Common use of Compliance Statements Clause in Contracts

Compliance Statements. The Oklahoma Blood Institute (OBI) manufacturers Blood and Blood Products under Food and Drug Administration (FDA) license number 0766. Each OBI facility has an FDA assigned Establishment Identification Number (FEIN) and is inspected by the FDA to evaluate Current Good Manufacturing Practices (CGMP) and compliance with relevant sections of 21 CFR 200, 600, 800 and 1200. AABB Blood Bank and Transfusion Services accreditation is maintained by OBI. In accordance with the Social Security Act and 42 CFR Parts 422.156, 422.157 and 422.158 the Health Care Financing Administration has granted AABB deemed status with the Centers for Medicare and Medicaid Services (CMS). Therefore, AABB standards have been found to meet or exceed all relevant CMS requirements for participation. AABB bi-annual assessments evaluate OBI against these standards. Infectious Disease Testing is provided under CLIA number 37D0470358 and Immunohematology Testing is provided under CLIA number 37D2175055 in the headquarters location in Oklahoma City. Immunohematology Testing is also provided under CLIA number 37D0931105 in the Tulsa location, CLIA number 04D2096885 in the Little Rock location, and CLIA number 45D0507042 in the Coffee Memorial Blood Center location. CLIA compliance inspections and renewals are performed bi- annually by the AABB. OBI Laboratories participate in CMS approved proficiency testing programs. AABB Immunohematology Laboratory Accreditation is maintained by the Clinical Laboratories in Oklahoma City, Tulsa, Little Rock, and Coffee Memorial Blood Center. OBI maintains a Quality Plan, Quality Manual, Emergency Preparedness and Disaster Plan, Transfusion Associated Disease Investigation Procedures, Look-Back Procedures (HCV and HIV), and Consignee Notification Procedures for Positive Test Results, Market Recalls and Market Withdrawals for non-conforming blood or blood components. Initial consignee notifications occur in accordance with federal and state statutes and regulations. Specifically within 3 calendar days if the blood collecting establishment supplied blood and blood components collected from a donor who tested negative at the time of donation but tests reactive for evidence of HIV or HCV infection on a later donation or who is determined to be at increased risk for transmitting HIV or HCV infection; within 3 calendar days after the blood collecting establishment supplied blood and blood components collected from an infectious donor, whenever records are available; and within 45 days of the test, of the results of the supplemental (additional, more specific) test for HIV or HCV, as relevant, or other follow-up testing required by FDA. These documents can be made available for reference during relevant facility inspections. OBI performs bacterial detection testing on all apheresis platelet components. This test is a culture that is incubated throughout the shelf life of the product. OBI maintains a Privacy Policy, Notification of Privacy Practices and Business Associate Agreements that include relevant requirements identified in 45 CFR 164, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the Information Technology for Economic and Clinical Health (HITECH) Act of 2009. Compliance Officer (▇▇▇)▇▇▇-▇▇▇▇ THIS AGREEMENT is entered into as of , by Mangum City Hospital Authority DBA: ▇▇▇▇▇▇ Regional Medical Center, ▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇, OK 73554 (“Hospital”) and the ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇ Center, Oklahoma Blood Institute, an Oklahoma not for profit corporation with its principal office located at ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇, ▇▇▇▇▇ ("Blood Institute").

Compliance Statements. The Oklahoma Blood Institute (OBI) manufacturers Blood and Blood Products under Food and Drug Administration (FDA) license number 0766. Each OBI facility has an FDA assigned Establishment Identification Number (FEIN) and is inspected by the FDA to evaluate Current Good Manufacturing Practices (CGMP) and compliance with relevant sections of 21 CFR 200, 600, 800 and 1200. AABB Blood Bank and Transfusion Services accreditation is maintained by OBI. In accordance with the Social Security Act and 42 CFR Parts 422.156, 422.157 and 422.158 the Health Care Financing Administration has granted AABB deemed status with the Centers for Medicare and Medicaid Services (CMS). Therefore, AABB standards have been found to meet or exceed all relevant CMS requirements for participation. AABB bi-annual assessments evaluate OBI against these standards. Infectious Disease Testing is provided under CLIA number 37D0470358 and Immunohematology Testing is provided under CLIA number 37D2175055 in the headquarters location in Oklahoma City. Immunohematology Testing is also provided under CLIA number 37D0931105 in the Tulsa location, CLIA number 04D2096885 in the Little Rock location, and CLIA number 45D0507042 in the Coffee Memorial Blood Center location. CLIA compliance inspections and renewals are performed bi- bi-annually by the AABB. OBI Laboratories participate in CMS approved proficiency testing programs. AABB Immunohematology Laboratory Accreditation is maintained by the Clinical Laboratories in Oklahoma City, Tulsa, Little Rock, and Coffee Memorial Blood Center. OBI ▇▇▇ maintains a Quality Plan, Quality Manual, Emergency Preparedness and Disaster Plan, Transfusion Associated Disease Investigation Procedures, Look-Back Procedures (HCV and HIV), and Consignee Notification Procedures for Positive Test Results, Market Recalls and Market Withdrawals for non-conforming blood or blood components. Initial consignee notifications occur in accordance with federal and state statutes and regulations. Specifically within 3 calendar days if the blood collecting establishment supplied blood and blood components collected from a donor who tested negative at the time of donation but tests reactive for evidence of HIV or HCV infection on a later donation or who is determined to be at increased risk for transmitting HIV or HCV infection; within 3 calendar days after the blood collecting establishment supplied blood and blood components collected from an infectious donor, whenever records are available; and within 45 days of the test, of the results of the supplemental (additional, more specific) test for HIV or HCV, as relevant, or other follow-up testing required by FDA. These documents can be made available for reference during relevant facility inspections. Except for apheresis platelets treated using an FDA-approved pathogen reduction process, OBI performs bacterial detection testing on all apheresis platelet components. This test is a culture that is incubated throughout the shelf life of the product. OBI ▇▇▇ maintains a Privacy Policy, Notification of Privacy Practices and Business Associate Agreements that include relevant requirements identified in 45 CFR 164, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the Information Technology for Economic and Clinical Health (HITECH) Act of 2009. Compliance Officer (▇▇▇)) ▇▇▇-▇▇▇▇ THIS AGREEMENT is entered into as of , by Mangum City Hospital Authority DBA: ▇▇▇▇▇▇ Regional Medical Center, ▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇, OK 73554 (“Hospital”) and the ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇ Center, Oklahoma Blood Institute, an Oklahoma not for profit corporation with its principal office located at ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇, ▇▇▇▇▇ ("Blood Institute").

Compliance Statements. The Oklahoma Blood Institute (OBI) manufacturers Blood and Blood Products under Food and Drug Administration (FDA) license number 0766. Each OBI facility has an FDA assigned Establishment Identification Number (FEIN) and is inspected by the FDA to evaluate Current Good Manufacturing Practices (CGMP) and compliance with relevant sections of 21 CFR 200, 600, 800 and 1200. AABB Blood Bank and Transfusion Services accreditation is maintained by OBI. In accordance with the Social Security Act and 42 CFR Parts 422.156, 422.157 and 422.158 the Health Care Financing Administration has granted AABB deemed status with the Centers for Medicare and Medicaid Services (CMS). Therefore, AABB standards have been found to meet or exceed all relevant CMS requirements for participation. AABB bi-annual assessments evaluate OBI against these standards. Infectious Disease Testing is provided under CLIA number 37D0470358 and Immunohematology Testing is provided under CLIA number 37D2175055 in the headquarters location in Oklahoma City. Immunohematology Testing is also provided under CLIA number 37D0931105 in the Tulsa location, CLIA number 04D2096885 in the Little Rock location, and CLIA number 45D0507042 in the Coffee Memorial Blood Center location. CLIA compliance inspections and renewals are performed bi- bi-annually by the AABB. OBI Laboratories participate in CMS approved proficiency testing programs. AABB Immunohematology Laboratory Accreditation is maintained by the Clinical Laboratories in Oklahoma City, Tulsa, Little Rock, and Coffee Memorial Blood Center. OBI maintains a Quality Plan, Quality Manual, Emergency Preparedness and Disaster Plan, Transfusion Associated Disease Investigation Procedures, Look-Back Procedures (HCV and HIV), and Consignee Notification Procedures for Positive Test Results, Market Recalls and Market Withdrawals for non-conforming blood or blood components. Initial consignee notifications occur in accordance with federal and state statutes and regulations. Specifically within 3 calendar days if the blood collecting establishment supplied blood and blood components collected from a donor who tested negative at the time of donation but tests reactive for evidence of HIV or HCV infection on a later donation or who is determined to be at increased risk for transmitting HIV or HCV infection; within 3 calendar days after the blood collecting establishment supplied blood and blood components collected from an infectious donor, whenever records are available; and within 45 days of the test, of the results of the supplemental (additional, more specific) test for HIV or HCV, as relevant, or other follow-up testing required by FDA. These documents can be made available for reference during relevant facility inspections. OBI performs bacterial detection testing on all apheresis platelet components. This test is a culture that is incubated throughout the shelf life of the product. OBI maintains a Privacy Policy, Notification of Privacy Practices and Business Associate Agreements that include relevant requirements identified in 45 CFR 164, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the Information Technology for Economic and Clinical Health (HITECH) Act of 2009. Compliance Officer (▇▇▇)) ▇▇▇-▇▇▇▇ THIS AGREEMENT is entered into as of , by Mangum City Hospital Authority DBA: ▇▇▇▇▇▇ Regional Medical Center, ▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇, OK 73554 (“Hospital”) and the ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇ Center, Oklahoma Blood Institute, an Oklahoma not for profit corporation with its principal office located at ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇, ▇▇▇▇▇ ("Blood Institute").