Patient Safety Programs for ASC’s

Updates for 2010

Richard Bays RN, MBA, CPHQ, CLNC

TASCS 2009 Annual Conference

Patient Safety Programs for ASC’s Updates for 2010

What changes do I need to know about?

Patient Safety Programs for ASC’s Updates for 2010

• The Accreditation Association for Ambulatory Health Care (AAAHC) recently sought public comment for proposed revisions to its standards for 2010.

• Interested parties — such as AAAHC-accredited organizations, surveyors, member organizations, medical specialty groups, regulatory agencies and the public at large were asked to review and provide comments on the proposed revisions.

• Details of the proposed revisions and instructions on how to submit comments were available on the AAAHC Web site through Sept. 14, 2009.

Patient Safety Programs for ASC’s Updates for 2010

• The most significant proposed change for 2010 is the inclusion of a new core Chapter 7.

• This chapter will consist of two subchapters:

– Subchapter I, Infection Control and Prevention, and

– Subchapter II, Safety.

• If the proposed changes are made final, the guidelines outlined in these chapters will be applicable to all AAAHC currently accredited organizations and those seeking future accreditation.

Patient Safety Programs for ASC’s Updates for 2010

Because AAAHC requires that the elements of a safety program

must meet or exceed local, state or federal safety requirements.

Let’s examine the State requirements.

Texas Administrative Code

TITLE 25 HEALTH SERVICES

PART 1 DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 135 AMBULATORY SURGICAL CENTERS

SUBCHAPTER A OPERATING REQUIREMENTS FOR AMBULATORY SURGICAL CENTERS

RULE §135.27 Patient Safety Program

Patient Safety Programs for ASC’s Updates for 2010

What do I need to know about the

Texas Administrative Code

RULE §135.27

Patient Safety Program?

Patient Safety Programs for ASC’s Updates for 2010

Texas Administrative Code RULE §135.27 Patient Safety Program

(a) Definitions.

(1) Adverse event--An event that results in unintended harm to the patient by an act of commission or omission rather than by the underlying disease or condition of the patient.

(2) Medical error--The failure of a planned action to be completed as intended, the use of a wrong plan to achieve an aim, or the failure of an unplanned action that should have been completed, that results in an adverse event.

(3) Reportable event--A medical error or adverse event or occurrence which staff are required to report internally.

(4) Root cause analysis--An interdisciplinary review process for identifying the basic or contributing causal factors that underlie a variation in performance associated with an adverse event or reportable event. It focuses primarily on systems and processes, includes an analysis of underlying cause and effect, progresses from special causes in clinical processes to common causes in organizational processes, and identifies potential improvements in processes or systems.

Patient Safety Programs for ASC’s Updates for 2010

Texas Administrative Code RULE §135.27 Patient Safety Program

(b) Content. The ambulatory surgical center (ASC) shall develop, implement and maintain an effective, ongoing, organization-wide, data driven patient safety program (PSP).

(1) The governing body shall ensure that the PSP reflects the complexity of the ASC's organization and services, including those services furnished under contract or arrangement, and focuses on the prevention and reduction of medical errors and adverse events.

(2) The PSP shall be in writing, approved by the governing body and made available for review by the department. It shall include the following components:

(A) the definition of medical errors, adverse events and reportable events;

(B) the process for internal reporting of medical errors, adverse events and reportable events;

Patient Safety Programs for ASC’s Updates for 2010

Texas Administrative Code RULE §135.27 Patient Safety Program

(b) Content. (Continued)

(C) a list of events and occurrences which staff are required to report internally, including at least the following events:

(i) a medication error resulting in a patient's unanticipated death or major permanent loss of bodily function in circumstances unrelated to the natural course of the illness or underlying condition of the patient;

(ii) the suicide of a patient in a setting in which the patient received care 24 hours a day;

(iii) the sexual assault of a patient during treatment or while the patient was on the premises of the ASC;

(iv) a hemolytic transfusion reaction in a patient resulting from the administration of blood or blood products with major blood group incompatibilities;

(v) a surgical procedure on the wrong patient or on the wrong body part of a patient;

(vi) a foreign object accidentally left in a patient during a procedure;

(vii) a patient death or serious disability associated with the use or function of a device designed for patient care that is used or functions other than as intended;

Patient Safety Programs for ASC’s Updates for 2010

Texas Administrative Code RULE §135.27 Patient Safety Program

(b) Content. (Continued)

(D) time frames for internal reporting of medical errors, adverse events and reportable events;

(E) consequences for failing to report events in accordance with ASC policy;

(F) mechanisms for preservation and collection of event data;

(G) the process for conducting root cause analysis;

(H) the process for communicating action plans; and

(I) the process for feedback to staff regarding the root cause analysis and action plan.

