2 Seperate Discussion Posts Due on Wednesday

Hey Tutor, there are two separate discussionsbelow. You will produce 2 separate word
documents. Please stick with the individual topics.
The first topic should be on a single-paced one
page and the other should be double-spaced, two
pages:
Discussion Topic 1:Voluntary versus Mandatory
Compliance
Discuss the difference between voluntary compliance and mandatory
compliance. Please discuss the significance and why is it…
Discussion Topic 2: Voluntary Regulation and
Accreditation
Discuss the positives and negatives of voluntary regulation, as well as the
positives and negatives of voluntary accreditation. Then, describe at least one
accrediting body that impacts your health care setting of choice–either where you
work or a health care setting that is of interest to you–and define the impact that
accrediting body has on selected setting.
•
•
Please read on the resource below if you can find it or read on a similar topic
to do the discussion posts. It is not in our library
Moran, K. M., Harris, I. B., & Valenta, A. L. (2016). Competencies for patient
safety and quality improvement: A synthesis of recommendations in
influential position papers. Joint Commission Journal On Quality & Patient
Safety, 42(4), 162–169.
Chapter reading is below.
CHAPTER FIVE
MEDICATION ERROR REDUCTION: Voluntary and Regulatory Oversight
David M. Benjamin
John P. Santell
•
Rozovsky, F. A., & Woods, J. R., Jr. (Ed.). (2011). The handbook of patient safety
compliance: A practical guide for health care organizations. San Francisco, CA:
Jossey-Bass. ISBN: 9781118086995.
• Read Chapter 5, “Medication Error Reduction: Voluntary and
Regulatory Oversight,” pages 64–95.
“Modern health care presents the most complex safety challenge of any activity
on earth. However, we have failed to design our systems for safety, relying
instead on requiring individual error-free performance enforced by punishment, a
strategy abandoned long ago by safer industries such as aviation and nuclear
power.” So say Lucian Leape and colleagues in a JAMA editorial (Leape and
others, 1998). Indeed, when you stop to think about it, why is it that the connector
fitting on the intravenous (IV) lines and the nasogastric (NG) tubes fit one
another? And aren’t you glad that anesthesia machines can no longer deliver an
anesthetic gas unless the oxygen is running?
Unfortunately, when it comes to health care, Murphy’s Law not only applies but
leads one to the inescapable conclusion of Murphy’s disciple, O’Brien, who said
of his mentor, “Murphy is an optimist!” The problem is that Leape is right; modern
health care is so complex that physicians, nurses, and pharmacists can no longer
carry around in their heads all the information they need to practice their
professions. Moreover, the health care system is designed not to prevent error
but rather in a manner that places the responsibility of error prevention squarely
on health care practitioners. There are still many common practices that can lead
to unintended tragedy, such as allowing nurses access to harmful floor stock
items like vials of concentrated potassium chloride (KCl), rather than restricting
such items to the pharmacy or operating room pharmacy satellites. Concentrated
potassium chloride is one of the three drugs used in lethal injection, and it
definitely will adversely affect a patient in one’s institution if it is given without
proper dilution (see 2004 Patient Safety Goal 3a of the Joint Commission on
Accreditation of Healthcare Organizations [ JCAHO] in Exhibit 5.1). And there are
other problem-prone practices. Many hospital pharmacies stock medications
alphabetically, with the result that different products with similar-looking names
(for example, Lamisil and Lamictal) are right next to each other on the shelf,
leading at times to the dispensing of the wrong drug. According to data collected
by the two medication error reporting programs of the United States
Pharmacopeia (USP), confusion because of the similarity of drug names when
either written or spoken (look-alike or sound-alike) accounts for approximately 5
to 15 percent of all reported errors (Hicks, Cousins, and Williams, 2003; USP,
2001). Still not convinced? Remember when omeprazole first came out on the
market for the treatment of gastric hyperacidity? Its brand name then was Losec.
After numerous prescriptions for Lasix 50 mg were mistakenly and unfortunately
dispensed as Losec 50 mg, the manufacturer changed the brand name of the
drug to Prilosec. This case signals a new awareness by manufacturers that
product naming and labeling play a role in medication errors. Medical and
medication errors are emerging from their cloak of invisibility, and health care is
entering the age of self-critical analysis slowly. Organizations in the private sector
like the National Patient Safety Foundation, the Institute for Healthcare
Improvement, and the Leapfrog Group have joined governmental agencies like
the Agency for Healthcare Research and Quality (AHRQ) and the Food and Drug
Administration (FDA) in jumping on the ambulance en route to treating our ailing
health care system.
What is the result of putting the practice of medicine under the microscope?
Physicians, patient safety experts, systems engineers, and software
manufacturers have identified many of the most common system errors and
unsafe practices that occur in the health care setting and are in the process of
redesigning systems to decrease the likelihood of making an error. In addition,
our legislators have proposed new law, in the form of the Patient Safety and
Quality Improvement Act, that not only encourages the reporting of medical and
medication errors to newly designated patient safety organizations (PSOs) but
also provides legal privilege for such documented reporting. According to this
proposed Act, in order to be certified as a PSO an organization must meet
certain specified criteria. It must conduct activities that improve patient safety and
the quality of health care delivery. It must not have any conflicts of interest with
its providers. The PSO must have appropriately trained staff, including licensed
or certified medical professionals. The PSO cannot be a component of an
insurance company. It must operate independently, and it must collect patient
safety data in a standardized manner that permits valid comparisons of similar
cases among similar providers.
EXHIBIT 5.1. 2004 JCAHO NATIONAL PATIENT SAFETY GOALS.
Improve the accuracy of patient identification.
Use at least two patient identifiers (neither to be the patient’s room number)
whenever taking blood samples or administering medications or blood products.
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.
Improve the effectiveness of communication among caregivers.
Implement a process for taking verbal or telephone orders or critical test results
that require a verification “read-back” of the complete order or test result by the
person receiving the order or test result.
Standardize the abbreviations, acronyms and symbols used throughout the
organization, including a list of abbreviations, acronyms and symbols not to use.
Improve the safety of using high-alert medications.
Remove concentrated electrolytes (including, but not limited to, potassium
chloride, potassium phosphate, sodium chloride >0.9%) from patient care units.
Standardize and limit the number of drug concentrations available in the
organization.
Eliminate wrong-site, wrong-patient, wrong-procedure surgery.
Create and use a preoperative verification process, such as a checklist, to
confirm that appropriate documents (e.g., medical records, imaging studies) are
available.
Implement a process to mark the surgical site and involve the patient in the
marking process.
Improve the safety of using infusion pumps.
Ensure free-flow protection on all general-use and PCA (patient controlled
analgesia) intravenous infusion pumps used in the organization.
Improve the effectiveness of clinical alarm systems.
Implement regular preventive maintenance and testing of alarm systems.
Assure that alarms are activated with appropriate settings and are sufficiently
audible with respect to distances and competing noise within the unit.
Reduce the risk of health care–acquired infections.
Comply with current CDC hand hygiene guidelines.
Manage as sentinel events all identified cases of unanticipated death or major
permanent loss of function associated with a health care–acquired infection.
Source: JCAHO, 2004.
It is to be hoped that in the near future, practitioners and hospitals no longer will
need to be concerned that quality improvement investigations or root cause
analyses will be used against them as evidence of negligence in any subsequent
legal proceeding. Moreover, PSOs will have opportunities to analyze error
reports and issue educational updates on the frequency and severity of reported
medication errors. Programs currently in place already provide hospitals a way to
measure (or compare) their improvement in medication safety and to determine
where they have progressed and where more effort is still needed. Such
programs will be of greatest value only if and when legislative protection for
submitted data is enacted.
One such existing program is the U.S. Pharmacopeia’s MEDMARX error
reporting program, which facilitates analysis of medication errors in the
institutional setting. This anonymous, confidential, deidentified, Internetaccessible program allows hospitals and other health care facilities to report,
track, and share medication error data in a standardized format. MEDMARX uses
the nationally recognized National Coordinating Council for Medication Error
Reporting and Prevention (NCC MERP) taxonomy, which includes an index for
categorizing error events by severity and outcome and allows the capture of both
potential and near-miss events as well as harmful errors. This system for
categorizing medication errors is summarized in Exhibit 5.2.
Recently, USP summarized data findings for the three-year period covering
January 1, 1999, to December 31, 2001, (Santell, Hicks, McMeekin, and
Cousins, 2003). During that period, USP examined 154,816 medication error
records that were reported to the MEDMARX database. Errors labeled as
Category C made up approximately 47 percent (72,000 out of 154,816) of the
total. Category B was the next most frequently cited error category (32 percent).
Records citing Category E errors occurred only 2.2 percent of the time. Category
F errors occurred only 0.4 percent of the time (4 times per 1,000 errors). The
most serious medication errors, in categories G, H, and I, occurred only 1, 3, and
1 time(s) in 10,000, respectively, and medication errors in categories E through I,
representing all harmful errors and those requiring intervention or hospitalization,
occurred 2.63 percent of the time overall.
Unfortunately, many hospitals have medication safety reporting systems
(whether for medication errors or adverse drug reactions) that suffer from
inadequate or inconsistent data capture. This results in great underreporting and
causes frustration for those charged with analyzing and communicating the
findings because key data elements often are missing. Other hospitals are
diligent about collecting complete data but are uncertain how best to use those
data. To help transform data into useful information, USP has constructed a
medication safety initiative model for hospitals (Figure 5.1). The model is based
on USP’s work with practitioners and health systems, work with error reporting
programs, and experience with the issues of medication safety. It consists of four
stages that deal with the environment and culture, data collection, data analysis,
and assessment of the impact of actions taken in response to errors.
