American Society of ExtraCorporeal Technology

Standards and Guidelines

for Mechanical Circulatory Support

The American Society of ExtraCorporeal Technology (AmSECT) has created the following document
based on clinical evidence and currently accepted perfusion practices. Perfusionists are the only allied
healthcare professionals formally trained and educated in the field of extracorporeal science and whose
scope of practice expressly includes the utilization of extracorporeal devices. The document is intended to
serve as a useful guide for teams developing institution-specific protocols to improve the reliability, safety
and effectiveness of mechanical circulatory support (MCS).

Goal Statement

The goal of this project was to provide perfusionists with a framework to guide safe and effective MCS
care to their patients. AmSECT recommends that clinical teams use this document as a guide for
developing institution-specific protocols for patients receiving MCS.

Approach

In 2012, the AmSECT Board of Directors (BOD) requested the MCS Committee to generate a MCS
Standards and Guidelines document. In 2013, the MCS committee submitted a proposed MCS
Standards and Guidelines to the BOD for review. Following that review, the document was shared with
the perfusion community at AmSECT’s International conference in 2014. Based on feedback from
conference attendees, the MCS Committee submitted a revised document to the membership for public
comment. In December of 2015 the BOD requested the International Consortium for Evidence-Based
Perfusion (ICEBP) Committee review the document. The feedback from the public comment and ICEBP
review were incorporated into the document and again presented to the membership at AmSECT’s 54th
International Conference in 2016. These Standards and Guidelines will be reviewed and updated as
necessary or as deemed appropriate by AmSECT’s BOD.

1
Definitions:

Standard: Practices, technology and/or conduct of care that institutions shall meet in order to fulfill the
minimum requirements for Mechanical Circulatory Support.

Guideline: A recommendation that should be considered and may assist in the development and
implementation of protocols.

Protocol: An institution-specific written document, derived from professional standards and guidelines,
which contains decision and treatment algorithms.

Mechanical Circulatory Support (MCS): Implantable, paracorporeal, and percutaneous univentricular

and biventricular devices used as acute or chronic support for assisting or replacing the failing heart.

Word Usage:

Shall: In this document, the word shall is used to indicate a mandatory requirement.

Should: In this document, the word should is used to indicate a recommendation.

Important Note on Scope:

AmSECT recognizes that individual medical centers may have local policies that may
supersede AmSECT’s Standards and Guidelines. Likewise, AmSECT recognizes that some
districts or states may have laws that supersede AmSECT’s Standards and Guidelines. As a
result, Perfusionists practicing within those jurisdictions should comply in all respects with
those policies and laws. These Standards and Guidelines may also be superseded by the
judgment of the healthcare professional taking into account the facts and circumstances of the
individual case.

2
Index: AmSECT Standards for Mechanical Circulatory Support

Standard 1: ................... Development of Institutionally-based Protocols

Standard 2: ................... Qualifications, Competency, Education and Proficiency
Standard 3: ................... Participation in a Multidisciplinary Mechanical Circulatory Support Team
Standard 4: ................... Documentation
Standard 5: ................... Responsibilities
Standard 6: ................... Safety
Standard 7: ................... Anticoagulation Management
Standard 8: ................... Quality Assurance and Improvement
Standard 9: ................... Maintenance

3
Standard 1: Development of Institutionally-based Protocols1

Standard 1.1: As a mechanism for applying each standard to clinical practice, an institution or
service provider shall develop and implement an operating procedure (protocol) for each of the
standards.

Standard 1.2: The protocol shall be:

• Approved by the Leader of the Multidisciplinary Team, or his/her designee, Director of
Perfusion or equivalent, and other relevant clinical governance committees if available.

• Reviewed and revised annually or more frequently when deemed necessary a.

Standard 1.3: Perfusionists shall participate in mechanical circulatory support (MCS) Clinical
Practice Protocol development.

Standard 1.4: Perfusionists shall participate in hospital compliance with the Disease Specific
Care standards required to achieve MCS Program Certification from an accrediting body.

