Press Report: December 2002
Solution Implementation Study on
Medical Errors
JCAHO’s Positive
Response to Critical Issues: Patient
and Specimen Identification Errors
The July 2002
issue of OUTCRY Magazine is dedicated to medical errors. Many of its articles are
about the search for solutions to medical errors, based on our ongoing study of error
prevention in health care institutions. What people on the outside of health care do not
realize is, there are many systemic problems associated with the continuation of medical
errors. Problems within the system and problems outside the system are impeding the
quality of care. Based on research study to date, evidence indicates that even though
known best practices are presented to health care professionals, health care organizations
have not been eager to incorporate these known practices into their daily procedures to
help improve the quality of patient care. This is similar to the observation made in our
ongoing national campaign and research on medical errors. Our study, like others,
encountered many types of resistance to solutions implementation and other ideas to
improve the quality of care. From our study,
it is evident that solutions can neither be engineered from the bottom (front-line
workers) nor starting from the middle (technical managers). Such attempts will not be as
successful. The best solution is for the initiation of coherent effort to be championed
and fired-up by the hospital CEO and the hospital medical director. Once the initiative
for the solution is ignited from the top, the real solutions can be discovered from the
frontline workers. Our current study is, therefore, in search of those conditions that are
making solution implementation easier to accomplish.
Despite the
lukewarm response to positive initiatives from many health care institutions, the Joint
Commission on Accreditation of Healthcare Organizations (JCAHO) responded immediately less
than two months after the result of our study was made known to various government
agencies, including the Senate and the White House. The report summarizes the latest
strategies to help improve quality of care and discusses problems encountered by
institutions resulting from the burden of over-regulation impeding the quality of care.
The interview with Sister Jean Ryan of SSM Hospitals and with Drs. MacGuire and Iverson
added to the echoes of over-regulation impeding the quality of care. It is important to
indicate here that the report in this magazine is perhaps not the first one about the
problems of over-regulation. It however helped to fire up the emotions and the immediate
and positive response of JCAHO to the problems. Below are the responses of JCAHO to some
of the issues of over-regulation raised from our report.
I wanted to know Sister Jean’s idea
of what the government can do to help improve the quality of care, since I had asked many
physicians the same question. We both agreed that more research money should be put in
local hospitals. These local hospitals are the ones that directly deal with continuous
problems and solution implementation compared to all the money being pumped into the rigid
teaching institutions. “Government needs to help remove the burden of overregulation
by removing the duplications and not forcing hospitals to comply with rules which do not
help to improve the quality of care in those particular institutions.”
Forcing all hospitals to comply with certain rules issued by a regulatory agency tends to impede each hospital’s ability to make improvements where they actually have problems. Sister Jean cited the case of medication error, which is one of the biggest sources of medical errors. If such problems can be corrected, it will help to improve the quality of patient care. Sister Jean emphasized that the number of errors as shown by collected data, not the Sentinel Event Report should be the driving force of improvement. She also added, “Just because we are overburdened with regulations is not an excuse for us not to do our job in taking care of patients.”
------
Interview with Sister Jean Ryan, OUTCRY
Magazine, July, 2002
Here is the JCAHO’s response
Beginning in 2004, a new complex organization survey process will replace JCAHO's
current process for conducting tailored surveys. Tailored surveys are conducted by
organizations that provide services covered by standards in more than one of JCAHO's nine
accreditation programs. Introduced in 1982, the tailored survey has become substantially
fragmented and inefficient, resulting in duplicative surveys of certain organization-wide
functions, such as leadership. The new complex organization survey process will include
the following:
| A survey profile that includes information about the
applicant organization's specific settings and services. |
| Customized sets of standards matched to the
organization's survey profile. |
| Surveyors who have the skills and expertise most
appropriate to the organization to be surveyed. |
| Use of inter-related evaluation techniques (e.g.,
self-assessment) to assess standards compliance. |
| Concurrent evaluation of the various organization
components. |
While the survey process will change,
complex organizations will continue to receive a comprehensive accreditation decision that
reflects the performance of the entire organization. Performance information at both the
organization and component levels will continue to be publicly disclosed.
