Patient Blood Management Revisions - Joint Commission · Current EP Text: Revision Type: Revised...

Assessments: Internal and External (PBMAM) Chapter

PBMAM.1Current Requirement Text:

The program performs internal and external assessments of operations and quality systems.

PBMAM.1 EP: 1 PBMAM.1 EP: 1Current EP Text: Revision Type: Revised New EP Text:

The program shall have policies, processes, and procedures to ensure that internal and external assessments of operations and quality systems are scheduled and conducted.

The program has policies, processes, and procedures to ensure that internal and external assessments of operations and quality systems are scheduled and conducted.


The program shall collect, tabulate, and analyze data at regular, specified times and determine the number and type of nonconformances.

The program collects, tabulates, and analyzes data at defined intervals and determines the number and type of nonconformances.


The results of internal and external assessments shall be provided to and reviewed by personnel having responsibility for the area being assessed.

The results of internal and external assessments are provided to and reviewed by personnel having responsibility for the area being assessed.


When corrective action is taken, it shall be developed, implemented, and evaluated in accordance with the "Process Improvement Through Corrective and Preventive Action" (PBMPI) chapter.

When corrective action is taken, it is developed, implemented, and evaluated in accordance with the "Process Improvement Through Corrective and Preventive Action" (PBMPI) chapter.

Patient Blood Management Revisions

© 2020 The Joint Commission of 48

Prepublication StandardsEffective January 1, 2021


The results of internal and external assessments and associated corrective and preventive actions shall be reviewed by the program’s executive management.

The results of internal and external assessments and associated corrective and preventive actions are reviewed by the program’s executive management.


The program reports on its performance.


The program shall report annually on its performance. The program reports annually on its performance.


The report shall include the following, as required for the program’s activity level:- Overall program effectiveness and opportunities for improvement.- Allogeneic transfusion rates by service line and/or procedure type.- Use and efficacy of preoperative anemia management interventions.- Component usage and discard, and cause(s) of waste.- Appropriateness of allogeneic transfusion by service line and/or procedure type.- Effectiveness of the emergency/massive transfusion processes and protocols.- Compliance with recommendations made by the program.- Suspected transfusion-associated adverse events and adverse events associated with the failure to transfuse.- Program performance goals for next reporting period.

The report includes the following, at a minimum, if required for the program’s activity level:- Overall program effectiveness and opportunities for improvement.- Allogeneic transfusion rates overall and by program defined high blood use groups.- Appropriateness of allogeneic transfusion overall and by program defined high blood use groups.- Blood and blood component discard and cause(s) of waste.- Use and efficacy of preoperative anemia management interventions.- Effectiveness of nonoperative anemia management.- Use and effectiveness of the emergency/massive transfusion processes and protocols.- Compliance with recommendations made by the program.- Transfusion-associated adverse events and adverse events associated with the failure to transfuse.- Program financial impact.- Program performance goals and other needs for next reporting period.Note: For more information on a program’s activity level, refer to Appendix A.





The program monitors quality indicator data.


The program shall have a process to collect and evaluate quality indicator data on a scheduled basis. (See also PBMPC.14, EP 1)Note: Quality indicator data includes single- or multiple-source information that may be collected and used to determine whether an organization is meeting its quality objectives as defined by executive management. Indicators are measured by data for movement or regressions with regard to those quality intentions.

The program has a process to collect and evaluate quality indicator data on a scheduled basis. (See also PBMPC.22, EP 1) Note: Quality indicator data includes single- or multiple-source information that may be collected and used to determine whether an organization is meeting its quality objectives as defined by executive management. Indicators are measured by data for movement or regressions with regard to those quality intentions.




Deviations, Nonconformances and Adverse Events (PBMDN) Chapter

PBMDN.1Current Requirement Text:

The program captures, investigates, and reports deviations, nonconformances, and adverse events.

PBMDN.1 EP: 1 PBMDN.1 EP: 1Current EP Text: Revision Type: Revised New EP Text:

The program shall have policies, processes, and procedures to ensure the capture, assessment, investigation, and monitoring of deviations from meeting, or failing to meet, specified requirements.Note: Specified requirements are any requirements in these PBM standards and including, but not limited to, US Food and Drug Administration (FDA) requirements; requirements of a facility's internal policies, processes, and procedures; manufacturers' instructions; customer agreements; practice standards; and requirements of accrediting organizations such as AABB and The Joint Commission.

The program has policies, processes, and procedures to ensure the capture, assessment, investigation, and monitoring of deviations from meeting, or failing to meet, specified requirements.Note: Specified requirements are any requirements in these PBM standards and including, but not limited to, US Food and Drug Administration (FDA) requirements; requirements of a facility's internal policies, processes, and procedures; manufacturers' instructions; customer agreements; practice standards; and requirements of accrediting organizations such as AABB and The Joint Commission.


The investigation shall, when applicable, include an assessment of the effect of policy deviations on patient safety.

When applicable, the investigation includes an assessment of the effect of policy deviations on patient safety.


The responsibility for review and authority for the disposition of nonconforming blood, blood components, perioperative products, critical materials, and services shall be defined.

The responsibility for review and authority for the disposition of nonconforming blood, blood components, perioperative products, critical materials, and services are defined.


Deviations, nonconformances, and adverse events shall be reported in accordance with specified requirements and to outside agencies as required.Note: Specified requirements are any requirements in these PBM Standards and including, but not limited to, FDA requirements; requirements of a facility's internal policies, processes, and procedures; manufacturers' instructions; customer agreements; practice standards; and requirements of accrediting organizations such as AABB and The Joint Commission.

Deviations, nonconformances, and adverse events are reported in accordance with specified requirements and to outside agencies as required.Note: Specified requirements are any requirements in these PBM standards and including, but not limited to, US Food and Drug Administration (FDA) requirements; requirements of a facility's internal policies, processes, and procedures; manufacturers' instructions; customer agreements; practice standards; and requirements of accrediting organizations such as AABB and The Joint Commission.





The program shall ensure that all deviations, nonconformances, and adverse events related to blood transfusion are managed in accordance with the current editions of AABB Standards for Blood Banks and Transfusion Services, AABB Standards for Perioperative Autologous Blood Collection and Administration, or the requirements of an equivalent accrediting body.

The program ensures that all deviations, nonconformances, and adverse events related to blood transfusion are managed in accordance with the current editions of AABB Standards for Blood Banks and Transfusion Services, AABB Standards for Perioperative Autologous Blood Collection and Administration, or the requirements of an equivalent accrediting body.

PBMDN.2Current Requirement Text:

The program captures and evaluates nonconformances.


Upon discovery, nonconformances shall be evaluated and their disposition determined. The "Process Improvement Through Corrective and Preventive Action" (PBMPI) chapter applies.

Upon discovery, nonconformances are evaluated and their disposition determined. The "Process Improvement Through Corrective and Preventive Action" (PBMPI) chapter applies.


The program shall have a process for the capture of nonconformances related to these PBM standards, including but not limited to the following:- Failure to capture potential candidates for patient blood management interventions.- Failure to deliver interventions to patients who have been identified as candidates for those interventions.- Failure to report findings to other service lines.- Failure of executive management to monitor the program.- Failure to follow the existing massive transfusion protocol.- Failure to prevent overtransfusion or inappropriate transfusions.- Failure to recognize and report suspected transfusion-associated adverse events.- Failure to transfuse when indicated.

The program has a process for the capture of nonconformances related to these PBM standards.




Documents and Records (PBMDR) Chapter

PBMDR.1Current Requirement Text:

The program develops, validates, and implements policies and procedures for documents and records.

