Family Dermatology Specialists, Llc

Summary Statement of Deficiencies D0000 A Recertification survey was performed at Family Dermatology Specialists, LLC, CLIA ID 19D0456688, on November 21, 2024. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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: I. Based on review of the laboratory's policies, competency records, and interview with personnel, the laboratory failed to follow their established competency assessment policy for one (1) of one (1) testing personnel for 2023. Findings: 1. Review of the laboratory's competency policy revealed the "Director of the laboratory will assess the laboratory personnel annually by completing the competency form located in the form section of this manual." 2. Review of the laboratory's "Personnel Assessment" form revealed "CLIA guidelines require the semiannual assessment of personnel competency during the first year of test performance for Moderate or High Complexity testing. Thereafter, evaluation must be performed at least annually." The "Personnel Assessment" form included the six (6) monitors required. 3. Further review of the "Personnel Assessment" form for the Testing Personnel revealed the Laboratory Director did not perform an annual assessment in 2023. 4. In interview on November 21, 2024 at 11:06 am, the Medical Assistant confirmed the Laboratory Director did not perform the 2023 annual competency assessment for the Testing Personnel. II. Based on review of the laboratory's CMS-209 form, policies, competency records, and interview with personnel, the laboratory failed to follow Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- their established competency assessment policy for one (1) of one (1) personnel serving as Clinical Consultant, Technical Supervisor, and General Supervisor for 2023. Findings: 1. Review of the laboratory's competency policy revealed the "Director of the laboratory will assess the laboratory personnel annually by completing the competency form located in the form section of this manual." 2. Review of the laboratory's CMS-209 (Laboratory Personnel Report) form revealed the Testing Personnel also served as the Clinical Consultant, Technical Supervisor, and General Supervisor. 3. Review of the laboratory's competency records revealed a delegation of duties letter dated "October 15, 2018" that stated "This will be reviewed by the Lab Director at six months and twelve months the first year, then annually thereafter for accuracy and completeness." 4. Review of the "Annual Assessment of Delegations (CC, GS, TS)" for the Testing Personnel revealed the following tasks: "Reviewed QC Data, Proficiency testing performed and test methodology, QA program monitored for compliance, Monitored proficiency testing, Monitored patient management system, Testing personnel assessments reviewed and signed for lab personnel, If applicable, notify laboratory director of any situation that could affect laboratory's performance or safety of employees." 5. Further review of the "Annual Assessment of Delegations (CC, GS, TS)" revealed the Laboratory Director did not perform an assessment in 2023 for the Testing Personnel's duties as Clinical Consultant, Technical Supervisor, and General Supervisor. 6. In interview on November 21, 2024 at 11:06 am, the Medical Assistant confirmed the Laboratory Director did not perform the 2023 annual competency assessment for the Testing Personnel's duties as Clinical Consultant, Technical Supervisor, and General Supervisor. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and interview with personnel, the laboratory failed to have a complete policy for twice a year verification for Histopathology testing. Findings: 1. Review of the laboratory's policies under the "Proficiency Testing/Quality Assessment Program" section revealed "Proficiency by a consulting dermatopathologist or another Mohs surgeon will be done twice a year. This form is for evaluation of diagnostic abilities of the Mohs surgeon and the quality of the slides produced by the histotechnologist." 2. Further review of the "Proficiency Testing/Quality Assessment" policy revealed the laboratory failed to include

