Sudipta And Bindu Dey, Md, Inc

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to perform proficiency testing (PT) samples exactly as patient samples in the specialty of hematology. Findings include: 1. Record review on 10/12/23 of the Horiba Micros 60CS instrument printouts (result report) for 2022 event 1 PT revealed testing personnel ran 5 of 5 PT samples twice on 03/30/2022. 2. Record review on 10/12/23 of the laboratory's procedure manual for "Proficiency Testing Policy" revealed "samples must be tested the same number of times as patient samples." 3. Staff interview with testing personnel#1 (TP1) on 10/12/23 at 11:30 AM confirmed the above findings. TP1 further stated routine patient samples are run only once in the laboratory. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(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. 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 -- This STANDARD is not met as evidenced by: Based on record review and staff interview the laboratory failed to investigate and take remedial action when unacceptable Proficiency Testing (PT) scores are received in the subspecialty of routine chemistry. Findings include: 1. Record review on 10/12 /2023 of the American Proficiency Institute (API) PT scores revealed the following: a. For 2023 Event 1, an unacceptable PT score of 80% for magnesium for 1 of 5 PT samples was obtained. c. Investigation and remedial action was not documented for the unacceptable result listed in 1a above. 2. Staff interview on 10/12/2023 on 12:15 PM with testing personnel #1 (TP1) confirmed the above findings and TP1 further commented he/she was unaware an investigation was required for PT scores less than 100%. 3. The laboratory performs 500 magnesium tests annually in the subspecialty of routine chemistry. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on record review, telephone interview and staff interview the laboratory failed to perform red cell distribution width (RDW) calibration as required by the manufacturer in the specialty of hematology. Findings include: 1. Record review on 10 /12/23 of the Horiba Micros 60CS operator's manual revealed "the RDW calibration is a separate calibration outside the auto-calibration menu." The Horiba Micros 60CS operator's manual further provided detailed information in performing RDW calibration. 2. Record review on 10/12/23 of the laboratory's procedure manual for Horiba Micros 60CS instrument revealed lack of documentation for RDW calibration procedures. 3. Telephone interview with Horiba Micros 60CS technical service personnel on 10/12/23 at 9:50AM confirmed RDW is a separate calibration procedure, and it needs to be performed semiannually. 4. Staff interview with the technical consultant on 10/12/23 at 10:00 AM confirmed the above findings. 5. The laboratory performs 4,000 RDW tests annually in the specialty of hematology. D5783

Summary Statement of Deficiencies D0000 A proficiency testing desk review of the Sudipta and Bindu Dey, MD Inc Laboratory was conducted pursuant to 42CFR Part 493 of the Clinical Laboratory Improvement Amendments (CLIA) of 1988. 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 Proficiency Testing (PT) data report (Report 155) and graded results from American Proficiency Institute (API), the laboratory failed to successfully participate in the regulated analyte chloride. The laboratory had unsatisfactory scores for the 3rd event 2021, the 1st event 2022 and the 2nd event 2022. Refer to D2096 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in 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 review of the Proficiency Testing (PT) data report (Report 155), graded results from American Proficiency Institute (API), and phone interview with the technical consultant, the laboratory failed to achieve satisfactory performance in three consecutive testing events for the chloride analyte and has sustained a subsequent occurrence of unsuccessful participation in PT. Findings include: 1. API 2021 Event #3 for Chloride the score of 20% and was unsatisfactory. 2. API 2022 Event #1 for Chloride the score of 60% and was unsatisfactory. 3. API 2022 Event # 2 for Chloride the score of 20% and was unsatisfactory. 4. Phone interview on 09/21/2022 at 02:02 PM with the technical consultant(TC) confirmed the laboratory failed to achieve satisfactory performance for the chloride analyte in the last event 2021 and the first and second PT events in 2022. The TC further stated," The laboratory is not testing the chloride analyte, and has not resumed testing since the failure of Event # 1 2022." 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 record review of 2021 Event #3 and 2022 Events # 1 & 2 of the American Proficiency Institute (API) proficiency testing (PT) results (3 testing events), the laboratory director failed to ensure effective remedial action was instituted in response to unsatisfactory PT results resulting in the second unsuccessful performance for the analyte chloride. Refer to D2016 & D2096 -- 2 of 2 --

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 an off-site desk review of the 2021 and 2022 Chemistry Core proficiency testing (PT) results reported to the CLIA database by the PT provider, American Proficiency Institute (API) PT records, email communication and telephone interview with the technical consultant, the laboratory failed to successfully participate in two consecutive testing events in the specialty of Chemistry resulting in unsuccessful PT performance. Refer to citation D2097 D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) 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 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 Proficiency Testing (PT) record review and email interview with technical consultant (TC) the laboratory failed to achieve successful performance for the same analyte in two consecutive PT events in the specialty of chemistry. Findings include: 1. Record review on 5/13/2022 of the Center for Medicare & Medicaid Services (CMS) CASPER 0155D Report revealed the laboratory failed to obtain a score of at least 80% leading to unsatisfactory scores for two consecutive PT events for the regulated analyte # 0355 chloride (CL) as follows: Year/Event # PT Score 2021 Event 3 20% 2022 Event 1 60% 2. Record review on 6/14/2022 of the American Proficiency Institute (API) PT Chemistry Core Performance Summary revealed the laboratory failed to obtain a score of at least 80% leading to unsatisfactory scores in two consecutive PT events for the regulated analyte # 0355 CL as evidenced below. Year /Event # PT score 2021 - Event -3 20% 2022 - Event -1 60% 3. Staff interview with the Technical Consultant on 6/7/2022 at 8:11 AM confirmed the above findings. 4. The laboratory performs 23,900 tests annually in the specialty of Chemistry. -- 2 of 2 --

Summary Statement of Deficiencies D5781

Summary Statement of Deficiencies D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require