Pharmasan Inc

Revdex.com:
I have reviewed the response made by the business in reference to complaint ID [redacted], and have determined that this does not resolve my complaint.  For your reference, details of the offer I reviewed appear below.
I appreciate the investigation into my complaint and the detailed response.  However, I cannot agree with your conclusions.  As you imply, the verylarge number of undetectable cytokine levels from my test would suggest a severely immunocompromised patient.  Since I am not immune compromised, I have every confidence that these results are invalid and can be of no use to me or my doctor.  You state that you are unable to identify the exact cause of the low cytokine levels. I submit that you can, however, very much deduce why these poor results occurred.  The whole blood sample for this test was taken, shipped, and treated the exact same way as two other tests which failed.  Two whole blood samples taken a few weeks later again failed viability tests.  It defies logic that this test was somehow protected from degradation while the other four were not.  I therefore believe the statistical analysis and QA criteria that you used to arrive at your conclusions are inadequate.  I appreciate your last paragraph and look forward to hearing from you to discuss a resolution to my concerns.
Regards,
[redacted]

Pharmasan Labs strives to provide quality testing in order to support the needs of healthcare businesses, including their practitioners and patients.  Pharmasan Labs is certified by the Clinical Laboratory Improvement Amendments (CLIA) program (CLIA ID# [redacted]) and New York State Department...

of Health (PFI# 7426). The three test profiles ordered by this individual (Panels 3013, 5111, and 5082) require whole blood specimens.  The lab has established specific rejection criteria for whole blood, which includes testing the viability of the cells in each sample received.  Whole blood specimens must have a cell viability of at least 80% when the sample arrives or the sample is rejected.  Two of the three samples received for this individual on 7/14/15 had cell viabilities of less than 80%.  Therefore, the samples were rejected for Panels 3013 and 5111 and the tests were not preformed.  However, the viability of the sample for Panel 5082 passed, as it was greater than 80%.  The ordered test was therefore performed.  All results passed the laboratory’s quality assurance (QA) processes and were released to the customer.  Pharmasan Labs has specific guidelines which determine whether or not results from an assay pass or fail.  Every batch is analyzed and reviewed by multiple people, including the laboratory director.  When results fall outside of the expected range, the test is repeated or a new sample is requested.  Upon statistically analyzing the specific results for this individual, none of the results were outliers.  While the majority of the results were below the reference range, the specimen and results did meet all of the QA criteria.  It is not abnormal for many cytokine results to fall outside of the reference range or below the measuring range; this does not automatically make a result invalid.  The statistical analysis of the data is used to determine if the results are unreliable and a new sample is required.  Results below the measuring range can be due to a number of different reasons.  Sample storage and handling, such as exposure to extreme heat, is one possible reason for low cytokine readings.  Improper blood draw technique is another factor that can affect the quality of a blood sample.  However, low cytokine levels can also be observed with the use of immunosuppressant medications or medial conditions that affect the immune system.  Therefore, low cytokine levels can actually be indicative of a patient’s health status and not only a result of improper sample handling.  Unfortunately, the lab is unable to identify the exact cause of low cytokine levels and is unable to determine if it is the health status of the patient or other outside factors.  In summary, the specimen and results for this individual met all of the QA criteria and the possibility of laboratory error has been ruled out.  The results were sent and the customer was charged for the test. In regards to the report being sent to the healthcare provider (HCP) without color graphics, there were a number of changes made to the stimulated cytokine report format that went into effect on 7/9/15.  Prior to this date, the cytokine results were graphed and displayed in color.  However, the new report format changes included removing the graphs as well as the color from the report.  No stimulated cytokine reports sent after this date include the colored graphics previously reported.  The samples for this patient were received after the changes took place.  Therefore, the report was sent in the new format with no color graphics.  Pharmasan Labs’ and NeuroScience’s direct customers are the healthcare providers who are licensed to order testing for their patients.  Therefore, when a report is complete, a copy is sent to the ordering HCP.  They are welcome to share a copy of the results with their patient, as appears to have happened in this situation.  However, if a patient desires to have us send a copy of their results sent directly to themselves, they must fill out a Release of Records form and include a copy of a government-issued ID with a signature.  In accordance with HIPAA regulations, this process allows us to ensure that the results are being sent to the correct individual.  However, if this individual chooses to go through the Release of Records process, the same report that was sent to the HCP will be sent to the patient as well.  It will not have the colored graphics the individual is requesting because the actual report format has changed.  Ultimately, Pharmasan Labs still stands behind the results released and did not find an error made on the lab’s behalf.  However, we do understand the concerns of this individual and believe in quality customer service.  Although we supply cool packs to help regulate the exposure to high temperatures during shipment, we do understand that heat exposure could have been a possible factor in the quality of this particular sample.  We will be in contact with this individual and his healthcare provider to discuss a resolution to his concerns.  Best,[redacted]
[redacted]NeuroScience Inc.373 280th Street - Osceola, WI 54020 – USAtel +1-715-294-2144, fax +1-715-294-3921www.neuroscienceinc.com

Review: Neuroscience Inc. provides testing services through Pharmasan Labs, Inc. located in Osceola, WI. This issue involves my desire to have specific immunological blood tests performed by Pharmasan Labs. My blood samples were sent by my doctor overnight to Pharmasan Labs on 7/14/15 for three separate tests (Panels 3013, 5111, and 5082). Although the blood samples are shipped with cold packs, they likely became degraded on the shipping trucks because of the very high heat at my location (Arizona). The company immediately recognized that the tests for Panels 2013 and 5111 were invalid because of sample degradation and never charged me for them. However, for some reason they did not reach the same conclusion for Panel 5082 and charged me $625. They faxed initial results of this test to my doctor which I have obtained. This test checks for many types of cytokines in the blood and the results in virtually all instances show undetectable levels (<0.2). This cannot be possible and proves that the test results are completely invalid.