Despite all the wonderful ideas outlined at this medical error
conference in Houston, Texas, many staggering problems were also uncovered. These problems
are not only going to diminish the quality of care, they are going to crush the delivery
of decent health care services to patients. Dr. Anne MacGuire and Dr. Ronald Iverson were
two of the outspoken physicians present during the workshop section of this conference
about serious problems crushing the system from within. The problems may, in part, be
responsible for the failure of some health
care institutions to respond adequately to the problems of medical errors. These problems
if not immediately addressed may eventually cause the collapse of health care services in
the future. Even those who have money to pay directly for services may not receive quality
care if the system has been crippled by these problems.
Of all the problems discussed, the ones that are of greatest concern include
the destruction of physicians caused by loss of malpractice insurance; the
criminalization of physicians due to good-faith medical practice; the overburdening of physicians
by overregulation resulting in increased in cost and decreased in efficiency; the shrinking
of payment for services rendered, forcing the elimination of services due to a
decrease in the number of physicians.
Overburden by overregulation that causes increase in cost and
decreased in efficiency is another serious problem many hospitals are facing at this time.
Presently, too many regulatory agencies are trying to regulate hospitals. They include
JCAHO, HICFA, CLIA, CAP, state regulators, FDA, OSHA, ADA, and others. Although some of
these regulatory agencies enforce different aspects of medical care, the first four
agencies can join forces and be reduced to one regulatory agency. Problems are created
when some of these agencies have their own regulations, governing particular aspects of
medical practice which contradict other agencies. It was mentioned by a hospital executive
that the first four agencies sometimes appear to compete with each other. One of them may
penalize a health care institution for complying more with one agency regulation than with
the other, thereby creating a problem of confusion and increased cost. Many health care
institutions are spending a lot of money and staffing to do paperwork to comply with all
these regulatory agencies. Such money can be more wisely spent to improve the quality of
patient care.
JCAHO’s
Response: Re-evaluation of Standards
Standards Review Project
Nearing Completion
The Joint Commission's comprehensive Standards Review Project is on schedule to be
completed in early 2003 for implementation in January 2004. The four goals of the project
are as follows:
1)
reduce the number of standards;
2)
improve the clarity and relevance of the
remaining standards;
3)
reduce the associated paperwork and
documentation of compliance burden;
4)
align the standards requirements with surveyor
assessment and scoring protocols.
The proposed modifications represent deletions,
consolidations or clarifications of existing standards.
Complex health care organizations that offer
multiple types of services will experience more customized, streamlined surveys by the
Joint Commission on Accreditation of Healthcare Organizations (JCAHO) beginning in 2004.
Approved this month by JCAHO's Board of
Commissioners, the new approach to surveying complex organizations will replace what is
now known as the "tailored survey." The board also authorized new evaluation
options for long-term care organizations, including elimination of the tailoring
requirement for long-term care services provided in a complex organization, which will go
into effect January 1, 2003.
A tailored survey is conducted when an
organization provides services covered by standards in more than one of JCAHO's
accreditation program manuals. The new survey process will continue to place a priority on
the integration of patient services across all levels and settings of care.
Changes to JCAHO's Long-term Care program are in
response to provider-organization concerns about the overlap between JCAHO accreditation
and Medicare/Medicaid certification requirements.
JCAHO, OAKBROOK TERRACE, Ill. – July 30, 2002)
Specimen Collection and Patient-Identification Errors
Correct specimen labeling and correct patient identification
(which our campaign has been battling to improve) is the number one issue on the new list
of the JCAHO regulations from August, 2002 press release. Below is the response of JCAHO
to patient-identification errors:
a. Use at
least two patient identifiers (neither to be the patient's room number) whenever taking
blood samples or administering medications or blood products.
b. Prior to
the start of any surgical or invasive procedure, conduct a final verification process,
such as a "time out," to confirm the correct patient, procedure and site, using
active--not passive--communication techniques.
As laudable as JCAHO’s
response to patient-identification errors may be, the regulation does not go far enough.
Is does not issue adequate directives of instructions based on the need for standards
across the nation. The leading cause of death due to medical errors is caused either by
patient misidentification, and specimen or medication misidentification. This particular
problem affects all the health care institutions across the nation. It is the more reason
why JCAHO should deal with the problem in a more extensive manner than just a couple of
paragraphs. Most institutions are looking for standards to be used as benchmarking or a
frame of comparative reference. Those two paragraphs above hardly provide any national
standard to base a benchmark upon.
Examples of the Incidents
of Patient-Identification Errors
The best practical guide for solution intervention is
to look at each of the processes involved in performing certain tasks within the health
care system. By reevaluating those processes defects can be identified and fixed.
