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Establishment Inspection Report

Physicians Plasma Alliance LLC

Johnson City, 1N 37615

OBSERVATION 1

Failure to have donor suitability detetmined by a qualified licensed physician or trained persons

under his supervision.

Donors must be screened using the health history questionnaire prior to each donation. In two out of

ten donor files chosen for review, I noted that two donors did not have the health history questions

asked, or at the least recorded, on the donor card for these dates of donation. This can directly

impact the safety of the donor. In the event that an answer to any of these questions changes from

previous visits, the donor could be harmed or the product\'s safety, purity or potency could be

affected.

OBSERVATION 2

Failure of the examining physician to cettify that each donor is in good health and suitable for

plasmapheresis.

Specifically, donorVJj(p)\'(~)}~reported to the examining physician and the individual presenting the medical history

questions that he was nof\"in good health and feeling well\" the day of donation, but he was accepted for donation of

plasma.

A donor who is feeling ill must not be pheresed as it could potentially harm the donor. A donor who

is not feeling well could be ill with a new disease or in the acute phase of a previously diagoosed

condition. Collecting plasma from an ill donor could put additional stress on an ill donor. Any new

conditions could also affect the safety, purity and potency of the product.

In the case of the donor mentioned in this item, the donor told both the physician conducting the

physical and the screener that he was not feeling well and healthy on the date of the donation.

Neither of these individuals apparently recogoized that the donor should have been temporarily

deferred from donating. The donor was connected to the apheresis machine and the process started,

but the donor then complained that he was feeling too ill to continue and needed to be disconnected.

Discussion with Management:

I showed this to Mr. King who stated that the donor could not have answered the way it had been

recorded on the chart because neither the physician nor his employee would accept the donor if he

was not feeling well. However, the record showing the same response in both locations and the

donor being too ill to continue after the pheresis procedure was begun indicates that the answers

recorded were the answers actually given by the donor and not an error on the part of the recorders.

Mr. King acknowledged that the evidence shows that there was an error and will be retraining his

employees on identifying responses which should cause a deferral. He also stated that this particular

donor was identified by the manufacturer as a Hepatitis A donor, but when the small amount of

plasma that was collected was tested, no evidence of the virus or any antibodies was found.

OBSERVATION 3

Failure to obtain written consent of prospective Source Plasma donors.

Exhibit #6 -Donor card for donor[~f~~liMlJ~~

Donors must give informed consent upon entering the pheresis program and then provide a separate

consent prior to ·each donation acknowledging their free participation in the program. This donor

was pheresed on two separate occasions without first signing the donor card indicating that consent

was given.

Discussion with Management:

Mr. King stated that he had no explanation for this oversight. He indicated that the employee would

be retrained in obtaining consent.

8 of16

Equipment used in the collection and processing of blood and blood components is not calibrated on

a regularly scheduled basis as prescribed in the SOP Manual.

Specifically, the=rn)Jffi\'))jE\'I\'!) plasmapheresis machines used to collect source plasma and thef,k@***i(lfl~

hematocrit device and refractometer used to determine donor suitability for plasmapheresis were not cafi6rated in

, accordance with the manufacturer\'s instructions each day of use prior to collection of source plasma. At least~l!\'~ units of

plasma have been collected between 3/12/11 and 6/5/11 when one or more of these devices were not calibrated-on the

days of collection. For example, two units of plasma were collected on 3/27/11 according to the Bleed Sequence Log.

According to the~~)I(~}Maintenance and Cleaning Logs neither of the plasmapheresis machines received their daily QC

check for that da),;\'nor \\vere the refractometer or[\'J~Jllf_\'1~ devices calibrated for that day according to their respective

control logs.

Discussion with Management:

Mr. King did not have an explanation for the failure of his QA unit to review the records. He

indicated that he would have to retrain and supervise his employees more closely.

OBSERVATION 6

Failure to maintain storage and distribution and quality control records.

OBSERVATION 7

A record is not available from which unsuitable (deferred) donors may be identified so that products

from such individuals will not be distributed.

Specifically, the finn does not have a method to record the identities of donors deferred for any reason so that products

are not distributed from these individuals, as necessary.

