Ravi Shankar Md

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's policy and procedure, American Proficiency Institute (API) proficiency testing (PT) records, and an interview with the testing personnel (TP), it was determined that the laboratory failed to attain at least 80 percent of the acceptable score in Routine Chemistry for the Partial Pressure of Carbon Dioxide (pCO2), Partial pressure of Oxygen (pO2), and pH analytes in the first event of 2025 (Q1-2025). The findings include: 1. The surveyor reviewed the PT records for Q1-2025, where API reported unsatisfactory scores for pCO2, pO2, and pH. The results were as follows: a. pCO2 PT Q1-2025 Overall score: 60% Specimen Reported Expected BG-01 67 60 - 71 BG-02 55 48 - 59 BG-03 *24 28 - 39 BG-04 *34 17 - 28 BG-05 26 19 - 30 b. pO2 PT Q1-2025 Overall score: 60% Specimen Reported Expected BG-01 60 47 - 78 BG-02 150 119 - 163 BG-03 *130 78 - 109 BG- 04 *94 106 - 144 BG-05 80 66 - 97 c. pH PT Q1-2025 Overall score: 60% Specimen Reported Expected BG-01 7.14 7.11 - 7.19 BG-02 7.21 7.17 - 7.26 BG-03 *7.62 7.38 - 7.47 BG-04 *7.42 7.58 - 7.67 BG-05 7.57 7.55 - 7.63 Legend: * = unsatisfactory score reported 2. The TP affirmed by interview on June 16, 2025, at approximately 10: 10 a.m. that the laboratory obtained the PT unsatisfactory scores mentioned in statement #1. Thus, the accuracy and reliability of patient test reported cannot be determined. 3. According to the testing declaration form submitted on the day of the survey, the laboratory performed approximately 100 Blood Gas patient test samples that included pCO2, pO2, and pH analytes during the time the laboratory received unsatisfactory proficiency testing scores. 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 -- D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on the surveyor's review of seven (7) patient records, lack of personnel competency documentation, and an interview with the testing personnel (TP); as specified in the personnel requirements in subpart M, it was determined that the laboratory failed to perform competency assessments for the testing personnel (TP) prior to the start of patient testing. The findings include: 1. Surveyor's review of 7 patient records showed that competency assessment for the TP was missed to be performed for the years 2024 and 2025 prior to the start of patient testing. 2. The TP affirmed by interview on June 26, 2025, at approximately 10:25 a.m. that no competency records were available for review for the years 2024 and 2025. Thus, the quality and reliability of patient results reported could not be assured. 3. According to the testing declaration form submitted at the time of the survey, the laboratory reported and performed approximately 100 Blood Gas patient samples annually including the time when competency assessment for TP was missed. D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. The technical consultant is not required to be onsite at all times testing is performed; however, he or she must be available to the laboratory on an as needed basis to provide consultation, as specified in paragraph (a) of this section. This STANDARD is not met as evidenced by: Based on the surveyor's findings on June 26, 2025, and an interview with the testing personnel, the laboratory director, as technical consultant, is herein cited for deficient practice in failure to provide technical and scientific oversight of the laboratory. The findings include: 1. Unsatisfactory proficiency testing score. See D2087. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based on the lack of competency assessment documentation for the years 2024 and 2025, review of laboratory's policy/procedure, patient records, and an interview with the testing personnel; it was determined that the laboratory director, who also served as the technical consultant is herein cited for the deficient practice in failure to perform or document the personnel competency assessment to ensure that the -- 2 of 3 -- individual maintained the necessary competency to conduct test procedures in a timely, accurate, and proficient manner. See D5209. -- 3 of 3 --

Summary Statement of Deficiencies D2089 ROUTINE CHEMISTRY CFR(s): 493.841(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: Based on a review of the CMS Casper report 096 and the lack of documentation related to the lab proficiency testing (PT) program, and an interview with the laboratory personnel (LP) , it was determined that the laboratory failed to submit proficiency testing (PT) over several event cycles for Chemistry during 2020 and 2021. The laboratory inspection occurred on 2/2/22 between 11 a.m. and 12:30 p.m. Findings include: 1. The Casper 096 report for the 2020-2021 was reviewed, and there was a score of 0 (zero) for several submissions. 2. The LP indicated that API (American Proficiency institute) was used for 2020 and 2021 for PT. 3. The failure to submit metrics are below: 2020 Event Cycle 3 Analyte CMS PT value Routine Chemistry 0 Ph Blood Gas 0 PO2 Blood Gas 0 PCO2 Blood Gas 0 2021 Event Cycles 1,2 and 3 Analyte CMS PT value Routine Chemistry 0 Ph Blood Gas 0 PO2 Blood Gas 0 PCO2 Blood Gas 0 4. At approximately 11:30 a.m. on 2/2/2022, the LP affirmed that there were no API proficiency report values submitted for the timeframes mentioned above. 5. There were no patients tested during the 2020 and 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 -- 2021 timeframes listed above. 6. Reagent controls were run during the above periods and were deemed acceptable. 7. PT testing was initiated with Event cycle 1 for 2022- lab is awaiting results. 8. Testing is moderate complexity. 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. This STANDARD is not met as evidenced by: Based on a review of the CMS Casper report 096 and the lack of documentation related to proficiency testing (PT) program and an interview with the laboratory personnel (LP) , it was determined that the laboratory failed to enroll in proficiency testing (PT) for Event cycle 3 of 2020 and all of 2021. The laboratory inspection occurred on 2/2/22 between 11 a.m. and 12:30 p.m. Findings include: 1. The laboratory director did not ensure that the laboratory was enrolled in an HHS approved proficiency program for each testing cycle. 2. See D 2089. -- 2 of 2 --