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   Ethics and
   Certification
   
Ethics: The way we do things
‘More than a business’


BoneSA is more than just a business. We do not sell ‘things’. Our first priority is to care about the human beings who have been disabled by disease or injury and are recipients of bone and tissue. It is our calling to build a bridge between those who unselfishly give of themselves and those who need this. Four values form the pillars of our bridge:

  • Integrity
  • Reliability
  • Innovation
  • Excellent service and quality product

Our integrity compels us do the right thing fairly, consistently and with respect Even when no none is watching. We know that the right thing to do is to preserve the dignity of our donors and those that benefit from this. It is with respect that we interact with each other, our clients and our partners to construct our donor-recipient bridge. Therein lies the trust of all those people whose lives we touch.
We acknowledge that we have an obligation to promote reliability in all that we do. Those that depend on us deserve nothing less. We make truthful promises and keep them. Our systems and processes are transparent, effective and easy to apply. As leaders and employees we get the job done through dedication, teamwork and supportive relationships. We strive to improve our competence and know that others’ trust is determined by our consistent quality and becoming better at what we do.
The sustained quality of the bridge we build is dependent on our innovation. We constantly explore and research new partnerships, the optimisation of processes, new technologies, response time, the improvement of our environmental footprint, and continued adherence to international quality standards. Improving the quality of how we do things build the reputation and value of our brand.
Our drive to maintain excellent service and quality product determine our reputation as the leading name in human bone and tissue supply. We aspire to go beyond mere sustainability. Our sustainable development and longevity is accomplished through financial accountability and security. We aim to be around for many years for our current and potential recipients, donors, partners and colleagues.
We live these values, with pride and humility. We love what we do. Above all, we care.



Certification:

Bone SA ISO:
(see certificate)

Ensure we consistently adhere to the highest standards of operational
excellence - distinguishing ourselves not only through our product offerings, but also through our business
practices. Bone SA is fully ISO 9001-2008 certified and are consistently searching for new ways to improve
everything we do.

B-BBEE Certification:
(see certificate)


Tax Clearance Certification:
(see certificate)
Empowerment rating.

SAMED:
(see certificate.
Bone SA is an active member of Samed. www.samed.org.za

CRICE:
(see certificate) Company Representative in Clinical Enviroment
Alida Rossouw
Ana Sterrenberg
Lauren Tweedie
Alishia Steyn
Lidia Naude
Gisele Anderson
     
   
     Tshwane-logo
      CTE ISO:
     See certificate ISO 9001: 2015.
      All bone allografts supplied by Bone SA are procured and processed with utmost care by
      the Centre for Tissue Engineering at the Tshwane University of Technology.

      The Centre for Tissue Engineering, (CTE) is a unique and specialised Centre within the Tshwane University of
      Technology and is situated at the Council for Scientific and Industrial Research (CSIR), in Pretoria. In our efforts
      to maintain tissue engineering and tissue banking at the highest level of quality and safety, the CTE:
•     Has acquired both the ISO 9001: 2015 (Quality Management Systems).
•     Can accept donated tissue according to section 3(1) of the Human Tissue Act, no 65 of 1983.
•     Processes, quality inspects and packages all allografts within ISO 14644-1 (ISO Class 7) and (ISO Class 5)
      Certified Clean Rooms, respectively.
•     Ensures that all pathology reports are reviewed by the Centre’s Medical Director for approval before tissue is
      released for processing.
     
   
     Tissue donor selection criteria
      The suitability of a specific donor for tissue allograft donation is based upon medical and behavioural history,
      a medical review, physical examination and donor autopsy findings. Donor evaluation includes an interview of the
      donor’s next of kin, performed by the liaison officer, and/or the tissue network manager..
     
   
Exclusion criteria: general contra-indications
•     History of chronic viral Hepatitis.
•     Presence of active viral Hepatitis or jaundice of unknown etiology.
•     History of, or clinical evidence, or suspicion, or laboratory evidence of HIV infection.
•     Risk factors for HIV, HBV and HCV have to be assessed by the Medical Director.
•     Presence or suspicion of central degenerative neurological diseases.
•     Use of all native human pituitary derived hormones (e.g. growth hormone),
      possible history of dura-matter allograft, including unspecified intracranial surgery.
•     Septicemia and systemic viral disease or mycosis or active tuberculosis.
•     Presence or history of malignant disease.
•     History of connective tissue disease.
•     Significant exposure to a toxic substance.
•     Presence or evidence of infection or prior irradiation at the site of donation.
•     Unknown cause of death
.
     
     
Retrieval instrumentation and inspection
All instruments are sterilised before every retrieval. Syringes and needles are inspected to ensure that packaging
is sealed before opening. The retrieval site must be according to hygenic specification.
The body is then inspected for any signs of contra-indications to donation. Areas from which tissue is to be
removed, and the retrieval surfaces are disinfected prior to retrieval.


Retrieval
The retrieval officer wears gloves, gown, a mask and protective shoes. A tissue sample and three blood
samples are taken from the donor for viral and bacterial testing.

Labelling and transportation
Containers are sealed and clearly marked with the following signage:

Keep Frozen
Medical Products
Tshwane University of Technology
Delivery Address
Date and time of retrieval
Retrieval officer’s name, etc.


The tissue retrieval officer seals, labels and signs all retrieval tissues. He/she notifies the national tissue network
manager to make suitable arrangements for the safe and controlled transportation of the tissue according to ISO
protocol.


Receiving a record
The retrieved tissues are received at the CTE by the QC manager, who inspects the parcel to see if the seal is still
intact. The bag inside the box is given a specimen number and quarantine sticker is attached.
This sticker is initialled, and dated, type and specimen of bone indicated. The bone is put in a quarantine freezer
until all the blood tests and mircobiological results are received.


Screening
Blood samples are centrifuged immediately upon arrival.
A pathology test request form is completed and results, once received are paired with the donor information form
signed by the Quality Manager. All results are noted in the donor information logbook. From here the tissue is
either stamped QC passed, or QC failed, in which case it is placed in a biological waste container for incineration.
     
         Q&A
   
      Safety
1.   What measures does the CTE utilise to ensure disease free allografts?
      CTE performs an extensive panel of serology tests for viruses/bacteria including Hepatitis B & C, Syphilis
      and HIV. Donor tissue is also tested for HIV DNA with the PCR method. Aerobic and anaerobic microbial
      testing is also conducted on donor tissue samples. Once packed and labelled, all allografts are further
      terminally sterilised by Gamma Irradiation, to ensure disease free and safe allografts.

2.   What is PCR testing?
      PCR is short for Polymerase Chain Reaction and is a highly sensitive molecular assay that can detect the HIV
      virus. Not all tissue banks utilise this test and hence this is another example of the CTE surpassing the
      competition in ensuring safe and superior quality allografts.

3.   How does the CTE ensure traceability of the tissue allografts?
      Each allograft processed by the CTE is identified and traced by a unique product reference number. Through
      the use of this unique traceability system, one is able to trace and link the entire process flow of the tissue from
      the donor to the recipient. Documentation and record keeping are tools to ensure traceability, however
      maintaining the confidentiality of donor information is vital to the CTE too.

4.   What is donor pooling? Does CTE participate in donor pooling?
      Donor pooling is a cost reduction policy that many tissue banks practice. Pooling is when tissues from several
      donors are processed and packaged together (pooled) into a single distribution lot. At the CTE, each donor is
      individually processed and packaged to ensure complete traceability.
     
 
 
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