Satish A Shah Md Pllc

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 laboratory's American Proficiency Institute (API) proficiency testing (PT) records and interview with Testing Personnel (CMS 209 TP #1) , the Laboratory Director (LD) failed to sign 1 of 3 API PT attestation statements for Hematology/Coagulation testing for 1 of 3 events in 2023 and 1 of 2 events in 2024. Findings Include: 1. On the day of the survey, 07/30/2024 at 11:30 am, the following API PT attestation statements reviewed were not signed by the LD in 2023 and 2024: - 2023 Hematology/Coagulation 2nd event - 2024 Hematology/Coagulation 2nd event 4. TP#1 confirmed the findings above on 07/30/2024 at 11:30 am. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. 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 review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records, and interview with testing personnel (CMS 209 TP#1), the laboratory failed to provide complete documentation for PT results of 1 of 3 API PT events in 2023. Findings Include: 1. On the day of survey, 07/30/2024, the laboratory failed to provide the following PT documentation: Hematology/Coagulation - Comparative Evaluation 2023 Hematology/Coagulation - Part 3 of 4, page 2 of 2. 2. TP #1 confirmed the findings above on 07/30/2024 at 11:35 am. 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. This STANDARD is not met as evidenced by: Based on review of laboratory quality control (QC) records and interview with the Testing Personnel (CMS 209 TP#1), the laboratory failed to retain the quantitative QC records for Abbott Cell-Dyn Emerald analyzer for hematology test Complete Blood Count (CBC) from 11/16/2022 to 07/25/2024. Findings include: 1. TP #1 revealed in interview that CBC patient test results were resulted twice a week between 11/16 /2022 to day of survey. 2. On the day of survey, 07/30/2024, the laboratory failed to provide quantitative QC records for Abbott Cell-Dyn Emerald analyzer for hematology test CBC from 11/16/2022 to 07/25/2024. 3 The laboratory's annual test volume for CBC for 2023 was 12000. 4 TP #1 confirmed the above findings on 07/30 /2024 at 12:00 pm. D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on lack of documentation, review of laboratory procedures, and interview with testing personnel (CMS 209 TP #1), the laboratory failed to establish and maintain a policy to ensure all complaints and problems reported to the laboratory are documented and investigated when needed from 11/16/2022 to the day of survey. Findings include: 1. On the day of survey, 07/30/2024 at 1:00 pm, the laboratory could not provide a policy to ensure all complaints and problems reported to the laboratory are documented and investigated as needed from 11/16/2022 to the 07/30 /2024. 2. TP #1 confirmed the finding above on 07/30/2024 at 1:00 pm. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test -- 2 of 6 -- procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on lack of laboratory test requisition records and an interview with the Office Manager (OM) the laboratory failed to have a written or electronic test requisition for Complete Blood Count (CBC) patient testing from 10/27/2020 to 11/16/2022 (1 of 1 patient test report reviewed). Findings include: 1. On the day of the survey, 11/16 /2022, the OM could not provide test requisitions for any CBC patient testing from 10 /27/2020 to 11/16/2022. 2. According to the CMS 116, 20,001 CBC patient testing has been performed for the year 2021. 3. OM confirmed the above finding on 11/16 /2022 at 12:31 PM. 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 of the temperature records, and an interview with the Office 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 -- Manager (OM), the laboratory failed to document the Room Temperature (RT) ranges for the storage of Abbott Cell Dyn Hematology analyzer reagents for 2021 and 2022 (21 of 22 months). Findings include: 1. According to the laboratory's "Recording of temperature" manual, the acceptable ranges should be listed on the temperature log sheet. 2. On the day of the survey, 11/16/2022 at 11:40 AM, a review of the laboratory's RT temperature logs showed that the laboratory did not have an acceptable RT range for 21 of 22 months of temperature recorded. 3. According to the manufacturer's instructions Cell Dyn Emerald reagents should be stored at 4 to 35 degrees Celsius. 4. Interview with OM confirmed the findings above on 11/16/2022 at 12:31 PM. 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 of the laboratory and interview with the Office Manager (OM), the laboratory failed to perform and document maintenance on the 1 of 1 thermometer used for taking the temperature at which the Cell Dyn Emerald Hematology reagents were stored to ensure they were consistence with the manufacturer's instructions from 08/2022 to 11/16/2022. Findings Include: 1. On 11/16/2022 at 12:06 PM an observation of the laboratory revealed that the following thermometer was used for recording RT and expired. -S/N 33293 Expired on 08/2022. 3. Interview with OM confirmed the findings above on 11/16/2022 at 12:31 PM. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iv) Ensure that an approved

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies 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 laboratory quality assessment (QA) policy, laboratory QA document, and interview with the laboratory testing personnel (TP) #1, the laboratory director (LD) failed to document quarterly QA activities in 2017. Findings include: 1. The laboratory QA policy (the LD signed off on 07/01/2016) states "The Medical Director will document any findings and