JHH1999

Typically expiration dates are established by the manufacturer. They perform stability testing for the duration of the assigned expiration date to support it with data. Data shows the product is capable of performing up until the claimed expiration date. It may continue to function they just do not have data to support it.
This should be done to support any "reagent" made that is not at least qualified in some way each day of use. Assigning an expiration date based upon the shortest dated component is not very good science. The different ingredients could be compatible with each other or could have a negative impact to on another. From a pure scientific and quality aspect one would prepare a reagent and place it on a stability schedule and test it periodically for performance. This data is then used to support the use. Any assessor should accept this science.
A simple analogy I like. If you made a cake today with milk that had a use by date of tomorrow does that mean the cake is not good after a day. Of course not, since it is now in a different form and could be stored in a different way. 

Typically expiration dates are established by the manufacturer. They perform stability testing for the duration of the assigned expiration date to support it with data. Data shows the product is capable of performing up until the claimed expiration date. It may continue to function they just do not have data to support it.
This should be done to support any "reagent" made that is not at least qualified in some way each day of use. Assigning an expiration date based upon the shortest dated component is not very good science. The different ingredients could be compatible with each other or could have a negative impact to on another. From a pure scientific and quality aspect one would prepare a reagent and place it on a stability schedule and test it periodically for performance. This data is then used to support the use. Any assessor should accept this science.
A simple analogy I like. If you made a cake today with milk that had a use by date of tomorrow does that mean the cake is not good after a day. Of course not, since it is now in a different form and could be stored in a different way. 

Typically expiration dates are established by the manufacturer. They perform stability testing for the duration of the assigned expiration date to support it with data. Data shows the product is capable of performing up until the claimed expiration date. It may continue to function they just do not have data to support it.
This should be done to support any "reagent" made that is not at least qualified in some way each day of use. Assigning an expiration date based upon the shortest dated component is not very good science. The different ingredients could be compatible with each other or could have a negative impact to on another. From a pure scientific and quality aspect one would prepare a reagent and place it on a stability schedule and test it periodically for performance. This data is then used to support the use. Any assessor should accept this science.
A simple analogy I like. If you made a cake today with milk that had a use by date of tomorrow does that mean the cake is not good after a day. Of course not, since it is now in a different form and could be stored in a different way. 

Typically expiration dates are established by the manufacturer. They perform stability testing for the duration of the assigned expiration date to support it with data. Data shows the product is capable of performing up until the claimed expiration date. It may continue to function they just do not have data to support it.
This should be done to support any "reagent" made that is not at least qualified in some way each day of use. Assigning an expiration date based upon the shortest dated component is not very good science. The different ingredients could be compatible with each other or could have a negative impact to on another. From a pure scientific and quality aspect one would prepare a reagent and place it on a stability schedule and test it periodically for performance. This data is then used to support the use. Any assessor should accept this science.
A simple analogy I like. If you made a cake today with milk that had a use by date of tomorrow does that mean the cake is not good after a day. Of course not, since it is now in a different form and could be stored in a different way. 

Typically expiration dates are established by the manufacturer. They perform stability testing for the duration of the assigned expiration date to support it with data. Data shows the product is capable of performing up until the claimed expiration date. It may continue to function they just do not have data to support it.
This should be done to support any "reagent" made that is not at least qualified in some way each day of use. Assigning an expiration date based upon the shortest dated component is not very good science. The different ingredients could be compatible with each other or could have a negative impact to on another. From a pure scientific and quality aspect one would prepare a reagent and place it on a stability schedule and test it periodically for performance. This data is then used to support the use. Any assessor should accept this science.
A simple analogy I like. If you made a cake today with milk that had a use by date of tomorrow does that mean the cake is not good after a day. Of course not, since it is now in a different form and could be stored in a different way. 

Typically expiration dates are established by the manufacturer. They perform stability testing for the duration of the assigned expiration date to support it with data. Data shows the product is capable of performing up until the claimed expiration date. It may continue to function they just do not have data to support it.
This should be done to support any "reagent" made that is not at least qualified in some way each day of use. Assigning an expiration date based upon the shortest dated component is not very good science. The different ingredients could be compatible with each other or could have a negative impact to on another. From a pure scientific and quality aspect one would prepare a reagent and place it on a stability schedule and test it periodically for performance. This data is then used to support the use. Any assessor should accept this science.
A simple analogy I like. If you made a cake today with milk that had a use by date of tomorrow does that mean the cake is not good after a day. Of course not, since it is now in a different form and could be stored in a different way. 

Typically expiration dates are established by the manufacturer. They perform stability testing for the duration of the assigned expiration date to support it with data. Data shows the product is capable of performing up until the claimed expiration date. It may continue to function they just do not have data to support it.
This should be done to support any "reagent" made that is not at least qualified in some way each day of use. Assigning an expiration date based upon the shortest dated component is not very good science. The different ingredients could be compatible with each other or could have a negative impact to on another. From a pure scientific and quality aspect one would prepare a reagent and place it on a stability schedule and test it periodically for performance. This data is then used to support the use. Any assessor should accept this science.
A simple analogy I like. If you made a cake today with milk that had a use by date of tomorrow does that mean the cake is not good after a day. Of course not, since it is now in a different form and could be stored in a different way. 