> \'\'.

Establishment Inspection Report

Physicians Plasma Alliance LLC

Johnson City, 1N 37615

OBSERVATION 1

Failure to have donor suitability detetmined by a qualified licensed physician or trained persons

under his supervision.

Donors must be screened using the health history questionnaire prior to each donation. In two out of

ten donor files chosen for review, I noted that two donors did not have the health history questions

asked, or at the least recorded, on the donor card for these dates of donation. This can directly

impact the safety of the donor. In the event that an answer to any of these questions changes from

previous visits, the donor could be harmed or the product\'s safety, purity or potency could be

affected.

OBSERVATION 2

Failure of the examining physician to cettify that each donor is in good health and suitable for

plasmapheresis.

Specifically, donorVJj(p)\'(~)}~reported to the examining physician and the individual presenting the medical history

questions that he was nof\"in good health and feeling well\" the day of donation, but he was accepted for donation of

plasma.

A donor who is feeling ill must not be pheresed as it could potentially harm the donor. A donor who

is not feeling well could be ill with a new disease or in the acute phase of a previously diagoosed

condition. Collecting plasma from an ill donor could put additional stress on an ill donor. Any new

conditions could also affect the safety, purity and potency of the product.

In the case of the donor mentioned in this item, the donor told both the physician conducting the

physical and the screener that he was not feeling well and healthy on the date of the donation.

Neither of these individuals apparently recogoized that the donor should have been temporarily

deferred from donating. The donor was connected to the apheresis machine and the process started,

but the donor then complained that he was feeling too ill to continue and needed to be disconnected.

Discussion with Management:

I showed this to Mr. King who stated that the donor could not have answered the way it had been

recorded on the chart because neither the physician nor his employee would accept the donor if he

was not feeling well. However, the record showing the same response in both locations and the

donor being too ill to continue after the pheresis procedure was begun indicates that the answers

recorded were the answers actually given by the donor and not an error on the part of the recorders.

Mr. King acknowledged that the evidence shows that there was an error and will be retraining his

employees on identifying responses which should cause a deferral. He also stated that this particular

donor was identified by the manufacturer as a Hepatitis A donor, but when the small amount of

plasma that was collected was tested, no evidence of the virus or any antibodies was found.

OBSERVATION 3

Failure to obtain written consent of prospective Source Plasma donors.

Exhibit #6 -Donor card for donor[~f~~liMlJ~~

Donors must give informed consent upon entering the pheresis program and then provide a separate

consent prior to ·each donation acknowledging their free participation in the program. This donor

was pheresed on two separate occasions without first signing the donor card indicating that consent

was given.

Discussion with Management:

Mr. King stated that he had no explanation for this oversight. He indicated that the employee would

be retrained in obtaining consent.

8 of16

Equipment used in the collection and processing of blood and blood components is not calibrated on

a regularly scheduled basis as prescribed in the SOP Manual.

Specifically, the=rn)Jffi\'))jE\'I\'!) plasmapheresis machines used to collect source plasma and thef,k@***i(lfl~

hematocrit device and refractometer used to determine donor suitability for plasmapheresis were not cafi6rated in

, accordance with the manufacturer\'s instructions each day of use prior to collection of source plasma. At least~l!\'~ units of

plasma have been collected between 3/12/11 and 6/5/11 when one or more of these devices were not calibrated-on the

days of collection. For example, two units of plasma were collected on 3/27/11 according to the Bleed Sequence Log.

According to the~~)I(~}Maintenance and Cleaning Logs neither of the plasmapheresis machines received their daily QC

check for that da),;\'nor \\vere the refractometer or[\'J~Jllf_\'1~ devices calibrated for that day according to their respective

control logs.

Discussion with Management:

Mr. King did not have an explanation for the failure of his QA unit to review the records. He

indicated that he would have to retrain and supervise his employees more closely.

OBSERVATION 6

Failure to maintain storage and distribution and quality control records.

OBSERVATION 7

A record is not available from which unsuitable (deferred) donors may be identified so that products

from such individuals will not be distributed.

Specifically, the finn does not have a method to record the identities of donors deferred for any reason so that products

are not distributed from these individuals, as necessary.