EXHIBIT 5.2. NCC MERP ERROR CATEGORY INDEX FOR SEVERITY
LEVELS AND OUTCOMES.
No error
Category A: Circumstances or events that have the capacity to cause error.
Error, no harm
Category B: An error occurred, but the error did not reach the patient.
Category C: An error occurred that reached the patient but did not cause patient
harm.
Category D: An error occurred that reached the patient and required monitoring
to confirm that it resulted in no harm to the patient or required intervention to
preclude harm.
Error, harm
Category E: An error occurred that may have contributed to or resulted in
temporary harm to the patient and required intervention.
Category F: An error occurred that may have contributed to or resulted in
temporary harm to the patient and required initial or prolonged hospitalization.
Category G: An error occurred that may have contributed to or resulted in
permanent patient harm.
Category H: An error occurred that required an intervention necessary to sustain
life.
Error, death
Category I: An error occurred that may have contributed to or resulted in patient’s
death.
Source: National Coordinating Council for Medication Error Reporting and
Prevention, 2001.
Published data from national error reporting programs such as MEDMARX,
accompanied by safety models and technology, are becoming more available as
risk management tools to improve the safety of health care. CEOs often seek a
business case for patient safety and for supportive tools like MEDMARX. But the
real question they should ask is how can one afford not to have some of these
new advances in quality improvement and risk assessment? The next step is to
get the word out to every practitioner and hospital administrator that patient
safety tools are available and need only be implemented in their health care
facilities and medical offices in order to work.
FIGURE 5.1. USP MEDICATION SAFETY INITIATIVE MODEL.
Source: USP, 2002a.
What about cost? How can one afford electronic medical records or
computerized prescriber order entry (CPOE) or clinical pharmacists on every
floor to assist physicians with drug therapy decisions and nurses with medicationrelated questions? Leape and others (1997) reported that the use of clinical
pharmacists to assist physicians in selecting and prescribing medications
reduced adverse drug reactions by 66 percent and was reported to have the
potential to save one intensive care unit an estimated $270,000 over the course
of a year, based on an estimated saving of $4,685 per preventable adverse drug
event. In 1998, Bates and others demonstrated that CPOE could decrease
adverse drug experiences (ADEs) by 84 percent and serious medication errors
by 55 percent. Decreasing medication errors saves money for the hospital and
the health care system in general, to say nothing about avoiding the costs of
litigation.
Medication Error Reduction in the Institutional Setting
In the institutional setting the medication use process (MUP) begins with writing
the medication order and ends with monitoring the effects of the prescribed drug
on the patient. The process can be schematized as illustrated in Figure 5.2. This
schematic makes it apparent that getting the right drug to the right patient
requires excellent communication skills (both oral and written) among the
members of the health care team. Unfortunately, language is inherently inexact,
and communication errors form the basis for many medication errors and
therapeutic misadventures (Benjamin, 2001b; USP, 2002b).
The danger of poorly written communication has been illustrated in several, wellpublicized cases. For example, when Boston Globe health reporter Betsy
Lehman received a fatal, fourfold overdose of her cyclophosphamide
chemotherapy, it opened everyone’s eyes to the dangers inherent in prescription
writing. The order had been written as, “4 g/sq m over four days” (that is, four
grams per square meter over 4 days). The intention was that one-quarter of the
dose (1 g/sq m) be given once daily for four days, but the order was
misinterpreted, and 4 g/sq m were given as a single lethal dose (ECRI, 2000).
Complete, accurate, and appropriately communicated medication orders are
essential in reducing medication errors. One of JCAHO’s National Patient Safety
Goals (Exhibit 5.1, Goal 2) advocates written policies aimed at minimizing errors
in the communication of medication orders, specifically in the areas of verbal (or
telephone) orders and the use of abbreviations. The goal recommends
developing a standardized list of abbreviations, including abbreviations that
should not be used because they can be confusing (see, for example, Table 5.1).
FIGURE 5.2. SCHEMATIC OF MEDICATION USE PROCESS IN THE
INSTITUTIONAL SETTING.
In 2002, data from USP’s MEDMARX program (Hicks, Cousins, and Williams,
2003) tracked error reports, listing seven different communication-related causes
of error: (1) communication, (2) verbal order, (3) brand names sound alike, (4)
brand and generic names sound alike, (5) generic names sound alike, (6)
abbreviations, and (7) nonmetric units used. Over 13 percent (26,386 out of
192,477) of all reported errors were associated with these communication
selections, with the majority of the errors (nearly 63 percent) reaching the patient.
Communication selections were reported in 7 out of every 20 reported fatal errors
(35 percent) during 2002.
The way health care professionals communicate drug information varies
considerably from hospital to hospital, floor to floor, and unit to unit. Patterns of
communication in health care are primarily conversational (casual) rather than
computational (analytical) (Coiera, 2000)—a style that in some situations
undermines patient safety. Additional confounding factors, such as organizational
processes, policies, and procedures, further contribute to the extent and scope of
the problem. In the institutional setting the process of getting the medication
“from the pen to the patient” may involve more than twenty individual steps, in
contrast to the simplicity of prescribing for a patient in the outpatient setting,
where the prescriber either calls, faxes, scans, or e-mails the prescription directly
to the pharmacy or gives the prescription directly to the patient for presentation at
the pharmacy. If there are twenty steps involved in getting the medicine to the
patient, then there are twenty opportunities to make an error. Simplifying the
system immediately helps. Even reducing the number of steps from twenty to
nineteen reduces the possibility of making an error by 5 percent. Moreover,
health care today is truly a team effort. No single health care professional can
carry out all the steps by himself or herself. Physicians, nurses, and pharmacists
must rely on each other as well as on specially trained clerks, nursing assistants,
pharmacy technicians, and other hospital employees to perform their duties.
The complexity of the MUP in hospitals may be the reason why studies funded
by the AHRQ revealed that 39 to 49 percent of medication errors at large
hospitals occurred at the physician-prescribing stage of the process. Nursing
administration was next at 26 to 38 percent, followed by transcription errors, 11
to 12 percent, and pharmacy dispensing errors, 11 to 14 percent (Bates and
others, 1995; Leape and others, 1995).
TABLE 5.1. POTENTIALLY DANGEROUS ABBREVIATIONS.
Sources: United States Pharmacopeia, 2004a, 2004b.
Abbreviation
Intended Meaning Potential Misinterpretation
Recommendations
.5
One-half
May be read as 5 Use leading zero and write “0.5”
>
Greater than
meaning
< Less than meaning May be confused with < (lesser than) Write out the May be confused with > (greater than)
Write out the
μg
Micrograms May be interpreted as mg (milligrams)
Write “mcg”
¼ NS Quarter-strength saline May be interpreted as 0.45% saline Write
“0.225% sodium chloride”
½ NS Half-strength saline
“0.45% sodium chloride”
May be interpreted as 0.225% saline Write
½ mg 0.5 mg
1.5 mg may be given to patient Spell out “one-half” or use
decimal (“0.5 mg”)
1 Amp
One ampoule
exact dose
12.0 Twelve
1 milligram; may confuse size with strength Write
May be read as 120
Don’t use trailing zero; write “12”
2–4 mg
2 mg up to 4 mg of medication to be given May be read as 24 mg
Don’t use hyphen; write “2 mg to 4 mg”
3lbs 3 pounds
May be read as 31 pounds
Spell out “pounds”
40 of K (verbal order)
40 mEq KCl (potassium chloride)
interpreted as Vitamin K 40 mg Convey full name of product
May be
5 ASA
5-acetylsalicylic acid (Mesalamine) suppository May be
interpreted as aspirin suppository, 5 grains Write out generic name
Write out “both ears”
AU
Both ears
Confused with optic
AS
Left ear
route for administration Write out “left ear”
AD
Right ear
CC or Cc
written
Write out “right ear”
Cubic centimeter May be mistaken for “U” (units) when poorly
Use metric system “mL” or write out “milliliters”
CHG in saline
name
Chlorhexidine gluconate in saline
D/C or DC Discharge or discontinue May be misinterpreted
“discharge” or “discontinue”
Write out generic
Write out
D/C PT or DC PT Discontinue physical therapy or discharge patient May be
misinterpreted
Write out intended meaning
DTaP Vaccine for diphtheria, tetanus, acellular pertussis May be confused with
DTP
FUDR
Fludarabine May be interpreted as floxuridine
complete drug product name—generic or trade
Write out
GM-CSF
Leukine
May be entered as G-CSF (Neupogen)
complete product name—generic or trade
H
Humalog
product name
HC oint
May be interpreted as Humulin R
Write out
Write out complete
Hydrocortisone ointment
HCTZ Hydrochlorothiazide
May be confused with hydrocortisone Write out
complete product name—generic or trade
HIB
Haemophilus influenzae B
Write out generic name
May be confused with hepatitis B (HEP-B)
HIB Haemophilus influenzae B
globulin (H-Big)
May be confused with hepatitis B immune
PTN Phenytoin
name
IV
May be interpreted with multiple meanings Write out generic
Intravenous or (4) May be misinterpreted
Write out intended meaning
Hs or hs
Every night or half-strength
May be interpreted with multiple
meanings; may be interpreted as every hour
Write out “every night” or “half
strength”
Humalog, 2 unit qac
every morning (q.am)
i/d
Humalog, 2 units, before each meal Humalog, 2 units,
Write out completely
Once daily May be read as TID
Write out “once daily”
L insulin
Lente insulin or Lantus insulin May be misinterpreted
generic or trade name
Write out
MgSO4 or MgSO4 Magnesium sulfate
May be confused with morphine
sulfate
Write out complete product name—generic or trade
MMC Mutamycin Unapproved abbreviation
name—generic or trade
Write out complete product
MS03 Morphine sulfate May be confused with magnesium sulfate
full name
NO
Nitroglycerin ointment
OD Right eye
“once daily”
May be read as mo
Write out generic name
May be interpreted as once daily
Write out “right eye” or
OJ Orange juice
juice”
Oxy-IR
Write out
May be interpreted as OD or OS
Write out “orange
IR may be interpreted as 1–2 Write out generic name
per os
Oral route of administration
May be read as per OS (left eye)
Write “orally” or “by mouth” or “P.O.”
