Associated Physicians Of Dearborn

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: . Based on record review and interview with the Technical Supervisor (TS), the laboratory failed to perform and document remedial action for 1 (the first event of 2018) of 6 proficiency testing events reviewed. Findings include: 1. A record review of the American Proficiency Institute reports for the first testing event of 2018 revealed the laboratory had the following analytes with the following scores: a. Calcium was 40% b. Chloride was 60% c. High Density Lipoprotein (HDL) was 80% d. Sodium was 80% 2. A record review of the laboratory's established "Policy for Proficiency Testing" included a section stating, "We will thoroughly investigate any unacceptable, unsatisfactory, or unsuccessful PT result in an effort to identify the cause of failure." 3. A record review of the laboratory's American Proficiency Institute proficiency testing documents revealed a lack of remedial action for the analytes listed above. 4. An interview on 11/13/19 at 11:45 am with the TS confirmed proficiency testing remedial action from the first testing event of 2018 were not available. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system 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 2 -- 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: . A. Based on record review and interview with the Technical Supervisor (TS), the laboratory failed to use criteria verified or established by the laboratory to evaluate calibration verification activities for 2 (November 2017 to November 2019) of 2 years. Findings include: 1. A record review of the calcium calibration verification testing from 8/31/18 revealed the three samples used in the study had the following percent difference: a. Level 1, 43.96% b. Level 2, 15.32% c. Level 3, 12.94% 2. A record review of the laboratory's calibration verification data revealed the laboratory did not specify criteria to evaluate calibration verification results in the reports. 3. An interview on 11/13/19 at 11:05 am with the TS revealed the laboratory did not have specific criteria to evaluate calibration verification results. B. Based on record review and interview with the Technical Supervisor (TS), the laboratory failed to perform calibration verification at least every 6 months for 1 (September 2019) of 4 testing events reviewed. Findings include: 1. A record review of the laboratory's calibration verification data revealed the most recent calibration verification was performed was on 3/2/19 for the following analytes: a. Blood Urea Nitrogen (BUN) b. Creatinine c. Magnesium d. Albumin e. Total Bilirubin f. Alkaline Phosphatase (ALP) g. Asparate Aminotransferase (AST) h. Alanine Aminotransferase (ALT) i. Calcium j. Carbon Dioxide k. Total Cholesterol l. Triglycerides m. High-Density Lipoproteins n. Uric Acid 2. A review of the laboratory's established "Calibration and calibration verification" procedure revealed a section stating, "Calibration every 6 months or as needed (example, controls not in range)." 3. An interview on 11/13/19 at 1:21 pm with the TS confirmed calibration verification data was not performed in September 2019 as required for the analytes listed above. -- 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 review of the CMS database and review of the American Proficiency Institute (API) proficiency testing reports, it was determined that the laboratory failed to successfully participate in a CMS approved proficiency testing program for the chemistry analyte: iron-total. Findings include: Review of the CMS database and the API proficiency testing reports showed unsatisfactory performance for two of three proficiency testing events for the chemistry analyte: iron - total. Refer to D2087 and D2096. D2087 ROUTINE CHEMISTRY 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 -- CFR(s): 493.841(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 review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to attain a score of at least 80% of acceptable responses for the analyte: iron-total, which is unsatisfactory performance for the testing events. Findings include: Iron-total PT Event Score 1st event 2018 60% 2nd event 2017 40% 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 CMS database and the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to achieve satisfactory performance for the chemistry analyte: iron-total in two out of three consecutive testing events. Findings include: Unsatisfactory performance for two out of three consecutive proficiency testing events constitutes unsuccessful performance for iron-total: iron- total PT event Score 1st event 2018 60% 2nd event 2017 40% -- 2 of 2 --