1. Admission: If a
patient is misidentified during admission, a wrong armband is generated and placed on the
patient’s wrist. If the patient is unable to speak, the problem remains. This happens
because the wrong patient is selected in the computer during admission. In cases when
patients do not receive identification armbands during admission, such patients may
sometimes remain on the floor for days before receiving
armbands. While they are waiting for the identification armbands, procedures
are being performed increasing the chance of medical errors.
2. Missing Armband: In
some situations either intentionally or accidentally the patients armbands have been
removed. Other times patients have actually removed their own armband. Regardless of the
cause of armband removal such situations have not prevented the continuation of procedures
and clinical treatment. Studies have indicated that many patient-identification errors
occur when patients are without identification armbands.
3. Wrong Patient Selection
in Surgery: Patients have received the wrong billing after surgery because the wrong
name was selected in computer by a secretary or a surgical tech to identify the specimen
collected in surgery. This is the more reason why patient and specimen identification
problems should be addressed together. This wrong selection leads not only to wrong
specimen identification but to wrong patient identification as well. So, the patient who
has an appendectomy receives hospital billing for a hysterectomy. There was a case in
which a woman who had not been in hospital for three years received a billing for delivery
of a baby. Anybody can imagine the emotional uproar when the husband saw the bill for the
mysterious birth by his wife.
4. Misidentified X-ray
Result: There was another case in which a diabetic woman in the hospital for poorly
regulated blood sugar was being taken to surgery for a hip fracture because somebody
misidentified the X-ray results. It was the daughter who arrived just on time to question
why they were taking her mother to surgery. The surgical team later realized an error was
made because the wrong patient was being taken to surgery. The x-ray result was
misidentified.
5. Dietary
Misidentification Error: How many people would have thought that a patient could be
severely harmed due to misidentification for a food tray? A young lady in her late
twenties was going to surgery the next morning. She was on
“nothing by mouth.” Due to error of misidentification, a tray was
inadvertently given to the patient on the morning of surgery. Perhaps the patient thought
it was okay, so she ate her food and said nothing. Later that morning, she was taken to
surgery. During the procedure, she threw up and aspirated her vomitus. She had a cardiac
arrest and was later revived. It was too late because the sensory nerve damage had
occurred. She sustained brain damage and became paralyzed. The hospital took good care of
her for a couple of years as part of the settlement. One day she was left unattended in
the x-ray department while waiting for a procedure, and she was later found dead. Correct
identification before issuing food tray to the patient going to surgery could have
prevented the tragedy. Just a simple note at the head of the bed that the patient is going
to surgery and not supposed to receive any food tray may also be helpful.
6. Charting Errors:
One of the most common charting errors involves a physician ordering on the wrong patient.
This is a very common occurrence when resident physicians are very tired. In one such
case, the orders were either misfiled or charted on the wrong patient. Consequently, the
pharmacy department filled the wrong medication because either the charting was wrong or
the person who placed the order in the computer made an error leading to tragic
consequences.
7. Medication
Misidentification: In a hurry a nurse picked up the wrong medication from the Pyxis
machine. The Pyxis was over-filled by pharmacy and spilling to another medication
compartment. The wrong medication was consequently administered to the patient. If she had
taken the time to double-check the order with the patient’s name and had realized the
medication was in the wrong compartment, perhaps it could have prevented the error. How
about preventing the pharmacist from over-filling the Pyxis machine to avoid a spill-over?
8. Patient
Misidentification Leading to Wrong Medication: In a hurry, a nurse picked up
medication for one patient and inadvertently administered it to a wrong patient. In a
hurry to do her work, she misidentified the patient supposed to receive the medication.
Although the “five rights” are supposed to help double check medication before
it is administered, in a hurry, deviation and shortcuts may occur leading to tragic
errors. The right medication for the right patient through the right
route, with the right dosage, at the right time is the standard in many
hospitals. This should help to decrease medication errors.
9. Misidentified Lab
Specimens: Many times, nurses, techs and even physicians will draw blood samples and
label them outside the patient’s room. This gross violation of specimen collection
rule which has led to many fatalities. Blood specimens, like any other specimens, are
supposed to be collected and labeled at the patient’s bedside by whoever collects the
specimen. Specimen misidentification occurred as a result of too much deviation from this
standard.