PH Pharmacy to dose May be confused with PTT
instructions; do not abbreviate
Write out complete
Pm or PM
Write “nightly”
Night dose May be confused with prn
PMV Passiy Muir Value May be confused with prenatal vitamins
intended meaning
Write out
PPN Peripheral parenteral nutrition May be interpreted as TPN (total parenteral
nutrition)
Write out intended meaning
QD or qd
Every day
May be read as qid
QOD or qod Every other day
out “every other day”
Q6 Every 6 hours
entry
Write out “daily”
May be confused with qid (four times daily) Write
May be confused with qD (every day) Write “hours” after
QD-HS
Daily at hour of sleep
hyphens and write out
QDx2 Every day for 2 days
“daily for 2 days only”
May be confused as QD & HS Avoid
May be confused with bid (twice daily)
Write
QID or qid 4 times daily
frequency
May be confused with once daily
Sq or sc
“subq”
Subcutaneous
The “q” may be read as meaning “every”
SS or Ss
scale”
Sliding scale
May be confused with one-half Write out “sliding
TAC Tetracaine, adrenaline, cocaine
Write out generic name
Spell out
Write
May be confused with triamcinolone
TAC Triamcinolone
May be confused with Tetracaine, adrenaline, cocaine
Write out generic name
Tbsp Tablespoon May be confused with tsp (teaspoon) Write “15 mL”
Td
Tetanus diphtheria May be confused with PPD
TID or tid
Tsp
Three times daily May be misinterpreted
Teaspoon
Write out “every 8 hours”
May be misinterpreted as tablespoon Spell out or use “5 mL”
TIW or tiw 3 times a week
week Spell out
May be interpreted as 3 times a day or twice a
U
Unit or units May be interpreted as O, 4, or CC
UD
Units per day
Write “unit” or “units”
May be interpreted as 60 cc/hr or unit dose Spell out
ZnSO4
out
Zinc sulfate May be confused with ferrous sulfate (FeSO4)
Spell
Z-PAK
Azithromycin pack May be read as 2 packs Write out generic name
The following sections look more closely at specific parts of the medication use
process.
Prescribing Process Issues: Benefits of an Integrated CPOE System in the
Hospital
In paper-based (noncomputerized) prescriber ordering systems, a physician (or
other authorized health care provider) writes a medication order in a patient’s
chart. A clerk may take a copy of that order and fax it to the pharmacy, or put a
hard copy of the order in an out-box to be picked up by a pharmacy technician. A
nurse will manually transcribe the physician’s order onto the patient’s medication
administration record (MAR), and later a different nurse will probably be the one
giving the medication to the patient. The key is to simplify this process and
provide less opportunity for error. How? By instituting computerized prescriber
order entry (CPOE). The patient’s name and the drug’s name are entered into
the CPOE program, and the physician responds to several screen prompts about
dosage, duration, and route. Incorrect doses (those not presented as choices)
and tenfold dosing errors that occur because a decimal point was not recognized
or a capital letter “U” (for units) was mistaken for a zero are diminished or
eliminated (see JCAHO’s 2004 Patient Safety Goal 2b in Exhibit 5.1 and also
Table 5.1). Once the computer system approves and finalizes the order, that
order simultaneously appears on the patient’s MAR and goes to the pharmacy’s
computer system for review, processing, and dispensing, undergoing a second
safety check there for drug interactions and contraindications.
One study indicated that CPOE decreased serious medication errors by 55
percent and reduced potential adverse drug experiences (ADEs) by 84 percent
(Bates and others, 1998). These numbers translate directly to dollars. In 1992,
Later Day Saints (LDS) Hospital in Salt Lake City had 567 ADEs, which cost the
hospital $1.1 million dollars in direct costs (not including the costs of injuries to
patients or legal costs). If half of these ADEs had been prevented, LDS Hospital
would have saved over $500,000 (Classen and others, 1997). The AHRQ
statistics on the effectiveness of instituting advances in reducing medication
errors and ADEs are impressive. CPOE saves money and lives (AHRQ, 2001).
AHRQ Findings: ADEs and Costs
Patients who experience ADEs have longer hospital stays.
A typical ADE costs $2,000 to 2,500; a preventable ADE costs ~$4,500.
Additional costs from an ADE range from $1,000 to $2,000 per day.
Computerized monitoring systems can reduce medication errors by 28 to 95
percent.
Hospitals can save millions of dollars in direct costs by reducing ADEs.
However, if not carefully and thoughtfully implemented, the use of computers in
health care can create new errors:
Computer entry was the fifth leading cause of errors reported to [USP’s
MEDMARX error reporting program] for both 2000 and 2001 [USP, 2002a,
2002b]…. This underscores concerns and cautions raised by researchers and
patient safety leaders that if not done carefully, implementation of CPOE and
other computer-based programs can result in new errors.
Approximately 10% (35,747/345,600) of all MEDMARX records from September
1998 through December 2002 documented computer entry as a cause of error.
Of those, 2% (635 records) indicated the patient was harmed [USP 2003]. In
2001, computer entry was listed as a cause in 11% of all reports where an error
did occur (N = 94,498) [see Figure 5.3] [USP, 2002b].
As shown in Table 5.2, the most frequently reported types of error associated
with computer entry errors were improper dose or quantity, omission error (failure
to administer), and prescribing error (owing to drug-drug or drug-food allergies,
patient’s condition, or an incomplete order).
FIGURE 5.3. TOP TEN CAUSES OF ERROR.
Source: USP, 2002b; based on 94,498 records.
Reports to MEDMARX reveal the common errors resulting from computer entry
(USP, 2003):
Dosing errors Look-alike strengths in close proximity on screen (e.g., 40,000
versus 4,000 units/mL)
Multiple and differing sliding scales (e.g., potassium, insulin)
Inadequate dosing algorithms or adjustments for renal failure
Wrong drug errors
Numerous similar drug names within single drug class (e.g., insulins)
Incorrect drug selected for patient’s condition or current drug therapy regimen
Wrong patient errors
Incorrect patient selected from screen due to distractions or patients with similar
names in same nursing unit (e.g., Smith, Ron vs Smith, Robert) or similar names
within an outpatient pharmacy computer information system.
TABLE 5.2. TYPES OF ERROR ASSOCIATED WITH COMPUTER ENTRY.
Type of Error
n
%
Improper dose/quantity 8,868 28.4
Omission error
6,526 20.9
Prescribing error 5,391 17.2
Unauthorized/wrong drug
3,924 12.5
Wrong time 2,632 8.4
Extra dose 2,513 8
Wrong patient
2,148 6.9
Wrong drug preparation 1,238 4
Wrong dosage form
Wrong route 900
1,148 3.7
2.9
Wrong administration technique
Expired producta 4
207
0.7
0.01
Note: Data from MEDMARX records from September 1998 through December
2002 (N = 31,272 records).
aNew type added (2002).
Source: USP, 2003.
Preventing Computer Entry Errors
USP has disseminated the following general recommendations to reduce errors
associated CPOE and other computer entry activities (including CPOE) (USP,
2003):
Conduct a Failure Mode and Effects Analysis (FMEA) on the use of computers in
the various stages of the medication use process to identify potentially confusing
abbreviations, dose designations, dosage forms, drug names, and other
problems that may be unique to the use of computers to convey information.
Standardize and simplify all dosing protocols, including sliding scales, to the
extent possible prior to implementing CPOE. Take into account complex or
unique drug orders (e.g., “hold 4pm dose until …,” steroid tapers).
Allocate ample space in the data fields that are used to communicate patient
names, drug names, dosing units, routes of administration, and frequencies.
Include properly spaced commas for dose numbers expressed in thousands
(e.g., 4,000 units).
Use USP standard abbreviations for dosage units to express weights and
measures in a consistent manner as follows:
m (lower case) = meter
kg = kilogram
g = gram
mg = milligram
mcg = microgram (do not use the Greek letter mu [µ] which has been misread as
mg)
L (upper case) = liter
mL (lower/upper case) = milliliter (do not use cc which has been misread as U or
the number 4)
mEq = milliequivalent
mmol = millimole.
Carefully construct the clinical rules/decision support framework using
appropriate in-house and outside expertise. The quality of the clinical rules used
will have a significant impact on the error-risk potential.
Establish the proper balance between sensitivity and specificity for computer
warnings/alerts to reduce … “false-alarm” fatigue [among practitioners] leading to
frequent overrides of the warnings.
Interface CPOE with the medication administration record (MAR) as well as
pharmacy and laboratory computer systems to maximize the exchange of
accurate and up-to-date patient information.
Establish a culture among prescribers and other practitioners that creates an
openness and willingness to transition to new operational methods for providing
health care that uses electronic information technology.
General USP Recommendations for Preventing Prescribing and Transcribing
Errors
Prescribers should submit orders electronically and avoid the need for additional
handwritten transcription.
Prescribers should order or select only standardized concentrations when
ordering IV infusions.
Protocols for ordering IV infusions should be clear and should eliminate the
possibility of calculation errors.
