Michigan Institute Of Medicine, P C

Summary Statement of Deficiencies D5020 ENDOCRINOLOGY CFR(s): 493.1212 If the laboratory provides services in the subspecialty of Endocrinology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on observations, review of records, and interviews, the laboratory failed to have a request for patient testing from an authorized person (Refer to D5301), failed to indicate the expiration dates of control materials used in endocrinology testing (Refer to D5415), failed to ensure control materials used in endocrinology testing had not exceeded their expiration date (Refer to D5417 A), failed to ensure supplies used in specimen collection had not exceeded their expiration dates (Refer to D5417 B), failed to establish the criteria for acceptability of control materials used in endocrinology testing (Refer to D5469), failed to perform

Summary Statement of Deficiencies 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 lack of documentation and interview with Testing Personnel #1 (TP1), the laboratory failed to review and evaluate the endocrinology results on the American Association of Bioanalysts (AAB) proficiency testing final graded report for one (event #3 of 2020) of seven events reviewed. Findings include: 1. A document review for the AAB proficiency testing reports revealed a lack of documentation of the final AAB proficiency testing reports for one (event #3 of 2020) of seven events performed. 2. When queried on 10/27/2021 at 11:55 am, TP1 was unable to provide the surveyor the final event report to show the results had been reviewed and evaluated. 3. An interview on 10/27/2021 at 11:55 am, TP1 confirmed the laboratory did not have documents of the final proficiency testing reports for event #3 of 2020, so no review was conducted. 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 D3007 FACILITIES CFR(s): 493.1101(b) The laboratory must have appropriate and sufficient equipment, instruments, reagents, materials, and supplies for the type and volume of testing it performs. This STANDARD is not met as evidenced by: . A. Based on record review and interview with the testing personnel, the laboratory failed to have the appropriate amount of reagents for routine chemistry and endocrinology testing for 3 (2/23/18 to 5/7/18) of 24 months reviewed. Findings include: 1. A review of patient charts revealed patient #1 had a specimen collected on 2/23/18 and orders for the following tests: a. Free Thyroxine (FT4) b. Triiodothyronine (T3) c. Thyroid Stimulating Hormone (TSH) d. Vitamin B12 e. Folate 2. A review of patient charts revealed the date of testing for the specimen collected on 2/23/18 was 5/7/18. 3. A review of the laboratory's established "Handling Procedure" revealed a section stating, "If testing is unable to be done because the machine is down or the tech is out of town, all patient samples will be sent to the reference lab for blood work." 4. An interview on 9/16/19 at 12:29 pm with the testing personnel revealed ample reagents were not available for patient testing between 2/13 /18 and 5/7/18. 5. A record review of "Communications, Complaints, Problems" biannual log from the period of 2/7/18 to 8/8/18 revealed no problems and/or complaints were reported and no