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i52pS6u9BkC4oifckwfzFSuIx7BfrkmkopGfUUDeQTAsbXD2WDe3auejWdpN58SIgQuY9ZVNkdUqehXgTpr

CDPHE Sterile Processing Department Needs Assessment

The Colorado Department of Public Health and Environment is launching an effort to prevent breaches in infection control related to instrument and device reprocessing. Infection control breaches during instrument and device reprocessing have been identified with increasing frequency in Colorado in recent years. By encouraging health care facilities to complete self assessment and implement prevention measures, CDPHE hopes to help healthcare partners reduce the risk of medical errors and communicable disease transmission, and related patient notification, and assure quality of care and patient safety.

The purpose of this survey is to assess current infection prevention needs of Sterile Processing Departments (SPD) and non-centralized reprocessing locations in hospitals and ambulatory surgical centers (including endoscopy centers). The survey will guide the development of an SPD toolkit to support SPD programs and improve standardization of best practices for infection prevention across all reprocessing settings. Survey findings will also inform CDPHE's outreach and allocation of prevention resources.

The Healthcare-Associated Infections and Antimicrobial Resistance (HAI/AR) program in the Communicable Diseases branch will analyze the survey data for the purpose of quality improvement. Survey data will not be used for regulation. We will share a de-identified summary of findings with participating facilities. We may discuss aggregate data with members of leadership within the Division of Disease Control and Public Health Response who oversee HAI/AR program activities.

We encourage all health care facilities to share this survey link with a multidisciplinary team involved in the SPD program, including frontline staff responsible for the reprocessing of instruments and devices, infection prevention, quality programs/managers, leadership, etc. The greater the number of surveys completed for each facility, the greater the ability to identify needs and target improvement.

The survey should take no longer than 15 minutes to complete. Respondents should be familiar with facility procedures and processes. However, there is no expectation that respondents conduct detailed research or observation. The goal is to gather current perceptions of best practices for infection prevention that are in place.

Name of your health care facility (Leave blank if completing the survey anonymously).

Health care facility setting type.

* must provide value

Acute care hospital.

Ambulatory surgical center.

Critical access hospital.

Short-term hospital.

Other.

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Other (specify):

* must provide value

First and last name of respondent (Leave blank if the respondent prefers to remain anonymous).

Email address of respondent (Leave blank if the respondent prefers to remain anonymous).

Role of respondent.

* must provide value

Infection Prevention.

SPD leadership.

SPD technicians.

PeriOperative.

Quality.

Facility leadership (CMO, CNO, etc.).

Other (specify):

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Other (specify):

* must provide value

1. The SPD program has support from facility leadership, which includes their participation in SPD's multidisciplinary team, understanding roles and processes of the SPD program, and participation in quality improvement.

Yes.

No.

Unknown.

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If yes, Leadership support includes (select all that apply):

* must provide value

Chief Executive Officer (CEO).

Chief Medical Officer (CMO).

Chief Nursing Officer (CNO).

Chief Financial Officer (CFO).

Chief Operating Officer (COO).

Department Directors.

Other administration.

Unknown.

My facility's SPD program does not have this level of leadership support.

Other administration.

* must provide value

1.a. Further describe the support that the SPD program receives from facility leadership.

* must provide value

2. The SPD program is part of a multidisciplinary team, which includes people from the following (select all that apply):

* must provide value

Administrative leadership (CMOs, CEOs, CNOs, etc.).

SPD management.

Infection Preventionist.

Quality.

PeriOperative management.

Frontline staff.

Water management.

Environmental/maintenance.

Unknown.

Other (specify):

* must provide value

2.a. The multidisciplinary team supports the SPD program by participating in the following (select all that apply)?

* must provide value

Evaluates new devices to confirm reprocessing compatibility with current sterilizers and products.

Develops, reviews, and updates policies and procedures prior to implementation.

Investigates breaches and/or reprocessing failures (suspected or confirmed).

Process improvement/Quality improvement.

3. The SPD program has policies and procedures that address the following (select all that apply):

* must provide value

Following manufacturers instructions for use.

Maintaining documentation for high level disinfection/sterilization.

Traceability of equipment and devices.

Standardized reprocessing process.

Equipment/device recall or maintenance.

Vendor equipment/devices.

Reprocessing of equipment/devices supplied by vendors.

Reprocessing timeframes.

Reprocessing failures.

Patient notification.

3.a. Policies and procedures related to the SPD program, which include equipment and device reprocessing, are reviewed and updated as follows (select all that apply):

* must provide value

Annually.

When new equipment/devices are introduced.

When new evidence based recommendations are published.

