How Can We Improve Patient Safety?

Patient Presentation
A 3-week-old premature male neonate was transferred because of a medication overdose.
The neonate had been admitted locally after a septic work-up because of a fever to 38.5° Centigrade.
He was initially treated with ampicillin and cefotaxime but the coverage was expanded 12 hours later to include vancomycin because of a high rate of methicillin-resistant staphylococcus aureus (MRSA) in the local community and hospital.
After the vancomycin infusion was completed 36 hours after admission, he was noted to be extremely flushed, sleepy and fussy, and it was determined that he had received 12 times the appropriate amount of vancomycin for his weight.
His parents reported that the antibiotic infusion bag was labeled with another patient’s name.
Laboratory studies were drawn while awaiting the transport team, which showed a vancomycin level of 242 mcg/ml and blood urea nitrogen of 8.0 mg/dl and creatinine of 0.6 mg/dl.
The past medical history revealed a 35.5 week premature infant who needed some supplemental oxygen for 12 hours for tachypnea that resolved. He had no difficulties feeding and was discharged at 3 days of life.
He was followed closely and regained his birth weight by 10 days of age.
The family history was negative for any kidney disease or hearing problems.
The pertinent physical exam on arrival showed normal vital signs. His weight was 3.2 kilograms (50%) and length and head circumferences were 50-75%.
He was alert with very flushed skin. He had a 1 cm lesion on right foot where an IV had infiltrated and now appeared to be healing.
The work-up included monitoring of electrolytes which were all normal.
Vancomycin levels were 105.9 mcg/dl on admission and were < 5 mcg/dl at 36 hours after the overdose.
The blood urea nitrogen was 7 mg/dl on discharge and never was higher than 11 mg/dl.
The creatinine slowly decreased and was 0.3 mg/dl at discharge.
Blood, urine and cerebrospinal fluid cultures locally all remained negative.
A hearing test on day 3 of admission was negative.
The diagnosis of fever in a neonate with vancomycin overdose was made.
The patient’s clinical course improved over the 6 total days of admission, and he was discharged to followup with his local healthcare provider and audiology in 4-6 weeks for repeated testing.
The local hospital was evaluating their medication administration system to find out why their system had failed and how they could effect change and respond to this critical incident.

Vancomycin is an antibiotic that has known ototoxicity and nephrotoxicity. “Red man syndrome” of severe flushing can be seen with rapid administration of the drug.
Vancomycin should be used for treatment of serious infections known to be caused by beta-lactam-resistant gram-positive organisms (like MRSA), in patients with serious allergy to beta-lactam antibiotics, antimicrobial-associated colitis (e.g. Clostridium difficile) that is severe and potentially life-threatening or fails to respond to metronidazole, endocarditis prophylaxis for certain high-risk patients, and for anti-microbial prophylaxis in major surgical procedures involving implantation of prosthetic materials or devices at institutions with a high rate of MRSA.
Vancomycin is also indicated for febrile, neutropenic patients (like a neonate) in an institution with a high prevalence of MRSA such as the local hospital in this case.

Vancomycin levels need to be checked during administration. A peak level of 25-40 mg/L and a trough of 5-10 mg/L are usually recommended. For central nervous system infections a higher peak (>35 mg/L) is recommended.
Peak and trough measurements are usually done around the time of the third vancomycin dosing.
As neonates have changing nephrogenic function, dosing is based upon patient weight and post-natal age.

Learning Point
Patient safety is an important issue for everyone. Errors of commission and omission occur inside hospitals and clinics and have been well-outlined by studies from the Institute of Medicine.
Errors occur because human beings have limitations, medicine is a highly complex system that changes continually, and because the barriers that are put into place to stop or mitigate an error fail for some reason.
For hospitalized children, medication errors are some of the most common errors and often they occur in infants and adolescents.

Systems to improve patient safety need approaches that include improving the overall system, improving human factors (i.e. limiting their limitations) and developing a safety culture.

Ideas for improved patient safety through systems:

  • Computer physician order entry (CPOE) – helps assure proper drug and dosage is ordered, transcription errors and errors because of poor handwriting are decreased or eliminated, CPOE can also “force” use of standard dosing and medications.
  • Computerized clinical decision support systems – helps assure drug is being used for the proper indication or reason, checks the drug ordered against allergies and other medications to make sure all drugs administered are compatible.
  • Barcode scanning of patients and medicine – helps assure that the proper medication is being given to the proper patient at the proper time.
  • Smart medication infusion pumps – only allows a certain volume of medication over a prescribed rate, i.e. is pre-set .
  • Streamline and simplify the process so opportunity for errors are decreased – fewer, simpler steps makes the process less likely to have an error.
  • Standardize medications – use the same medication, e.g. have available only 1 concentration of an intravenous medication and not multiple ones so the wrong dilution is used inadvertently.

