Millennium Physician Group

Summary Statement of Deficiencies D0000 At the time of the announced, onsite recertification survey, Millennium Physician Group was found to be NOT in compliance with the CLIA laboratory requirements of 42 CFR 493. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to perform calibrations every 6 months on the Medonic Hematology analyzer in 2022 and 2023. The findings include: The 12/12/23 review of calibration records for the Medonic analyzer showed a calibration was performed on 3/4/22. During an interview on 12/12 /23 at 10:40am with Technical Consultant A, it was confirmed the every 6 month calibrations were not performed. . 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 --

Summary Statement of Deficiencies D0000 At the time of the announced, onsite recertification survey, Millennium Physician Group was found to be NOT in compliance with the CLIA laboratory requirements of 42 CFR 493. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of proficiency testing records and staff interview, the laboratory failed to review proficiency test scores for 5 of 6 testing events in 2020 and 2021. Findings include: Review of American Proficiency Institute (API) proficiency test records showed the Laboratory Director or designee failed to document review of the 1st and 2nd Hematology testing events in 2020. The Laboratory Director or designee failed to document review of the 1st, 2nd, and 3rd Hematology testing events in 2021. During interview on 2/1/22 at 11:15am, Technical Consultant A confirmed the laboratory did not document review of proficiency test scores for the events listed above. . D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for 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 -- the laboratory's patient population. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to complete verification for Complete Blood Count testing on the Medonic hematology analyzer. The findings include: Review of the laboratory's records for performance verification for Complete Blood Counts (CBCs) on the Medonic analyzer showed that the laboratory had not completed the correlation studies. During an interview on 2/1/22 at 10:41 AM, Technical Consultant A confirmed that the laboratory had not performed correlation studies. . D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to perform calibrations every 6 months on the Medonic Hematology analyzer since the instrument was put in use (October 2020). The findings include: Review of calibration records for the Medonic analyzer showed a calibration was performed on 3/4/21. During an interview on 2/1/22 at 11:40am with Technical Consultant A, it was confirmed the every 6 month calibrations were not performed. . -- 2 of 2 --

