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 Proficiency Testing (PT) policy, American Proficiency Institute (API) PT records and interview with the Medical Assistant (MA), the laboratory director (LD)/designee and testing personnel (TP) failed to attest to the routine integration of samples into the patient workload for 2 of 3 Hematology /Coagulation PT events performed in 2022 and 1 of 3 Hematology/Coagulation PT events performed in 2023. Findings include: 1. The laboratory's Addendum to Proficiency Testing Policy states, "Lab director will monitor all proficiency testing, scores, attestations, and events". 2. On the day of survey, 01/03/2024 at 09:30 am., review of API PT records revealed the following attestation statements were not signed by either the LD/designee or TP: -2022 Hematology/Coagulation 1st and 3rd events: Hematology -3S: Red Blood Cell (RBC) count, White Blood Cell (WBC) count differential, Platelet count, Hematocrit (%), Hemoglobin (g/dL) - 2023 Hematology/Coagulation 3rd event: Hematology -3S: Red Blood Cell (RBC) count, White Blood Cell (WBC) count differential, Platelet count, Hematocrit (%), Hemoglobin (g/dL) 3. The MA confirmed the findings above on 01/03/2024 at 11:00 am D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance 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 -- (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). 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 Medical Assistant (MA), the laboratory failed to verify the accuracy of the PT results obtained for 1 of 1 API Hematology/Coagulation testing events in 2023. Findings Include: 1. On the day of survey, 01/03/2024 at 09:39 am., review of the laboratory's API PT records revealed that the laboratory did not verify the accuracy for the following analyte that was not scored by the PT agency due to non-consensus: - API 2023 (2nd event): White Blood Cell Differential, Monocytes/mixed (%), HSY-07, HSY-09 2. The API Proficiency Testing performance Evaluation form states " Laboratories are responsible for documenting and performing

Summary Statement of Deficiencies 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 (TP)#1, the laboratory failed to retain daily QC records for Medonic M Complete Blood Count (CBC) analyzer from 12/18/2019 to 12/31/2021. Findings include: 1. On the day of survey, 04/27/2022 at 10:30am, the laboratory could not to provide QC records for CBC examinations performed from 12/18/2019 to 12/31/2021. 2. The laboratory's annual test volume for CBC is 300 (CMS 116). 3. On 04/27/2020 at 10:33am, the TP#1 stated that all the QC for 2020 and 2021 was shredded and discarded. 4. The TP#1 confirmed the findings above on 04/27/2021 around 11:45am. 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 the American Proficiency Institute (API) proficiency testing (PT) records and interview with the Testing Personnel (TP) #1, the laboratory failed to provide 1 of 3 API PT attestation statement in 2020, 1 of 3 API PT result records in 2020, and 1 of 3 API PT records in 2021 for Hematology/Coagulation events. Findings include: 1. On the day of survey, 04/27/2022 at 10:50am., the TP#1 could 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 -- not provide the the following: - 2020: Attestation statement: Event #2. - 2020: PT results: Event #3. - 2021: PT records: Event #1. 2. The TP#1 confirmed the finding above on 04/27/2022 at 11:45am. 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 a review of American Proficiency Institute (API) proficiency testing (PT) records and interview with the testing personnel (TP)#1, the Laboratory failed to review and evaluate the results obtained on proficiency testing for 3 of 3 (API) for Hematology/Coagulation in 2020 and 2021. Findings: 1. On the day of survey, 04/27 /2022 at 10:50 am., the records reviewed revealed that the laboratory could not provide records of the evaluation and review of the following: a. API Hematology: 2020 Event#2 and Event#3 b. API Hematology: 2021 Event#1. 2. The TP#1 confirmed the finding above on 04/27/2022 around 11:45 am. 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 D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a review of the CASPER Report 155 report and graded results from the proficiency testing organization American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for the analytes Cell ID, Red Blood Cell (RBC), Hematocrit Hemoglobin, White Blood Cell (WBC), Platelets . Refer to D2130, D2131. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CASPER 155 report and graded results from the proficiency testing organization American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for the analyte: Cell Identification (Cell ID), Red Blood Cell (RBC), Hematocrit (HCT), Hemoglobin (HGB), White Blood Cell (WBC), Platelets (PLT). The laboratory had unsatisfactory scores for the 2nd event of 2021, and 3rd event 2021. Findings include: Analyte Year Event Score Cell ID 2021 2 0% Cell ID 2021 3 0% RBC 2021 2 0% RBC 2021 3 0% HCT 2021 2 0% HCT 2021 3 0% HGB 2021 2 0% HGB 2021 3 0% WBC 2021 2 0% WBC 2021 3 0% PLT 2021 2 0% PLT 2021 3 0% D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of the CASPER Report 155 report and graded results from the proficiency testing organization American Proficiency Institute (API), the laboratory failed to achieve an overall testing score of satisfactory performance in the Specialty Hematology. The laboratory had unsatisfactory scores for the 2nd event of 2021, and 3rd event of 2021. Findings include: Specialty Year Event Score Hematology 2021 2 0% Hematology 2021 3 0% -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a review of the laboratory records and an interview of laboratory testing personnel, the laboratory failed to enroll in a proficiency testing (PT) program that is approved by HHS, for Complete Blood Counts, for 2of 2 years from 2018 through 2019. Findings include: 1. At the time of the survey, the laboratory could not provide evidence of enrollment in an approved proficiency testing program for Complete Blood Counts for calendar years 2018 and 2019. Refer to D6015. 2. During the survey (14:30 12/18/2019), Laboratory Testing Personnel 1 confirmed the above finding. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. 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 -- This STANDARD is not met as evidenced by: Based on a review of the laboratory records and an interview of laboratory testing personnel, the Laboratory Director failed to ensure the laboratory was enrolled in a proficiency testing (PT) program that is approved by HHS, for Complete Blood Counts, for 2of 2 years from 2018 through 2019. specimens. Findings include: 1. At the time of the survey, the laboratory could not provide evidence of enrollment in an approved proficiency testing program for Complete Blood Counts for calendar years 2018 and 2019. 2. During the survey (14:30 12/18/2019), Laboratory Testing Personnel 1 confirmed the above finding. -- 2 of 2 --