JCI Survey 2015 - National Guard Health Affairsngha.med.sa/English/Professionals/pgme/orientationwr/JCI_Reference... · JCI Survey 2015 Reference Guide. JCI ... (GLD ... A Joint Commission

MINISTRY OF NATIONAL GUARD HEALTH AFFAIRSKing Abdulaziz Medical City - Jeddah

JCI Survey 2015Reference Guide

JCI Survey Reference Guide (2015)

1

CEO’s Message

Dr. Bandar Al Knawy, MD, FRCPC

Chief Executive Officer, Ministry of National Guard Health Affairs President, King Saud bin Abdulaziz University for Health Sciences

Dear Colleague,

Patients and Family Safety First is the shared commitment in the Ministry of National Guard Health Affairs and it is within this principle that the organization continues to explore means of advancing its services. The approach is strengthening the organization’s ability to achieve world class outcomes in education, research and patient care through an atmosphere of team work, trust, passion and pursuit of excellence.

As part of the journey to provide the best care to our patients and their families, the MNGHA made the decision to pursue the Joint Commission International (JCI) accreditation and successfully achieved the initial accreditation in 2006 and re-accreditation in 2009 and 2012.

This achievement was a product of the collective work of each and every one of us and once again the opportunity calls on us as members of this great organization to improve the safety and quality of care that we provide by implementing and complying with the organizational and JCI standards.

The third re-accreditation of the organization is due by end of 2015, and in order to increase the awareness of the JCI re-accreditation, your colleagues in the Department of Quality Management in collaboration with other departments developed this pocket guide that outlines the most important JCI standards, safe practices as well as pertinent policies and procedures. I have found it most useful and I am sure you would too.

I would like to thank you on behalf of all the patients and their families for your excellent hard work and to congratulate you for your unwavering commitment and loyalty to this organization in its pursuit of excellence.


2

TABLE OF CONTENTS

CEO’s Message

Table of Contents

Ministry of National Guard Health Affairs: Mission, Vision, Values …………………………………....

The JCI Survey Overview………………………………………………………………………………....

Tracer Methodology ……………………………………………………………………………………...

DO’s and DON’Ts during the Hospital Survey…………………………………………………………..

Accreditation Preparation Requirements (APR)………………………………………………………….

International Patient Safety Goals (IPSG) ………………………………………………………………..

IPSG 1: Identify Patient Correctly……………………………………………………………......

IPSG 2: Improve Effective Communication……………………………………………………...

IPSG 3: Improve the Safety of High-Alert Medications………………………………………….

IPSG 4: Ensure Correct-Site, Correct-Procedure, Correct-Patient Surgery……………………..

IPSG 5: Reduce the Risk of Health Care Associated Infections ………………………………….

IPSG 6: Reduce the Risk of Patient Harm Resulting from Falls…………………………..………

Access to Care and Continuity of Care (ACC)……………………………………………………………

Patient and Family Rights (PFR)…………………………………………………………………………..

Assessment of Patients (AOP) …………………………………………………………………..………...

Care of Patients (COP) …………………………………………………………………………………....

Anesthesia and Surgical Care (ASC) ……………………………………………………………………..

Medication Management and Use (MMU) ……………………………………………………...………

Patient and Family Education (PFE) ……………………………………………………………….……..

Quality Improvement and Patient Safety (QPS) …………………………………………………….…...

Prevention and Control of Infections (PCI) ……………………………………………………………...

Governance, Leadership and Direction (GLD) ………………………………………………….……….

Facility Management and Safety (FMS) ………………………………………………………….………

Staff Qualifications and Education (SQE) ……………………………………………………………..…

Management of Information (MOI) …………………………………………………………………..…

Medical Professional Education (MPE) ……………………………………………………………..……

Human Subject Research Program (HRP) ………………………………………………………………..

1 2 3

4

4

5

6

8

8

9

11

14

16

17

19

20

24

27

32

33

36

37

40

45

46

50

51

52

53


3

INTRODUCTION

This reference guide has been developed to provide education regarding accreditation standards, and information about how King Abdulaziz Medical City-Jeddah utilizes these standards to continually improve care, treatment, and services. We ask that you review and refer back to this booklet as we embark together on our journey towards another successful Joint Commission International re-accreditation survey. In previous surveys, our staff have stepped up to the plate and been able to demonstrate the exemplary care they provide. It is our goal that the information contained within this booklet will prove useful for your day to day practice, and also serves as a guide in the quest to provide excellent patient care.

MINISTRY OF NATIONAL GUARD HEALTH AFFAIRS

Ministry of National Guard Health Affairs (MNGHA) provides optimum healthcare to SANG personnel, their dependants and other eligible patients. MNGHA also provides excellent academic opportunities conducts research and participates in industry and community service programs in the health field.

MISSION

VISION

Ministry of National Guard Health Affairs will be recognized as an internationally acclaimed Center of Excellence to enhance individual and public health status.

Values Ministry of National Guard Health Affairs adheres to core values taken from religious, social and professional principles, abiding by:

1. Respect of religious and social values – Respect for religious and social values of the Saudi society, and refrain from violating the rules.

2. Patient safety and satisfaction – Focusing on patient safety, through provision of outstanding services that guarantee patient satisfaction.

3. Quality performance – Continuously seeking improvement and development of quality performance.

4. Respect and dignity – Valuing Patients and families and employees with respect and dignity. 5. Transparency – Being open and direct in dealing with patients and staff. 6. Teamwork – Workplace cooperation for optimum utilization of team members and positive

performance and patient outcomes. 7. Productive work environment – Provision of work environments that encourage productivity,

efficiency and optimum utilization of resources. 8. Accountability – Building individual and team loyalty and responsibility toward work activities. 9. Behavior and work ethic – Performing work in accordance with behavior and work ethics which

include truthfulness, sincerity and mutual respect for each other. 10. Excellence and innovation – Innovation and excellence in dealing with all health organizational

activities.


4

THE JCI SURVEY OVERVIEW

A Joint Commission International on-site accreditation survey provides an assessment of an organization’s compliance with standards and their measurable elements of performance.

TRACER METHODOLOGY

The Joint Commission International uses the “Tracer Methodology” as a method of assessment.

What are the primary objectives of tracer activities?

1. Follow the course of care, treatment, and services provided to the patient by and within the hospital using current records when possible.

2. Assess the interrelationships between and among disciplines and departments, programs, services,

or units.

3. Evaluate the performance of relevant processes, with particular focus on the integration and coordination of distinct but related processes.

4. Identify potential concerns in the relevant processes. Who will participate during Tracer Activity?

What will occur during Tracer activity?

1. Observation of direct patient care, medication processes, infection prevention and control issues, care planning processes, impact of the environment on safety and staff roles in minimizing environmental risk.

2. Review of the record with the staff person responsible for the patient’s care, treatment, and services provided.

3. Discussion of data use in individual departments/services. (NEW REQUIREMENT)

4. Review of emergency equipment, supplies, and processes.

5. Interview with the patient and/or family (if it is appropriate and permission is granted by the patient and/or family).

6. When visiting the emergency department, the surveyor(s) will also address emergency management and explore patient flow issues. (NEW REQUIREMENT)

7. The surveyor(s) may pull and review two to three additional records to verify issues that may have

been identified. (Concurrent chart review)

During a tracer, the surveyor(s) will converse with a wide variety of staff involved in the patient’s care, treatment, and services. Staff could include nurses, physicians, medical students, trainees, therapists, managers, patient care technicians, pharmacy staff, lab personnel, dieticians, respiratory therapists, patient educators and support staff.


5

DURING THE HOSPITAL SURVEY

DO’s DON’Ts

1. Welcome the surveyor to your area 2. Allocate appropriate space for the tracer team

to do the interviews 3. Be truthful, describe your regular practice 4. Be professional in your attitude and

appearance 5. Reply to surveyors’ questions directly and

concisely

6. If unsure of the answer, the safest response is that you would check the policy or ask your supervisor

7. Keep your answers focused and specific to their questions

8. Answer with confidence

9. If you don’t understand something, ask the surveyor to clarify or explain

1. Argue with the surveyor or defend your

practice

2. Mislead the surveyor

3. Volunteer unnecessary information.

4. Provide non requested documents

5. Use phrases such as, “most of the time”, “we

usually”, “well, sometimes we do”

6. Talk about past surveys or the future plan of

the department

7. Offer gift as this may be intepreted as

bribery, offering water will be sufficient

8. Prompt the staff during the interview


6

NEW JCI STANDARD (APR.9)

To create a “safe” reporting environment, the hospital educates all staff that concerns about the safety or quality of patient care provided in the hospital may be reported to JCI. The hospital also informs its staff that it will take no disciplinary or punitive action because a staff member reports safety or quality-of-care concerns to JCI.

There will be NO formal disciplinary actions (for example, demotions, reassignments, or change in working conditions or hours) or informal punitive actions (for example, harassment, isolation, or abuse) will be threatened or carried out in retaliation for reporting concerns through SRS or to JCI. HOW TO REPORT TO JCI

ACCREDITATION PREPARATION REQUIREMENTS

Concerns about patient safety and quality of care: Patient rights Care of patients Safety Infection control Medication use Security

Billing issues Payment disputes Staff conflicts Employee Relations issues Individual clinical management

of a single patient

What to report to JCI

1. Summarize your Patient Safety concerns (1-2 pages) 2. Include the Name, street address, city, and country of the health care organization 3. Name and contact information of the individual submitting the complaint (optional)

Complaints that contain contact information will allow JCI to follow up with the submitter if further clarification is needed or to request additional necessary information.

4. The name and contact information of the individual or individuals submitting the complaint will be kept confidential and will not be disclosed to any other party

What NOT to report to JCI

1. Any hospital staff member (clinical or administrative) shall report

concerns about patient safety and quality of healthcare through Safety Reporting System(SRS).

2. If there is no Corrective Action at the hospital level, staff can report

the concerns to Joint Commission International Accreditation (JCI) without retaliatory action from the hospital.