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 facility failed to perform the testing of proficiency testing samples the same way patient samples are tested for 6 of 6 proficiency testing events reviewed (2016 & 2017). The findings include: The 1/8/18 record review of the Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) events for 2016 and 2017 showed the following: 1. The 2016 1st event for Hematology samples AT-01, AT-02, AT-03, AT-04, AT-05 were tested multiple times. AT-01: 2/26/16 at 11:51 and 12:06. AT-02: 2/26/16 at 11:53 and 12:08. AT-03: 2/26/16 at 11:55 and 12:09. AT-04: 2/26/16 at 11:57 and 12:11. AT-05: 2/26/16 at 11: 59 and 12:16. The tests performed were: White Cell Count, Red Cell Count, Hemoglobin, Hematocrit, Platelet Count, Mean corpuscular volume (MCV), Lymphocytes, Monocytes, Granulocytes. 2. The 2016 2nd event for Hematology samples AT-06, AT-07, AT-08, AT-09, AT-10 were tested multiple dates and times. AT-06: 6/15/16 at 12:04 and on 6/16/16 at 7:53. AT-07: 6/15/16 at 12:07 and on 6/16 /16 at 7:56. AT-08: 6/15/16 at 12:08 and on 6/16/16 at 7:59. AT-09: 6/15/16 at 12:11 and on 6/16/16 at 8:01. AT-10: 6/15/16 at 12:13 and on 6/16/16 at 8:02. The tests performed were: White Cell Count, Red Cell Count, Hemoglobin, Hematocrit, Platelet Count, Mean corpuscular volume (MCV), Lymphocytes, Monocytes, Granulocytes. 3. The 2016 3rd event for Hematology samples AT-11, AT-12, AT-13, AT-14, AT-15 were tested multiple dates and times. AT-11: 9/22/16 at 9:56 and on 9/23/16 at 7:42. AT-12: 9/22/16 at 9:58 and on 9/23/16 at 7:44. AT-13: 9/22/16 at 10:01 and on 9/23 /16 at 7:47. AT-14: 9/22/16 at 10:09 and on 9/23/16 at 7:48. AT-15: 9/22/16 at 10:13 and on 9/23/16 at 7:50. The tests performed were: White Cell Count, Red Cell Count, Hemoglobin, Hematocrit, Platelet Count, Mean corpuscular volume (MCV), 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 -- Lymphocytes, Monocytes, Granulocytes. 4. The 2017 1st event for Hematology samples AT-01, AT-02, AT-03, AT-04, AT-5 were tested multiple dates and times. AT-01: 2/24/17 at 11:06 and on 2/28/17 at 13:43. AT-02: 2/24/17 at 11:09 and on 2/28 /17 at 13:46. AT-03: 2/24/17 at 11:11 and on 2/28/17 at 13:50. AT-04: 2/24/17 at 11: 14 and on 2/28/17 at 13:54. AT-05: 2/24/17 at 11:16 and on 2/28/17 at 13:56.. The tests performed were: White Cell Count, Red Cell Count, Hemoglobin, Hematocrit, Platelet Count, Mean corpuscular volume (MCV), Lymphocytes, Monocytes, Granulocytes. 5. The 2017 2nd event for Hematology samples AT-06, AT-07, AT-08, AT-09, AT-10 were tested multiple dates and times. AT-06: 6/14/17 at 14:42 and on 6 /16/17 at 7:36. AT-07: 6/14/17 at 14:44 and on 6/16/17 at 7:38. AT-08: 6/14/17 at 14: 48 and on 6/16/17 at 7:43. AT-09: 6/14/17 at 14:50 and on 6/16/17 at 8:10. AT-10: 6 /14/17 at 14:52 and on 6/16/17 at 8:00. The tests performed were: White Cell Count, Red Cell Count, Hemoglobin, Hematocrit, Platelet Count, Mean corpuscular volume (MCV), Lymphocytes, Monocytes, Granulocytes. 6. The 2017 3rd event for Hematology samples AT-11, AT-12, AT-13, AT-14, AT-15 were tested multiple dates and times. AT-11: 9/20/17 at 14:48 and on 9/21/17 at 7:30. AT-12: 9/20/17 at 14:52 and on 9/21/17 at 7:31. AT-13: 9/20/17 at 14:54 and on 9/21/17 at 7:33. AT-14: 9/20 /17 at 15:02 and on 9/21/17 at 7:35. AT-15: 9/20/17 at 15:04 and on 9/21/17 at 7:37. The tests performed were: White Cell Count, Red Cell Count, Hemoglobin, Hematocrit, Platelet Count, Mean corpuscular volume (MCV), Lymphocytes, Monocytes, Granulocytes. During interview on 1/8/18 at 11:15, the testing personnel #1 confirmed the proficiency samples were tested in duplicate, which is not how patient samples are normally tested. . D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to ensure the laboratory testing conducted on patient samples for lipid profile testing met the applicable manufacturer's instructions. The findings include: The record review on 1/8 /18 of the test menu showed the laboratory performs lipid testing on the Alere Cholestech LDX instrument. The manufacturer instructions for the lipid profile cassette pulled from the current lot in use showed the instructions were last updated on July 2013. The instructions stated, "The Alere Cholestech LDX System is CLIA waived for fingerstick or venous whole blood unprocessed samples only". The laboratory testing person stated on 1/8/18 at 10:00am that the facility uses patient serum for lipid testing. The testing person provided manufacturer instruction documentation from an unknown date that stated, "The Alere Cholestech LDX System is CLIA waived for fingerstick or venous whole blood unprocessed samples only. If you run serum or plasma on the Alere Cholestech LDX System you will have to comply with the regulations for moderate complexity". At 12:33pm on 1/8/18, the -- 2 of 3 -- surveyor contacted Alere Technical Support and spoke with a consultant that confirmed the Alere Cholestech LDX system when used with the Lipid Profile cassette is CLIA waived only and that using serum is not an acceptable specimen for patient testing. -- 3 of 3 --