INFORMED CONSENT

Good day to you all! On this day of September 11, 2008, seven years after "9/11," it is so painful to see the people on tv today commemorating the events of 9/11. Families and lives broken and taken! What senseless acts! What "affects" even one person will affect many.

Dear patients, this is how I also feel about ALL the operating room "issues" I have seen or heard about or read about! The numbers of operating room "issues" in various articles are just the tip of the iceberg The "numbers" which are being revealed on the web by very valid persons indicate that the numbers are increasing every day. The "numbers" that people talk about in secret will probably never be revealed because "QI or QA or Risk Management" reports are written up by each hospital, stored in some file drawer, and are not "admissible" in a court of law!

There are attempts to collect anonymously QI reports so we can all learn about our patient errors / issues, which is a start in the right direction BUT there is no way that monetary incentives should be given to those reporting "patient errors / issues."

There should not be any monetary incentives for doing a good job! Doing a good job is what is expected of anyone doing a job whether it is in the operating room, in the healthcare arena or in a grocery store! The attempt by CMS (MEDICARE) to encourage "reporting" by also offering an "incentive payment" to physicians is a JOKE. CMS is using Federal tax money, our money, to pay physicians this reward! I say no way! Read about the CMS / PQR (Physician Quality Reporting Initiative) on the web. Tell your federal legislators that this "action" is just "pork barrel!"

My goal, my passion, is inform you, the patient, who will be undergoing any type of surgical procedure, how to prevent issues" which could affect your life and limb. No one wants to wake up worse off than before surgery. Nor does anyone in their right mind want to die before their time! Nor should anyone have to start a FOUNDATION in someone's memory such as many families have done when their loved ones died from an issue / error when they were a patient. Read about "Justins Hope" for one example. Justin's family would rather have him be alive so their memories would be of him growing up, going to college, and getting married not memories of him lying in a casket before his time!

Again, my comments are merely my opinions, based on my education and on my experience. Over the years as I worked in the operating room, I always wanted to put out information / suggestions to patients in order to help keep them safe during surgery! Life was too busy for many years to accomplish this goal. Now, however, I had to quit OR nursing because of my own "post- operative issues." I was not able to pick up heavy OR instrument pans, or push open doors, or help position patients on the OR table, or push the next case cart into the OR room and do all the physical aspects of OR nursing without experiencing a lot of pain. I didn't complain much. But wow, did I hurt! By the time I got home from work in the evenings, I was in tears. Now, I have the time. How ironic!

My own misunderstanding of informed consent:

In my 33 years of OR nursing none of my patients, that I ever knew about, were ever hurt under my care. And now I have many issues! I did not sign an informed consent. I just signed the consent. Nothing was explained to me. I thought I understood the simple verbiage on the consent. As a nurse, I thought I understood! "Pain" was on the list of "risks," well, sure, pain is normal after surgery, pain at the site of surgery is normal.

I would not question the term "pain." However, after surgery, I screamed for days with pain. Not pain in my surgical site i.e. left neck disectomies and fusion at two levels, but with excruciating pain in both of my arms, especially my right arm. No one could even lightly touch my right arm without aggravating the constant stabbing and burning I had in my right arm! The only way I can describe the pain was that it felt like I was being stabbed and stabbed and stabbed with a hot knife! Oh, the pain is not as excruciating now but after a year post-op, my arms, wrists, shoulders especially my right arm and especially at night, hurt like hell!

And pain is just the first of my many post-op issues. NO one told me that I would have pain in my arms. The surgery was on my neck! I left my job and my salary as a RN, my arms hurt when I extend my arms as I drive the car, I can't pick up my great granddaughter, a year old toddler without having shooting pains in my arms. I can't push a full grocery cart without causing pain in my arms and back of my neck, I can't, I can't, I can't. It is frustrating, it's painful and it makes me angry!

I'll discuss my next post-op issue in my next correspondence.

So, reflecting back over the past year after surgery, I realized that not only was I not really informed, I was too trusting! However, even IF I had researched my type of procedure on the web, not being a neurosurgeon, I still would not have understood the issues involved pertaining to my surgery because some of my issues are rare and beyond my comprehension as a nurse. AND all these "rare issues" and more were NOT explained to me, the consent was signed in the presence of an office RN and myself. I was too trusting and I was not INFORMED.
So, folks, beware of a "consent," informed or not informed is only for the risk management office of the hospital so someone can say, in the case of an injury, "Oh, the patient was informed, here is the consent."

One can read on the web thousands of examples of errors which occurred in the Operating Room. Let us suppose, for example, a consent was signed for a right breast mastectomy, but the actual "correct" breast was the left breast. When the right breast was removed, the argument would be, "YOU, my dear, signed the 'informed consent.'" So, you were also part of the problem. The hospital and the OR will do a RCA i.e. a Root Cause Analysis but in my opinion, a RCA, is like putting the horse before the cart. And in my opinion, most all of the errors I have seen and I have read about or heard about ALL could have been avoided! Once a patient is injured or dies, the die is cast. As an opinionated OR nurse, I always said to new staff, "Slow down, be meticulous about everything. Be a team player, don't be disruptive, and resolve issues before they become a patient issue." Drinking the night before and sleeping with the docs also muddies the waters of patient care.

As a FYI, I have heard in meetings that situations that are settled out of court never become public knowledge. Only the cases that go to court are released. In my opinion, this lack of disclosure does not help the public, i.e. patients, to find out who is a good surgeon or who is a bad surgeon.

NICE does not mean GOOD!

