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Hospital Policies and Procedures Manual
Number: S120
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TITLE:
SERIOUS ADVERSE EVENTS/SENTINEL EVENTS and MEDICAL
DEVICE REPORTING AND MANAGEMENT
POLICY:
New York-Presbyterian Ho spital is co mmitted to enhancing quality and patient safety thro ugh
rigo ro us analyses o f serio us adverse events/sentinel events (―SAE/SE‖). C ritical elements o f
this co mmitment include timely identificatio n, reporting, and evaluation o f unanticipated
adverse patient o utcomes, identification o f risk reduction and impro vement strategies and
implementatio n o f corrective actions as indicated.
The regulatory agencies to w hich the Ho spital must report certain SAE/SEs include, but are
no t limited to :
- The New Yo rk State Department o f Health (NYSDOH) into its New Yo rk Patient
Occurrence Repo rting and Tracking System (NYPORTS) pro gram;
- The New Yo rk State Department o f Health – Wadsworth C enter Blo od and Tissue Resource
Pro gram, related to any blo od o r tissue serious events;
The New Yo rk State Justice C enter (JC), fo r the Pro tection o f People w ith Special Needs;
- The New Yo rk State Office o f Mental Hygiene (NYSOMH);
- The New Yo rk C ity Department o f Health – Bureau o f Enviro nmental Radiatio n Protection
(BERP)
- The C enters fo r Medicare and Medicaid Services (―CMS‖);
- The Jo int C o mmission (TJC) through its surveillance pro gram;
- The Organ Pro curement and Transplantation Network (OPTN), and the End-stage Renal
Disease (ESRD) Network fo r any transplant related serious event.
- The U.S. Food and Drug Administration (FDA)
PURPOSE:
The purpo se o f this po licy is to define SAE/SEs that require ro o t cause analyses, describe
the mechanism fo r repo rting SAE/SEs, and to set fo rth the pro cess fo r co nducting ro ot
cause analyses in acco rdance with regulato ry (NYC , NYS and Federal) requirements.
APPLICABILITY:
All ho spital, medical and pro fessio nal staff
Serious Adverse/Sentinel Event Required reporting:
Acco rding to the DOH, much o f w hat is repo rtable reflects adverse events that are
kno w n to o ccur w ith certain frequency and in no w ay implies that an erro r has been
made o r particular blame is to be assigned. To w ards that end, there are certain
NYPORTS that are repo rtable to DOH fo r the purpo ses o f tracking and trending. There
are o ther NYPORTS w hich in additio n to being part o f the NYPORTS database require
a tho ro ugh investigatio n and in so me cases require the Ho spital to co nduct a Ro o t
C ause Analysis (RC A). No tificatio n to DOH is do ne w ithin 24 ho urs o f aw areness by
Patient Services Administratio n.
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Therefo re each o f the o ccurrences must be repo rted immediately by staff to :
Pat i ent Servi ces Admi ni s trat ion at NY P/CU/W C/TAH/MSCH/W D and LM or
t he Admi ni s trat or-On-Cal l
and
ent ered i nt o t he Hos pi tal’s on-l i ne medi cal event report i ng s ys t em i n
accordance wi t h t he hos pi t al’s procedure
Definitions:
Serious Adverse Event / Sentinel Event:
A serio us adverse event / sentinel event is an unexpected o ccurrence invo lving death
or serio us physical o r psycho lo gical injury, o r the risk thereo f, i.e. a near miss
Root Cause Analysis:
Ro o t cause analysis is a tho ro ugh pro cess fo r identifying the co ntributory
factors that underlie variatio n in perfo rmance, and result in a SAE/SE o r near
miss. A ro o t cause analysis fo cuses primarily o n systems and pro cesses, no t
o n individual perfo rmance. It identifies po tential impro vements in pro cesses o r
systems that w o uld tend to decrease the likeliho o d o f such events in the
future, o r determines that no such impro vement o pportunities exist.
