anesthesia – ProCRNA

Clinical Topic: Patient Safety, The Helsinki Declaration

The European Board of and Society of Anesthesiology have adopted the Helsinki Declaration for Patient Safety in Anesthesia and have made recommendations for standards that further improve patient safety.

The authors state that patient safety has 3 components; a set of guiding principles, a body of knowledge and a collection of tools. The basic principles are the tendency for things to go wrong is both natural and normal, rather than an opportunity to find someone to blame; safety can be improved by analyzing errors and critical incidents, rather than pretending they have not happened; and humans, machines and equipment are all part of a system, the component parts of which interact to make the system safe or unsafe.

The following Abstract was printed in the European Journal of Anesthesiology:

Anaesthesiology, which includes anaesthesia, perioperative care, intensive care medicine, pain therapy and emergency medicine, has always participated in systematic attempts to improve patient safety. Anaesthesiologists have a unique, cross-specialty opportunity to influence the safety and quality of patient care. Past achievements have allowed our specialty a perception that it has become safe, but there should be no room for complacency when there is more to be done. Increasingly older and sicker patients, more complex surgical interventions, more pressure on throughput, new drugs and devices and simple chance all pose hazards in the work of anaesthesiologists. In response to this increasingly difficult and complex working environment, the European Board of Anaesthesiology (EBA), in cooperation with the European Society of Anaesthesiology (ESA), has produced a blueprint for patient safety in anaesthesiology. This document, to be known as the Helsinki Declaration on Patient Safety in Anaesthesiology, was endorsed by these two bodies together with the World Health Organization (WHO), the World Federation of Societies of Anaesthesiologists (WFSA), and the European Patients’ Federation (EPF) at the Euroanaesthesia meeting in Helsinki in June 2010. The Declaration represents a shared European view of that which is worthy, achievable, and needed to improve patient safety in anaesthesiology in 2010. The Declaration recommends practical steps that all anaesthesiologists who are not already using them can successfully include in their own clinical practice. In parallel, EBA and ESA have launched a joint patient safety task-force in order to put these recommendations into practice. It is planned to review this Declaration document regularly.

The original article by Staender et al is a “must read” for all providers who sincerely seek to improve patient safety. Click here to read the original article.

Return to procrna.com to share your thoughts with your colleagues.

Legal Topic: Documentation

Same Song Different Verse – If It Wasn’t Documented…..

Consider for a moment, that you or a colleague is facing legal action that, on the face of things, appears absurd. How absurd? Well, think for a moment about the first time that you learned how to place an intravenous (IV) line. The first thing that you were taught to do (after determining the correct patient, catheter size, and limb selection) was – clean the site. Traditionally we used alcohol either provided in an IV start kit or provided by our facility. How many of us thought about, or consulted the relevant science, regarding which preparation solution was actually better for patient care?

Now lets take it up notch. Consider what you do as an anesthesia provider when you are preparing to place an epidural catheter or a subarachnoid block. Most of the kits that we used in school and current practice have supplied within them a skin cleansing preparation. According to one manufacturer, B. Braun (bbraunusa.com/images/bbraun_usa/bbrauncatalog.pdf; F3), the supplied cleaning preparation in standard single dose epidural trays is povidone iodine. Again, how many of us question the skin preparation solution provided in a kit by a manufacturer that our facility has chosen to select for us? Relevant science indicates that a better skin preparation solution for neuraxial blocks is chlorhexidine. Furthermore, this solution is optimal when used from a single use package, instead of poured from a multi-use container.

What is the importance of such minutiae? Well, suppose a post-partum patient presented to the ER 4 days after discharge from the mother-baby unit of Smallville Community Hospital with the following symptoms: low grade fever, back ache, intermittent weakness of the right lower extremity. During her ER workup, the on call anesthesiologist, Dr. Nurves, is consulted since the patient had an epidural for labor analgesia. After his physical exam, Dr. Nurves suspects the patient has an epidural abscess. He orders an MRI that confirms his suspicions. Now fast forward 18 months. The patient decides to file a claim against her anesthesia providers for causing the pain and disability from which she now suffers. She suspects her current problems are from the epidural abscess…….

When an attorney is tasked to evaluate this type of claim, the attorney will seek a healthcare professional who is familiar with the standards of care surrounding the activities related the client’s labor epidural for analgesia. Imagine the professional conundrum provided by the following clause on the anesthesia record “Sterile prep and drape” without further elaboration. Would it make any difference if we added another detail: the epidural was placed by a trainee (either physician or nurse) and the use of the trainee was NOT noted on the anesthesia record. Additionally, the patient, and her spouse, recalls multiple attempts at placing the epidural; this is also not noted on the chart. So how does one determine if standards of customary practice were met in such a situation? The use of the trainee, and the multiple attempts at placing the epidural catheter are not documented in the records. These items are not facts in evidence. It is a fact however, that if cultures are obtained from an epidural abscess with bacterium that are not normally found in the epidural space, AND the patient’s physical exam prior to the placement of the epidural does not specifically indicate a bacterial infection in the area where the epidural catheter was to be placed AND (perhaps most importantly to us) the modality for transmission of bacterium into the epidural space is under the exclusive control of the anesthesia provider, then supporting data can be introduced to create a scenario whereby the anesthesia providers who placed the epidural catheter caused the epidural abscess AND the related sequela. What type of supporting data? Standards of care regarding neuraxial blockade; sterile skin preparation; and care documentation. Documents of professional standards, along with several peer- reviewed clinical reports regarding sterile skin preparation are readily available in any medical library (electronic or traditional) or via the world wide web.

A well researched review providing the who, what, when, where, and why of how we are supposed to practice our craft can speak volumes to a trier of fact (a judge or a jury) as to whether or not a patient’s claim has merit. So what is the take home message: Know and adhere to your professional standards of care (review them if necessary) and keep up with the state of your science.

Pamela Chambers, MSN, CRNA, EJD
www.lexterraeconsulting.com

References
Barash, P.G., Cullen, B.F., & Stoelting, R.K. Clinical Anesthesia 3rd Ed. Ch 26 Epidual and Spinal Anesthesia p 651 Lippincott Raven, New York 1997

Birnbach D.J. et al, Povidone Iodine and skin disinfection before initiation of epidural anesthesia. Anesthesiology. 1998; 88:668-672

Nagelhout, J. J., Zaglaniczny, K.L. Nurse Anesthesia 3rd Ed. Ch 44 Obstetric Anesthesia p 1066 Elsevier Saunders, St. Louis 2005

Stoelting, R. K., Miller, R.D. Basics of Anesthesia 3rd Ed., Ch. 12 Spinal and Epidural Anesthesia p 173, Churchill Livingstone, New York. 1994

Pamela Chambers, MSN, CRNA, EJD
www.lexterraeconsulting.com

Clinical Topic: Controlled Substances and State Law

CRNAs are certified as qualified to practice by the Council on Certification and Recertification of Nurse Anesthetists. In addition, they must be licensed to practice nursing by the state in which they practice. Questions often arise regarding prescriptive authority and the legal ability to use controlled substances in our daily practice. Laws vary from state to state. Below is an excellent review of the Law of the State of Texas prepared by Pamela Chambers, CRNA. Contact Ms Chambers at Lex Terrae consulting if you have questions about the laws in your state.

Submitted by Pamela Chambers, MSN, CRNA, EJD

Every year new laws become effective that affect all of us. Some are so obscure that we never become aware of them – unless we violate them. As mentioned in earlier articles, ignorance of the law is rarely a defense to violating it. Two recent legislative changes (i.e. new laws) that affect nurse anesthesia practice are the new consent requirements and the controlled substance program requirements.