7

NEW JCI STANDARD (APR.11)

The hospital also needs to inform the public about how to report concerns about patient safety and quality of care to JCI, in particular when the hospital process has not been effective in resolving the concern. Patient Relations staff answer questions, provides information, assist with special needs and facilitate problem solving and complaint management and ensure that all issues and complaints are handled with sensitivity and confidentiality. They identify opportunities to improve the patient experience, assist caregivers in meeting patients' needs, expectations and concern, and gather data for patient satisfaction. Whether you have a question, concern, complaint or compliment, our Patient Relations team ensures that you have a voice.

APP 1431–17 Patient Complaints, Suggestions and Compliments APP 1433–21 Rights and Responsibilities if Patients/Families

APP 1432–09 Patient Visiting Hours and Regulations

Staff, patients and the public can contact JCI offices directly to report patient safety issues that are not resolved by the organization.

The program must recognize the right of the patient to receive a high standard of care and treatment. The patient/family has the RIGHT to make a complaint or suggestion when the expectations are not met or the patient/family experiences/notices any lapse in the service rendered.

The Program must establish and maintain an open and transparent system to respond to complaints and suggestions of patients, their families and visitors. The complaints and suggestions must receive sympathetic attention and must be investigated and resolved as expeditiously as possible, in accordance with the MNGHA complaint handling process.

Email: [email protected]

Patient Information Desks :

22019 / 22731 / 22933

Patient Relations Department

To contact JCI office visit their website

http://www.jointcommissioninternational.org/reporting-quality-and-safety-issues/

or email [email protected]

Mail Quality and Safety Monitoring

Joint Commission International Accreditation 1515 West 22nd Street, Suite 1300W

Oak Brook, IL 60523 USA


8

IPSG

1

INTERNATIONAL PATIENT SAFETY GOALS It is critical that EVERYONE be familiar with the International Patient Safety Goals (IPSGs) and other Joint Commission patient safety-related standards and incorporates them into your daily practice. The purpose of the IPSG is to promote specific improvements in patient safety. The goals highlight problematic areas in health care and describe evidence- and expert-based consensus solutions to problems related to patient safety.

THE INTENT OF THIS GOAL IS TWO FOLD:

FIRST, to reliably identify the individual as the person for whom the service or treatment is intended. SECOND, to match the service or treatment to that individual.

1. Patients must be identified using “two unique identifiers” i.e. FULL NAME and MEDICAL RECORD

NUMBER (MRN) throughout the organization. 2. MUST NEVER use patient’s room or location to identify patient.

3. Patients are identified before providing treatments and procedures (Such as administering

medications, blood, or blood products; serving a restricted diet tray; or providing radiation therapy, taking blood and other specimens for clinical testing)

4. Patients are identified before any diagnostic procedures (performing a cardiac catheterization or

diagnostic radiology procedure)

You should always check the “two identifiers” from:

Patient’s Medical Record

Patient’s Identity band

Electronic Medical Record ALWAYS ask the patient/guardian/parent to verbalize patient’s name if possible.

Identify Patients Correctly The hospital develops and implements a process to improve accuracy of patient identifications. APP 1430–16 Patient Identification DPP 7800-01-016 Patient Identification

IPSG


9

IPSG

2

Verbal Orders Verbal orders are reserved for codes and emergency situations ONLY, and must be ordered in the system within 4 hours.

Telephone Orders Telephone orders are reserved for situations in which the Physician cannot access the hospital’s electronic health system, and a delay will compromise patient care. Telephone orders must be entered into the system within 24 hours.

When receiving a telephone order from a Physician: 1. Nurse A writes the order in the physician order sheet. 2. Nurse B will read back the order written by Nurse A to the physician. 3. The prescriber will verify the order is correct to Nurse B. 4. Both Nurse A and Nurse B must document the date and time the order was received, badge

number of the prescriber, and their own names, job title and badge numbers and both must sign the order sheet.

Read back procedure for the receipt of laboratory or radiology results:

1. The technologist/reporter will provide the report to the Receiver (Requesting Physician/Ward Nurse).

2. The receiver will document (hand -WRITE) the critical results. 3. The receiver (or another person - could be another nurse) will READ BACK the information

provided, including the patient’s medical record number and name to the reporter. 4. The technologists/reporter will verify the information is correct. 5. Both the reporter and the receiver must document the READ BACK verification procedure was

carried out; date and time the report was received, badge number of the person providing/receiving the report.

ALWAYS REMEMBER

Physicians MUST ALWAYS respond to critical result notification. Document the results in the patient chart, and the corresponding action needed ACTION NE based on the patient’s clinical condition.

Improve Effective Communication The hospital develops and implements a process to improve the effectiveness of verbal and/or telephone communication among caregivers. APP 1429–03 Prescribing and Dispensing Medication Guidelines DPP 7800-01-071 Improve Effective Communication DPP 7800-01-171 Clinical Communication

The hospital develops and implements a process for reporting critical results of diagnostic tests. APP 1426–06 Reporting Critical Laboratory Values APP 1426–09 Reporting Critical Radiological Findings DPP 7800-01-071 Improve Effective Communication

IPSG 2.1


10

Effective communication, which is timely, accurate, complete, unambiguous, and understood by the recipient, reduces errors and results in improved patient safety. Breakdowns in communication can occur during any handover of patient care and can result in adverse events. The SBAR technique provides a framework for communication between members of the health care team about a patient's condition.

(S) Situation: a statement of the problem (What is happening at the present time?)

(B) Background: sets the context by providing background information (What are the circumstances leading to this situation?)

(A) Assessment: Based on your assessment. (What do I think the problem is?)

(R) Recommendation: What is the recommendation or what is the problem that needs addressed. Provides

an opportunity to make a request for action. (What should we do to correct the problem?)

Handovers of patient care within a hospital occur:

Between health care providers and during shift changes; Between different levels of care in the same hospital (General ward to Critical care); From inpatient units to diagnostic units (endoscopy, physiotherapy, Cath Lab, etc.); When temporarily transferring nursing assignments of a patient for an extended period (greater

than 30 minutes) such as meal breaks; When referring any abnormal values or change in patient’s condition to the Physician or another

Colleague.

ALWAYS REMEMBER The standardized approach to patient care handover, namely SBAR, must be used by all MNGHA healthcare workers (Physicians, Pharmacists, Residents and all other Healthcare Professionals) in all situations without fail.

The hospital develops and implements a process for handover communication. APP 1430–33 Integration and Coordination of Patient Care DPP 6020-01-09-01 SBAR Communication within Nursing Division DPP 7800-01-171 Clinical Communication

IPSG 2.2


11

IPSG

3

High Alert Medications are medications that pose an increased risk of causing significant harm to patients if used in error.

1. Standardized auxiliary labels will be used for high alert medications.

2. An independent double check procedure will be performed for some High Alert Medications (APP 1429-02 Appendixes C and D) and Paediatric/Neonatal Medication administration.

3. Independent double check procedure must be completed without distractions or interruptions.

4. Always use the 5 Rights before medication administration: Right Patient, Right

Medication, Right Time, Right Dose and the Right Route.

5. Segregate them to reduce the risk of error.

6. Store the High Alert medications in RED BOXES with standardized medication labels.

Improve the Safety of High-Alert Medications The hospital develops and implements a process to improve the safety of high-alert medications. APP 1429–02 Look–Alike, Sound–Alike and High Alert Medications


12

Look-Alike and Sound-Alike Medications are medications whose names/packages sound/look similar to other drug names/packages.

Healthcare providers will adhere to the following:

1. Use TALL man Lettering labels for (Look-Alike, Sound-Alike) LASA medications that are available via the Intranet, One Stop Resource.

2. Look-Alike, Sound-Alike medications without approved TALL Man Lettering will be labelled as

“Name Alert”.

3. Use medication segregation methods for LASA medications, e.g., separate according to routes of administration, drug formulary status, LASA names or packaging, high alert designation, etc. Rather than following an alphabetical sequence of storage.

4. Be aware of automated alerts/advisories for LASA medications that are in the HIS-CPR System.

5. Logistics & Contracts Management will consider the List of Look-Alike, Sound-Alike Medications in the process of medication procurement. PURCHASE FOR SAFETY.

For more information on MEDICATION SAFETY please visit “ONE STOP RESOURCE” site on the hospital Homepage


13

Concentrated Electrolytes are High Alert Medications that must first be diluted prior to parenteral administration, to ensure patient safety.

Outside of the Pharmaceutical Care Services, concentrated (undiluted) electrolytes will be limited for handling ONLY by the staff during the medical emergencies in which Magnesium Sulphate is presented on the crash carts.

NOT ALL High Alert Medications require an INDEPENDENT DOUBLE CHECK. Please review the revised Policy (APP 1429-02 Appendixes C and D)

Improve the Safety of High-Alert Medications The hospital develops and implements a process to manage the safe use of concentrated electrolytes. APP 1433–18 Concentrated Electrolytes

IPSG

3.1

Concentrated electrolytes will be:

1. Stored and kept in a locked cabinet, with a similar sign in/out procedure used for Narcotics and Controlled Substances.

2. Separated from other medications and stored in red boxes with lids

3. Labeled with “High Alert

Medication/Concentrated Electrolyte”


14

Wrong-site, wrong-procedure, wrong-patient surgery errors are the result of ineffective or inadequate communication between members of the surgical team, lack of patient involvement in site marking, and lack of procedures for verifying the operative site. The essential processes found in the Universal Protocol are: marking the surgical site; a preoperative verification process; and a time-out that is held immediately before the start of a procedure. REMEMBER - These requirements also apply for any invasive procedures that are performed outside of the OR.

.

