STANDARD 6: Patient Safety System

6.1 General 

1. The healthcare organization shall appoint a multi-disciplinary committee to oversee the patient safety system. This committee shall be responsible for the AACI Patient Safety Goals selection. 

2. This committee shall ensure an environment and culture that promotes awareness of patient and staff safety. It shall have a specific risk-based process for identifying and mitigating the possible presence of incidents or conditions that impact and negatively threaten patient, staff, and other personnel. These considerations shall also extend to factors that impact physical, mental, and environmental stress in the workplace. 

3. The patient safety committee shall meet quarterly. Output shall be input for management review and retained as documented information. 

NOTE 1 AACI has established a universal patient safety program pertinent to all healthcare organizations. Key indicators form monitoring and measuring will be established by AACI on an annual basis. These indicators shall be determined by current conditions relevant to patient safety in the healthcare arena and by input from all AACI stakeholders. The Patient Safety Committee shall demonstrate oversight and improvement efforts regarding at least three (3) specific topics of patient and facility risk. These goals are available on http://aacihealthcare.com/patient-safety-goals. 

4. These goals shall be met by: 

a) focus on high-risk, high-volume, or problem-prone areas; 

b) consideration of the incidence, prevalence, and severity of problems in those areas; 

c) the result of health outcomes, patient safety, and quality of care; 

d) review of occurrence and resulting impact on the healthcare organization; 

e) promoting any required training indicated by the result of the above activities. 

5. Output resulting from the activities of the Patient Safety Committee shall be input for Top management review and retained as documented information. 

6.2 Traceability 

1. The healthcare organization shall use suitable means to uniquely identify services, products, outputs and/or equipment when conformity of outputs or use results are determined to be critical to patient, staff, or other interested party safety. 

2. The healthcare organization shall continuously monitor and measure the suitability of the above services and outputs throughout their preparation, production, and delivery (use, output, etc.). 

3. Persons authorizing the release and suitability of the preparation services and outputs above shall be identified throughout this overall process. 

4. The resulting unique identification information shall be retained as documented information for

reference and traceability in the event of non-conforming and unexpected adverse outcomes

requiring correction and corrective actions discovered during or after use/delivery of service.

5. The traceability information required shall become linked to and included in all medical records

associated with products and services identified by the healthcare organization in 1) above. This

information shall be retrievable and used to contact and inform all recipients of related products

and services in the event of required follow-up and mitigation.

6. These requirements shall be established, reviewed, controlled, and updated by collaborative input from Infection control and sterile processing at a minimum.

7. The following areas of traceability monitoring shall include but are not limited to:

a) reusable medical equipment requiring sterilization (instrument packs and instances of

flash (immediate) sterilization);

b) associated sterilization equipment;

c) anesthesia machine use;

d) ventilator use;

e) reusable medical equipment requiring decontamination processing (endoscopes, etc);

f) associated decontamination equipment;

g) critical equipment requiring calibration for use;

h) ionizing radiology equipment use;

i) vaccinations;

j) blood transfusions;

k) pharmaceutical agents as determined appropriate by the healthcare organization;

l) known events of exposure to harmful circumstances requiring follow-up supervision or care;

m) traceability recommended by manufacturer’s instruction for use;

n) other points of control as determined to be immediately necessary for safety control.

6.3 Opioid Oversight and Use Committee

1. The healthcare organization shall establish a multidisciplinary Committee to analyze risk and

mitigate untoward incidents associated with opioid use within the facility. It shall develop and implement written policies and procedures related to this purpose.

2. This Committee shall be composed of members of the medical staff and nursing service to include but not limited to, representatives of:

a) internal medicine;

b) surgery;

c) anesthesiology;

d) pain management;

e) nursing leadership in related special care and PAC units.

3. This Committee shall monitor, measure, analyze, correct, take corrective actions and review its

procedures for effectiveness to ensure patient safety and all intended outcomes by:

a) identification of the physician responsible for pain control in each patient;

b) assessment of patient history risk factors related to opioid use;

c) establishing the use of standard order sets addressing various modalities for effective pain control;

d) use of patient-controlled analgesia (PSA) order sets with parameters preventing hyperalgesia

and opioid resistance;

e) use of time scheduled pain medication orders with 24 hour renewal requirements;

f) tempering techniques;

g) regular evaluation of pain level evaluation and response to pain medications;

h) on-going monitoring of consciousness and ventilatory competence.

4. The Committee shall establish policies and guidelines to facilitate effective monitoring and assessment of patients receiving opioid treatment. This policy shall include:

a) physician awareness of patient’s history including relevant co-morbidities;

b) awareness of other related risk factors noted by interview or family history and input;

c) handoff reports between consecutive care givers accurately describing the patient response

to recently administered opioids.

5. There shall be a risk assessment for post-operative patients receiving intravenous, PCA, or neuraxial opioids. This risk assessment shall consider opiate dose, frequency, mode of delivery, and duration of anticipated therapy.

6. The healthcare organization shall determine the monitoring modes to be utilized in patients based on a level of the assessed risk particularly associated with patients within the first 24 post-operative hours. Of special consideration shall be the use of continuous ventilatory and oxygenation monitoring in patients receiving IV, PCA, or neuraxial opioids.

7. Documented information shall be retained and maintained as required by the healthcare organization (see 4.6.4.j).