Title 25 of the Texas Administrative Code (Health Services) Part 7 (Texas Medical Disclosure Panel) Chapter 601 (Informed Consent) codifies the requirements of the Texas Civil Practice and Remedies Code, Chapter 74, Medical Liability, Subchapter C, section 74.102. In English: the new consent rules are laws that further explain the law regarding medical liability in Texas. The importance of this cannot be overstated. The new consent procedure, requiring a specific form to be completed and signed by the anesthesia practitioner, is a law. This is not “just another rule” designed to test our memory of rules. This new law was likely the result of changing health care realities (i.e. such as the patient who awakens from surgery having had procedures that were necessary but not specifically discussed prior to induction). When society changes we have the ability to change our laws to reflect the will of the electorate, and the good of society.

In an effort to protect society by controlling dissemination of federally controlled substances, the Texas Department of Public Safety (DPS) requires registration of all individuals who possess a DEA# for the purpose of prescribing, or dispensing controlled substances in the state of Texas. As with many of our laws in every state of the union, this instance derives from federal law.

In the State of Texas, relevant guidance pertaining to controlled substances is found in the Controlled Substance Act; Title 21 United States Code (USC) sections 801-971 (specifically sections 821-829); Department of Justice Drug Enforcement Agency (DEA) Clarification of Registration Requirements for Individual Practitioners 21 Code of Federal Regulations (CFR) Part 1301; and Texas Occupations Code Title 3 Health Professions Subtitle B Physicians (“medical practice acts”) Chapter 157 Authority of Physician to Delegate Certain Medical Acts.

Additionally, registered nurses are governed by the Texas Occupations Code Title 3 Subchapter E Regulation of Nursing (“nurse practice acts”) Chapter 301 Nurses. Section 301.154 section (a) states the following: Rules regarding delegation of certain medical acts. (a) The board may recommend to the Texas State Board of Medical Examiners the adoption of rules relating to the delegation by physicians of medical acts to registered nurses and vocational nurses licensed by the board. In making a recommendation, the board may distinguish between nurses on the basis of special training and education. Further, chapter 222 of the Texas Board of Nursing Rules and Regulations relating to Nurse Education, Licensure, and Practice states that for approval of prescriptive authority, an RN shall “have full licensure from the Board to practice as an advanced practice registered nurse” and submit an application with evidence of successful completion of specific graduate level courses.
Subsection 157.0511 of the medical practice acts indicates the following: Prescription Drug Orders (a) A physician’s authority to delegate the carrying out or signing of a prescription drug order under this subchapter is limited to: (1) dangerous drugs; and (2) controlled substances to the extent provided by Subsection (b). Subsection (b): A physician may delegate the carrying out or signing of a prescription drug order for a controlled substance only if: (1) the prescription is for a controlled substance listed in Schedule III, IV, or V as established by the commissioner of public health under Chapter 481, Health and Safety Code… (4) (b-1) The board shall adopt rules that require a physician who delegates the carrying out or signing of a prescription drug order under this subchapter to register with the board the name and license number of the physician assistant or advanced practice nurse to whom a delegation is made. The board may develop and use an electronic online delegation registration process for registration under this subsection.
(c) This subchapter does not modify the authority granted by law for a licensed registered nurse or physician assistant to administer or provide a medication, including a controlled substance listed in Schedule II as established by the commissioner of public health under Chapter 481, Health and Safety Code, that is authorized by a physician under a physician’s order, standing medical order, standing delegation order, or protocol.