Ensure Correct-Site, Correct-Procedure, Correct-Patient Surgery The hospital develops and implements a process for ensuring correct-site, correct-procedure, and correct-patient surgery. APP 1426-08 Surgical / Procedural Site Verification DPP 7800–01–17 Verification Of Correct Patient, Correct Procedure, Correct Site for Surgical and Invasive Procedures

Surgical and invasive procedure site marking should:

be done by the person performing the procedure with a permanent skin marker.

take place with the patient AWAKE and AWARE, if possible.

be done in all cases involving laterality (right, left), multiple structures (fingers, toes, lesions) or multiple levels (spine).

be done using an instantly recognizable mark (ARROW as per policy) that is consistent throughout the hospital.

Preoperative verification There are various elements of the preoperative verification process that can be completed before the patient arrives at the preoperative area: Ensure that documents, imaging and test results,

vital signs and paperwork are properly labeled and readily available.

Informed consents are completed and signed by the

Physician, Patient/Guardian or Parent and the witness.

Proper handover is done in the preoperative area

and all discrepancies should be corrected before sending the patient into the Operating Theatre.

IPSG

4


15

1. Time Out should be performed in a "fail-safe" mode, i.e., the procedure is not started until all questions or concerns are resolved.

2. The responsibility for the "Time Out" process lies with the Physician performing the surgery/ procedure on that patient.

ALWAYS REMEMBER Surgical- and invasive procedure-site marking is done by the person performing the procedure and involves the patient in the marking process. The full team conducts and documents a time-out procedure in the area in which the surgery/invasive procedure will be performed, just before starting a surgical/invasive procedure.

Time Out This is the final verification that is performed immediately prior to the start of any surgical and invasive procedure whereby the entire care team actively and verbally confirms:

Patient's identity (two identifiers)

Procedure to be performed

Correct procedure side/site

Necessary imaging, equipment, implants or special requirements are present

“SAFE SURGERY SAVES LIVES”

PAUSE WITH A PURPOSE (AORN)-Association of peri-Operative Registered Nurses


16

Clean Hands Save Lives MNGHA adapted the WHO Guidelines of Hand Hygiene in Health Care 2009 to reduce the risk of health care-associated infections. 5 Moments for Hand Hygiene:

Wash hands with soap and water when hands are visibly soiled. Limitation of alcohol based hand rub (ABHR): ABHR is inactive when hands are visibly dirty and when dealing with spore forming bacteria, i.e.,

clostridium difficile patients.

Using alcohol-based sanitizers Use alcohol-based hand rub when hands are NOT visibly soiled.

* Note: Always be AWARE of your unit’s hand hygiene compliance rate.

Reduce the Risk of Health Care–Associated Infections The hospital adopts and implements evidence-based hand-hygiene guidelines to reduce the risk of healthcare–associated infections. ICM–II–04 Hand Hygiene

40-60 seconds 20-30 seconds

IPSG

5


17

Many injuries in hospitals to both inpatients and outpatients are a result of falls. Risks associated with patients might include patient history of falls, medications use, alcohol consumption, gait or balance disturbances, visual impairments, altered mental status, and the like.

Joint Commission Requirements:

NURSING STAFF RESPONSIBILITIES ON FALL PREVENTION

Reduce the Risk of Patient Harm Resulting from Falls The hospital develops and implements a process to reduce the risk of patient harm resulting from falls. APP 1430–05 Fall Prevention & Management Program DPP 7800-01-084 v4 KAMC-Jeddah Falls Program

1. The nurse shall assess all inpatients for any high fall risk factors within four (4) hours of admission and /or their condition or level of care changes.

2. Identify High Risk patients with a “Falling Star” logo

on the Nursing White Board, patient’s wrist band, head of the bed, and medical file.

3. Perform an Environmental Fall Risk Safety Check of

each patient's room and bathroom once per shift.

4. Educate the patient/family/sitter as required.

5. Implement an age sensitive Nursing Plan of Care aimed at managing the risk of the patient falling.

6. Process a Direct Referral from Nursing to Clinical

Pharmacy or Physiotherapy as per Policy DPP 7800-01-084 v4.

1. The hospital implements a process for assessing all inpatients and those outpatients whose condition (patients with gait or balance disturbances, visual impairments, altered mental status, and the like), diagnosis, situation (such as patients arriving by ambulance, patient transfers from wheelchairs, or the use of patient-lifting devices, or location (such as the physical therapy department) identifies them as at high risk for falls.

2. The hospital implements a process for the initial and ongoing assessment, reassessment, and intervention of inpatients and outpatients identified as at risk for falls based on documented criteria.

3. Measures are implemented to reduce fall risk for those identified patients, situations, and locations assessed to be at risk.

IPSG

6


18

PHYSICIAN’S ROLE IN FALLS PREVENTION PHARMACIST’S ROLE IN FALLS PREVENTION PHYSIOTHERAPIST’S ROLE IN FALLS PREVENTION

ALWAYS REMEMBER Any member of the patient care team (Nurses, Physicians and other Healthcare Professionals) shall use their assessment and clinical judgment to determine if a patient is at risk for falls, and shall communicate with the primary nurse to implement appropriate falls prevention.

Pharmacist review within twenty-four (24) hours, if the patient has all three (3) criteria as follows:

1. Patient is more than sixty (60) years old. 2. Patient takes two (2) or more High Risk Fall

Medications 3. Patient has a history of falls within the past

six (6) months, except for complete paralysis or completely immobilized patients.

Physiotherapist / Occupational Therapist (PT / OT) screen within thirty-six (36) hours, if the patient:

1. Is more than sixty (60) years old

2. Has a history of falls within the past

six (6) months

3. Has mobility impairment

1. Upon initial admission assessment, Physicians should screen Patient’s Functional status which include “FALL RISK”.

2. Functional Screening should be

documented in the Physicians History and Physical.

3. Fall Risk assessment should be

complementary with the Nursing Fall Risk assessment.


19

These standards address which patient needs can be met by the health care organization, the efficient flow of services to patients, and the appropriate transfer or discharge of patients to their home or to another care setting.

NEW JCI STANDARD

IMPROVE PATIENT FLOW APP 780–06 Managing a Bed Shortage and Activation of Code Bed Crisis

DPP 7800-01-150 Bed Management During Bed crisis, JCI requires the hospital to develop a process to manage the flow of patients throughout the hospital by providing:

LEAVE AGAINST MEDICAL ADVICE APP 1428–19 Management of Missing or Absconded Patients

When a patient decides to leave the hospital after an examination has been completed and a treatment plan recommended, whether it is an inpatient or an outpatient, this is identified as “leaving against medical advice.” The Joint Commission Requirements

ACC ACCESS TO CARE AND CONTINUITY OF CARE

a. Adequate inpatient beds b. Staff to support temporary allocation of patients c. Facility Plans : Space, Medical Technology and supplies d. Non clinical services e.g. housekeeping and transportation e. Adequate clinical services e.g. Laboratory, Radiology

Operating room etc f. Same level of care as inpatients g. Support services (such as social work, religious or spiritual

support, and the like)

1. There is a process for the management of inpatients and outpatients who leave the hospital against medical advice without notifying hospital staff.

2. There is a process for the management of outpatients

receiving complex treatment who do not return for treatment.

3. If the family physician is known and has not been

involved in the process, the physician is notified. 4. The process is consistent with applicable laws and

regulations, including requirements for reporting cases of infectious disease and cases in which patients may be a threat to themselves or others.


20

These standards address issues such as promoting consideration of patients’ values, recognizing the hospital’s responsibilities under law, and informing patients of their responsibilities in the care process. Standards regarding patient rights with respect to informed consent, resolution of complaints, and confidentiality are also included.

APP 1433–21 Rights & Responsibilities of Patients/Families

The “Patient’s Rights & Responsibilities” brochure is provided to the patient at the time of Admission or Outpatient Visit.

Privacy The patient has the right to refuse to talk to or meet anyone who is not officially and directly involved in the healthcare provided to him/her including visitors.

Medical assessments and examinations are to be conducted in designated areas out of the sight and hearing of others. Confidentiality Only direct health care providers have access to patients’ files and details of their condition. Refusal of Treatment When a patient refuses care or chooses to discontinue treatment, he/she will be advised of the consequences of his/her refusal and the expected outcome of this decision. Complaints Resolution The Patient Relations Department and its representatives familiarize patients and their families with valid rules and regulations and how to submit proposals, opinions, and complaints and provide them with the required feedback. Informed Consent The patient (or his/her family) is entitled to have a complete explanation of the medical procedure required for his/her treatment, including risks and benefits of the proposed procedure, its complications, and alternative treatments.

Pain Management Patients have the right to have his/her pain assessed and addressed as part of his/her treatment plan.

Safety The Patient has the right to expect appropriate and reasonable provision of personal safety insofar as MNGHA treating/healthcare facilities, the environment, and personnel practices are concerned.

PFR PATIENT AND FAMILY RIGHTS


21

Respect, Dignity and Consideration Patients have the right to considerate and respectful care at all times and under all circumstances with due recognition of his/her personal dignity.

Privacy and Confidentiality These are some best practices to maintain patient privacy & confidentiality:

DO’s DON’Ts

1. Log-out after using the computers in patient care areas.

2. Knock before entering a room. 3. Close doors and curtains during treatment

and examination. 4. Cover patients

appropriately during treatment and transport.

5. Modulate voice volume in areas where privacy could be compromised.

1. Do not share computer passwords. 2. Do not discuss patient-specific information in

public areas like elevators, food courts and hallways.

3. Do not display patient-specific information on notice boards accessible to the public.

4. Do not leave medical records in public areas or unattended by staff.

5. Do not give treatment, or perform physical examination or procedures if the patient belongs to the opposite gender, without the presence of a person/chaperone/care-provider of the same (patient’s) gender present.


22

Informed Consent APP 1419–08 Patient Informed Consent It is the process whereby the attending physician or designee, from the team performing the surgery/procedure, provides the following information to the patient, legal guardian, custodian about specialized (non-routine) procedure(s). JCI REQUIREMENTS Staff members clearly explain any proposed treatment(s) or procedures to the patient and the family. The information provided includes

1. the patient’s condition; 2. the proposed treatment(s); 3. the name of the person providing the treatment; 4. potential benefits and drawbacks; 5. possible alternatives; 6. the likelihood of success; 7. possible problems related to recovery; and 8. possible results of non-treatment.