Guideline 1.1: Deviation from protocol may be at the discretion of the Multidisciplinary Team and
should be documented in the perfusion record.

a
Joint Commission standard/ recommendation

4
Standard 2: Qualifications, Competency, Education and Proficiency3-7, 15

Standard 2.1: A Perfusionist, who is Board Certified by the American Board of Cardiovascular
Perfusion or who demonstrates equivalent qualifications and competency, shall provide
mechanical circulatory support (MCS) services.

Standard 2.2: The MCS Team leader(s) shall make certain that practitioners practice within the
scope of their licensure, certification, training, and current competency b.

Standard 2.3: Competency shall be assessed and documented at the time of hire and at least
annually to evaluate compliance with departmental MCS protocols c.

Standard 2.4: Members of the MCS team shall attend, participate, and engage in MCS-related
continuing education.

Standard 2.5: Orientation shall provide information and necessary training pertinent to the
practitioner’s responsibilities. Completion of the orientation shall be documented d.

Guideline 2.1: Resource material, specific for perfusion practices, for each MCS device should
be readily available.

b
Joint Commission standard/ recommendation
c
Joint Commission standard/ recommendation
d
Joint Commission standard/ recommendation

5
Standard 3: Participation in a Multidisciplinary Mechanical Circulatory Support Team1, 2, 19

Standard 3.1: Perfusionists shall be active participants in a multidisciplinary mechanical

circulatory support (MCS) program as directed by institutional protocol.

Guideline 3.1: Perfusionists should directly participate or supervise MCS including, but not
limited to, device selection, application, initiation, termination, management, support and
instruction in coordination with the MCS Team.

6
Standard 4: Documentation9-14

Standard 4.1: The mechanical circulatory support (MCS) record (written and/or electronic) for
each MCS procedure shall be included as part of the patient’s permanent medical record. The
MCS record shall be maintained and stored according to institution policy for retaining patient
medical records.

Standard 4.2: Documentation shall include the technical, laboratory, and physiologic
parameters pertinent to the patient/device operation, upon initiation and at a minimum frequency
according to established institutional protocols (Appendix A, B).

Standard 4.3 e : A checklist shall be used for MCS procedures. The checklist shall be included
in the patient’s permanent medical record.

e
To be considered in conjunction with AmSECT Perfusion Standards and Guidelines, Standard 4:
Checklist

7
Standard 5: Responsibilities

Standard 5.1: Setup and initiation of support with all mechanical circulatory support (MCS) devices shall
be according to protocol.

Standard 5.2: Perfusionist shall provide support, instruction and troubleshooting as appropriate to all
members of the MCS team.

Standard 5.3: A protocol shall exist to ensure the safe transport of MCS device patients within or
between hospitals.

Guideline 5.1: Perfusionists should be involved in the assembly and preparation of MCS devices for
implantation.

Guideline 5.2: Perfusionists should be involved in the transport of MCS devices during support for
patients, both within and between institutions.

Guideline 5.3: Perfusionists should conduct routine assessments for proper and optimal functioning of
MCS devices with all in-patients, either as part of formal medical rounds or as an independent event.

Guideline 5.4: Perfusionists should support the training and education of other MCS direct patient care
providers and caregivers.

8
Standard 6: Safety8

Standard 6.1: The Perfusion department shall have protocols in place to address device failure or
complications.

Standard 6.2: Mechanical circulatory support (MCS) devices shall be equipped with available safety
devices.

9
Standards 7: Anticoagulation Management 16-18

Standard 7.1: Anticoagulation testing equipment or access to laboratory services shall be

available for proper maintenance of anticoagulation during mechanical circulatory support
(MCS) per manufacturer’s guidelines.

10
Standard 8 f: Quality Assurance and Improvement 4,5

Standard 8.1: Perfusionists shall support mechanical circulatory support (MCS) data collection.

Standard 8.2: The perfusionist shall actively participate in both institutional and departmental
MCS quality assurance and improvement programs.

