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People, Places, Processes & Products that Influence the Supply Chain

 

INSIDE THE CURRENT ISSUE

March 2010

Letters

Dear Editor:

I need to see if you can give me some suggestions or lead me in the right direction on storage questions that I have. First of all, I have worked in surgery for 20 years and I am used to supplies, equipment, decontam, clean and sterile areas being kept separated. So, now that I am working in an ER I feel like I am in a different world. We are remodeling and I have asked for a supply storage room to keep clean and sterile patient care items separate from equipment and clerical supplies. I was told that our ice machine would have to be housed in this new supply room. I just don’t feel comfortable with this (strike through-contaminations?). Can you direct me to some documentation that would ease my mind either way?

AllaMae Hickox, AAS-CST

Dear Ms. Hickox:

To answer your question - not as a clinician but as a journalist - I recommend you contact your local chapter, regional group or even the national group of AORN and APIC, either of whom should have that documentation, hopefully for your state. You might also want to contact AAMI as a viable information source.

Personally and professionally, I would vote against installing an ice machine in the sterile supply room. Again, I’m not a clinician and only am relying on my reporting and research background. My logic goes something like this. Sterile means absence of bacterial and viral microorganisms, which can linger on solid surfaces, liquid surfaces and in the air. Ice is nothing more than frozen liquid. Even contained, ice can harbor microorganisms. Clinicians who do not wear proper PPE in a sterile environment (e.g., gloves, etc.) can transmit bodily secretions (e.g., sweat, shed skin cells, etc.) that potentially can contaminate the environment. Also, I believe a Virginia college recently publicized a study that found e.coli in the tubing of ice machines or soda dispensing machines that posed a risk of transmission.

Bottom line: I think it’s a bad idea. But I’m not a clinician. All you might be able to do is raise the specter of infection being introduced, which can contaminate HCWs or even patients and then seal the deal by saying this would be considered a preventable medical error by CMS, which means your facility would not be reimbursed for any post-infection treatment possibilities. I hope that helps.

Sincerely,
Rick Dana Barlow
Senior Editor, Healthcare Purchasing News

Editor’s Note: Hickox noted in a follow-up e-mail: "I do appreciate everyone who responded to this question. I have brought this to my supervisor’s attention and the contractors are working on a modified design (which is already almost completed) to put the ice machine somewhere else."


Dear Editor:

I was just reading your article posted here: www.hpnonline.com/inside/2010-02/1002-CSsolutions.html  [CS Solutions, February 2010].  

Considering this recent discovery of vCJD found in SPLEEN1, instruments used on spleen should be incinerated, and not considered ‘low-risk’! In my opinion, you are playing with fire, possibly putting hundreds if not thousands of patients’ lives at risk by not disposing of and incinerating EVERY instrument that ever comes in contact with ANY part of a CJD victim’s body.

In the study, "Variant CJD infection in the spleen of a neurologically asymptomatic UK adult patient with haemophilia", which was published online January 12, 2010, in Haemophilia1, the authors noted: 

"Summary: All UK patients with bleeding disorders treated with any UK-sourced pooled factor concentrates between 1980 and 2001 have been informed that they may be at an increased risk of infection with variant Creutzfeldt–Jakob disease (vCJD). We describe a study to detect disease-associated, protease-resistant prion protein (PrPres) in 17 neurologically aysmptomatic patients with haemophilia considered to be at increased risk of vCJD…

"A single specimen from the spleen of one autopsy case gave a strong positive result on repeated testing for PrPres by Western blot analysis. This tissue came from a 73-year-old male patient with no history of neurological disease, who was heterozygous (methionine/valine) at codon 129 in the prion protein gene. He had received over 9000 units of factor VIII concentrate prepared from plasma pools known to include donations from a vCJD-infected donor, and some 400 000 units not known to include donations from vCJD-infected donors. He had also received 14 units of red blood cells and had undergone several surgical and invasive endoscopic procedures. Estimates of the relative risks of exposure through diet, surgery, endoscopy, blood transfusion and receipt of UK-sourced plasma products suggest that by far the most likely route of infection in this patient was receipt of UK plasma products." 

Also, a study published January 2010 in PLOS One,2 concluded, "Our results indicate that the number of organs affected in vCJD is greater than previously realized and further underscore the risk of iatrogenic transmission in vCJD."  

Sincerely,
Barb Dunsmore, San Diego

Editor’s Note: Dunsmore noted: "I’m just a layperson doing my small part to raise awareness about CJD by commenting on articles I read. I’ve been a member of cjdVoice@yahoogroups.com  for a few years, a wonderful support group for families of victims to CJD." See additional references below.