Consent for:

1. Surgery/Procedure 2. Anesthesia and Sedation 3. Blood and Blood Products 4. Instrumental delivery 5. Manual removal of placenta 6. Termination of pregnancy 7. DNA banking and genetic studies 8. Photography 9. Elective Cesarean Section 10. Sterilization

VALIDITY PERIOD FOR OTHER CONSENTS

Consent for General Treatment

Outpatient: All subsequent outpatient visits Inpatient: Only for the duration of that hospitalization

Consent for Imaging of Pregnant Patients’ Abdomen or Pelvis 30 Days

Consent for Cryopreservation of Sperm One Session only (Preservation is valid for two years)

Consent for Cryopreservation of Embryos One Session only (Preservation is valid for two years)

Consent for IVF Treatment One cycle ONLY

Consent Form for Critical Care Patients Per admission

Consent for Chemotherapy Per protocol

Valid for 90 days

Unless there are changes to the patient’s condition


23

General Consent

JCI requirements for the General Consent

General consent for treatment, if obtained when a patient is admitted as an inpatient or is registered for the first time as an outpatient, is clear in its scope and limits.

THINGS TO REMEMBER ABOUT THE INFORMED CONSENT

FROM THE HOSPITAL POLICY

1. The legal age to give consent is eighteen (18) Hijrah years for both males and females 2. Consent must be obtained by the attending physician or designee (R3 or above) who is going to perform

the treatment, procedure/intervention from the patient, legal guardian. 3. The attending physician or designee will write in full on the respective consent form (no abbreviations

will be accepted), the name of the procedure, the site, side, and level (if applicable) of the procedure to be performed.

4. The consent form shall be completed in English for non-Arabic speaking patients and in both English

and Arabic for Arabic speaking patients. 5. Consent must be obtained from a patient or legal representative on behalf of the patient (should the

patient be unable to give consent) for all treatments, procedures.

1. General consent for treatment, if obtained when a patient is admitted as an inpatient or is registered for the first time as an outpatient, is clear in its scope and limits.

2. Patients and families are informed as to the scope of a

general consent, when used by the hospital. 3. The hospital has defined how a general consent, when

used, is documented in the patient record. 4. Patients and families are informed about which tests and

treatments require informed consent. (Also see PFR.5.1) 5. The general consent notes if it is likely that students and

trainees will participate in care processes.

Consent must be obtained by the attending physician or designee (Resident 3 or above) as per policy.


24

This chapter addresses patient assessment at all points of care within the hospital. Assessment includes collecting information and data on the patient’s physical and psychosocial history, analyzing the data and information to identify the patient’s health care needs, and developing a plan of care to meet those identified needs. This chapter also includes standards that address laboratory services and diagnostic imaging and radiology services.

APP 1430–27 Patient Admission (H&P) Assessment

DAILY REASSESSMENT OF PATIENTS

AOP ASSESSMENT OF PATIENTS

The Initial Admission Assessment will include at a minimum, an evaluation of patient's:

Presenting illness. Medical, Surgical and Family History; Psychosocial and Economic Assessment. Nutritional and Functional Screening. All medications being taken at admission. Allergies. A complete Review of Systems. Pain Screening. A Complete Physical Exam. Initial Assessment Impression. Initial Care Plan Educational and Discharge planning needs

A Detailed History and Physical examination MUST be completed and documented in the clinical record (Physician Admission Assessment) within 24HRS of admission.

1. Reassessments are conducted by the MRP (or consultant

designee) daily including weekends and holidays, or more often as required by the patient's condition until discharge.

2. Each reassessment will result in an update to the care plan

and will be documented in the Physician Progress Notes. 3. Discussion with the patient (his/her family) will be

documented in the progress notes or appropriate form.


25

APP 1430–32 Patient Assessment & Reassessment by Allied Health Professionals

DPP 7800-01-175 Interdisciplinary Assessment and Reassessment of patient: Inpatient

1. The initial physician assessment process may identify a need for additional specialized services such as, but not limited to, Respiratory, Speech Therapy, Nutrition, Psychology, Audiology, Physiotherapy and Occupational Therapy.

2. All specialized assessments and reassessments must be completed and documented in

the patient clinical record (electronically or hardcopy) within the timeframe stipulated in each discipline's DPP.

1. Initial Nursing Assessment: a systematic collection of

data collated during admission to aid in the determination of the patients health status and the early identification of any actual or potential health problems and discharge needs.

2. Nursing Reassessment: an ongoing systematic collection

of data, to identify patient's clinical status and response to therapy and interventions.

3. Core Nursing Assessment: minimal, age sensitive,

Nursing Admission Assessment and Reassessment elements to be performed on all Inpatients.

All unit-based nursing orientation programs will include a review of the policies and procedures related to Nursing Assessment or Reassessment Standards.

CORE INPATIENT NURSING ADMISSION ASSESSMENT STANDARDS Nurses to observe the Time Frame indicated in the appendices of the Policy for the completion of assessment and re-assessment of patients.


26

Pain Screening and Assessment APP1430–07 Pain Management

DPP 7800-01-002 KAMC Pain Assessment and Management The pain management standards address the assessment and management of pain. The standards require

organizations to:

1. Recognize the right of patients to appropriate assessment and management of pain. 2. Screen patients for pain during their initial assessment and, when clinically required, during

ongoing, periodic re-assessments. 3. Educate patients suffering from pain and their families about pain management.

Pain Assessment Tools for Different Age Groups

Patient Tools

Neonate- 3 months Cries

Infant above 3 months FLACC(0-10)

Developmentally delayed FLACC(0-10)

3 yrs. and above Wong-baker

7 yrs. and above Wong-baker Numeric Scale (0-10)

Verbal Adult Wong-baker Numeric Scale (0-10)

Non-verbal Adult FLACC(0-10)

1-3/10 Mild Pain

4-6/10 Moderate

Pain

7-10/10 Severe Pain

1. Check last time analgesic given.

2. Give analgesic immediately if due within 30 minutes.

3. Implement non-pharmacological interventions.

4. Notify MRP if analgesic is not due for another 1 hour

5. If no order present, obtain order immediately for pain medication or if pain present despite interventions.

DPP 7800-01-002 KAMC Pain Assessment and Management

PAIN RELIEF EVALUATION & OUTCOME 15 min Post IV administration of analgesia. 20 min Post SC administration of analgesia. 30 min Post IM administration of analgesia. 60 min Post oral analgesia. Immediately after Non pharmacological interventions.


27

This chapter discusses activities basic to patient care, including processes for planning and coordinating care, monitoring results, modifying care, and conducting follow ups. The chapter also includes high-risk care services, nutrition care, pain management, and end-of-life care. JCI Standard requires organization to develop and document an individualized plan of care for each patient. The plan of care for a patient must be related to his or her identified needs.

Examples of assessed needs and measurable goals include the following:

Hospitals Providing Organ and/or Tissue Transplant Services New JCI Standard

APP 1433–11 Deceased “Brain-Dead” Organs & the Organ Procurement Process

COP CARE OF PATIENTS

Diagnosis: Diabetes Mellitus

Assessed Needs Individual Measurable Goals Blood sugar control Blood glucose reading <180mg/dL; fasting blood

glucose reading < 140mg/dL Leg Ulcer Skin color red; not brown or black

No bad-smelling discharge Infection Normal temperature after 48 hours of antibiotics

The Program recognizes the major contribution of organ

transplantation for the good of human health and relief of human suffering.

The human organ procurement and transplantation process must conform to the SCOT (Saudi Center for Organ transplantation) policies and regulations.

Respect and full support must be offered to patients and families

regarding their choices to donate human organs and other tissues.

The provisions of this APP apply to all medical, clinical and administrative staff involved in organ procurement and transplantation at MNGHA or any affiliated facility.

Leadership’s commitment to creating a culture conducive to organ and tissue donation can have significant impact on the overall success of the hospital’s organ and tissue procurement efforts. These standards address the hospital’s organization-wide responsibilities for organ and tissue donation and procurement.


28

End-of-Life Care

APP 1430–06 Palliative Care and End-of-Life Care Patients who are dying have unique needs for respectful, compassionate care. To accomplish this, all staff are made aware of the unique needs of patients at the end of life.

This Policy aims to:

Joint Commission Standard recommends that End-of-life care provided by the hospital includes:

No patient should die alone. When death occurs, the patient must be treated with dignity. (APP 1430–06 Palliative Care and End–of–Life Care)

a. Providing appropriate treatment for any symptoms according to the wishes of the patient and family;

b. Sensitively addressing such issues as autopsy and organ donation; c. Respecting the patient’s values, religion, and cultural preferences; d. Involving the patient and family in all aspects of care, and e. Responding to the psychological, emotional, spiritual, and cultural concerns of the patient and

family.

Address ethical and medical standards and religious issues related to end-of-life care.

Define the responsibilities of MNGHA

employees involved in caring for patients diagnosed with a terminal illness, when functionally debilitated, dying, and/or after their death, regardless of their nationality or age.


29

APP 1430–21 Physical Restraint DPP 7800-01-00-42 Restraint of Patient

Physical Restraint is an approved mechanical device or devices which restrict the movement of the whole or a portion of the patient’s body for the purpose of preventing harm to self or others.

.

CODE BLUE APP 1430–41 Cardiopulmonary Resuscitation & Activation of Code Blue

POINTS TO REMEMBER:

1. Initiation of Physical Restraint is by the Physician’s order only. Orders for the restraints shall not exceed twenty-four (24) hours in duration.

