Radiant Dermatology And Aesthetics Pllc

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 11/18/2024. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. STANDARD LEVEL DEFICIENCIES were cited. D3013 FACILITIES CFR(s): 493.1101(e) Records and, as applicable, slides, blocks, and tissues must be maintained and stored under conditions that ensure proper preservation. This STANDARD is not met as evidenced by: Based on staff interview, review of laboratory's policies/procedures, temperature records and annual case volumes, the laboratory failed to ensure temperature and humidity for storage/preservation of patient specimen slides was defined and monitored for one of one slide storage area used by the laboratory. Findings included: 1. In an interview on 11/18/2024 at 1000 hours in the breakroom the laboratory's histotechnologist stated that patient specimen slides were stored at the nursing station area. She also indicated that the area was not monitored for temperature or humidity to ensure slide preservation. 2. Review of laboratory's policies/procedures revealed the laboratory did not have in place protocols defining required temperature/humidity for storage of patient specimen slides to ensure their preservation. 3. Review of laboratory's temperature/humidity records revealed there was no documentation of environmental monitoring for the patient specimen slide storage area. 4. Review of laboratory's annual case volumes for 2023 revealed the laboratory performed testing on patient sample slides for 622 cases annually. 5. In an interview on 11/18/2024 at 1030 hours in the office, the facility's Practice Manager (as indicated on submitted Survey Entrance/Exit Conference document) confirmed the findings. D5781

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 44697 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the laboratory policy Quality Control Policy in section VIII, H&E Quality control (QC) logs from 5/1/2019 to 4/21/21, patient final reports, and confirmed in an interview the laboratory failed to document H&E stain quality for 4 of 20 days reviewed. The findings were: 1. Review of Quality Control policy in section VIII revealed: "A control slide will be made and evaluated each day that a frozen section is prepared. A record of the control slide will be maintained. The first slide from the first Mohs case may serve as the control slide for each day." 2. Review of H&E QC logs from 5/1/2019 to 4/21/21 revealed the laboratory failed to document H&E stain quality for 4 of 20 days. 6/24/19 7/29/19 9/16/19 4/9/21 3. Random review of patient reports from 5/1/2019 to 4/21/21 revealed the laboratory performed the following 7 patients with no documentation of the H&E stain quality. 6/24/19 Case# 179 and Case# 183 7/29/19 Case# 221 9/16/19 Case# 282 and Case# 285 4/9/21 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 -- Case# 125 4. An interview with the practice manager on 4/21/21 at 11:00am in the office confirmed the above findings. D5785

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. 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 review of the 2017 and 2018 personnel records, laboratory policies, and confirmed in interview, the laboratory failed to establish policy and procedures to assess competency for 1 of 1 general supervisor, 1 of 1 technical supervisors and 1 of 1 testing personnel. Findings were: 1. Review of the laboratory records available revealed no documentation of a policy and procedure to assess competency for 1 of 1 general supervisor , 1 of 1 technical supervisor and 1 of 1 testing personnel (hire date 11/27/01). 2. An interview with the office manager on 1/8/19 at 1035 hours in the laboratory confirmed the above findings. She was unaware the laboratory was required to perform the competencies. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory records and confirmed in an interview, the laboratory failed to document at least twice annually the accuracy of 1 of 1 tests in 2017 and 2018. (Mohs) Findings were: 1. A review of laboratory testing records from 2017 revealed no documentation of the laboratory verifying the accuracy for the Mohs test for 2017. 2. A review of laboratory testing records from 2018 revealed 1 of 2 documentation of the laboratory verifying the accuracy for the Mohs test for 2018. No documentation was provided for the 2nd annual accuracy assessment for 2018. 3. An interview with office manager on 1/8/19 at 1050 hours in the laboratory confirmed the above findings. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the laboratory policies, laboratory records, and confirmed in interview, the laboratory director failed to establish and maintain a quality assessment policy to identify and detect problems in the laboratory. Refer to D5217 D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must 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 review of the laboratory records and confirmed in interview, the laboratory director failed to ensure the laboratory established policies and procedures to assess competencies for 1 of 1 technical supervisor, 1 of 1 general supervisor, and 1 of 1 testing personnel performing Mohs histopathology testing. Refer to D5209 D8105 BASIC INSPECTION REQUIREMENTS CFR(s): 493.1773(e)(f)(g) (e) Reinspection. CMS or a CMS agent may reinspect a laboratory at any time to evaluate the ability of the laboratory to provide accurate and reliable test results. (f) Complaint inspection. CMS or a CMS agent may conduct an inspection when there are complaints alleging noncompliance with any of the requirements of this part. (g) Failure to permit CMS or a CMS agent to conduct an inspection or reinspection results in the suspension or cancellation of the laboratory's participation in Medicare and Medicaid for payment, and suspension or limitation of, or action to revoke the -- 2 of 3 -- laboratory's CLIA certificate, in accordance with subpart R of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's Certificate of Registration, review of the 2016- 2018 patient test records, and staff interview, the laboratory failed to obtain a CLIA certificate prior to performing patient samples for Mohs histopathology tests. The findings were: 1. A review of the laboratory's Certificate of Registration revealed the laboratory's certificate was issued by CMS on 03/10/17. 2. A tour of the facility on 1/8 /19 at 0955 hours revealed the laboratory stored patient slides in the nursing area. Review of the slides stored revealed the laboratory performed 37 Mohs patient testing from 10/15/16 to 3/4/17, prior to the CLIA certificate of registration effective date of 03/10/17. Patient ID RD16-01 RD16-02 RD16-03 RD16-04 RD16-05 RD16-06 RD16-07 RD16-08 RD16-09 RD16-10 RD16-11 RD16-12 RD16-13 RD16-15 RD16- 16 RD16-17 RD16-18 RD17-01 RD17-02 RD17-03 RD17-04 RD17-06 RD17-07 RD17-08 RD17-09 RD17-10 RD17-11 RD17-12 RD17-13 RD17-14 RD17-15 RD17- 16 RD17-17 RD17-18 RD17-19 RD17-20 RD17-21 3. An interview with the laboratory manager on 1/8/19 at 1045 hours in the office confirmed the laboratory performed Mohs patient testing prior to 3/1017. She was unaware the laboratory didn't have the correct CLIA certificate to perform Mohs testing prior to change of ownership. -- 3 of 3 --