Typically expiration dates are established by the manufacturer. They perform stability testing for the duration of the assigned expiration date to support it with data. Data shows the product is capable of performing up until the claimed expiration date. It may continue to function they just do not have data to support it.
This should be done to support any "reagent" made that is not at least qualified in some way each day of use. Assigning an expiration date based upon the shortest dated component is not very good science. The different ingredients could be compatible with each other or could have a negative impact to on another. From a pure scientific and quality aspect one would prepare a reagent and place it on a stability schedule and test it periodically for performance. This data is then used to support the use. Any assessor should accept this science.
A simple analogy I like. If you made a cake today with milk that had a use by date of tomorrow does that mean the cake is not good after a day. Of course not, since it is now in a different form and could be stored in a different way. 

Typically expiration dates are established by the manufacturer. They perform stability testing for the duration of the assigned expiration date to support it with data. Data shows the product is capable of performing up until the claimed expiration date. It may continue to function they just do not have data to support it.
This should be done to support any "reagent" made that is not at least qualified in some way each day of use. Assigning an expiration date based upon the shortest dated component is not very good science. The different ingredients could be compatible with each other or could have a negative impact to on another. From a pure scientific and quality aspect one would prepare a reagent and place it on a stability schedule and test it periodically for performance. This data is then used to support the use. Any assessor should accept this science.
A simple analogy I like. If you made a cake today with milk that had a use by date of tomorrow does that mean the cake is not good after a day. Of course not, since it is now in a different form and could be stored in a different way. 

Typically expiration dates are established by the manufacturer. They perform stability testing for the duration of the assigned expiration date to support it with data. Data shows the product is capable of performing up until the claimed expiration date. It may continue to function they just do not have data to support it.
This should be done to support any "reagent" made that is not at least qualified in some way each day of use. Assigning an expiration date based upon the shortest dated component is not very good science. The different ingredients could be compatible with each other or could have a negative impact to on another. From a pure scientific and quality aspect one would prepare a reagent and place it on a stability schedule and test it periodically for performance. This data is then used to support the use. Any assessor should accept this science.
A simple analogy I like. If you made a cake today with milk that had a use by date of tomorrow does that mean the cake is not good after a day. Of course not, since it is now in a different form and could be stored in a different way. 

Typically expiration dates are established by the manufacturer. They perform stability testing for the duration of the assigned expiration date to support it with data. Data shows the product is capable of performing up until the claimed expiration date. It may continue to function they just do not have data to support it.
This should be done to support any "reagent" made that is not at least qualified in some way each day of use. Assigning an expiration date based upon the shortest dated component is not very good science. The different ingredients could be compatible with each other or could have a negative impact to on another. From a pure scientific and quality aspect one would prepare a reagent and place it on a stability schedule and test it periodically for performance. This data is then used to support the use. Any assessor should accept this science.
A simple analogy I like. If you made a cake today with milk that had a use by date of tomorrow does that mean the cake is not good after a day. Of course not, since it is now in a different form and could be stored in a different way. 

Typically expiration dates are established by the manufacturer. They perform stability testing for the duration of the assigned expiration date to support it with data. Data shows the product is capable of performing up until the claimed expiration date. It may continue to function they just do not have data to support it.
This should be done to support any "reagent" made that is not at least qualified in some way each day of use. Assigning an expiration date based upon the shortest dated component is not very good science. The different ingredients could be compatible with each other or could have a negative impact to on another. From a pure scientific and quality aspect one would prepare a reagent and place it on a stability schedule and test it periodically for performance. This data is then used to support the use. Any assessor should accept this science.
A simple analogy I like. If you made a cake today with milk that had a use by date of tomorrow does that mean the cake is not good after a day. Of course not, since it is now in a different form and could be stored in a different way. 

Basically some labs struggle with QC and the actual intent. They also may have issues with staff not detecting weak reactions, specifically in tubes. Manufacturer's in the US tend to make QC material so strong that it is less likely to be missed. The result is the manufacturer avoids product complaints and the labs do not have QC failures requiring investigation. However, the intent of QC is missed in my opinion. QC should ensure your test system is capable of detecting weak reactions. 
 
QC products manufactured where I work were developed (IgG coated control cells and Daily QC Kit) to detect if there is a weakness rather than just checking a box that QC has been done.  

Basically some labs struggle with QC and the actual intent. They also may have issues with staff not detecting weak reactions, specifically in tubes. Manufacturer's in the US tend to make QC material so strong that it is less likely to be missed. The result is the manufacturer avoids product complaints and the labs do not have QC failures requiring investigation. However, the intent of QC is missed in my opinion. QC should ensure your test system is capable of detecting weak reactions. 
 
QC products manufactured where I work were developed (IgG coated control cells and Daily QC Kit) to detect if there is a weakness rather than just checking a box that QC has been done.  

