Martinsville Dermatology And Skin Surgery Center

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Martinsville Dermatology and Skin Surgery Center on 05/04/23 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on tour of the laboratory, review of manufacturer's Safety Data Sheet (SDS), policy and procedures (P&P) and interview, the laboratory failed to follow manufacturer's instructions for disposing the StatLab XS-3, Xlyene Substitute reagent utilized to fix Mohs histological samples to examination glass slides at the date of survey on 05/04/23. Findings include: 1. A tour of the laboratory on 05/04/23 at approximately 11:15 AM revealed the laboratory utilizes the StatLab XS-3, Xlyene Substitute reagent utilized to fix Mohs histological samples to examination glass slides for microscopic review. During the tour, the inspector asked the laboratory manager and testing personnel how they dispose of the xylene substitute reagent. In conjunction they stated, "we pour the reagent down the utility sink with copious amounts of water." 2. Review of the SDS for the Xylene substitute reagent revealed the following instructions, "Section 6 Environmental Precautions- Prevent entry to sewers and public waters, Avoid release to the environment. Collect spillage." "Section 13: Disposal Considerations, Waste Disposal Recommendations- Dispose of contents/container in accordance with local, regional, national, territorial, provincial, and international regulations. Ecological- Waste Materials- Avoid release to the environment. This material is hazardous to the aquatic environment. Keep out 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 -- sewers and waterways." 3. Review of P&P revealed the following statements, "Reagent, Storage, Use and Handling- Reagents are disposed of according to federal, state, and local law. Material Safety Data Sheets are located online at Medtrainer. com." 4. An exit interview with the laboratory manager and testing personnel on 05/04 /23 at 11:35 AM confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Martinsville Dermatology and Skin Surgery Center on August 24, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: 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 the tour of the laboratory, review of policy and procedures (P&P), available microscope maintenance records, lack of documentation and interviews, the laboratory failed to retain the preventative maintenance (PM) documents for the two microscopes in the calendar year 2020. Findings include: 1. The entrance tour of the laboratory on 08/24/21 at approximately 9:15 AM revealed two microscopes (Olympus BX43 and Labomed) utilized to perform histological examination of Mohs tissue samples. 2. Review of the P&P, "Microscope Use Protocol" (approved by the lab director 11/01/19) revealed the following statement, "Preventative maintenance /grounding check is monitored yearly." 3. Review of available microscope maintenance documents revealed PM performed by an external company on 08/11/21. During an interview with on 08/24/21 at approximately 12:40 PM with Testing Personnel A (TP A), the inspector requested documentation to review of the PM performed for the two microscopes in the calendar year 2020. They stated that the sticker was removed from 2020 when the maintenance was performed on 08/11/21 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- and that they did not have the documentation from the external company for review. 4. An exit interview with the laboratory director, office manager and TP A on 08/24 /21 at approximately 1 PM confirmed the findings. 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 the review of policy and procedures (P&P), lack of documentation, and interviews, the laboratory failed to follow the established policy for reviewing every thirtieth Mohs case for acceptable results by peer review for nineteen (19) of 19 months reviewed. Dates of record review 01/01/20 up to 07/31/21. Findings include: 1. Review of the P&P "Skin Surgery Center Quality Assessment Plan" (approved by the lab director 11/01/19) revealed the following statement, "Proficiency Testing" - "Every 30th Mohs case will be sent to dermatopathologist at the affiliated site for review and evaluation. The results will be recorded and reviewed by the laboratory director. The director will carefully evaluate any unacceptable, unsatisfactory, or unsuccessful result in an effort to identify the cause of failure." "Comparison of Test Results"- "Frozen section slides from every thirtieth Mohs case are reviewed by the dermatopathologist. If a discrepancy is discovered, the slides and map are returned to the appropriate surgeon who will then make a decision on how to proceed." 2. The inspector requested to review the documentation for peer review according to the established policy on 08/24/21 at approximately 11:15 AM. The documentation was not available for review. 3. An exit interview with the laboratory director, office manager and TP A on 08/24/21 at approximately 1 PM confirmed the findings. 