PBMDR.1 EP: 1 PBMDR.1 EP: 1Current EP Text: Revision Type: Revised New EP Text:

The program shall have policies, processes, and procedures to ensure that documents are identified, reviewed, approved, and retained.

The program has policies, processes, and procedures to ensure that documents are identified, reviewed, approved, and retained.


The program shall have policies, processes, and procedures to ensure that records are created, stored, and archived in accordance with record retention policies.

The program has policies, processes, and procedures to ensure that records are created, stored, and archived in accordance with record retention policies.


Documents and records related to transfusion medicine or perioperative programs shall be created and controlled in accordance with the current edition of the AABB Standards for Blood Banks and Transfusion Services, AABB Standards for Perioperative Autologous Blood Collection and Administration, or the requirements of an equivalent accrediting body.

Documents and records related to transfusion medicine or perioperative programs are created and controlled in accordance with the current edition of the AABB Standards for Blood Banks and Transfusion Services, AABB Standards for Perioperative Autologous Blood Collection and Administration, or the requirements of an equivalent accrediting body.





The program has a process for document control.


The program shall have a process for document control that includes the following elements: - A master list of documents, including policies, processes, procedures, labels, and forms that relate to these PBM standards- Use of standardized formats for all policies, processes, procedures, and forms. Additional procedures (such as those in an operator’s manual) may be incorporated by reference- Review and approval of new and revised documents before use- Review of each policy, process, and procedure by an authorized individual at a minimum every 2 years.- Use of only current and valid documents- Appropriate and applicable documents shall be available at all locations where activities essential to meeting these PBM standards are performed- Identification and appropriate archival of obsolete documents- Storage in a manner that preserves legibility and protects from accidental or unauthorized access, destruction, or modification

The program has a process for document control that includes the following elements: - A master list of documents, including policies, processes, procedures, labels, and forms that relate to these PBM standards.- Use of standardized formats for all policies, processes, procedures, and forms. Additional procedures (such as those in an operator’s manual) may be incorporated by reference.- Review and approval of new and revised documents before use.- Review of each policy, process, and procedure by an authorized individual at a minimum every 2 years.- Use of only current and valid documents.- Documents are available at all locations where activities essential to meeting these PBM standards are performed.- Identification and archival of obsolete documents.- Storage in a manner that preserves legibility and protects from accidental or unauthorized access, destruction, or modification.


The program has a process for record retention.


The program shall ensure identification, collection, indexing, access, filing, storage, and disposition of records (including electronic records) as required by the facility.

The program ensures the identification, collection, indexing, access, filing, storage, and disposition of records (including electronic records) as required by the facility.


Records shall be complete, retrievable in a period appropriate to the circumstances, and protected from accidental or unauthorized destruction or modification.

Records are complete, retrievable in a period appropriate to the circumstances, and protected from accidental or unauthorized destruction or modification.





Before the destruction of the original records, the program shall have a process to ensure that copies of records are as follows:- Verified as containing the original content.- Legible, complete, and accessible.

Before the destruction of the original records, the program has a process to ensure that copies of records are as follows:- Verified as containing the original content.- Legible, complete, and accessible.


The program has a record system.


A system designed to prevent unauthorized access and ensure confidentiality of records shall be established and followed.

A system designed to prevent unauthorized access and ensure confidentiality of records is established and followed.


The record system shall ensure compliance with Health Insurance Portability and Accountability Act (HIPAA) regulations.

The record system ensures compliance with Health Insurance Portability and Accountability Act (HIPAA) regulations.


The program shall have access to patient records. The program has access to patient records.


Information in the record system shall allow the program to trace any patient, from the preoperative/pretransfusion period to the postoperative/posttransfusion period, as well as the care of, and blood management services provided to, the patient.

Information in the record system allows the program to trace any patient from the preoperative/pretransfusion period to the postoperative/posttransfusion period, as well as trace the care of and blood management services provided to the patient.


The record system shall allow the evaluation of outcomes of specific interventions associated with patient blood management, and to investigate adverse events.

The record system allows the evaluation of outcomes of specific interventions associated with blood management and the investigation of adverse events.





The program supports its information management systems.


There shall be processes and procedures to support the management of information systems. (See also PBMOR.4, EP 11)

There are processes and procedures to support the management of information systems.


There shall be a process in place for routine backup of all critical data. There is a process in place for routine backup of all critical data.


Procedures shall be in place to ensure that data are retrievable and usable. Procedures are in place to ensure that data are retrievable and usable.


Backup data shall be stored in an off-site location. Backup data are stored in an off-site location.


There shall be a process in place for linking patient records to those contained in the laboratory information system.

There is a process in place for linking patient records to those contained in the laboratory information system.





The program is involved in the development of policies, processes, and procedures that affect the quality of the program’s activities.


The program shall participate in the development of new policies and in changes to existing policies, processes, and procedures that affect the quality of the program’s activities, even when these documents are controlled by another department.

The program participates in the development of new policies and in changes to existing policies, processes, and procedures that affect the quality of the program’s activities, even when these documents are controlled by another department.


The program shall ensure that responsibility for revision and changes to policies, processes, and procedures that affect the quality of the program’s activities is defined. (See also PBMPC.2, EPs 1–3)

The program ensures that responsibility for revision and changes to policies, processes, and procedures that affect the quality of the program’s activities is defined. (See also PBMPC.2, EPs 1–3)


The program retains records of program activities. (See also Appendix B)


The following records are retained for a minimum of 5 years: Personnel records of all employees.

The following records are retained for a minimum of 5 years: Personnel records of patient blood management program employees.


The following records are retained for a minimum of 5 years: Review of patient blood management and utilization practices.

The following records are retained for a minimum of 5 years: Review of blood management and utilization practices.


The following records are retained for a minimum of 5 years: Patient blood management educational materials.

The following records are retained for a minimum of 5 years: Blood management educational materials.




PBMDR.7 EP: PBMDR.7 EP: 15Current EP Text: Revision Type: New New EP Text:

N/A The following records are retained for a minimum of 5 years: Patient consent.

PBMDR.7 EP: PBMDR.7 EP: 16Current EP Text: Revision Type: New New EP Text:

N/A The following records are retained for a minimum of 5 years: Alternative strategies acceptable to patients who decline blood.

PBMDR.7 EP: 15 PBMDR.7 EP: 17Current EP Text: Revision Type: Moved New EP Text:

The following records are retained for a minimum of 5 years: Review and approval of new and revised documents before use.

The following records are retained for a minimum of 5 years: Review and approval of new and revised documents before use.


The following records are retained for a minimum of 5 years: Biennial review of policies, processes, and procedures.

The following records are retained for a minimum of 5 years: Biennial review of policies, processes, and procedures.


The following records are retained for a minimum of 5 years: Identification and appropriate archival of obsolete documents.

The following records are retained for a minimum of 5 years: Identification and appropriate archival of obsolete documents.


The following records are retained for a minimum of 5 years: Description and evaluation of nonconformances.

The following records are retained for a minimum of 5 years: Description and evaluation of nonconformances.


The following records are retained for a minimum of 5 years: Reviews of results of internal and external assessments and associated corrective and preventive action.

The following records are retained for a minimum of 5 years: Reviews of results of internal and external assessments and associated corrective and preventive action.





The following records are retained for a minimum of 5 years: Implementation of changes to policies, processes, and procedures resulting from corrective and preventive action.

The following records are retained for a minimum of 5 years: Implementation of changes to policies, processes, and procedures resulting from corrective and preventive action.


The following records are retained for a minimum of 5 years: Corrective action. The following records are retained for a minimum of 5 years: Corrective action.


