Great Lakes Foot And Ankle

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #2 (TP2), the laboratory failed to establish written procedures for microscopic tissue evaluations for 6 (October 2021 to April 2022) of 6 months since the laboratory added microscopic tissue examination testing. Findings include: 1. A review of the laboratory's patient test reports revealed the laboratory had added microscopic tissue examination testing in October 2021. 2. A review of the laboratory's procedure manual revealed a lack of an established procedure for the performance of microscopic tissue examinations. 3. An interview on 4/18/22 at 3:53 pm with TP2 confirmed the laboratory had not established a procedure for the performance of microscopic tissue examinations. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. 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 -- This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #2 (TP2), the laboratory failed to ensure daily maintenance was performed each day of patient testing for 2 (2/10/21 and 2/24/22) of 9 patient testing dates reviewed. Findings include: 1. A review of 9 patient test records and daily maintenance records revealed the following dates patient testing was performed when daily maintenance for the tissue processor, tissue embedding system, flotation bath, rotary microtome, and automated stainer had not been performed: a. 2/10/21 b. 2/24/22 2. A review of the laboratory's "Tisue Processing- Tissue Tek VIP 5 Tissue Processor" procedure revealed a section titled "General Maintenance" stating, "Every use clean the inside of the retort, retort rim and lid gasket by wiping with gauze. Insepct gasket for deterioration. Change water in fume control system. Clean outlet filter- unscrew counterclockwise, remove from retort, remove any debris, thoroughly clean by soaking in clearant, dry and reinstall filter." 3. A review of the laboratory's "Embedding- Tissue TEC 5 Tissue Embedding Console System" revealed a section titled "Procedure" stating, "At the end of embedding, all residual paraffin will be scrapped off the embedding center. The unit can be cleaned with gauze or soft cloth slightly moistened with clearant. Dry and polish with gauze or soft cloth. Waste drawer should be emptied weekly. Clean forcep holder with a cotton swab. Cooling plate should be cleaned and dried after each use. The temperature of the paraffin is taken and recorded every workday. Maintain paraffin temperature 2-4 degrees above the manufacturers recommended melting point." 4. A review of the laboratory's "Floatation Bath- Boekel Round Tissue Bath" procedure revealed a section titled "Quality Control" stating, "Daily cleaning temperature recording" and "Document maintenance of floatation bath." 5. A review of the laboratory's "Microtomy Leica Rotary Microtome RM2235" procedure revealed a section titled "Maintenance" stating, "At the end of the day the microtome will be thoroughly cleaned. All paraffin rolls and tissue debris will be brushed off the machine." 6. A review of the laboratory's "Tissue Tek Prisma Automated Stainer" procedure revealed a section titled "Daily/Every workday" stating, "Keep outside clean by wiping with damp cloth. Rotate reagents as needed. Filter Hematoxylin and Eosin. Check temperature." 7. An interview on 4/18/22 at 3:50 pm with TP2 confirmed the laboratory had not documented maintenance on the dates listed above. -- 2 of 2 --

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #1 (TP1), the laboratory failed to ensure the name and address of the laboratory location where tissue microscopic examinations were performed was on the test report for 8 (Patients 1-8) of 8 patient testing records reviewed. Findings include: 1. An interview with TP1 on 9/14/20 at 10:44 am revealed slides, once prepared, are sent to another location for the microscopic examination. 2. A record review of patient testing records revealed patient test reports did not have the name and address of the laboratory performing the tissue microscopic examinations for the following patients: a. Patient 1 b. Patient 2 c. Patient 3 d. Patient 4 e. Patient 5 f. Patient 6 g. Patient 7 h. Patient 8 3. An interview on 9/14/20 at 10:48 am with TP1 confirmed the laboratory did not list the name and address of the laboratory performing the microscopic tissue examinations on test reports. D6122 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(ii) The procedures for evaluation of the competency of the staff must include, but are not 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 -- limited to monitoring the recording and reporting of test results. This STANDARD is not met as evidenced by: . Based on record review and interview with Testing Personnel #1 (TP1), the Technical Supervisor failed to evaluate the recording and reporting of test results for 1 (TP1) of 1 testing personnel listed on the CMS-209 form. Findings include: 1. A review of the laboratory's CMS-209 form revealed there was one testing personnel listed (TP1). 2. A review of the laboratory's competency assessment records revealed a lack of documentation for monitoring the recording and reporting of test results for TP1's competency assessment performed on 5/1/20. 3. An interview on 9/14/20 at 11: 15 am with TP1 confirmed the Technical Supervisor did not evaluate the recording and reporting of test results for TP1 during the 5/1/20 competency assessment. -- 2 of 2 --