2. Recurrent use of Restraint: A registered Nurse or Physician shall document in the patient's record the

justification for recurrent use of restraints in addition to the patient's physical and behavioral status. 3. Assessment of patient’s physical and psychological well-being shall be made throughout the restraint

period with a maximum of two (2) hours interval.

a. Application of restraint devices – ensuring that patients have as much freedom as possible. b. Circulation and degree of movement in the extremities are evaluated. c. Each restrained limb is released from restraints and examined from bruising or skin tears

and exercised (range of motion) every two (2) hours. 4. Meals are provided at regular time and fluids are offered every two (2) hours to ensure nutrition and

hydration. 5. Elimination needs are met at least every two (2) hours or as requested. Hygiene is offered on a daily

basis. Restraint must not be applied before physician assessment and order, patient are assessed every 2 hours, and restraint order evaluated every 24 hour

JCI Requirements 1. Resuscitation services are available and provided to all

patients 24 hours a day, every day, throughout all areas of the hospital.

2. Medical technology for resuscitation and medications for

basic and advanced life support are standardized and available for use based on the needs of the population served

3. In all areas of the hospital, basic life support is implemented

immediately upon recognition of cardiac or respiratory arrest, and advanced life support is implemented in fewer than 5 minutes.


30

Critical Care Response Team is a formally designated multidisciplinary critical care team that assesses and manages a patient demonstrating the early signs of deterioration in clinical status, prior to the development of progressive and irreversible deterioration.

Indicators of sudden or unexpected deterioration in adult patient’s condition may include but not limited to:

1. Hypotension (systolic blood pressure less than or equal to 90 mmHg 2. Hypertension (systolic blood pressure more than or equal to 200 mmHg 3. Hypoxaemia with SaO2 of less than 90% 4. Respiratory distress (RR less than 8 or greater than 24) 5. Onset of chest pain 6. Increase in heart rate to greater than 130 7. Decrease in heart rate to less than 40 8. Fever of 38.5oC in neutropenic/immunocompromised patients (with no written orders to cover

such event) 9. Bleeding with hypotension 10. Seizures 11. Onset of confusional state 12. Deterioration in level of consciousness (GCS decreased by two (2) points)

For those departments that have implemented Modified Early Warning Scoring System The Modified Early Warning System (MEWS) is a tool for nurses to help monitor their patients and improve how quickly a patient experiencing a sudden decline receives clinical care. Front of the MEWS Score Card

MODIFIED EARLY WARNING SCORING (MEWS) SYSTEM If AIRWAY is threatened: Total MEWS is = 9 (Immediately refer to back of the card)

Criteria MEWS Value

Score 8 5 3 2 1 0 1 2 3

AVPU Responsive

to Pain

Responsive to

verbal

Alert

Respiration

(RR/min)

<8 Unrespon

sive

9-20 21-30 31-35 >35

NEW JCI STANDARD CRITICAL CARE RESPONSE TEAM CALLING CRITERIA

DPP 7800-01-54 Adult Critical Care Response Team for unexpected deterioration in patient’s condition.

ACTIVATION SYSTEM FOR THE CCRT: THE AFFERENT ARM

1. Initiation of the CCRT is at the discretion of the bedside healthcare provider(s), including the primary nurse, respiratory therapist, physician or other healthcare workers.

2. Activation of the CCRT does not require a prior order or an explanatory progress note. 3. CCRT will not be activated for patients who are labeled with “NO CODE” status.

ALWAYS REMEMBER THE CCRT CALLING CRITERIA


31

SPO2 (%) <84 85-89 90-92 >93

Temperature (°C) <34 34.1-35 35.1-36 36.1-37.9 38-38.5 >38.6

Heart Rate (b/min) <40 40-50 51-99 100-110 110-130 >130

Circulation

(Capillary

Refill/Pulse)

Markedly

delayed /

weak pulse

>2sec / weak or

bounding pulse

<2sec /

full pulse

Systolic BP

(mmHg)

<79 /

>190

80-89 or 145-

190

90-144

Urine Output (mL

for last 4H)

<80 /

Anuria

80-119 /

Oliguria

120-800/

Normal/

Reg HD

>800/

polyuria

Get Total MEWS (score), Refer to back of card for ADVISORY

Back of the MEWS Score Card

TMEWS System Advisory Nursing Actions/Remarks

0 Routine Care Routine Care and Monitoring as per unit workflow

1-4 Continue

Monitoring

Inform Nurse-in-Charge or Physician as necessary

Monitor pt. as per sorklist and more as appropriate

(e.g. vital signs q 1 hour)

Document in QCPR

5-8 Contact

Physician and

Activate MEWS

Inform Nurse-in-Charge

Call/Page Senior Physician (Follow Physician Notification / Call Out

Protocol)

Monitor pt. as per worklist and more as appropriate

(e.g. vital signs q 15 min, Adult LOC, Blood Glucose)

Document in QCPR

Expectation: Physician review and assess patient within 30 min.

9 or > 9 Activate CCRT

Protocol

Inform Nurse-in-Charge

Call/Page Senior Physician (Follow CCRT Protocol)

Monitor pt. as per worklist and more as appropriate

(e.g. vital signs q 5 min, Adult LOC, Blood Glucose)

Stay with patient

Document in QCPR and CCRT form

Expectation: Physician review and assess patient within 30 min.


32

This chapter addresses sedation and anesthesia use and surgical care. Topics include procedures for preparing, monitoring, and planning for aftercare for patients who received sedation or anesthesia and/or who had surgery.

NEW JCI STANDARD (ASC 7.4) Many surgical procedures involve the implantation of prosthesis, such as a hip, or a medical device such as a pacemaker, insulin pump, or remote monitoring device. These types of surgical procedures require that routine surgical care must be modified to consider special factors such as:

ASC ANESTHESIA AND SURGICAL CARE

APP 1433–31 Sedation by Non Anesthesiologists DPP 7800-01-013 Sedation by Non-Anesthesiologist at KAMC-Jeddah

1. PRE –SEDATION ASSESSSMNET- Pre-Procedure Preparation: An appropriate pre-procedure

evaluation of the patient will be undertaken and documented on the sedation form.

2. INTRA-SEDATION ASSESSMENT: All patients will have the indicated minimum parameters monitored and documented at least every five (5) minutes during the procedure.

3. POST-SEDATION ASSESSMENT- All monitored vital signs will be recorded at least every five

(5) minutes until the patient has achieved the criteria for discharge from the recovery area.

STAFF CREDENTIALING: Current BLS or preferably ACLS or PALS issued by MNGHA Physician sits for the Sedation/Analgesia Competency Course On-line consists of multiple

choice questions. Passing score is 80%. Competency recertification is mandated if the physician performed less than 10

moderate/deep sedation procedures per year.

a. selection of device based on available science and research;

b. modifications to the surgical checklist to ensure that implants are

present in the operating theatre an special considerations in marking

the surgical site;

c. the qualifications and training of any outside technical staff required

during the implant procedure;

d. an understanding of and reporting process for device-related adverse

events;

e. unique infection control considerations;

f. any special discharge instructions to the patient; and

g. the traceability of devices in the event of a recall


33

This chapter addresses systems and processes for selecting, procuring, storing, ordering/prescribing, transcribing, distributing, preparing, dispensing, administering, documenting, and monitoring medication therapies.

APP 1427–16 Error Prone Abbreviations, Symbols and Dose Designations

Abbreviations Why this is not to be used What is acceptable practice

µg Can be mistaken for mg (milligram), which can result in a thousand-fold dosing overdose

Use ‘microgram’

cc Can be mistaken for units (with the cc looking like a ‘u’ or ‘0’) Use ‘mL’ or ‘ml’

D/C Can be interchanged to mean discontinue or discharge Use ‘discharge’ or ‘discontinue’

IU Can be mistaken for intravenous or 10 (ten) Use ‘international units’ QD, o.d, OD, q1d Can be mistaken for ‘right eye’ Use ‘daily’ q.o.d, QOD Can be mistaken for q.i.d. Use ‘every other day’

SC, SQ, Sub q SC can be mistaken for SL, and the ‘q’ in ‘sub q’ can be mistaken as ‘every’ Use ‘subcut’ or ‘subcutaneously’

U or u Can be mistaken for the number 0 or the number 4 Use ‘unit’

HS hs

Mistaken as bedtime Mistaken as half-strength

Use ‘half-strength’ or ‘bedtime’

Dose Designations Why this is not to be used What is acceptable practice

Trailing zero after decimal point Example: 1.0 mg

Can be mistaken as 10 mg if the decimal point is not seen

Do not use trailing zeros for doses expressed in whole numbers. Example: 1 mg

Dose Designations Why this is not to be used What is acceptable practice No leading zero before a decimal point Example: .5mg

Can be mistaken as 5mg if the decimal point is not seen

Use zero before a decimal point when the dose is less than a whole unit Example: 0.5mg

Symbols Why this is not to be used What is acceptable practice

> and < Can be misinterpreted to mean the opposite of what is intended Use ‘greater than’ or ‘less than’

Stemmed Drugs Names Why this is not to be used What is acceptable practice

Shorten Names of Drugs Example ‘Nitro drip’

Can be mistaken for other drug names, such as in the example –’Nitro’ drip can mean nitroglycerin or sodium Nitroprusside

Write out the ‘complete name of drug’

MMU MEDICATION MANAGEMENT AND USE


34

The purposes of monitoring are to evaluate the medication’s effect on the patient’s symptoms or illness, as well as blood count, renal function, liver function, and other monitoring with select medications, and to evaluate the patient for adverse effects. Based on monitoring, the dosage or type of medication can be adjusted when needed.

The safe administration of medications includes verifying the:

1. Medication with the prescription or order; 2. Identity of the patient; 3. Time and frequency of administration with the

prescription or order; 4. Dosage/amount with the prescription or order; and 5. Route of administration with the prescription or order.

1. Medication effects on patients are monitored. 2. Medication adverse effects on patients are monitored and

documented. 3. The hospital establishes and implements a process that identifies

those adverse effects that are to be recorded in the patient’s record and those that must be reported to the hospital.

4. Adverse effects are documented in the patient’s record as identified. 5. Adverse effects are reported as identified by the process in the time

frame. required.