The following records are retained for a minimum of 5 years: Preventive action. The following records are retained for a minimum of 5 years: Preventive action.


The following records are retained for a minimum of 2 years after retirement of the system: Implementation of new or modified software, hardware, or databases and modifications of existing software, hardware, or databases.

The following records are retained for a minimum of 2 years after retirement of the system: Implementation of new or modified software, hardware, or databases and modifications of existing software, hardware, or databases.


The following records are retained for a minimum of 2 years after retirement of the system: Information systems records that include the following:- Validation of system software, hardware, databases, and user-defined tables.- Fulfillment of applicable life-cycle requirements.- Numerical designation of system versions, if applicable, with inclusive dates of use.- Monitoring of data integrity for critical data elements.

The following records are retained for a minimum of 2 years after retirement of the system: Information systems records that include the following:- Validation of system software, hardware, databases, and user-defined tables.- Fulfillment of applicable life-cycle requirements.- Numerical designation of system versions, if applicable, with inclusive dates of use.- Monitoring of data integrity for critical data elements.




Equipment (PBMEQ) Chapter

PBMEQ.1Current Requirement Text:

The program manages its medical equipment.

PBMEQ.1 EP: 1 PBMEQ.1 EP: 1Current EP Text: Revision Type: Revised New EP Text:

The program shall identify equipment that is critical to the activities defined in these PBM standards.

The program identifies equipment that is critical to the activities defined in these PBM standards.


The program obtains documentation that the equipment has undergone, and satisfied, the required scheduled maintenance.

The program obtains documentation that the equipment has undergone and satisfied the required scheduled maintenance.


The program shall have input in the acquisition of equipment needed to perform the activities defined in these PBM standards.

The program has input in the acquisition of equipment needed to perform the activities defined in these PBM standards.


The program has information management systems.


The program shall have processes to support the implementation and modification of software, hardware, and databases relating to these PBM standards.

The program has processes to support the implementation and modification of software, hardware, and databases relating to these PBM standards.





Processes to support the implementation and modification of software, hardware, and databases shall include:- Risk analysis, training, validation, implementation, and evaluation of postimplementation performance.- Information system maintenance and operation.- Documentation written in language understandable to the user.- Display and verification of data before final acceptance, when data are added, or when data are amended.- Evaluation, authorization, and documentation of modifications to the system.

Processes to support the implementation and modification of software, hardware, and databases include:- Risk analysis, training, validation, implementation, and evaluation of postimplementation performance.- Information system maintenance and operation.- Documentation written in language understandable to the user.- Display and verification of data before final acceptance, when data are added, or when data are amended.- Evaluation, authorization, and documentation of modifications to the system.


The program maintains information management systems records.


Records of the following shall be maintained:- Validation of system software, hardware, databases, user-defined tables, electronic data transfer, and/or electronic data receipt.- Fulfillment of applicable life-cycle requirements for internally developed software.- Numerical designation of system versions, if applicable, with inclusive dates of use.- Monitoring of data integrity for critical data elements.

Records of the following are maintained:- Validation of system software, hardware, databases, user-defined tables, electronic data transfer, and/or electronic data receipt.- Fulfillment of applicable life-cycle requirements for internally developed software.- Numerical designation of system versions, if applicable, with inclusive dates of use.- Monitoring of data integrity for critical data elements.


The program maintains an alternate information management system.


An alternate (backup) system shall be maintained to ensure continuous operation in the event that computerized data and computer-assisted functions are unavailable.

An alternate (backup) system is maintained to ensure continuous operation in the event that computerized data and computer-assisted functions are unavailable.





The alternate system shall be tested periodically. The alternate system is tested periodically.


Processes and procedures shall address mitigation of the effects of disasters and include recovery plans.

Processes and procedures address mitigation of the effects of disasters and include recovery plans.


The program defines quality control activities for equipment controlled by other departments.


The program shall ensure that responsibility for control of equipment critical to patient blood management–related activities is defined.

The program ensures that responsibility for control of equipment critical to patient blood management–related activities is defined.


Equipment controlled by the blood bank, transfusion service, or perioperative program shall be controlled in accordance with the manufacturer’s instructions and/or the current editions of AABB Standards for Blood Banks and Transfusion Services and AABB Standards for Perioperative Autologous Blood Collection and Administration.

Equipment controlled by the blood bank, transfusion service, clinical laboratory, or perioperative program are controlled in accordance with the manufacturer’s written instructions and/or the current editions of AABB Standards for Blood Banks and Transfusion Services and AABB Standards for Perioperative Autologous Blood Collection and Administration.




Facilities and Safety (PBMFS) Chapter

PBMFS.1Current Requirement Text:

The program provides safe environmental conditions.

PBMFS.1 EP: 1 PBMFS.1 EP: 1Current EP Text: Revision Type: Revised New EP Text:

The program shall adhere to the facility’s policies, processes, and procedures for the provision of safe environmental conditions.

The program adheres to the facility’s policies, processes, and procedures for the provision of safe environmental conditions.

PBMFS.1 EP: 2 PBMFS.1 EP: 2Current EP Text: Revision Type: Revised New EP Text:

Safety programs shall meet local, state, and federal regulations, where applicable. Safety programs meet local, state, and federal regulations, where applicable.




Organization (PBMOR) Chapter

PBMOR.1Current Requirement Text:

The program has a defined organizational structure.

PBMOR.1 EP: 1 PBMOR.1 EP: 1Current EP Text: Revision Type: Revised

The program shall have a structure that clearly defines and documents the parties responsible for the oversight and review of patient blood management activities and the relationship of individuals responsible for key quality functions.

New EP Text:

The program has a structure that clearly defines and documents the parties responsible for the oversight and review of patient blood management activities and the relationship of individuals responsible for key quality functions.

PBMOR.1 EP: 2 PBMOR.1 EP: 2Current EP Text: Revision Type: Revised New EP Text:

The interdisciplinary program shall be patient centered, data driven, and outcomes focused.

The interdisciplinary program is patient centered, data driven, and outcomes focused.


The program defines the roles and responsibilities of the executive management team.


The program shall have a defined executive management structure. The program has a defined executive management structure.





Executive management shall have:- The responsibility and authority for oversight and review of the program.- The authority to establish or make changes to the program's quality system.- The responsibility for compliance with these PBM standards and applicable lawsand regulations.- The responsibility for collection and review of data on patient blood managementincluding patient outcomes and program performance metrics.- The responsibility to identify stakeholders and to communicate results to thesestakeholders.

Executive management has:- The responsibility and authority for oversight and review of the program.- The authority to establish or make changes to the program's quality system.- The responsibility for compliance with these PBM standards and applicable lawsand regulations.- The responsibility for collection and review of data on patient blood managementincluding patient outcomes and program performance metrics.- The responsibility to identify stakeholders and to communicate results to thesestakeholders.


The program defines the roles and responsibilities of the medical director.


The program shall have a medical director who is a licensed physician and qualified by education, training, and/or experience.

The program has a medical director who is a licensed physician and qualified by education, training, and/or experience.


The medical director’s responsibilities shall include, but is not limited to, the following:- Leadership and oversight on clinical issues.- Consultative and support services on patient blood management matters thatrelate to the care and safety of patients.- Identification of program resources needed to conform to these PBM standards.- Communication of program results and opportunities for improvement to executivemanagement and hospital staff at least annually.

The medical director’s responsibilities include, but are not limited to:- Leadership and oversight on clinical issues.- Consultative and support services on patient blood management matters thatrelate to the care and safety of patients.- Identification of program resources needed to conform to these PBM standards.- Communication of program results and opportunities for improvement to executivemanagement and hospital staff at least annually.