In the meantime we tried repeating the Panel 3013 and 5111 tests. Blood samples were again shipped overnight to Pharmasan Labs on 8/13/15. Once again the samples were likely degraded because of the high heat in Arizona. The company recognized this and reversed the charges for both of the tests.

I have spoken to the company billing multiple times trying to get the $625 charge removed for Panel 5082. Calls were made on 8/19/15, 8/21/15, and 8/27/15. My doctor’s office has also made calls to the company informing them that the test was invalid but without any result.

Results of the test are normally provided with color graphics showing the cytokines that are out of normal range. This is not what they faxed to my doctor; she only received a printout of individual cytokine values. My doctor has requested that they directly send me a copy of graph results for Panel 5082 but they never have (probably because the results are invalid).

I do not believe I should be paying for invalid test results especially when I can’t even get a copy of them.

Business

Response:

Pharmasan Labs strives to provide quality testing in order to support the needs of healthcare businesses, including their practitioners and patients. Pharmasan Labs is certified by the Clinical Laboratory Improvement Amendments (CLIA) program (CLIA ID# [redacted]) and New York State Department of Health (PFI# 7426). The three test profiles ordered by this individual (Panels 3013, 5111, and 5082) require whole blood specimens. The lab has established specific rejection criteria for whole blood, which includes testing the viability of the cells in each sample received. Whole blood specimens must have a cell viability of at least 80% when the sample arrives or the sample is rejected. Two of the three samples received for this individual on 7/14/15 had cell viabilities of less than 80%. Therefore, the samples were rejected for Panels 3013 and 5111 and the tests were not preformed. However, the viability of the sample for Panel 5082 passed, as it was greater than 80%. The ordered test was therefore performed. All results passed the laboratory’s quality assurance (QA) processes and were released to the customer. Pharmasan Labs has specific guidelines which determine whether or not results from an assay pass or fail. Every batch is analyzed and reviewed by multiple people, including the laboratory director. When results fall outside of the expected range, the test is repeated or a new sample is requested. Upon statistically analyzing the specific results for this individual, none of the results were outliers. While the majority of the results were below the reference range, the specimen and results did meet all of the QA criteria. It is not abnormal for many cytokine results to fall outside of the reference range or below the measuring range; this does not automatically make a result invalid. The statistical analysis of the data is used to determine if the results are unreliable and a new sample is required. Results below the measuring range can be due to a number of different reasons. Sample storage and handling, such as exposure to extreme heat, is one possible reason for low cytokine readings. Improper blood draw technique is another factor that can affect the quality of a blood sample. However, low cytokine levels can also be observed with the use of immunosuppressant medications or medial conditions that affect the immune system. Therefore, low cytokine levels can actually be indicative of a patient’s health status and not only a result of improper sample handling. Unfortunately, the lab is unable to identify the exact cause of low cytokine levels and is unable to determine if it is the health status of the patient or other outside factors. In summary, the specimen and results for this individual met all of the QA criteria and the possibility of laboratory error has been ruled out. The results were sent and the customer was charged for the test. In regards to the report being sent to the healthcare provider (HCP) without color graphics, there were a number of changes made to the stimulated cytokine report format that went into effect on 7/9/15. Prior to this date, the cytokine results were graphed and displayed in color. However, the new report format changes included removing the graphs as well as the color from the report. No stimulated cytokine reports sent after this date include the colored graphics previously reported. The samples for this patient were received after the changes took place. Therefore, the report was sent in the new format with no color graphics. Pharmasan Labs’ and NeuroScience’s direct customers are the healthcare providers who are licensed to order testing for their patients. Therefore, when a report is complete, a copy is sent to the ordering HCP. They are welcome to share a copy of the results with their patient, as appears to have happened in this situation. However, if a patient desires to have us send a copy of their results sent directly to themselves, they must fill out a Release of Records form and include a copy of a government-issued ID with a signature. In accordance with HIPAA regulations, this process allows us to ensure that the results are being sent to the correct individual. However, if this individual chooses to go through the Release of Records process, the same report that was sent to the HCP will be sent to the patient as well. It will not have the colored graphics the individual is requesting because the actual report format has changed. Ultimately, Pharmasan Labs still stands behind the results released and did not find an error made on the lab’s behalf. However, we do understand the concerns of this individual and believe in quality customer service. Although we supply cool packs to help regulate the exposure to high temperatures during shipment, we do understand that heat exposure could have been a possible factor in the quality of this particular sample. We will be in contact with this individual and his healthcare provider to discuss a resolution to his concerns. Best,[redacted]

[redacted]NeuroScience Inc.373 280th Street - Osceola, WI 54020 – USAtel +1-715-294-2144, fax +1-715-294-3921www.neuroscienceinc.com

Consumer

Response: