Committee Opinion
Number 526, May 2012

Committee on Patient Safety and Quality Improvement
This document reflects emerging concepts on patient safety and is subject to change. The information should not be construed as dictating an exclusive course of treatment or procedure to be followed.

PDF Format

Standardization of Practice to Improve Outcomes

ABSTRACT: Protocols and checklists have been shown to improve patient safety through standardization and communication. Standardization of practice to improve quality outcomes is an important tool in achieving the shared vision of patients and their health care providers.

Protocols and checklists have been shown to reduce patient harm through improved standardization and communication (1–7). In the absence of evidenced-based medicine for a given clinical decision (8), development of these protocols sometimes may be contentious. However, the use of checklists and protocols has clearly been demonstrated to improve outcomes and their use is strongly encouraged (1). Refinement and sophistication of checklists has shown decreased morbidity and mortality by meeting standards of care (9). Factors other than patient safety and quality, such as cost containment and utilization, should not be the prime consideration for using these tools.

It is clear that wide variation exists in many areas of practice within obstetrics and gynecology. Two types of variation are recognized by scholars in the field of medical process improvement. Necessary clinical variation is that which is dictated by, among others, differences such as a patient’s age, ethnicity, weight, medical history, and desired outcomes of therapy. Unexplained clinical variation is that which is not accounted for by any of these things. Variation in processes of care is problematic because it leads to increased rates of error. Performing critical tasks the same way every time can reduce the kind of slips and lapses that all human beings are subject to, especially when fatigue is a factor and in stressful environments such as the labor and delivery suite or operating room. Elimination of variation in processes has been a cornerstone of improved performance and reliability over the past several decades in commercial aviation. In health care, a similar level of success has been achieved in the field of anesthesia, where adverse events have been significantly reduced over the past 25 years through standardization of patient monitoring, dispensing of inhaled gases, and medication administration. In obstetrics, standardization of antenatal testing for group B streptococci, combined with standardized antibiotic prophylaxis, has resulted in a marked reduction in the incidence of neonatal group B streptococcal infection. Similarly, standardization of any process of care through the use of protocols and checklists can be expected to achieve a similar reduction in harmful events. These should be recognized as a guide to the management of a clinical situation or process of care that will apply to most patients. For the occasional patient whose care proves to be an exception for valid reasons, the physician should document in the medical record why the protocol is not being followed.

It is imperative that obstetrician–gynecologists take the lead in designing and collaboratively implementing standardized protocols and checklists for their practices in the hospital and the office setting. If physicians are not actively engaged in defining the process, it may be imposed on them from external sources. If externally crafted, the process and requirements may or may not be evidence-based or appropriate. The motivation and intent for any protocol or checklist should be to ensure high-quality, safe, and, when possible, evidence-based practice. Although not driven by economics, standardization often will result in significant economic savings. When standardized care is used, quality increases, variation decreases, and cost decreases (8, 10–13).

The process to develop these protocols must be collaborative, inclusive, and multidisciplinary, and should include hospital administration working with and supporting health care providers, patient advocates, nurses, and support staff in their initiatives. Although the components of a particular checklist or protocol may be established at a national level and some requirements may be mandated by regulatory agencies such as federal or state governments or The Joint Commission, they may be adapted to the local practice setting; thus, standardization of checklists or protocols within an institution is strongly encouraged. It is important that physicians are informed whenever checklists or protocols are to be used. Encouraging input from physicians in the review and distribution of checklists and protocols will help foster buy-in from physicians for their use. Procedures should be in place for notifying and training all practitioners whenever the use of these tools is to be implemented.

Adverse outcomes often occur because of system deficiencies or inadequate safety measures that fail to prevent error from causing harm. Standardization is a process to be used to overcome system deficiencies, which, with data analysis, will decrease or prevent errors or reduce the likelihood of their recurrence.

