CMS SOM App. L, Tag Q-0081

§416.43(a) Standard: Program Scope

(1) The program must include, but not be limited to, an ongoing program that

demonstrates measurable improvement in patient health outcomes, and

improves patient safety by using quality indicators or performance measures

associated with improved health outcomes and by the identification and

reduction of medical errors.

(2) The ASC must measure, analyze, and track quality indicators, adverse

patient events, infection control and other aspects of performance that

includes care and services furnished in the ASC.

§416.43(c) Standard: Program Activities

(1) The ASC must set priorities for its performance improvement activities that –

(i) Focus on high risk, high volume, and problem-prone areas.

(ii) Consider incidence, prevalence and severity of problems in those areas.

(iii) Affect health outcomes, patient safety and quality of care.

Interpretive Guidelines: §416.43(a) & §416.43(c)(1)

There are a variety of types of indicators that are currently in use for measuring and

improving quality of healthcare. This is also a rapidly changing field, as interest and

research in patient safety and healthcare quality measurement grows. As a result of a

recommendation of a 1998 Presidential Advisory Commission, the National Quality

Forum (NQF), a public-private not-for-profit membership organization, was created in

1999 to develop and implement a national strategy for healthcare quality measurement

and reporting. Since then NQF has developed detailed recommendations for ways to

promote and measure quality and patient safety, including in ASCs. The federal Agency

for Healthcare Quality and Research (AHRQ) supports research assessing the

effectiveness of care practices and procedures. A number of other organizations are also

active in the field of healthcare quality improvement and patient safety. As a result,

ASCs have many choices of indicators to use.

Indicators can be broken down into several types:

• Outcomes Indicators measure results of care; typical outcomes measures include

risk-adjusted mortality rates, complication rates, healthcare-associated infection rates,

length of stay, readmission rates, etc. In the ASC setting, outcomes measures might

focus on things like complication rates, healthcare-associated infection rates, cases

exceeding 24 hours, transfers to hospitals, wrong site surgeries, etc.

• Process of Care Indicators measure how often the standard of care was met for

patients with a diagnosis related to that standard. For example, in the ASC setting,

measures might focus on the administration and time of prophylactic antibiotics.

• Patient Perception Indicators measure a patient’s experience of the care he/she

received in the ASC. AHRQ sponsored development of one patient experience of

care instrument, H-CAHPS, that CMS now uses in reporting on hospital quality.

There may be similar patient survey instruments that could be used in the ASC

setting.

The regulation at §416.43(a) requires that an ASC’s QAPI program must improve both

patient health outcomes and patient safety in the ASC. In order to achieve these goals,

the ASC’s QAPI program must:

1. Be ongoing – i.e., the program is a continuing one, not just a one-time effort or

occasional effort. Evidence that the ASC’s program is ongoing would include, for

example, collection by the ASC of quality data at regular intervals; analysis of the

updated data at regular intervals; and updated records of actions taken to address

quality problems identified in the analyses, as well as new data collection to

determine if the corrective actions were effective.

2. Use quality indicators or performance measures associated with improved health

outcomes in a surgical setting. The quality and safety indicators available differ

in terms of the weight and type of evidence for their effectiveness in measuring

quality. For some indicators there is compelling peer-reviewed research of an

association with improved health outcomes. For others, typically process of care

indicators, consensus among experts in the field suggests a strong association with

improved quality of care. Indicators also differ in terms of how the data is

collected, and how frequently the data should be collected.

For example, measures of how quickly an ASC produces error-free billing claims,

while relevant to the ASC’s financial performance and of interest to ASC

governing bodies, have no direct relationship to the quality of care the ASC

provides. On the other hand, a measure of the frequency with which the ASC

administers antibiotic prophylaxis consistent with generally accepted standards of

care would be related to improved health outcomes, i.e., prevention of surgical

site infections. Likewise, an ASC could choose to collect data measuring its

compliance with applicable National Quality Forum Safe Practices, or with

applicable Centers for Disease Control and Prevention (CDC) infection control

guidelines, or with guidelines issued by national professional societies, such as

the American College of Surgeons, or with recommended practices developed by

national accreditation organizations or other organizations specializing in

healthcare quality improvement, such as the Institute for Healthcare

Improvement. CMS does not prescribe a certain set of indicators/measures for

ASCs to use, but ASCs must be able to demonstrate that the indicators they are

tracking will enable them to improve outcomes for ASC patients.

The regulations at §416.43(c)(1) also require the ASC to set priorities in choosing

its quality indicators/measures, because what is measured will determine where

the ASC focuses its efforts to make changes that improve performance. For

example, if the ASC does not track measures related to infection control, it will

not be in a position to determine whether or not its infection control program is

working well or poorly, and thus will not be in a position to improve it.

The ASC is required to focus on high risk, high volume, and problem-prone areas.

It is required to consider, when selecting the measures/indicators that will shape

its improvement activities in these areas, the following:

• The incidence, i.e., the rate or frequency at which problems occur in the ASC

related to area measured by the indicator. “Incidence” is a technical term used in

epidemiology, referring to the frequency with which something, such as a disease,

appears in a particular population or area. In disease epidemiology, the incidence

is the number of newly diagnosed cases during a specific time period. Applying

this concept in the ASC setting, as an example, the annual incidence of surgical

site infections in an ASC would be the rate that results when dividing the number

of such infections that occurred in a calendar year by the total number of surgical

cases in the ASC during that same year. Likewise, the annual incidence of

emergency transfers to a hospital would be the rate that results when dividing the

number of such transfers by the total number of surgical cases during the same

year;

• The prevalence, i.e., how widespread something is in an ASC at a given point in

time. “Prevalence” is also a technical term used in epidemiology, and is a

statistical concept referring to the number of cases of a disease that are present in

a particular population at a given time. In an ASC setting, for example, it would

make little sense to employ measures related to prevalence of pressure ulcers

among ASC patients, since the limited amount of time a patient typically spends

in an ASC makes it unlikely that the ASC’s care processes contributes to pressure

ulcers. On the other hand a more appropriate measure might be periodic

observation of the hand hygiene practices of all staff providing direct patient care,

in order to assess the prevalence of good versus deficient practices; and

• The severity of problems. For example, any single instance of a transfer of a

patient to a hospital represents a serious adverse, unplanned outcome of the

surgical procedure, and it would be appropriate for an ASC to track and evaluate

all such cases, due to their severity, even if they are low volume incidents.

