Alan L Tannenbaum Md Pa

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on May 12, 2020 for the Alan L Tannenbaum MD, PA laboratory. The Alan L. Tannenbaum MD, PA 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 2019 and 2020, the laboratory did not have successful performance in proficiency testing for the subspecialty of endocrinology. Refer to D 2107. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review of the 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 -- Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on May 12, 2020 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analytes, free thyroxine (fT4), thyroid stimulating hormone (TSH), and thyroxine (T4) for two consecutive testing events in 2019 and 2020. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 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 subspecialty of endocrinology. Findings include: On May 12, 2020 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 analytes, free thyroxine (fT4), thyroid stimulating hormone (TSH), and thyroxine (T4), as shown below. Event #3, 2019 fT4- 0% TSH-0% T4-0% Event #1, 2020 fT4-0% TSH-20% T4-0% 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 subspecialty of endocrinology. Findings include: On May 12, 2020 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 consecutive testing events for the analytes, free thyroxine (fT4), thyroid stimulating hormone (TSH), and thyroxine (T4), in the subspecialty of endocrinology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D 2107. 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; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing for the analytes, free thyroxine (fT4), thyroid stimulating hormone (TSH), and thyroxine (T4), in the subspecialty of endocrinology. Findings Include: The review of the American Proficiency Institute (API) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on May 12, 2020 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #3, 2019 fT4-0% TSH-0% T4-0% Event #1, 2020 fT4-0% TSH-20% T4-0% -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 11/7/19 at Alan L. Tannenbaum, M.D. PA, a clinical laboratory in Cape Coral, Florida. Alan L. Tannenbaum, M.D. PA was not in compliance with Code of Federal Regulations (CFR), Part 493, requirements for clinical laboratories. The following is a description of the non-compliance. D2098 ENDOCRINOLOGY CFR(s): 493.843(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 record review and interview with laboratory personnel, the laboratory did not get at least 80 percent for each analyte in two testing events over the past two years. The findings included: Review of proficiency testing records for the past two years on 11/7/19 revealed that the laboratory received a score of 0 percent for thyroxine on the third testing event of 2018, and 0 percent for free thyroxine, thyroid- stimulating hormone (TSH), and thyroxine on the third testing event of 2019. During an interview with the testing person at 10:20 a.m. on 11/7/19, she confirmed that they had received some unacceptable scores in endocrinology. D2105 ENDOCRINOLOGY CFR(s): 493.843(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 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 -- 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 record review and interview with laboratory personnel, there was no documentation of remedial action taken when the laboratory received unacceptable scores in an endocrinology proficiency testing event. The findings included: Review of proficiency testing records on 11/7/19 revealed that the laboratory received unacceptable score in free thyroxine, thyroid-stimulating hormone, and thyroxine for the third testing event of 2019 and that there was no documentation of remedial action. During an interview with the testing person at 10:20 a.m. on 11/7/19 she said that the problem was a calculation error and confirmed that there was no documentation of what happened or of remedial action taken. 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 and interview with laboratory personnel, the laboratory did not do calibrations on the cell counter every six months as their procedure manual specified. The findings included: Review of procedures for maintenance of the cell counter revealed that calibrations should be done every six months. Review of calibration records showed that calibrations were performed 6/20/19, 7/02/18, and 6/22 /17. During an interview with the testing person at 10:50 a.m. on 11/7/19, she confirmed that there was no documentation to indicate that the instrument had been calibrated every six months. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) The laboratory director is responsible for the overall operation and administration of -- 2 of 3 -- 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 No Tags No deficiency details available. 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 --