Skinmd - Bielinski Dermatology Group Llc

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of laboratory's procedures manual, patients' test reports, and interview with the laboratory director, the test report did not indicate the name and address of the laboratory location where the test was performed. Findings include: 1. Review of the laboratory's procedures revealed that the laboratory sent biopsied tissue specimens to Consolidated Pathology Group for processing and staining. The stained slide is sent back to Dermatology & Dermatologic Surgery laboratory for interpretation (diagnosis). 2. On October 26, 2020 at 10:30 AM, the surveyor selected 10 patients test reports along with their corresponding slides. 3. Patients' test reports revealed that Consolidated Pathology Group performed the interpretation of the patient's slide for 1 of 10 patients' test reports reviewed. The address of Consolidated Pathology Group was not documented on the test report. 4. The laboratory director of Dermatology & Dermatologic Surgery signed and dated the final report. Not Consolidated Pathology Group. 5. On October 26, 2020 at 10:40 AM, the laboratory director confirmed the surveyor's findings. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) 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 laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of patients' test reports and interview with the laboratory director, the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, correct problems identified in the post analytic systems specified 493.1291. Findings: 1. There were no written procedures that describe the process the laboratory follows when there is a need to correct problems in the postanalytical systems. 2. Review of patients' test results revealed 1 of 10 patients test results was performed by a different laboratory. 3. Review of 10 patients' test results revealed, the name and address location of the laboratory performing the test was not documented on the final report for 1 of 10 patients test results reviewed. 4. On October 26, 2020 at 10:30 AM, the surveyor asked the laboratory director if any other patients tests are missing the name and address location, as well as the signature and date of the person interpreting the results. The laboratory director told the surveyor that there may be quite a few. 5. There is no documentation to show a corrected report was issued. 6. On October 26, 2020 at 10:40 AM, the laboratory director confirmed the surveyor's 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 observation, review, and interview; the laboratory failed to properly manage and evaluate the overall quality of the general laboratory systems and correct problems specified in 493.1239 for it Histopathology testing. Findings: 1. The laboratory failed to perform bi-annual evaluation of testing for histopathology. See D5217 2. The laboratory failed to have a comprehensive procedures manual that includes preanalytic, analytic, and post analytic instructions for histopathology testing. See D5403 3. The laboratory failed to have quality control procedures for its histopathology testing. See D5601 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 the laboratory's procedures manual, proficiency testing (PT) records, patients' test records and interview; the laboratory failed to perform bi-annual Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- method accuracy evaluations for histopathology testing for January 2017 through April 2018. Findings: 1. There were no procedures that described the laboratory's process for how it performs bi-annual verification of the accuracy of its histopathology procedures. 2. Review of PT records revealed that that there is a form titled, "Proficiency Testing: Derma pathology." The following information is documented on the form: a. Patient ID #; b. Lab # ; c. Date; d. Physician Reading (Laboratory Director); Consultation; e. Score (+/-); and f. Date Completed. There was no documentation to show that bi- annual method verification procedures were performed in 2017 and at least once between January to April 2018. 3. Review of patient's test records identified 9 of 9 patients' test records from 2017 through April 2018 for histopathology testing but no corresponding method accuracy evaluations were documented for the following records reviewed: a. P1 Biopsy Date 02/03/2017 b. P2 Biopsy Date 06/21/2017 c. P3 Biopsy Date 07/05 2017 d. P4 Biopsy Date 09/01 /2017 e. P5 Biopsy Date 11/21/2017 f. P6 Biopsy Date 12/22/2017 g. P7 Biopsy Date 01/31/2018 h. P8 Biopsy Date 02/28/2018 i. P9 Biopsy Date 03/07/2018 4. During survey date 05/09/18, the laboratory director confirmed the surveyor's findings. 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)