Subject: Quality Assurance of the NASA Medical Care (Revalidated w/change 1)

Responsible Office: Office of the Chief Health & Medical Officer

Chapter 2. Medical Incident Investigation

2.1 Introduction

2.1.1 A Medical Incident is defined as a deviation from the standard of care occurring in the NASA health-care system, as perceived by the patient, another practitioner, or a reviewing quality monitoring body. In addition, any medical incident in which undue harm, illness, morbidity, or mortality or excessive financial burden to the patient or agency occurs as a result of the care provided or omitted will be cause for review. Such Medical Incidents include, but are not limited to:

a. Missed diagnosis;

b. Incorrect diagnosis;

c. Therapeutic error;

d. Delay of diagnosis and/or treatment;

e. Admissions to a medical facility as a result of delayed diagnosis or treatment;

f. Complication of treatment;

g. Any incident with NASA medical system-wide implications;

h. Any incident in which legal recourse or claims for perceived malpractice or negligence has been brought by the patient or the patient's guardian; and

i. Any incident in which there has been a perceived moral or ethical breach of appropriate practitioner conduct.

2.1.2 Any such incident involving NASA medical care will be immediately reported, with recommendation for disposition, to the Chief Health and Medical Officer (CHMO) by the Center Chief Medical Officer (CMO) or Medical Director (MD). If the incident involves a CMO or MD, it should be reported directly to the CHMO.

a. Similarly, any adverse trend in clinical performance will be immediately reported to the CHMO.

b. The CHMO will determine if the reported incident or adverse trend in clinical performance willl be formally investigated to determine cause and possible remedial action.

2.1.3 Medical incident investigations will be conducted by a provider, or a panel if appropriate, independent to the episode of care or incident, and according to the prescribed procedures established by the CHMO to ensure consistency of review across the Agency (Appendix D). For NASA institutions that act as the primary care providers to their patients, a Quality Assurance/Improvement Committee shall exist to review deviations and conformance to the standard of care, as well as conformance to credentialing and privileging documentation. This panel will provide the CHMO with a summary of all completed investigations at least quarterly.

2.1.4 Results of a medical incident investigation will be reported to the CHMO. The CHMO may convene the CMO for appropriate review. This group will be referred to as the Executive Medical Committee. If a CMO served on the original incident review committee, they will not serve on the Executive Medical Committee for that subsequent review.

2.2 Responsibilities

2.2.1 The CHMO shall be responsible for:

a. Determining when a medical incident investigation is warranted and assigning impartial investigating officials as required;

b. Monitoring all medical incident investigations to assure established processes and procedures are followed;

c. Convening the Executive Medical Committee to review the results of medical incident investigations for final response and determination of any necessary actions;

d. Ensuring any health-care provider under investigation is afforded a fair hearing according to the prescribed procedures established by the CHMO (see Appendix E);

e. Convening a Medical Review Board, as required, to review all cases of adverse privileging actions for privileged health-care providers as established in Appendix E;

f. Determining if any reporting of an adverse credentialing action should be reported to appropriate authorities, including the National Practitioner Data Bank. Only the CHMO will make the report if it is deemed appropriate; and

g. Maintaining all records associated with any medical incident investigation.

2.2.2 Center Chief Medical Officers/Medical Directors, in collaboration with NASA Center Occupational Health Contracting Officer Technical Representatives (COTRs) or the official that serves as a COTR, when appropriate, and in the case of the Johnson Space Center, the Chief of Space Medicine and/or the Clinical Services Branch Chief, shall be responsible for:

a. Notifying the CHMO in writing (e.g., letter and/or e-mail) of any medical incidents occurring at their Center or facility that may warrant a formal medical incident investigation;

b. Overseeing/conducting a medical incident investigation, including assignment of impartial investigating officers where appropriate, according to the proscribed procedures established by the CHMO and noted in Appendix D;

c. Providing to the CHMO the results of a medical incident investigation and all relevant records and data collected during the investigation; and

d. Report to the CHMO any temporary or permanent limitation of privileges, as described in Appendix E, for a privileged health-care provider, pending investigation, and establishment of a Medical Review Board.

2.2.3 No individual will conduct or oversee the investigation of a reported medical incident in which they were personally and directly involved. Where necessary, such investigation should be conducted by another NASA facility with the approval of the CHMO.

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