Press Report: December 2002
Solution Implementation Study on Medical Errors
JCAHOs 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 Jeans 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 hospitals 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 JCAHOs 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.
Response: Re-evaluation of Standards
Standards Review Project
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 JCAHOs 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 patients 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 patients 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 patients 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 patients 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 patients 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 patients room, the transfusing nurse failed to check the patients 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 patients room to be labeled with another patients name. The national standard should be, whoever draws the blood must label the tube at the patients bedside without taking the tube away from the patients 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 patients 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 patients armband. So, double-checking done at the patients bedside with both nurses checking the patients armband decreases the chance of transfusion to the wrong patient. Another common error results from the nursing staff calling out the patients 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 staffs 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 patients 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 JCAHOs 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 , author of 101 Ways to Prevent Medical Errors.
See him being featured in the forthcoming documentary on the
Discovery Channel in spring, 2003
, author of 101 Ways to Prevent Medical Errors. See him being featured in the forthcoming documentary on the Discovery Channel in spring, 2003
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