JCI REQUIREMENTS ON MONITORING

Hierarchy of Medication Safety Incidents

Near Miss Hazardous Condition

PotentialAdverse Drug Event

(PADE)

Adverse Drug Reaction(ADR)

Medication Error

Adverse Drug Event(ADE)

MedicationSafety

Incident

MEDICATION ADMINISTRATION DPP 7800-01-040 Medication Administration Times & Guidelines

REMEMBER WHAT TO REPORT Safety Reporting System (SRS)


35

APP 1430–41 Cardiopulmonary Resuscitation and Activation of Code Blue APP 1433-16 Allergy & Hypersensitivity Recording & Documentation

Emergency medications are available, monitored, and safe when stored out of the pharmacy. When patient emergencies occur, quick access to appropriate emergency medications is critical. Each hospital plans the location of emergency medications and the medications to be supplied in these locations.

ICM-II-05 Aseptic Technique

The hospital identifies the standards of practice for a safe and clean preparation and dispensing environment. Medications stored and dispensed from areas outside the pharmacy (for example, patient care units) comply with the same safety and cleanliness measures.

EMERGENCY MEDICATIONS

Emergency medications are available in the units where they will be needed or are readily accessible within the hospital to meet emergency needs.

The hospital establishes and implements a process for how emergency medications are stored, maintained, and protected from loss or theft.

Emergency medications are monitored and replaced in a timely manner after use or when expired or damaged.

ANTIDOTES CRASH CART

MEDICATIONS ANAPHYLACTIC KIT

MEDICATION PREPARATION

1. Medications are prepared and dispensed in clean and

safe areas with appropriate medical technology, equipment, and supplies.

2. Staff preparing sterile products is trained in the

principles of medication preparation and aseptic technique.


36

This chapter contains standards that address the effectiveness of education that is provided to patients and families and the modalities employed to successfully educate these individuals. This chapter also examines patients’ readiness to learn by considering their language needs and learning preferences.

APP 1426–18 Patient & Family Education

Providing education to the patients and their families about their health or medical problems enables them to make informed decisions about their healthcare needs. It is important for our patients and families to assume a proactive role in the maintenance and/or improvement of their own health.

All health care providers are responsible to provide patient education to meet their health needs or to achieve their health goal. All activities or any actions relating to patient/family education will be documented in QCPR and can be reviewed in the electronic Interdisciplinary Patient / Family Education Record (e-IPER).

e-IPER Screenshots:

PFE PATIENT AND FAMILY EDUCATION

A patient/family’s educational needs assessment includes an assessment of their preferences or barriers to learning, such as sensory impairment, language barriers, as well as, cultural and religious beliefs.

The Patient Educators complete the initial educational needs assessment within 48 hours of admission.

Patient education is the most vital step toward making the patient independent in his own care.


37

The standards in this chapter identify the structure, leadership, and activities to support the data collection, analysis and improvement for the identified priorities hospital wide and department- and service-specific. This includes the collection and analysis of data on, and response to, hospital wide sentinel events, adverse events, and near-miss events.

Science of Improvement: Testing Changes

KAMC-WR uses the Model of Improvement as well as other methodologies for conducting performance improvement projects.

QPS

The Plan-Do-Study-Act (PDSA) cycle is shorthand for testing a change — by planning it, trying it, observing the results, and acting on what is learned. This is the scientific method, used for action-oriented learning.

The Model for Improvement is a simple, yet powerful approach to achieving rapid and significant improvements in care delivery and outcomes. It has been used very successfully by hundreds of health care organizations in many countries to improve many different health care processes and outcomes.

What are we trying to accomplish? The improvement team develops a specific, time-limited and measurable aim statement (setting aims)

How will we know if a change is an improvement? The team identifies process and outcome measures to collect over time in order to track improvement and evaluate progress (establishing measures)

What changes can we make that will result in improvement? The team identifies ideas for changes to try (selecting changes to test)

Quality Improvement and Patient Safety


38

Electronic Safety Reporting System (SRS)

Guidelines for Management of Electronic Safety Reports (SR) SRS is the first electronic web-based incidents reporting and management system at MNGHA. The system was launched in May 2009 at the Central Region, and has been rolled out to all MNGHA facilities in May, 2013. The Electronic Safety Reporting System (SRS) is a non-punitive system and is not a method of blaming any particular individual/service. The emphasis is on the prevention of recurrence and on communication with all affected departments and units in a context of a “JUST CULTURE”. Staff involved in a serious event shall be offered appropriate support, which may involve psychological first aid, or other support. STAFF RESPONSIBLITIES FOR SAFETY REPORTING SYSTEM

RESPONSIBILTY OF HOSPITAL STAFF:

Any employee involved in or eyewitnesses an incident is responsible for initiating a Safety Report as soon as possible within twenty-four (24) hours using the Hospital-wide electronic Safety Reporting System (SRS) if any of the following occur: 1. An error or mistake that injures, or could

have injured a patient, employee or visitor. 2. Failure or shortage of direct patient care

equipment, utility or material that had adverse impact, or could have adverse impact upon patient care outcome.

3. An incident that caused an angry reaction by a patient or family member.

4. An incident that inhibits process or system and has an adverse effect upon patient care.

The report should focus on the objective and factual description of the incident; subjective opinions on individuals or services should not be included in reports.

RESPONSIBILTY OF A SUPERVISOR

1. To review & investigate the Safety Reports (SR) submitted within five (5) working days for the report`s originating unit; another five (5) working days for the other units/services involved in the incident.

2. Ensure that the entered General Incident Type, Person affected information, Specific occurrence Location, Specific Incident Type and Degree of Injury, are correct and appropriate to the nature and location of the incident.

3. To Analyze and Close the Safety Report. 4. Provide feedback for the reporting

employee and share the lessons learned with other staff concerned to avoid recurrences of similar issues.


39

SENTINEL EVENT APP 1423–05 Sentinel Events and Root Cause Analysis

DPP 7800-01-106 Sentinel Event & Root Cause Analysis A sentinel event is an unanticipated occurrence involving death or serious physical or psychological injury. Serious physical injury specifically includes loss of limb or function. Such events are called sentinel because they signal the need for immediate investigation and response. Sentinel Events includes any occurrences that meet the following criteria:

a) an unanticipated death, including, but not limited to, death that is unrelated to the natural course of the patient’s illness or underlying condition (for example, death from a postoperative infection or a hospital-

acquired pulmonary embolism); death of a full-term infant; and suicide;

b) major permanent loss of function unrelated to the patient’s natural course of illness or underlying

condition;

c) wrong-site, wrong-procedure, wrong-patient surgery;

d) transmission of a chronic or fatal disease or illness as a result of infusing blood or blood products or transplanting contaminated organs or tissues;

e) infant abduction or an infant sent home with the wrong parents; and

f) rape, workplace violence such as assault (leading to death or permanent loss of function); or homicide (willful killing) of a patient, staff member, practitioner, medical student, trainee, visitor, or vendor while on hospital property.

Root Cause Analysis (RCA) is a process for identifying the basic or causal factor(s) that underlies variation in performance, including the occurrence or possible occurrence of a sentinel event. RCA primarily focuses on Systems and Processes, not individual performance. Team Formation Once a sentinel event has been identified the Executive Director of Medical Services immediately appoints a multidisciplinary team to direct the investigation. The team members are staff trained in the techniques and goals of RCA. The team utilizes the root cause analysis template and completes an action plan. The Root cause analysis and action plan is completed within 45 days of the event or becoming aware of the event.

Conducting Root Cause Analysis Multidisciplinary Team

Formulate Action Plan within 45 Days


40

These standards address the methods a hospital uses to design and implement a program to identify and reduce the risk of patients and staff acquiring and transmitting infections. Areas covered in this chapter include the process for reporting infections and the types of ongoing surveillance activities that are in place.

5 Moments of Hand Hygiene Strict Hand Hygiene (when and why?)

Use of PPEs (Personal Protective Equipment) ICM–II–03 Standard Precautions

PCI PREVENTION AND CONTROL OF INFECTIONS

Standard Precautions to prevent infection transmission Foundation for preventing transmission of infectious agents during interactions between healthcare personnel and patients are the work practices in having basic level of infection control to reduce the risk of transmission. These infection control practices should be applied to all body fluids, non-intact skin, and mucous membranes; and, should be used for all patients regardless of their diagnosis or presumed infectious status.

Put on in this order: Hand hygiene, gown, mask, (goggles or face shield), gloves. Remove in this order: Gloves, gown, hand hygiene, mask or respirator.

Note: if goggles or face shield are worn, they should be removed after the gloves because they are more cumbersome and would interfere with removal of other PPEs. (Gloves, HH, goggles or face shield, gown, HH, surgical mask or respirator).

Use of aseptic techniques for all invasive procedures and any procedure

requiring asepsis Safe handling and disposal of sharps Proper handling of contaminated items Collection and handling of lab specimens (these are considered infectious

at all times) Respiratory Hygiene and Cough Etiquette (cover the nose/mouth when

coughing/sneezing; use tissues to contain respiratory secretions; dispose the tissues in the nearest waste disposal; and, then perform hand hygiene)


41

What to do if you have an occupational exposure to blood and/ body fluid ICM–VII–04 Management of Occupational Exposure to HBV, HCV and HIV

Employee Health Clinic during working hours

Emergency Department (ER) after hours, weekends and holidays

2. Reporting the Injury (a) I will report the incident to the supervisor and complete a Safety

Reporting System (SRS)

(b.) The report will include: The date and time of the incident. The location where the incident occurred. The department where the employee works. The source patient’s Medical Record Number (MRN), if known.

1. I will perform the First Aid : (a) For percutaneous injuries I will wash needle sticks and cuts with soap and water. I will apply isopropyl alcohol 70%. I will place a bandage appropriately.

(b) For the Mucutaneous and non-intact skin exposures I will flush splashes to the nose, mouth, or non-intact skin with

water. I will irrigate the eyes with clean or sterile water or saline. I will flush site for 10 minutes.