Summary Statement of Deficiencies D0000 A Certification survey was performed on December 21, 2022 at Family Dermatology Specialists, LLC, CLIA ID # 19D0456688. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5609 HISTOPATHOLOGY CFR(s): 493.1273(e)(f) (e) The laboratory must use acceptable terminology of a recognized system of disease nomenclature in reporting results. (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's policies, quality control logs, test menu, and interview with personnel, the laboratory failed to ensure the testing personnel documented the stain quality of the Toluidine Blue stains for Histopathology testing in 2021 and 2022. Findings: 1. Review of the laboratory's policies under the "Control Slides" section revealed "The first frozen section of the day (tumor tissue from the first lesion) serves as the stain control slide. It is checked by the histotechnician first and by the surgeon/pathologist when he/she becomes available." 2. Review of the laboratory's "Control Tissue Quality Log" for 2021 and 2022 revealed the Testing Personnel did not document the stain quality. 3. In interview on December 21, 2022 at 12:20 pm, the histotech and Laboratory Director stated the histotech performs the initial review of the stain quality and signs the quality log and the Laboratory Director reviews the log to verify the assessment was completed. The Laboratory Director confirmed the Testing Personnel does not document her assessment of the stain quality. 4. Review of the laboratory's test menu revealed the laboratory performs 253 Mohs (Histopathology) tests annually. 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 -- 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 patient test reports and interview with personnel, the laboratory failed to include the name and address of the laboratory where testing was performed for seven (7) of seven (7) patients reviewed. Findings: 1. Review of the following patient final reports revealed the name and address of the laboratory where the slide interpretation (testing) was performed was not included: M21-131 M21-201 M21-232 M22-030 M22-102 M22-148 M22-231 2. In interview on December 21, 2022 at 1:48 pm, the office manager confirmed the name and address of the laboratory where testing was performed was not included on the patient final test reports. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control 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 record review and interview with personnel, the Laboratory Director failed to ensure that a quality control program was maintained to assure the quality of laboratory testing. Refer to D5609. D6098 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(8) The laboratory director must ensure that reports of test results include pertinent information required for interpretation. This STANDARD is not met as evidenced by: Based on review of patient final reports and interview with personnel, the Laboratory Director failed to ensure patient final reports included required information. Refer to D5805. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Certification Survey was performed on October 11, 2018 at Family Dermatology Specialists, LLC, CLIA ID # 19D0456688. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. 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 record review and interview with personnel, the laboratory failed to include the name and/or address of the laboratory on patient final reports for Histopathology testing. Findings: 1. Review of random selection of Histopathology patient test records from October 24, 2017 through October 9, 2018 revealed the laboratory utilized an office visit form and "Operative Report" form for patient test results. 2. In interview on October 11, 2018 at approximately 10:30 am, Personnel 3 stated the laboratory utilizes the office visit and "Operative Report" forms as their patient reports. Personnel 3 stated the operative report is a more detailed report of the office visit that includes the doctor's electronic signature. 3. Review of the patient test reports revealed the office visit forms did not include the address of the laboratory. 4. Further review of the random selection of patient test reports revealed the following 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 -- five (5) of ten (10) patient reports reviewed did not include the name and/or address of the laboratory where testing was performed: May 1, 2018: Patient 1; laboratory name not listed on "Operative Report" June 26, 2018: Patient 2: laboratory name and address not listed on "Operative Report" July 10, 2018: Patient 3: laboratory name and address not listed on "Operative Report" September 11, 2018: Patient 4: laboratory name and address not listed on "Operative Report" October 9, 2018: Patient 5: laboratory name and address not listed on "Operative Report" 5. In interview on October 11, 2018 at approximately 10:47 am, Personnel 3 stated the office visit forms changed and currently include only the office logo. Personnel 3 stated the laboratory's address was removed from the form. Personnel 3 further stated testing for the identified patients was performed at their laboratory location. Personnel 3 stated she did not know why the "Operative Reports" for the identified patients included the name and/or address of a different laboratory. D6098 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(8) The laboratory director must ensure that reports of test results include pertinent information required for interpretation. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to ensure the patient test reports included pertinent information required for interpretation. Refer to D5805. 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 record review and interview with personnel, the Laboratory Director failed to ensure policies and procedures were maintained for assessing personnel competency, and whenever necessary, identify needs for remedial training or continuing education to improve skills. Findings: 1. Review of the laboratory's CMS- 209 form (Laboratory Personnel Report) revealed Personnel 2 serves as the laboratory's Testing Personnel. 2. Review of the laboratory's policies and procedures manual revealed a "Personnel Assessment" form that stated "CLIA guidelines require the semiannual assessment of personnel competency during the first year of test performance for Moderate or High Complexity testing. Thereafter, evaluation must be performed at least annually. Additionally, an individual's performance must be reevaluated with methodology or instrument changes. Personnel competency must be assessed by the Laboratory Director or Technical Consultant and will be an on-going process at this facility. Problems and/or supporting documentation will be noted in the comments section of this form." 3. In interview on October 11, 2018, Personnel 3 stated Personnel 2 was hired October 24, 2017. 4. Review of personnel records for -- 2 of 3 -- Personnel 2 revealed no documentation of performance of a semi-annual competency assessment. 5. In interview on October 11, 2018 at 10:00 am, Personnel 3 stated the Laboratory Director did not perform a competency assessment for Personnel 2's Testing Personnel duties. D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) The laboratory director must specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the Laboratory Director failed to provide a written job description for all Laboratory Personnel. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not have written job descriptions for the following personnel: a) Clinical Consultant b) Technical Supervisor c) General Supervisor d) Testing Personnel 2. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed Personnel 2 serves as the Clinical Consultant, Technical Supervisor, General Supervisor, and Testing Personnel. 3. In interview on October 11. 2018 at 10:00 am , Personnel 3 stated the laboratory did not have written job descriptions for the identified positions. Personnel 3 further stated the laboratory had a list of duties for Personnel 2 that the Laboratory Director assesses annually, which the laboratory thought was sufficient. -- 3 of 3 --

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --