Azizkhan Internal Medicine Associates

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on review of laboratory records, and interview with Technical Consultant (TC ) #1, the laboratory director/owner failed to ensure that 1 of 1 laboratory personnel met the minimum qualifications specified in the Pennsylvania (PA) Clinical Lab Act to perform supervisor responsibilities from 7/1/2025 to 7/15/2025. Findings include: 1. On the day of survey, 7/15/2025 at 1:30 pm, review of personnel credentials and the Laboratory Personnel Report (Pennsylvania State) onsite revealed Testing Personnel (TP) #1 (PA LPR document) was performing the duties of a General Supervisor from 7/1/2025 to 7/15/2025. 2. Review of personnel credentials revealed that TP#1 attained a Bachelor of Science degree in Medical Technology in May 2022. 3. Further review of laboratory records revealed that TP#1 had reviewed documents pertaining to quality assurance, quality control reports, temperature records, and test logs. 4. The laboratory was unable to provide the acceptable documentation of 6 years experience for TP#1 needed to perform the duties of a supervisor in the state of Pennsylvania from 7/1/2025 to 7/15/2025. 5. TC#1 confirmed the findings above on 7/15/2025 at 02: 00 pm. 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. In addition, retain the following: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- This STANDARD is not met as evidenced by: Based on lack of documentation and interview with Technical Consultant (TC) #1, the laboratory failed to retain records for background counts on 1 of 1 Horiba Pentra XL80 used for complete blood cell count (CBC) testing performed from 9/1/2023 to 9 /11/2023. Findings include: 1. On the day of the survey, 7/15/2025 at 11:45 am, the laboratory failed to provide documentation for the background counts performed on 1 of 1 Horiba Pentra XL80 used for CBC testing from 9/1/2023 to 9/11/2023. 2. TS #1 confirmed the finding above on 7/15/2025 at 12:30 pm. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the Laboratory's Quality Assurance (QA) Program policy, lack of documentation, and interview with Technical Consultant (TC) #1, the laboratory failed to follow the laboratory's written QA policy for 8 of 8 quarters from 8/22/2023 to 7/15/2025. Findings include: 1. The laboratory's Quality Assurance Program policy stated, "The Regulations specify ten different standards to be included in a laboratory's quality assurance program. Standard 1 Patient Test Management Standard 6 Personnel Assessment Standard 2 Quality Control Assessment Standard 7 Communications Standard 3 Proficiency Testing Standard 8 Complaint Investigations Standard 4 Test Comparisons Standard 9 Quality Assurance Review with Staff Standard 5 Relate Results to Clinical Data Standard 10 Quality Assurance Records The Quality Assurance Monthly Report contains: Patient Test management, Quality Control Assessment, and Complaint Investigations. The Quality Assurance Quarterly Report contains Patient Test Management, Quality Control Assessment, Proficiency Testing Assessment, Personnel Assessment, Communications, and Quality Assurance Review with Staff." 2. On the day of the survey, 7/15/2025 at 11:30 am, the laboratory failed to provide documentation of the Quality Assurance Quarterly Report performed for 8 of 8 quarters from 8/22/2023 to 7/15/2025. 3. TC #1 confirmed the above findings on 7/15/2025 at 12:30 pm. 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. -- 2 of 6 -- This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of laboratory temperature records, and interview with Technical Consultant (TC) #1, the laboratory failed to monitor room temperatures to ensure proper storage of reagents were met for 224 of 692 days from 8 /22/2023 to 7/15/2025. Findings include: 1. On the day of survey, 7/15/2025, at 1:00 pm, during the tour of the laboratory, the surveyor observed the following supplies stored in the laboratory: - 3 XPert COV2/FLU/RSV kits. Storage requirements 2C to 28C . - 1 each of Sed Plus Normal and Abnormal QC. Storage requirements 18C to 30C . - 1 OSOM H Pylori kit. Storage requirements 2C to 30C . - 2 OSOM Mono kits. Storage requirements 15C to 30C . - 1 OSOM HCG kit. Storage requirements 15C to 30C . - 3 Siemens Multistix. Storage requirements 15C to 30C . 2. Review of the laboratory's temperature records revealed the laboratory failed to monitor and document room temperatures to ensure the proper storage of reagents for 224 of 692 days when the laboratory was not performing testing from 8/22/2023 to 7/15/2025. 3. TC #1 confirmed the findings above on 7/15/2025 at 1:30 pm. D5783

Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) proficiency testing (PT) records and interview with testing personnel (TP) #1 (CMS 209), the laboratory failed to verify the accuracy of the nongraded result obtained for 1 of 3 API PT events for Chemistry in 2022. Findings Include: 1. On the day of survey, 08/22/2023 at 12:17 PM, a review of the laboratory's API PT records revealed that the laboratory did not verify the accuracy for the following analyte in Chemistry that were not graded by the PT agency: -API 2022 Chemistry Core 1st Event-TIBC 2. The TP #1 confirmed the findings above on 08/22/2023 at 02:19 PM. 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 the American Proficiency Institute (API) proficiency testing (PT) records and interview with the testing personnel (TP) #1 (CMS 209), the laboratory failed to document the evaluation and verification activities for 1 of 3 events of Chemistry for the Unacceptable Proficiency Testing (PT) performance in 2022. Findings Include: 1. On the day of survey, 08/22/2023 at 12:06 PM, a review of API proficiency testing records revealed that the laboratory received an unacceptable grade 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 -- for: - 80% on API 2023 2nd event Chemistry Core: Glycated Hemoglobin. 2. The laboratory failed to provide documentation of the evaluation and verification activities for the above PT event. 3. TP #1 confirmed the findings above on 08/22/2023 at 02:19 PM. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing (PT) records and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to sign 1 of 3 Chemistry-Core API PT attestation statements in 2020 Findings include: 1. On the day of survey 07/06/2021, review of API PT records revealed, 2020 Event 1 Chemistry-Core API PT attestation statement was not signed by the LD. 2. The TP confirmed the finding above on 07/06/2021 at 10:00 am. D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: 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 -- Based on review of the American Proficiency Institute (API) proficiency test (PT) records, lack of documentation and interview with the Testing Personnel (TP), the laboratory failed to participate in 1 of 3 hematology/coagulation proficiency events in 2020. Findings include: 1. On the day of survey, 07/06/2021 at 10:00 a.m. review of API PT records revealed the laboratory failed to participate in the Hematology /Coagulation event #1 in 2020. 2. The TP confirmed the findings above on 07/06/2021 around 10:00 a.m. 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 review of the American Proficiency Institute (API) proficiency testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to evaluate PT results for 1 of 3 Hematology/Coagulation events in 2021. Findings include: 1. On the day of survey 07/06/2021, The laboratory could not provide documentation of evaluation & review performed on the 2021 Hematology /Coagulation Event 1. The laboratory received a 80% score 2. The TP confirmed the finding above on 07/06/2021 at 10:00 a.m. 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 review of the laboratory procedure manuals and interview with the Testing Personnel (TP), the laboratory failed to include procedures for verification of performance specifications when adding a new instrument/test and reporting positive and negative SARS-CoV-2 testing to the appropriate health agencies as required from 07/06/2019 to the day of survey. Findings include: 1. On the day of survey, 07/06 /2021 at 12:40 p.m., the laboratory could not provide procedures for the following: - Verification of performance specifications when adding a new instrument/test from 07 /06/2019 to the day of survey. - reporting positive and negative SARS-CoV-2 testing to the appropriate health agencies as required from 11/16/2020 to the day of survey. 2. The TP confirmed the findings above on 07/06/2021 at 12: 45 p.m. 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: -- 2 of 5 -- Based on review of laboratory policies and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to approve and sign 3 of 3 procedures in the laboratory from 07/06/2019 to the date of survey. Findings included: 1. On the day of survey 07/06/2021, a review of the manuals revealed, the following procedures were not approved and signed by the LD prior to patient testing: - Personnel Competency. - Quality Assurance Program. - Maintenance and Quality Control Procedures. 2. The TP confirmed the findings above on 07/06/2021 at 12:00 p.m. 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 D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) 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 laboratory tour and interview with the sole Testing Personnel (TP), the laboratory failed to ensure that 2 of 2 Becton Dickinson (BD) Sodium Citrate vacutainer tubes were not used beyond their expiration date. Findings Include: 1. On the day of survey (01/24/2019). While on tour of the laboratory, 2 of 2 BD blue top Sodium Citrate tubes (Lot # 011842) were found that expired 10/31/2018. 2. The TP confirmed the above finding above on 01/24/2019 around 11:00 am. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of equipment calibration records, review of the Traceable Certificate of Calibration for Dual Thermometer w/ Bottle Probe, and interview with the sole Testing Personnel (TP), the laboratory failed to establish, perform and document the calibration of 3 of 3 Fisher Scientific Traceable Min - Max thermometers. Findings include: 1. The manufacturer's form titled, "Traceable Certificate of Calibration for 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 -- Dual Thermometer w/ Bottle Probe", shows a calibration date of 01/30/2012 and a calibration due date of 01/30/2014. 2. On the day of survey, 01/24/2019, while on tour of the laboratory, observation of 3 of 3 Fisher Scientific Traceable Min - Max thermometers maintenance stickers, revealed there refrigerator and freezer thermometers were due to be calibrated on 01/30/2014 and the TP was unable to produce a maintenance procedure and calibration documentation for the thermometers. 3. The TP confirmed the findings above on 01/24/2019 around 10:45 am. -- 2 of 2 --