Guideline 8.1: A Perfusionist should contribute to the institution’s MCS data collection system
for use in a national registry, performance improvement, quality assessment, evaluation and
research.

f fTo
be considered in conjunction with AmSECT Perfusion Standards and Guidelines, Standard 13: Quality Assurance and
Improvement

11
Standard 9b: Device and Equipment Maintenance8

Standard 9.1: All mechanical circulatory support (MCS) equipment shall be properly maintained
in a safe and functional condition per manufacturer specifications.

Standard 9.2: Adequate backup equipment for all MCS devices in use at the institution shall be
accessible and in good working order (maintained).

Guideline 9.1: The Perfusionist should evaluate and minimize risks to power, gas, and
communication for safe and continuous operation of MCS devices in compliance with the
institution’s MCS protocol.

12
References:

1. Murray MA, Osaki S, Edwards NM, et al. Multidisciplinary approach decreases length of stay and
reduces cost for ventricular assist device therapy. Interact Cardiovasc Thorac Surg 2009;8:84-8.

2. Joint Commission Requirements for Ventricular Assist Device Destination Therapy Advanced
Certification. 2016.

3. The Joint Commission. 2016 Comprehensive Accreditation Manual for Hospitals: The Official
Handbook. Oakbrook Terrace, IL: Author. 2016.

4. Joint Commission HEALTH CARE STAFFING SERVICES PERFORMANCE MEASUREMENT

IMPLEMENTATION GUIDE 2ND EDITION

5. AmSECT Position Statement on Portable and Percutaneous Extracorporeal and Mechanical

Circulatory Support Devices

6. Joint Commission on Accreditation of Healthcare Organizations. Assessing Hospital Staff

Competence. Oakbrook Terrace, IL: Joint Commission Resources; 2007.

7. IOM (Institute of Medicine). 2010. Redesigning Continuing Education in the Health Professions.
Washington, DC: The National Academies Press.

8. Centers for Medicare and Medicaid Services §482.41(c)(2) - Facilities, supplies, and equipment
must be maintained to ensure an acceptable level of safety and quality. Interpretive Guidelines
§482.41(c)(2)
9. Recommendations for standards of monitoring during cardiopulmonary bypass. July, 2007.
http://www.scps.org.uk/index.php?option=com_content&task=view&id=27&Itemid=42

10. Guidelines for Medical Record and Clinical Documentation

WHO-SEARO coding workshop September 2007

11. Smith, CM. "Documentation Requirements for the Acute Care Inpatient Record (AHIMA Practice
Brief)." Journal of AHIMA 72, no.3 (2001): 56A-G.

12. Guidelines for Medical Record and Clinical Documentation WHO-SEARO coding workshop
September 2007
http://occupationaltherapy2012.files.wordpress.com/2012/03/2007_guidelines_for_clinical_doc.pd
f

13. Department of Health and Human Services. "42 CFR, Part 482 Conditions of Participation for
Hospitals." http://www.access.gpo.gov/nara/cfr/waisidx_99/42cfr482_99.html

14. Staunton & Chiarella Nursing and the Law 5th Edit Churchill Livingstone 2003
American Health Information Management Association - Legal Documentation Standards
http://www.ahima.org/resources/infocenter/ltc/guide5.aspx

15. Stahl MA, Richards NM. Ventricular assist devices: developing and maintaining a training and
competency program. J Cardiovasc Nurs 2002;16:34-43.

16. Slaughter et al, Clinical management of continuous-flow left ventricular assist devices in
advanced heart failure J Heart Lung Transplant 2010;29:S1–S39

13
17. Feldman et al, The 2013 International Society for Heart and Lung Transplantation Guidelines for
mechanical circulatory support: Executive summary J Heart Lung Transplant 2013;32:157–187

18. Hunt et al, 2009 Focused Update Incorporated Into the ACC/AHA 2005 Guidelines for the
Diagnosis and Management of Heart Failure in Adults JACC Vol. 53, No. 15, 2009

19. Deng et al., Destination Mechanical Circulatory Support: Proposal for Clinical Standards J Heart
Lung Transplant 2003;22:365–369

