Regulatory compliance Flashcards
Everything that has to do with tissue is regulated by who?
American Association of tissue banks (AATB)
What 3 organizations work together to provide oversight and standards for surgical tissue banking?
- American Association of Tissue Banks (AATB)
- Joint Commission (JC)
- Food and Drug Administration (FDA)
Autologous tissue should be separated from what?
allografts
Why do autologous tissue and allograft tissue need to be separated?
because autologous tissue does not go through infection testing like allografts
What needs to be on the packages of tissues?
expiration time of tissue
How are surgical tissues stored?
refrigerator and freezer
What are important notes for refrigerator and freezer for surgical tissue?
they should have limited access and temperature monitoring with an alarm
Records for surgical tissue banking has to be kept for how long?
10 years
What is kept on record for a tissue?
- consent
- donor assessment
- procurement processing
- preservation labeling and storage
- quarantining
- testing, releasing and distribution
- quality control
What is the uniform anatomical gift act of 1968?
this is what put paramaters around what is a suitable donor
What are the guidelines for suitability of a donor? (10 things)
- free from infection
- free from autoimmune disease
- neurological disease
- bone disease
- systemic medication use (chemo) - has changed a little, some are using it now
- exposure to toxic substances - has changed a little, some are using it now
- patient cannot have been ventilator dependent or immobile form more than 7 days prior to brain death
- normothermic for the week prior to brain death
- exclude patients at high risk for blood borne pathogens - no exclusion of lifestyle now
- state registries - up to state law what you can do
What happens if we drop tissue on the floor?
soak in providone-iodine, antibiotic solution or both
Steam of sterilization of bone is not what?
recommended
Why can we not steam sterilize bone?
the body will just absorb it because it softens the bone, it becomes like swiss cheese
What happens if you choose to discard tissue?
you can’t discard human tissue and get more human tissue, so you have to go to a more synthetic option
If we have any type of contamination, what needs to happen?
always report to infection prevention personnel
If you plan to not use autologous tissue, what do you need to do?
pass tissue off the field immediately. Processed and stored by tissue bank immediately. We don’t want it to dry out during procedure
If we pass off autologous tissue and process it, what does the nurse need to confirm?
- confirm patient’s identity using two unique identifiers
- originating source of tissue including laterality if applicable
- type of tissue
- diagnosis and any pertinent clinical info
when we talk about regular specimens during surgery, what is expected?
ACCURACY.
What two things mean a correct diagnosis with specimens?
correct patient name and correct specimen name
Who do we want to confirm specimens with? when?
surgeon during debriefing
What is important for multiple specimens and scrub techs?
they can label multiple specimens on sterile field
For legal evidence or specimens that are going to be part of legal case, what are 3 important factors?
- chain of custody
- prevent alteration
- prevent decomposition
For the exam, where do we put legal evidence specimens?
into a dry plastic specimen container
What can you not use to retrieve a bullet?
metal instruments to retrieve
What do you use to retrieve bullets? Where do you put it?
a piece of gauze. Plastic basin
Once a specimen (like a bullet) is taken out, what should happen with that specimen? Second step?
Keep it on your persons or in your pocket. Document “kept on person at all times” and name of officer you handed it to
What does pathology examine?
examines pieces of tissue. Fresh, frozen, and preserved
What does cytology examine?
examines cell types of fluid
What kind of container does cytology specimen go into?
dry plastic container
What does microbiology examine?
examines for microbial growth
What 3 types of specimens go in a dry container?
- fresh
- frozen
- cytology
What type of specimens go into a preservative?
- preserved
- permanent
What type of specimens go into a culture medium?
microbiology
For product selection, what has to be in place?
a mechanism for product and medical device standardization and evaluation
What are the 3 things we are looking at when making a product selection? (from most to less important)
- select function and reliable products.
- safe, cost effective, environmentally conscious.
- avoid duplication and fads.
What are fads?
we want the new thing
Product and medical device evaluation is based on what?
criteria specific to the item’s use
What are 3 things we evaluate a product and medical device
- safety, ease of use, compatibility with other products
- impact on quality patient care
- cost, can we sterilize it, environmental impact
We don’t buy things to what?
to trial them - we trial them before we buy
A clinical evaluation should be based on what?
based on an identified need or opportunity
What 4 things are we remembering when we are doing a clinical evaluation based on an identified need or opportunity?
- don’t waste time or money in a clinical trial
- all departments affected should participate in trial - need to have time and scope to get info to all those people.
- trial should have time and scope parameters
- education and instruction before trial
Personnel selecting ESU and accessories do what 2 things?
- make decisions based on safety features
- minimize risks to patients
If you are going to trial a product, what has to happen first?
education and instruction have to happen before a trial. (in-service).
What injures patients the most in the OR?
ESU
What is the nursing process:
- assessment
- nursing diagnosis
- identification of outcomes
- planning
- implementation
- evaluation
What is the purpose of assessment?
- to formulate nursing diagnosis
- collection of data
What is the purpose of nursing diagnosis?
to identify and classify data collected in the assessment
What is the body that gives us approved nursing diagnoses?
NANDA
What kind of response is nursing diagnosis?
a human response to a medical diagnosis
What is a medical diagnosis
pathophysiology?
What is the difference between medical diagnosis and nursing diagnosis
nursing diagnosis is a human response to a medical diagnosis, and medical diagnosis is pathophysiology
What 2 things can a nursing diagnosis be?
actual or potential
Nursing treatment has to be what?
has to be capable of correcting the issue independent of a physician’s order
What are things that are in the preoperative patient assessment?
- baseline vital signs
- medical history
- medications
- mobility
- communication barriers
- diagnostic results
- allergies
- NPO status
- detrimental behavior
- educational needs
- diversity/cultural considerations
What is the PNDS?
perioperative nursing data sets
What is the purpose of outcome?
to describe the desired condition achievable through nursing care
What is outcome also known as?
goal
Identification of outcomes and planning are both written in what?
future tense
Who is always the subject in identification of outcomes?
the patient
Identification of outcomes is also criteria by which what?
nursing interventions are measured
What is the purpose of planning?
to select interventions to meet desired outcome
Who is the subject in planning?
not always the patient. Could be i.e. forced air warmer applied to patient. or i.e. gathering supplies (patient is not in front of you)
When planning, it is what?
individualized plan of care
What are 3 parts of the individualized plan of care?
- write client goals
- select interventions
- communicate plan to patient and family - interdisciplinary team - change of shift
What is the purpose of implementation?
to carry out the plan of care
What is the tense of planning? who is the subject?
- future
- patient is not always the subject. Like gathering supplies, so the patient is not always in front.
Implementation happens with who? who is the main subject tho?
Nurse is doing and patient is right in front. so… nurse
What 4 things should implementation do?
- promote wellness
- prevent disease
- restore health
- cope with altered functions
What is the purpose of evaluation?
to identify if goal was met
What is the purpose of evaluation?
to identify if goal was met
What are the 3 questions we ask when evaluating?
- was the goal met or not met
- what factors were met or not met
- modify plan of care accordingly
What is the key word in evaluation?
MODIFY
What is tense of evaluation?
past
What is subject of evaluation?
patient