ALWAYS REMEMBER TO REPORT THE INCIDENCE TO:


42

What is the shelf life of patient care items and supplies by CSSD?

ICM–IX–01 Sterile Supplies and Equipment Management (Preparation, Storage and Shelf Life)

ICM–I–05 Reporting Communicable Diseases to the Ministry of Health

APP 1425–05 Infection Prevention and Control Procedures during Healthcare Facility Construction,

Renovation or Maintenance

The charge nurse will perform the following duties: 1. Confirm the diagnosis of the communicable disease with the MRP in

charge.

2. Verify the diagnosis of a communicable disease on clinical grounds and confirm with Laboratory results when appropriate.

3. Immediately notify the Infection Control Practitioner (ICP) who covers that area.

4. Fill out the appropriate form, refer to policy ICM–I–06 Ministry of

Health Forms, and fax to the Infection Control Department (22140), who will forward the forms to the MOH.

1. The IP&C will be pre-informed and involved in all current and

future construction activities at MNGHA healthcare facilities.

2. An Environmental Infection Control Construction/Renovation PERMIT must be completed and signed prior to the commencement of any project/task.

3. This PERMIT must be posted on the door of the work site and

copy of the permit must be given by the responsible Engineering party to the head of the department hosting the construction work.

1. The shelf life for all items processed in CSSD is “event-related” and are issued with a sterilization date.

2. Sterile packages processes by CSSD that are not used within 4 years

must be returned to CSSD for re-sterilization. These items or supplies are considered sterile only if integrity of sterile packs was inspected regularly especially prior to use, and found that the packages possess no tears, compressions, abrasions, punctures, moisture, dirt, bending or damage in any way.


43

ICM–IX–02 Waste Management

Waste segregation must be followed at the point of generation (i.e., by the end user):

Black Bags

a. Used to dispose of general hospital waste. b. Items that would not release (drip) blood or other

potentially infectious materials in a liquid or semi-liquid state if squeezed.

Yellow Bags

a. Used to dispose of infectious waste. b. Containers with blood/body fluids that cannot be emptied. c. All microbiological waste (specimens, cultures, and

stocks of etiologic agents). d. Items moderately or heavily soaked (dripping) in

blood or body fluids. e. Chemotherapy waste. f. Place infectious waste in the appropriate designated

container, lined with yellow disposal bags. g. One garbage bin lined with a yellow disposal bag can be kept in the

dirty utility room of non-ICU units or areas.

Red Bags

a. Use to transport body parts, organs, or fetuses for burial.

Sharps Containers

a. Used to dispose all needles, scalpels, pipettes,

syringes, and glass items.

APP 1430–31 Management of Spills of Hazardous Materials ICM–IX–02 Waste Management

Every employee working with hazardous chemicals/drugs, blood and body fluid or other potentially infections materials must have the knowledge for proper handling and best resources for assistance in spill management.

1. Healthcare workers are responsible for the initial cleaning of the blood and body fluids' spill and small chemical spill (non-toxic).

2. Housekeeping service is responsible for completing the cleaning process. 3. Fire Protection Services is responsible for cleaning chemicals spill. 4. Environmental Services are responsible on the proper disposal of spill

management process residuals through a competent contractor.

Call for assistance if needed e.g., Fire Protection Services including initiating the

call for CODE ORANGE CALL 88

Refer to the Policy to learn more about the management of SPILLS


44

Management of Local/Global Outbreaks (e.g. MERS-CoV, Ebola)

Refer to the home page on the intranet:

Infection control is EVERYBODY’S BUSINESS Refer to the Infection Prevention and Control Manual for more details

For more information contact Infection Control Department: ext. 22138/23476


45

Governance, Leadership and Direction

Standards in this chapter are grouped using the following leadership hierarchy (and illustrated below) LEADERSHIP STRUCTURE AND RESPONSINILTIES

Level I: GLD.1 – GLD.1.2 Governance

Level II: GLD.2 Chief Executive

Level III: GLD.3 – Gld.7.1 Hospital Leadership

Medicine Nursing Administration Others

Level IV: GLD.8 – GLD.11.2 Department/Service Leaders

Clinical Departments

Diagnostic Services Pharmacy Ancillary

Services Managers of Clinical and Nonclinical

Services

GLD.12 – GLD.19 Culture of Safety

Ethics Health Care Professional Education

Clinical Research

GLD

Level 1- Governance 1. The governance structure approves or provides for all of the

hospital’s programs and policies and allocates resources to meet the hospital’s mission.

2. Those responsible for governance approve the hospital’s program for quality and patient safety and regularly receive and act on reports of the quality and patient safety program.

Level 11- CHIEF EXECUTIVE OFFICER (CEO) The chief executive cooperates with hospital leadership to define the hospital’s mission and to plan the policies, procedures, and clinical services related to that mission. The chief executive is responsible for the hospital’s overall, day-to-day operations.

Level IV: Department/Service Leaders Department/service leaders Recommend space, medical technology,

equipment, staffing, and other resources needed by the department.

Improve quality and patient safety by participating in hospital wide improvement

Priorities and in monitoring and improving patient care specific to the department/service.

Level III: Hospital Leadership 1. Plans for the type of clinical services required to meet the

needs of the patients 2. Ensures effective communication throughout the hospital. 3. Plans, develops, and implements a quality improvement and

patient safety program. 4. Prioritizes which hospital wide processes will be measured.

Hospital leadership establishes a framework for ethical management that promotes a culture of ethical practices and decision making to ensure that patient care is provided within business, financial, ethical, and legal norms and protects patients and their rights.


46

These standards measure the hospital’s maintenance of a safe, functional, and effective environment for patients, staff members, and other individuals. Areas addressed include emergency preparedness, security, safety, life safety, medical equipment, utility systems, hazardous materials, and waste management. The Safety Management Department ensures that NGHA provide a safe and healthy environment by developing creative collaborations among various departments, committees and individuals, ensuring that the healthcare safety risk (pertaining to building, equipment and people) are eliminated, minimized or mitigated. JOINT COMMISSION REQUIREMENTS

1.

These standards measure the hospital’s maintenance of a safe, functional, and effective environment for patients, staff members, and other individuals. Areas addressed include emergency preparedness, security, safety, life safety, medical equipment, utility systems, hazardous materials, and waste management.

JCI REQUIRED PROGRAMS for FMS STANDARDS

The hospital develops and maintains a written program(s) describing the processes to manage risks to patients, families, visitors, and staff.

The Safety Management Department ensures that MNGHA provide a safe and healthy environment by developing creative collaborations among various departments, committees and individuals, ensuring that the healthcare safety risk (pertaining to building, equipment and people) are eliminated, minimized or mitigated.

Material Safety Data Sheet (MSDS) Database

Discuss all you safety concerns with Safety Management Department Location: MCI Fire Station

Extensions: 23436 / 23423 Departmental Email: SafetyManagement-WR <[email protected]>

FMS Facility Management and Safety

1) Safety and Security

2) Hazardous materials

3) Emergencies

4) Fire safety

5) Medical technology

6) Utility systems

Program oversight includes the following:

1. Planning all aspects of the program

2. Implementing the program

3. Educating staff

4. Testing and monitoring the program

5. Periodically reviewing and revising the

program

6. Providing annual reports to the governing

body on the effectiveness of the program.

How to access MSDS Database

1. Open MNGHA Home Page

2. Click Regulations

3. Scroll down and locate MSDS Database

4. Use Search Engine to filter information according to your Department


47

2.

Emergency Eyewash

Refer to NGHA Facility Safety Manual

THINGS TO REMEMBER:

Discuss all your safety concerns with Safety Management Department Location: MCI Fire Station

Extensions: 23436 / 23423 Departmental Email: SafetyManagement-WR <[email protected]>

Best Management Practices – American National Standard Institute (ANSI . Z358.1-1998) :

Eyewash units must be able to flush both eyes simultaneously.

The nozzles must be protected from the airborne contaminants (e.g. Covers need to be cleaned weekly).

No Electrical Appliances within 18 inches or plastic shield in between.

The travel distance to the eyewash should be no more than 50 ft.

The units must be verified annually by Utility & Maintenance Department.

Valves must have a stay open feature (allowing both hands to be free to open eyelids).

Know the storage requirement of Hazardous Material such as Alcohol Hand Rub Gel (AHRG) not more than 19 liters.

Know the 6” inch clearance of wall mounted Alcohol Hand Rub Gel (AHRG) from electrical outlets.

Know the clearance of 36” inch in front and side of main electrical panels.

Know the clearance from sprinkler heads i.e. 18” inch for any storage.

Know the clearance in non-sprinkler areas i.e. 24” inch for any storage.

Know the storage limitation of compressed gas cylinders i.e. less than 300 cubic feet.

Mandatory Department to contact with before allowing any construction(i.e. Safety Management, Fire Protection Services & IPC)


48

Fire Safety APP 1428–21 Hospital Fire Safety Program

Remember: Always use proper type of extinguisher to fight fire

Observe effective Fire safety and Fire prevention measures:

When you discover a fire JUST REMEMBER

CODE RED PROCEDURES

R Rescue patient in area of immediate hazard A Activate the Alarm – alert others and call 88 C Contain fire and smoke, ClOSE all doors E Extinguish the fire if you can without endangering yourself

FIRE EXTINGUISHER PROCEDURE

P Pull out the safety pin A Aim nozzle at the base of the fire S Squeeze the operating lever and handle S Sweep over the fire

- HALON & DRY POWDER : CLASS "A","B" & “C" - CO2 : CLASS "B" & "C" - WATER : CLASS "A" ONLY

1. Ensure that your department/ward practices good housekeeping. 2. Report any faulty equipment. 3. Store flammable/combustible items properly. 4. Ensure that staff are aware of the procedures for safe handling of such items. 5. Ensure that staff are aware of the evacuation route(s) and assembly point of the

department/ward. 6. Know where your fire extinguishers are and how to operate them. 7. Familiarize yourself with the safety manual and attend regularly Fire safety drills & Fire safety in-

service training. 8. Always treat a spilled substance as hazardous until identified as non-hazardous by proper

authority. 9. Be aware of the Hazardous material spill procedure (by Fire Department).

