Adarsh A Kumar Md

Summary Statement of Deficiencies D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: REPEAT DEFICIENCIES: Based on surveyor review of the laboratory records, lack of documentation, the Allegation of Compliance (AOC) submitted 10/11/2018, and interview with the office manager; the laboratory failed to properly manage and evaluate the overall quality of testing. The laboratory must meet the requirements in 493.1231 through 493.1236. Findings include: 1. The laboratory failed to verify the accuracy bi-annually for the Mycology, Parasitology and Histopathology testing performed during 2019 and 2020. See D5217. 2. The laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems. See D5291. 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: 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 -- REPEAT DEFICIENCY Based on record review, lack of documentation, the Allegation of Compliance (AOC) submitted 10/11/2018, and an interview with the office manager, the laboratory failed to verify the accuracy twice annually for Mycology, Parasitology, and histopathology biopsy interpretations performed during the years of 2019 thru 2020. Findings include: 1. The Quality Assessment (QA) Plan, patient test review logs, proficiency testing slide worksheets, the AOC submitted on 10 /11/2018, and test volume worksheets were reviewed. 2. Review of the patients' test review logs and proficiency testing (PT) slide worksheets revealed that twice annual PT for Histopathology, Mycology, and Parasitology were not performed in 2019 and 2020. 3. The laboratory failed to follow the written QA plan submitted as an Allegation of Compliance in 10/11/2018 to perform bi-annual PT for Histopathology, Mycology, and Parasitology.. 4. The tests volume worksheets showed during 01/2020 through 01/2021, the laboratory performed the following patient tests: *Dermatopathology Test Medium (DTM) - 36; *Potassium Oxide (KOH) - 42; and *Histopathology slide interpretations - 532 5. On a Recertification survey conducted on 02/11/2021 at 3:15 PM, the office manager confirmed the above findings. 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: REPEAT DEFICIENCY Based on record review, lack of documentation, the Allegation of Compliance (AOC) submitted 10/11/2018, and an interview with the office manager, the laboratory failed to 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, during the years of 2019 thru 2020. Findings include: 1. The Quality Assessment (QA) Plan, patient test review logs, proficiency testing slide worksheets, and the AOC submitted 10/11/2018 were reviewed. 2. The laboratory's QA plan stated the following: *"This laboratory does proficiency testing with a local qualified dermatopathologist on a bi-annual basis for histopathology (10 samples); Mycology (Dermatophyte Test Medium (DTM) - 3 samples, KOH (potassium oxide) - 3 samples), and Parasitology (2 samples). If at any time, there are not enough samples to do Bi-annual testing the lab will order formal test kits from AAB (American Association of Bioanalysts) Proficiency testing Service..." 3. Review of the patients' test review logs and proficiency testing (PT) slide worksheets revealed that PT for Histopathology, Mycology, and Parasitology were not performed in 2019 and 2020. 4. Further review showed the laboratory failed to enroll with AAB PT Service during the above time period. 5. The laboratory failed to follow the written QA plan submitted as an Allegation of Compliance in 10/11/2018. 6. On a Recertification survey conducted on 02/11/2021 at 3:15 PM, the office manager confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of laboratory records and interview with the laboratory director (LD); the laboratory failed to properly monitor, evaluate, and maintain compliance since the last CLIA inspection of April 13, 2016. The laboratory must meet the requirements in 493.1231 through 493.1236. Findings Include: 1. The laboratory failed to perform bi-annual evaluations of testing for histopathology, mycology, and parasitology. See D5217. Repeat Deficiency. 2. The laboratory failed to monitor and follow the written quality assessment plan. The laboratory failed to ensure continued compliance since the 2016 CLIA survey. See D5291. Repeat Deficiency. 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 review of laboratory records and interview with the laboratory director (LD); the laboratory still fails to perform bi-annual method accuracy evaluations for Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- mycology, parasitology, and histopathology testing in 2016 through 2018. Findings Include: Repeat Deficiency 1. Review of PT records found no bi-annual verification documents to demonstrate accuracy for dermatophyte test medium (DTM) fungal cultures after previous allegation of compliance response completed in May of 2016. 2. Review of PT records found no bi-annual verification documents to demonstrate accuracy for KOH preparations, scabies examinations, and histopathology were completed in 2016 and 2017. Again, PT was completed for the above mentioned tests in May of 2016 as part of the allegation of compliance to the previous survey and then not completed again till January of 2018. 3. Review of the laboratory's policy and procedure manual identified the policy, "Quality Assessment Plan", on page 3, under the heading of "Proficiency Testing Program" which stated the following: "At least twice annually, the laboratory will verify accuracy of any test performed in each of the specialties. The bi-annual verification of testing will be sent to a qualified individual at another location of verify the accuracy of tests performed." Mycology: 1. Dermatophyte Test Medium Accuracy of DTM interpretation Ten (10) DTM samples inoculated with known samples will be sent to a qualified individual to verify the accuracy of DTM interpretations. 2.KOH Accuracy of KOH interpretations Three (3) KOH preparations with patient samples will be sent to another individual to verify the accuracy of KOH interpretations. Histopathology: Accuracy of slide interpretations Ten (10) slides will be sent to a qualified individual to verify accuracy of histopathology slide interpretations. Parasitology: Scabies Accuracy of slide interpretations Two (2) slides will be sent to another facility to verify accuracy of scabies slide interpretations." 4. PT performed for KOH (potassium hydroxide) and scabies preparations in January of 2018 only had evaluations for 1 slide of each test and not the 3 slides indicated in the PT policy for KOH and 2 slides indicated in the policy for scabies examination. 5. Interview with the LD on 04-04-2018 at 2:30 pm confirmed the laboratory had failed to perform the bi-annual method accuracy evaluations for Dermatophyte fungal cultures with DTM since May of 2016. The LD also confirmed bi-annual method accuracy evaluations failed to be performed as stated in the laboratory PT policy for histopathology, KOH, and scabies preparations after May of 2016 through April 4, 2018. 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 review of laboratory records and interview with the laboratory director (LD); the laboratory failed to follow the written policies for monitoring proficiency testing (PT) and failed to identify problems related to monitoring PT. Findings Include: Repeat Deficiency 1. No records were made available for review when requested by the surveyor. There were no records to demonstrate bi-annual method accuracy evaluations for KOH preparations, scabies examinations, dermatophyte test medium (DTM) fungal cultures, and histopathology testing as directed in the laboratory PT policy. See D5217. 2. Interview with the LD on 04-04-2018 at 2:30 pm confirmed the laboratory had failed to follow the quality assessment plan as described in the document "Quality Assessment Plan" for the twice per year verification of DTM and slide reading testing. -- 2 of 5 -- D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of laboratory records and interview with the laboratory director (LD); the laboratory failed to meet the applicable analytic systems requirements in 493.1251 through 493.1283. Findings Include: 1. The current laboratory procedures in use for scabies examinations, potassium hydroxide (KOH) preps, fungal cultures, and histopathology slide examinations failed to include all the required elements of a test procedure. See D5403. 2. The laboratory failed to perform quality control measures for fungal cultures. The laboratory failed to check each batch of dermatophyte test medium (DTM) for sterility, growth, inhibition of growth, and a biochemical response. See D5477. Repeat Deficiency. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)