The ro o t cause analysis and actio n plan must be co mpleted in a timely manner
in acco rdance with vario us regulato ry requirements. The time frame fo r
co mpletio n required by: NYSDOH-NYPORTS is 30 days fro m submission o f the
event into the system and fo r the Jo int C o mmission is w ithin 45 business days
o f the event o r o f beco ming aw are o f the event. Any exceptio ns must be vetted
thro ugh Patient Services Administratio n. Appro val fro m the specific agency
w o uld need to be so ught. An RC A is no t o nly perfo rmed fo r situatio ns that are
required by regulato ry entities but may also be do ne as mandated by the GEM
C o mmittee (see belo w ).
Global Event Management Committee
The Glo bal Event Management (―GEM‖) C o mmittee is a co mponent o f the
Ho spital’s quality and patient safety pro gram. It is a multidisciplinary gro up that
is scheduled to meet tw ice w eekly to review repo rted po ssible SAE/SEs. The GEM
C o mmittee is respo nsible fo r determining w hether a SAE/SE is repo rtable to an
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o utside regulato ry agency, and w hether o r no t a ro o t cause analysis (―RC A‖) is
required. Members o f the GEM C o mmittee participate in RC As.
The standing members of the GEM Committee include the following:
Vice President, Patient Services Administratio n
Vice President/MD, Quality and Patient Safety
Vice President, Risk Management and Asso ciate General C o unsel or designee
Asso ciate C hief Quality Officers/MD (6)
Asso ciate C hief Medical Officer
C o rporate Director, Patient Services Regulato ry Affairs
Directo rs Patient Services Administration (3)
Directo r Patient Services / Quality-Behavioral Health, NYP/WD
Directo r, Patient Safety & Significant Events
Asso ciate General C o unsel (3)
Directo rs o f Nursing, NYP/C U, WC , MSC H, TAH, WD, LM
Directo r o f Nursing – Quality (C o rporate)
Directo r o f Nursing – Quality (3)
Manager, Significant Events Repo rting (3)
Manager, Quality/Behavio ral Health, NYP/C U, MSC H, TAH
Manager, Patient Services Regulato ry Affairs
Ad Ho c Representatives fro m departments as indicated
PROCEDURE:
1. Identification of SAEs/SEs:
a. New York State Department Of Health and The Joint Commission
Listing of SAE Categories:
Attachment ―A‖ lists the occurrences that must be repo rted immediately to Patient
Services Administratio n o r the Administrato r-On- C all and entered into the
Ho spital’s o n-line medical event repo rting system in acco rdance w ith the pro cedures
discussed in Sectio n 2.
Note: Level 1 events (NYPORTS) require a Ro o t Cause Analysis. No te, the list o f SAE/SEs
requiring ro o t cause analyses is no t all-inclusive. If an o ccurrence do es not fit o ne o f the
descriptio ns, but is a serio us event, o r near miss, it may still be repo rted to DOH and undergo
ro o t cause analysis; such determinatio n shall be made by the Glo bal Event Management
(―GEM‖) C o mmittee.
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b. The Justice Center (JC) and NYS Office of Mental Health (OMH) reporting:
Attachment B lists the incidents determined by the New York State Office of Mental
Health (OMH) to be repo rtable as fo llo w s :
1. ―Reportable Incidents‖ a r e required to be repo rted to the Justice
C enter and/o r OMH. These include Allegatio ns o f Abuse, and Significant
Incidents. Significant incident means a repo rtable incident, o ther than an
incident o f abuse o r neglect, that because o f its severity o r the sensitivity
o f the situatio n may result in, o r has the reaso nably fo reseeable po tential
to result in, harm to the health, safety o r w elfare o f a patient.
2. ―Reviewable Incidents‖ Review able incident means adverse events that do no t
result in injury to patients that requires medical interventio n o r treatment beyo nd
first aid, o r w hich do no t o ccur o n pro gram premises o r under the actual o r
intended supervisio n o f staff, but w hich must be internally review ed by pro viders.
3. Death o f a patient enro lled in an OMH o r OASAS pro gram must be repo rted to the
Death Repo rting line (855-373-2124). An OMH NIMRS fo rm must be co mpleted
w ithin 5 business days o f this call. Fo r OASAS pro grams, a required fo rm must be
co mpleted and submitted. If there is any reaso n to suspect that the death w as
due to neglect o r abuse, a separate repo rt must be made to the Vulnerable
Perso ns C entral Register (VPCR) (855-373-2122).