10. Mislabeled Blood Specimen for Transfusion: In another
situation, a nurse checked the blood to be transfused
with another nurse prior to giving it to the patient. They used the patient’s chart
and the identification armband to identify the patient before transfusion. The nurses
would be in compliance if they followed the JCAHO direction of using two identifiers. The
nurse was of the impression she was transfusing the blood to the correct patient. Two days
later, the patient died after going into renal failure. In adding more to the problem, the
blood transfusion reactions were either ignored or unrecognized. It was later discovered
that the tube of blood sent by the nurse tech to prepare the blood for transfusion was
mislabeled. Since the blood sample used to prepare blood for the patient was wrong, the
patient subsequently received the wrong blood type. Death was caused because the patient
received incompatible unit of blood.
11. Misidentified Blood
Recipient: In another situation, correct blood was prepared for a patient with correct
specimen. The transfusing nurse double-checked the blood and papers with her coworker at
the nursing station. But on reaching the patient’s room, the transfusing nurse failed
to check the patient’s armband. She transfused the blood into the wrong patient. The
patient later died from complications associated with the blood transfusion.
In a similar situation, a
surgery department received three little refrigerators containing blood for three
different patients. When one of the patients was about to be transfused, the nurse went to
the wrong refrigerator, despite the fact that the refrigerators were correctly marked with
the patients’ names. The nurse failed to look at the name of the patient on the
refrigerator thereby picking the wrong blood. Fortunately, another surgical nurse
rechecked the blood before transfusion was about to start. It was then the error was
discovered and the blood transfusion stopped before it started.
12. Mislabeled Anesthetic
Agent: A young boy was going for a minor surgery. He was given the wrong medication
during the surgery. He later died after the surgery. This young boy died because he
received the wrong medication because the medication containers were mislabeled in
surgery. The young patient received a large dose of the wrong medication, which
prematurely ended his life.
The above twelve incidents
are just few of the ways patient and specimen misidentification may lead to disaster. Correct patient and specimen identification,
therefore, affect all aspects of patient care. One thing that is common to all medical
errors is the systemic failure which allows the errors to happen. In addition, the
propagation of those errors occurs down the process-line of patient care due to lack of
adequate checks and balances to catch the errors before killing patients. Of all these cases mentioned above, not a single
one of them is caused by complicated medicine or due to complex operation. All the errors
occur due to simple systemic failures of not adequately and efficiently identifying the
patient and the specimen correctly.
Hints to JCAHO for Action
As a result of many things
that may go wrong during the process of caring for patients, the JCAHO should recognize
that “patient identification errors” cannot be addressed in isolation without
addressing “specimen identification errors.” Both of these two go hand in hand.
JCAHO should therefore give “national standards” of a process, because every
work in the hospital is part of that larger process of taking care of patients. However,
before JCAHO can give directives about national standards, it should study many hospitals
across the nation to arrive at a national standard. The standards should therefore be
based on the most popular and well-established safe methods of identifying patients and
labeling specimens.
Just using two identifiers to
identify a patient will not do any good if the blood is collected and taken out of the
patient’s room to be labeled with another patient’s name. The national standard
should be, whoever draws the blood must label the tube at the patient’s bedside
without taking the tube away from the patient’s beside. Similarly, when units
of blood are to be transfused to the patient, a second identifier like the Hollister
system should be used to re-identify the patient when the specimen is collected for
transfusion preparation. This should be done at the time of draw, not done on the blood
sample that was collected hours before. The
laboratory should set the guidelines for the sample to be used for the preparation of
blood for transfusion. If a sample does not meet standard criteria, such sample should
immediately be rejected by the Blood Bank. Based on best practices, it is better for two
nurses to double check units of blood for transfusion at the patient’s bedside, not
at the nursing station. In the past, checking was done at the nursing station, and the
transfusing nurse gave the blood to the wrong patient because she did not check the
patient’s armband. So, double-checking
done at the patient’s bedside with both nurses checking the patient’s armband
decreases the chance of transfusion to the wrong patient.
Another common error results from the nursing staff calling out the
patient’s name and expecting the patient to answer. To avoid the error of soundex,
patients are supposed to be asked their name instead of being told. If they do not know
their names or are unable to talk, two armbands can be used as two identifiers. Most
patients from nursing homes come to the hospital with identification armbands. Regardless
of such armbands, the hospital always place its own armbands on the patients. It is much
better to place the second identification armband on a different arm except in a situation
where the second hand is unavailable.