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 observation of testing procedures, policy and procedure (P&P), lack of documentation and interview, the laboratory failed to provide an established written protocol for identifying Mohs tissue sample transportation from the surgical room to the laboratory for the two (2) of 2 patients observed at the date of survey on 08/24/21. Findings include: 1. Observation of testing procedures for patient A and patient B on 08/24/21 at approximately 10:32 AM revealed transportation of the Mohs tissue samples from the surgical room to the laboratory on a surgical gauze, covered with a petri dish top. The tissue sample(s) placed on the grossing block and the Mohs surgical map(s) placed on the side of the grossing table. The tissue sample(s) for patient A and patient B lacked identification. 2. Review of the P&P for Mohs surgical testing revealed lack of documentation of a protocol for labeling/identifying the Mohs -- 2 of 3 -- tissue sample from the time of collection and transportation to the laboratory. 3. An exit interview with the laboratory director, office manager and TP A on 08/24/21 at approximately 1 PM confirmed the findings. D6127 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on the review of Laboratory Personnel Report Form (CLIA) (CMS-209 Form), testing personnel (TP) records, lack of documentation, and interview, the technical supervisor (TS) failed to perform the semi-annual competency assessment for one (1) TP in 2020. Findings include: 1. Review of the CMS-209 Form revealed the laboratory director performs the duties of TS and TP A performs patient testing. 2. Review of TP A records revealed initial assessment performed in November 11, 2019 and lack of documentation of a semi-annual competency assessment in the calendar year 2020. (See attached list Personnel Code list.) 3. An exit interview with the laboratory director, office manager and TP A on 08/24/21 at approximately 1 PM confirmed the findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA Initial survey was conducted at the Martinsville Dermatology and Skin Surgery Center on November 5, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: A. Based on the review of the Laboratory Personnel Report Form (CLIA) (CMS-209 Form), testing personnel (TP) records, policy and procedures (P&P), lack of documentation, and interviews with the laboratory manager and TP, the lab director failed to ensure the laboratory maintained documentation of personnel education qualifications for one (1) of 2 TP at the date of survey on November 5, 2019 (Cross Reference D6171). B. Based on the review of the Laboratory Personnel Report Form (CLIA) (CMS-209 Form), testing personnel (TP) records, policy and procedures (P&P), patient testing records, and interviews with the laboratory manager and TP, the lab director failed to ensure the performance and documentation of initial training and competency assessment for one (1) of 2 TP and seventy-five (75) patients performed from August 19, 2019 up to October 14, 2019. Findings include: 1. Review of the CLIA CMS-209 Form and an interview with TP A at approximately 11:30 AM revealed that TP A was new and began inking and grossing Mohs histology tissue samples on August 19, 2019. (See attached TP code sheet). 2. Review of TP A records revealed an incomplete initial training and competency assessment prior to TP 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 3 -- inking and grossing histology tissue samples. The document lacked assessor information and the "Assessment of Problem Solving Skills" was blank. The laboratory director did not sign the document. 3. Review of Quality Assurance (QA) P&P (signed by lab director 11/01/19) revealed the following statements: "5. Personnel Competency Assessment"- "Policy"-Training and competency of all testing personnel will be ensured prior to testing patient specimens. "Procedure"- New personnel training will be provided by the clinical supervisor, technical consultant, and /or laboratory director." 4. Review of the patient testing records from August 19, 2019 up to October 14, 2019 revealed that TP A performed 75 patient samples. 5. An interview with the laboratory manager at approximately 12:45 PM confirmed the findings. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on the review of the Laboratory Personnel Report Form (CLIA) (CMS-209 Form), testing personnel (TP) records, lack of documentation, and interviews with the testing personnel (TP) and laboratory manager, the laboratory failed to maintain documentation of personnel education qualifications for one (1) of 2 TP at the date of survey on November 5, 2019 (Cross Reference D6171). D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training -- 2 of 3 -- program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on the review of the Laboratory Personnel Report Form (CLIA) (CMS-209 Form), testing personnel (TP) records, lack of documentation, and interviews with the testing personnel (TP) and laboratory manager, the laboratory failed to maintain documentation of personnel education qualifications for one (1) of 2 TP at the date of survey on November 5, 2019. Findings include: 1. Review of the CLIA CMS-209 form revealed that there were 2 TP. An interview with the laboratory manager and TP A at approximately 11:30 AM revealed that TP A performed the grossing and inking of Mohs histological tissue samples from August 19, 2019 up to October 14, 2019. 2. Review of the laboratory's personnel records revealed a lack of education documentation for TP A (See attached TP code sheet). The inspector requested to review the education documentation for TP A. The documentation was not available at the date of survey. 3. An interview with the laboratory manager at approximately 12:45 PM confirmed the findings. -- 3 of 3 --