4. Each o f the o ccurrences must be repo rted immediately to Patient Services
Administratio n at NYP/C U/WC/TAH/MSCH/WD and LM o r the Administrato r-OnC all and entered into the Ho spital’s o n-line medical event repo rting system in
acco rdance w ith the pro cedures discussed in Sectio n 2.
c. Transplant Service:
As applied to transplant pro grams, examples o f adverse events include, but are
no t limited to :
 Death o f a living do no r, within 2 years fo llo wing o rgan do natio n
 Serio us medical co mplicatio ns o r death as a result o f living do natio n o f an
organ
 Aborted living donor organ recovery after administration of general anesthesia
 A living liver donor is listed on the liver wait list within 2 years after organ
donation
 A living kidney donor is listed on the kidney wait list or begins dialysis within
2 years after organ donation
 A living donor organ is recovered but not transplanted
 A living donor organ is recovered and transplanted into someone other than
the intended recipient
 Unintentio nal transplantatio n o f o rgans o f mismatched blo o d types
 Transplantatio n o f o rgans to unintended recipients
 Unintended transmissio n o f infectio us disease and or malignancy to a recipient
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Each transplant pro gram administrator is respo nsible fo r no tificatio n o f any serio us
adverse event to Patient Services Administration o r the Administrato r-On-C all and
entered into the Ho spital’s o n-line medical event repo rting system w ithin 24 ho urs
o f aw areness o f the event.
External repo rting o f events to United Netw ork fo r Organ Sharing (UNOS),
Organ Pro curement and Transplantatio n Network (OPTN), End-stage Renal Disease
Netw ork (ESRD), the DOH and o ther regulato ry agencies as indicated w ill be jo intly
determined by Transplant Service leadership, and the Glo bal Events Management
(GEM) C o mmittee. The need to co nduct a ro o t cause analysis w ill be determined in
acco rdance with regulatio n and o r by the GEM C o mmittee. If the event o ccurred
w ithin the co ntext o f an appro ved clinical research study o r invo lves an
investigatio nal medicatio n o r device, the appro priate Institutio nal Review Bo ard (IRB)
is no tified by the Attending Physician and/o r the pro tocol’s Primary Investigator.
d. The U.S. Food and Drug Administration
In accordance with FDA regulations (see Attachment C), the Hospital complies with
medical device reporting requirements.
(1) Reports of death: The Hospital will submit a report to the FDA as soon as practicable
but no more than 10 work days after the day that it becomes aware of information, from any
source, that reasonably suggests that a device has or may have caused or contributed to the
death of a Hospital patient. The Hospital will also submit the report to the device
manufacturer, if known. The Hospital must submit the information required by, and in the
form required by, applicable FDA regulations.
(2) Reports of serious injury: The Hospital will submit a report to the manufacturer of the
device no later than 10 work days after the day that it becomes aware of information, from
any source, that reasonably suggests that a device has or may have caused or contributed to
a serious injury to a patient of your facility. If the manufacturer is not known, the Hospital
must submit the report to the FDA containing the information required by, and in the form
required by, applicable FDA regulations.
2. Internal reporting of SAE/SE:
Whenever any member o f the Ho spital's medical o r nursing staff o r any o ther
Ho spital emplo yee becomes aw are o f any event o r o ccurrence w hich may be a
SAE/SE, that perso n sho uld immediately:
i. No tify Patient Services Administratio n at NYP/C U/WC/TAH/MSCH/WD and LM as
indicated belo w fo r each campus:
AND
ii. Enter the event into the Ho spital’s o n-line medical event repo rting system
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NYP/Columbia University Medical Center and Morgan Stanley
Children's Hospital
Patient Services Administratio n at 305-5904, Mo nday – Friday, 9 AM – 5
PM (excluding holidays);
All o ther times co ntact the Administrator-on-Call thro ugh the page operato r.
NYP/Allen Hospital
Patient Services Administratio n at 932-4321, Mo nday – Friday, 9 AM – 5
PM (excluding holidays);
All o ther times co ntact the Administrator-on-Call thro ugh the page operato r.
NYP/Weill Cornell Medical Center
Patient Services Administratio n at 746-4293, Mo nday – Friday, 9 AM – 5 PM
(excluding holidays);
All o ther times co ntact the Administrator-on-Call thro ugh the page operato r.