The medical director may delegate these responsibilities to another qualified individual(s); however, the medical director shall retain ultimate responsibility.

The medical director may delegate these responsibilities to another qualified individual(s); however, the medical director retains ultimate responsibility.




PBMOR.4 PBMOR.4Current Requirement Text: Revision Type: Revised New Requirement Text:

The executive management defines, oversees, and monitors the activities of the program.Note: A patient blood management program can be designated as a program activity level 1, 2, or 3. Depending on the designated activity level, the program shall be responsible for or have direct involvement with oversight and monitoring of the various activities defined in PBMOR.4, EPs 2–21. (See also Appendix A)

The executive management defines, oversees, and monitors the activities of the program.Note: A patient blood management program can be designated as a program activity level 1, 2, or 3. To be designated a specific activity level, the program is responsible for or has direct involvement with oversight and monitoring of the various activities defined in PBMOR.4, EPs 2–25. For more information on a program’s activity level, refer to Appendix A.


Executive management shall define the activities of the patient blood management program that are tied to patient outcomes.

Executive management defines the activities of the patient blood management program that are tied to patient outcomes.


The program shall be responsible for, or have direct involvement with, oversight and monitoring of the following activities: Evidence of institutional support for the patient blood management program at the hospital administration level.

The program is responsible for, or has direct involvement with, oversight and monitoring of the following activities: Evidence of institutional support for the patient blood management program at the hospital administration level.

PBMOR.4 EP: PBMOR.4 EP: 3Current EP Text: Revision Type: New New EP Text:

N/A The program is responsible for, or has direct involvement with, oversight and monitoring of the following activities: Metrics regarding transfusion appropriateness in accordance with transfusion guidelines.

PBMOR.4 EP: 3 PBMOR.4 EP: 4Current EP Text: Revision Type: Moved and Revised New EP Text:

The program shall be responsible for, or have direct involvement with, oversight and monitoring of the following activities: Patient outcomes related to transfusion.

The program is responsible for, or has direct involvement with, oversight and monitoring of the following activities: Documentation of transfusion including patient consent, observation, adverse events, and outcomes.


The program shall be responsible for, or have direct involvement with, oversight and monitoring of the following activities: Budgeting to the level of care required by the implementation of these PBM standards.

The program is responsible for, or has direct involvement with, oversight and monitoring of the following activities: Budgeting to the level of care required by the implementation of these PBM standards.





The program shall be responsible for, or have direct involvement with, oversight and monitoring of the following activities: Pretransfusion patient testing and evaluation.

The program is responsible for, or has direct involvement with, oversight and monitoring of the following activities: Pretransfusion patient testing and evaluation.


The program shall be responsible for, or have direct involvement with, oversight and monitoring of the following activities: Patient- or case-specific assessment of potential blood usage.

The program is responsible for, or has direct involvement with, oversight and monitoring of the following activities: Patient- or case-specific assessment of potential blood usage.


The program shall be responsible for, or have direct involvement with, oversight and monitoring of the following activities: Ordering of blood, including completion of type and antibody testing before procedure start time with a plan for antibody-positive patients.

The program is responsible for, or has direct involvement with, oversight and monitoring of the following activities: Preprocedural blood ordering including completion of type and antibody testing before procedure start time with a plan for antibody-positive patients.


The program shall be responsible for, or have direct involvement with, oversight and monitoring of the following activities: Preprocedure optimization of patient coagulation function including discontinuation of medications and herbal supplements that impair hemostasis.

The program is responsible for, or has direct involvement with, oversight and monitoring of the following activities: Preprocedure optimization of patient coagulation function.


The program shall be responsible for, or have direct involvement with, oversight and monitoring of the following activities: Percentage of blood components wasted by component type (such as red cells, rare unit red cells, platelets, matched platelets, plasma, AB plasma, cryoprecipitate, and granulocytes) and cause for wastage (misordering, mishandling, not releasing in a timely manner, outdating in stock, and so forth).

The program is responsible for, or has direct involvement with, oversight and monitoring of the following activities: Monitoring of blood components wastage and cause.


The program shall be responsible for, or have direct involvement with, oversight and monitoring of the following activities: Minimize blood loss due to laboratory testing.

The program is responsible for, or has direct involvement with, oversight and monitoring of the following activities: Minimize blood loss due to laboratory testing.





The program shall be responsible for, or have direct involvement with, oversight and monitoring of the following activities: Process for managing the blood needs of unidentified patients and resolving their identification. (See also PBMDR.5, EP 1)

The program is responsible for, or has direct involvement with, oversight and monitoring of the following activities: Process for managing the blood needs of unidentified patients and resolving their identification.

PBMOR.4 EP: 13Current EP Text: Revision Type: Deleted

The program shall be responsible for, or have direct involvement with, oversight and monitoring of the following activities: Adverse events and incidents related to transfusion.


The program shall be responsible for, or have direct involvement with, oversight and monitoring of the following activities: Processes to identify, prior to or upon admission, patients who may refuse transfusion under any circumstances.

The program is responsible for, or has direct involvement with, oversight and monitoring of the following activities: Processes to identify, before or upon admission, patients who may decline transfusion under any circumstances with notification to the appropriate individuals.


The program shall be responsible for, or have direct involvement with, oversight and monitoring of the following activities: Evidence-based-massive-transfusion protocol that includes treatment of massive blood loss.

The program is responsible for, or has direct involvement with, oversight and monitoring of the following activities: Massive transfusion protocol with documented evidence of its use.


N/A The program is responsible for, or has direct involvement with, oversight and monitoring of the following activities: Transfusion care and anemia management of preterm, neonate, infant, and pediatric critical care patients, if applicable.


N/A The program is responsible for, or has direct involvement with, oversight and monitoring of the following activities: Patient blood management care for obstetrics patients including postpartum hemorrhage protocol with evidence of its use, plan(s) for patients with known high bleeding risk (e.g. placental abnormalities), and plans for patients for whom blood is not an option.





N/A The program is responsible for, or has direct involvement with, oversight and monitoring of the following activities: Single-unit transfusion strategies for defined patient population(s).


N/A The program is responsible for, or has direct involvement with, oversight and monitoring of the following activities: Management of acquired coagulopathy.


N/A The program is responsible for, or has direct involvement with, oversight and monitoring of the following activities: Blood conservation strategies for service lines associated with high blood usage.


The program shall be responsible for, or have direct involvement with, oversight and monitoring of the following activities: Processes and/or equipment to facilitate rapid decision making with regard to anemia and coagulation management.

The program is responsible for, or has direct involvement with, oversight and monitoring of the following activities: Processes and/or equipment to facilitate rapid decision making with regard to anemia and coagulation management.

PBMOR.4 EP: 21Current EP Text: Revision Type: Deleted

The program shall be responsible for, or have direct involvement with, oversight and monitoring of the following activities: An active program with evidence-based metrics and clinician feedback to ensure compliance with transfusion guidelines.


The program shall be responsible for, or have direct involvement with, oversight and monitoring of the following activities: A plan by each service line to reduce perioperative blood loss.

The program is be responsible for, or has direct involvement with, oversight and monitoring of the following activities: Evaluating and managing iron and micronutrient deficiencies in defined patients with red blood cells ordered in the outpatient setting.





The program shall be responsible for, or have direct involvement with, oversight and monitoring of the following activities: Strategies to reduce blood loss and manage anemia and coagulopathy in non-operative patients.

The program is responsible for, or has direct involvement with, oversight and monitoring of the following activities: Evaluation and management of anemia in nonoperative patients.


