Validation of self-assessment instrument for the Patient Safety Center

Non-experimental methodological study. Divided in the following stages: literature review and construction of the preliminary instrument; content validation by nine professionals with experience in Quality Management and patient safety, who contributed to the adequacy of the items in terms of clarity and relevance; finally, 12 PSC coordinators, which conducted the reliability validation of the final instrument, using Cronbach's Alpha.

Results:

The instrument presented content validity regarding clarity and relevance, evidenced by an agreement level greater than 70%. The internal consistency presented high reliability, with a Cronbach's alpha of 0.857 for the general instrument, 0.825 for the domain Structure, and 0.809 for the domain Process.

Conclusion:

The instrument presented evidence of content validity and reliability for self-assessment, implementation and evaluation of the PSC in health institutions.

Descriptors:
Risk Management; Patient Safety; Health Services Research; Hospitals; Validation Studies

Item 1st version	Item 2º versão
The PSC has a strategy to improve the processes, articulated with managers from other areas of the hospital.	There is an adverse event prevention strategy articulated with other managers.
The PSC, together with the institution, has a strategy to promote patient safety culture.	The upper management participates in and supports the safety culture strategies.
Uses risk management instruments in the investigative process.	Uses quality instruments to manage risks of adverse events.
It has a strategy to identify non-conformity in the processes and procedures carried out.	There is a strategy for the notification of risks and events contemplated in the Patient's Safety Plan.
The PSC communicates the outcomes of the notifications to the teams.	There are strategies for disseminating the results to the teams.
Safety in the use of technologies.	Safety in the use of equipment and material.
Actions to prevent adverse events.	Guidelines and actions to prevent sentinel events.
Risk management.	Management and risk management.

	Cronbach's Alpha by domains	Cronbach's Alpha of the instrument
Domain Structure	0.825	0.857
Domain Process	0.809	0.857

I - Human Resources and Material.		Y	N	NA
01	Physical space.
02	Computer.
03	Printer.
04	Telephone.
05	Internet access.
06	Office supplies.
07	Human resources.
II - Implementation of the PSC.
08	Structured PSC.
09	There is an adverse event prevention strategy articulated with other managers.
10	The upper management participates in and supports the safety culture strategies.
11	There are strategies and actions to avoid individual accountability.
12	Uses quality instruments to manage risks of adverse events.
13	There is a strategy for the notification of risks and events contemplated In the Patient's Safety Plan (PSP).
14	There are strategies for disseminating the results to the teams.
III - Main activities of the PSC.
15	Promotes risk management actions.
16	Develops actions for multi-professional integration.
17	Identifies and evaluates existing AEs in the processes and procedures.
18	Elaborates, implements, disseminates and updates the PSP.
19	Follows the actions linked to the PSP.
20	Implements patient safety protocols and monitors its indicators.
21	Establishes an accident prevention barrier.
22	Develops, implements and monitors patient safety training programs.
23	Analyzes and evaluates the data on incidents and AEs arising from the assistance provided.
24	Disseminates the results of analysis of AEs and incidents to the direction and the professionals.
25	Notifies the AEs to the National Health Surveillance service.
26	Files the notifications.
27	Follows health alerts and other risk announcements.
IV - Guidelines and actions to prevent Sentinel Events.
28	Surgical procedures. (Surgery or procedure on wrong patient or body part, non-intentional retention of foreign bodies inside the patient, etc.)
29	Products and devices. (Death or severe injury related to the use of products and/or devices)
30	Patient protection. (Suicide of a patient, death or severe injury due to evasion of the patient, etc.)
31	Care management. (Death or severe injury associated with medication error, fall, transfusion error, etc.)
32	Environmental events. (Injury or death associated with electric shock, chemical or biological risk, etc.)
33	Radiological events. (Injury or death of the patient or contributor associated with the introduction of metallic object in the magnetic resonance area, etc.)
34	Potential criminal events. (Patient abduction, sexual abuse of patient or employee, non-licensed professional, etc.)
V - Risk management strategies and actions.
35	Patient identification.
36	Incentive to hand hygiene.
37	Safe surgery.
38	Safety in the prescription, use and administration of medication.
39	Safety in the prescription, use and administration of blood components.
40	Encourages the patient and family to get involved in their own safety.
41	Effective communication.
42	Prevention of pressure injuries.
43	Prevention of patient falls.
44	Safety in the use of equipment and material.
45	Identification, analysis, monitoring and notification of risks.
46	Integration of the different risk management processes developed in the service.
47	Implementation of the protocols established by the Ministry of Health.
48	Safety in the prescription, use and administration of enteral and parenteral nutrition therapies.
49	Registers orthoses and prostheses, when used.
50	Prevention and control of AEs, including care-related infections.
51	Actions to encourage a safe environment.
VI - Professional training.
52	Quality and patient safety.
53	Basic principles in patient safety
54	Types of AEs related to health care.
55	Patient safety protocols.
56	Patient safety indicators.
57	Strategies for improving quality and safety.
58	Safety culture.
59	Patient Safety Center.
60	Patient Safety Plan.
61	Management and Risk Management.
62	Notification system and AEs.
63	Investigation of AEs.
64	Analysis of root causes.
65	Failure modes and effects analysis.

Associação Brasileira de Enfermagem SGA Norte Quadra 603 Conj. "B" - Av. L2 Norte 70830-102 Brasília, DF, Brasil, Tel.: (55 61) 3226-0653, Fax: (55 61) 3225-4473 - Brasília - DF - Brazil
E-mail: reben@abennacional.org.br

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[1] Corresponding Author: Renata Soares de Macedo E-mail: re_mcd@hotmail.com