Term
What is acronym stand for
LASIK?
PRK?
RK? |
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Definition
Laser Insitu Keratomileus
Photorefractive Keratectomy
Radial Keratotomy
Intacs: iintracroneal ring for keratoconus |
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Term
| Meaning of Sepsis Syndrome? |
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Definition
TWO of these:
<96 F or >101F
>90bpm or <20bpm heart
infection site w/ organ not perfusd or alterd cerebral fx
hypoxemia (PaO2<75)
lactate increased or urine decreased
pathogenic microorganisms in tissue or blood
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Term
Meaning of SIRS?
As word and as symptoms |
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Definition
Systemic Inflammatory Response Syndrome
2 of:
<96.8 or >100.4
>90bpm heart
>20 breathes per min
WBC <4k or >12k |
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Term
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Definition
| cartilage like plate within the eyelids that harbors the meibomian glands and gives structural support to the lid |
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Term
| What do the oblique muscles function in doing? |
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Definition
Superior: down and lateral
Inferior: upward and lateral |
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Term
Acronyms:
AATB
AOPO
AST
ASTS
CFR
DRAI
FDA
HCT/P
OPTN
RCDAD
SOP |
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Definition
Amer Assoc of Tissue Banks
Assoc of Organ Procurement Organizations
American Soc of Transplantation
Amer Society of Transplant Surgeons
Code of Federal Regulations
Donor Risk Assessment Interview
Food and Drug Administration
Human Cell, Tissue, and Cellular and Tissue Bank Prod.
Organ Procurement & Transplantation Network
Relevant Communicable Disease Agent and Disease
Standard Operating Procedures |
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Term
| When is Amyloidosis a R/O? |
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Definition
| If associated with Multiple Myeloma |
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Term
What is steam sterilzation parameters?
How often manual need to be reviewed? |
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Definition
121 C ( 250 F) for 30 min
Manual to be reviewed yearly |
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Term
What is Tenon's Capsule?
Where and what purpose is RPE? |
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Definition
Tenon's capsule is what wraps sclera and separates orbital fat from eye but has lymph flowing between it and sclera
RPE is between choroid and retina and absorbs scattered light, Vit A metabolism, and phagocytosis of cones/rods. This deteriorates in AMD |
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Term
| What is a quality program? |
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Definition
An organization's comprehensive system for manufacturing and tracking HCT/Ps in accordance to FDA guidelines. It is designed prevent, detecy, and correct deficiencies that may lead to increase in intro, transmission, or spread of disease.
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Term
| What is a "quality audit"? |
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Definition
| Documented, independent inspection and review of the establishments activities related to core cGTP requirements by objective evidence |
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Term
| Where environmental conditions could reasonably be expected to cause contamination you must provide or 4 things? |
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Definition
1) Temp and humidity
2) Ventilation and Air filtration
3) Cleaning and disinfecting of rooms and equipment
4) Maintaining equip used to control conditions necessary for aseptic operation. |
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Term
| What does each serology test inform us of? |
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Definition
HIV 1/2 Elisa: Ab test for 25 days
Hep BsAg: test acute or chronic active
Hep BsAb: recovery & immunity or vacc.
Hep BcAb: previous or ongoing:if + core & - surface Ab then had infect. If - core & + surf Ab then vaccinated.
Hep C Ab: previous or current
Hep C NAT: current
RPR: looks for Ab |
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Term
| Is leukemia or active disseminating lymphoma a r/o? |
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Definition
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Term
| What are r/o of donor tissue for PKP? |
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Definition
Intraocular or anterior segment Sx
Refractive corneal Sx (RK/Lam insert)
Laser photoablation Sx
Cataract IOL |
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Term
When and how do you submit a deviation to FDA?