14
Appendix A:

1. Patient specific identifiers, demographics and diagnosis

2. Extracorporeal equipment in use; make, model and serial or lot number

3. Mechanical circulatory support (MCS) implantables and supplies assigned to the patient; make,
model and serial or lot number

4. Names of Perfusion practitioners and associated personnel responsible for MCS order and
management

5. Signature of the practitioner providing MCS services

6. Function of equipment

7. Availability of backup equipment

8. Those physiologic parameters of the patient directly associated with ongoing care

9. Laboratory tests pertinent to the procedure

10. Comments and interventions

Appendix B:

Patient Physiologic Parameters;

1. Heart rate

2. Blood pressures

3. Temperature

4. Medications

5. Input and output of fluids

Patient Laboratory Values - patient arterial and/or venous blood analysis for;

1. pH

2. pCO2

3. pO2

4. Sodium Bicarbonate

5. O2 saturation Pa O2

6. O2 saturation Pv O2

7. Hemoglobin/Hematocrit

15
 8. Sodium

9. Potassium

10. Ionized Calcium

11. Glucose

12. Lactate

13. Activated Coagulation Time (ACT)

14. Anti-Xa test

15. Activated partial thrombin time (aPTT)

16. Prothrombin time (PT)

17. Heparin-protamine titration test (HPT)

18. Antithrombin function

19. Thromboelastography

20. International normalized ratio (INR)

Support Device and Circuit Parameters - information specific to the implanted device upon
initiation of mechanical circulatory support and at a minimum frequency according to established
institutional protocols g.

1. Pump rate
2. Blood flow
3. Device power source
4. Battery charge
5. Integrity of MCS circuit
6. Alarm function and parameters
7. Backup settings
8. Device specific operating parameters

g
Joint Commission standard/ recommendation

16
 Appendix C: Regulatory documents, Revision 2016

REGULATORY CITATION LEGEND

Regulations, Standards and Guidelines Resources Citation

Prefix

DNV-GL Healthcare
DNV-GL
VAD Facility Credentialing Program Requirements 4.0 - 2014

The Joint Commission

Disease-Specific Care: Ventricular Assist Device (VAD) Destination Therapy TJC-DSC
Certification - 2016

*Note: The Centers for Medicare & Medicaid Services (CMS) outlines the criteria
required for payment of provision of services and for program certification
requirements by CMS approved Credentialing Organizations in the National
Coverage Determination (NCD) for Ventricular Assist Devices document (Publication
#: 100-3; Manual Section #: 20.9.1; Manual Section Title: Ventricular Assist
Devices; Version # 1; Effective Date: 10/30/2013; Implementation Date:
9/30/2014).

**Note: As of September 2016 the current CMS approved Ventricular Assist Device
Credentialing Organizations include:
1) The Joint Commission (TJC) and
2) DNV-GL Healthcare

17
Standard/Guideline Regulations, Section
Standards and
Guidelines
Resources

Standard 1.1 DNV-GL QM.1_CR.5; QM.2; QM.6_CR.2; PC.2_CR.1,

CR.3 – CR.4; SM.1; PR.1
DSPR.1_EP.5; DSPR.2_EP 1 – EP 4;
TJC-DSC DSPR.3_EP 1; DSPR.5_EP 1; DSDF.2_EP 1 –
EP 3; DSPM.1_EP 1 – EP 3
Standard 1.2
• Dot Point 1 DNV-GL QM.1_CR.5; QM.2; PC.2_CR.1, CR.3 – CR.4

TJC-DSC DSPR.1_EP.5; DSPR.2_EP1– EP 4; DSPR.3_EP

1; DSPR.5_EP1;DSDF.2_EP1–EP3; DSPM.1_EP
1 – EP 3

• Dot Point 2 DNV-GL QM.1_CR 5a; PC.2_CR.1, CR.3 – CR.4

TJC-DSC DSDF.2_EP 6;

Standard 1.3 DNV-GL QM.1_CR.5; QM.2; PC.2_CR.1, CR.3 – CR.4

TJC-DSC DSPR.1_EP.5; DSPR.2_EP1– EP 4; DSPR.3_EP

1; DSPR.5_EP1;DSDF.2_EP1–EP3; DSPM.1_EP
1 – EP 3

Standard 1.4 DNV-GL PM.1_CR.1 (a-e)

