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The IAC Standards
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4.1A Patient
and employee safety is ensured by written protocols. Written protocols must be
in place for the following:
Comment: As required, there also must be documentation for initial and
recurrent training (such as for HIPAA, OSHA, etc.) as required by local, state
or federal rules.
4.1.1A Patient
Identification Policy
– For all clinical procedures there must be a process that assures
accurate patient identification immediately prior to administration of
radiopharmaceutical, pharmaceuticals
and/or initiating the test.
4.1.1.1A The identification procedure
must reliably identify the individual as the correct person for whom the scan
or therapy is intended and to match the correct scan or therapy to that
individual.
4.1.1.2A Two
independent patient-specific identifiers must be used. Examples of
patient-specific identifiers include the patient’s identification
bracelet, hospital identification card, driver’s license or asking the
patient to state his or her full name or birth date, avoiding procedures in
which the patient can answer “yes” or “no.”
4.1.1.3A When a
test requires the collection and/or administration of blood or blood products,
two independent patient specific identifiers must be used to label the collection
containers.
4.1.1.4A For therapy procedures, immediately
prior to dosing, two members of the medical and/or technical staff must verify
the patient’s identity with two identifiers (see Standard 4.1.1.2A).
4.1.2A Pregnancy
Screening Policy – For
all clinical procedures there must be a process that assures that patients who
could be pregnant are identified. This must be documented and contain the
signature/initials of the patient and/or technologist verifying the
information. This procedure must include an explanation of the proper steps to
be taken if a patient may be or is pregnant. For nuclear medicine therapies or
diagnostic procedures using 131I-sodium iodide, the
pregnancy screening protocol must assure that patients who are pregnant are not
administered the radiopharmaceutical.
4.1.2.1A If a
diagnostic study (e.g., lung perfusion) is needed for a patient who is
pregnant, knowledgeable staff (e.g., Medical Director, authorized user,
consultant physicist or other designee) must discuss the potential risk to the
fetus and document the general content of the discussion.
4.1.2.2A If it is
determined that the study will not be performed, then the patient must receive
options for alternative care.
4.1.2.3A There
must be a protocol for determining fetal dose (intended or unintended) and
providing this information to the patient after radiopharmaceutical
administration to a pregnant patient.
4.1.2.4A There
must be a protocol for reporting any unintended radiation exposure greater than
5 rem to an embryo/fetus or nursing child, if this is possible based on type
and amounts of radioactivity being administered.
4.1.2.5A Warning signage must be present to help
prevent inadvertent administration of radiopharmaceuticals to patients who are
pregnant. At a minimum, these must be easily seen by the patient (and in
language(s) understandable to most patients) in the area(s) where initial
radiopharmaceutical administration is performed.
4.1.3A Breast-feeding
Screening Policy – For
all clinical procedures there must be a process that assures that patients who
are breast-feeding are identified. This must be documented and must contain the
signature/initials of the patient and/or technologist verifying the
information. This procedure must include an explanation of the proper steps to
be taken if a patient is breast-feeding. To enable mothers to receive needed
medical care and yet minimize the disruption of breast-feeding, appropriate
guidelines must be available so that breast-feeding may be discontinued and,
whenever possible, resumed as soon as safe for the child being breast-fed. The
staff (Medical Director, RSO, authorized user, medical physicist or other
appropriate designated staff) must be able to instruct the patient regarding
timing of pumping breast milk rather than breast-feeding and appropriate discard
versus storage/use of pumped breast milk.
4.1.3.1A For
nuclear medicine therapies or diagnostic procedures using
131I-sodium iodide, the breast-feeding screening protocol must assure that any
patient who is breast-feeding is not administered the radiopharmaceutical. A
patient who is breast-feeding must also be given the opportunity to stop
lactating for an appropriate time (usually at least three weeks) prior to
receiving 131I therapy to reduce the radiation to the breasts.
4.1.3.2A Warning
signage must be present to help prevent inadvertent administration of
radiopharmaceuticals to patients who are breast-feeding. At a minimum, these
must be easily seen by the patient (and in a language understandable to most
patients) in the area where initial radiopharmaceutical administration is
performed.
4.1.4A Informed
Consent Policy – When
required by local policy or state/federal statutes/regulations, informed
consent must be obtained from the patient or guardian for nuclear medicine
procedures. There must be informed consent for therapeutic procedures.
4.1.5A Request
for Services Policy –
There must be a written policy for requesting clinical nuclear medicine
procedures. Documentation of a request, including the identity of the patient,
the referring health care provider and clinical information that indicates the
rationale for the procedure, must be present prior to performing any procedure.