The program shall be responsible for, or have direct involvement with, oversight and monitoring of the following activities: A formal program to care for patients who decline use of blood or blood-derived products.

The program is responsible for, or has direct involvement with, oversight and monitoring of the following activities: A program to care for patients who decline use of blood or blood-derived components.


The program shall be responsible for, or have direct involvement with, oversight and monitoring of the following activities: Identification and management of pre-surgical anemia before elective procedures for which type and screen or type and crossmatch is recommended.

The program is responsible for, or has direct involvement with, oversight and monitoring of the following activities: Identification and management of presurgical anemia before elective procedures for which type and screen or type and crossmatch is recommended.


The program shall be responsible for, or have direct involvement with, oversight and monitoring of the following activities: Use of perioperative techniques consistent with current AABB Standards for Perioperative Autologous Blood Collection and Administration.

The program is responsible for, or has direct involvement with, oversight and monitoring of the following activities: Use of perioperative techniques consistent with current AABB Standards for Perioperative Autologous Blood Collection and Administration.


The program defines the roles and responsibilities of the program team.


The program shall have a program coordinator who is responsible for the operational aspects of the program.

The program has a program coordinator who is responsible for the operational aspects of the program.





The program shall include representatives from administration, transfusion medicine, informatics, quality assurance, pharmacy, nursing, laboratory, and other departments that regularly transfuse, provide recommendations, or have programmatic responsibility for the oversight of the transfusion of blood products.

The program includes representatives from administration, transfusion medicine, informatics, quality assurance, pharmacy, nursing, laboratory, and other departments that regularly transfuse, recommend and/or have programmatic responsibility for the oversight of the transfusion of blood components and the management of anemic and bleeding patients.


The program has a patient-centered quality plan.


A patient-centered quality plan shall be defined, documented, implemented, and maintained in order to ensure reliability and reproducibility and to optimize patient outcomes.

A patient-centered quality plan is defined, documented, implemented, and maintained in order to ensure reliability and reproducibility and to optimize patient outcomes.


All program member representatives shall be aware of the quality plan’s content. All program member representatives are aware of the quality plan’s content.


The quality plan shall encompass all of the relevant policies, processes, procedures, protocols, and other work documents related to the treatment of patients who may receive a blood transfusion or desire bloodless medical care.

The quality plan encompasses all of the relevant policies, processes, procedures, protocols, and other work documents related to the treatment of patients who may receive a blood transfusion, decline blood transfusion, or are managed in accordance with the activity level. Note: For more information on a program’s activity level, refer to Appendix A.


The quality plan shall be under the supervision of a designated person who reports to the medical director.

The quality plan is under the supervision of a designated person who reports to the medical director.





Executive management shall assess the effectiveness of the quality plan through scheduled reviews with the medical director.

Executive management assesses the effectiveness of the quality plan through scheduled reviews with the medical director.


The program has policies, processes, and procedures for patient blood management.


Quality and operational policies, processes, and procedures shall be developed and implemented to ensure that these PBM standards are satisfied and that patient outcomes are optimized.

Quality and operational policies, processes, and procedures are developed and implemented to ensure that these PBM standards are satisfied and that patient outcomes are optimized.


All such policies, processes, and procedures shall be in writing or captured electronically and shall be followed.

All such policies, processes, and procedures are in writing or captured electronically and are followed.


Any exceptions to policies, processes, and procedures warranted by clinical situations shall require justification and prior approval by the medical director or medical director designee on a case-by-case basis.

Any exceptions to policies, processes, and procedures warranted by clinical situations require justification and prior approval by the medical director or medical director designee on a case-by-case basis.





The program has emergency operation policies, processes, and procedures.


The program shall have emergency operation policies, processes, and procedures for all blood components to respond to the effects of internal or external disasters and massive casualty events.

The program has emergency operation policies, processes, and procedures for all blood components to respond to the effects of internal disasters, external disasters, and massive casualty events.


The emergency operation policies, processes, and procedures shall address all blood components.

The emergency operation policies, processes, and procedures address all blood components.


The emergency management plan, including emergency communication systems, shall be tested at defined intervals.

The emergency management plan, including emergency communication systems, are tested at defined intervals.

PBMOR.9 PBMOR.9Current Requirement Text: Revision Type: New New Requirement Text:

N/A The program has policies, processes, and procedures for operational continuity.


N/A Executive management ensures that the facility has policies, processes, and procedures that address continuity for potential events that put operations at risk.




PBMOR.10Revision Type: Moved New Requirement Text:

PBMOR.9Current Requirement Text: The program has a process to communicate concerns about quality and safety. The program has a process to communicate concerns about quality and safety.


The program shall have a process for personnel to anonymously communicate concerns about quality or safety.

The program has a process for personnel to anonymously communicate concerns about quality or safety.


Personnel shall be given the option to communicate such concerns either to their facility's executive management, The Joint Commission, or both.

Personnel are given the option to communicate such concerns either to their facility's executive management, The Joint Commission, or both.


The Joint Commission’s contact information shall be readily available to all personnel.

The Joint Commission’s contact information is readily available to all personnel.




Process Control (PBMPC) Chapter

PBMPC.1 PBMPC.1Current Requirement Text: Revision Type: Revised New Requirement Text:

The program develops, validates, and implements policies and procedures. The program develops and implements policies and procedures.

PBMPC.1 EP: 1 PBMPC.1 EP: 1Current EP Text: Revision Type: Revised New EP Text:

The program shall have policies and validated processes and procedures to ensure that patients who may need a transfusion are evaluated and managed in a manner to ensure that blood is or is not given when clinically appropriate.

The program has policies, processes, and procedures to ensure that patients who may need a transfusion are evaluated and managed in a manner to ensure that blood is or is not given when clinically appropriate.


The program shall ensure that these policies, processes, and procedures are carried out consistently and under controlled conditions.

The program ensures that transfusion policies, processes, and procedures are carried out consistently and under controlled conditions.


Program policies shall address blood-related care of emergent and nonemergent situations, and cases where patients refuse blood transfusion.

Program policies address anemia and transfusion-related care of emergent and nonemergent situations.

PBMPC.1 EP: PBMPC.1 EP: 4Current EP Text: Revision Type: New New EP Text:

N/A Program policies address patients who decline blood transfusion.


N/A The program reviews, revises, or creates the policies, processes, and procedures regarding pretransfusion testing.


N/A Program policies are consistent with current AABB Standards for Blood Banks and Transfusion Services.




PBMPC.1 EP: 4 PBMPC.1 EP: 7Current EP Text: Revision Type: Moved and Revised New EP Text:

In emergent cases, policies shall define and ensure the timely provision of blood and proper patient identification.

For the situation of emergent transfusion, policies define and ensure proper patient identification and the timely provision of blood.


N/A The program has policies, processes, and procedures to ensure that:- Patients who may need transfusion are evaluated and managed such that blood isgiven when clinically indicated.- Internal quality metrics for transfusion appropriateness are in place and reported.- Patients with anemia who may or may not need a transfusion are also assessed forother means by which it may be managed, including by minimizing bleeding andtreating anemia with medications.

PBMPC.2 PBMPC.2Current Requirement Text: Revision Type: Revised New Requirement Text:

The program develops or changes processes or procedures. The program develops new or changes existing processes or procedures.


The program shall have a process to develop new processes or procedures or to change existing ones. (See also PBMDR.6, EP 2)

The program has a process to develop new processes or procedures or to change existing ones.


The process to develop new processes or procedures or to change existing ones shall include identification of specifications and verification that specifications have been met. (See also PBMDR.6, EP 2)

The process to develop new processes or procedures or to change existing ones include identification of specifications and verification that specifications have been met.