NYP/Westchester Division
Patient Services Administratio n at 914-997-5920, Monday – Friday, 9 AM – 5 PM
(excluding holidays);
All o ther times co ntact the Do ctor-on-Call at 914-682-9100.
NYP/Lower Manhattan
Patient Services Administration at 212 312-5034, Mo nday – Friday, 9 AM – 5 PM
(excluding holidays);
All o ther times co ntact the On-C all Administrato r Nursing Superviso r.
3. Notification and Initial Hospital Investigation:
Patient Services Administratio n at NYP/C U/WC/TAH/MSCH/WD and LM w ill
co nduct an initial investigatio n o f the event and w ill pro mptly report the po tential
SAE/SE to the Gem C ommittee and as appro priate, to the senio r administration o f
the Ho spital. Patient Services Administratio n at NYP/C U/WC/TAH/MSCH/WD and
LM in co nsultation w ith the G EM C o mmittee w ill determine w hether the event
requires an RC A and repo rtability to regulatory agencies, including but no t limited
to , NYS DOH, Justice C enter, New Yo rk State Office o f Mental Hygiene, and C MS.
All no tificatio ns regarding an SAE are made by Patient Services Administratio n at
NYP/C U/WC/TAH/MSCH/WD and LM.
4. Designation of Team to Assess Variation in Performance:
The GEM C o mmittee w ill review the event and identify team(s), services and/or
clinical departments appropriate to co nduct quality reviews and participate in a
ro o t cause analysis. Additio nal members o f the team may be designated as the ro o t
cause analysis pro gresses.
The ro o t cause analysis team is respo nsible fo r reviewing the SAE/SE fo r ro ot cause(s) as
w ell as assisting departments in fo rmulating, as needed, a plan(s) o f action and
mechanism(s) to monitor and measure the effectiveness o f such actio n plan(s). This shall be
do ne in co nsultation w ith the departmental Quality C hair, C linical Service C hief and/or
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Administrator. Quality and Patient Safety w ill assist in the pro cess o f co nducting the review
and w ill be respo nsible fo r the final preparatio n o f the ro o t cause analysis in the
appro priate fo rmat.
5. Internal Reporting:
SAE/SE’s and co rresponding ro o t cause analyses including findings and
reco mmendations w ill be repo rted thro ugh the Ho spital’s Quality and Patient Safety
Pro gram. Ro ot cause analysis findings and reco mmendations w ill be appro ved by the GEM
C o mmittee. A summary report w ill also be presented to the Executive C ommittees o f the
Medical Bo ard Quality and Perfo rmance Committee and Bo ard o f Trustees Quality and
Perfo rmance Impro vement Committee’s regular meetings. The full w ritten repo rt o f the
ro o t cause analysis w ill be pro vided to the Medical Bo ard/QPI C o mmittee, BOT/QPI
C o mmittee, and senio r leadership as requested.
6. Implementing and Monitoring of RCA – Action Plans:
The C linical Service C hief(s) and/or Administrator(s) o f the invo lved department(s) is
respo nsible fo r the fo llo w ing: implementing any recommendations identified by the root
cause analysis, including w itho ut limitation, educating staff w ithin their departments as to
all system changes and impro vements, monitoring o f co mpliance w ith and effectiveness
o f the plan as w ell as repo rting the results o f that monitoring thro ugh the Quality and
Perfo rmance/Patient Safety Pro gram across all campuses perfo rming like
pro cedures/processes.
The Quality and Patient Safety Department shall review the status o f all plans o f
actio n fo r co mpleteness. A summary repo rt w ill be presented to the GEM
C o mmittee perio dically and the Bo ard o f Trustee Quality and Perfo rmance
Impro vement C o mmittee at least o n an annual basis and as requested.
7. Maintenance of Documentation:
A co py o f the final ro o t cause analysis and suppo rting do cumentation w ill be maintained in
each campus specific Patient Services Administratio n o ffice, NYP/C U/WC/TAH/MSCH/WD
and LM and the Quality and Patient Safety department.