4.1.6A Infection
Control/Communicable Diseases Policy – There must be a policy to ensure appropriate precautions to
protect both patients and facility personnel are taken, in accordance with
universal precautions, when handling toxic, biologic materials (i.e., used
syringes, needles, blood and/or body fluid, etc.) or when in contact with
communicable diseases. This includes policies/procedures regarding decreasing
the probability of needle stick of staff and what to do if a worker is
punctured by a used needle.
4.1.7A Hazardous
Materials Policy – There
must be a policy to ensure appropriate precautions to be taken when using and
storing flammable and/or toxic materials.
4.1.8A Medical
Emergencies Policy –
There must be written plan for
responding to patient medical emergencies, which includes an outline of staff
responsibilities. Each staff member must be familiar with his/her role in the
plan. The plan should be appropriate for the risks of the procedures performed
by the facility.
4.1.9A Handling
of Non-Radioactive Pharmaceuticals Policy
4.1.9.1A Pharmaceuticals
must be properly stored. Controlled substances kept on-site (e.g., such as in a
crash cart) must be secured to limit access only to authorized personnel.
4.1.9.2A Pharmaceuticals
must be properly prepared.
4.1.9.3A Patient dosages must be determined
using standardized protocols (approved by the Medical Director or appropriate
designee [see Standard 2.3.4.1B]) or by individually written prescriptions. For
each patient dose, the prescribing physician must be clearly identifiable.
4.1.9.4A Patient
identity must be verified prior to pharmaceutical administration (see Standard
4.1.1.1A).
4.1.9.5A The
identity and dosage of each pharmaceutical must be verified immediately prior
to administration by the prescribed route.
4.1.9.6A The
expiration date of the pharmaceutical must be checked and the dosage
administered prior to the expiration.
4.1.9.7A There
must be clear documentation of the administration of pharmaceuticals
(substance, amount, route, site, time and identity of person administering).
4.1.10A Drug
Administration Errors Policy
– Records of medication (non-radioactive) administration errors must be
maintained. Events must be reported as required. Documentation of actions taken
in response to identified problems must be available.
4.1.11A Adverse
Drug Reactions Policy – There must be a procedure for
documenting and reporting adverse reactions (e.g., unexpected, unintended, undesired or excessive
response) to medications.
(See Guidelines below for further
recommendations.)
4.2A There
must be written radiation safety and radioactive materials handling protocols.
4.2.1A The Radiation Protection Program
content and implementation must be reviewed at least annually.
4.2.1.1A The annual review must include protocol
evaluation to minimize the effective radiation dose while producing interpretable,
diagnostic quality images.
4.2.1.2A Records of this review must include
program changes, noted deficiencies and actions taken (or a statement that none
is needed). This must be signed/initialed and dated by the Medical Director or
an appropriate designee.
Comment: Records must also include justification of any administered
radiopharmaceutical dose exceeding standard protocol for adults.
4.2.2A There
must be written designation of a Radiation Safety Officer. This is generally
found on the radioactive materials license.
4.2.3A Designation
of who may handle/administer radionuclides (i.e., list of authorized user
physicians, nuclear medicine technologists, trained nurses and/or others who
are properly trained and approved, as appropriate).
4.3A Facility
operations must comply with accepted federal, state and local radiation safety
standards for medical diagnostic and/or therapeutic use of radioisotopes. The
facility must retain copies of any facility inspections/surveys as well as
evidence of correction of any deficiencies found.
4.4A Radiation
safety protocols must address the following topics:
4.4.1A General
Radioactive Materials Handling and Radiation Safety (i.e., Safe Use and Handling of Radioactive
Materials)
4.4.1.1A Provision
for a safe working environment, including an ALARA (as low as reasonably
achievable) radiation exposure policy (for workers and general public).
4.4.1.2A The use
of signage for radioactive materials use and storage areas, as required by
applicable regulations.
4.4.1.3A Monitoring
and reporting of excessive radiation levels to the general public. Including
method of monitoring, method of calculation, trigger levels and reporting
requirements.
4.4.1.4A Radiation
safety instruction upon hire and annually thereafter for all personnel in the
facility who are handling or are potentially exposed to, radioactive materials,
including all authorized users. Records of this training must be retained.
Comment: Individuals who become authorized users during their tenure on
staff must receive initial and annual training.
4.4.1.5A Monitoring
of all staff for radiation exposure as required by federal or state guidelines.