Obstetrician–gynecologists are committed to continuously improving safety in the care of their patients. Standardization of practice to improve quality outcomes is an important tool in achieving the inspired shared vision of patients and their health care providers. The responsibility clearly focuses on innovative, empowered, and committed physician leadership. Continuous quality improvement depends on a disciplined and well-defined data-driven process that is constantly monitored and improved. The process is ideally led by obstetrician–gynecologists in collaboration with nurses and other health care professionals to achieve the highest level of quality and safety in women’s health care.


  1. Gawande A. The checklist manifesto: how to get things right. New York (NY): Metropolitan Books; 2009.
  2. Kirkpatrick DH, Burkman RT. Does standardization of care through clinical guidelines improve outcomes and reduce medical liability? Obstet Gynecol 2010;116:1022–6. [PubMed] [Obstetrics & Gynecology]
  3. Patient safety in obstetrics and gynecology. ACOG Committee Opinion No. 447. American College of Obstetricians and Gynecologists. Obstet Gynecol 2009;114:1424–7. [PubMed] [Obstetrics & Gynecology]
  4. Pizzi L, Goldbarb N, Nash D. Crew resource management and its applications in medicine. In: Agency for Healthcare Research and Quality. Making health care safer: a critical analysis of patient safety practices. Evidence Report/Technology Assessment No. 43. Rockville (MD): AHRQ; 2001. p. 505–13.
  5. Ransom SB, Pinsky WW, Tropman JE, editors. Enhancing physician performance: advanced principles of medical management. Tampa (FL): American College of Physician Executives; 2001.
  6. Berwick DM. A user’s manual for the IOM’s ‘Quality Chasm’ report. Health Aff 2002;21(3):80–90. [PubMed] [Full Text]
  7. Grol R. Between evidence-based practice and total quality management: the implementation of cost-effective care. Intl J Qual Health Care 2000;12:297–304. [PubMed] [Full Text]
  8. Landon BE, Norwood SL, Blumenthal D, Daley J. Physician clinical performance assessment: prospects and barriers. JAMA 2003;290:1183–9. [PubMed] [Full Text]
  9. Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AH, Dellinger EP, et al. A surgical safety checklist to reduce morbidity and mortality in a global population. Safe Surgery Saves Lives Study Group. N Engl J Med 2009;360:491–9. [PubMed] [Full Text]
  10. Darmstadt GL, Bhutta ZA, Cousens S, Adam T, Walker N, de Bernis L. Evidence-based, cost-effective interventions: how many newborn babies can we save? Lancet Neonatal Survival Steering Team. Lancet 2005;365:977–88. [PubMed] [Full Text]
  11. Timmermans S, Mauck A. The promises and pitfalls of evidence-based medicine. Health Aff 2005;24:18–28. [PubMed] [Full Text]
  12. Priori SG, Klein W, Bassant JP. Medical Practice Guidelines. Separating science from economics. European Society of Cardiology. Eur Heart J 2003;24:1962–4. [PubMed] [Full Text]
  13. Brown GC, Brown MM, Sharma S. Health care in the 21st century: evidence-based medicine, patient preference-based quality, and cost effectiveness. Qual Manag Health Care 2000;9:23–31. [PubMed]

Copyright May 2012 by the American College of Obstetricians and Gynecologists, 409 12th Street, SW, PO Box 96920, Washington, DC 20090-6920. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, posted on the Internet, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission from the publisher. Requests for authorization to make photocopies should be directed to: Copyright Clearance Center, 222 Rosewood Drive, Danvers, MA 01923, (978) 750-8400.

ISSN 1074-861X

Standardization of practice to improve outcomes. Committee Opinion No. 526. American College of Obstetricians and Gynecologists. Obstet Gynecol 2012;119:1081–2.

American Congress of Obstetricians and Gynecologists
409 12th Street SW, Washington, DC  20024-2188 | Mailing Address: PO Box 70620, Washington, DC 20024-9998