Protocols, Checklists and I HAVE NOTHING TO DISCLOSE - - PowerPoint PPT Presentation

Steven L. Clark, M.D. Texas Children’s Hospital/Baylor College of Medicine

Protocols, Checklists and Standardization

I HAVE NOTHING TO DISCLOSE PROTOCOLS AND STANDARDIZATION Rationale for standardization Examples of successful standardization in

• bstetrics

How do I do it at my facility? The future AUDIENCE RESPONSE QUESTION How do you feel about protocols and standardization in obstetric practice?

• A. This is simply “cookbook medicine” and is a step

backwards

• B. This is the future and I embrace it
• C. Undecided

T h i s i s s i m p l y “ c

• k

b

• k

. . . T h i s i s t h e f u t u r e a n d I e . . . U n d e c i d e d

9% 19% 72%

NO DECREASE IN DECADES IN RATES OF : Cerebral palsy Brachial plexus injury Maternal mortality Cesarean delivery rate Preterm birth rate * We rank 47th in perinatal mortality rate NO DECREASE IN DECADES IN RATES OF : Cerebral palsy Brachial plexus injury Maternal mortality Cesarean delivery rate Preterm birth rate * We rank 47th in perinatal mortality rate and have a maternal mortality rate approximating that in some low-resource countries OUR HEALTH CARE EXPENDITURES ARE TWICE THAT OF ANY OTHER NATION WHY TO WE DO SO POORLY? Large geographic area Non- homogeneous population Poverty The Democrats The Republicans Climate change The dog ate my homework

“EVERY SYSTEM IS PERFECTLY DESIGNED TO ACHIEVE EXACTLY THE RESULTS IT IS ACHIEVING”

Batalden/ Berwick

WHY TO WE DO SO POORLY? Large geographic area Non-homogenous population Poverty The Democrats The Republicans Climate change The dog ate my homework THE U.S. SYSTEM OF OBSTETRIC CARE IS BROKEN PROTOCOLS AND STANDARDIZATION “ We are confident that this higher level of care cannot be achieved by further stressing current systems of care. The current care system cannot do the job. Trying harder will not work. Changing systems of care will. The Institute of Medicine – Crossing the Quality Chasm

A BROKEN HEALTH CARE SYSTEM HOW WE PAY FOR HEALTH CARE HOW WE TRAIN – THE NATURE OF THE SPECIALTY HOW WE ORGANIZE SERVICES HOW WE DELIVER SERVICES OBSTETRIC PRACTICE IN THE U.S. Based upon 2 fundamental conceptual errors Physician autonomy is a positive good. Litigation is best reduced by ambiguity in guidelines, such that almost any action can be defended. PROTOCOLS AND STANDARDIZATION STANDARDIZATION OF PRACTICE : ONE KEY TO PATIENT SAFETY Protocols Checklists Drills Team Training Forcing functions

PROTOCOLS AND STANDARDIZATION STANDARDIZATION OF PRACTICE : THE KEY TO LITIGATION REDUCTION

• 1. REDUCES ADVERSE OUTCOMES
• 2. CANONIZES ACCEPTABLE PRACTICE

UNIFORM PROCESS = IMPROVED PRODUCT Commercial aviation Nuclear power generation Automobile manufacturing Professional baseball Organic evolution Appears to apply to any human activity, particularly if technology or other humans are involved. PROTOCOLS AND STANDARDIZATION PROCESS STANDARDIZATION WILL IMPROVE OUTCOMES EVEN WHEN MULTIPLE APPROACHES EXIST WHICH, BY THEMSELVES ARE EQUALLY EFFECTIVE.

EXAMPLES

OBSTETRICS

STANDARDIZATON AND PROTOCOLS

Early examples

Early onset group B Streptococcus. Steroids for lung maturity STANDARDIZATON AND PROTOCOLS

Recent examples

Oxytocin administration

Clark et al AJOG 2015;212:494

OXYTOCIN CHECKLIST (q 30 minutes)

• 1 acceleration (15 x 15) is present,

OR adequate variability for at least 10 of past 30 minutes No more than 1 late deceleration No more than 2 variables exceeding 60 bpm depth from baseline for > 60 seconds OXYTOCIN CHECKLIST (q 30 minutes) No more than 5 UCs/10 min for any 2 consecutive 10 minute intervals No 2 UCs lasting > 2 minutes Uterus palpates soft in between contractions If IUPC in place, < 300 MVU, and baseline tone < 25 mmHg

