Gary M Kramer Md Pa

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on May 12, 2021 for Gary M. Kramer, MD. The Gary M. Kramer, MD laboratory is not in compliance with Code of Federal Regulations (CFR), Part 493, Laboratory Requirements. 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 laboratory's proficiency testing records for 2020 and 2021, the laboratory did not have successful performance in proficiency testing for the specialty of hematology. Refer to D2130. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review of the Centers 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 -- for Medicare & Medicaid Services (CMS) 153 and 155 reports, on May 12, 2021 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, platelet count, for two out of three testing events in 2020 and 2021. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful performance in proficiency testing in the specialty of hematology. Findings include: On May 12, 2021 on or about 10:00 AM the American Proficiency Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analyte, platelet count, as shown below. Event #2, 2020 Platelet count-60% Event #1, 2020 Platelet count-0% 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 the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the specialty of hematology. Findings include: On May 12, 2021 on or about 10:00 AM, the American Proficiency Institute (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two out of three testing events for the analyte, platelet count, in the specialty of hematology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2130. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory -- 2 of 3 -- director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing in the specialty of hematology. Findings Include: The review of the American Association of Bioanalysts (AAB) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on May 12, 2021 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores for two out of three testing events as shown below. Event #2, 2020 Platelet count-60% Event #1, 2021 Platelet count-0% -- 3 of 3 --

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 record review and interview with laboratory director, the testing person and the laboratory director did not sign the American Proficiency Institute (API) attestation statements-1st and 3rd events of 2017 in the specialty of hematology. The findings include: API Proficiency testing record review on 8/8/18 at 2pm for two-year review period (8/2016 to 8/8/2018) showed that the testing person and the director did not sign Hematology/Coagulation 1st event and 3rdevent for year 2017 API proficiency testing attestation statements. During an interview on 8/8/18 at 4:00 PM, laboratory director confirmed that the testing person and the director did not sign the API proficiency testing attestation statements for Hematology/Coagulation- 1st event and 3rd event of year 2017. 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 record review and interview with laboratory director, Hematology specialty laboratory failed to establish and follow written policies and procedures to access 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 -- clinical consultant competency for the two year record review period (8/2016 - 8/8 /18). The findings include: Laboratory Procedures and policy records reviewed on 8/8 /18 at 2:30pm for two-year review period (8/2016 - 8/8/2018) did not show established policy to access clinical consultant competency. Personnel record review did not show the new hire competency assessment for the clinical consultant. During an interview on August 8, 2018, at 4:00pm, the laboratory director confirmed that the laboratory did not have the written policies and procedures to access clinical consultant competency and personnel records did not include the new hire competency assessment for the clinical consultant. 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, record review and interview with laboratory director, laboratory failed to have the manufacturer's instructions -operator's manual for the recommended maintenance and function checks for Quest Diagnostics Horizon centrifuge. The findings include: During a laboratory tour on 8/8/18 at 3:30 pm, surveyor observed a centrifuge; Quest Diagnostics Horizon model 642 E with no manufacturer's instructions or operator's manual for the recommended maintenance and function checks. During an interview on August 8, 2018, at 4:00pm, the laboratory director confirmed that the laboratory did not have manufacturer's instructions or operator's manual for the recommended maintenance and function checks for Quest Diagnostics Horizon model 642 E centrifuge. 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on instrument calibration record review for two-year period (8/2016 to 8/8 /2018) and interview with the laboratory director, the laboratory failed to conduct and document the calibration verification for at least every six months for CDS Medonic M series hematology analyzer. The findings include: Calibration record review on 8/8 /18 at 3pm from two-year review period (8/2016-8/8/2018) showed that the laboratory did not perform the calibration verification for CDS Medonic M series hematology analyzer after November 2017 to August 8, 2018 and did not have the calibration verification records. During an interview on 8/8/18 at 4:00 PM, laboratory director confirmed that the laboratory did not perform the calibration verification for CDS Medonic M series hematology analyzer after November 2017 until August 8, 2018 and did not have the calibration verification records. -- 3 of 3 --