Class A: Solid or ordinary combustible materials

Class B: Flammable liquids and gases Class C: Involving energized electrical

equipment


49

Safety and Security System for Newborn APP 1429–08 Safety and Security System for Newborns

The purpose of this APP is to identify areas and conditions where newborns are exposed to the risk of abduction, and implement security measures that prevent abduction of newborns. All staff in the clinical areas must be aware and uphold the provisions for visitors by allowing no more than two visitors at any given time. All babies shall be transported in the hospital & discharge by a Nurse.

1. The Program endeavors to provide preventive and security measures that shall be implemented

24 hours/7 days to protect newborns from abduction.

2. All staff in the clinical areas must be aware and uphold the provisions for visitors, that is, allowing two visitors at one time.

3. Abduction Prevention Team shall be established in each facility to develop, implement and evaluate all quality improvement strategies, including education on neonatal / infant abduction.

4. Education programs shall be provided for patients and employees.

5. All women in the Obstetrics and Neonatal areas will receive education on risk reduction

strategies, which include patients in the Obstetrics Clinic.

6. All babies shall be transported in the Hospital and discharged by a Nurse. 7. Military Police / Security personnel shall guarantee the function of the security system

implemented and assure the presence and quality of work of the required security system and military personnel around the clock.

8. RFID (Radio Frequency Identification) system will be implemented in all the areas where medical

care is provided to in-patient newborns and babies born in the Emergency Care Centre at any hospital/healthcare facilities of NGHA.

Emergency Codes

APP 1428–16 Emergency Coding System

Code Incident Ext.

Code Red Fire 88

Code Blue Adult Cardiopulmonary Arrest 77

Pediatric Code Blue Pediatric Cardiopulmonary Arrest 77

CCRT Activation Hemodynamic Instability or respiratory compromise 77

Code Yellow Infant / Child is missing or is known to have been kidnapped 77

Code Gray Security Threat 77

Code Orange Hazardous materials / spill emergency or biological agent threat 88

Trauma Team Activation Single or multiple trauma victims (does not require disaster activation) 77

Code Black Disaster 77

Bed Crisis Extreme shortage of bed capacity in the Emergency Department 0


50

This chapter includes sections on human resources planning; staff orientation, training, and education; staff competence assessments; handling staff requests; and credentialing and privileging of licensed independent practitioners, nurses, and other practitioners.

APP 1427–02 Employee Personnel File

1. This APP applies to the personnel files/records of all employees hired by the Program at the Ministry of National Guard Health Affairs (MNGHA) and affiliated facilities including the King Saud Bin Abdulaziz University for Health Sciences (KSAU-HS) and King Abdullah International Medical Research Center (KAIMRC).

A hospital’s staff health and SAFETY PROGRAM is important to maintain staff physical and mental health, satisfaction, productivity, and safe conditions for work. Staff health and safety must be a part of the hospital’s quality and patient safety program.

SQE STAFF QUALIFICATIONS AND EDUCATION

JCI REQUIREMENTS FOR SQE 1. Personnel files must:

Contain the qualifications of the staff member. Contain the job description of the staff member when applicable. Contain the work history of the staff member. Contain the results of evaluations (Probation and Annual Evaluation) Contain a record of in-service education attended by the staff member. Contain a proof of cardiac life support training for those staff who provide patient

care. Contain a proof of education, licensure/registration, and other credentials issued by

recognized education entities and verified from the original source that issued the credential.(PSV)

Standardized and current and maintained according to hospital policy.

1. The hospital identifies areas for potential workplace violence and implements measures to reduce the risk.

2. The hospital provides evaluation, counseling, and follow-up treatment of staff who are injured as a result of workplace violence.

New Requirement from the JCI 5Th Edition (SQE 8.2)


51

Formerly named Management of Communication and Information (MCI), these standards have been focused to address how well the hospital obtains, manages, and uses information to provide, coordinate, and integrate services.

APP 1430–10 Clinical Record Content & Documentation Standards

Do Not Use

Error-prone abbreviations, symbols, and dose designations (Refer to APP 1427–16 Error–Prone Abbreviations, Symbols, and Dose Designations)

Unapproved Abbreviations (Refer to APP 1430–10 Clinical Record Content & Documentation Standards for the list of approved abbreviations)

MOI MANAGEMENT OF INFORMATION

Write Legibly Use Black Ball Point Pen Gregorian Date: (dd/mm/yy) Time: Use 24 hr clock e.g. (1300 for 1 pm) The heading of all Physician entries should include the

Date, Time, Physician’s Name and Title (Intern, Resident, Consultant etc)

Documentation is co-signed by the Supervisor if the author is a trainee.

The tail of Physician entries should include Signature, Name, Badge Number, and Beeper. Physicians should include their stamp when applicable.

Physicians Documentation- Write it Right

Cross It Right

1. Cross out wrong entries with a single horizontal line.

2. Write “Error” next to it. 3. Put your initials beside it.


52

Medical Professional Education

These standards address how the academic medical center hospital educates, supervises, grants privileges, and otherwise incorporates its medical students and trainees into its care processes and other daily operations.

JCI REQUIREMENTS FOR MEDICAL EDUCATION DPP 7800-01-162 Supervision of Residents and Fellows

MPE

SAUDI COUNCIL RESIDENCY TRAINING PROGRAM

Residency Training Programs at KSAU-HS are designed to provide residents with an opportunity for the incremental acquisition of knowledge, skills and responsibilities which will enable them proficiently to practice medicine in their given specialties. KSAU-HS Residency Programs enjoy a reputation among the local community for having outstanding training programs, because it starts with outstanding individuals, who are driven to success and eventually become Saudi Board and/or Arab Board Certified.

1. Those responsible for governance and leadership of the hospital approve and monitor the participation of the hospital in providing medical education.

2. The hospital’s clinical staff, patient population, technology, and facility are consistent with the goals

and objectives of the education program. 3. Clinical teaching staff are identified, and each staff member’s role and relationship to the academic

institution is defined. 4. The hospital understands and provides the required frequency and intensity of medical supervision

for each type and level of medical student and trainee.

5. Medical students and trainees comply with all hospital policies and procedures, and all care is provided within the quality and patient safety parameters of the hospital.

6. Medical trainees who provide care or services within the hospital—outside of the parameters of their academic program—are granted permission to provide those services through the hospital’s established credentialing, privileging, job specification, or other relevant processes.

Orientation for Medical Students must include the following:

a) Hospital quality and patient safety program b) Infection control program c) Medication safety program d) International Patient Safety Goals; e) All other required hospital orientation, including at the

department and unit level and f) any ongoing required education


53

Human Subject Research Program

Mission: To generate cutting-edge scientific research that helps improve the health of the population.

Vision: To be a leading international institution in biomedical and clinical research.

JOINT COMMSSION STANDARDS

APP 1419–005: Preparation of Research Proposal, Processing and Approval

APP 1426–02: Institutional Review Board (IRB) Policy and Procedures

APP 1432–20: Monitoring Research Studies

HRP

The organization supports research programs for the advancement of knowledge in health sciences and endeavors to maintain high quality level of health / medical researches through KAIMRC. All proposed studies must be in compliance with the rules and regulations of the Kingdom of Saudi Arabia, the institutional regulations of KAIMRC / MNGHA, and GCP.

This APP describes the policy and applicable procedures for monitoring approved research studies to ensure that they have been executed in compliance with the approved study proposal, ICH/GCP guidelines, King Abdullah International Medical Research Center (KAIMRC) and other requirements from the regulatory authorities.

1. Hospital leadership is accountable for the protection of human research subjects. 2. Hospital leadership establishes the scope of research activities. 3. Hospital leadership establishes requirements for sponsors of research to ensure their

commitment to the conduct of ethical research. 4. Hospital leadership creates or contracts for a process to provide the initial and ongoing

review of all human subjects’ research. 5. The hospital identifies and manages conflicts of interest with research conducted at the

hospital. 6. The hospital integrates the human subjects research program into the quality and patient

safety program of the hospital. 7. The hospital establishes and implements an informed consent process that enables patients to

make informed and voluntary decisions about participating in clinical research, clinical investigations, or clinical trials.

Institutional Review Board (IRB) refers to an independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing the continuing review of research study protocol and amendments, and of the methods and material used in obtaining and documenting informed consent of trial subjects.


54

JCI Requirements on Informed Consent

1. The hospital establishes and implements an informed consent process that enables patients to make informed and voluntary decisions about participating in clinical research, clinical investigations, or clinical trials.

2. A hospital that conducts clinical research, clinical investigations, or clinical trials involving patients

knows that its first responsibility is to patients’ health and well-being.

What will happen in Academic Medical Center Hospitals where patient tracers will include patients on a research protocol? The discussion for Research may include the following:

Review HRP

Standards and Policies

1. How staff were trained on the protocol.

2. How patients on research protocols were identified.

3. What staff understand about the informed consent process.

4. What happens when a patient asks to leave the study.

5. The process when a protocol has changed.

6. If a protocol changes, how patients are re-enrolled and sign another

consent.

7. The process when an adverse event occurs.

The information provided during the informed consent process includes

an explanation of the research, duration of patient participation, and procedures to be followed by patients;

expected benefits; potential discomforts and risks; alternative treatments and procedures that might also be beneficial; extent to which confidentiality of records will be maintained; compensation or medical treatments available if injury occurs; a statement that participation is voluntary; and assurance that refusal to participate or withdrawal from participation

will not compromise care or access to the hospital’s services; and who to contact with questions about the research.

Documents

JCI Survey 2015 - National Guard Health Affairsngha.med.sa/English/Professionals/pgme/orientationwr/JCI_Reference... · JCI Survey 2015 Reference Guide. JCI ... (GLD ... A Joint Commission