Patient Safety Programs for ASC’s Updates for 2010

Texas Administrative Code RULE §135.27 Patient Safety Program

(c) Education and training. The ASC shall provide patient safety education and training to

staff who have responsibilities related to the implementation, development, supervision, or

evaluation of the PSP. Training shall include all PSP components as set out in subsection

(b)(2) of this section.

Patient Safety Programs for ASC’s Updates for 2010

Texas Administrative Code RULE §135.27 Patient Safety Program

(d) Management. The ASC shall designate one or more individuals, or an interdisciplinary

group, qualified by training or experience to be responsible for the management of the patient safety program. These responsibilities shall include:

(1) coordinating all patient safety activities;

(2) facilitating assessment and appropriate response to reported events;

(3) monitoring the root cause analysis and resulting action plans; and

(4) serving as liaison among ASC departments and committees to ensure facility-wide integration of the PSP.

Patient Safety Programs for ASC’s Updates for 2010

Texas Administrative Code RULE §135.27 Patient Safety Program

(e) Reportable event. Within 45 days of becoming aware of a reportable event specified under subsection (b)(2)(C) of this section, the ambulatory surgery center shall:

(1) complete a root cause analysis to examine the cause and effect of the event through an impartial process; and

(2) develop an action plan identifying the strategies that the ASC intends to employ to reduce the risk of similar events occurring in the future. The action plan shall:

(A) designate responsibility for implementation and oversight;

(B) specify time frames for implementation; and

(C) include a strategy for measuring the effectiveness of the actions taken.

(3) The ASC shall make the root cause analysis and action plan available for on-site review by department representatives.

Patient Safety Programs for ASC’s Updates for 2010

What do I need to know about the

AAAHC Chapter 7 proposed for 2010?

Patient Safety Programs for ASC’s Updates for 2010

AAAHC Chapter 7 – proposed for 2010

Chapter 7 Preamble: An accreditable organization provides

health care services while adhering to safe practices for

patients, staff and all others. The organization maintains

ongoing programs designed to (1) control and prevent

infections and communicable diseases, and (2) to provide a

safe and sanitary environment of care.

Patient Safety Programs for ASC’s Updates for 2010

7.I. Infection Control and Prevention – An accreditable organization maintains an active and ongoing infection control and prevention program as evidenced by the following characteristics:

A. The infection control and prevention program includes documentation that the organization has considered, selected, and implemented nationally-recognized infection control guidelines. The program is:

1. Approved by the governing body

2. An integral part of the organization’s quality improvement program

3. Under the direction of a designated and qualified health care professional who has training and current competence in infection control

4. Implemented with a plan of action to:

a. Prevent, identify, minimize and manage infections and communicable diseases

b. Immediately implement corrective and preventive measures that result in improvements.

Patient Safety Programs for ASC’s Updates for 2010

7.I. Infection Control and Prevention – (Continued)

B. The organization must establish a program for identifying and preventing infections, maintaining a sanitary environment, and reporting the results to appropriate authorities.

(Relocated from 2009 8.N-MS Additional Medicare Requirement to 2010 AAAHC Chapter 7)

C. The infection control and prevention program reduces the risk of healthcare associated infection as evidenced by education and active surveillance, consistent with:

1. WHO, CDC or other nationally-recognized guidelines for hand hygiene

2. CDC or other nationally-recognized guidelines for safe injection practices

3. Precautions to minimize communicable disease exposure to patients, healthcare staff and others.

Patient Safety Programs for ASC’s Updates for 2010

7.I. Infection Control and Prevention – (Continued)

D. The organization provides a functional and sanitary environment for the provision of services. The organization adheres to professionally accepted standards of practice, manufacturer’s recommendations, and state and federal guidelines, including but not limited to the cleaning, disinfection and sterilization of instruments, equipment, supplies, and implants.

E. A sharps injury prevention program must be present in the organization. Such a program will include:

1. Documentation of employee orientation and annual staff education

2. Disposal of intact needles and syringes into appropriate puncture-resistant sharps containers, in

accordance with current state and federal guidelines

3. Sharps containers placement into appropriate care areas and secured from tampering

4. Sharps containers replacement before the fill line is reached

5. Handling and disposal of filled sharps containers done in accordance with applicable regulations.

Patient Safety Programs for ASC’s Updates for 2010

7.I. Infection Control and Prevention – (Continued)

F. A safe environment for treating surgical patients, including adequate safeguards to protect the patient from cross-infection, is assured through the provision of adequate space, equipment, supplies and personnel.