Before implementation, the new or changed processes or procedures shall be validated. (See also PBMDR.6, EP 2)

Before implementation, the new or changed processes or procedures are validated.




PBMPC.3Current Requirement Text:

The program has patient blood management guidelines.


The program shall establish evidence-based (when available) patient blood management guidelines specific to the hospital’s patient population.

The program establishes evidence-based (when available) patient blood management guidelines specific to the hospital’s inpatient and outpatient populations.


The patient blood management guidelines shall include efforts to avoid transfusion when possible and ensure early and rapid delivery of products to those who do need them.

The patient blood management guidelines include practices to avoid transfusion when possible and ensure early and rapid delivery of blood components to those who need them.


N/A The patient blood management guidelines shall include managing anemia through transfusion and other methods, including minimizing blood loss, recovery and autotransfusion of shed blood, and managing asymptomatic anemia with medications, as laboratory data support and in accordance with activity level.Note: For more information on a program’s activity level, refer to Appendix A.


Guidelines from major patient groups within the facility (service lines, care pathways) shall be reviewed to ensure consideration of optimal patient blood management.

Guidelines from major patient groups within the facility (service lines, care pathways) are reviewed to ensure consideration of optimal patient blood management.





The program reviews patient blood management practices.


The program shall have a process for ongoing review of patient blood management practices.

The program has a process for ongoing review of patient blood management practices.


The program shall review all nonconformances, deviations from established procedures or protocol, and other incidents where transfusion guidelines are not followed.

The program reviews all nonconformances, deviations from established procedures or protocol, and other incidents where transfusion guidelines are not followed. The "Deviations, Nonconformances and Adverse Events" (PBMDN) and the "Process Improvement Through Corrective and Preventive Action" (PBMPI) chapters apply.


The program has educational materials.


The program shall develop and distribute educational materials for hospital personnel and patients that are as follows:- Describe patient blood management.- Discuss the risks and benefits of transfusion of blood products and components and transfusion avoidance.- Review the alternatives to transfusion, including pharmacological therapies.

The program develops and distributes educational materials for hospital personnel and patients that are as follows:- Describe patient blood management elements in the facility including, and as relevant to activity level, general patient blood management and any or all of patient blood management in pediatrics, obstetrics, and outpatients.- Describe anemia management in perioperative patients.- Describe anemia management in medical patients. - Discuss the risks and benefits of transfusion of blood components and transfusion avoidance.- Review the alternatives to transfusion, including pharmacological therapies.Note: For more information on a program’s activity level, refer to Appendix A.





The program has a quality control program.


A program of quality control shall be established and is sufficiently comprehensive to ensure that patient blood management–related equipment and methods function as expected.

A program of quality control is established that is sufficiently comprehensive to ensure that patient blood management–related equipment and methods function as expected.


Quality control results shall be reviewed and corrective action is taken. Quality control results are reviewed and corrective action taken.

Revision Type: New

PBMPC.7Current Requirement Text: N/A

PBMPC.7New Requirement Text:

The program has policies, processes, and procedures for phlebotomy.


The program shall review, revise, or create policies, processes, and procedures that minimize blood volume collected for laboratory testing.

The program reviews, revises, or creates policies, processes, and procedures that minimize blood volume collected for laboratory testing.


The program has policies, processes, and procedures regarding patient consent for transfusion and right to decline transfusion.


The program shall participate in the development and revision of policies, processes, and procedures regarding patient consent for transfusion and the right to decline transfusion.

The program participates in the development and revision of policies, processes, and procedures regarding patient consent for transfusion and the right to decline transfusion.




Revision Type: MovedPBMPC.8Current Requirement Text:

The program has policies, processes, and procedures regarding patient consent for transfusion and right to decline transfusion.


At a minimum, elements of consent shall include all of the following:- A description of the risks, benefits, and treatment alternatives.- The opportunity to ask and receive answers to the questions.- The right to accept or refuse treatment.

At a minimum, elements of consent include all of the following:- A description of the risks, benefits, and treatment alternatives.- The opportunity to ask and receive answers to the questions.- The right to accept or refuse treatment.

EP: PBMPC.8 EP: 3Revision Type: New New EP Text:

PBMPC.8 Current EP Text: N/A For patients who decline blood or blood components, alternative strategies for blood

loss minimization and anemia management, which are acceptable to the patient, are documented in the medical record.

PBMPC.9Revision Type: New New Requirement Text:

PBMPC.9Current Requirement Text: N/A The program has guidelines for transfusion orders.


The program shall have defined guidelines for transfusion orders that include indications for transfusion.

Transfusion orders include indication(s) for transfusion, as determined by program-defined guidelines.

EP: PBMPC.9 EP: 2Revision Type: New

PBMPC.9 Current EP Text: N/A

New EP Text:

The program has policies for single-unit transfusion strategies for defined patient populations.

PBMPC.10Revision Type: Moved and Revised New Requirement Text:

PBMPC.8Current Requirement Text: The program has guidelines for phlebotomy, transfusion orders, and for pre- and posttransfusion patient care.

The program has guidelines for pre- and posttransfusion patient care.

EP: 2Revision Type: Moved and Revised

PBMPC.10 EP: 1New EP Text:

The program has guidelines for patient care in the pre- and posttransfusion settings.




PBMPC.8 Current EP Text:

The program shall have guidelines for patient care in the pre- and posttransfusion settings.


The program shall review, revise, or create the policies, processes, and procedures regarding pretransfusion testing consistent with the current edition of AABB Standards for Blood Banks and Transfusion Services.

The program reviews, revises, or creates the policies, processes, and procedures regarding pretransfusion testing. These policies are consistent with the current edition of AABB Standards for Blood Banks and Transfusion Services.


The program shall create, review, and revise, as necessary, the policies, processes, and procedures to measure transfusion effectiveness and appropriateness.

The program creates, reviews, and revises, as necessary, the policies, processes, and procedures to measure transfusion effectiveness and appropriateness.


The program shall implement transfusion guidelines and monitor adherence to these guidelines.

The program implements transfusion guidelines and monitors adherence to these guidelines.


Situations of over-transfusion, or when a failure to transfuse is identified, shall be evaluated and, if indicated, root cause analysis performed.

Situations of overtransfusion or failure to transfuse are identified and evaluated, and a root-cause analysis is performed.


Data regarding adherence to patient blood management guidelines shall be shared with supervisory personnel at least quarterly and with the hospital administration and quality committees at least annually.

Data regarding adherence to the guidelines for pre- and posttransfusion patient care are reviewed at least quarterly and shared with the hospital administration and quality committees at least annually.




PBMPC.11Revision Type: Moved New Requirement Text:

PBMPC.9Current Requirement Text: The program has procedures for preoperative or preintervention patient care. The program has procedures for preoperative or preintervention patient care.


The program shall oversee and review the following: - The maximum surgical blood ordering schedule (MSBOS) or equivalent and updateif needed. At a minimum, the MSBOS shall be reviewed biennially.- Procedures for identification of patients who refuse transfusion.- Procedures for interventions to reduce the use of allogeneic transfusion.- The prescribing and ordering of appropriate blood components or transfusion-related pharmaceuticals (for example, factor concentrates, antifibrinolytics,hemostatic agents).

The program oversees and reviews the following: - The maximum surgical blood ordering schedule (MSBOS) or equivalent and updateas needed. The MSBOS is reviewed at a minimum biennially.- Procedures for identification of patients who decline transfusion.- Procedures for interventions to minimize the need for allogeneic transfusion.- The prescribing and ordering of appropriate blood components or transfusion-related pharmaceuticals (for example, factor concentrates, antifibrinolytics,hemostatic agents).