Setting national standard is
very important. Years ago, patients were sometimes transfused with the wrong blood in
situations in which two units were issued to one nurse for two different patients. When
the FDA realized the problem, a national standard was set declaring that a nurse or a
transfusionist could only receive one unit of blood for only one patient. In some cases,
it is acceptable to issue two units of blood, but must be for the same patient. So when
the nurses came to the blood bank, and demanding for blood units on two different patients
while they stamped their feet and bulged their eyes at the tech, they were directed to see
the FDA rule elegantly placed in front of the blood bank refrigerator. The blood bank tech
looked on with a smile as the nurse uncomfortably gazed through the information. After a
while, they all got used to it, and that danger of wrong transfusion was eliminated
because the nurse never received two units at one time for two different patients.
Although it took a while
before the nurses got used to the new process redesign of receiving blood from the blood
bank. Today, in most cases, nurses receive only one unit of blood for one patient and
leave the blood bank smiling, in contrast to years ago when they wanted to start a fight
because the blood bank tech refused to issue units for two different patients at one time.
Similarly, JCAHO needs to set
national standards, not as a form of regulation, but to serve as a frame of reference for
all hospitals with problems of patient and specimen misidentification. The present battle
involves the question, “What is the correct process?” These types of standard
will help the lab to negotiate with the nursing staff about the correct process and
hopefully diminish the high level of resistance to change and the animosity from the
nursing department towards the lab workers. It is very difficult to force the nursing
service to reduce variation of their process if there is no national standard. The nursing
staff’s anger directed to the lab staff after specimens are rejected is due to lack
of understanding by those drawing blood or collecting specimens that compromising the
quality of collected specimens will also compromise the quality of lab results. The
biggest fight between the lab and the nursing staff is the question about the acceptable
ways of doing things. This is more critical when the nursing staff members are the ones
drawing blood for the laboratory. So, when the lab complained to the nursing department
that specimens had been mislabeled because the blood samples were taken out of the
patients’ room before being labeled, the nursing director was indifferent to the
complaint. Her position was, the lab just did not have any idea what the nursing staff had
to deal with while taking care of patients. A better response will be obtained if the same
lab director goes to the hospital administration (if the nursing department refuses to
listen) stating that the hospital is in violation of the national standard according to
JCAHO which dictates that blood samples are supposed to be labeled at the patient’s
bedside.
The biggest problem in our
“solution implementation study” is to make the nursing staff be more receptive
to the correct process of patient and specimen identification. Many of them have been
known to draw blood and label them away from patients’ bedsides increasing the
chances of misidentification. Specimens have been mislabeled in some situations in which
somebody draws the blood and another person places the labels on the tubes. Physicians
have been seen bringing to the lab a syringe (with needle still attached) filled with body
fluids. In some of those cases, they were looking for different tubes to put the specimen.
Other times, the entire syringe has been sent to the lab without bothering to place sample
in various tubes, and sometimes the syringe has not been labeled.
Importance of Setting
National Standard
Most of the time JCAHO’s
regulations are either unclear or confusing. They are perhaps made so purposely to give
each hospital allowance for variation in the accomplishment of expected tasks. However,
regardless to the freedom of variation adherent to individual hospitals, a standard should
be set as a frame of reference for all hospitals. We may not expect JCAHO to set up
standards in all areas of hospital operations and patient interventions. However, in very
crucial areas of common errors with tragic results, it is important to set such standards.
If JCAHO is unable to set the standards, another organization should be contracted to set
these standards. And the JCAHO should subsequently place its approval stamp on the
procedure marking it a national standard. This is highly important if we must solve the
problem of medical errors.
In setting such a standard,
we must be very careful not to make the same mistakes that have been made over the years.
Pen-pushers should not design the procedure for setting national standards. Those working
with the process or in direct contact with patients are those who should design the
national standards after looking at common practices across the nation. This is the reason
why Lara Publications’ study over the years has been more valuable than cooking up
statistics. We work directly with those health care workers in direct contact with
patients. Our study also observes that even managers of various clinical departments are
detached to some extent from some issues because they do not experience certain events.
Those managers who do not work on the bench or in direct contact with patients, are unable
to understand the depth of the emotional implications of errors to both patients and
employees. Consequently, those managers do not respond to concerns as promptly as they
should. It cannot be over emphasized that for solution implementation to be effective,
those who work on the process-line, or in direct contact with patients are in a better
position to redesign their work environments and make them less error prone.
written by Yinka Vidal, BS.
MA. H.ASCP