8. Confidentiality:
Oral o r w ritten communications, reports, memoranda, reco mmendations, o r info rmation
created by o r fo r, any perso n, bo dy, department, o r co mmittee regarding quality
review s and RC A’s o f a SAE/SE are privileged and shall be kept strictly co nfidential. Such
info rmation sho uld be clearly identified as Q.A. Data Pro tected by P.H.L. The info rmatio n is
to be used to impro ve patient care pro cesses or systems at New York-Presbyterian
Ho spital. Questio ns co ncerning the use o r release o f info rmation co ncerning SAE/SE’s
sho uld be directed to the Office o f Legal Affairs/Risk Management.
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RESPONSIBILITY:
Patient Services Administratio n
Quality and Patient Safety
Office o f Legal Affairs/Risk Management
REFERENCES:
- The Jo int C o mmission – Accreditation Manual – Sentinel Events – January &
June 2015
- NYSDOH NYPORTS / DOH Wadsworth – Sentinel Events – July 2013
- Justice C enter & NYS OMH – NIMRS Incident Types and Severity Ratings June 2013
- UNOS – Transplant Regulatio ns
- FDA – Medical Device Reporting 21 CFR 803
POLICY DATES:
Revised:
Octo ber 1999
Revised:
May 2002 (Previo usly Po licy #S105)
Revised:
August 2005; March 2006; Octo ber 2008; October 2009;
No vember 2010; April 2011; April 2012; No vember 2012;
December 2012
Review ed: September 2011; No vember 2012; December 2012
Revised:
February 2014; May 2015, July 2015, December 2015
APPROVAL:
Medical Board:
No vember 2008, No vember 2010, May 2011; May 2012;
February 2013, April 2014, August 2015; February 2016
[No te: Po licy I125 I ncident Reporting to T he New Y ork State Department of Health
(NY SDOH) has been merged w ith the current Po licy S120 Serious Adverse
Events/Sentinel Events]
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Attachment A – NYP Reviewable Events – NYS-DOH and T JC:
Serious Adverse / Sentinel Events
Event Category
*Root Cause Analysis (RCA) Required
NYS
DOH
Abductio n o f a patient o f any age*
X
Death o r serio us injury, patient o r staff, asso ciated w ith a
burn*
Death, near death o r serio us injury, patient, asso ciated
w ith a fall*
Death o r serio us injury, maternal, asso ciated w ith labo r
and delivery. Includes events that o ccur w ithin 42 days
po st-delivery *
Death o r serio us injury, neo nate, asso ciated w ith labo r
and delivery*
Death, full-term infant (unanticipated)*
X
Death o r serio us injury, patient, asso ciated w ith a
medicatio n erro r: w ro ng patient, drug, do se, time, rate,
preparatio n, ro ute o f administratio n o r o missio ns*
Death, patient, unexpected – intra-o perative o r
immediately po st-o perative/post pro cedure (ASA C lass 1
o r 1E patient)*
Death o r serio us injury, patient o r staff, resulting fro m a
physical assault*
Death o r serio us injury, patient, asso ciated w ith patient
elo pement*
Death o r serio us injury, patient asso ciated w ith the use o r
functio n o f a device (includes user erro r)*
Death o r serio us injury, patient, asso ciated w ith unsafe
administratio n o f blo o d pro ducts (Repo rted to DOH –
Wadsw o rth C enter Blo o d Reso urces Pro gram)*
Death o r serio us injury resulting fro m the irretrievable
bio lo gic specimen*
Death o r serio us injury asso ciated fro m failure to fo llo w up
o r co mmunicate lab, patho lo gy, o r radio lo gical test results*
Death o r serio us injury o f patient o r staff asso ciated w ith
the intro ductio n o f a metallic o bject into the MRI area*
Death o r serio us injury in circumstances o ther than tho se
related to the natural co urse o f illness, disease o r pro per
treatment in acco rdance w ith generally accepted medical
standards*
X
Applies to:
The Joint
Commission
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
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Page 12 of 18
Serious Adverse / Sentinel Events
Event Category
*Root Cause Analysis (RCA) Required
Death o r serio us injury asso ciated w ith the use o f physical
restraints o r bedrails w hile being fo r in a healthcare
setting*
Disaster, external, o utside the co ntrol o f the ho spital that
effects facility o peratio n
Disaster, internal, e.g. Ho spital fire o r o ther internal
disaster, disrupting patient care o r causing harm to
patients o r staff
Discharge o r release o f a patient o f any age, w ho is unable to
make decisio ns, to o ther than an autho riz ed perso n
(―individuals w ho do no t have ―decisio n-making capacity‖ e.g.