Prescribers should avoid the use of unclear or unsafe abbreviations (Table 5.1).
Transcription of original orders to medication administration records should be
timely, with minimal interruption, and should be independently verified for
accuracy. Optimally, transcription should be done electronically, as the manual
process (for example, recopying and assigning administration times) is repetitive
and has been shown to be error prone (Hicks, Cousins, and Williams, 2003).
Dispensing Process Issues
A medication order goes through numerous processing steps once it reaches the
pharmacy. Initially, it should be reviewed by a pharmacist, using clinical rules
built into a computer system. This system should evaluate the order against the
patient’s other prescribed medications for potential drug-drug interactions,
contraindications, and inappropriate dose or route based on the patient’s age,
disease state(s), and clinical condition. If the order is deemed appropriate as
written, the pharmacy prepares the medication and delivers it to the nursing unit
or patient care area, or ensures that a sufficient quantity exists in the unit’s
medication storage area or automated dispensing device (for example, Pyxis).
Delivery to the floor can be done in many ways. A pharmacist, pharmacy
technician, or other designee may bring medications to the floor and place them
in a drop-off box, place them in a patient-specific drug drawer, or simply place
them in the medication room, cabinet, or automated dispensing machine. Many
larger hospitals use automation (for example, pneumatic tubes) to deliver drugs
quickly to nursing units spread across their expansive buildings. In addition to
having various drug delivery modes, the vast majority of hospitals use a
combination of processes for balancing medication supply and demand in the
health care facility. The pharmacy may prepare and deliver a single, patientspecific, unit-dose package for some types of orders and for others it may
provide a twenty-four-hour supply. Frequently used medications may be stocked
routinely on the unit, and nurses may have to go to the medication storage area,
medication refrigerator, or automated dispensing machine to retrieve the proper
medication for the patient.
Each of these scenarios provides an opportunity for error. The ideal situation is to
have the pharmacy dispense all ordered medications in unit-dose form (or as
close as possible to it) to minimize the need for further calculation or
manipulation by nursing staff. Labeling on unit-dose packages should contain the
patient’s name, nursing unit, room number, medication name, dose, frequency of
administration, and route of administration (Hicks, Cousins, and Williams, 2003).
General USP Recommendations for Preventing Dispensing Errors
Pharmacy services should stock or prepare standardized concentrations for all IV
medications. Intravenous solution bags should be properly labeled with the
complete patient name and should display the product(s) or ingredient(s) name,
the dosage(s), the final concentration of the product(s), and the infusion rate, as
appropriate.
Commercially prepared solutions should be used whenever possible. Use of
different strengths of the same solution or medication in a facility should be
limited and standardized.
The pharmacy should always dispense a unit-of-use (as opposed to a multidose)
package, to the extent possible, to avert the potential for improper dose or
quantity errors (Hicks, Cousins, and Williams, 2003).
Administering and Monitoring Medication
According to data from USP’s 2002 MEDMARX data summary report (Hicks,
Cousins, and Williams, 2003), approximately one-third of reported errors occur in
the administering stage of the medication use process and 1 percent in the
monitoring stage. Wrong-patient errors rank seventh in frequency among the
fourteen different types of error. With a computerized bar-coding system, both
the patient’s and medication’s identification can be incorporated into the
medication label. If the patient wears a bar-coded identification bracelet, then the
patient also can be identified more easily, and facilities will move halfway toward
satisfying the JCAHO’s first Patient Safety Goal for 2004—“Improve the accuracy
of patient identification”— by using “at least two patient identifiers … whenever
administering medications or blood” (see Exhibit 5.1). Both the FDA and the NCC
MERP agree that placing bar codes on drug packaging can improve patient
safety (FDA, 2004). Since 1999, Veterans Administration (VA) hospitals have
employed the VA Bar Code Administration Project (BCAP), which has prevented
an estimated 378,000 medication errors (Cannistra, 2002). The FDA estimates
that bar coding could save hospitals $41.4 billion in direct costs and an additional
$7.6 billion in administrative costs by preventing 50 percent of their medication
errors (Becker, 2003).
General USP Recommendations for Preventing Administering and Monitoring
Errors
Staff should be familiar with the institution’s policies and procedures for
medication administration.
Preprinted and standardized infusion rate charts should be readily accessible
and widely used. These charts offer some protection against calculation errors.
Programmable infusion devices (for example, smart pumps) that offer
customized settings to meet the hospital’s guidelines for selected drug dosages
for specific patient types and specialized clinical care areas should be widely
used. Variability of types and models of infusion devices should be limited to
avoid staff confusion.
Infusion pump settings for initiation of high-alert medications and for any required
dosage adjustment should be independently confirmed by two qualified
individuals.
Documentation of the medication infusion, adjustments, and independent
confirmation should be readily apparent.
Infusion tubing should be traced from the infusion bag to the point of delivery
(where it reaches the patient). If multiple infusions and pumps are in use on a
patient, each pump and its respective tubing should be readily identifiable and
labeled.
Free-flow errors can be avoided through proper and reasonable safety
measures. IV administration cassettes that offer anti-free-flow mechanisms
should be used routinely. Free flow should be avoided when the IV administration
cassette has been removed from the pump (that is, during a gown change or to
clear air).
The patient’s clinical response to the medication infusion should be monitored
according to critical pathways that incorporate standardized flow sheets or
monitoring protocols developed by interdisciplinary committees. The therapeutic
class of the medication, particularly of high-alert drugs, should dictate the type of
observation (for example, cardiopulmonary function or laboratory values) (Hicks,
Cousins, and Williams, 2003).
Medication Errors That Do Not Reach or Cause Harm to a Patient
Some individuals use the term near miss to refer to a medication error that did
not reach the patient or to describe a system that failed but did not cause harm to
the patient. However, despite the fact that the patient was not injured, an error
did occur. That error was a signal that the system is not error-proof and needs to
be fixed. Excluding a near miss from an analysis of medication errors simply
because a patient was not injured prevents the risk management team from
learning valuable information about the system or process that failed. This
information about near misses can be acted on to minimize or prevent the
recurrence of similar system failure–induced medication errors (Cohoon, 2003).
The Joint Commission on Accreditation of Healthcare Organizations recognizes
the value of identifying and analyzing near misses in its definition of a reportable
sentinel event as “an unexpected occurrence involving death or serious physical
or psychological injury, or the risk thereof.” “Risk thereof ” means that this
definition includes “any process variation for which a recurrence would carry a
significant chance of serious adverse outcome” (JCAHO, 2002), indicating that if
the process or system isn’t reengineered, another error is likely to occur.
Remember, those who misread history are doomed to repeat the mistakes of the
past!
Types of Drugs Most Commonly Involved in Medication Errors
JCAHO’s Sentinel Event Program has identified the following high-alert drugs
(JCAHO, 1999).
TABLE 5.3. PRODUCT GROUPS CAUSING PATIENT HARM MOST
COMMONLY REPORTED TO MEDMARX.
Product’s Generic Name n
%
Errors involving harm (Categories E–I)
Morphinea 164
5.5
Heparina
4.6
139
Potassium Chloridea
Warfarina
89
244
8.1
3.0
3.0
Hydromorphonea 83
Fentanyla
90
Insulina
66
2.2
Vancomycin 61
2.0
Enoxaparin 60
2.0
Meperidinea 57
1.9
Furosemide 52
1.7
Diltiazem
45
1.5
Metoprolol 38
1.3
Dopamine 37
1.2
Lorazepam 37
1.2
2.8
Note: Product groups include all dosage forms and formulations.
aHigh-alert medication.
Source: Hicks, Cousins, and Williams, 2003.
High-Alert Drugs Identified by JCAHO
Concentrated electrolytes including KCl, Potassium phosphate, and NaCl (>0.9
percent)
Insulin
Opiates, narcotics, and patient controlled analgesia (PCA)
IV anticoagulants, such as Heparin
USP’s MEDMARX program has identified a similar list of high-alert drugs,
summarized in Table 5.3. In addition a recent study (Benjamin and Pendrak,
2003) has summarized the drugs most frequently cited in the PHICO Insurance
Company’s Closed Claims project:
Drugs Involved in Claims at PHICO: Two out of Three Years Between 1996 and
1998.
Antibiotics
Electrolytes
Opiates
Anticoagulants
Tranquilizers
TABLE 5.4. TYPES OF MEDICATION ERRORS TRIGGERING CLAIMS IN
1998.
Type of Error
%
Allergic/adverse reaction 25
Contraindicated drug given
IM technique issue
22
10
Wrong dose 10
Wrong drug 10
Wrong patient
3
Wrong route 3
Labeling/dispensing error
1
Not classified, includes failure to monitor & failure to prescribe 17
Source: Data from Benjamin and Pendrak, 2003.
Fibrinolytics
Insulin
Oral antidiabetics
Antihypertensives
The PHICO data also captured the types of medication errors that triggered
claims. It is apparent from these data (Table 5.4) that the same basic medication
errors (sometimes called the five wrongs) continue to be made: wrong drug,
wrong dose, wrong time, wrong route, and wrong patient. Inadequate monitoring
or failure to follow up can also lead to adverse drug reactions. However, first on
PHICO’s list is allergic or adverse reaction, which constituted 25 percent of
medication error claims, meaning that patients who were allergic to a drug or had
a history of not tolerating a drug well received the same drug again. Second on
the list is contraindicated drug, with 22 percent of claims due to that problem. A
drug is contraindicated when the patient has a peculiar sensitivity to it, when the
patient is taking other medications that can interact with the proposed drug and
increase its toxicity or decrease its effectiveness, when the patient is pregnant or
nursing and should not receive the drug because of maternal-fetal or maternalinfant transmission, or when the patient has some pathological condition (for
example, decreased renal or hepatic function) that makes the drug more toxic in
that patient. Usually no strict contraindication exists for using drugs in patients
with decreased renal or hepatic function, but the dose must be greatly reduced.
In the reported claims, significant injury must have occurred or the patient would
not have had sufficient damages to sustain a lawsuit. Drug-drug interactions
have also been the primary cause of the withdrawal from the market of many
well-known drugs, such as Seldane (terfenadine), Hismanyl (astemizole), Posicor
(mibefradil), and Propulsid (cisapride) (Benjamin, 2001a). Had CPOE been
available, the computer could have alerted prescribers to the potential drug-drug
interactions, dosages could have been reduced, and both nationwide drug recalls
and patient injury could have been averted.
Medication Errors and Human Factors
People make errors. It is part of being human. Mental errors can occur during
periods of high stress—when the nursing unit or patient care area is understaffed or the workload is unrealistically high—or they can occur when people are
distracted—by a phone call, page, banter, or ordering pizza. However, the people
we work with are not only staff, they are our colleagues and friends, and now
more than ever, health care is truly a team effort. The physician is the head of the
team but needs assistance and feedback from all team members in order to
establish and maintain the needed culture of patient safety. Each member of the
team should collaborate with other members to establish a safety net designed to
catch errors and to identify system flaws (practices) that can lead to errors so
these flaws can be rectified before errors occur. Because of the large number of
people and professions employed in the institutional setting, professionals who
supervise other employees are responsible for reviewing their work and ensuring
that they are adequately trained and performing at an acceptable level.
Pharmacists should check medications prepared and dispensed by technicians
before they are delivered to nursing units or floor stock or placed in automated
dispensing devices. Nurses should care for sicker patients and let nursing
assistants care for patients who do not need to be monitored as closely. No one
should program an IV pump, PCA machine, or other piece of equipment unless
he or she is well educated about the equipment (see JCAHO’s 2004 Patient
Safety Goal 5 in Exhibit 5.1). The American Society for Healthcare Risk
Management (ASHRM) discusses many aspects of human factors in medication
error reduction and reviews much of the recent medication error literature in its
publication Risk Management PEARLS for Medication Error Reduction (Benjamin
and others, 2001).
Defining Medication Error
The National Coordinating Council for Medication Error Reporting and Prevention
(NCC MERP) was established in 1995 and includes representation from the U.S.
Pharmacopeia, FDA, JCAHO, Institute for Safe Medical Practices (ISMP),
American Hospital Association (AHA), American Medical Association (AMA),
American Nursing Association (ANA), American Society for Healthcare Risk
Management (ASHRM), and American Society of Health-System Pharmacists
(ASHP). NCC MERP has developed a comprehensive medication error
taxonomy and definition that has come to be widely recognized and accepted by
health care professionals. The council defines a medication error as “any
preventable event that may cause or lead to inappropriate medication use or
patient harm while the medication is in the control of the healthcare professional,
patient, or consumer. Such events may be related to professional practice,
healthcare products, procedures, and systems, including prescribing; order
communication; product labeling, packaging, and nomenclature; compounding;
dispensing; distribution; administration; education; monitoring; and use” (NCC
MERP, 2004). Of course, the most important word in the definition is preventable.
What Small Facilities with Limited Resources Can Do to Prevent Medication
Errors
The first thing for small facilities to do when they cannot afford to computerize or
adopt other innovative technology is to review the lists of high-risk drugs and
common medication errors given in this chapter. This is an important starting
place. All of these drugs can cause serious injury or death to patients. In order to
reduce the likelihood of patient injury, prepare a memorandum containing the
names and classes of these drugs and circulate the memo to physicians,
pharmacists, and nurses in your facility. Announce to your staff that these are the
drugs that can cause the most harm and that staff should be cautious and vigilant
when prescribing, dispensing, or administering them to patients.
To eliminate the risk of excessive doses, consider developing special protocols
or standardized order forms for high-risk drugs that list the lowest or most
common doses, frequencies, and routes of administration. Such preprinted order
forms allow the prescriber to simply check off the desired prescription
requirements for the patient. Also include known drug-drug interactions and
clinical conditions and contraindications that need to be ruled out prior to initiation
of therapy. Remember also that the drugs listed in this chapter are not the only
drugs that can cause unintended injury to a patient. Aminoglycoside antibiotics
and digoxin must be given at lower doses to patients with renal failure to avoid
toxicity. Antihypertensives, tricyclic antidepressants, alpha-blockers (now used to
facilitate urination in patients with benign prostatic hyperplasia), and narcotics all
can cause fainting or orthostatic (positional) hypotension and lead to falls in the
hospital and at home.
Problems with ordering drugs can be ameliorated by implementing a training
program for your prescribers. An excellent and free resource for training
prescribers can be found on the Tufts University School of Medicine Web site.
This Web-based teaching program, titled “Prescription Writing: A Mini Learning
Module” (Shader and Benjamin, 2001), has been used to retrain physicians who
have lost their prescribing privileges, medical students, nurse practitioners, and
physician assistants. The course also offers a review of abbreviations, acronyms,
and symbols that should and should not be used in writing prescriptions and
provides guidance on how to write a prescription or drug order that
communicates the desired information in the most effective, least ambiguous
way, as recommended in JCAHO’s 2004 Patient Safety Goal 2b (see Exhibit 5.1
and Table 5.1).
In addition to identifying faulty processes and potential system failures, health
care facilities must also update their philosophies for dealing with people and
events that have led or could lead to medication errors. Contemporary experts in
reducing medication errors all stress developing a culture of safety and
dispensing with the anachronistic practice of finding someone to blame. Today’s
objectives are to identify high-risk practices and failure-prone areas of the
medication use process and then fix them! When a medication error occurs, do a
root cause analysis (RCA), not because JCAHO requires it of accredited
hospitals but in order to figure out why the error occurred. Hold monthly quality
improvement meetings, and review the RCA results with staff. Also ask members
of the medical, nursing, and pharmacy staffs to bring areas of concern to the
attention of the rest of the staff. You may want to begin by having medicine,
pharmacy, and nursing personnel meet separately and then bring the entire
group together after everyone is comfortable with the process.
Several years ago, one of the authors of this chapter (DMB) was asked to
conduct a risk management audit of a large Midwestern hospital that had
experienced ten respiratory depressions (and two deaths) over the past two
years in patients receiving patient controlled analgesia. During the course of the
site visit, he asked the hospital risk manager if she ever got the doctors, the
pharmacists, and the nurses together to talk about any concerns any of them had
regarding medication ordering, dispensing, or administration. The answer was
no. He recommended that the risk management practitioner function establish
such a committee. About a year later, the nurse risk manager called him to tell
him she had been accepted to law school and also mentioned that she had
established a committee of doctors, pharmacists, and nurses to discuss
medication errors. She also said that as a result of some of his specific
recommendations for reducing the concomitant use of narcotics, Benadryl,
hydroxyzine, Phenergan, and a benzodiazepine “sleeping pill” in the same
patient and his urging to “bring everything out in the open” under the peer review
function of the hospital, there had been no further respiratory depressions (or
deaths) in the last year. The lesson to be learned is, if you don’t identify the
problem, analyze the problem, and take steps to change those areas that lead to
patient injury, you can’t prevent that problem from occurring again.
Be very selective about adding new drugs to the hospital formulary. Newly
approved drugs have been tested in only approximately 5,000 patients. Safety
data about rare but severe adverse drug reactions like Stevens-Johnson
syndrome, toxic epidermal necrolysis (TEN), and acute renal failure may not
have been reported or included in the labeling (package insert), and these
reactions could occur even though you don’t anticipate them (Benjamin, 1998).
For this reason, it is also important to review a product’s labeling every year to
determine whether new warnings have been added because of postmarketing
reports of adverse drug reactions.
Lastly, review JCAHO’s current National Patient Safety Goals (NPSGs) (for
example, Exhibit 5.1) and implement as many goals (or acceptable alternatives)
as possible, whether your organization is a JCAHO-accredited facility or not.
Why? Because these patient safety goals were developed after reviewing actual
instances of medication errors, are evidence based, and will assist your facility in
improving quality of care, reducing medication errors, and increasing patient
safety.
Medication Error Reduction in the Outpatient Setting
When it comes to prescribing drugs for patients, most clinical pharmacologists
are therapeutic nihilists. It follows logically that if you don’t want to have to treat
any adverse drug reactions in your patients, then don’t prescribe any drugs for
them. However, if you really must prescribe drugs, use the lowest dose, for the
shortest time. Moreover, the likelihood of a drug-drug interaction increases as
more drugs are added to the patient’s regimen. In order to reduce the likelihood
of drug-drug interactions, and also the additive effects of similarly acting
medications, prescribe as few drugs as possible, at the lowest dose, for the
shortest period of time. Whenever possible, prescribe something for topical or
local use rather than a systemic medication. When you write an initial
prescription, order only one to two weeks worth of medication. Many patients
discontinue their medications, can’t tolerate them, or switch to another drug prior
to using all the medication or dosing strength originally prescribed. The adage
“Start low—go slow” remains valid.
In 1982, the National Council on Patient Information and Education (NCPIE) was
formed to raise awareness about the role of communication in promoting safe,
appropriate use of medications. NCPIE (2004) offers some very useful
information about U.S. physicians’ prescribing practices. For example, in 1998,
nearly two-thirds (65.1 percent) of physician office visits culminated with the
writing of a prescription, 36.5 percent of patients received two or more
prescriptions, and over 10 percent received four or more prescriptions. Over 80
percent of office visits to cardiologists resulted in a prescription, although only 18
percent of visits to general surgeons did so. In 2000, there were 2.7 billion retail
prescriptions filled, which brought in revenues of $148.2 billion; in 2001, 3.3
billion were filled, which cost $175.2 billion; and by 2004, the number of retail
prescriptions is expected to exceed 4 billion, and an even greater amount of
resources will be spent.