For patients undergoing elective surgery, the following shall be performed sufficiently in advance of the planned procedure to allow for successful treatment: - Evaluation and management of preprocedure anemia.- Assurance of safe and effective discontinuation of anticoagulants and/or plateletinhibitors.- Assessment of bleeding risk.- Assessment of physiologic ability to tolerate anemia, iron deficiency, andcoagulation systems stress.- Consideration and plan for allogeneic blood needs and their alternatives, includingclinically indicated preoperative autologous blood donation, intraoperative bloodrecovery, hemostatic agents, acute normovolemic hemodilution, treatingpostoperative anemia with medications, and/or anemia tolerance.

For elective surgical patients, the following are performed sufficiently in advance of the planned procedure to allow for successful treatment: - Evaluation and management of preprocedure anemia.- Assurance of safe and effective discontinuation of anticoagulants and/or plateletinhibitors.- Assessment of bleeding risk.- Assessment of physiologic ability to tolerate anemia, iron deficiency, andcoagulation systems stress.- Consideration and plan for allogeneic blood needs and the alternatives, includingclinically indicated preoperative autologous blood donation, intraoperative bloodrecovery, hemostatic agents, acute normovolemic hemodilution, treatingpostoperative anemia with medications, and/or anemia tolerance.





For patients undergoing emergent/urgent treatment, there shall be processes and/or procedures for the following: - Identification of unknown patients.- Assessment of patients’ physiologic ability to tolerate blood loss.- Timely delivery of blood components.- Interventions to stop bleeding.- Assessment of bleeding risk.- Consideration of directed interventions including hemostatic agents and protocolsfor rapid reversal of anticoagulants.- Assessment of safely recovering and reinfusing shed blood.

For emergent/urgent patients, there are processes and/or procedures for the following: - Identification of unknown patients.- Assessment of bleeding risk.- Assessment of patients’ physiologic ability to tolerate blood loss.- Timely delivery of blood components.- Interventions to stop bleeding, including the following:

- Directed interventions including hemostatic agents.- Protocols for rapid reversal of anticoagulants.- Assessment of recovering and reinfusing shed blood.


PBMPC.10Current Requirement Text: The program has procedures to review intraoperative methods for patient blood management during surgery and invasive procedures.

The program has methods for patient blood management during surgery and invasive procedures.


The program shall define and review methods for minimizing blood loss during surgery or invasive procedures.

The program defines and reviews methods for managing blood loss during surgery or invasive procedures.


PBMPC.11Current Requirement Text: The program oversees postoperative or postintervention patient care. The program oversees postoperative or postintervention patient care.


N/A The program ensures that postoperative or postintervention patients are monitored to determine the need for postoperative transfusion or anemia care.


The program shall oversee and review compliance with established patient blood management guidelines.

The program oversees and reviews compliance with established patient blood management guidelines.





PBMPC.12Current Requirement Text: The program has procedures for patients who do not require invasive procedures. The program has procedures for patients who do not require invasive procedures.


The program shall oversee and review the following:- Procedures for identification of patients who refuse transfusion.- Procedures for identification of patients who may benefit from medications ortreatments to reduce the need for allogeneic transfusion.- The prescribing and ordering of blood components or alternatives to transfusion.

The program oversees and reviews the following:- Procedures for identification of patients who decline transfusion.- Procedures for identification of patients who may benefit from medications ortreatments to minimize the need for allogeneic transfusion.- The prescribing and ordering of blood components or alternatives to transfusion.

PBMPC.15 PBMPC.15Current Requirement Text: Revision Type: New New Requirement Text:

N/A The program has policies, processes, and procedures to manage anemia in nonsurgical inpatients.


N/A The program, based on activity level, has policies, processes, and procedures in place to manage anemia in nonsurgical inpatients, including patients suffering from iron and/or micronutrient deficiency. Note: For more information on a program’s activity level, refer to Appendix A.





The program has processes and procedures for massive blood loss and emergent care.


N/A The program has policies, processes, and procedures for obstetric patients.


N/A The program oversees and reviews policies, processes, and procedures for obstetric patients including the following:- Patients for whom blood is not an option.- Identification and management of pregnancies with known risk for hemolyticdisease of the fetus and newborn or neonatal alloimmune thrombocytopenia.- Prenatal anemia management.


N/A Postpartum hemorrhage preparedness and management identify the following:- Quantitative cumulative assessment of maternal blood loss for all patients.- Patients with known high-bleeding risk (that is, placental abnormalities).- Postpartum hemorrhage protocol including predelivery risk assessment,postdelivery patient identification with step-wise process to manage bleeding,massive transfusion protocol, and/or patient transfer.


The program has processes and procedures for massive blood loss and emergent care.


The program shall have processes and procedures for managing massive blood loss and timely delivery of blood components for patients experiencing massive bleeding and other emergent situations.

The program has processes and procedures for timely delivery of blood and blood components to manage patients experiencing massive bleeding and patients in other emergent situations.





The program shall ensure compliance with the processes and procedures for the management and delivery of blood components for patients with emergency blood requirements, including massive blood loss.

The program ensures compliance with the processes and procedures for the management and delivery of blood and blood components for patients with emergency blood requirements, including massive blood loss.


N/A The program has a plan for the reversal of acquired coagulopathy.


N/A The program has a plan in place to rapidly reverse acquired coagulopathy.


N/A The plan to rapidly reverse acquired coagulopathy includes the dispensing of medications and/or blood and blood components, when clinically indicated.


N/A The program monitors the plan to rapidly reverse acquired coagulopathy at defined intervals.


N/A The program addresses patient blood management for pediatric patients.


N/A The program establishes guidelines and plans for the care of preterm and term neonates, infants, and children.





N/A The program addresses patient blood management for outpatients.


N/A The program oversees and reviews policies or processes to ensure that iron and/or micronutrient deficiency is considered, evaluated, and corrected in patients with red blood cell orders in the outpatient setting.


N/A The program oversees and reviews policies, procedures, and plans by high blood use service lines.


N/A The program oversees and reviews policies, procedures, and plans by high blood loss service lines to ensure strategies are in place to manage blood loss and treat anemia.





PBMPC.14Current Requirement Text: The program reviews data from other service lines that affect the quality of the program’s activities.

The program reviews performance indicator data.


The program shall obtain and review the following data at least quarterly (unless noted):- Blood component use.- Blood component wastage and outdating, including reasons for unusedcomponents.- Crossmatch to transfusion ratio.- Deviation from transfusion service procedures or protocols.- Transfusion reactions.- Use of intraoperative blood recovery equipment and quality control.- Informed consent for blood transfusion documentation.- Massive transfusion protocol use.- Blood infusion equipment (for example, IV pumps) and warmer(s) maintenanceprogram (annually).- External assessment results (for example, AABB or equivalent accrediting body)(biennially).(See also PBMAM.3, EP 1)

The program obtains and reviews the following data at least quarterly (unless noted):- Blood and blood component use.- Blood and blood component use appropriateness.- Blood administration policy compliance.- Blood and blood component wastage and discard, including reasons for unusedcomponents.- Crossmatch-to-transfusion ratio.- Deviation from transfusion service procedures or protocols.- Transfusion reactions by type.- Informed consent for blood transfusion.- Massive transfusion protocol use.- Single-unit red blood cell transfusion practice performance metric.- Use of intraoperative blood recovery equipment and quality control.- Anemia program utilization.- Iron and micronutrient deficiency identification and management in the outpatienttransfusion setting.- Blood infusion equipment and warmer(s) maintenance program (annually).- External assessment results (for example, AABB, The Joint Commission, or anequivalent accrediting body) (biennially).(See also PBMAM.3, EP 1)




Process Improvement Through Corrective and Preventive Action (PBMPI) Chapter

PBMPI.1Current Requirement Text:

The program performs process improvement through corrective and preventive action.

