Gift Of Life Michigan

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 record review of the CMS database and the Wisconsin State Laboratory of Hygiene Proficiency Testing reports, it was determined the laboratory failed to successfully participate in a CMS-approved proficiency testing program for the specialty of hematology. Findings include: The laboratory failed to achieve satisfactory performance for the specialty of hematology. Refer to D2131. D2131 HEMATOLOGY CFR(s): 493.851(g) 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 -- (g) Failure to achieve an overall testing event score of satisfactory performance for 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 Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing reports, it was determined the laboratory failed to achieve satisfactory performance for the specialty of hematology for 2 (1st event of 2025 and the 2nd event of 2025) of 3 testing events. Findings include: Unsatisfactory performance for 2 of 3 testing events constitutes unsuccessful performance for the specialty of hematology. Provider Testing Event Analyte/Specialty/Subspecialty Score WSLH 1st 2025 Hematology | WBC 60% WSLH 2nd 2025 Hematology | WBC 60% -- 2 of 2 --

Summary Statement of Deficiencies D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: . Based on record review and interviews, the laboratory failed to perform control procedures each date of patient testing for its Abaxis Piccolo Xpress chemistry analyzer (Refer to D5445 A) and failed to perform control procedures each date of patient testing for its Accriva Diagnostics Hemochron Jr. Whole Blood Microcoagulation test system (Refer to D5445 B). D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures 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 2 -- This STANDARD is not met as evidenced by: . A. Based on record review and interview with the Point of Care Coordinator, the laboratory failed to perform control procedures each date of patient testing for its Abaxis Piccolo Xpress chemistry analyzer for 12 (March 2022 to March 2023) of 12 months since the test system was put into use. Findings include: 1. An interview on 4/4 /23 at 9:22 am with the Point of Care Coordinator revealed the laboratory performed external quality control testing with each new lot, new shipment, and every 30 days the Abaxis Piccolo Xpress chemistry analyzer was in use. 2. A review of the laboratory's patient test records revealed patient testing using the Abaxis Piccolo Xpress chemistry analyzer began on 3/28/22. 3. A review of the laboratory's "POCT Maintenance and Controls Log" and patient test records from January 2023 to March 2023 revealed the following dates when patients testing was performed without at least two levels of external quality control testing performed for the Hepatic and the MetLac (albumin, calcium, chloride, creatinine, glucose, lactate, magnesium, phosphorus, potassium, sodium, total carbon dioxide and blood urea nitrogen (BUN)) panels: a. January 2023 i. 1/10/23 ii. 1/21/23 iii. 1/25/23 iv. 1/26/23 b. February 2023 i. 2/10/23 c. March 2023 i. 3/3/23 ii. 3/6/23 iii. 3/7/23 iv. 3/9/23, no MetLac panel controls performed. v. 3/13/23 vi. 3/14/23 vii. 3/21/23 viii. 3/23/23 ix. 3/24/23 x. 3/27 /23 xi.3/28/23 xii. 3/30/23 4. An interview on 4/4/23 at 11:22 am with the Point of Care Coordinator revealed the laboratory had not implemented an Individualized Quality Control Program (IQCP) and the laboratory had not performed controls each date of patient testing using the Abaxis Piccolo Xpress chemistry analyzer. B. Based on record review and interview with the Point of Care Coordinator, the laboratory failed to perform control procedures each date of patient testing for its Accriva Diagnostics Hemochron Jr. Whole Blood Microcoagulation test system for 11 (3/6/23, 3/7/23, 3/9/23, 3/13/23, 3/17/23, 3/21/23, 3/23/23, 3/24/23, 3/27/23, 3/28/23, and 3/30 /23) of 12 patient testing dates since the test system was put into use. Findings include: 1. An interview on 4/4/23 at 9:22 am with the Point of Care Coordinator revealed the laboratory performed external quality control testing with each new lot, new shipment, and every 30 days the Accriva Diagnostics Hemochron Jr. Whole Blood Microcoagulation test system was in use. 2. A review of the laboratory's patient test records revealed patient testing using the Accriva Diagnostics Hemochron Jr. Whole Blood Microcoagulation test system began on 3/6/23. 3. A review of the laboratory's "POCT Maintenance and Controls Log" and patient test records for March 2023 revealed the following dates when patients had testing performed without external quality control testing performed: a. 3/6/23 b. 3/7/23 c. 3/9/23 d. 3/13/23 e. 3 /17/23 f. 3/21/23 g. 3/23/23 h. 3/24/23 i. 3/27/23 j. 3/28/23 k. 3/30/23 4. An interview on 4/4/23 at 11:22 am with the Point of Care Coordinator revealed the laboratory had not implemented an Individualized Quality Control Program (IQCP) and the laboratory had not performed controls each date of patient testing using the Accriva Diagnostics Hemochron Jr. Whole Blood Microcoagulation test system. -- 2 of 2 --