Richardson Dermatology, Pllc

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of laboratory policy, patient test records, and confirmed in interview, the laboratory failed to ensure patient histopathology (Mohs) slides were labeled with at least 2 unique patient identifiers for 25 of 25 slides in 2023 (December random review) and 40 of 40 slides in 2024 (January random review). The findings include: 1. Review of laboratory policy stated the following: "Specimen Handling, Storage, Transport, Preservation and Identification ...Slides are labeled with accession number, patient name, date and specimen source (if applicable)." At the bottom of the policy under "Changes" was a handwritten statement dated on 04/05/2022 which stated "Slides will be labeled with pt last name" The laboratory policy did not include labeling instructions to reliably identify patients using at least 2 unique patient identifiers to distinguish between specimens. 2. A random review of patient slides from December 15, 2023, and January 2, 2024 revealed 65 slides labeled with a patient last name, Mohs accession number, and number of stages. The laboratory failed to ensure patient histopathology (Mohs) slides were labeled with at least 2 unique patient identifiers. 3. During an interview on 02/07/2024 at 1515 hours, the histotechnician confirmed the above findings. 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 --

Summary Statement of Deficiencies D0000 An entrance conference was held with the laboratory representatives. The survey process was discussed, and survey forms were provided. An opportunity for questions and comments was given. Noted deficiencies and plans of correction were discussed with the laboratory representatives at the exit conference. The laboratory representatives 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 NOT in compliance with the CLIA conditions for specialties /subspecialties surveyed for 42 CFR 493.1441 Laboratory Director, (high complexity) CMS form 2567 will be emailed from the Texas State Health and Human Services Commission, Health Facility Compliance Arlington Group. 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 procedure manual, "Proficiency Testing" records, and in interview with staff, the laboratory failed to ensure accuracy was verified for Mohs procedure for 2 or 2 events in 2018, 2 of 2 events in 2019 and 1 of 1 event in 2020 (not included in subpart I of this part). Findings: 1. Review of the laboratory's procedure manual (page 8) stated, "Since there do not seem to be any suitable, commercially available control materials for this procedure, randomly-selected sample slides will be sent every 6 months for peer review to another CLIA-certified laboratory (see Appendix D). Twice yearly the Director of operations (via calendar reminder) will initiate a peer review. The Clinical Coordinator or lab technician will ensure that the slides are sent. The Lab Director will compare results. The slides will be submitted to [Dr. Name]. Results will be kept in the front pocket of the instrument Control Log Binder." 2. Review of the laboratory's "Mohs Micrographic Surgery Skin 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 -- Specimens Proficiency Testing" records revealed the following: 08/21/2018 Patient #MV18-920 record stated, "Slide Interpretation: Agree with original dx; Additional Comments: Excellent sections; good staining" Mohs maps were included with diagnosis and stages. 11/26/2018 Patient #MV18-1353 record stated, "Slide Interpretation: Agree with original interpretation; Additional Comments: Very nice sections/staining quality" Mohs maps were included with diagnosis and stages. 07/15 /2019 Patient #MV19-787 record stated, "Slide Interpretation: Agree original interpretation; Additional Comments: Great sections" Mohs maps were included with diagnosis and stages. 12/20/2019 Patient #MV19-1661 record stated, "Slide Interpretation: Agree with original interpretation; Additional Comments: Excellent staining & complete sections" Mohs maps were included with diagnosis and stages. 07 /27/2020 Patient #MV20-780 record stated, "Slide Interpretation: Agree with original interpretation; Additional Comments: Excellent quality sections" Mohs maps were included with diagnosis and stages. The slide interpretation and additional comments were documented by the outside laboratory doctor. The outside doctor had access to the original interpretation of the Mohs slides. The laboratory did not ensure verification of accuracy with blind patient samples when submitted to an outside laboratory. 3. According to records, the laboratory's annual volume was 1600 histopathology tests. 4. During an interview on 01/07/2018 at 2:36 pm, the Medical Assistant (MA) was asked what was submitted to the outside doctor for twice annual verification, she stated, "The slides and Mohs map with patient demographics blacked out." The Mohs maps included diagnosis of patient Mohs slides, the diagnosis was not blacked out. Note this was a repeat deficiency from recertification survey conducted on 05/22/2018. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the laboratory's procedure manual, "Proficiency Testing" records, and in interview with staff, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6082. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual, "Proficiency Testing" records, and in interview with staff, the laboratory director failed to ensure that testing systems performed in the laboratory provided quality laboratory services for all aspects of test performance as evidenced by: 1. The laboratory failed to ensure accuracy was verified for Mohs procedure for 2 or 2 events in 2018, 2 of 2 events in 2019 and 1 of 1 events -- 2 of 3 -- in 2020 (not included in subpart I of this part). Refer to D5217. Note this was a repeat deficiency from recertification survey conducted on 05/22/2018. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An entrance conference was held 05/22/2018 with the Medical Assistant (MA) and the Laboratory Director. The survey process was discussed. An opportunity for questions and comments was given. Based upon the onsite survey conducted 05/22 /2018, this facility was found to be in substantial compliance for the specialties /subspecialties in which it was surveyed. An exit conference was held 05/22/2018 with the MA and the Laboratory Director. The standard level deficiencies cited were discussed. The process for submitting the corrections was explained. An opportunity for questions and comments was provided. 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 procedure manual, "Proficiency Testing" records and in interview with staff, the laboratory failed to ensure accuracy was verified for Mohs procedure in 11/2017 and 12/2017 (not included in subpart I of this part). Findings included: 1. Review of the laboratory's procedure manual (page 8) stated, "Since there do not seem to be any suitable, commercially available control materials for this procedure, randomly-selected sample slides will be sent every 6 months for peer review to another CLIA-certified laboratory (see Appendix D). Twice yearly the Director of operations (via calendar reminder) will initiate a peer review. The Clinical Coordinator or lab technician will ensure that the slides are sent. The Lab Director will compare results. The slides will be submitted to [Dr. Name]. Results will be kept in the front pocket of the instrument Control Log Binder." 2. Review of the laboratory's "Mohs Micrographic Surgery Skin Specimens Proficiency Testing" records revealed the following: 11/27/2017 - Patient #MV17-1064 record stated, "Slide Interpretation: Agree with original interpretation (BCC on Stage I; clear Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- margins on Stage II); Additional Comments: Excellent overall quality." Patient #MV17-1062 record stated, "Slide Interpretation: BCC present on Stage I, Margins clear on Stage II; Additional Comments: Agree with outside/original interpretation, great quality slides." Mohs maps were included with diagnosis and stages. 12/18/2017 - Patient #MV17-1183 record stated, "Slide Interpretation: Agree BCC present on Stage I, margins clear on Stage II; Additional Comments: Good quality slides, Agree with original interpretation." Patient #MV17-1181 record stated, "Slide Interpretation: Agree with outside interpretation (BCC on Stage I; clear margins on Stage II); Additional Comments: Excellent staining/quality." Mohs maps were included with diagnosis and stages. The slide interpretation and additional comments were documented by the outside laboratory doctor. The outside doctor had access to the original interpretation of the Mohs slides. The laboratory did not ensure verification of accuracy with blind patient samples when submitted to an outside laboratory. 3. According to records, the laboratory's annual volume was 1200 histopathology tests. 4. During an interview on 05/22/2018 at 2:20 pm, the Medical Assistant (MA) was asked what was submitted to the outside doctor for twice annual verification, she stated, "The slides, Mohs map, and op notes." The Mohs maps and operation notes included diagnosis of patient Mohs slides. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory policy manual, patient slides and confirmed in interview with MA, the laboratory failed to follow its own written policy for labeling patient slides with the collection date for 12 of 12 randomly selected MOHS patient slides for 2016, 2017 and 2018. (Note: Multiple slides were prepared for each individual patient case.) Findings include: 1. Review of the laboratory's policy manual stated, "Slides are labeled with accession number, patient name, date and specimen source (if applicable)." 2. Review of selected patient slides from 11 /2016, 09/2017, 12/2017, 02/2018, 03/2018, 04/2018, 05/2018 revealed the laboratory failed to follow its own written policy for labeling patient slides with collection date for the following identified patients: BX18-020 MV18-481 MV18-488 MV18-429 MV18-430 MV18-335 MV18-336 MV18-148 MV17-1216 MV17-808 E17-010 MV16-027 3. According to records, the laboratory's annual volume was 1200 histopathology tests. 4. During an interview on 05/22/18 at 04:20 PM, the MA confirmed the above 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 -- 2 of 4 -- 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)