includes new borns, mino rs, adults w ith Alz heimer’s Disease)*
Fire, flame, or unanticipated smoke, heat, or flashes
occurring during an episode of patient care*
Hemo lytic transfusio n reactio n invo lving administratio n o f
blo o d o r blo o d pro ducts having majo r blo o d gro up
inco mpatibilities (ABO, Rh, o ther blo o d gro ups)*
Applies to:
NYS
The Joint
DOH
Commission
X
X
X
X
X
X
X
X
Misadministratio n o f radiatio n o r radio active material
(pro lo nged fluo ro scopy w ith cumulative do se >1,500 rad to
a single filed o r any delivery o f radio therapy to the w ro ng
bo dy regio n o r >25% abo ve the planned radio therapy
do se)
Po iso ning o ccurring w ithin the ho spital
X
X
Rape, assault (leading to death, permanent harm o r severe
tempo rary harm), o r ho micide o f any patient or staff
member receiving care, treatment, and services w hile o n
site at the ho spital*
Rape, assault (leading to death, permanent harm o r severe
tempo rary harm), o r ho micide o f a staff member, licensed
independent practitio ner, visito r, o r vendo r w hile o n site at
the ho spital*
Sever maternal mo rbidity is care that is unexpected and
no t directly related to the co nditio n o f the patient o n
admissio n, and that results in admissio n to the intensive
care unit(IC U) and/o r transfusio n o f 4 o r mo re units o f
packed blo o d cells(PRBC )*,
Severe neo natal hyperbilirubinemia (bilirubin >30
milligrams/deciliter)
X
X
X
X
X
X
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Page 12 of 18
Serious Adverse / Sentinel Events
Event Category
*Root Cause Analysis (RCA) Required
Sexual abuse / Sexual assault o n a patient o r staff
member w ithin ho spital/o n gro unds*
Strike by ho spital staff
Applies to:
NYS
DOH
X
The Joint
Commission
X
Suicide o f any patient, all attempted suicides, o r selfharm that results in serio us injury w hile being cared fo r in
a healthcare setting*
Surgical o r o ther no n-surgical invasive pro cedure /
treatment o n the w ro ng patient, bo dy part o r site no t
co nsistent w ith do cumented pro cedural/surgical plan fo r
patient: w ro ng site/level/side/digit, o r w ro ng pro cedure*
X
Terminatio n o f any services vital to the co ntinued safe
o peratio n o f the ho spital o r to the health and safety o f its
patients and perso nnel
Unintended retentio n o f a fo reign bo dy*
X
X
X
X
X
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Page 12 of 18
Attachment B – NYP Reviewable and/or Reportable Events– New York
State Office of Mental Hygiene(OMH) and/or the Justice Center (JC):
NIMRS Serious / Sentinel Adverse Event Category
*Root Cause Analysis (RCA) Required
Adverse drug reactio n, severe*
Allegatio n o f staff abuse o r neglect (physical, psycho lo gical, sexual, medicatio n, o r
neglect)*
Assault o r physical attack using fo rce o r vio lence by a perso n o ther than a
custo dian w hich client is either victim o r aggresso r w hich results in injury/harm
C hild missing fro m staff supervisio n (o utpatient pro gram)*
C ho king event
C o ntraband, po ssessio n o f
C rimes (Ho micide attempt, ho micide by client, narco tics sale o r po ssessio n,
ro bbery, po ssessio n o f a deadly w eapo n)*
C rimes, o ther
Death o f a client (natural causes, ho micide, suicide, accidental, lack o f appro priate
treatment, restraint o r seclusio n related, unexplained) inpatient and/o r o utpatient
w ithin 30 days o f discharge*
Deliberate inappro priate use o f restraints*
Falls w ith Harm o r Risk level 2 o r 3
Fights physical altercatio ns betw een 2 o r mo re patients in w hich there is no clear
aggresso r/victim w ith Harm o r Risk level 2 o r 3
Fire Setting
Inappro priate sexual behavio r, children and ado lescents
Injury, accidental/unkno w n o rigin
Medicatio n Erro r in prescribing, dispensing, o r administering a drug
Missing patient (inpatient)
Missing subject o f AOT C o urt Order*
Mistreatment:
Unautho riz ed Restraints o r Seclusio n
Intentio nal impro per Administratio n o f Medicatio n
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NIMRS Serious / Sentinel Adverse Event Category
*Root Cause Analysis (RCA) Required
Misappro priatio n o f patient reso urces
Obstructio n o f repo rts o f repo rtable incidents
Self-abuse no t intended to result in death that results in serio us injury o r harm
Sexual assault (rape o r no n-co nsensual so do my, o ther)*
Sexual co ntact o r activity, child*
Sexual co ntact, adult (no n-co nsensual o r co nsensual)
Suicide Attempt*
Verbal aggressio n by patients
Other Incident (no t listed abo ve, w hich has o r may have an adverse effect o n the
life, health o r w elfare o f the client)
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Attachment C – NYP Reviewable and/or Reportable Events– The U.S.