Problems Contributing to Medication Errors in the Outpatient Setting
From the NCPIE data, it is obvious that physicians are prescribing drugs too
often and that polypharmacotherapy is rampant. Moreover, a recent report from
the Institute of Medicine (2003) concluded that health professionals are not being
adequately prepared to provide the highest-quality and safest medical care
possible and that there is insufficient assessment of their ongoing proficiency.
Indeed, another recent study of formal training on medication errors in medical
school indicates that only 16 percent of internal medicine clerkships include
formal lectures on adverse drug reactions and drug-drug interactions
(Rosebraugh and others, 2001). The message is clear. More teaching has to be
done in this area. Also, physicians apparently need to adjust the way they view
medical error. Despite the fact that 35 percent of physicians surveyed reported
errors in their own care or the care of a family member, medical error was not
considered one of the greatest problems in health care today. Instead, physicians
emphasized the cost of malpractice insurance and lawsuits (29 percent), the cost
of health care (27 percent), and problems with insurance companies and health
plans (22 percent). Only 5 percent of physicians identified medical errors as one
of the most serious problems (Blendon and others, 2002).
Although the costs of obtaining malpractice insurance are high (especially for
certain high-risk specialties), physicians and others who believe that lawsuits are
the greatest impediment to quality health care are not only mistaken but are ten
years behind in reading the literature, as indicated by the famous Harvard
Medical Practice Study (Localio and others, 1991). As part of this landmark
study, investigators reviewed approximately 31,000 charts for evidence of
malpractice and found 280 instances of medical negligence. However, only 8 of
the 280 instances of malpractice resulted in lawsuits, an incidence of less than 3
percent. The authors correctly concluded that patients who deserved to be
compensated for negligence had not been compensated. In these cases,
negligence was identified rarely, and providers of substandard care rarely were
held accountable for their actions. In actuality, the major reasons patients sue
their doctors are poor communication and problematic relationships (Beckman,
Markakis, Suchman, and Frankel, 1994). Some of the reasons cited in Beckman
and others’ review of forty-five plaintiffs’ depositions are that the patient felt
deserted by the doctor (32 percent), the patient felt the doctor devalued the
patient’s or a family member’s view or perspective (42 percent), and the doctor
delivered information poorly (26 percent). Many other studies have come to the
same conclusion. For example, another decade-old study (Hickson and others,
1994) concluded that patients of physicians who had been sued frequently had
more complaints about the interpersonal care and physician-patient
communication the doctors provided than did patients of doctors who had not
been sued repeatedly. Some of the complaints were that patients felt rushed, test
results were not explained, and the patients felt ignored. The lesson to be
learned is that if you are a physician who wants to reduce your exposure to a
lawsuit, your communication skills are more important than your clinical skills.
Patients won’t sue you if they like you.
It would seem that physicians are not willing to take responsibility for their own
actions and that they are more willing to blame insurance companies and
lawsuits than they are willing to stay current in their fields. This type of hubris will
only perpetuate the communication and education deficit in health care today, not
ameliorate it. According to a recent study from the RAND Corporation, a
corporate think tank, patients received the “recommended care” for thirty
common acute and chronic conditions only about 55.5 percent of the time. In an
interview published in the Washington Post, the study’s lead author, Elizabeth A.
McGlynn, said, “Everyone is at risk of failing to get care that they need to live a
longer and healthier life… . It is time to stop having a debate whether we have a
problem, and start having a talk about how we can solve the problem” (Brown,
2003, p. A02).
Some problems arising from the apparently low quality of care provided and the
misuse of medications can be cured by continuing education and the expanding
role of information technology. For example, another landmark study identified
the major system errors responsible for medication errors that resulted in
adverse drug events. Lack of knowledge about the drug and lack of information
about the patient were major contributing factors. The authors concluded that
“the most common defects were in systems to disseminate knowledge about
drugs and to make drug and patient information readily accessible at the time it is
needed” (Leape and others, 1995, p. 35). Certainly CPOE and electronic medical
records could be instrumental in decreasing errors caused by deficits in
knowledge about either the drug or the patient. Now do we all accept that we
can’t keep all the information in our heads that we need to practice our
professions?
Although the process for writing and dispensing a prescription in the outpatient
setting is a lot less complicated than it is in an institutional setting, many of the
same problems arise. A poorly written prescription is still a poorly written
prescription. At the least it means that the pharmacist will have to call the
physician for clarification. At the worst the pharmacist guesses, and a medication
error may well be made.
Decreasing Dispensing Errors in the Outpatient Setting
Outpatient pharmacies still stock drugs alphabetically, and look-alike drugs may
be found right next to each other. Sometimes there is confusion between a
regular-acting formulation—say, for a drug like theophylline (for asthma)—and a
sustained-release (SR) formulation. Sometimes the wrong dose is dispensed for
the right drug. Using computerized bar codes, based on each drug’s NDC
number, is a good way to minimize or eliminate wrong-dose or wrong-formulation
dispensing errors.
Telephone orders present another type of problem. Imagine how easily Cardiem
and Cardizem can be confused when a doctor calls in a prescription to a
pharmacy. Or better yet, how about the difficulty of distinguishing verbal orders
for Celebrex, Cerebryx, and Celexa? The proper procedure for calling in a
prescription is for the doctor to dictate the prescription order as the pharmacist
writes it down. Then the pharmacist must read back the order, just as it was
transcribed. This could be the last chance to at least record the prescription order
properly. Getting the right drug off the shelf and putting it in the right container
and labeling the container with the right directions still provide plenty of
opportunities for error. What all health care providers are trying to achieve is
referred to collectively as the five rights: the right drug, the right dose, the right
route, the right time, and the right patient!
Conclusion: The Imperative for Federal Legislation
Since the publication of the Institute of Medicine report To Err Is Human: Building
a Safer Health System (Kohn, Corrigan, and Donaldson, 2000), awareness of
medication errors has been elevated to the national level. In an effort to improve
the quality of health care and reduce medical errors, numerous federal bills have
been introduced to encourage medication error reporting and quality
improvement initiatives. Although no federal bill has been enacted, it appears
that Congress has made tremendous progress toward adopting legislation that
would provide protection (create a federal privilege) for patient safety data,
including medication error reports.
In response to the IOM report, Congress has been working toward implementing
federal patient safety legislation. Recommendation 6.1. of the IOM report
encourages Congress to pass legislation that creates a legal environment that
encourages “health care professionals and organizations to identify, analyze, and
prevent errors without increasing the threat of litigation and without compromising
patients’ rights” (Kohn, Corrigan, and Donaldson, 2000, p. 96). The IOM report
recognizes that no federal protection currently exists against the disclosure of
medication error information that is shared with reporting programs for health
care facilities and practitioners. Absent clear federal legal protection, practitioners
will continue to resist requests to report medication errors in a consistent and
uniform manner, a situation that merely mimics the status quo and perpetuates
our current inability to recognize and identify many medication errors. The
continued lack of privilege also impairs the efforts of educators and researchers
to improve the quality of pharmacotherapy at the national level, now and in the
future.
During the 107th Congress (January 2001 to December 2002) five medical error
reporting bills were introduced but not passed, including S 3029, sponsored by
Senator Kennedy; S 2390, sponsored by Senators Frist and Jeffords; HR 4889,
sponsored by Representative Johnson; and HR 5478, introduced by
Representative Bilirakis. These bills proposed to encourage medical and
medication error reporting by establishing a federal privilege for information
submitted to patient safety reporting programs (commonly referred to in the bills
as patient safety organizations [PSOs]). Such legislation would build on the
foundations of a similar standard adopted by the state of Oklahoma on May 8,
2001, which provides that reports to the U.S. Pharmacopeia’s MEDMARX
system are to be considered privileged communications and cannot be
introduced as evidence in any legal proceeding (Benjamin and others, 2001).
Although progress was made toward implementing patient safety legislation
during the 107th Congress, important differences among the bills were not
resolved. These differences involved the extent of legal privilege and
confidentiality and the qualification of PSOs.
In January 2003, the 108th Congress began, and patient safety legislation was
once again addressed. On March 12, 2003, the House of Representatives
passed the Patient Safety and Quality Improvement Act (HR 663) to encourage
the voluntary reporting and analysis of medication errors. Section 2(b) of HR 663
was intended to encourage a culture of safety and quality by providing for a
reporting system that both protected information and improved patient safety,
thus improving the quality of health care. On March 26, 2003, Senators Gregg,
Frist, Jeffords, and Breaux reintroduced the patient safety legislation (S 720) first
introduced in the Senate during the 107th Congress. The bill was revised, and on
July 23, 2003, the Senate Health, Education, Labor, and Pensions (HELP)
Committee unanimously approved the revised legislation. According to Section
2(b) of the Act, the purpose of S 720 is “to encourage a culture of safety and
quality by providing for legal protection of information reported voluntarily for the
purposes of quality improvement and patient safety.” The Senate had hoped to
vote on the legislation by the end of the year.
Although federal patient safety legislation has yet to pass both the House and
Senate, it appears that Congress is well positioned to accomplish this goal.
