Amit H Sheth Md Pc

Summary Statement of Deficiencies D6070 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(1) Each individual performing moderate complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. This STANDARD is not met as evidenced by: Based on review of the Coulter Act2 Diff (hematology analyzer) patient log, patient reports, and interview with the technical consultant (TC), the testing personnel (TP) failed to assign the correct analyzer sequence ID number to two of five patients that were reviewed during the survey. Findings: 1. The Coulter Act2 Diff patient log was reviewed and five patient reports were pulled for verification. Two of the five that were reviewed failed to have the correct analyzer sequence identification (ID) number (#) listed on the final report. 2. The Coulter Act2 Diff patient log for 02/28/22 showed that patient "NV" had a sequence ID# of 88. When the patient chart was pulled the sequence ID# was listed on the analyzer printout as 89. 3. The Coulter Act2 Diff patient log for 03/07/23 showed that patient "VS" had a sequence ID# of 8. When the patient chart was pulled the sequence ID# was listed on the analyzer printout as 10. 4. During the survey on 01/31/2024 at 12:30 pm, the TC confirmed that the TP were not documenting the correct analyzer sequence ID# on the Coulter Act2 Diff patient log and entering the correct analyzer sequence ID# into the analyzer when the patient sample was being testing. The ID# listed on the patient log did not match the ID# of the printout in the patient's chart. The cumulative effect of these ID# errors can result in the laboratory's ability to ensure accurate and reliable patient test results. 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 record review and interview with laboratory staff, the laboratory did not take

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 review of the federal proficiency testing data report and review of the comparative evaluation summery from Medical Laboratory Evaluation (MLE) proficiency testing (PT) program, the laboratory failed to successfully participate in the MLE PT program for hematology testing, in which the laboratory is certified under CLIA. (Refer to D2130) 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 review of the federal proficiency testing data report and review of the comparative evaluation summery from Medical Laboratory Evaluation (MLE) proficiency testing (PT) program, the laboratory failed to successfully participate in the MLE PT program for hematology testing, in which the laboratory is certified under CLIA. The following analyte was noted as failed in the 2019 first and third event. Findings: 1. Medical Laboratory Evaluation 2019 1st event Cell I.D. or WBC Diff 0% 2. Medical Laboratory Evaluation 2019 3rd event Cell I.D. or WBC Diff 66% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the federal proficiency testing data report and review of the comparative evaluation summery from Medical Laboratory Evaluation (MLE) proficiency testing (PT) program, the laboratory director failed to ensure that the laboratory successfully participated in the MLE PT program for hematology testing, in which the laboratory is certified under CLIA. (Refer to D2130) 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 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 proficiency testing (PT) record review and interview with the laboratory staff, the laboratory failed to ensure that the laboratory director (LD) signed PT attestation statements, attesting that PT specimens were run in the same way as patient samples. Findings: 1. A review of hematology PT records from 6 events from 2017 to 2019 showed that the LD did not sign the attestation statements for the 1st hematology PT event, 2019. 2. During an interview on 4/11/19 at 3:00 PM, the laboratory staff confirmed that the attestation statement was not signed by the LD. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record review and interview with the 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 6 -- staff, the laboratory failed to ensure that