Naaman Clinic Llc

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 reviews of the humidity records for the embedding and processing rooms, the manufacturer's manual on environmental operating specifications, and an interview with the Office Manager (OM) and Testing Personnel (TP) #1, the laboratory failed to ensure that the humidity in the embedding and processing rooms were within the manufacturer's acceptable limits. Humidity was noted below acceptable ranges for the embedding room for 66 out of 133 days, and the processing room for 71 out of 133 days from 2024 to 2026. The findings include: 1. A review of the embedding and processing room humidity records revealed that humidity was below the manufacturer's acceptable parameters. The following months were affected: a. Embedding room: i. December 2024; 3 out of 10 days ii. January through April 2025; 23 out of 45 days iii. November through December 2025; 13 out of 22 days iv. January through April 2026; 27 out of 56 days b. Processing room: i. December 2024; 3 out of 10 days ii. January through April 2025; 26 out of 45 days iii. November through December 2025; 16 out of 22 days iv. January through April 2026; 26 out of 56 days 2. Reviews of the manufacturer's manuals revealed the following Humidity specifications: a. Tissue-Tek VIP 5 page 1.8, " Under Introduction, Operating Conditions, Relative Humidity: 30-85%". b. Tissue-Tek TEC 5 page 1.3, "Under 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 -- Specifications, ...Relative Humidity Range 30-85%". c. Tissue-Tek DRS 2000 page 1.7, "Under Specifications, Operating Conditions: Relative Humidity: 30-85%". 3. The OM and TP #1 confirmed the above findings during the exit interview on 9/17 /26, at 12:30pm. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on a review of the Testing Personnel (TP) competency assessment records, and an interview with the Office Manager (OM) and TP #1, the Technical Supervisor (TS) failed to ensure the competency assessment of TP listed on the CMS 209 form (Laboratory Personnel Report) included the six minimal CLIA regulatory requirements for high complexity testing. The surveyor noted two of the two TP annual competency assessments in 2025 and 2026 were missing all regulatory requirements. The findings include: 1. A review of the laboratory's competency assessment form showed the following instructions: a. "Carefully evaluate employee's work performance in relation to the essential functions of the job". b. There is a comment section for the employee to write a self-evaluation. 2. A further review of the laboratory's assessment form revealed it was missing the following six minimal CLIA regulatory requirements: a. Direct observation of routine test performance. b. Monitoring test recording and reporting. c. Review of intermediate results, worksheets, QC, PT, and maintenance records. d. Direct observation of instrument maintenance and function checks. e. Assessment via previously analyzed specimens, blind samples, or PT. f. Assessment of problem-solving skills. 3. The OM and TP #1 confirmed the above findings during the exit interview on 9/17/26, at 12:30pm. -- 2 of 2 --

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a review of the Tissue Tek VIP (Vacuum Infiltration Processor) maintenance records, Tissue Tek Stainer maintenance records, policy and procedures, and an interview with Histotech #1, the Laboratory failed to document daily, weekly, monthly, and bi-monthly maintenance on the Tissue Tek VIP and daily maintenance on the Tissue Tek Stainer as per the policy and procedures. This was noted from the date of the previous survey (11/9/2022) to the date of the current survey (12/4/2024). The findings include: 1. A review of the Tissue Tek VIP and Tissue Tek Stainer maintenance records revealed no evidence of documentation since the previous survey (11/9/2024) to the current survey (12/4/2024) for the following: A. Tissue Tek VIP: Daily, Weekly, Monthly, and Bi-monthly maintenance. B. Tissue Tek Stainer: Daily maintenance. 2. A further review of the Tissue Tek VIP maintenance policy and procedure revealed the following maintenance to be performed and documented: A. "Daily: Normal Cleaning Cycle." B. "Weekly: Cleaning water changed." C. "Monthly: Reagents rotated and changed. Flush and Fume changed." D. "Bi-Monthly: Cleaning xylene and 100% changed." 3. A review of the Tissue Tek Stainer maintenance policy and procedure revealed the following maintenance to be performed and documented: A. "Daily (of use): Acid Wash and Bluing changed." 4. During an interview on December 4, 2024, at 11:30 AM, Histotech #1 said the maintenance was performed but she forgets to document. 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 --

Summary Statement of Deficiencies 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 a review of the Tissue-Tek TEC 5 Tissue Embedding Console System Operator's Manual, temperature records, and an interview with the Testing Personnel, the laboratory failed to monitor and document room temperature and humidity for the room in which the Embedding Console System is located for more than two and a half years since the previous survey on 5/15/2018. The findings include: 1. A review of Tissue-Tek TEC 5 Tissue Embedding Console System Operator's Manual stated on page 1.3 "Ambient Operating Temperature and Relative Humidity Range: Embedding Module 10 - 40 degrees Celsius 30% - 85% RH (noncondensing), Cryo Module 10 - 40 degrees Celsius 30% - 85% RH (noncondensing)". 2. A review of the temperature records (May 2018 to January 2021) revealed that the laboratory was documenting the room temperature and humidity in the room that housed the Processor and Stainer, but the Embedding Console System was located in a separate room where temperature and humidity was not documented. 3. During an interview conducted on 01/12/2021 at 1:15 PM, the Testing Personnel confirmed the above noted findings. . D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) 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 -- (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on a review of the personnel records and interviews with the Testing Personnel and Practice Manager, the Technical Supervisor (who also serves as the Laboratory Director) failed to ensure initial training and competency evaluations were performed by qualified personnel. This was noted on one of one testing personnel records reviewed by the surveyor. The finding include: 1. A review of the personnel records revealed that Testing Personnel #1 was employed in May 2019, however there was no documentation of initial training. 2. A review of the personnel records revealed that Testing Personnel #1 had a six-month evaluation performed on 11/01/2019, and annual evaluations performed on 05/06/2020 and 09/10/2020. These evaluations were performed and signed by the Practice Manager. 3. During an interview conducted on 01/12/2021 at 11:15 AM, Testing Personnel #1 provided a training guide used for her initial training, however the previous employee had failed to document the training. 4. During an interview conducted on 01/12/2021 at 11:25 AM, the Practice Manager confirmed he had performed the competency evaluations for the Testing Personnel; the Practice Manager further confirmed did not have laboratory experience in the specialty of Histopathology, and did not have a degree in a Chemical, Physical or Biological Science. SURVEYOR ID #32258 Licensure and Certification Surveyor -- 2 of 2 --