(Relocated from 10.I.M to Chapter 7.I)

G. Procedures are available to minimize the sources and transmission of infections, including adequate surveillance techniques.

(Relocated from 8.N to Chapter 7.I)

H. A process is in place for the monitoring and documentation of the cleaning, high level disinfection and sterilization of medical equipment, accessories, instruments and implants. Sterile packs of equipment and instruments are within current dates.

Patient Safety Programs for ASC’s Updates for 2010

7.I. Infection Control and Prevention – (Continued)

I. A policy addresses the identification and processing of medical equipment

and instruments that did not meet sterilization parameters.

J. Policies are in place for the isolation or immediate transfer of patients with a communicable disease.

(Relocated from 10.I.M-1 to Chapter 7.I)

K. Patient treatment and care areas are appropriately cleaned according to the organization’s policy which includes:

1. Cleaning before daily use

2. Cleaning between patients

3. Terminal cleaning at the end of day.

Patient Safety Programs for ASC’s Updates for 2010

7.II. Safety – An accreditable organization adheres to safe practices for patients, staff and others as evidenced by the following characteristics:

A. Elements of a safety program address, but are not limited to, the organization’s environment of care and the safety of patients, staff, and others, and must meet or exceed local, state or federal safety requirements. The elements of the safety program include, but are not limited to:

1. Processes for the management of identified hazards, potential threats, near misses and other safety concerns

2. An awareness of, and a process for, the reporting of known adverse incidents to appropriate state and federal agencies when required by law to do so

3. Processes to reduce and avoid medication errors

4. Policies regarding food and drink, if made available

5. Policies addressing manufacturer or regulatory agency recalls related to medications, medical equipment and devices, and food products

6. Prevention of falls or physical injuries involving patients, staff, and all others

Patient Safety Programs for ASC’s Updates for 2010

7.II. Safety – (Continued)

B. There is a person or committee designated by the governing body that is responsible for the organization’s safety program.

C. Medical staff members, employees, volunteers and contracted individuals are responsible for carrying out the program, and must receive education and training to include and not to be limited to:

1. Adverse incident reporting system as described in 2.I.B-21

2. Infection control and prevention program

3. Safety program

Patient Safety Programs for ASC’s Updates for 2010

7.II. Safety – (Continued)

D. Unique patient identifiers are consistently used throughout care.

E. There must be written policies and procedures for all organizationally-

defined invasive procedures. These must include criteria for patient

selection, the need for anesthesia support, and post-procedural care

Patient Safety Programs for ASC’s Updates for 2010

7.II. Safety – (Continued)

F. The organization has a written emergency and disaster preparedness plan to address internal and external emergencies, including participating in community health emergency or disaster preparedness, when applicable. The written plan must include a provision for the safe evacuation of individuals during an emergency, especially individuals who may be unable to self-evacuate from the organization.

( Relocated from 8.E to Chapter 7.II)

G. The organization adopts the appropriate policies and procedures to educate providers and personnel in fire prevention and fire hazard reduction.

Patient Safety Programs for ASC’s Updates for 2010

7.II. Safety – (Continued)

H. Fire safety, fire prevention and fire drills are included in surveillance activities of the personnel with the responsibilities for safety and risk management.

I. Potential environmental hazards associated with fire safety are identified and safe practices are established.

J. Measures are implemented to prevent skin and tissue injury from chemicals, cleaning solutions and other hazardous exposure.

Patient Safety Programs for ASC’s Updates for 2010

7.II. Safety – (Continued)

K. Written policies that comply with local, state and federal guidelines are present and adhered to regarding preparing, serving and storing of food and drink for patient use.

L. Only patients are allowed to consume food or drink in patient care areas.

M. Patients are educated about prescribed medical devices and associated protocols and guidelines. Patient competence with device is verified before independent use.

Patient Safety Programs for ASC’s Updates for 2010

7.II. Safety – (Continued)

N. Reprocessing of single-use devices must comply with FDA guidelines, and the devices

must have been cleared under the FDA 510(k) process. Policies must dictate the cleaning and handling of these devices in-house before sending them out for reprocessing, or if processed in-house, must define the processes to ensure that the FDA guidelines are met. A written log of reprocessed devices is maintained.

(Relocated from 10.I.N to Chapter 7.II)

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories.