What is meaning of deviation? |
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Definition
Within 45 days by web or direct mail
Deviation is from standards that relate to prevention of comm dx or contamination. |
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Term
| What records of contracts need to be kept and availabe? |
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Definition
| Name, address, and list of responsibilities of any establishments that perform a manufacturing step (must have for inspection). |
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Term
| Does donor i.d. have to be on all records assoc with donor |
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Definition
| NO, but does have to be on HCT/P container |
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Term
| Can a donor SS#, name, or MRN be used as the i.d. for tissue? |
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Definition
| NO, unless autologous or family member |
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Term
| What does "processing" refer to? |
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Definition
Testing for micro-organsims
Preparation (DSAEK)
Sterilization
Steps to inactivate or remove adventitious agents
Preservation of storage
Removal from storage |
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Term
| What are 3 ways to validate a process? |
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Definition
Use previous validated ones
Literature search
Test it (use microorganisms and kill it) |
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Term
| What are ways to prevent mix-up of donor info? |
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Definition
Dedicate work areas
Enclose extra label to keep original on
Label one donor at a time
Confirm removal of any extta labels after done with donor |
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Term
| Process needs revalidated if this occurs? |
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Definition
Type of antibiotic used
concentration of reagent
Amt of time HCT/P exposed to reagent
Temp during processing
lyphilization cycle of freeze/dry |
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Term
| What is the meaning of "Adverse Rxn" |
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Definition
| Noxious and unintended response to any HCT/P for which there is a reasonable possibility the HCT/P caused it? |
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Term
| What are the conditions when adverse rxn needs reported to FDA? |
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Definition
| Fatal, Life-threatening, permanent impairment, necessitates medical/surgical intervention |
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Term
| Does a primary graft failure need to be reported after transplant? |
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Definition
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Term
| What information should be reviewed when investigating reports for adverse reactions? |
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Definition
Pre- & Post-Process cultures
Donor Screening Records
Donor Testing results
DED
Donor ID
Lot number
complaints of other reciepents of donor
Any deviations |
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Term
| When and what is needed to submit a FDA follow-up report? |
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Definition
| 15 days of receipt of new info or as requested by FDA. If no new info then submit F/U describing steps taken to seek additional info |
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Term
| Who of FDA handles complaints? |
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Definition
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Term
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Definition
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Term
| What are the records that must be kept in relation to supplies? |
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Definition
* Receipts: type, quantity, manufacturer, lot #, date receipt, exp date
* Verification of each suppy (COA or test result) |
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Term
| What 4 components does the QA program include? |
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Definition
Establish/maintain procedures
Monitor by audits to indiv not regular performers
Identify prob & complaints
Develop corrective plan & monitor |
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Term
| How is eye tissue determined if eligible, who makes call? |
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Definition
| Eye Bank specifies if meets criteria for PK, ALK, EK, tectonic, or keratolimbal |
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Term
| What does verification mean? |
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Definition
| The confirmation and provision of objective evidence that specified requirements have been fulfilled |
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Term
| What must be included in donor screening eval and put on recovery form? (26) |
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Definition
| eye bank tech, date/time ref, origin ref, name hosp died, full name person giving info, ph# of unit, donor name,age,ht/wt,sex,race, id#, date/time admit, time brain death, heart stopd, cause of death, name/add of NOK, consent, ME or coroner case?, autopsy?,vent?,ocular hx, infusion name/ph fam doc, PMH, Physical exam |
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Term
| TSE screening, what asking for? |
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Definition
CJD or blood rel of CJD
recpnt of hu-pit-hGH1963-1985
rec of non-syn dura mater
prog encephalopathy
encephalitis (viral or unknown)
death of unknown cause
Neuro Dz of unestablish dx
Subacute sclerosng panenceph
Reye's syndrome
Rabies |
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Term
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Definition
Polysac:Albumin, Dextran, Hetastarch, & also
Plasma, Platelets
Increases intravascular volume by increase osmotic pressure |
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Term
| What surgery makes cuts in steep curve of cornea to fix astigmatism? |
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Definition
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Term
| What is info from ME or coroner case that is necessary? (7) |
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Definition
1) Name pathologist
2) Autopsy date
3) Cause of Death
4) Evidence of high risk
5) Signs of sepsis
6) Sign of path,
7) Sign of date/time eye bank took info
8) Name of person (path tech) providing info |
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Term
1) What is sclera rim size expected?