The Texas Department of Public Safety governs the Texas Prescription Program which regulates the dissemination of controlled substances to consumers in Texas. According to the DPS website, http://www.txdps.state.tx.us/RegulatoryServices/prescription_program/prescriptionforms.htm accessed January 12, 2012, “Every Official Prescription form, produced from January 1982 through the present, contains the practitioner’s DPS and DEA registration numbers, a unique control number and the DPS seal (as a watermark) on the face of the prescription. The modifications to the Official Prescription forms do not invalidate previously issued prescription forms. An Official Prescription form is considered valid if it contains the security features associated with that particular format/layout and the practitioner’s DPS Controlled Substance Registration number is current and valid.” Further, the DPS drug rules, subchapter D section 13.81 indicates specific actions to be taken if a prescription for a controlled substance is questionable, to wit: If a dispensing pharmacist receives an official prescription form that creates a substantial question or doubt in the mind of the dispensing pharmacist, the pharmacist must, before filling the prescription, communicate with the prescribing practitioner in order to resolve the question or doubt. Additionally, Section 481.061 Subsection 2 (h), of the Texas Health and Safety Code was amended to include the following rule “ A pharmacist may dispense a controlled substance listed in Schedule III, IV, or V under a written, electronic, oral, or telephonically communicated prescription issued by a practitioner defined by section 481.002 (39) (C) and only if the pharmacist determines that the prescription was issued for a valid medical purpose and in the course of professional practice…“

The available resources repeatedly indicate the requirement of the DEA# and registration in the DPS controlled substance registration program. Registrants in the Texas DPS controlled substance program may use the specified form which has the DEA# and DPS# preprinted on the prescription form. An advanced practice nurse who has satisfied all of the applicable state and federal requirements, may indeed prescribe controlled substances in Texas. However, an advanced practice nurse may also facilitate a prescription for controlled substances as a delegated duty from a supervising physician. In this capacity, the signature on the prescription form of an advance practice nurse acting on behalf of the supervising physician is the same as a valid signature from the prescribing physician. If, hypothetically, an error or omission is noted on a prescription form – the pharmacist has a duty as indicated in the above referenced statute to contact the prescribing provider to clarify the suspected error or omission.

Let’s use an example that may illustrate the importance of being aware of this law: Let’s say a CRNA has a DEA# because they have at one time practiced as a locums provider in an arrangement that required the individual CRNA have their own DEA# (i.e. without a supervising physician or “medical direction”); then the CRNA changes practice arrangements (i.e. relocates or takes another locums assignment) to a facility, which has its own DEA#, and permits advanced practice nurses practicing within the facility, (with or without “medical direction”), use of the facility DEA#……..Hmmm Such a set of facts might prompt a call from the DEA to inquire about your DPS number. Why? DEA #’s are specific not only to the provider to whom they are issued, but they are also specific to one facility or one state.

Keep in mind, our legislated laws are written for the masses. Thus laws that are designed to cast a very wide net, may inadvertently harm some of the small fish. Forewarned is forearmed.

Additional resource:
http://codes.lp.findlaw.com/uscode/21/13/I/C

About the author: Pamela Chambers is a staff CRNA a Central Texas regional trauma center and the affiliated Children’s hospital. Ms Chambers received her MSN in 2000 while on active duty in the U.S. Army; then received her Executive Juris Doctor (EJD) in Health Law in 2008 from Concord Law School. Ms. Chambers owns Lex Terrae Consulting a health law research and consulting firm and also teaches Legal Nurse Consulting for Kaplan University. Ms. Chambers is not an attorney. The information provided is legal research and should not replace consultation with an attorney or physician when warranted. Click here to learn more about Lex Terrae Legal consulting services.

ultrasound visualization

CRNAs and Anesthesiologists worldwide are using ultrasound visualization to improve patient safety, increase efficiency and decrease complications. SonoSite works closely with anesthesiologists to develop customized solutions that meet the rapidly expanding clinical requirements. Advanced needle visualization is just one example of our forward-thinking product enhancements. Advanced needle visualization makes the needle clearly distinguishable while maintaining striking image quality of the target and surrounding anatomy—especially at the steep angles needed on common procedures such as deep femoral blocks.

Click here to go to the manufacturer’s web page and learn about the Sonosite system. If you have experience with the product, please leave a comment and tell us about your experience.