Food and Drug Administration (FDA):
Hospital’s FDA Medical Device Reporting (MDR) Requirements as per
21 CFR 803, Subpart C—User Facility Reporting Requirements
(a)§803.30: The Hospital must submit reports of death to the manufacturer or to
the FDA, or both, as specified below:
(1)Report of deaths must be submitted to the FDA as soon as practicable but no
more than 10 work days after the day of aware of information, from any source, that
reasonably suggests that a device has or may have caused or contributed to a
patient’s death. The hospital must also submit a Report of death to the device
manufacturer, if known. Reports submitted must include the information required
by §803.32. Reports sent to the Agency must be submitted in accordance with the
requirements of §803.12(b).
(2)Reports of serious injury must be submitted to the manufacturer of the device
no later than 10 work days after the day that you become aware of information, from
any source, that reasonably suggests that a device has or may have caused or
contributed to a serious injury to a patient. If the manufacturer is not known, the
report must be submitted to the FDA. Reports submitted must include the
information required by §803.32. Reports sent to the Agency must be submitted in
accordance with the requirements of §803.12 (b).
(b)Reports submitted must include all information required in this subpart C that is
―reasonably known‖ to the Hospital. The FDA considers ―reasonably known‖
information to include information found in documents possessed by the hospital and
any information that becomes available as a result of reasonable follow up within our
facility/hospital. The hospital is not required to evaluate or investigate the event by
obtaining or evaluating information that is not reasonably know by the hospital.
FDA Medical Device Reporting (MDR) Requirements as per §803.32 regarding
what information must be submit in the hospital’s individual adverse event reports:
Reports must include information reasonably known to the hospital, as described in
§803.30(b). These types of information correspond generally to the elements of Form
FDA 3500A. See below
a) Patient
(1) Patient
(2) Patient
(3) Patient
(4) Patient
information (Form FDA 3500A, Block A). Must submit the following:
name or other identifier;
age at the time of event, or date of birth;
gender; and
weight.
(b) Adverse event or product problem (Form FDA 3500A, Block B). The Hospital
must submit the following:
(1) Identification of adverse event or product problem;
(2) Outcomes attributed to the adverse event (e.g., death or serious injury). An
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outcome is considered a serious injury if it is:
(i) A life-threatening injury or illness;
(ii) A disability resulting in permanent impairment of a body function or permanent
damage to a body structure; or
(iii) An injury or illness that requires intervention to prevent permanent impairment
of a body structure or function;
(3) Date of event;
(4) Date of this report;
(5) Description of event or problem, including a discussion of how the device was
involved, nature of the problem, patient followup or required treatment, and any
environmental conditions that may have influenced the event;
(6) Description of relevant tests, including dates and laboratory data; and
(7) Description of other relevant history, including preexisting medical conditions.