2) What is amt/length for kerato/limbal allograft? |
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Definition
1) 3-4mm
2) 2mm of conjunctiva |
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Term
| Who determines recovery culturing? |
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Definition
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Term
| What is to be on blood tube? (5) |
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Definition
| Date, Time, Donor Name, Donor ID, Tech initials |
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Term
| How many colonies must clean room NOT have and in what size plate? |
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Definition
| 25 cfu in 90mm settle plate for 1 hour |
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Term
| If you recover High-Risk tissue does the instruments need special cleaning before sterilization? |
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Definition
| NO - unless find out had TSE then dispose |
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Term
| Do you need to keep records of the instruments used in recovery or processing? |
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Definition
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Term
Confirmation by examination and provision of objective evidence that specified requirements have been fulfilled?
Verification or Validation |
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Definition
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Term
| How often must equip be cleaned? |
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Definition
| Determined by establishment |
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Term
| Does computers need to be calibrated? |
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Definition
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Term
| What does NIST stand for? |
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Definition
| National Institute of Standards & Technology |
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Term
| What is included periodic recertification of laminar flow hood? (3) |
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Definition
Air flow and velocity
Proper operation of HEPA
Exhaust properly works |
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Term
| What warrants a recertification of LFH |
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Definition
Repair or replacement of parts
or moving it |
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Term
| Can you put instruments from different donors together in washer? |
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Definition
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Term
| What is irreversible cornea edema as a complication of cataract sx called? |
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Definition
Pseudophakic bullous keratopathy
or
Aphakic bullous keratopathy |
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Term
| What is 3 dx of ectasial thinning of cornea? |
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Definition
Keratoconus
Keratoglobus
Pellucid marginal degeneration |
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Term
| What are 4 endothelial dystrophies? |
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Definition
1) Fuchs
2) Posterior Polymorphous dystrophy
3) Iridocorneal endothelial dystrophies: which incld: chandlers syndrome, iris-nevus, essential iris atrophy |
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Term
| What must be documented when HCT/P contaminated? |
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Definition
ID of tissue affected
Description of disposition
Nature of prob needed correction
Description of corrective action
Date of corrective action |
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Term
| If you have legal right to donor/tissue does it need to be screened? |
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Definition
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Term
| What is required in donor screening? (6) |
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Definition
Donor hx eval
Med director oversight
ID donor
Physical Exam
Serological Test
Tissue Eval |
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Term
| What 5 sources must we have records regarding donor? |
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Definition
Path/ME physical assess or death report
ME invest. report
Med chart
Physician interview
Family interview |
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Term
| How long is the optic nerve to be? |
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Definition
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Term
| what should be on form attached to body for FH? |
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Definition
| Name of eye bank, location, and phone number |
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Term
| When procuring for PKP or other how far should conjunctiva be cut back from limbus? |
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Definition
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Term
| What are the required serology tests for FDA? |
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Definition
HIV 1/2 Ab , HIV-1 NAT
Heb BsAg, Hep BcAb
Hep C Ab, Hep C NAT
RPR |
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Term
How long can whole globes for PK be stored in moist chamber and at what temp?
What about lamellar keratoplasty? |
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Definition
1) 24-48hrs at 2-8 C
2) Med Director determines |
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Term
| If you are to run laminar flow hood, how long must it run before using? |
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Definition
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Term
| Refrigerator should be calibrated against what standard and how often? |
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Definition
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Term
| Cleaning records should be kept? |
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Definition
10 years after calibrating fridge and hood
3 years thereafter and for all equipment |
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Term
| Refrigerator should have labels for what 3 categories? |
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Definition
Quarantine
Research
Surgical |
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Term
How often should autoclave be cleaned?