Once having identified the quality indicators it will use, the ASC must collect and

analyze data on these indicators.

3. Identify and reduce medical errors/adverse patient events. Although there is no

single, standard definition of a medical error or adverse event, the Institute of

Medicine created a series of definitions related to patient safety that are helpful in

understanding the regulatory requirement:

“An error is defined as the failure of a planned action to be completed as

intended (i.e., error of execution) or the use of a wrong plan to achieve an aim

(i.e., error of planning).”

“An adverse event is an injury caused by medical management rather than the

underlying condition of the patient.”

“An adverse event attributable to error is a preventable adverse event.”

1

Using these definitions, if an ASC performing orthopedic procedures operates on

the right shoulder of a patient with a left shoulder rotator cuff injury requiring

surgery, then the ASC has committed an error. The patient suffered an adverse

event – i.e., the harm to the patient of undergoing surgery on the wrong shoulder,

and presumably having to undergo yet another surgery on the correct shoulder.

Because the ASC’s error resulted in the adverse event, it is a preventable adverse

event that could and should have been avoided.

Not every adverse event is the result of an error. For example, the standard of

practice might call for use of a particular medication when certain indications are

present. A patient might have an allergy to that medication that is unknown to the

patient and the patient’s physicians. The patient develops an allergic reaction to

the medication, requiring further medical intervention to counteract the reaction.

Due to the unknown nature of the patient’s allergy, there was no error, even

though there was an injury resulting from medical management. On the other

hand, if the allergy had been documented in the patient’s medical record and the

medication had been administered anyway, this would constitute an error.

Not every error results in an adverse event; for example, an ASC with two

operating rooms might mix up the records of two ASC patients scheduled to have

the same orthopedic procedure, e.g., foot surgery, on the same date, but on the

opposite feet. This is an error. But the ASC employs a time-out procedure to

verify the identity of the patients and site of the surgery and recognizes the error

before surgery begins. The error did not result in an adverse event, but it was a

near miss.

ASCs must track all patient adverse events, in order to determine through

subsequent analysis whether they were the result of errors that should have been

preventable, to reduce the likelihood of such events in the future. ASCs are also

expected to identify errors that result in near misses, since such errors have the

potential to cause future adverse events.

ASCs seeking initial enrollment in the Medicare program are unlikely to have

collected extensive data for their QAPI program indicators, since they likely have

been in operation for a relatively brief period of time. Nevertheless, these initial

applicants must have a QAPI program in place, and must be able to describe how

the program functions, including which indicators/measures are being tracked, at

what intervals, and how the information will be used by the ASC to improve

quality and safety.

Examples of ASC Quality/Patient Safety Indicators

The following information is based on the National Quality Forum’s (NQF) consensus

standards for ASCs, and is provided only as an illustration of several types of measures

an ASC might choose to include in its QAPI program. An ASC is free to use different

measures, so long as the measures it chooses meets the regulatory criteria. ASCs are also

expected to develop additional measures related to infection control, for example to

enable it to comply with the requirement at §416.51(b)(2) for its infection control

program to be integrated into its QAPI program, and at §416.44(a)(3) to have a program

to identify healthcare associated infections and report diseases as required under State

law. Depending on the individual characteristics of the ASC, including problems it had

experienced in the past, it may be necessary to track other additional indicators as well.

More information on these and other NQF ASC measures is available at:

http://www.qualityforum.org/pdf/ambulatory/tbAMBALLMeasuresendorsed%201

2-10-07.pdf

• Patient Burn – Percentage of ASC admissions experiencing a burn prior to

discharge. Approximately 100 surgical fires occur each year nationally, in all

surgical settings, with about 20 resulting in serious injuries to patients.

• Prophylactic Intravenous Antibiotic Timing – Percentage of ASC patients who

received appropriate antibiotics ordered for surgical site infection prophylaxis on

time.

• Hospital Transfer/Admission – Percentage of ASC admissions requiring a

hospital transfer or hospital admission prior to being discharged from the ASC.

• Patient Fall – Percentage of ASC admissions experiencing a fall in the ASC.

• Wrong Site, Wrong Side, Wrong Patient, Wrong Procedure, Wrong Implant

- Percentage of ASC admissions experiencing a wrong site, wrong side, wrong

patient, wrong procedure, or wrong implant.

Survey Procedures: §416.43(a)

• Ask the ASC’s leadership to describe the QAPI program, including staff

responsibilities for QAPI and the quality/safety indicators being tracked.

• Ask what the rationale is for the particular indicators that the ASC has chosen to

track. Are they based on nationally-recognized recommendations? If not, what

evidence does the ASC have that the indicators it has chosen are associated with

improvement in patient health outcomes and safety?

• At a minimum, do the indicators include cases of patients transferred from the

ASC to a hospital?

• At a minimum, do the indicators include measures appropriate for surgery and

infection control measures?

• At a minimum, does the ASC have a system for tracking adverse patient

events?

• Ask the staff responsible for QAPI what the method and frequency is for data

collection for each QAPI program indicator.

1P. 28, ToErr is Human, Institute of Medicine, November, 1999.