Patient Safety Programs for ASC’s Updates for 2010

7.II. Safety – (Continued)

O. The organization has a policy and process that addresses the recall of items including drugs and vaccines, blood and blood products, medical devices, equipment and supplies, and food products. At a minimum, the policy addresses:

1. Sources of recall information (FDA, CDC, manufacturers, and other local, state or other federal sources)

2. Methods of notification of staff that need to know

3. Methods to determine if a recalled product is present at the organization or has been given or administered to patients

4. Documentation of response to recalled products

5. Disposition or return of recalled items

6. Patient notification, as appropriate

Patient Safety Programs for ASC’s Updates for 2010

7.II. Safety – (Continued)

P. Products, including medications, reagents and solutions that carry an

expiration date are monitored. The organization has a policy for disposal or return of expired medications and supplies that is in accordance with local, state and federal guidelines.

Q. Prior to use, appropriate education is provided to intended operators of newly-acquired devices or products to be used in the care of patients.

1. The organization shall designate a person to be responsible for ensuring education is done prior to allowing the use of the device in the care of a patient. Vendor representatives are not used as the sole source for clinical education.

Patient Safety Programs for ASC’s Updates for 2010

What if an inspector/surveyor visits my facility?

Patient Safety Programs for ASC’s Updates for 2010

Evaluating Compliance

• A root cause analysis and action plan must be completed for

all events related to a “reportable occurrence”

• The state will review the RCA related to the complaint, and

may review any others which were completed for similar

events.

Patient Safety Programs for ASC’s Updates for 2010

Evaluating Compliance

• In evaluating the RCA, DSHS will look for:

Any immediate actions taken

A thorough description of the events

Descriptions of the root causes and contributing factors

Recommended actions for addressing the root causes and contributing factors

Responsibility for implementing actions

Description of the outcome measures for the actions

Target dates for completion

Patient Safety Programs for ASC’s Updates for 2010

Evaluating Compliance

• Remember that the RCA must focus on systems and processes, including an analysis of underlying cause and effect.

• Actions must be clear and have direct relevance to the root cause.

• Outcome measures should be specific and quantifiable, and must measure the impact of the action on the root cause

Patient Safety Programs for ASC’s Updates for 2010

Evaluating Compliance

• Review of the overall patient safety program:

• Is it effective, ongoing and organization-wide?

• Does it focus on the prevention and reduction of

adverse events and medical errors?

• Is it integrated with other departments in the facility?

• Are staff knowledgeable of the patient safety program

and their responsibilities?

Patient Safety Programs for ASC’s Updates for 2010

Evaluating Compliance

• Review of the overall patient safety program:

• Are events being reported internally within the specified time frames?

• Is an RCA and action plan being completed within 45 days?

• Is the effectiveness of the action plan being evaluated?

• Has the facility accurately reported their data to the state?

Patient Safety Programs for ASC’s Updates for 2010

Evaluating Compliance

• The goal is to improve patient safety, not to use the RCA against you.

• The RCA is confidential, and inspectors may not “remove, copy, reproduce, redact, or dictate from any part of a root cause analysis or action plan.”

• The law only requires that the state be allowed to review the RCA and action plan related to a reportable event.

Patient Safety Programs for ASC’s Updates for 2010

Evaluating Compliance

• If something goes wrong, you must be able to demonstrate what you did to investigate it, and what actions you took to prevent it from happening again.

• You could be cited for failing to:

– Complete an RCA and action plan on required reportable events.

– If your safety program and RCA process does not meet the intent of the law and the rules.

– If you fail to report to the state in accordance with the law

• Ishikawa fishbone diagram process:

Brainstorm causes

Put into pre-defined categories

Identify most likely to cause problems

Generate solutions

Tools & Methods Patient Safety Programs for ASC’s Updates for 2010

RCA’s

Patient Safety Programs for ASC’s Updates for 2010

Summary Points

• Know what is expected of your PSP by the State

• Know what is proposed if you are accreditable by the AAAHC

• Understand the requirements & standards of each organization

• Obtain training to be in compliance in necessary

• Formulate a plan to achieve 100% compliance

References

1. Accreditation Association for Ambulatory Health Care (AAAHC).

http://www.aaahc.org/eweb/docs/Public%20Comment%20Document%2

08%2014%2009.pdf

2. Becker’s ASC Review. 18 August 2009.

http://www.beckersasc.com/news-analysis-asc/accreditation-patient-

safety/aaahc-seeking-public-comment-on-revisions-to-standards.html

3. Protect Texas: Reading Between the Rules, DSHS. Cindy Bednar R.N.

4. Texas Administrative Code. Chapter 135 Ambulatory Surgical Centers

http://info.sos.state.tx.us/pls/pub/readtac$ext.ViewTAC?tac_view=4&ti=

25&pt=1&ch=135

Contact Information:

Richard Bays RN, MBA, CPHQ, CLNC

RBaysConsulting@gmail.com

Phone (832) 316-2701