This includes the use of hand monitoring (“ring badge”) of those
directly handling radiopharmaceuticals.
i. Personnel
dosimeters that require processing must be processed by a National Voluntary Laboratory
Accreditation Program (NVLAP)-approved and accredited dosimetry
processor.
ii. Employees
who are monitored must be advised of their dose annually if their occupational dose exceeds
one millisievert (100 millirem) TEDE or one millisievert to any organ or tissue.
iii. Exposure
records must be easily retrievable and made available to the employee.
iv. Results
of personnel monitoring must be reviewed periodically to assure that exposures
are as low as reasonably achievable.
· This must be documented (such as by signature/initials
and date by the responsible reviewer) and any excess exposures reported as
appropriate.
· Additionally,
results of personnel monitoring must also reflect appropriate use of monitoring
device (e.g., for a technologist who is preparing radiopharmaceuticals for use,
their ring badge exposure result should not routinely be background level).
4.4.1.6A Information
for employees, who are or may become pregnant, regarding their responsibility
to voluntarily declare the pregnancy to management and the facility’s
plan for addressing the employee's radiation safety needs.
4.4.1.7A Proper
use of shielding, radiation protection devices (e.g., syringe shields, glass
shields, etc.) and protective clothing (e.g., facility coats) as well as
refraining from eating or drinking in radiation use areas.
4.4.1.8A Each
syringe and vial that contains a radiopharmaceutical must be labeled to
identify the radionuclide and quantity of radioactivity at a specified date and
time. Each syringe shield and vial shield must also be labeled unless the label
on the syringe or vial is visible when shielded.
4.4.1.9A Spill
confinement/decontamination procedures include guidelines posted in the
facility (with the radiation safety officer’s phone number for work and
after hours contact) and documentation requirements for reporting
spills/decontamination. The procedures must include instructions for the
reporting, documentation and possible investigation of all spills.
4.4.1.10A Proper
use of radiation monitoring devices.
4.4.1.11A Periodic
area surveys (particularly dose preparation areas) and wipe tests including
tolerance limits and response to trigger levels.
Comment: For facilities performing only routine diagnostic nuclear cardiology,
unless there is a more stringent state or local requirement, area surveys and
wipe tests may be performed weekly or even less frequently if site experience
shows that the extended interval is appropriate based on historical data at the
site. Alternatively, at facilities where there is a greater risk of
contamination (e.g., training sites), more frequent monitoring may be
appropriate. The facility protocol must document the chosen frequency.
i. For
sites performing nuclear medicine procedures requiring a written directive
(therapies or procedures using dosages greater than 30 microcuries of
131I-sodium iodide), area surveys must be performed daily in areas of dosage
preparation and administration.
4.4.1.12A Sealed
source inventory and wipe/leak testing protocol and documentation including:
i. frequency;
ii. radionuclide
identity;
iii. model
and serial number, if assigned;
iv. activity,
date and name of the person performing the inventory;
v. wipe/leak
test.
· The
location of the source at the time of the inventory and the results of the
wipe/leak test must be documented.
· The
frequency of the sealed source wipe/leak test is a minimum of every six months.
4.4.1.13A Protocol
for reporting theft or loss of radioactive materials based on types and amounts
of materials and the risk to the public. This should include instruction for
notification of the proper agencies or individuals as well as the information
to be reported.
4.4.1.14A Procedure
for monitoring radiation exposure for visitors to radiation use areas, if
needed based on the potential exposure (this is generally not needed if
performing only routine diagnostic procedures).
4.4.1.15A As
needed, instruction of patients, family members and hospital staff (e.g.,
nursing personnel) regarding radiation precautions for all therapeutic
procedures and/or when appropriate for diagnostic procedures.
4.4.1.16A Protocols establishing, defining and explaining specific
procedures for following and adhering to the “written directive”
policy for all personnel involved in administration of nuclear medicine
therapies or diagnostic dosages of 131I-sodium iodide greater than 30
microcuries. When protocols regarding written directives are not followed, the
cause of the deviation and the actions to prevent recurrence must be
identified.
4.4.2A Receipt
of Radioactive Materials
4.4.2.1A designation
of a specific secured area for placing shipments of radionuclides;
4.4.2.2A recording
of receipt of all shipments of radionuclides;
4.4.2.3A survey
of shipments of radionuclides, prior to opening, including tolerance limits and
response to triggers (including proper notification if damage or leak).
4.4.3A All
facilities compounding radiopharmaceuticals must be aware of and in compliance
with the guidelines of the United States Pharmacopeia (USP) Chapter 797.