Promises, Promises

Submitted by Pamela Chambers, CRNA, MSN, EJD

A guy walks into a bar… he says to the guy next to him, “My laryngoscope is bigger than your laryngoscope”. Unbeknownst to guy #1, guy #2 was a surgeon and was offended to be mistaken for an anesthetist. So guy #2, Dr. Alice, punches guy #1, Dr. Guedel, in the jaw.

Now Dr. Alice has an injured and deformed right hand. He goes to see his friend Dr. Adson – the plastic surgeon. Dr. Adson observes how distraught Dr. Alice is and tells him he can indeed fix his injured hand. Dr Adson tells Dr. Alice that he can give him a good hand so that he can return to surgery.

During the procedure, Dr. Adson realizes he must apply a skin graft to effectively correct Dr. Alice’s injured hand. The operative consent gives Dr. Adson permission to use a skin graft if necessary during the procedure. Dr. Adson obtains skin from Dr. Alices’s chest for use in the skin graft.

Days later, Dr. Alice returns to see Dr. Adson for a follow-up visit and to have his bandages removed. Both doctors observe hair growing from the grafted skin that now is growing on Dr. Alice’s right hand. Dr. Alice is distraught and decides to sue Dr. Adson. But under what theory? If a malpractice suit is filed, Dr. Adson would have to establish negligence and all of the required elements necessary to sustain such a theory. Additionally, expert witness testimony would be needed to establish standard of care and the deviation from it if present.

Dr. Alice sued Dr. Adson for breach of contract. Dr. Adson promised Dr. Alice “a good hand”, presumably that meant a hand free of hair. Does this sound absurd? Well a contract claim can be more advantageous in some circumstances over a malpractice claim. Why? Because, the remedy that is awarded in a contract claim is the difference between what was promised in the contract and what is present. There is no question of wrongdoing, no questions of standards of care, and no pesky expert witness. When there exists a dispute as to the terms of a contract, courts try to interpret contracts based what the parties intended at the time of the agreement. In Guilmet vs. Campbell, 385 Mich.57. 188 N.W.2d 601 (1971), a jury found for the plaintiff under a breach of contract theory. In this case the surgeon promised a particular result. The patient suffered severe postoperative after-effects – which were very different from the promise of “it’s a very simple operation… you’ll be out of work 3-4 weeks at most”.

As with all areas of jurisprudence, the measure of damages in a breach of contract suit can be computed various ways. Expectancy damages would be some amount that would place the plaintiff in the position that he would have had if the contract had been performed as promised. Whereas restitution damages would be an amount equivalent to the benefit conferred upon the defendant by breaching the contract. In Sullivan vs. O’Connor, 363 Mass.579, 296 N.E2d 183 (1973) the court decided to compute damages using an intermediate method – reliance damages. In Sullivan, the plaintiff recovered expenditures and costs that he bore as a result of the defendant’s breach of their contract.

Who said the only contracts in the hospital were the ones in administration??

Belmont Rapid Infusion System

The Belmont Rapid Infusion System has had wide use by the Military in the Middle East war. The system enables the rapid delivery of large volumes of warmed fluid during a resuscitation. The following testimonial was reported on the manufacturer’s web site:

Soldiers are Alive Today Because of the Belmont
“We were able to sustain their lives long enough so the surgeons could fix them. When we were in Baghdad we pumped over 100 units of blood products through the Belmont on this single patient,and ten years ago…he would not have lived.”

This rapid infusion system is gaining popularity in trauma centers throughout the United States. Again, a testimonial from the manufacturer’s web site:

The Anesthesiology Practice at a Major New York Metro Area Medical Center
“Switched from the Level 1 to the Belmont Rapid Infuser about three months ago. We purchased two, one for our main O.R. and one for Obstetrics. We have already used it in a case requiring more than 32 units of blood. It was flawless and clean.”
Major New York Metro Area Medical Center

For more information about the infusion system, click here to go to the manufacturer’s web site.

PROCRNA.COM would like to hear from those using the Belmont Rapid Infusion System. How is it working for you? Leave a comment and help your colleagues who are in need of a rapid infusion system.