Joseph E Mouhanna Md Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at JOSEPH E MOUHANNA MD PA from 09/18/2025 to 09/25/2025. The laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) 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. (b)(1)(ii) 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 record review and staff interview, the laboratory failed to document all maintenance activities for the Immunalysis IMMTOX as per the ImmTox Maintenance log from July 2024 to August 2025. Findings included: 1-The laboratory used ImmTox Maintenance Log to document the Daily Start Up (DU), Daily Shutdown (DS), and Weekly and Monthly maintenance. 2-Review of ImmTox Maintenance Log from July 2024 to August 2025, revealed the following: July 2024: 07/01/2024 and 07/02/2024 the laboratory failed to document the DS, no weekly, no monthly. August 2024: The laboratory missed weekly maintenance on 08/12/2025. No monthly maintenance. September 2024: Missed weekly maintenance on 09/04/2024 October 2024: No monthly maintenance documented. On 10/18/2024, The laboratory ran Quality Controls (QC) and 7 patients, the laboratory failed to document the DU, DS. On 10/31/2024 no DS documented November 2024: No DS on 11/01/2024, 11/05 /2025, 11/08/2025, 11/11/2025, 11/13/2025 and 11/19/2025. No weekly maintenance, no monthly maintenance. January 2025: Documented on 01/08/2025 and 01/09/2025 DU and DS, no weekly maintenance no monthly. February 2025: No weekly maintenance on 02/27/2025. April 2025: Missed weekly maintenance on 04/01/2025 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 -- and 04/16/2025. May 2025: Missed weekly maintenance on 05/28/2025. June 2025: Missed weekly maintenance on 06/24/2025. July: Missed weekly maintenance on 06 /09/2025. August: Missed weekly maintenance on 08/07/2025. 3- During an interview on 09/18/2025 at 12:30 PM, the Testing Personnel confirmed that the laboratory failed to have documentation of the maintenance activities listed above. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 03/20/2024 found the JOSEPH E MOUHANNA MD PA clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following Conditions were cited: -D5400 Analytic Systems 493.1250. -D6000 Moderate Complexity Laboratory Director 493.1403. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) records and interview with Testing Person (TP), the laboratory failed to retain the instrument printout for one (2nd event of 2022) out of four (1st and 2nd events in 2022 and 2023) events reviewed for Toxicology. Findings included: Review of API Proficiency Testing records for 2022 and 2023 revealed that the laboratory failed to have instrument printout for second event of 2022 for Toxicology. During an interview on 03/20/2024 at 3:35 PM, the TP confirmed that the laboratory failed to retain the instrument printout for the event of reference. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of API (American Proficiency Institute) proficiency testing (PT) records and interview with Testing Personnel (TP), the laboratory failed to have Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 --

Summary Statement of Deficiencies D0000 An initial certification survey conducted at JOSEPH E MOUHANNA MD PA on 04 /18-22/2022 found the clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to keep the signed attestation for 1 out of 1 event reviewed for Toxicology. Findings include: Review of American Proficiency Institute (API) PT records for 2021, revealed that the laboratory failed to have the signed attestation for second Event 2021 for the specialty of Toxicology. During an interview on 04/22/2022 at 10:30 AM, the Office Manager confirmed that the laboratory failed to have signed attestation for the event of reference. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on records review and staff interview, the Laboratory Director (LD) failed to document the review and evaluation of Proficiency Testing (PT) for 1 (second event 2021) out of 1 event for the specialty of Toxicology. Findings include: Review of American Proficiency Institute (API) PT records showed the LD failed to sign the 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 -- "Proficiency Performance Evaluation" form for the second event of 2021. During an interview on 04/18/2022 at 3:00 PM, the Office Manager confirmed that the LD failed to sign the "Proficiency Performance Evaluation" form for the PT second event of 2021. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on lack of records and staff interview, the laboratory failed to perform a calibration verification for the Biolis 24i Analyzer from Carolina Chemistries Corp at least every six months since June 2021 to present. Findings include: -Review of Biolis 24i Analyzer records, revealed that the laboratory failed to perform the calibration verification since June 2021 to present, in this period the laboratory tested 1272 patients. During an interview on 04/22/2022 at 11:00 AM, the office manager confirmed that the laboratory failed to perform instrument calibration verification at least every 6 months since June 2021 to present. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on lack of records and staff interview, the laboratory failed to follow the Quality Assurance (QA) policy from June 2021 to present. Findings include: -A Review of Quality Assessment policy revealed that the laboratory will review and document monthly the QA activity. -No records found of the QA activity since June -- 2 of 3 -- 2021 to present. During an interview on 04/22/2022 at 11:05 AM, the Office Manager confirmed that the laboratory failed to document the QA activity since June 2021 to present. -- 3 of 3 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on API (American Proficiency Institute) proficiency testing record review for two-year period (years 2017 and 2018), and interview with testing person #2, the laboratory failed to rotate proficiency testing (PT) events to include all testing personnel who routinely performed patient testing for: - 4 out of 4 events for urine cocaine and opiates. - 2 out of 2 events for urine cannabinoids. - 2 out of 2 events for urine PH (a numeric scale used to specify the acidity or basicity). The findings include: On December 28, 2018 at 1:30pm surveyor reviewed API proficiency testing records for years 2017 and 2018. Record review revealed that testing person #2 did not