan Dermatological Society Certificates of Completion for Testing Personnel #1 revealed a lack of documentation for exams completed in 2022 for Scabies and KOH preparations. 2. A review of patient test records revealed a total of three patients had received Scabies or KOH preparation testing in 2022. 3. An interview on 3/8/23 at 10: 50 am with the Office Manager revealed the laboratory used the Michigan Dermatological Society exams to meet the testing personnel competency requirements for Testing Personnel #1 and they had not been completed in 2022. 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 record review and interview with the Office Manager, the laboratory failed to verify the accuracy of its Scabies and Potassium Hydroxide (KOH) preparations at 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 -- least twice annually for 1 (2022) of 2 years reviewed. Findings include: 1. A review of the laboratory's "Potassium Hydroxide (KOH) Examination" procedure revealed a section titled "Quality Control" stating, "Quality control will consist of one or both of the following: 1. Successfully participating in the laboratory assessment program held biannually through the Michigan Derm. Society. 2. Successfully interpreting slides and having slides reviewed by another practicing dermatologist twice yearly. 3. Two successful completions of the above activity constitutes adequate Quality Control." 2. A review of the laboratory's "Ectoparasites" procedure revealed a section titled "Quality Control" stating "Quality control will consist of one or both of the following: 1. Successfully participating in the laboratory assessment program held biannually through the Michigan Derm. Society. 2. Successfully interpreting slides and having slides reviewed by another practicing dermatologist twice yearly. 3. Two successful completions of the above activity constitutes adequate Quality Control." 3. A review of the laboratory's Michigan Dermatological Society Certificates of Completion for Testing Personnel #1 revealed a lack of documentation for exams completed in 2022 for Scabies and KOH preparations. 4. A review of patient test records revealed a total of three patients had received Scabies or KOH preparation testing in 2022. 5. An interview on 3/8/23 at 10:50 am with the Office Manager revealed Michigan Dermatological Society exams had not been completed in 2022 and no documentation of slide interpretation by a second provider was present. -- 2 of 2 --

Summary Statement of Deficiencies D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: The laboratory director failed to provide overall management and direction for 2 (August 2017 to August 2019) of 2 years. Findings include: 1. The laboratory director failed to establish an acceptable Individualized Quality Control Plan (IQCP) to assure the quality of fungal cultures. Refer to D6020. D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: . Based on record review and interview with the office manager, the laboratory director failed to establish an acceptable Individualized Quality Control Plan (IQCP) to assure the quality of fungal cultures for 2 (August 2017 to August 2019) of 2 years. Findings include: 1. A record review of the laboratory's established Individualized Quality Control Program (IQCP) showed lack of laboratory director review and 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 -- approval. 2. . A review of the laboratory's IQCP revealed a section titled "Risk Assessment" and did not contain the following components: a. The identification and evaluation of potential failures and sources of errors in the testing process and the frequency and impact of those failures and sources of error on test quality. b. Documentation of all activities completed for the risk assessment decisions. c. Data to support the laboratory's risk assessment decisions including in-house data, established by the laboratory in its own environment and by its own personnel demonstrating the stability of the test system as it is used in the laboratory supports the number and frequency of the quality control documented in the quality control plan. 3. A review of the laboratory's IQCP revealed a section titled "QCP" and did not contain a description of the practices, resources, and procedures to control the quality of the fungal culture test process. The quality control plan did not contain the number, type, frequency of testing and criteria for acceptable result(s) of the quality control. 4. A review of the laboratory's IQCP revealed a section titled "QA" and did not contain procedures for the ongoing monitoring of the effectiveness of their IQCP. 5. An interview on 8/13/19 at 10:45 am with the office manager confirmed the IQCP was in use by the laboratory. -- 2 of 2 --