4.4.4A Preparation
of Radiopharmaceuticals (as applicable)
Comment: If only unit doses are used, no protocols are needed since this is
done by supplier.
4.4.4.1A assay of
generator eluate for total activity;
4.4.4.2A assay of
generator eluate for breakthrough of parent radionuclide;
4.4.4.3A preparation
of radiopharmaceuticals according to product insert or other written protocol;
4.4.4.4A verification
of radiochemical purity of radiopharmaceuticals;
4.4.4.5A documentation
of lot or batch numbers of components used in radiopharmaceutical preparation;
4.4.4.6A verification
of pH of radiopharmaceutical preparations when appropriate;
4.4.4.7A performance
of sterility testing on radiopharmaceuticals prepared using non-commercial
kits;
4.4.4.8A performance
of endotoxin testing on radiopharmaceuticals prepared using non-commercial
kits;
4.4.4.9A proper
storage of kits and prepared radiopharmaceuticals.
4.4.5A Administration
of Radiopharmaceuticals to Patients
4.4.5.1A Patient
dosages must be determined using standardized protocols (approved by the
Medical Director or an appropriate designee [see Standard 2.4.1.3B) or by
individually written prescriptions. For each patient dose, the prescribing
physician must be an authorized user for the specific radioisotope and amount.
i. Administered radiopharmaceuticals must
use the lowest radiation dose necessary to acquire a diagnostic quality image.
ii. The
system for adjusting radiopharmaceutical dosages by weight or appropriate
adjustment in imaging acquisition parameters to compensate for
patient size/weight must be documented. If adjusting
radiopharmaceutical dosages, this must be signed by the Medical Director or a
designated authorized user. An
onsite dose calibrator may be helpful for dose adjustment based on the
patient’s weight.
iii. There
must be individual determination of doses for pediatric patients prior to
administration. These must be signed by the Medical Director or other
authorized user (as a protocol or individual dosages).
4.4.5.2A Assay of
patient dosages of radiopharmaceuticals (using a dose calibrator) on-site prior
to administration.
i. Alternatively,
for sites using unit doses, where permitted, the dosages may be determined
based on decay correction of the unit dose.
ii. For
sites using other than unit doses, the dosages being administered may be
determined using a combination of measurement and mathematical calculations or
a combination of volumetric measurements and mathematical calculations based on
measurements done by an appropriate preparer (radiopharmacy/supplier).
4.4.5.3A Recording
of specific patient dosages (as determined by methods noted in Standard 4.4.5.1A)
prior to administration.
4.4.5.4A Verification
of patient identity prior to radiopharmaceutical administration as well as
pregnancy/breast-feeding status, as described in Standard 4.1.3A.
4.4.5.5A Verification
of the radiopharmaceutical identity and dosage immediately prior to
administration by the prescribed route.
4.4.5.6A Verification
of the expiration date/time of the radiopharmaceutical and assurance it is
administered prior to expiration.
4.4.5.7A Clear
documentation of the administration of radiopharmaceuticals (substance, amount,
route, site, date, time, identity of person administering).
4.4.6A Records of radioactive materials
administration errors must be maintained for both reportable and non-reportable
errors. Events must be reported as required. Actions taken in response to
identified problems must be available.
4.4.7A Adverse Radiopharmaceutical Reactions
– There must be a procedure for documentation and reporting adverse
reactions (e.g., unexpected, unintended, undesired or excessive response) to
radiopharmaceuticals.
4.5A Radioactive
Materials Storage and Disposal
4.5.1.1A Radioactive
trash (wipes, syringes, alcohol swabs, etc.) is kept separate from normal
trash, stored and appropriately discarded.
4.5.1.2A Security
(e.g., locking) of areas containing radioactive materials (including hot laboratory,
other radioactive use and storage/decay areas) when not under direct supervision
of clinic personnel must ensure that non-authorized personnel (including
visitors, patients and non-authorized staff) cannot access any radioactive
materials.
4.5.1.3A Adequate
shielding of radioactive materials storage areas based on the types and amounts
of radionuclides as well as the types of use of surrounding areas.
4.1A Written
protocols should be in place for the following:
Safety/Security
for Staff and Patients – There should be a written procedure for
responding to disasters or other threats to staff or patient safety/security.
This includes when staff may be present after normal facility hours.
Special Needs Patient Care – Personnel should be trained to deal with
patients with language barriers, physical disabilities, serious illness or
those unable to cooperate.
Sample documents
for policies and protocols listed in Section 4A are available on the IAC website at www.intersocietal.org/helpful-resources/sample-documents-repository.