So, in my opinion, by signing a "informed consent" or any consent, one really signs away all liability to the surgeon and hospital, even IF you die during a OR procedure. There are many companies on the web which sell hospital models for Informed Consents. Very expensive! PERHAPS, an informed consent which is dictated and recorded by the surgeon to the patient would solve the argument of "what was or was not discussed with the patient and what questions the patient had.

The dictation / recording then could be signed electronically, with copies going to the patient! Wow, an explanation, with questions and answers on a recording as well as a hard copy and recording to the patient. Perhaps even a video would be best! Videos are being taken all the time in the OR when the procedure is being performed under laparoscopy i.e. band aid surgery.

IT IS VERY IMPORTANT TO REMEMBER:

• DON'T sign any consent AFTER you received ANY medication of any kind! Most of the time medication is slipped into one's IV without one's knowledge or someone will say, "oh, this will take the edge off of things." One medication slipped into one's IV line is called Versed. It does relax you but it also causes amnesia. I always wonder to this day, how many of my patients don't even remember me "interviewing" them for their pre-op assessment? This is another good reason to review the chart thoroughly as well as to interview thoroughly as well as communicate with all team members thoroughly. Many pieces of the "patient puzzle" are never in just in one place
• The word in "SUPERVISION" on the consent does not mean the surgeon is with YOU the entire time during your surgery. The word SUPERVISION means only during the critical times during surgery! My opinion is that the entire duration of surgery is CRITICAL! One never knows when a scenario is OK or when a scenario will be CRITICAL. Things happen in split seconds! Things like a perforated bowel, hemorrhage, respiratory arrest, dislodging of the breathing tube (ET Tube or a LMA), cardiac arrest, etc. This is not like on TV. The word "SUPERVISION" can denote a surgeon even going to another room to operate on another patient, or going to a short meeting, going to the computer to check their email, or even going to another building. Just because he or she is in SUPERVISION does not mean that they are there at your side operating or watching the residents as they operate under "supervision!" Maybe they might be on the phone watching the procedure via a operating room video set up which is connected to their office.
• For separate surgeries on the same patient, there needs to be separate consents. For example, if you are having a gastric bypass as well as a cyst removed from your neck, then there needs to be two consents by the two surgeons.
• IMPORTANT: a recent ruling by CMS (MEDICARE) was changed. The Consent was to have all names of all OR staff and what their role was in the OR noted on the consent, e.g. name of who was taking the saphenous vein from your leg from which a portion of this vein would replace the blocked artery on your heart. I ask you to ask, "Who is going to hold my Heart?" "Who is taking the saphenous vein from my leg?" "Who has what credentials, education, and certification?" "Who is JUST on the JOB Trained?" Who is holding your leg when you are having a hip replacement? Who is prepping your body parts? The list of "who is on your case" really does not show the entire picture. And usually the "n and out times" on the chart is not the true time of all the "ins and outs" of the surgeon. The "in" means time in the room, and the "out" means time out of the room.
• IMPORTANT: MAKE SURE YOU HAVE SOMEONE TO SIGN FOR YOU IN CASE OF EMERGENCY (AN ADVOCATE). I doubt if this does any real good, however, for example my husband signed for an emergency MRI and CT for me though he understands nothing about medical issues, especially under duress. BUT anything performed on a patient without a consent is ASSUALT and BATTERY. FYI , no one can even give you an "injection" or take your BP, etc. if you refuse!

So dear patients, YES one always hears about the slogan, "DO NO HARM." However, there are stats on OR errors which would make your toes curl and might even convince you to go the homeopathic route! Nurses are to be YOUR advocates. Nurses by the nature of their state license are regulated by their Board of Nursing which exists basically to "Protect the Safety of the Public." The nurses see everything! But the zinger is that nurses are afraid of "whistle blowing" about the conditions they are aware of or see as they'll lose their jobs. I know of one nurse who complained about a situation, and she lost her job. It took her over a year and a half to find another job. Then there are also variables such as allegiances to the hospitals, to the docs, to their peers, and to power, We MUST be careful that the healthcare system does not become like the story of the Emperor's New Clothes. We must be honest about what we see and then honestly fix the "issues" without bringing retribution to those who report patient issues! It could be your LIFE or the LIFE of one of your Loved ones at stake! Each community needs to place a burden of responsibility on their local hospitals. Ask about "their" issues and demand "good results!"

REMEMBER: the verbiage is important: i.e. even by CMS (MEDICARE / 482.22) are:

• SHOULD: meaning it is a suggestion to a hospital or surgeon.
• MUST: meaning it is required by a hospital or surgeon

So each state, each hospital, each surgeon can modify the "shoulds and musts" basically anyway they deem fit. AND someone may be described as having a lack of "health knowledge" or "limited ENGLISH PROFICIENTCY." "LIMITED HEALTH LITERACY," I believe, describes most of us, healthcare professional or not! And with regard to surgery, I believe that most of us don't know what we don't know until it is too late, and not because we are stupid, BUT because we are uninformed!

(read a Wall St. Journal article, 02/06/08 on "informed consents")

Another example of "verbiage" is the word: SUPERVISION, as discussed above.

I am not even going to attempt to give my opinion on "informed consent" related to "Human Research Consents." As an OR nurse, I had to make sure this consent was on the chart IF the patient was to be part of a research project. I would not be able to give a good opinion to you on this topic. There are too many federal guidelines on this topic depending on what the research Involves; drugs, tissue, etc. Read about the topic on the web.

Finally, Informed Consents are to be signed before surgery and on the chart before you enter the OR room. There are a lot of different views and hospital policies on who should get your signature on the informed consent. Personally, after hearing for 33 years from many OR staff that informed consents are a joke (from the patient's perspective), I finally agree! Yes, it is still hospital policy.

God bless,