Background
Close to 40% of wrong
surgeries/procedures reported under
the Minnesota Adverse Event
Reporting
Law last year (October 7, 2010-October 6, 2011) were related
to wrong implants.
Review of reported
wrong procedure events involving implants
indicated issues with verification of the correct implant at each step of
the process including:
- Scheduling
- Requesting the implant(s)
- Pulling the implant(s) prior to case
- Team Briefing
- Pre-procedure verification
- Time
Out
- Selecting implant(s) from case cart
In January of 2007, a Minnesota Safety Alert was
issued related to preventing wrong eye/wrong lens procedures: http://www.mnhospitals.org/inc/data/pdfs/Alert_Advisory_1-9-07.pdf.
The Minnesota
Department of Health and Minnesota Hospital
Association have reviewed: 1) the root cause analyses from wrong procedure
events occurring this past year involving implants;
and 2) national and local best practices to
develop a set of recommendations
for implant verification. The
recommendations include
verifications steps for:
1. Intraocular implants (IOL)
2. Other implants
— when implant is known prior to the
case
3. Other implants
— when implant is not known prior to the case, e.g. hip or knee
replacements.
The resulting
recommendations are outlined
beginning on page two of this safety alert.
Implant Verification Recommendations
These recommendations are intended to provide guidance
to improve the consistency of implant verification practices
across Minnesota hospitals and ambulatory surgical centers
and address issues identified through the reporting of wrong procedures related to incorrect
implants. The recommendations are not intended to address all implant related clinical
and regulatory requirements.
Implants — Intraocular lens (IOL)
Verification of correct intraocular lens placement (IOL)
-
The facility
has a process in place to require
ordering providers
to submit IOL requests in writing.
- IOL requests must be received
prior to case prep, at minimum,
for the case to proceed.
- IOL requests include, at a minimum,
the following key IOL information:
- Date of surgery
- Patient
- Surgeon
- Right vs. Left
- Posterior vs. anterior
- Model #
- Diopter
- If the facility does not receive
a written IOL request prior to case prep (ideally received
earlier in the process) with completed key IOL information, the case does not move forward.
- If the surgeon selects the IOL for the case from the supply
area, the written
request including the key IOL information still
needs to be completed
by the surgeon prior to case
prep.
-
A process is in place to verify
the correct lens at the following times, at minimum:
- Selection of IOL implants
for case from supply area
- Verification: Verify correct
lens against source documents such as the
implant request form,
patient’s medical record,
surgical notes.
- Pre-operative team briefing
- Verification: Verify implant is available for case.
- Time Out process
- Verification: Verify implant is available in the room for case.
- Opening the implant
to the sterile field.
- Verification: 1) confirm
the implant packaging against source
documents,
such as the implant request
form; 2) read aloud the implant
information
from the packaging; and 3) show the packaging information to the
surgeon.
-
The source documents, such as the implant request
form, and selected
implant are kept together after selection of the IOL for the case.
- The facility requires that only one lens (per operative eye) per case is in the procedure room. If the surgeon
requests more than one option, as soon as a decision is made on the
correct lens for the case, the second
lens is placed out of sight in a pre-designated
area.
Implants — If implant is known prior to procedure (non-IOL procedures)
-
The facility
has a process in place to require
ordering providers
to submit implant requests in writing.
- Implant requests include,
at a minimum, the following key information:
- Date of surgery
- Patient
o Surgeon
- Implant and specifications the facility will need to order or pull the implant for the
case
- Right vs. Left, if applicable
- For breast implants: Saline
vs. Silicone
-
If the facility
does not receive
a written implant
request prior to case prep (ideally
received earlier in the process) with completed key information, the case does not move
forward.
- A process is in place to verify
the correct implant
at the following times,
at minimum:
o
- Selection of implants for case from supply area, if applicable
§
- Verification: Verify correct
implant against
source documents such as the
implant request form,
patient’s medical record,
surgical notes.
o
- Pre-operative team briefing
§
- Verification: Verify implant is available for case.
o
- Time Out process
§
- Verification: Verify implant is available in room for case.
o
- Opening the implant
to the sterile field.
§
- Verification: 1) confirm
the implant packaging against source
documents,
such as the implant request
form; 2) read aloud the implant
information from the packaging, including laterality if applicable; and 3) show the packaging information to the surgeon.
-
The facility
requires that only the implant needed
for the case is in the procedure room. If
the surgeon requests more than one option,
as soon as a decision is made on the
correct implant
for the case,
additional implants
are placed out of sight in a pre-
designated area.
- The facility has developed an orientation for vendors
involved in selecting implants for
procedures which includes expectations for the vendor’s
role in implant
verification.
- The facility requires that vendors complete
orientation prior to handling
implants prior to,
or during, a case.
- If a vendor selects
the implant for the case,
the implant is handed off to a member of the procedure team who completes verification of the implant against
source documents.
- The vendor does not introduce the implant to the sterile
field.
Implants — If correct implant is not known prior to
procedure (e.g., need to trial multiple knee components during procedure prior to final implant
selection):
- The facility has a process in place to require
ordering providers
to submit implant requests in writing.
- Implant requests include,
at a minimum, the following key information:
- Date of surgery
- Patient
- Surgeon
o Right vs. Left, if applicable
- Which implant options to have available
-
If the facility
does not receive
a written implant
request prior to case prep (ideally
received earlier in the process) with completed key information, the case does not move
forward.
- A process is in place to verify
the correct implant
at the following times,
at minimum:
- Selection of implants for case from supply area, if applicable
- Verification: Verify correct
implant against
source documents such as the
implant request form,
patient’s medical record,
surgical notes.
- Pre-operative team briefing
- Verification: Verify implant is available for case.
- Time Out process
- Verification: Verify implant is available in room for case.
- Selection of implant
from case cart,
if applicable
- Verification: Verify correct
implant against
source documents such as the
implant request form.
- Opening the implant
to the sterile field.
- Verification: 1) confirm
the implant packaging against source
documents,
such as the implant request
form; 2) read aloud the implant
information from the packaging, including laterality if applicable; and 3) show the packaging information to the surgeon.
-
If cart is in procedure room with multiple implants, ideally only the cart with the correct
side implants (L vs. R) is in the room. If carts are not able to be separated
(L vs. R) due to storage
or other issues, left and right components are clearly separated and labeled
on the cart.
- The facility has developed an orientation for vendors
involved in selecting implants for
procedures which includes expectations for the vendor’s
role in implant
verification.
- The facility requires that vendors complete
orientation prior to handling
implants prior to,
or during, a case.
- If a vendor selects the implant for the case,
the implant is handed off to a member of the procedure team who completes verification of the implant against
source documents.
- The vendor does not introduce the implant to the sterile
field.