Federal protection for patient safety data, including medication error reports
shared with PSOs, should help to reduce medication errors, increase the quality
of pharmaceutical care, and improve patient safety in the United States. Failure
to pass such legislation would continue to act as a significant obstacle to the full
implementation of medication error reporting programs and to the valuable
lessons that can be learned from the examination of reported errors. Without
such legislation, health care facilities and practitioners will continue to be
reluctant to track, report, and learn from prior medication errors, thereby reducing
opportunities to identify and prevent medication errors at the regional, state, and
national level.
There can be no doubt that quality improvement costs a lot less than making
errors and defending lawsuits. At an approximate cost of $4,500 per preventable
medication error, preventing just twenty-five medication errors saves $112,500.
That’s enough to hire a PharmD to make rounds in one’s intensive care unit
(ICU), which can save an additional $270,000 in costs associated with extended
hospitalization and costs of additional treatment (excluding the costs of litigation)
(Leape and others, 1997; Bates and others, 1998). Moreover, isn’t it better to pay
for progress and an improved quality of care than to pay to defend a lawsuit that
could have been prevented? Those who misread history are doomed to repeat
the mistakes of the past. Welcome to the era of enlightenment. The tools of
progress are available to us right now. What are we going to do with them, build
a better health care system or hit our thumbs with the hammer?
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Brubakk et al. BMC Health Services Research (2015) 15:280
DOI 10.1186/s12913-015-0933-x
RESEARCH ARTICLE
Open Access
A systematic review of hospital
accreditation: the challenges of measuring
complex intervention effects
Kirsten Brubakk1*, Gunn E. Vist2, Geir Bukholm3, Paul Barach4 and Ole Tjomsland5
Abstract
Background: The increased international focus on improving patient outcomes, safety and quality of care has led
stakeholders, policy makers and healthcare provider organizations to adopt standardized processes for evaluating
healthcare organizations. Accreditation and certification have been proposed as interventions to support patient
safety and high quality healthcare. Guidelines recommend accreditation but are cautious about the evidence,
judged as inconclusive. The push for accreditation continues despite sparse evidence to support its efficiency or
effectiveness.
Methods: We searched MEDLINE, EMBASE and The Cochrane Library using Medical Subject Headings (MeSH)
indexes and keyword searches in any language. Studies were assessed using the Cochrane Risk of Bias Tool and
AMSTAR framework. 915 abstracts were screened and 20 papers were reviewed in full in January 2013. Inclusion
criteria included studies addressing the effect of hospital accreditation and certification using systematic reviews,
randomized controlled trials, observational studies with a control group, or interrupted time series. Outcomes
included both clinical outcomes and process measures. An updated literature search in July 2014 identified no new
studies.
Results: The literature review uncovered three systematic reviews and one randomized controlled trial. The lone
study assessed the effects of accreditation on hospital outcomes and reported inconsistent results. Excluded studies
were reviewed and their findings summarized.
Conclusion: Accreditation continues to grow internationally but due to scant evidence, no conclusions could be
reached to support its effectiveness. Our review did not find evidence to support accreditation and certification of
hospitals being linked to measurable changes in quality of care as measured by quality metrics and standards. Most
studies did not report intervention context, implementation, or cost. This might reflect the challenges in assessing
complex, heterogeneous interventions such as accreditation and certification. It is also may be magnified by the
impact of how accreditation is managed and executed, and the varied financial and organizational healthcare
constraints. The strategies hospitals should impelment to improve patient safety and organizational outcomes
related to accreditation and certification components remains unclear.
Keywords: Accreditation, Certification, Hospital, Patient Safety, Evaluation
* Correspondence: kirsten.brubakk@helse-sorost.no
1
South-Eastern Norway Regional Health Authority, Hamar, Norway
Full list of author information is available at the end of the article
© 2015 Brubakk et al. This is an Open Access article distributed under the terms of the Creative Commons Attribution License
(http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium,
provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://
creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Brubakk et al. BMC Health Services Research (2015) 15:280
Background
Patient safety and patient centered care are emerging as
key drivers in healthcare reform.
Accreditation is the most frequently external quality assessment of healthcare organizations’ strategic
goals [1]. We defined hospital accreditation programs
as the systematic assessment of hospitals against
accepted standards [2] and certification is a confirmation of characteristics of an object, person, or
organization against published standards [3]. Little
information is available on effective accreditation and
certification strategies. Prominent national organizations have recommended accreditation which is being
implemented widely. However, little evidence supports their effect on patient outcomes or other important markers such as core measures, organizational
culture nor reliability.
Hospital accreditation was started by The American
College of Surgeons 100 years ago, and since then the
number of hospital accreditation programs has expanded
rapidly. The World Health Organization identified 36
nationwide healthcare accreditation programs in 2000
[4]. Accreditation is an essential part of healthcare
systems in more than 70 countries and is often provided
by external and independent review, assessment or
audit [5]. The systematic evaluation of healthcare services is a way to obtain regulatory peer review on the
organizational maturity and reliability [6]. Literature
reviews on the effects of accreditation on the quality of
care do not provide strong evidence due to limitations
of the studies [7–12].
Greenfield and Braithwaite [7] identified the effects of
accreditation on promoting change and professional development, indicating that the effects were probably due
to accreditation and certification, but lacking firm evidence. A systematic review by Nicklin et al. [8] found
several positive benefits of accreditation, however, the
study lacked rigor to support their conclusions. Shaw et
al. [13] found evidence for positive effects between accreditation, certification and clinical leadership, systems
for patient safety and clinical review, but was fell short
of endorsing accreditation, and concluded with recommending further analysis to explore the association of
accreditation and certification with clinical outcomes.
Furthermore, Ho et al. have demonstrated an unintended negative impact on the learning environment
of medical students and trainees, including decreased clinical learning opportunities, increased
non-clinical workload, and violation of professional
integrity in preparation and during accreditation
and certification [14].
The aim of this study is to systematically assess the effects of accreditation and/or certification of hospitals on
both organizational processes and outcomes.
Page 2 of 10
Methods
We searched for published articles that assessed the
effects of accreditation and/or certification of hospitals.
The studies were reviewed for their research design and
internal validity. We assessed each study’s findings in
regard to their effects on patient mortality, morbidity,
patient safety, as well as process outcomes.
Data sources and search strategy
We searched MEDLINE, EMBASE, CRD, and the
Cochrane Library, including the Cochrane Database of
Systematic Reviews (CDSR), Database of Abstracts of
Reviews of Effects (DARE) and Health Technology
Assessment Database (HTA) for all studies on accreditation/certification in 2006 [11], and this was repeated in
2009 [12], 2013 and 2014. The same search criteria were
used to monitor the studies addressing effect of accreditation/certification in hospitals.
The search was designed and conducted by an information specialist librarian who updated the search strategies from 2006 to 2009 and used the combinations of
key words and Medical Subject Heading terms (MeSH)
related to accreditation, certification and hospitals. The
reference lists of selected articles were searched for potentially relevant studies meeting the inclusion criteria
(snowballing). In addition, we used Google search engine
using the search words accreditation, certification and
patient safety. We updated our literature search in July
2014, searching the same databases with the same inclusion criteria. We found no relevant additional studies to
include in our analysis.
Study selection
We included studies identified in any language using the
search strategy with the following study design: systematic
reviews, randomized controlled trials (RCT), nonrandomized controlled trials, controlled before and after
studies (CBAs), and interrupted time series (ITS) (defined
as at least three measurements before and three after the
introduction of accreditation and/or certification).
The inclusion criteria used were:
Population: all types of hospitals were included.
Intervention: all types of accreditation and/or
certification of hospitals.
Comparison: any hospital that was not accredited or
certified, either by not seeking or not receiving
accreditation and/or certification.
Outcomes: both clinical outcomes and process
measures.
Two of the authors (GEV, KB) independently reviewed
all titles, references and abstracts generated by the original search in order to identify articles for potential
Brubakk et al. BMC Health Services Research (2015) 15:280
inclusion. All reports, independent of language, were
evaluated for the inclusion criteria.
Each article considered potentially eligible according to
the chosen criteria was independently read in full text and
then assessed using a standardized form for internal validity
by two authors (GEV, KB,). If several estimates for one
study outcome were reported, the most fully adjusted estimate was abstracted. Each assessment was conducted independently by two reviewers, the results were compared,
and the differences were all reconciled by consensus.
This study did not involve human material or human
data, so an ethic approval was not needed. No written
consent was obtained from participants for this literature
study. Additional file 1 provides a complete description
of the search strategies; and Additional file 2 provides a
detailed overview of the updated search results. The
PRISMA checklist (Preferred Items for Systematic Reviews and Meta-Analyses) was used for this systematic
review. Please see Additional file 3.
Results
Search results
Our search of electronic databases identified a considerable increase in studies addressing the effect of accreditation and/or certification. In 2006, 672 studies were
identified [11]. Over the next 3 years 522 new studies
were published. In 2013 we identified another 910 relevant studies. Of the identified studies in 2013 fifteen citations were considered potentially eligible based on the
inclusion criteria. Two additional articles were identified,
and an additional three references were identified by
manually searching the articles’ reference lists. Twenty
references were considered potentially eligible and were
retrieved for a full text assessment. Of these, 16 articles
were excluded because they did not fulfil the inclusion
criteria; Table 4 presents the excluded studies and the
detailed reasons for their exclusion.
The agreement between reviewers for study eligibility
was complete. As only one original study was included a
meta-analysis was not possible (Fig. 1).
Characteristics of included studies
We included systematic reviews as well as controlled studies. A total of four references, three systematic reviews and
one primary study met the inclusion [15–18]. The aims and
the inclusion criteria of the three reviews were slightly different. However, their inclusion criteria overlapped with the
inclusion criteria for this review. Please see Table 1 for included systematic reviews in this review.