As a reagent manufacturer one of the requirements is to ensure products work as intended over the shelf life of the product when in the end users hands. This includes ensuring the product is able to withstand shipping. Manufacturers perform stability testing of these products to a greater extent than most end users would be cabable of repeating. This would include making sure red cells antigens are viable. Daily QC of red cell panels by the end user is not necessary in my opinion and a waste of time and resources.

Using expired antisera and panel cells is and has been standard practice for years in my experience. It has become more sound with additional QC people are now doing. If ever cited for this I would push back. Provide scientific rationale and a risk evaluation for what you are doing. These are tools used to solve problems. Without them your hands are tied and patients may not receive compatible blood. A bigger risk.
 
No matter what you call them (inspectors, investigators, assessors) they all have opinions and you may not be about to change their mind during the inspection. What they may cite you for during an inspection can be disputed in your response. The repsonse is typically reviewed by others.
 
Some of these things are just driving up the cost of health care without improving actual patient care.

Using expired antisera and panel cells is and has been standard practice for years in my experience. It has become more sound with additional QC people are now doing. If ever cited for this I would push back. Provide scientific rationale and a risk evaluation for what you are doing. These are tools used to solve problems. Without them your hands are tied and patients may not receive compatible blood. A bigger risk.
 
No matter what you call them (inspectors, investigators, assessors) they all have opinions and you may not be about to change their mind during the inspection. What they may cite you for during an inspection can be disputed in your response. The repsonse is typically reviewed by others.
 
Some of these things are just driving up the cost of health care without improving actual patient care.

Using expired antisera and panel cells is and has been standard practice for years in my experience. It has become more sound with additional QC people are now doing. If ever cited for this I would push back. Provide scientific rationale and a risk evaluation for what you are doing. These are tools used to solve problems. Without them your hands are tied and patients may not receive compatible blood. A bigger risk.
 
No matter what you call them (inspectors, investigators, assessors) they all have opinions and you may not be about to change their mind during the inspection. What they may cite you for during an inspection can be disputed in your response. The repsonse is typically reviewed by others.
 
Some of these things are just driving up the cost of health care without improving actual patient care.

Using expired antisera and panel cells is and has been standard practice for years in my experience. It has become more sound with additional QC people are now doing. If ever cited for this I would push back. Provide scientific rationale and a risk evaluation for what you are doing. These are tools used to solve problems. Without them your hands are tied and patients may not receive compatible blood. A bigger risk.
 
No matter what you call them (inspectors, investigators, assessors) they all have opinions and you may not be about to change their mind during the inspection. What they may cite you for during an inspection can be disputed in your response. The repsonse is typically reviewed by others.
 
Some of these things are just driving up the cost of health care without improving actual patient care.

Using expired antisera and panel cells is and has been standard practice for years in my experience. It has become more sound with additional QC people are now doing. If ever cited for this I would push back. Provide scientific rationale and a risk evaluation for what you are doing. These are tools used to solve problems. Without them your hands are tied and patients may not receive compatible blood. A bigger risk.
 
No matter what you call them (inspectors, investigators, assessors) they all have opinions and you may not be about to change their mind during the inspection. What they may cite you for during an inspection can be disputed in your response. The repsonse is typically reviewed by others.
 
Some of these things are just driving up the cost of health care without improving actual patient care.

Using expired antisera and panel cells is and has been standard practice for years in my experience. It has become more sound with additional QC people are now doing. If ever cited for this I would push back. Provide scientific rationale and a risk evaluation for what you are doing. These are tools used to solve problems. Without them your hands are tied and patients may not receive compatible blood. A bigger risk.
 
No matter what you call them (inspectors, investigators, assessors) they all have opinions and you may not be about to change their mind during the inspection. What they may cite you for during an inspection can be disputed in your response. The repsonse is typically reviewed by others.
 
Some of these things are just driving up the cost of health care without improving actual patient care.

Using expired antisera and panel cells is and has been standard practice for years in my experience. It has become more sound with additional QC people are now doing. If ever cited for this I would push back. Provide scientific rationale and a risk evaluation for what you are doing. These are tools used to solve problems. Without them your hands are tied and patients may not receive compatible blood. A bigger risk.
 
No matter what you call them (inspectors, investigators, assessors) they all have opinions and you may not be about to change their mind during the inspection. What they may cite you for during an inspection can be disputed in your response. The repsonse is typically reviewed by others.
 
Some of these things are just driving up the cost of health care without improving actual patient care.

Using expired antisera and panel cells is and has been standard practice for years in my experience. It has become more sound with additional QC people are now doing. If ever cited for this I would push back. Provide scientific rationale and a risk evaluation for what you are doing. These are tools used to solve problems. Without them your hands are tied and patients may not receive compatible blood. A bigger risk.
 
No matter what you call them (inspectors, investigators, assessors) they all have opinions and you may not be about to change their mind during the inspection. What they may cite you for during an inspection can be disputed in your response. The repsonse is typically reviewed by others.
 
Some of these things are just driving up the cost of health care without improving actual patient care.