perform proficiency testing for: A) 4 out of 4 proficiency testing events (years 2017 and 2018) for cocaine and opiates - urine toxicology test analytes. B) 2 out of 2 proficiency testing events (year 2017) for cannabinoids (urine toxicology test analyte) and urine PH (urine chemistry test). During an interview on December 28, 2018, at 3: 00pm, testing person #2 confirmed findings A and B. D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory 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 -- results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on the record review of one patient (test order date 12/12/18, test run date 12/28 /18 for urine cocaine and opiates) and interview with the testing person #2, laboratory failed to have type of specimen, time of specimen collected, test ordered, and the name of the ordering physician on test requisition form (test order). The findings include: On 12/28/18 at 2pm, surveyor reviewed one test requisition form (test order) and test report record for urine cocaine and opiates for the test order date 12/12/18 and test date of 12/28/18. It showed that: A- Requisition form did not include the test ordered, type of specimen, time of specimen collected, and the name of the ordering physician. B- Hand written date for specimen collection was not clear. During an interview on December 28, 2018 at 3:00 PM, testing person #2 confirmed that: (a) Test requisition form (test order date 12/12/18, test run date 12/28/18 for urine cocaine and opiates) did not have type of specimen, time of specimen collected, the test ordered, and the name of the ordering physician. (b) Hand written date for specimen collection was not clear. 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 the observation, record review and interview with the testing person #2, laboratory failed to follow the specimen labeling as per laboratory procedure manual for 30 out of 30 urine specimens for cocaine and opiates- drug screening. The findings include: On December 28, 2018 at 2:15pm surveyor observed 30 urine specimens for urine drug (cocaine and opiates) screening that had only first and last name of the patient, with no date, time, tech initials, or unique patient identification number to match with requisition forms. Two specimens had the names with the running ink. Procedure manual review under patient test management described: "Correct and timely labeling is critical. All specimens should contain the proper information: date, time, tech initials, unique patient identification number. Make sure you use a black pen that does not run when wet. Always: 1-Confirm the patient's full name. 2-Label the specimen completely before patient leaves drawing area. 3-Note the condition of specimen if unacceptable. 4-Assign it a lab accession number if applicable". During an interview on December 28, 2018, at 3:00pm, testing person #2 confirmed that 30 urine specimens collected for drug (cocaine and opiates) screening had: I- Only the -- 2 of 4 -- first and last names of the patient. II- No other information to match the requisition form or as described in the laboratory procedure manual- to include date, time, tech initials, unique patient identification number, or accession number. III- Two specimens had the names with the running ink. 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 observation and record review from 1/ 2017 to 12/28/2018 and interview with testing person #2, laboratory failed to: - log correctly (April and May 2018), and record (October 2018) the daily temperature and humidity, refrigerator and freezer temperatures. The findings include: On December 28, 2018 at 11: am surveyor reviewed the laboratory temperature worksheets, instrument maintenance and quality control records for years 2017 and 2018. It showed that: I- Room temperature, humidity, refrigerator temperature and freezer temperature record dates were April12, 2018 while instrument maintenance records and test controls run dates were April 15, 2018. II- Room temperature, humidity, refrigerator and freezer temperature record dates were May 5, 2018 while instrument maintenance records and test controls run dates were May 6, 2018. III No records of room temperature, humidity, refrigerator and freezer temperature for October 21 and 28, 2018. During an interview on December 28, 2018, at 3:00pm, testing person #2 confirmed: A) Findings I and II and that the temperature and humidity records did not match with the instrument maintenance and test control run dates. B) Finding III, that laboratory did not record the room temperature, humidity, refrigerator and freezer temperature for October 21 and 28, 2018. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on the urine cocaine and opiates tests record review for 6 out of 6 patients and interview with the testing person #2, laboratory failed to include the identity of testing person. The findings include: On 12/28/18 at 2pm, surveyor reviewed 6 patient test reports for urine cocaine and opiates screening tests. The instrument print out - test report did not include the testing person identity for all 6-test reports reviewed. During an interview on December 28, 2018 at 3:00 PM, testing person #2 confirmed that urine cocaine and opiates screening test instrument print out - test report for all six patients did not include the testing person identity. -- 3 of 4 -- D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on the record review and interview with the testing person #2, laboratory failed to report the patient test results in timely manner by: Running the specimens collected from 12/12/18 to 12/20/18, on 12/28/18 and then to be waiting the results to be verified by physician in EMR (Electronic medical records) for cocaine and opiates- drug screening tests. The findings include: On December 28, 2018 at 2:00pm surveyor reviewed: A) Six patients test reports (urine cocaine and opiates- drug screening) for specimen collection dates 12/12/18, 12/14/18, 12/17/18, 12/17/18, 12/18/18, and 12/20 /18 with the test run date of 12/28/18. During an interview on December 28, 2018, at 3:00pm, testing person #2 confirmed that the laboratory ran the urine drug screening tests( cocaine and opiates) for the collection dates from 12/12/18 to 12/20/18 on 12/28 /18 for the six patients reviewed. The results then to be scanned in to EMR and then to be verified by the physician. -- 4 of 4 --