PBMPI.1 EP: 1 PBMPI.1 EP: 1Current EP Text: Revision Type: Revised New EP Text:

The program shall have policies, processes, and procedures for data collection, analysis, and follow-up of issues requiring corrective and preventive action, including near-miss events.

The program has policies, processes, and procedures for data collection, analysis, and follow-up of issues requiring corrective and preventive action, including near-miss events.


The program shall provide all data generated from the utilization review process to the program members for review and analysis.

The program provides all data generated from the utilization review process to the program members for review and analysis.


Utilization review data shall be analyzed for trends across the institution and within specific departments or services.

Utilization review data are analyzed for trends across the institution and within specific departments or services.


The program has a process for corrective action.


The program shall have a process for corrective action of deviations, nonconformances, and complaints relating to blood, blood components, blood products, critical materials, and services.

The program has a process for corrective action of deviations, nonconformances, and complaints relating to blood, blood components, perioperative products, critical materials, and services.





The process for corrective action of deviations, nonconformances, and complaints includes the following elements: - Description of the event- Investigation of the cause- Determination of the corrective action(s)- Implementation of correction action(s)- Evaluation to ensure that corrective action is taken and that it is effective

The process for corrective action of deviations, nonconformances, and complaints includes the following elements: - Description of the event.- Investigation of the cause.- Determination of the corrective action(s).- Implementation of correction action(s).- Evaluation to ensure that corrective action is taken and that it is effective.


The program shall monitor the following:- A provider’s ordering practices- Use of transfusion and/or alternatives- Effectiveness of transfusions and/or alternatives- Adverse events, including suspected transfusion reactions and other patient complicationsNote: These Findings shall be reported to the provider(s) by the medical director of the program.

As an element of corrective action, the program monitors the following:- A provider’s ordering practices.- Use of transfusion and/or alternatives.- Effectiveness of transfusions and/or alternatives.- Adverse events, including suspected transfusion reactions and other patient complications.

PBMPI.2 EP: PBMPI.2 EP: 4Current EP Text: Revision Type: New New EP Text:

N/A Program findings are reported to the provider(s) by the medical director of the program.





The program has a process for preventive action.


The program shall have a process for preventive action that includes the following elements: - Review of information, including assessment results and complaints, to detect and analyze potential causes of nonconformances- Determination of steps needed to respond to potential problems requiring preventive action- Initiation of preventive actions to respond to nonconformances and application of controls to monitor effectiveness

The program has a process for preventive action that includes the following elements: - Review of information, including assessment results and complaints, to detect and analyze potential causes of nonconformances.- Determination of steps needed to respond to potential problems requiring preventive action.- Initiation of preventive actions and application of controls to monitor effectiveness.




Resources (PBMRS) Chapter

PBMRS.1Current Requirement Text:

Resources are available to perform, verify, and manage program activities.

PBMRS.1 EP: 1 PBMRS.1 EP: 1Current EP Text: Revision Type: Revised New EP Text:

The program shall have policies, processes, and procedures that ensure the provision of adequate resources to perform, verify, and manage all activities in the oversight and review of patient blood management.

The program has policies, processes, and procedures that ensure the provision of adequate resources to perform, verify, and manage all activities in the oversight and review of patient blood management.

PBMRS.2Current Requirement Text:

Staff are qualified, trained, and competent to perform their responsibilities.


The program shall have a process to ensure the employment and participation of individuals qualified by education, training, and/or experience.

The program has a process to ensure the employment and participation of individuals qualified by education, training, and/or experience.


Current job descriptions shall be maintained and shall define appropriate qualifications for each position.

Current job descriptions are maintained and define appropriate qualifications for each position.


Personnel performing critical tasks shall be qualified to perform assigned activities on the basis of appropriate education, training, and/or experience.

Personnel performing critical tasks are qualified to perform assigned activities on the basis of appropriate education, training, and/or experience.





The program shall have a process for identifying training needs and shall provide training for personnel performing critical tasks.

The program has a process for identifying training needs and provides training for personnel performing critical tasks.


Evaluations of competence shall be performed before independent performance of assigned activities and at specified intervals.

Evaluations of competence are performed before independent performance of assigned activities and at specified intervals.


Individuals who order and/or transfuse blood shall meet facility-defined requirements for education related to patient blood management.

Individuals who order and/or transfuse blood meet facility-defined requirements for education related to patient blood management.




Supplier and Customer Issues (PBMSC) Chapter

PBMSC.1Current Requirement Text:

The program evaluates the performance of its suppliers.

PBMSC.1 EP: 1 PBMSC.1 EP: 1Current EP Text: Revision Type: Revised New EP Text:

The program shall have policies, processes, and procedures to evaluate the ability of suppliers of products and services to consistently meet specified requirements.Note: Specified requirements are any requirements in these PBM standards and including, but not limited to, US Food and Drug Administration (FDA) requirements; requirements of a facility's internal policies, processes, and procedures; manufacturers' instructions; customer agreements; practice standards; and requirements of accrediting organizations such as AABB and The Joint Commission.

The program has policies, processes, and procedures to evaluate the ability of suppliers of components and services to consistently meet specified requirements.Note: Specified requirements are any requirements in these PBM standards and including, but not limited to, US Food and Drug Administration (FDA) requirements; requirements of a facility's internal policies, processes, and procedures; manufacturers' instructions; customer agreements; practice standards; and requirements of accrediting organizations such as AABB and The Joint Commission.


The program shall evaluate and participate in the selection of suppliers, when possible, before acceptance of an agreement.

The program evaluates and participates in the selection of suppliers, when possible, before acceptance of an agreement.


When a supplier fails to meet specified requirements, it shall be reported to the management with contracting authority.Note: Specified requirements are any requirements in these PBM standards and including, but not limited to, US Food and Drug Administration (FDA) requirements; requirements of a facility's internal policies, processes, and procedures; manufacturers' instructions; customer agreements; practice standards; and requirements of accrediting organizations such as AABB and The Joint Commission.

When a supplier fails to meet specified requirements, it is reported to the management with contracting authority.Note: Specified requirements are any requirements in these PBM standards and including, but not limited to, US Food and Drug Administration (FDA) requirements; requirements of a facility's internal policies, processes, and procedures; manufacturers' instructions; customer agreements; practice standards; and requirements of accrediting organizations such as AABB and The Joint Commission.


Testing or services shall be performed in a facility accredited by The Joint Commission or an equivalent accrediting body.

Testing or services are performed in a facility accredited by The Joint Commission or an equivalent accrediting body.





The program has written agreements with its suppliers.


Agreements, or changes to agreements, shall define supplier and customer expectations and shall reflect agreement.

Agreements, or changes to agreements, define supplier and customer expectations and reflect agreement.


Agreements and any incorporated changes shall be reviewed and communicated. Agreements and any incorporated changes are reviewed and communicated.


The program has written agreements with organizations that provide contracted services.


The program shall participate in the review and evaluation of agreements with suppliers responsible for providing any products or services critical to patient blood management.

The program participates in the review and evaluation of agreements with suppliers responsible for providing any components or services critical to patient blood management.


If any patient blood management activities are performed by a third-party provider, the program shall be involved in the supplier qualification process.

If any patient blood management activities are performed by a third-party provider, the program is involved in the supplier qualification process.




Patient Blood Management Revisions - Joint Commission · Current EP Text: Revision Type: Revised...

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