Laplace Dermatology Clinic

Summary Statement of Deficiencies D0000 A Recertification survey was performed at LaPlace Dermatology, CLIA ID 19D0457792, on May 23, 2024. 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 patient reports, quality control records, and interview with personnel, the laboratory failed to ensure testing personnel documented the stain quality for Hematoxylin and Eosin (H&E) stains for two (2) of eleven (11) random selection of patients. Findings: 1. Review of random selection of patient reports which included documentation of stain quality on each report, revealed the Laboratory Director, who serves as Testing Personnel, did not document the stain quality for the following two (2) patients: September 19, 2023: LP-328 March 13, 2024: LP-081 2. In interview on May 23, 2024 at 9:45 am, the Lead Medical Assistant stated the stain quality is documented on each patient report. The Lead Medical Assistant confirmed for the identified two (2) patients the stain quality was not documented. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 A Recertification survey was performed on July 6, 2022 at LaPlace Dermatology Clinic, CLIA ID # 19D0457792. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D3043 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(7) The laboratory must retain cytology slide preparations for at least 5 years from the date of examination (see 493.1274(f) for proficiency testing exception). The laboratory must retain histopathology slides for at least 10 years from the date of examination. The laboratory must retain pathology specimen blocks for at least 2 years from the date of examination. The laboratory must preserve remnants of tissue for pathology examination until a diagnosis is made on the specimen. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, patient histopathology slides, patient final reports, and interview with personnel, the laboratory failed to retain patient histopathology slides for at least ten (10) years after the date of examination for three (3) of eight (8) randomly selected patients reviewed. Findings: 1. Review of the laboratory's "Patient Record and Sample Retention"policy revealed the following retention requirement: "Histopathology slide preparations for at least ten years from the date of examination." 2. Review of random selection of patient final reports and corresponding histopathology slides revealed the laboratory did not retain the following patient histopathology slides from August 23, 2021 for at least ten (10) years as required: a) LP21x374 b) LP21x375 c) LP21x380 3. In interview on July 6, 2022 at 9:50 am, the Medical Assistant stated the laboratory could not find the identified slides. The Medical Assistant stated the slides were packed and moved due to Hurricane Ida. 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 -- D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the Laboratory Director failed to provide overall management and direction to the laboratory. Refer to D3043. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Certification Survey was performed on November 6, 2020 at LaPlace Dermatology, CLIA ID # 19D0457792. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's microscope maintenance records, policies, and interview with personnel, the laboratory failed to perform microscope grounding checks every six (6) months per laboratory policy for one (1) of four (4) checks reviewed. Findings: 1. Review of the laboratory's "Equipment Quality Control Form 1: Microscope Use Protocol" revealed "Grounding check is monitored every six months." 2. Review of the laboratory's "Maintenance Record-Microscope" records for 2019 and 2020 revealed the laboratory did not have documentation of grounding check performance due January 2020. 3. In interview on November 6, 2020 at 9:42 am, the laboratory's medical assistant stated she did not know why the microscope's grounding check was not documented in January 2020. The medical assistant confirmed the laboratory did not have documentation of a grounding check in January 2020. D6095 LABORATORY DIRECTOR RESPONSIBILITIES 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 -- 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 record review and interview with personnel, the Laboratory Director failed to ensure required maintenance was performed to ensure acceptable levels of performance. Refer to D5433. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Certification Survey was conducted on May 4, 2018 at LaPlace Dermatology, CLIA ID# 19D0457792. 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: Based on record review and interview with personnel, the laboratory failed to establish and follow written policies and procedures to assess personnel competency. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not include the following six (6) procedures as a minimal requirement for assessing the competency of all personnel performing laboratory testing: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b) Monitoring the recording and reporting or test results. c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records. d) Direct observation of performance of instrument maintenance and function checks. e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. f) Assessment of problem solving skills. 2. In interview on May 4, 2018 at 9:10 am, Personnel 2 stated the laboratory utilizes the "CLIA Manual: A Guide for Dermatology Practices" as their policy and procedure manual. Personnel 2 further stated she was unaware of the six (6) procedures as the minimum requirement for competency assessments. 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 -- 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 record review and interview with personnel, the laboratory failed to establish a complete policy and procedure for twice a year verification for the accuracy of Histopathology testing. Findings: 1. Review of the laboratory's "Proficiency Testing" policy revealed the laboratory did not include a procedure, acceptability criteria or