Who's Who
These people are considered CLIA lab personnel.
Who is anyone who has been trained and performed tasks related to clinical sample processing? (Currently Semra, Katie, Abdullah)
Where do you receive samples?
*Direct inspector to accessioning area*
What environmental conditions are monitored?
Temperature and humidity are recorded in general areas and some equipment have additional values recorded per their operating manuals and/or our SOPs.
How do you prevent contamination or know if somethings contaminated?
How do you maintain patient confidentiality?
We follow company policy. If someone calls asking about protected health information, the caller must confirm their identity with two unique identifiers before discussing sample status.
Results are not allowed to be released over the phone.
These people assist in assay development but do not perform clinical testing.
Who is the R&D team? (James, Floy, Laura-most of the time)
How do you determine if a sample can be received?
We refer to our rejection policy.
How is this assay quality controlled?
Qualified QCs are run with each assay according to SOP.
Where are the safety and spill stations? Where are hazardous chemicals stored?
*Point out areas in lab (eye washes, shower, spill kit, first aid kit, fire extinguisher, cabinet under fume hoods)*
How are patient results requested and sent?
A patients result request form is completed and submitted to customer care. The form is evaluated and if all is in order, results are released in a HIPAA compliant manner within 30 days.
The name of the lab general supervisor.
Who is Semra?
-Kaitlin has delegated duties, but is secondary supervisor.
Where can I find the SOPs?
SOPs are located at various points in the lab and also on our shared drive.
What do you do if something abnormal happens?
Reach out to a supervisor for guidance on next steps.
What do you do if an injury occurs?
Reach out to a supervisor if not medically emergent. If medically emergent, call 911.
What do you do if a patient calls asking about a test?
The name of the lab technical supervisor.
What are you doing right now? Why?
I am performing X assay or Y procedure because that is what our SOP states. Do not elaborate further. If asked questions that are not within the scope of the SOP, refer to supervisor.
What is the stability for this assay?
How/what maintenance/calibrations is performed for X instrument?
We follow manufacturers instructions and/or our internal SOPs.
Who can order testing? Where can we receive specimens from?
Only a licensed provider can order Galaxy testing. Everywhere except New York and Rhode Island.
The name of the lab director and clinical consultant.
Who is Dr. Orton? (Susie)
What are the technical specifications of this assay?
We have validated all our clinical assays to CLIA standards and those specifications can be found in our validation reports. Our technical supervisor or applicable R & D staff can answer any follow-up questions you may have.
We check the results of our QCs compared to the criteria listed in the SOP.
Where can I find the evacuation route?
*Show signage on wall*
What is the issue/resolution process? Who contacts who?
Issues are logged and resolved per SOP. Customer care/sales reach out to the clinic.