Schweiger Dermatology Group

Summary Statement of Deficiencies 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 record review and interview with the assistance general manager (AGM), the LD failed to provide overall management and direction in accordance with 42 CFR 493.1445 from 08/30/2022 to 05/14/2024. Findings include: 1. The laboratory director failed to ensure that quality assessment programs were maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. Refer to 6094. 2. The laboratory director failed to establish and maintain competency assessment for each supervisor and laboratory personnel involved in preanalytical, analytical, and post analytical phases of testing. Refer to D6103. 3. The laboratory director failed to ensure the maintenance of acceptable levels of analytical performance for each test system. Refer to D6095. 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 Quality Assurance policy, Monthly Patient Quality Assurance Checklists, and interview with the Assistant General Manager (AGM), the laboratory 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 -- director (LD) failed to ensure quality assessment (QA) programs were followed to assure the quality of laboratory services provided from 08/30/2022 to 05/14/2024. Findings Include: 1. The laboratory's Quality Assurance procedure states, "The lab director will also review and sign off the checklist monthly." 2. On the day of survey, 05/14/2024 at 11:30 am, review of the Monthly Patient Quality Assurance Checklist revealed the LD failed to review and sign off the monthly QA checklists for the following 8 of 16 months from September 2022 to December 2023. 2022- September, October, November, and December 2023- April, May, June, and December 3. The AGM confirmed the findings above on 05/14/2024 around 1:00 pm. ****** Repeat Deficiency****** D6095 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(6) The laboratory director must ensure the establishment and maintenance of acceptable levels of analytical performance for each test system. This STANDARD is not met as evidenced by: Based on lack of documentation, review of procedure manual, and interview with the Assistant General Manager (AGM), the laboratory director (LD) failed to ensure the daily maintenance for 1 of 1 Cryostat was documented when macroscopic histopathology examinations were performed in 2023. Findings include: 1. The laboratory's Cryostat Maintenance manual stated "the machine is wiped daily with dry gauze, to collect waste material Then wiped with gauze containing 100% alcohol to disinfect. Wiped again with a dry gauze and ready for Next Day." 2. On the date of survey, 05/14/2024 at 12:00 pm, the laboratory failed to provide documentation for the daily maintenance performed on 1 of 1 Avantik QS-12 Cryostat when histopathology examinations were performed in 2023. 3. The AGM confirmed the findings above on 05/14/2024 at 1:00 pm. 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 procedure manuals and interview with the Assistant General Manager (AGM), the laboratory director (LD) failed to establish and follow a competency assessment procedure to assess 1 of 1 Clinical Consultant (CC), 1 of 2 Technical Supervisors (TS) and 1 of 1 testing personnel (TP) for their supervisory and testing responsibilities for histopathology examinations performed from 8/30/2022 to the day of survey. Findings Include: 1. On the day of survey, 05/14/2024 at 11:54 am, the laboratory could not provide a competency assessment procedure to assess the competency for 1 of 1 CC (CMS 209 TP #1), and 1 of 2 TS (CMS 209 TP # 1) for their supervisory responsibilities from 08/30/2022 to 05/14/2024. 2. The laboratory could not provide competency assessment documentation for 1 of 1 CC (CMS 209 TP -- 2 of 3 -- #1), 1 of 2 TS (CMS 209 TP # 1) for 2022 and 2023. 3. The laboratory failed to provide competency assessment for 1 of 1 TP who performed histopathology examinations in 2022 and 2023. 4. The AGM confirmed the findings above on 05/14 /2024 around 1:00 pm. -- 3 of 3 --

Summary Statement of Deficiencies 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 laboratory procedure manuals and interview with the Office Manager, the laboratory failed to establish a competency assessment procedure to assess 1 of 2 Clinical Consultants (CC) for their supervisory responsibilities from 07 /29/2020 to the day of survey. Findings Include: 1. On the day of survey, 08/30/2022 at 10:30 am, the laboratory could not provide a competency assessment procedure to assess the competency for 1 of 2 CC (CMS 209 Personnel #2) from 7/29/2020 to 08/30 /2022. 2. The Office Manager could not provide competency assessment documentation for 1 of 2 CC from 07/29/2020 to 08/30/2022. 3. The Office Manager confirmed the findings above on 08/30/2022 around 11:00 am. 