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POLICY: |
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1. The
term Health Care Industry (HCI) representative refers to all health
care industry employees who provide services in operative / invasive
procedure settings (eg, clinical consultants, sales representatives,
technicians, and repair / maintenance personnel). |
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2. HCI
representatives may be present during procedures under the
conditions prescribed in this protocol and in compliance with
accreditation requirements; local, state, and federal regulations;
and UCHC infection control, patient privacy, and department- or
unit-specific standards. |
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3. The
role of the HCI representative is to provide essential technical
training and assistance related to the product, equipment, device or
technology for the safe care of the patient. The HCI representative
is not considered part of the clinical team and should not be
requested to perform tasks outside his / her approved role. |
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4. HCI
representatives must obtain specific authorization from nursing
management or their designee’ and the attending surgeon / physician
each time the operative / invasive procedure setting is entered.
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5.
Authorization to enter the operative / invasive procedure setting
shall be specific to the product, equipment, device or technology
that the HCI representative will be using, discussing or
demonstrating in the operative / invasive procedure setting and will
ideally be obtained at least 24 hours prior to scheduled cases. |
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6. The
surgeon / physician or his/her designee’ must inform the patient or
his/her legal agent (conservator, guardian, health care agent or
next of kin) about the presence of any HCI representative during the
procedure and consent will be documented on the Authorization for
Medical-Surgical Procedure form HCH-127. Whenever possible, the
consent should note the name of the HCI representative who will be
present during the procedure. |
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7. If a
life-threatening emergency occurs, it will be considered a
legitimate exception to the usual consent process. It is
“reasonable” that the patient would consent to the presence of an
HCI representative if it would increase the likelihood of a positive
outcome. The surgeon / physician must make a note in the medical
record and inform the family of the HCI representative’s presence as
soon as possible after the procedure. |
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8. HCI
representatives must check in with Materials Management during
regular weekday hours prior to entering the operative / invasive
procedure setting. Materials Management staff will clear the HCI
representative for admission to the unit and provide an approved
photo ID pass for the representative to wear at all times and that
will include:
a. name and company of the HCI representative;
b. time and location of appointment;
c. UCHC contact for the appointment;
d. completion of basic educational requirements documented and on
file.
During non-weekday hours, permission will be obtained from nursing
management or their designee’ and the HCI representative will wear
identification. The HCI representative will register on the unit and
staff will obtain contact information (eg, business card) for
Materials Management follow-up. |
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9.
After being cleared by Materials Management, the HCI representative
will present their ID pass and register on the unit prior to
entering any patient care area. If they will be working in a
semi-restricted or restricted area, they will don scrub attire
provided by the hospital, ideally colored to promote identification
of their role, and will wear appropriate personal protective
apparel. |
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10. Any
product, equipment, device or technology used in the operative /
invasive procedure setting must be approved and / or prepared for
use prior to the procedure:
a. Clinical Engineering (CE) staff will inspect and approve any
equipment or device not owned by the hospital prior to use; after
hours, the operative / invasive procedure team either should
determine if use of the item can wait until CE can inspect and
approve it or they can be responsible for a visual check and permit
patient use of the item. If CE is not available and the item is
used, they will be notified of the item’s use;
b. Instrument Room or OR staff will sterilize instrumentation or
other items on site prior to use in the operative setting, as
necessary. (HCI representatives will ensure that any necessary
decontamination is performed before / after procedures.) |
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11. The
nursing staff should be informed before the procedure that an HCI
representative will be present during a specific procedure as well
as the purpose for being in attendance. Notification of staff will
be done by nursing management or their designee’. |
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12. The
RN is responsible for monitoring patient safety, privacy, dignity,
and confidentiality. HCI representatives will not be allowed into
patient care areas until prepping and draping has been completed. RN
monitoring may include restriction of the movement and number of
people in the operative / invasive procedure location to prevent
airborne contamination. |
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13. The
RN will document in the medical record the name and role / title of
the HCI representative present during the procedure. |
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14. The
RN will monitor the HCI representative’s activities whenever
possible and will facilitate their service to the patient and
operative / invasive procedure team. Further, the HCI representative
will only perform activities that facilitate use of the products,
equipment, devices, or technology for which s/he has been authorized
to enter the OR. Under no circumstances will the HCI representative
scrub and assist in operative procedures; however, the HCI
representative with specialized training and facility approval may
perform calibration to adjust devices to the surgeon / physician’s
specification (eg, pacemakers and lasers). |
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15.
Patient education materials will be provided as they are available
from the manufacturer and patient care indicates. |
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16. HCI
representatives will provide education and training about products,
equipment, devices, or technology prior to bringing them to the
operative / invasive procedure setting whenever possible and as
requested by the nurse manager, the attending surgeon / physician,
the CNS or their designee’. If education and training cannot occur
prior to the procedure, the sales representative will provide
one-on-one training, 24-hour assistance through their employer, and
/or operate the item, as appropriate. |
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17.
Materials Management will maintain documentation that the HCI
representative has completed instruction in the principles of
asepsis, fire and safety protocols, infection control practices,
bloodborne pathogens and patients’ rights. The representative must
be aware of and follow federal regulations and OSHA Bloodborne
Pathogens Standard and any UCHC requirements related to them.
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18.
Experienced HCI representatives who are accompanied by persons in
training from their own organizations for the purposes of
orientation will make arrangements with Materials Management and
will comply with any accreditation requirements and local, state,
and federal regulations. |
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19.
Trials of products, equipment, devices, or technology that require
the presence of an HCI representative will comply with established
Materials Management and Department of Nursing standards. |
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20. Any
departure from established policy will be addressed immediately:
a. nursing management or their designee’ will be notified;
b. Materials Management will be notified;
c. if patient harm results, the RN will complete a Risk
Identification Report;
d. non-compliance with any policy statements will result in UCHC
assuming no responsibility for payment of products used, lost, or
damaged, and may lead to possible vendor restrictions at the
facility. |
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21.
Failure to observe the policy statements contained within this
protocol will be considered willful disregard and will result in the
following actions:
a. Nursing or Materials Management Staff:
disciplinary action, as deemed appropriate by management;
b. Physicians:
reporting to Chief of Service for disciplinary action;
c. HCI Representatives (nature of offense may affect action
taken, but in general:
1st offense: counsel with specific offender, along
with formal written warning;
2nd offense” access to UCHC restricted with a letter
sent to his / her division manager;
3rd offense: letter sent to the HCI representative
and his / her division manager, resulting in banning of the
representative from business with UCHC. Review of current
business between company and UCHC will be evaluated to determine
further actions with the company. |
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APPROVAL: |
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OR
Committee
Nursing
Standards Committee
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EFFECTIVE
DATE: |
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6/00
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REVISION
DATE: |
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11/03,
9/06 |