How often do you need certified and to validate what 3 things? |
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Definition
Cleaned as often as manufacturer says
Annual certification
Temp, Pressure, Time |
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Term
| How often need to monitor for efficiency to kill what bacteria? |
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Definition
Weekly
Bacillus Stearothermophilus |
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Term
| If tissue is returned what needs recorded? |
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Definition
Method of transportation used and storage while out of eye bank
examine seal too |
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Term
| What needs to be passed on to next surgeon after tissue has been returned? |
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Definition
| Surgeon needs to know storage and transportation to consider suitability |
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Term
| When do you not see well with Fuchs Dystrophy? |
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Definition
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Term
How long must alcohol be on sclera before distributing?
Who determines length of storage and temp for sclera? |
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Definition
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Term
If freezing sclera, how long does it need to be in antibiotic solution and at what temp?
What temp need to be for freezing? |
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Definition
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|
Term
|
Definition
Isotonic salt:
Saline, D5W, Lactate Ringer
Glucose
Increases intravascular volume |
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Term
| What are 4 ways for consent? |
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Definition
Written
Telephone
Living Donor
Implied/ME |
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Term
Who determines minimal count on Endo Density?
What happens if doesn't meet min count? |
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Definition
Med Director
Med director may waive on case-by-case |
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Term
| How often calibrate specular microscope? |
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Definition
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Term
Myopia?
Hyperopia?
Stigmatism? |
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Definition
Myopia: Nearsightedness (M-N)
Hyperopia: Far (F-H)
Stigmatism: Axis not same, images fall on different places |
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Term
What disease causes Uveitis?
What is Uveitis? |
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Definition
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Term
| Which corneal layer best defends against infection? |
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Definition
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Term
| What percentage of cornea hydration is H2O? |
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Definition
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Term
What is most common organism to cause endophalmitis?
what is endophalmitis? |
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Definition
| Staph, Candida, Aspergillus |
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Term
| What is best way to view keratic precipitates? |
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Definition
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Term
What does AK correct?
What is AK? |
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Definition
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Term
|
Definition
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Term
| How much of eye is cornea? |
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Definition
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Term
Difference btwn:
LASIK
PRK
Clear Lens Replacement |
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Definition
LASIK: Flap is formed
PRK: no flap, remove epi and 2-4 wk healing needed
Clear Lens: Like cataract, downfall not able to adjust lens anymore, no glare |
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Term
|
Definition
Center of retina
Vision for fine work/readings |
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Term
| What is function of fovea? |
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Definition
| Center of macula, densest cones sharpest acuity. |
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Term
What is RPE?
What does it do? |
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Definition
Retinal Pigmented Epithelial Cells
nourishes retina
absorbs scattered light
phagocytosis the rod/cones |
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Term
How long do you have to report Adverse Rxn to EBAA
FDA
Med Director Role |
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Definition
EBAA: 30 days
FDA: 15 days
Med Director: reviews all adverse Rxn and document corrective actn |
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Term
| How long do you have to report to EBAA, FDA, and Surgeon of a tissue recall? |
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Definition
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Term
| If it is non-transplant tissue, what must be on label on tissue? |
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Definition
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Term
Is it necessary to have a file of all complaints to present FDA?
How can complaint file be requested? |
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Definition
yes
Telephone, Fax, person, mail |
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Term
| What is it that a med or surg intervention considered to be for txt known or suspectd transmission of communicable disease |
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Definition
Any change from normal medical txt after transplant.
Includes: Changing med dose & rehospitalization |
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Term
| When does eye bank have to submit adverse rxn by? |
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Definition
| 15 days after an initial receipt |
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Term
1) What is trabeculopasty?
2) trabeculectomy? |
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Definition
1)Laser txt to open canals (not r/o)
2) Filtration system surgically placed (not a r/o) |
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Term
|
Definition
| Peripheral vision lost can be irreparable |
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Term
| What is more rapid closed or open angle glaucoma? |
|
Definition
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Term
| How does closed angle glaucoma occur? |
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Definition
| Lens extends and blocks pupil/iris opening |
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Term
| What is time limit for tissue recovery? |
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Definition
24 hours after death if body is cooled within the first 12 hours
If not cooled 15 hours after death |
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Term
| From what date does retaining records for 10 years refer to? |
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Definition
| After creation unless stated otherwise, if a specific HCT/P then 10yrs after distribution |
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Term
How far back is r/o if have rabies?