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 Quality Assurance policy, review of Monthly Patient Quality Assurance Checklists and interview with the Office Manager, the laboratory director (LD) failed to ensure quality assessment (QA) programs were followed to assure the 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 -- quality of laboratory services provided from August 2020 to May 2022. Findings Include: 1. The quality assurance procedure states, "The lab director will also review and sign off the checklist monthly." 2. On the day of survey, 08/30/2022 at 10:04 am, review of the Monthly Patient Quality Assurance Checklist revealed that the LD did not review and sign off the monthly QA checklists from August 2020 to May 2022. 3. The Office Manager confirmed the findings above on 08/30/2022 around 11:00 am. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of the laboratory competency assessment records and interview with the Office Manager, the Technical Supervisor (TS) failed to evaluate the annual competency assessment for 1 of 2 Testing Personnel (TP) who performed MOHS Micrographic surgery slides examined from 07/29/2020 to the day of survey. Findings include: 1. On the day of survey 08/30/2022 at 10:07 am, the Office Manager could not provide competency assessment records for 1 of 2 TP (CMS 209 personnel #2) who performed MOHS Micrographic surgery slide examinations from 07/29/2020 to the day of survey. 2. The laboratory performed 375 MOHS Micrographic surgery slide examinations in 2021 (CMS 116 annual volume). 3. The Office Manager confirmed the findings above on 08/30/2022 around 11:00 am. -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of laboratory quality control (QC) records and interview with the office manager, the laboratory failed to retain QC records for Potassium Hydroxide (KOH), scabies and frozen section examinations analyzed from 02/28/2018 to 09/04 /2018. Findings include: 1. On the day of survey, 07/29/2020, the laboratory could not to provide QC records for KOH, scabies and frozen section examinations performed from 02/28/2018 to 09/04/2018. 2. The office manager confirmed the above finding on 07/29/2020 around 12:15 am. 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: A. Based on review of competency assessment records and interview with office manager, the laboratory failed to assess the competency for 4 of 5 testing personnel (TP) who performed KOH and Scabies in 2018, 2019 and 2020. Findings include: 1. On the day of survey, 07/29/2020, review of TP competency assessment recorded reviewed, the laboratory did not document competency assessment separately for 4 of 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 -- 5 TP performing KOH and Scabies examinations analyzed in 2018, 2019 and 2020. 2. The office manager confirmed the above finding on 07/29/2020 around 10:15 am. B. Based on review of the laboratory policies and interview with the office manager, the laboratory failed to establish a competency assessment policy to assess the competency for 4 of 5 personnel for their regulatory responsibilities in 2018, 2019 and 2020. Findings include: 1. On the day of survey, 07/29/2020, the laboratory could not provide a competency assessment policy or documented competency assessments for 4 of 5 personnel (On the CMS 2019 Testing Personnel form, listed as a clinical consultant and as a technical supervisor) in 2018, 2019 and 2020. 2. The office manager confirmed the above finding on 07/29/2020 around 10:15 am. D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with office manager, the laboratory failed to establish a test requisition for Potassium Hydroxide (KOH) and Scabies examinations analyzed from 02/28/2018 to the day of survey. Findings include: 1. On the day of survey, 07/29/2020, the laboratory could not to provide test requisitions for KOH and Scabies examinations analyzed from 02/28/2018 to 07/29 /2020. 2. The laboratory performed the following number of tests in 2018, 2019 and 2020: - 2018 (02/28/2018 to 12/31/2018) KOH - 43 Scabies - 8 - 2019 KOH - 31 Scabies - 5 - 2020 (01/01/2020 to 07/29/2020) KOH - 14 Scabies - 2 3. The office manager confirmed the above finding on 07/29/2020 around 10:35 am 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 records and interview with the office manager, the laboratory failed to establish a patient test report for Potassium Hydroxide (KOH) and Scabies examinations analyzed from 02/28/2018 to the day of survey. Findings include: 1. On the day of survey, 07/29/2020, the laboratory could not to provide patient test reports for KOH and scabies examinations analyzed from 02/28/2018 to 07 /29/2020. 2. The laboratory performed the following number of tests in 2018, 2019 and 2020: - 2018 (02/28/2018 to 12/31/2018) KOH - 43 Scabies - 8 - 2019 KOH - 31 Scabies - 5 - 2020 (01/01/2020 to 07/29/2020) KOH - 14 Scabies - 2 3. The office manager confirmed the above finding on 07/29/2020 around 10:37 am. -- 2 of 2 --