Oxytocin Protocol : Impact PROTOCOLS AND STANDARDIZATION PROCESS STANDARDIZATION WILL IMPROVE OUTCOMES EVEN WHEN MULTIPLE APPROACHES EXIST WHICH, BY THEMSELVES ARE EQUALLY EFFECTIVE. Need only to establish rough equivalence and standardize/ implement one good approach. STANDARDIZATON AND PROTOCOLS Recent examples Oxytocin administration Post cesarean VTE prophylaxis Clark et al AJOG 2014;211:32 N = 2.7 million Deaths from post cesarean pulmonary embolism decreased from 2/100,000 to 0.2/100,000, p = 0.038

STANDARDIZATON AND PROTOCOLS Recent examples Oxytocin administration Post cesarean VTE prophylaxis Elective delivery < 39 weeks Clark et al AJOG 2010;203:449 N = 17,000 Early elective delivery declined from 9.6% to 4.3% (p=0.001) Accompanied by a 16% decrease in NICU admissions (p=0.001) STANDARDIZATON AND PROTOCOLS Recent examples Oxytocin administration Post cesarean VTE prophylaxis Elective delivery < 39 weeks Management of hypertensive crisis Clark et al AJOG 2014;211:32 N = 2.7 million Mortality from hypertension reduced from 1/100,000 to 1/300,000 (p=0.02) From #1 cause of death to #10 cause of death Hypertensive Crisis 160/110 mmHg well established What about 170/100? What about 158/112? Should you repeat the BP before treatment? If so, how long should you wait to repeat the BP?

HYPERTENSIVE CRISIS The following protocol should be initiated if the systolic blood pressure is ≥ 160 mmHg OR the diastolic blood pressure is ≥ 110 mmHg. __ Notify physician __ Administer hydralazine, 5 mg IV over 2 minutes __ Repeat blood pressure in 15 minutes __ If either blood pressure threshold is still exceeded, administer hydralazine 10 mg IV over 2 minutes. __ Repeat blood pressure in 15 minutes ___If either blood pressure threshold is still exceeded, administer labetalol, 20 mg IV over 2 minutes ___ Repeat blood pressure in 10 minutes ___If either blood pressure criteria is still exceeded, administer labetalol 40 mg IV

• ver 2 minutes and obtain emergency

maternal-fetal medicine, internal medicine or anesthesia consultation.

STANDARDIZATON AND PROTOCOLS

Recent examples

Oxytocin administration Post cesarean VTE prophylaxis Elective delivery < 39 weeks Management of hypertensive crisis Management of morbidly adherent placenta

Shamshsiraz et al AJOG 2015;212:218

STANDARDIZATON AND PROTOCOLS

Recent examples

Oxytocin administration Post cesarean VTE prophylaxis Elective delivery < 39 weeks Management of hypertensive crisis Management of morbidly adherent placenta Massive transfusion protocols

Pacheco et al. AJOG 2015 Sept 15 (epub ahead of print)

STANDARDIZATON AND PROTOCOLS

Recent examples

Oxytocin administration Post cesarean VTE prophylaxis Elective delivery < 39 weeks Management of hypertensive crisis Management of morbidly adherent placenta Massive transfusion protocols Postpartum hemorrhage

Shields et al AJOG 2015;212:272

STANDARDIZATON AND PROTOCOLS

Recent examples

Oxytocin administration Post cesarean VTE prophylaxis Elective delivery < 39 weeks Management of hypertensive crisis Management of morbidly adherent placenta Massive transfusion protocols Postpartum hemorrhage Management of category II FHRT

Clark et al 2013;209:89 Clark et al 2016 – SMFM Significantly less metabolic acidosis with identical cesarean rate

2 4 6 8 10 12 14 16 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009

Frequency Trends - HCA Reported Claims per 10,000 Births

PROTOCOLS AND STANDARDIZATION PROCESS STANDARDIZATION WILL IMPROVE OUTCOMES EVEN WHEN MULTIPLE APPROACHES EXIST WHICH, BY THEMSELVES ARE EQUALLY EFFECTIVE. “There is no literature to support the superiority of that approach over mine” is irrelevant if patient safety is of principle concern. Variation from protocol is always allowed, with a note explaining why, but is subject to peer review. PROTOCOLS AND STANDARDIZATION STANDARDIZATION OF PRACTICE : ONE KEY TO PATIENT SAFETY Protocols Checklists Drills Team Training Forcing functions

FORCING FUNCTIONS IN PATIENT SAFETY The next frontier Forcing function: A process or procedure which prevents patient harm even when an error is made. Examples:

• MgSO4 only in 4 g bags
• EMR order stops for incorrect doses of

hazardous meds

• Integration of pattern recognition software with

the oxytocin pump. “ Leaders must ensure that their organization has the ability to change. Yet many leaders now view their role as shielding and protecting the

• rganization from environmental pressures that may

require them to change.” Institute of Medicine – Crossing the Quality Chasm