David B Minor, Md, Pc

Summary Statement of Deficiencies D0000 The recertification survey was performed on 07/28/2021. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the technical consultant at the conclusion of the survey. 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 a review of records and interview with the technical consultant, the laboratory failed to verify the accuracy of Fungal Culture, KOH, and Scabies testing at least twice annually. Findings include: (1) On 07/28/2021 at 09:30 am, the technical consultant stated to the surveyors the following testing was performed in the laboratory: (a) Fungal culture testing (positive/negative growth) using Acu-Mycosel media; (b) KOH (Potassium Hydroxide) testing as a PPM (Provider Performed Microscopy) procedure; (c) Scabies testing as a PPM procedure. (2) Surveyor #1 reviewed 2019, 2020, and to date in 2021 and identified the testing had not been verified for accuracy twice annually as follows: (a) Fungal Culture testing had not been verified for accuracy between 11/10/2019 and 06/24/2021; (b) KOH testing had not been verified for accuracy between 11/10/2019 and 06/24/2021; (c) Scabies testing had not been verified for accuracy prior to 06/24/2021. (3) The records were reviewed with the technical consultant who stated to surveyor #1 on 07/28/2021 at 10: 35, the testing had not been verified for accuracy at least twice annually as shown above. NOTE: D5217 was cited on the recertification surveys performed on 08/02 /2019. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) 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 -- (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor, the laboratory failed to have a policy for monitoring the effectiveness of their IQCP. Findings include: (1) On 07/28/2021 at 09:30 am, the technical consultant stated the following to the surveyors: (a) Fungal culture testing (positive/negative growth) was performed using Acu-Mycosel media; (b) An IQCP (Individualized Quality Control Plan) had been developed for the test system. (2) Surveyor #1 reviewed the IQCP (dated as approved on 11/05/2018). The section titled, "Quality Assessment: Ongoing Monitoring for QCP Effectiveness" required an annual review of the QCP (Quality Control Plan); (3) Surveyor #1 reviewed records for 2019, 2020, and to date in 2021 and could not locate annual QA reviews since the IQCP had been approved on 11/05 /2018; (4) The surveyor reviewed the records with the technical consultant and asked if there was documentation of QA reviews to evaluate the QCP annually. The technical consultant stated to surveyor #1 on 07/28/2021 at 10:10 am the QA reviews had not been performed annually as stated in the policy. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the technical consultant at the conclusion of the survey. 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 a review of records and interview with the technical consultant, the laboratory failed to verify the accuracy of KOH testing at least twice annually. Findings include: (1) At the beginning of the survey, the technical consultant stated to the surveyors KOH (Potassium Hydroxide) testing was performed as a PPM (Provider Performed Microscopy) procedure; (2) Surveyor #2 reviewed 2018 and 2019 records and identified the testing had not been verified for accuracy twice annually during 2018. Although the testing had been verified for accuracy towards the end of 2018 (11 /6,21,28/18 and 12/05/18), there were no records the testing had been verified for accuracy earlier in the year; (3) The records were reviewed with the technical consultant who stated he did not begin employment at the facility until November 2018 and KOH testing had not been verified for accuracy prior to November 2018. 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. 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 a review of records, manufacturer's instructions, and interview with the technical consultant, the laboratory failed to follow the manufacturer's instructions for performing fungal culture testing. Findings include: (1) At the beginning of the survey, the technical consultant stated the following to the surveyors: (a) Fungal culture testing (positive/negative growth) was performed using Acu-Mycosel media; (b) Cultures were incubated at room temperature (68-86 degrees F-Fahrenheit). (2) The surveyors reviewed the manufacturer's package insert for the Acu-Mycosel media. Under the heading "Procedure" it stated, "Examine the cultures after 24 hours and repeat daily. Culture tubes should be held for 4 weeks before being considered negative"; (3) The surveyors requested patient test records from 01/01/19 through the day of the survey. The technical consultant provided the surveyors with the patient "Fungal Culture Reading Logs"; (4) The surveyors reviewed 28 patient fungal culture records performed during the requested timeframe. The review verified the laboratory did not follow the manufacturer's instructions. The documentation verified the cultures were being examined on a weekly basis instead of being examined after 24 hours and repeated daily until the final result was reported for 28 of 28 patient records reviewed: (a) Record #1 - Inoculated on 01/02/19 (b) Record #2 - Inoculated on 01/08 /19 (c) Record #3 - Inoculated on 01/09/19 (d) Record #4 - Inoculated on 01/10/19 (e) Record #5 - Inoculated on 01/10/19 (f) Record #6 - Inoculated on 01/22/19 (g) Record #7 - Inoculated on 01/25/19 (h) Record #8 - Inoculated on 01/30/19 (i) Record #9 - Inoculated on 01/29/19 (j) Record #10 - Inoculated on 02/05/19 (k) Record #11 - Inoculated on 02/15/19 (l) Record #12 - Inoculated on 02/27/19 (m) Record #13 - Inoculated on 03/12/19 (n) Record #14 -Inoculated on 03/13/19 (o) Record #15 - Inoculated on 03/19/19 (p) Record #16 - Inoculated on 03/20/19 (q) Record #17 - Inoculated on 03/28/19 (r) Record #18 - Inoculated on 04/04/19 (s) Record #19 - Inoculated on 04/12/19 (t) Record #20 - Inoculated on 05/06/19 (u) Record #21 - Inoculated on 05/08/19 (v) Record #22 - Inoculated on 05/17/19 (w) Record #23 - Inoculated on 05/20/19 (x) Record #24 - Inoculated on 05/28/19 (y) Record #25 - Inoculated on 06/06/19 (z) Record #26 - Inoculated on 06/07/19 (aa) Record #27 - Inoculated on 06/11/19 (bb) Record #28 - Inoculated on 06/11/19 (5) The surveyors reviewed the records with the technical consultant who stated the cultures, as indicated above, had been examined on a weekly basis and not examined after 24 hours and repeated daily until the final result was reported. -- 2 of 2 --

Summary Statement of Deficiencies D0000 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 --