References:

1. "Variant CJD infection in the spleen of a neurologically asymptomatic UK adult patient with haemophilia," Haemophilia, Published Online: Jan 12, 2010. http://www3.interscience.wiley.com/journal/123238033/abstract

2. "Multiorgan Detection and Characterization of Protease-Resistant Prion Protein in a Case of Variant CJD Examined in the United States," PLoS One. January 2010, Volume 5, Issue 1. Published Online: Jan 19, 2010. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2808239/pdf/pone.0008765.pdf

3. "Fast, broad-range disinfection of bacteria, fungi, viruses and prions," Originally published as JGV in Press, on October 28, 2009. J Gen Virol 91 (2010), 580-589; DOI 10.1099/vir. 0.016337- 0. http://vir.sgmjournals.org/cgi/content/abstract/91/2/580?maxtoshow=&HITS=10&hits=
10&RESULTFORMAT=&fulltext=
prion&searchid=1&FIRSTINDEX=0&volume=91&issue=2&resourcetype=HWCIT

4. "ProMetic Life Sciences Inc./VCJD Infection: A Continuing Threat to Public Health." http://interestalert.com/story/02040000aaa05c6d.iw/siteia/SAFETY01/safety.html


To the Editor:

I read with interest your article on the potential for – and wisdom of – vendor-credentialing standards ("Data standards for vendor reps debatable"). If hospitals could agree on the information they require of their vendors, costs for everyone in the supply chain would be reduced. As your sources point out, however, that’s a tall order if no one resolves to lead the charge.

As president (and now past-president) of IMDA, the association for specialty sales and marketing companies, I have been quite involved in the vendor-credentialing issue. Last year, IMDA was part of a consortium of associations – including AHRMM, AORN, AdvaMed, HIGPA and others – that hammered out recommended standards for the credentialing of "clinical" sales reps, that is, those who call on areas in close proximity to patients receiving treatment. Unfortunately, AHRMM withdrew its support for this document at the last moment. But the other organizations have stood by it. (To see the document, go to www. IMDA.org and click on the vendor credentialing box.)

As the people you interviewed point out, there’s no way standards can be legislated or pushed down materials managers’ throats. Even if it were possible to enforce, it seems inconceivable that any one metric could "measure up" an organization’s financial viability/ability to provide products & services.

If this were possible, I feel certain that Wall Street would have had much more visibility to our current economic crisis WELL in advance of it’s coming to pass. Alas, such is not the case. Conversely, millions of us successfully fly all over the globe everyday on bankrupt airlines. Clearly, there is not a "one-size-fits-all" diagnosis that a vendor credentialing company can use to identify risk in the supply chain.

That said, we believe that it is in the best interest of all players in the supply chain to bring some order to this process. IMDA members – many of which are small companies – incur huge costs in terms of dollars and time to meet the many, varied, credentialing requirements of all our customers. I know of at least one major US manufacturer who spent $1 million in 2009 on vendor credentialing. Due to these credentials artificially "expiring" after one year, they will no doubt spend at least another $1 million in 2010.

We’re heartened that the Healthcare Industry Supply Chain Institute – a sister organization to the Health Industry Group Purchasing Association – has commissioned a study to try to attach a dollar amount to today’s vendor credentialing activities. We believe HISCI will find the amount to be in the hundreds of millions of dollars.

Hospitals admit that ultimately, these fees will more likely than not get passed along to them in the form of price increases. This benefits no one, as there is no discernable increase in patient safety or quality of care as a result of all this expenditure.

If voluntary standards were to be put in place, we believe that a system not unlike that of today’s credit reporting system – mentioned several times in your article – could take shape. Vendors could register with these companies once, and hospital supply chain executives could scan proof of credentialing on demand, or reps could show a "Vendor Passport" that would enable them to get a badge.

Materials managers and suppliers should work together to get standards in place now. To wait until the industry adopts electronic health records, as one of the people you spoke to suggested, would be wasting an opportunity to improve efficiency in the supply chain. Indeed, the argument for delaying standardization in this area seems only to serve the cottage industry that vendor credentialing has become. The rest of us, hospitals, distributors and manufacturers alike, end up paying more and more as the chaos continues.

Now that Joint Commission has unequivocally stated that it is bowing out of the vendor credentialing morass1, it falls to the rest of us to get together and try to make some sense out of an out-of-control process. I implore you and your members to come up with a national standard—similar to a Code of Ethics—which your members would embrace and enforce. There are many organizations in this industry who would happily work with you to achieve this goal in a timely and cost-effective basis.

Thank you.
Shawn Walker
Partner, Bay State Anesthesia, North Andover, MA

Reference:

1. http://www.jointcommission.org/AccreditationPrograms/LongTermCare/
Standards/09_FAQs/HR/hc_industry_vendor_representatives.htm

2. http://interestalert.com/story/02040000aaa05c6d.iw/siteia/SAFETY01/safety.html