How far back if Reye's? |
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Definition
Rabies: 6 months
Reyes: 3 months |
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Term
| What procedures are r/o for PKP? |
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Definition
Cataract IOL,
RK,
lamellar inserts
Laser photoablation
intraocular or Ant Seg Sx |
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Term
| If you have conflicting serology results when do you need to let EBAA know? |
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Definition
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Term
What are ways to preserve sclera?
4 ways |
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Definition
70% or > ethyl alcohol
Sterile glycerin
Cryopreservation
Gamma radiation |
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Term
| How long do you have to report adverse rxn to EBAA |
|
Definition
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|
Term
| Adverse rxn involving communicable disease need reported to FDA within? |
|
Definition
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|
Term
Most common microorganism and cause of endophthalimitis?
what is endophthalimits? |
|
Definition
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|
Term
| Most common virus to cause blindness? |
|
Definition
| Herpes (down trigeminal nerve) |
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Term
| What are common bacteria of contact lens? |
|
Definition
Staph aureus
Pseudomonas aeruginosa |
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Term
| What moves and controls lens? |
|
Definition
| Ciliary muscle and zonules fibers |
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Term
| Where and what is function of choroid? |
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Definition
Btwn sclera and RPE/retina.
It nourishes outer later of retina |
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Term
| What is age for keratoconus? |
|
Definition
20-40 yrs
It is a r/o
Causes blurry vision |
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|
Term
| How do you treat keratoconus? |
|
Definition
| Glasses, contacts, rings or corneal transplant (PKP/LKP) |
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|
Term
| What agencies provide regulatory oversight to eye banking? |
|
Definition
FDA
CMS (Center for Medicare services)
Joint commission
OSHA
State: UAGA, Health department |
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Term
| What is difference between guidance and rule? |
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Definition
Guidance defines the rule and helps understand how to follow rule.
Rule is what must be done |
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Term
| What is regulatory agency over referrals? |
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Definition
CMS
*requires hospitals to report all death to OPO, and have contractsw with OPO and eye and tissue banks
Joint commission checks this at inspection |
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Term
| What is regulatory agency over authorization? |
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Definition
States:
Uniform Anatomical Gift Act
First Person Authorization/Donor Registry
Legislative Consent (ME)
May be: written, tape-recorded, witnessed, faxed. |
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Term
| What is regulatory agency over donor eligbility? |
|
Definition
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|
Term
| cGTP require reporting all adverse rxn or deviations...when for each? |
|
Definition
Adverse rxn to FDA within 15 days
Deviations to FDA in 45 days |
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|
Term
| Is primary graft failure a factor for cGTP? |
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Definition
| no it is not related to communicable diseases and this is the only concern |
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Term
| What are the five things a lab must have? |
|
Definition
limited access
sink with running water
counter space
cleaned regularly
stable electric source |
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|
Term
| Does alarm on fridge need to be challenged and how often? |
|
Definition
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|
Term
| How long do you let instruments sit in disinfectant solution to decontaminate (according to big book of TES) |
|
Definition
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Term
| What are the two parameters for autoclaving to sterilize and kill spores? |
|
Definition
270F (132C) @ 31 psi x 6 min
250F (121C) @ 15 psi x 30 min
*KNOW* |
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Term
| To clean instruments do you want warm or cold water, suds or no suds, air or cloth dry? |
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Definition
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|
Term
| Is dry heat or moist heat better for steam sterilization? |
|
Definition
|
|
Term
| how do you reduce risk of prion on instruments? |
|
Definition
unwashed 270F x 60 min
wash, rinse, milk, dry, wrap
resterilize at 270 x 30 |
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|
Term
| Where does pseudophakic bullous keratopathy develop bulging? |
|
Definition
| Basal Epithelial layers, as result of damage to endothelial layer |
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