HSPA Chapter 18

Quality

The consistent delivery of a product or service according to established standards.

Quality Is Non-Negotiable in Healthcare

Everyone demands quality — and in healthcare, there are no exceptions.

Sterile Processing's Role

Serves internal customers: Nurses, surgical technologists, surgeons.

Empowerment in Quality

Granting employees the authority (power) to make decisions within their area of responsibility.

Data in Quality Monitoring

Without measurable results, quality becomes a matter of opinion rather than fact.

Metrics for Monitoring Quality

Each department must determine which metrics will be used to monitor quality — such as error rates, turnaround times, customer feedback, compliance scores, and equipment performance.

Good Data vs. Bad Data

Not all data is good data. Numbers without context can be misleading.

Quality Improvement

Quality improvement is a team effort — leadership sets the vision, but Sterile Processing technicians must have a voice and actively follow the improvements set forth.

Principles of Quality Management

Includes Patient Focus, Process Management, Continuous Quality Improvement (CQI), and Fact-Based Decisions.

Patient Focus

Meeting the needs of the patient is the ultimate goal.

Process Management

Drive the processes rather than the people.

Continuous Quality Improvement (CQI)

Always believe things can be done better, and actively pursue it.

Fact-Based Decisions

Rely on data and measurable facts, not assumptions.

Quality Planning

Helps reduce existing problems and prevent potential ones before they occur.

Learning from Others

Study how other facilities achieve quality success.

Focus on Process

It's usually the process, not the people, that causes most problems.

SPD Example: Tray Errors

If tray errors are tracked and the data shows that 8% of surgical sets arrive incomplete, leaders can investigate the cause.

Quality Improvement Example

Reviewing tray error reports monthly and updating workflow to reduce repeated mistakes.

Bioburden Test Results

Using bioburden test results to determine the effectiveness of cleaning equipment, rather than assuming it's performing correctly.

Empowering the Frontline

They are the ones who execute the process every day.

Critical Thinking Skills

Solid education and training to build strong critical-thinking skills on the job.

Long-term Problem-solving Projects

Projects assigned to technicians who want additional responsibility.

Cross-functional Teams

Teams that bring together members from multiple departments within the healthcare facility to collaborate and resolve issues.

Department Performance Evaluation

Assessing how well the department meets quality and operational standards.

Key Indicators of Success

Metrics used to evaluate departmental performance, including specific examples.

STAT Supplies

Supplies that are received within minutes, such as a critical orthopedic screw arriving in the OR within 5 minutes of request.

Current Supplies in Stock

Ensuring no outdated items are present, such as all peel-packed instruments being within expiration date.

Sterility Processes

Processes that meet requirements, with examples including passing chemical and biological indicator tests.

Instrument Sets

Sets that are functional, accurate, and neatly organized, such as a laparoscopic set arriving with all clamps functioning.

Powered Clinical Equipment (PCE)

Equipment that is fully functional, such as powered drills and saws passing function tests before use.

Immediate Use Steam Sterilization (IUSS)

A process that is avoided whenever possible, with examples including having backup instrument sets available.

Case Carts

Carts that are correct and complete, such as a general surgery case cart arriving with every tray listed on the surgeon's preference card.

Biological Indicators (BIs)

Indicators included in every load to confirm sterility assurance, such as being placed in every steam sterilization cycle.

Total Quality Improvement (TQI)

Measuring output and making improvements to increase efficiency, such as tracking tray assembly times.

Total Quality Management (TQM)

Participation of the entire team aimed at long-term customer satisfaction, such as SPD and OR staff working together.

Six Sigma

A process focus on delivering near-perfect products and services, such as reducing surgical tray defects to fewer than 3.4 per million opportunities.

Lean

A process focused on eliminating waste in processes and products, such as removing unused instruments from trays.

TJC (The Joint Commission)

Measures facility performance against established standards and regulations, ensuring compliance with sterilization logs and documentation.

CMS (Centers for Medicare & Medicaid Services)

Focuses on patient safety and security, such as following infection control guidelines for instrument reprocessing.

NCQA (National Committee for Quality Assurance)

Assists facilities in identifying and prioritizing quality goals, such as setting measurable targets for error reduction.

HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems Survey)

A standardized survey tool tied to value-based initiatives, influencing patient experience scores.

ISO (International Organization for Standardization)

Provides ISO 9000 and 9001 quality standards to ensure effective processes.

PPE

Personal Protective Equipment - Gloves, gown, mask in decon to prevent cross-contamination.

Document temp/humidity/pressure

Log daily to meet standards.

Sort & disassemble

Remove scope lenses before ultrasonic cleaning.

Proper chemical dosing

Mix enzymatic per IFU, not by guesswork.

Load equipment correctly

Keep instruments open for full spray contact.

Follow IFUs

Use correct cycle times and temps.

Maintain equipment

Schedule preventative maintenance.

Use quality monitoring devices

Run daily washer TOSI tests.

Verify cleanliness

Check box locks with magnifier before packing.

Cleanliness verification

Soil tests & ATP testing.

Function testing

Check alignment, sharpness, and integrity.

Accuracy

Match count sheet: correct items & quantity.

FDA-cleared devices only

No unapproved tools.

Correct indicators

Use proper internal CI (Type 3-6).

Packaging check

Ensure no defects; validated for use.

Daily testing

Perform and record required sterilizer tests.

Load configuration

Arrange items per IFU for proper sterilant contact.

Verify external indicators

Check before & after sterilization.

Incubate BI correctly

Follow time/temp requirements.

Allow proper cooling

Prevent wet packs and contamination.

Complete documentation

Record all cycle data accurately.

Load stickers on each package

Maintain full traceability.

Keep shelves clean

Maintain a dust-free storage area.

Verify package integrity

No tears, holes, or moisture.

Document returns, damages, & picked items

Maintain accurate inventory records.

Follow policies & procedures

Maintain compliance at all times.