(c) Device information (Form FDA 3500A, Block D). The Hospital must submit the
following:
(1) Brand name;
(2) Product Code, if known, and Common Device Name;
(3) Manufacturer name, city, and state;
(4) Model number, catalog number, serial number, lot number, or other identifying
number; expiration date; and unique device identifier (UDI) that appears on the
device label or on the device package;
(5) Operator of the device (health professional, lay user/patient, other); (6)Date of
device implantation (month, day, year), if applicable;
(7)Date of device explantation (month, day, year), if applicable;
(8) Whether the device is a single-use device that was reprocessed and reused on a
patient (Yes, No)
(9) If the device is a single-use device that was reprocessed and reused on a patient
(yes to paragraph (c)(8) of this section), the name and address of the reprocessor;
(10) Whether the device was available for evaluation and whether the device was
returned to the manufacturer; if so, the date it was returned to the manufacturer;
and
(11) Concomitant medical products and therapy dates. (Do not report products that
were used to treat the event.)
(d) Initial reporter information (Form FDA 3500A, Block E). The hospital reporter
must submit the following:
(1) Name, address, and telephone number of the reporter who initially provided
information to the hospital, or to the manufacturer or distributor;
(2) Whether the initial reporter is a health professional;
(3) Occupation; and
(4) Whether the initial reporter also sent a copy of the report to us, if known.
(e) User facility information (Form FDA 3500A, Block F). The hospital reporter must
submit the following:
(1) An indication that this is a user facility report (by marking the user facility box on
the form);
(2) Our user facility number;
(3) Our Hospitals address;
(4) Our Hospitals contact person;
(5) Our contact person's telephone number;
(6) Date the hospital’s reporter became aware of the event (month, day, year);
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(7) Type of report (initial or followup); if it is a followup, our reporter must include
the report number of the initial report;
(8) Date of the report (month, day, year);
(9) Approximate age of device;
(10) Event problem codes—patient code and device code (refer to the ―MedWatch
Medical Device Reporting Code Instructions‖);
(11) Whether a report was sent to FDA and the date it was sent (month, day, year);
(12) Location where the event occurred;
(13) Whether the report was sent to the manufacturer and the date it was sent
(month, day, year); and
(14) Manufacturer’s name and address, if available.
Hospital’s FDA Medical Device Reporting (MDR) Requirements regarding
what must be included in the facility’s/hospital’s required annual report as per
§803.33.
(a) An annual report must be submitted by the hospital on Form FDA 3419 each year
by January 1. The form can be obtained from the following sources:
(1) On the Internet at:
http://www.fda.go v/downloads /AboutFDA /Repo rtsManualsForms /Forms/UCM080796.pdf
or
(2) From the: Division of International and Consumer Education, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 66, Rm. 4621, Silver Spring, MD 20993-0002,
by email: DICE@fda.hhs.gov, FAX: 301-847-8149, or telephone: 800-638-2041
(b) The hospital’s annual report must be clearly identify as such. The hospital’s
annual report must be submitted to: FDA, CDRH, Medical Device Reporting, P.O.
Box 3002, Rockville, MD 20847-3002. Our annual report must include:
(1) Our hospital’s CMS provider number used for medical device reports, or the
number assigned by the FDA for reporting purposes in accordance with §803.3; (2)
Reporting year;
(3) The hospital’s name and complete address;
(4) Total number of reports attached or summarized;
(5) Date of the annual report and report numbers identifying the range of medical device
reports that you submitted during the report period (e.g., 1234567890-2011-0001
through 1000);
(6) Name, position title, and complete address of the individual designated as our
Hospital’s contact person responsible for FDA reporting and identify whether that
person is a new contact for the hospital; and
(7) Information for each reportable event that occurred during the annual reporting
period including:
(i) Report number;
(ii) Name and address of the device manufacturer;
(iii) Device brand name and common name;
(iv) Product model, catalog, serial, and lot number and unique device identifier (UDI)
that appears on the device label or on the device package;
(v) A brief description of the event reported to the manufacturer and/or the FDA;
and
(vi) Where the report was submitted, i.e., to the manufacturer, importer, or FDA.
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(c) In lieu of submitting the information in paragraph (b)(7) of this section, our
facility/hospital may submit a copy of each medical device report that was submitted
to the manufacturers and/or to the FDA during the repo rting period.
(d) If our facility/hospital did not submit any medical device reports to manufacturers
or the FDA during the time period, the facility/hospital does not need to submit an
annual report.