The qualities of the systematic reviews were assessed
using the AMSTAR quality checklist framework, the standard for assessing methodological quality of systematic reviews [19]. The results of the assessment are shown in
Table 2. Two of the reviews were of moderate quality scoring
Page 3 of 10
6/11 [17], and 7/11 [16], respectively, whereas the third review was scored as high quality with a score of 9/11 [15].
Our review scored 9/11 in the AMSTAR assessment. The
primary study [18] was assessed as having a high risk of bias
after using the risk of bias assessment as described in the
Cochrane Handbook for randomized controlled trails [20].
The assessment is shown in Table 3.
Included systematic reviews
The Cochrane review by Flodgren et al. has the best quality AMSTAR score [15]. The authors identified two studies which met their inclusion criteria that focused on the
effect of external inspection on: a) compliance with standards improving healthcare organizations; b) healthcare
professional behavior; and, c) patient outcomes.
The first study was a cluster-randomized controlled
trial by Salmon et al. [18] that involved 20 South African
public hospitals. The other study was an interrupted
time- series conducted to identify the effects of the NHS
Healthcare Commissions Infection Inspection program
on the MRSA rates in UK trusts hospitals, but did not
meet our inclusion criteria. Flodgren et al. concluded
that the results could not be used to draw firm conclusions on the effectiveness of external inspection.
The Matrix Knowledge group searched the literature
in 2010 and found 56 articles that addressed the impact
of hospital accreditation [16]. The vast majority of these
studies used surveys with standardized questionnaires,
and reported staff, patient and stakeholders’ perceptions
of impact. Overall they reported a positive impact of accreditation on hospital and professional practice. Only
the South African cluster-randomized controlled trial
was consistent with the inclusion criteria of our study.
Alkhenizan and Shaw searched the literature in 2009
and included 26 studies that assessed either the general
impact of accreditation on hospitals or impact on a single
aspect of performance of healthcare services, and on subspecialty accreditation programs. The authors found a
positive effect of accreditation on improving the process
of care and clinical outcomes [17]. Sixteen (62 %) of the
26 included studies reported significant positive results attributed to accreditation, mainly related to better compliance with guidelines. Ten studies (38 %) reported weak or
no improvement after accreditation. Alkhenizan and Shaw
included the one RCT by Salmon et al. [18].
Included primary study
There was one primary study identified that met all of
our criteria, the randomized controlled trial from South
Africa by Salmon et al. [18]. This study was not identified through the database search, but by searching reference lists (snowballing); it was missed by our literature
review in 2009. The authors included 20 hospitals in
their study. The hospitals were randomly selected and
Brubakk et al. BMC Health Services Research (2015) 15:280
Page 4 of 10
915 Titles/abstracts reviewed.
910 Articles from PubMed,
Embase, Cochrane.
5 Articles from reference lists
895 Excluded based on
review of title and abstract.
20 Potentially relevant articles
retrieved for full-text review.
16 Excluded,based on fulltext assessment.
4 Articles included. Three
review articls and 1
randomized controlled study
abstracted.
Fig. 1 Flowchart. Flowchart of study selection process. Database searched January 18, 2013
stratified into groups according to hospital size (number
of beds). Ten hospitals were randomized to start an
accreditation program, while the other 10 served as controls. Two sets of data, before and after measures, were
collected by the Council for Health Services Accreditation of Southern Africa (COHSASA), and by independent research teams. Initially, 12 indicators of hospital
care quality were identified and used for the first data
collection – this number was reduced to eight in the
second data collection. Of these indicators, surgical
wound infection, time to surgery, neonatal mortality rate
and financial solvency were left out due to challenges in
data collection. It is unclear whether the four indicators
that were abandoned would have influenced the overall
magnitude, range of results or conclusions of the study.
The compliance with the COHSASA accreditation
standard was found to have increased substantially in
the accredited hospitals (p < 0.001), whereas the control hospitals maintained their score throughout the study. Eight hospital quality indicators were reported. The nurses’ perceptions of clinical quality was increased in the accredited hospitals (p = 0.031); however, the other seven indicators showed little or no effect on the quality indicators; patient satisfaction with care (p = 0.484); patient medication education (p = 0.395); accessibility of medical records (p = 0.492); completeness of medical records (p = 0.114); completeness of peri-operative notes (p = 0.489); labelling of ward stock (p = 0.112); and, composite assessment of hospital sanitation (p = 0.641). Excluded studies Sixteen of the 20 studies were excluded after they were independently evaluated by two researchers (GVE, KB). The reasons for exclusion were as follows: four studies had no control groups [21–24]; two performed the study outside hospitals [25, 26]; four studies did not report on the effects of accreditation [27–30]; two studies lacked baseline measurements [31, 32]; one study lacked description of the accreditation intervention [33]; two studies did a comparison of the clinical outcome in accredited hospitals with outcome in non-accredited hospitals, but did not assess the effect of the intervention per se. [34, 35]; and, one systematic review conducted a qualitative assessment of healthcare professionals’ attitude toward accreditation, but the effect of the intervention was not assessed [36]. A complete list of the excluded studies and the reasons for their exclusion is presented in Table 4. Reference Search date Aim of review Study design included Number of included studies Main conclusion stated by authors Studies that match our inclusion criteria Flodgren et al. 2011 [15] May 2011 Evaluate the effectiveness of external inspection of compliance with standards in improving healthcare organizations behavior, healthcare professionals behavior and patient outcomes RCT, CCT, ITS, CBA Two in total, 1 RCT, 1 ITS No firm conclusion were drawn due to paucity of high-quality controlled evaluations Salmon et al. [18] Matrix Knowledge group 2010 [16] August 2010 Produce a general overview of results obtained and methodologies used to assess impact of accreditation Studies containing an element of comparison 56 in total, 40 studies with quantitative design of which 1 study presented empirical data Most studies suggest that accreditation/certification has an impact on the organization or on the professional practice. The impact on health outcomes or improvement in these outcomes was not demonstrated. Salmon et al. [18] Alkhenizan & Shaw 2011 [17] June 2009 Evaluate the impact of accreditation programs on the quality of healthcare services Clinical trials, observational studies and qualitative studies 26 in total, 10 studied accreditation of hospitals of which 1 had a hospital control group Accreditation improves the process of care provided by healthcare services Salmon et al. [18] Brubakk et al. BMC Health Services Research (2015) 15:280 Table 1 Included systematic reviews A synthesis of the three included systematic reviews Page 5 of 10 Brubakk et al. BMC Health Services Research (2015) 15:280 Page 6 of 10 Table 2 AMSTAR, assessing methodological quality of systematic reviews Study Alkhenzian et al. 2011 Flodgren et al. 2011 Brubakk et al. AMSTAR question Yes, No, Can’t answer, Not applicable 1. Was an ‘a priori’ design provided? Yes 2. Was there duplicate study selection and data extraction? No Yes Yes Yes No Yes Yes Matrix group 2010 3. Was a comprehensive literature search performed? Yes Yes Yes Yes 4. Was the status of publication (i.e. grey literature) used in the inclusion criterion? No Yes No No 5. Was a list of studies (included and excluded) provided? Yes, although only for the included Yes, although only Yes, both included Yes, both included for the included and excluded studies and excluded studies 6. Were the characteristics of the included studies provided? Yes Yes Yes Yes 7. Was the scientific quality of the included studies assessed and documented? Yes Yes, No Yes Yes 8. Was the scientific quality of the included studies used appropriately in formulating conclusions? No Can’t answer Yes Yes 9. Were the methods used to combine the findings of studies appropriate? Not applicable (N/A) Yes Not applicable (N/A) Not applicable (N/A) 10. Was the likelihood of publication bias assessed? No No Yes Yes 11. Was the conflict of interest stated? No No Yes Yes AMSTAR. Assessing Methodological Quality of Systematic Review, quality assessment of included systematic reviews categorized by yes, no, cannot answer, not applicable Narrative review of excluded studies We identified one primary study and three systematic reviews. Notably, we had strict inclusion criteria and found few studies that met these strict criteria. A summary of the methods used in the excluded studies is relevant to the discussion on assessing the full measure of complex interventions. Accreditation was addressed in several ways in the publications that failed to fulfil the criteria for inclusion in the present review. Seven of the 16 excluded studies conducted cross-sectional studies Table 3 Risk of bias assessment of study by Salmon et al. [18]a Domain Support for judgement Review author’s judgement Random sequence generation They state stratified randomisation, but give no information about the procedure Unclear Allocation concealment Not mentioned Unclear Not mentioned and appears impossible/not possible to blind hospitals Unclear Not mentioned Unclear The largest hospital did not complete the study. Follow- up time was shortened because controls wanted to receive the intervention High risk Outcome selection conducted by participants and accreditor. Many outcomes/ indicators were dropped from the follow- up measurement High risk This was a cluster randomized trial, adjustment for clustering in analysis of results were not mentioned Unclear Selection bias Performance bias Blinding of participants and personnel Detection bias Blinding of outcome assessor Attrition bias Incomplete outcome date Reporting bias Selective reporting Other bias Other sources of bias a The risk of bias assessment as described in the Cochrane Handbook for randomized controlled trails [20] Risk of bias assessment of the included primary study by Salmon el at [18] SOURCE: Higgins J, Green S. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011 Brubakk et al. BMC Health Services Research (2015) 15:280 Page 7 of 10 Table 4 Excluded studies Reference (country) Reason cited for exclusion Aim of study Al Awa et al. 2011 [22], Saudi Arabia No control group Determine if patient safety and quality care indicators improve post accreditation Al Awa et al. 2011 [23], Saudi Arabia No control group Evaluate nursing perception of care/safety after accreditation Al Tehewy et a...