Inspections: Preparation and Process
When it comes to medical laboratory inspections and for that matter surgery center inspections, it can be pretty daunting. The regulatory bodies that govern medical laboratories are strict and want to ensure that patients are being taken care of properly.
You can be certain that all of the documentation and identifiers will be reviewed regarding the patient’s protected health information aka PHI.
In the laboratory setting there are many moving parts.
Patient specimens arrive in the lab and need to be given identifiers. Each bottle should be marked with two patient identifiers to ensure that the biopsy was not placed in the wrong container or biopsies are mixed. As you can imagine this would have serious impact on patient care.
Unfortunately it has happened in the past. People have had their biopsies switched with some other person. Can you imagine undergoing surgery that wasn’t meant for you but was meant for someone else.
So once the biopsy reaches the building it is given a new identifier in order to remove the patient name and make it easy to track the specimen numerically throughout the pathology process.
First the patient’s information is registered into the computer. The identifier then is marked on all the paperwork associated with that patient and will follow this patient throughout the whole process.
Next the patients biopsy goes to Grossing. Typically the grosser will evaluate the color and dimensions of the biopsy and record them accordingly so that they can be transcribed onto the final report as the gross description.
After Grossing, the biopsy is then put into cassettes which are loaded into a tissue processor. The tissue processor’s job is simply to remove the human fluids out of the tissue and replace it with molten wax.
This preserves the tissue in form and allows it to be sliced using a microtome.
After the tissue comes out of the tissue processor it goes to embedding. The tissue is embedded in wax creating a block. This block and then go to cutting. The Histo technologist uses a microtome to slice then layers off of the block which already here to a slide.
Once these layers have been put on the slides then they will go through a staining process and last the preserved by sealing it with another piece of glass called coverslipping.
At the end of this process the pathologist will look at the tissue samples under a microscope in order to determine the if any disease stage.
If the pathologist determines that there are additional tests needed they may submit the tissue for further differentiated standing.
Upon completion of all of the steps a final report is generated and sent back to the physician who requested the test to be done.
Anatomic pathology is an important process in determining the cause of health problems and otherwise healthy individuals.
Each one of these stages will be reviewed closely by an inspector appointed by the regulatory body.
Typically the inspector will ask for random samples of patients with all of the information described above to be presented and reviewed.
This is to determine whether or not the process is correct.
In order to ensure that the process is correct there are many quality measures that are put in place in order to determine any breakdown in the process.
Typically a breakdown if it is well documented will not cause any adverse reaction to the lab.
In other words if you catch it good for you. If the inspector catches it that’s not necessarily a good thing. The regulatory that I am most familiar with is AHCA. You can visit them at ahca.myflorida.com