TJC-DSC DSPR.1_EP.5; DSPR.2_EP1– EP 4; DSPR.3_EP

1; DSPR.5_EP1;DSDF.2_EP1–EP3; DSPM.1_EP
1 – EP 3

Guideline 1.1 DNV-GL QM.7_CR.1b;

TJC-DSC DSPR.4_EP 1; DSPM.4_EP 2 – EP 3

Standard 2.1 DNV-GL PC.5_CR.1;PC.5_CR.1c;PC.5_CR.1e;SM.1_CR.

1

TJC-DSC DSDF.1_EP 1 – EP 3; DSDF.1_EP 6;

18
 Standard 2.2 DNV-GL PM.1_CR.1a

TJC-DSC DSDF.1_EP 1 - 4; DSPR.1_EP 7

Standard 2.3 DNV-GL PC.2_CR.5;SM.1_CR.3; SM.6_CR.1; SM.6_CR.2

TJC-DSC DSDF.1_EP 3, EP 5

Standard 2.4 DNV-GL PC.2_CR.5;SM.1_CR.2; SM.1_CR.4; SM.6_CR.6

TJC-DSC DSDF.1_EP 7

Standard 2.5 DNV-GL SM.1_CR.1; SM.5_CR.1

TJC-DSC DSDF.1_EP 4

Guideline 2.1 DNV-GL PM.2_CR.3

TJC-DSC DSPR.6_EP 1 – EP 2; DSDF.1_EP 6 – EP 7

Standard 3.1 DNV-GL PC.5_CR.1f

TJC-DSC DSPR.1_EP 3; DSPR.1_EP 6; DSPR.2_EP 1 –

EP 4

Guideline 3.1 DNV-GL PC.8_CR.1; PC.5_CR.2; PE.5_CR.1

TJC-DSC DSPR.1_EP 5; DSDF.2_EP 4; DSPM.4_EP 2a

Standard 4.1 DNV-GL PC.8_CR.4e;MR.1_CR.1–CR.3;MR.2_CR.1CR.2;

MR.4_CR.1 – CR.5; MR.5_CR.3 – CR.4, CR.6

TJC-DSC DSCT.1_EP 3 – EP 4; DSCT.2_EP 2 – EP 5;

DSCT.3_EP 1 – EP 2; DSCT.5_EP1 – EP 7

Standard 4.2 DNV-GL PC.8_CR.4e; PC.9_CR.1 – CR.2; MR.1_CR.1;

MR.4_CR.1

TJC-DSC DSCT.2_EP 2 – EP 5; DSCT.5_EP 2 – EP 7

Standard 4.3 h DNV-GL MR.1_CR.1; MR.2_CR.1

h
To be considered in conjunction with AmSECT Perfusion Standards and Guidelines, Standard 4:
Checklist
19
 TJC-DSC DSCT.2_EP2–EP5;DSCT.3_EP 2; DSCT.5_EP2–
EP 7

Standard 5.1 DNV-GL QM.1_CR.5; QM.6_CR.2

TJC-DSC DSPR.1_EP.5; DSPR.2_EP 1 – EP 4;

DSPR.3_EP 1; DSPR.5_EP 1; DSDF.2_EP 1 –
EP 3

Standard 5.2 DNV-GL PC.3_CR.2; PC.5_CR.1

TJC-DSC DSDF.2_EP 4

Standard 5.3 DNV-GL QM.1_CR.5; QM.6_CR.2

TJC-DSC DSPR.1_EP.5;DSPR.2_EP1 – EP 4; DSPR.3_EP

1; DSPR.5_EP 1; DSDF.2_EP 1 – EP 3

Guideline 5.1 DNV-GL QM.1_CR.5; QM.6_CR.2

TJC-DSC DSPR.1_EP.5; DSPR.2_EP1 –EP 4; DSPR.3_EP

1; DSPR.5_EP 1; DSDF.2_EP 1 – EP 3

Guideline 5.2 DNV-GL QM.1_CR.5; QM.6_CR.2

TJC-DSC DSPR.1_EP.5; DSPR.2_EP1 –EP 4; DSPR.3_EP

1; DSPR.5_EP 1; DSDF.2_EP 1 – EP 3

Guideline 5.3 DNV-GL PM.3_CR.2 – CR.5; QM.7_CR.7; PC.10_CR.2;