Ideas for improved patient safety through human factors:

    • Limit prolonged work hours – fatigue and sleep deprivation are known causes of increased errors so methods to limit total hours worked and protect sleep are important
    • Protect sleep recovery periods
    • Employ strategic napping and judicious use of caffeine
    • Improve communications through decreased patient handoffs, decrease cross-coverage of patients by healthcare providers (i.e. increase continuity of healthcare providers and the patient)
    • Improve communications through improved information transfer during handoffs and feedback – e.g. use a computerized sign-out program to assure all pertinent information is communicated verbally and in written form

    Ideas for improved patient safety through developing a safety culture:

    • Develop methods for error reporting that is non-punitive
    • Develop methods for anonymous error reporting to a central registry
    • Conduct audits of patient safety with non-punitive feedback given to healthcare providers and the institution
    • Analysis by the institution of critical incidents that occur, along with the authority of the analyzing body to change the system to improve it
    • Educate healthcare personnel and the public

    Questions for Further Discussion
    1. What patient safety efforts are ongoing in your own institution?
    2. How can you report a patient safety problem in your own institution?

    Related Cases

To Learn More
To view pediatric review articles on this topic from the past year check PubMed.

Information prescriptions for patients can be found at MedlinePlus for these topics: Drug Safety and Poisoning.

To view current news articles on this topic check Google News.

To view images related to this topic check Google Images.

Committee on Quality of Health Care in America.
To Err is Human. Institute of Medicine, National Academy Press.
Washington, D.C..
Available from the Internet at (rev. 11/1/1999, cited 11/12/07).

Committee on Quality of Health Care in America.
Crossing the Quality Chasm:
A New Health System for the 21st Century. Institute of Medicine, National Academy Press.
Washington, D.C..
Available from the Internet at (rev. 3/1/2001, cited 11/12/07).

Committee on Quality of Health Care in America.
Patient Safety:
Achieving a New Standard for Care. Institute of Medicine, National Academy Press.
Washington, D.C..
Available from the Internet at (rev. 11/20/2003, cited 11/12/07).

Robertson J, Shilkofski N. The Harriet Lane Handbook. 17th. Edit. Mosby Publications: St. Louis. 2005:996-997.

Committee on Quality of Health Care in America.
Preventing Medication Errors: Quality Chasm Series. Institute of Medicine, National Academy Press.
Washington, D.C..
Available from the Internet at (rev. 7/20/2006, cited 11/12/07).

American Academy of Pediatrics. Appropriate Use of Antimicrobial Agents, In Pickering LD, Baker CJ, Long SS, McMillan JA, eds. Red Book: 2006 Report of the Committee on Infectious Diseases. 27th edit. Elk Grove Village, IL: American Academy of Pediatrics; 2006;740-741.

Morriss, FW. Patient Safety in Pediatrics. Presentation at the Department of Pediatrics’ Societal, Professional and Ethical Issues Conference. University of Iowa Children’s Hospital, 11/8/2007.

ACGME Competencies Highlighted by Case

  • Patient Care
    1. When interacting with patients and their families, the health care professional communicates effectively and demonstrates caring and respectful behaviors.
    2. Essential and accurate information about the patients’ is gathered.
    3. Informed decisions about diagnostic and therapeutic interventions based on patient information and preferences, up-to-date scientific evidence, and clinical judgment is made.
    4. Patient management plans are developed and carried out.
    7. All medical and invasive procedures considered essential for the area of practice are competently performed.
    8. Health care services aimed at preventing health problems or maintaining health are provided.

  • Medical Knowledge
    10. An investigatory and analytic thinking approach to the clinical situation is demonstrated.
    11. Basic and clinically supportive sciences appropriate to their discipline are known and applied.

  • Practice Based Learning and Improvement
    12. Evidence from scientific studies related to the patients’ health problems is located, appraised and assimilated.
    13. Information about other populations of patients, especially the larger population from which this patient is drawn, is obtained and used.
    14. Knowledge of study designs and statistical methods to appraisal clinical studies and other information on diagnostic and therapeutic effectiveness is applied.

    16. Learning of students and other health care professionals is facilitated.

  • Systems Based Practice
    23. Differing types of medical practice and delivery systems including methods of controlling health care costs and allocating resources are known.
    24. Cost-effective health care and resource allocation that does not compromise quality of care is practiced.
    25. Quality patient care and assisting patients in dealing with system complexities is advocated.
    26. Partnering with health care managers and health care providers to assess, coordinate, and improve health care and how these activities can affect system performance are known.

    Donna M. D’Alessandro, MD
    Professor of Pediatrics, University of Iowa Children’s Hospital

    December 17, 2007