pamela chambers CRNA

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.

Standards, the Expert Witness

Submitted by Pamela Chambers, MSN, CRNA, EJD

Click here for Lex Terrae consulting

As we all know, legislative bodies enact the laws that we must all abide by – whether we are aware of them or not. Ignorance of the law is rarely a defense to violating it, whereas professions set their own standards of care. Ignorance of the standard of care while not illegal, may be described as poor practice. But how does the public – or the courts, know what constitutes poor practices? How would a court determine the standard of care for nurse anesthesia practice in Temple, TX; or in Dallas, TX; or in Bay City, TX?

The United States Supreme Court held that expert opinion is only admissible when it is generally accepted as reliable the relevant scientific community Frye v. United States, 54 App.D.C. 46, 293 Fed.1013 (1923). The decision handed down in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 113 S.Ct. 2786, 125 L.Ed.2d 469 (1993) went a step further in clarifying that expert testimony must have a valid scientific connection to the issues of a particular case. So why is this important to know?

Upon review of Carolan v. Hill, 553 N.W. 2d 882, Iowa 996, the issue on appeal was the admissibility of expert testimony. The harm suffered by the plaintiff (Carolan) was ulnar nerve damage sustained during the administration of anesthesia for a surgical procedure unrelated to plaintiff’s arm. The trial court refused to allow the plaintiff’s expert witness testimony. The trial court relied upon its interpretation of the Iowa Code regarding who could establish standard of care. On appeal, the Iowa Supreme Court clarified the interpretation of the law in Iowa. The relevant code noted that a “person” qualified to provide expert testimony shall be so qualified based on medical or dental qualifications that relate directly to the issues in the case at bar. Furthermore, if the legislature had intended qualified individuals be restricted to physicians and dentists, it would have done so explicitly. In this instance, this issue was reversed (overturned the jury verdict for the defendant anesthesiologist) and remanded to the lower court. Plaintiff’s expert witness was a Nurse Anesthetist.

The Federal Rules of Evidence, rule 702, state the following with regard to expert witnesses: A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if: the expert’s scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue; the testimony is based on sufficient facts or data; the testimony is the product of reliable principles and methods; and the expert has reliably applied the principles and methods to the facts of the case. This rule is based largely on Daubert, but has been amended and modified as other landmark decisions (such as Kumho Tire Co. v. Carmichael, 119 S.Ct. 1167 (1999) have been decided regarding expert testimony.

Daubert set forth a non-exclusive checklist for trial courts to use in assessing the reliability of scientific expert testimony. The specific factors delineated by the Daubert Court are (1) whether the expert’s technique or theory can be or has been tested—that is, whether the expert’s theory can be challenged in some objective sense, or whether it is instead simply a subjective, conclusory approach that cannot reasonably be assessed for reliability (i.e. an opinion); (2) whether the technique or theory has been subject to peer review and publication; (3) the known or potential rate of error of the technique or theory when applied; (4) the existence and maintenance of standards and controls; and (5) whether the technique or theory has been generally accepted in the scientific community. The Court in Kumho held that these factors might also be applicable in assessing the reliability of nonscientific expert testimony, depending upon “the particular circumstances of the particular case at issue.” 119 S.Ct. at 1175.

So what does all of this mean? How does affect your practice if it affects it at all? Consider this, when you make a decision as to which nondepolarizing muscle relaxant you will use (when you have a choice) ask yourself if the decision you’ve made is accepted practice. When you decide to conduct your anesthetic in a manner that you deem best for your patient, ask yourself if the methods that you use are (still) relevant and valid? If any of us are practicing the “way we’ve always done it”, ask yourself this question – Is this defensible in a court of law?

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.

Ketamine Supplement for Anesthesia

Ketamine is an old drug which has come in and out of favor many times over the past decades. Currently, articles are emerging touting the advantages of Ketamine as a supplement for both general anesthesia and monitored anesthesia care. Below is a description by Pamela Chambers, CRNA regarding her clinical experience using Ketamine as a supplement. Read her excellent review, scan the articles and leave a comment to share your experiences with your colleagues.

Submitted by Pamela Chambers, CRNA

Lexterrae legal consulting service

For the EP case that lasted 6+ hours, GETA with .5 mac Desflurane and Propofol infusion at 30 ug/kg/min, the Propofol Ketamine mixture performed very well. I mixed 50mg Ketamine in each 50ml bottle of propofol. I used less than 3 bottles for the case and never used more than .5 mac Des. I used a total of 25 ug Fent, just after intubation, for the case. The patient was 83 yo male, approx 90 kg, EF 20%.

Upon emergence the patient denied any pain or discomfort. He was appropriately responsive to verbal and did not cough on extubation. VS were stable and he was A&O x3 on arrival to the EP room for phase 2 recovery.

A few days later, I used Ketamine as an analgesic adjunct for another long case (10 hr bilateral mastectomy and tram flap). I used a total of 195 mg Ketamine. The patient was an ASA 1. After 100 ug Fent (and 3mg Versed) prior to induction, I used 30 mg Ketamine approximately 3 mins prior to incision. Then I administered 30 mg Ketamine at hr number 2, and hr #3. Around hr #4, I decreased the Ketamine to 15mg for each hrs successive dose with a plan to halt Ketamine admin when I believed the case was 2 hrs from completion. My last Ketamine dose was at 1430 during the last phases of the case. The patient began spontaneous ventilations after reversal of NDMR at approximately 1640. The case ended at approximately 1730. The patient

received a total of 2200 ug Fent dosed approximately 100 ug every 30-45 mins.

Intermittent rescue doses for SNS spike were not required. Pressor agents were not used. Hemodynamics were extremely stable, almost like the proverbial railroad track!

Total fluid administered was 2 liters NS and 1 liter 5% Albumin, UO was 150 ml, EBL 300ml. I also adminstered 2 mg Versed at 1600 to facilitate decreasing the inhaled agent level and to ameliorate any emergence delirium associated with the Ketamine. The patient was appropriately responsive to verbal prior to extubation, and did not cough during extubation. She also denied any c/o pain immediately post-operatively. No emergence delirium was appreciated.

Click here to read a review article by Laskowshi et. al regarding Ketamine use

Click here to read an article by McCartney et al regarding the role of the NMDA receptor