NS.1_CR.2

TJC-DSC DSDF.4_EP 1 – EP 4, EP 7 – EP 8

Guideline 5.4 DNV-GL QM.7_CR.6;PC.8_CR.2,CR.4;NS.1_CR.3;

SM.2_CR.1;SM.2_CR.4;SM.2_CR.6; SM.2_CR.7;

TJC-DSC DSPR.5_EP 2, EP 5 – 6; DSDF.4_EP 5 – EP 8;

DSDF.5_EP 1 – EP 3; DSDF.6_EP 1 – EP 4;
DSSE.1_EP 2 – EP 5; DSSE.2_EP 5 -EP6;
DSSE.3_EP 1 – EP 5; DSCT.4_EP 2

20
Standard 6.1 DNV-GL QM.1_CR.5;QM.6_CR.2; PE.5_CR.1; PE.6_CR.2

TJC-DSC DSPR.7_EP 7 – EP 11

Standard 6.2 DNV-GL QM.1_CR.5; QM.6_CR.1 – CR.2

TJC-DSC DSPR.7_EP 7 – EP 8

Standard 7.1 DNV-GL PC.9_CR.1 – CR.2; PE.3_CR.1

TJC-DSC DSPR.1_EP.5; DSPR.2_EP 1 – EP 4;

DSPR.3_EP 1; DSPR.5_EP 1;DSDF.2_EP 1 –
EP 3; DSPM.1_EP 1 – EP 3

Standard 8.1 DNV-GL QM1_CR.1 – CR.4, CR.7 – CR.9; QM.2; QM.3;

QM.4; QM.5; QM.6_CR.1 – CR.4; QM.7_CR.1,
CR.7; PC.5_CR.1h

TJC-DSC CPR 4; CPR 5; DSPM.1_EP 1 – EP 7; DSPM

PM.2_EP 1 – EP 6; DSPM.3_EP 1 - EP 4;
DSPM.4_EP 1 - EP3; DSPM.6_EP 1 – EP 4

Standard 8.2 DNV-GL QM1_CR.1 – CR.4, CR.7 – CR.9; QM.2; QM.3;

QM.4; QM.5; QM.6_CR.1 – CR.4; QM.7_CR.1,
CR.7

TJC-DSC CPR 4; CPR 5; DSPM.1_EP 1 – EP 7; DSPM

PM.2_EP 1 – EP 6; DSPM.3_EP 1 - EP 4;
DSPM.4_EP 1 - EP3; DSPM.6_EP 1 – EP 4

Guideline 8.1 DNV-GL QM1_CR.1 – CR.4, CR.7 – CR.9; QM.2; QM.3;

QM.4; QM.5; QM.6_CR.1 – CR.4; QM.7_CR.1,
CR.7

TJC-DSC CPR 4; CPR 5; DSPM.1_EP 1 – EP 7; DSPM

PM.2_EP 1 – EP 6; DSPM.3_EP 1 - EP 4;
DSPM.4_EP 1 - EP3; DSPM.6_EP 1 – EP 4

Standard 9.1 DNV-GL PE.3_CR.1 – CR.2; PE.5_CR.1 -CR.2

TJC-DSC DSPR.7_EP 7 – EP 8; DSPR.7_EP 11

21
Standard 9.2 DNV-GL PE.6_CR.1 – CR.3

TJC-DSC DSPR.7_EP 7 – EP 8; DSPR.7_EP 11

Guideline 9.1 DNV-GL PE.6_CR.1 – CR.3

TJC-DSC DSPR.7_EP 7 – EP 10; DSPR.7_EP 11

22