When new/updated manufacturers instructions are received.

When gaps are identified.

All of the above.

None of the above.

Unknown.

Other (specify):

* must provide value

3.b. The SPD program's policies and procedures are in compliance with the following federal and local regulatory agencies and/or relevant accrediting organizations (select all that apply):

* must provide value

Food and Drug Administration (FDA).

Centers for Medicare and Medicaid Services (CMS).

Occupational Safety and Health Administration (OSHA).

Colorado Department of Public Health and Environment (CDPHE).

American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF).

Accreditation Association for Ambulatory Health Care (AAAHC).

The Joint Commission (TJC).

Det Norske Veritas Healthcare (DNV).

Unknown.

None of the above.

Describe.

* must provide value

3.c. Staff have access to the policies and procedures related to reprocessing equipment and devices.

* must provide value

Yes.

No.

Unknown.

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4. Staff have access to manufacturer instructions for use for all instruments being reprocessed.

* must provide value

Yes.

No.

Unknown.

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4.a. Manufacturer instructions for use are made available where reprocessing occurs.

* must provide value

Yes.

No.

Unknown.

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5. My facility maintains a competency-based training program, which includes (select all that apply):

* must provide value

Staff are required to follow all reprocessing steps for equipment and devices outlined in the manufacturers instructions for use.

Staff are required to perform all job duties in accordance with the standardized procedures (i.e., following the same pattern and processes each time).

Staff are required to review and be competent in following IFUs before being allowed to reprocess equipment.

Staff are required to review and be competent in following new IFUs before being allowed to resume reprocessing equipment.

Staff are trained on the reprocessing of specialty equipment/surgeon specific sets before being allowed to reprocess instruments.

5.a. My facility provides training and competency-based assessments for the reprocessing of instruments, which includes (select all that apply):

* must provide value

Initially upon hire.

Before staff are allowed to reprocess instruments.

Periodically as required by facility policy.

At least annually.

When updated manufacturers instructions are received.

When new instruments or products are introduced.

When new processes are introduced.

When gaps are identified.

5.b. The training and competency-based assessments performed at my facility are (select all that apply):

* must provide value

Based on manufacturers IFUs.

Model-specific.

Account for the chemicals used.

Adapted to reflect the diversity of the workforce and type of equipment (e.g., scopes, surgical instruments).

5.c. Reprocessing steps included in the training are as follows (select all that apply):

* must provide value

Pre-cleaning at point of use (e.g., bedside).

Leak testing.

Manual/mechanical cleaning.

Visual inspection.

Disinfection and/or sterilization.

Drying.

Storage.

Documentation.

5.d. Who is responsible for training and verifying staff competencies (select all that apply):

* must provide value

SPD management.

Infection Prevention.

Peers.

Self-assessments.

Unknown.

No one is assigned to assess staff competencies.

Other (specify):

* must provide value

5.e. Those responsible for training and assessing staff competencies are qualified, maintaining competencies in the designated areas, including (select all that apply):

* must provide value

Follows all reprocessing steps for equipment and devices outlined in the manufacturers instructions for use.

Performs all job duties in accordance with the standardized procedures (i.e., following the same pattern and processes each time).

Competent in reprocessing of specialty equipment/surgeon specific sets.

Competent in the essential steps of reprocessing (e.g., point-of-use cleaning, leak testing, cleaning, disinfection, sterilization, drying, storage, and documentation).

Follows policies and procedures pertaining to SPD.

5.f. When was the last time you received/performed a competency evaluation?

* must provide value

Upon hire.

Within the last 12 months.

Never.

Other (specify):

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Other (specify):

* must provide value

6. Routine audits include the following (select all that apply):

* must provide value

All areas where high-level disinfection (HLD) and sterilization are performed.

Include visual observations of staff practices.

Include on-the-spot feedback with recommendations to mitigate gaps identified.

All staff from each category and shift.

Includes travelers and contracted staff.

Maintaining documentation of assessments and feedback reports.

7. My SPD program maintains documentation for the following (select all that apply):

* must provide value

Patient identifiers for each instrument used.

Dates when reprocessed.

Times when reprocessed.

Names of those reprocessing instruments, and for each step.

Visual inspections.

Products used for reprocessing such as enzymatics, washers, sterilizers, etc.

Maintenance records (including vendor/repair records) for all equipment, including any retired equipment.

HLD/sterilization logs (e.g., temperature, concentration, expiration dates, sterilization receipt, etc.).

Investigations related to suspected or confirmed HLD/sterilization failures.

Investigations related to suspected or confirmed equipment failures.

