Integrated Dermatology Of Ponchatoula, Llc

Summary Statement of Deficiencies D0000 A Recertification survey was performed at Integrated Dermatology of Ponchatoula, LLC, CLIA ID 19D2120643, on September 27, 2024. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of the laboratory's policies, temperature logs, manufacturer's storage requirements, and interview with personnel, the laboratory failed to define the humidity limit for area where the cryostat is stored. Findings: 1. Observation by the surveyor during the laboratory tour revealed the laboratory utilized the Leica CM 1510 S cryostat. 2. Review of the Leica CM 1510 S Cryostat manual revealed the acceptable humidity was defined as less than or equal to 60%. 3. Review of the laboratory's policies and temperature logs revealed the laboratory did not define the acceptable humidity limit. 4. In interview on September 27, 2024 at 10:50 am, the Medical Assistant confirmed the laboratory did not define the acceptable humidity limit for the room where the cryostat is stored. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) 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 -- Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation by surveyor and interview with personnel, the laboratory failed to ensure laboratory reagents and supplies had not exceeded their expiration date for Histopathology testing. Findings: 1. Observation by surveyor during the laboratory tour on September 27, 2024 at 9:37 am revealed the following expired items: a) Cancer Diagnostics CDI's Tissue Marking Black Dye, Lot 22075, Expiration Date: 2024-03-31, Quantity: one (1) bottle b) Cancer Diagnostics CDI's Tissue Marking Orange Dye, Lot 22056, Expiration Date: 2024-02-28, Quantity: one (1) bottle c) Cancer Diagnostics CDI's Tissue Marking Violet Dye, Lot 22033, Expiration Date: 2024-02-28, Quantity: one (1) bottle d) Platinum Line Microtome Oil, Lot 111649, Expiration Date: 2022-12-31, Quantity: one (1) bottle e) Scott's Tap Water Substitute, Lot 2310024, Expiration Date: 2024-04-20, Quantity: one fourth (1/4) of one (1) gallon 2. In interview on September 27, 2024 at 9:48 am, the Medical Assistant confirmed the identified items were expired. 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 CMS-209 form, review of policies, 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 four (4) of eight (8) random selection of cases reviewed. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed the Laboratory Director and Testing Personnel 1 served as Testing Personnel. 2. Review of the laboratory's "Quality Assurance" policy under the "Monitor of Quality Control Testing" revealed "The first slides of the day will be reviewed for staining quality. The testing Physician will review the slides for quality." 3. Review of the laboratory's quality control logs and random selection of patients revealed the quality control slides were not assessed by Testing Personnel 1 on the following test dates: September 15, 2023: P23 056 November 10, 2023: P23 071 March 15, 2024: P24 020 August 23, 2024: P24 040 4. In interview on September 27, 2024 at 10:50 am, the Medical Assistant confirmed Testing Personnel 1 did not document his assessment of the stain quality for his cases for the identified dates. D6087 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(iii) The laboratory director must ensure that laboratory personnel are performing the test methods as required for accurate and reliable results. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on observation by surveyor, record review, and interview with personnel, the Laboratory Director failed to ensure the laboratory personnel performed test methods as required. Findings: 1. The laboratory failed to define the humidity limit for area where the cryostat is stored. Refer to D5413. 2. The laboratory failed to ensure laboratory reagents and supplies had not exceeded their expiration date for Histopathology testing. Refer to D5417. 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. 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 the 2023 annual competency assessment was performed for one (1) of two (2) testing personnel performing high complexity testing. Refer to D6128. 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's policies, personnel records, and interview with personnel, the Technical Supervisor failed to perform competency assessments annually in 2023 for one (1) of two (2) testing personnel reviewed. Findings: 1. Review of the laboratory's policies revealed "Competency Evaluations: Yearly evaluations will be conducted on all laboratory personnel. These evaluations will be -- 3 of 4 -- maintained in the Laboratory Manual." 2. Review of personnel records revealed the 2023 competency assessment for Testing Personnel 1 was not completed. 3. In interview on September 27, 2024 at 10:07 am, the Medical Assistant confirmed the 2023 annual competency was not completed for Testing Personnel 1. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A Certification Survey was conducted on July 19, 2018 at Integrated Dermatology of Ponchatoula-CLIA ID # 19D2120643. The laboratory was found in compliance with 42 CFR 493 Requirement for Laboratories; however, standard 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 record review and interview with personnel, the laboratory failed to ensure written policies and procedures to address competency for the Clinical Consultant, Technical Supervisor, and General Supervisor were complete. Findings: 1. Review of the laboratory's CMS-209 form (Laboratory Personnel Report) revealed Personnel 2 serves as the laboratory's Clinical Consultant, Technical Supervisor, and General Supervisor. 2. Review of the laboratory's policies and procedures revealed the laboratory did not have a policy for competency assessment of Clinical Consultant, Technical Supervisor, and General Supervisor. 3. Review of personnel records for Personnel 2 revealed competency assessments for the duties of Clinical Consultant, Technical Supervisor, and General Supervisor were not performed. 4. In interview on July 19, 2018 at 1:33 pm, Personnel 3 stated Personnel 2 was hired July 1, 2018. Personnel 3 further stated the laboratory did not perform competency assessments for Personnel 2's duties as Clinical Consultant, Technical Supervisor and General Supervisor. II. Based on record review and interview with personnel, the laboratory failed to establish and follow written policies and procedures to assess competency for testing personnel. 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 policy and procedure manual revealed the laboratory did 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 -- 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. 3. In interview on July 19, 2018 at 1:33 pm, Personnel 3 stated the laboratory did not have a policy to assess testing personnel competency. Personnel 3 further stated she was unaware it was required since a doctor is performing the testing. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to have the policy and procedure manual, approved, signed, and dated by the current Laboratory Director. Findings: 1. In interview on July 19, 2018 at 1:08 pm, Personnel 3 stated the laboratory had a new Laboratory Director as of June 2018. 2. Review of the laboratory's policy and procedure manual revealed the manual was not approved and signed by the current Laboratory Director. 3. In further interview on July 19, 2018 at 1:08 pm, Personnel 3 stated the new Laboratory Director did not sign the policy and procedure manual. 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 established for assessing personnel competency, and whenever necessary, identify needs for remedial training or continuing education to improve skills. Findings: 1. The laboratory failed to ensure written policies and procedures to address competency for the Clinical Consultant, Technical Supervisor, and General Supervisor were complete. Refer to D5209 I. 2. The laboratory failed to establish and follow written policies and procedures to assess personnel competency. Refer to D5209 II. -- 2 of 2 --