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QCAM ERRATA & UPDATES

We would appreciate your input should you find errors, learn or updated information, or have suggestions to improve the text. Contact the author by email (put QCAM in the subject line of your message): kailin@convergentmedical.com

Dated entries are found below:

2006 QCAM ERRATA & UPDATES

08/24/06 Errata

Page 159: Second word of second full paragraph ("Interventions") should be in boldface type.

Page 201: Correction of citation:

ACCR 1992. Diagnostic Imaging In Chiropractic For General And Specialty Practice. Practice Guidelines Committee, ACCR.

10/10/06 Update: Safer retractable lancets

The discussion of safer medcial devices (p134) gives several examples of sharps with engineered sharps injury protection (SESIPs). Another example is single use disposable retractable lancets, which can be used for bleeding acupuncture points, or for drawing a drop or two of capillary blood for various blood tests.

10/19/06 Update: Influenza vaccination recommendations for health care personnel

The CDC now recommends annual influeza vaccination of all health care personnel (HCP), as well as obtaining a signed declination from those who decline when vaccination is not medically contraindicated. They suggest using HCP influenza vaccination rates as one measure of a clinic's patient safety or quality performance. As of 2005, seven States had legislation requiring annual influenza vaccination of HCP (or signed informed declination). For more information, see:

A. Influenza Vaccination of Health-Care Personnel, MMWR Reccommendations & Reports 55(RR02);1-16 Feb.24, 2006

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5502a1.htm

B. Recommendations for Influenza Vaccination of Health-Care Workers, MMWR Recommendations & Reports 55(RR10);1-42 Jul 28, 2006

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5510a1.htm

http://www.cdc.gov/flu/professionals/vaccination/hcw.htm

10/25/06 Update: California Prohibition Of Re-Use Of Acupuncture Needles

The QCAM text (p354, p480) states that one should never re-process acupuncture needles for re-use, and provides several reasons. The California Acupuncture Board has added another reason: on August 22, 2005, they approved regulations that require only single use of acupuncture needles, and that define re-use of acupuncture needles to be unprofessional conduct.

10/26/06 Update: Revised CMS-1500 Claim Form For April, 2007

The standard insurance claim form CMS-1500 will be changed in 2007. The primary alteration is inclusion of fields for the National Provider Identifier (NPI) number. If you have not applied for an NPI, then do so (use the link on p323). If you use a software program to fill out the CMS-1500, that software will need to be modified. The new CMS-1500 form may be used beginning Jan 2, 2007, and must be used beginning April 2, 2007 and thereafter. If you must re-bill after April 2, 2007 for a claim submitted on the old form, use the new form.

For a summary of all the changes in the form, see:

http://www.nucc.org/images/stories/PDF/final_1500_change_log.pdf

For the full National Uniform Claim Committee instruction manual, see:

http://www.nucc.org/images/stories/PDF/claim_form_manual_v1-3_7-06.pdf 


2007 QCAM ERRATA & UPDATES

06/19/07 Update: Pandemic Flu Guidance

OSHA recently posted an extensive document entitled Pandemic Influenza Preparedness and Response Guidance for Healthcare Workers and Healthcare Employers. It can be downloaded at: http://www.osha.gov/Publications/OSHA_pandemic_health.pdf

At this time, OSHA’s guidance is what it purports to be: timely guidance which does not create any new standards, regulations, duties or legal obligations. You can use this guidance to further develop your clinic’s emergency management and infection control plans.

A more encompassing set of pandemic flu related documents, maintained by Department of Health and Human Services, is posted at: http://www.pandemicflu.gov Use the Health Care Planning menu tab to locate those documents most relevant for healthcare contexts.

08/01/07 Update: FDA CGMP OPTIONS FOR HERBALISTS

The FDA published in the Federal Register on June 25, 2007 its final rule for current good manufacturing practice (CGMP) for dietary supplements. Herbalist practitioners are defined therein as manufacturers of dietary supplements subject to the rule. The FDA will consider the use of enforcement discretion with respect to such practitioners. Given the rule's requirements and the FDA's enforcement stance, how should herbal practitioners proceed in response? A 2-page pdf file in the Newsdesk section of this website presents the pros and cons of three options for herbalists.


09/10/07 Update: CMS ISSUES STARK III FINAL RULE

On September 5, 2007, Centers for Medicare & Medicaid Services (CMS) published in the Federal Register the third version of the Stark Rule, which governs self-dealing and kickbacks in the treatment of Medicare and Medicaid patients. The final rule takes effect December 4, 2007. A one page pdf file in the Newsdesk section of this website guides you to the text of the final rule, and to CMS resources on self-dealing.


2008 QCAM ERRATA & UPDATES

02/19/08 Update: The Dietary Supplement and Nonprescription
Drug Consumer Protection Act

A brief summary of the FDA Dietary Supplement and Nonprescription
Drug Consumer Protection Act is located under the Newsdesk
heading on the website. The law applies to dietary supplements,
defined as a vitamin, herb or other botanical, amino acid,
supplement, concentrate, metabolite, constituent, extract,
or combination of any of the above intended for ingestion.
The law requires reporting and record keeping of serious
adverse events associated with dietary supplements
marketed in the US.

To access FDA Form 3500A:

http://www.fda.gov/medwatch/how.htm

To access the FDA Draft Guidance document:

http://www.cfsan.fda.gov/~dms/dsaergui.html


2010 QCAM ERRATA & UPDATES


February 15, 2010 Update: Change in guidance re: cupping devices

QCAM, p482, classifies cups that have not drawn blood or OPIM as non-critical instruments which require intermediate level or low level disinfection prior to re-use. This update in guidance classifies all cups as critical instruments which require sterilization prior to re-use. Because many cups are made of materials unable to withstand sterilization, the practical approach is to treat all cups as single use disposables, and to adjust fees to reflect this cost.

It would be acceptable to use cup liners, dispose of the used liners, and re-use the cups. But cup liners only come in two inch diameter, and they have a hole at their apex to transmit the vacuum. This design feature means that if the cup draws blood or fluids, the liner and the cup may be contaminated, and both should be safely disposed. The use of cup liners also requires a system for segregating used cups whose liners have not been obviously contaminated by blood or OPIM, from all other used cups. There is less room for error if all cups are treated as single use disposable items.

The rationale for this change in guidance is drawn from the observation that with strong pressure in the cups, there is a potential for skin micro-abrasions where the lip of the cup presses against the skin. This may - or may not - cause microscopic blood contamination of the lip of the cup. Furthermore, sometimes strong cupping pressure unintentionally draws visible blood or OPIM into the cups. Hence there is the possibility of unintentionally drawing minute quantities of blood or OPIM into cups, below the level of unaided visible perception.  We may well be erring on the side of safety to classify all cups as critical instruments. We will do so until research data supports revisions.