7.a. Documentation is maintained in alignment with the facilities record retention policy.

* must provide value

Yes.

No.

Unknown.

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8. To ensure proper reprocessing of all equipment and devices, my facility maintains the following (select all that apply):

* must provide value

Adequate space.

Adequate reprocessing time.

Staffing ratios.

Inventory.

Procedure volume/scheduling.

Reprocessing equipment (e.g., sinks, washers, sterilizers, etc.).

Most of the device and equipment reprocessing is done in a central processing department.

8.a. The reprocessing area is a dedicated location, which includes the following (select all that apply):

* must provide value

Separate from the procedural area.

Clearly labeled.

Maintains a one-way workflow.

Maintains appropriate airflow.

Separates dirty from clean work spaces.

Contains a designated decontamination area.

Contains a designated prep and packaging area.

Provides instruments for visual inspection (e.g., borescope and magnification).

Provides instruments for forced air drying.

Contains a designated space for sterilization.

Contains a designated space for storage.

9. An Infection Preventionist is a part of the reprocessing program's multidisciplinary team and participates in the following (select all that apply):

* must provide value

Completing reprocessing audits/visual observations.

Maintaining appropriate documentation (e.g., audits, feedback, etc.).

Notified when breaches are identified (suspected or confirmed).

Review of SPD measures in infection prevention meetings.

Consulted before implementing new equipment/devices.

Consulted when reviewing policies and procedures, before changes are made.

10. When was a risk assessment or gap analysis conducted to assess if all essential steps of the reprocessing program are met and maintained, including staff competencies?

* must provide value

Less than six months.

Greater than six months.

Not assessed.

Unknown.

Other (specify):

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Other (specify):

* must provide value

10.a. The frequency for risk assessments or gap analysis for the reprocessing program include (select all that apply):

* must provide value

Annually.

When gaps are identified.

New equipment/devices.

Other (specify):

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Other (specify):

* must provide value

10.b. Procedures are in place to identify and respond to reprocessing failures, which includes (select all that apply):

* must provide value

Internal notification to the multidisciplinary team.

Internal notification to administrative leadership (CMO's, CFO's, etc.).

CDPHE notification.

Device/vendor/manufacturer notification.

Water management (internal and external).

FDA MedWatch.

Patient notification.

Gap mitigation.

Staff education.

Prospective/perspective surveillance.

Unknown.

No applicable policy.

Other (specify):

* must provide value

10.c. The decision to notify patients of potential exposures following the breach, are made in consultation with state and local health departments.

* must provide value

Yes.

No.

Unknown.

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I am interested in learning more about evidence-based best practices and resources for (select all that apply):

Endoscope reprocessing.

High-level disinfection.

Sterilization.

Policies and procedures.

Reprocessing failure/breach next steps.

Patient notification.

CDPHE's HAI/AR program can best support me and my facility by providing (select all that apply):

Webinars (i.e., accreditation survey preparation, vendor support, IFU assessment, patient notification of IPC breaches, etc.).

Meetings to discuss common gaps and prevention.

Newsletter with educational resources.

Resource and tool development (i.e., risk assessment matrix, policies, self-assessment tools, etc.).

CDPHE onsite assessment (non-punitive and non-regulatory) to assess practices and provide recommendations for focused education and mitigation.

Other (specify):

Does your facility have tools (including self-assessment tools), resources, and/or policy templates that you would be willing to share?

Yes.

No.

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If yes, please describe:

Are you interested in participating in the development of the SPD toolkit and/or resources?

Yes.

No.

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If yes, please confirm your contact information:

Are you interested in participating in a SPD workgroup and/or discussion group?

Yes.

No.

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If yes, please confirm your contact information:

Are you interested in providing additional information about your SPD program, including a self-evaluation of your SPD program?

Yes.

No.

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My facility follows all equipment and device manufacturers instructions for use.

Never.

Rarely.

Usually.

Always.

Unknown.

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My facility performs visual assessments to ensure competencies and compliance are maintained in the SPD program, including endoscope reprocessing, high-level disinfection, and sterilization.

Never.

Rarely.

Usually.

Always.

Unknown.

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My facility consistently documents the reprocessing process, including traceability of instruments.

Never.

Rarely.

Usually.

Always.

Unknown.

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My facility provides and maintains the appropriate amount of inventory, supplies, space, and time for SPD staff to reprocess equipment.

Never.

Rarely.

Usually.

Always.

Unknown.

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My facility has established and maintains standardized reprocessing procedures (following the same pattern and processes each time).

Never.

Rarely.

Usually.

Always.

Unknown.

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Anything further you would like to share about your SPD program?

Expand

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