SRH BioMedical PM Audit

• Audit Subject:

• Department or Service:

• Location

  Select Access Health Accounting Accountable Care Behavioral Health BioMedical Services Cancer Center Cath Lab Cardiac Surgery Case Management Chaplain Corporate Compliance ECC Employee Health Environmental Svcs Facility Services Fleet Operations Food & Nutrition Grounds HIM Foundation Hospitality Services Human Resources Information Systems Laboratory Laundry & Linen Managed Care Marketing Montgomery Center Patient Access Pharmacy Pt Financial Svcs Quality Mgmt Svcs Radiology Rehabilitation Svcs Respiratory Svcs SC Joint Center SC Spine Center Security Self Excellance Sleep Lab Supply Chain Mgmt Telecommunications Wellness Works Wound Healing Institute 2 Tower 3 Tower 4 Tower 5 Tower 6 Tower 7 Tower Other

  • Access Health
  • Accounting
  • Accountable Care
  • Behavioral Health
  • BioMedical Services
  • Cancer Center
  • Cath Lab
  • Cardiac Surgery
  • Case Management
  • Chaplain
  • Corporate Compliance
  • ECC
  • Employee Health
  • Environmental Svcs
  • Facility Services
  • Fleet Operations
  • Food & Nutrition
  • Grounds
  • HIM
  • Foundation
  • Hospitality Services
  • Human Resources
  • Information Systems
  • Laboratory
  • Laundry & Linen
  • Managed Care
  • Marketing
  • Montgomery Center
  • Patient Access
  • Pharmacy
  • Pt Financial Svcs
  • Quality Mgmt Svcs
  • Radiology
  • Rehabilitation Svcs
  • Respiratory Svcs
  • SC Joint Center
  • SC Spine Center
  • Security
  • Self Excellance
  • Sleep Lab
  • Supply Chain Mgmt
  • Telecommunications
  • Wellness Works
  • Wound Healing Institute
  • 2 Tower
  • 3 Tower
  • 4 Tower
  • 5 Tower
  • 6 Tower
  • 7 Tower
  • Other

• Location

• Conducted on

  Date

• Audited By:

  Select Wesley Allen Ronnie Autry Cliff Collie Janice Cunningham Tony Eakin Rebekah James Cynthia Kinney Terri Mayfield Sonya Sheppard Bridget Still Lindsey Thompson Krista Uldrick Trieste Underhill Sharon Walb Chad Webster Jeffrey Wright

  • Wesley Allen
  • Ronnie Autry
  • Cliff Collie
  • Janice Cunningham
  • Tony Eakin
  • Rebekah James
  • Cynthia Kinney
  • Terri Mayfield
  • Sonya Sheppard
  • Bridget Still
  • Lindsey Thompson
  • Krista Uldrick
  • Trieste Underhill
  • Sharon Walb
  • Chad Webster
  • Jeffrey Wright

• Team Members Present:

Participant

• Attendee:

• Position or Title:

• QSF-SRH-0007, Rev 1.

Resources

Infrastructure (7.1.3)

• Are there any tools, products, or equipment required for this process?<br>(Scanner, Insulated tools, imaging equipment, lasers, power tools, etc.)

  Yes

  No

  N/A

• Equipment requires inspection or calibration prior to use

Equipment/Device

• Device

• Is there an inspection/calibration sticker present?

  Yes

  No

  N/A

• Remove from service and contact BioMedical Services . Do not use until the equipment has an inspection/calibration completed.

• Is today's date < 12 months from the sticker date?

  Yes

  No

  N/A

• Remove from service and contact BioMedical Services . Do not use until the equipment has an inspection/calibration completed.

• Is the work area in suitable condition?

  Yes

  No

  N/A

• Location of finding:

• Notify Facilities and/or management of issues found.

• (Look for dirt, dust, noise, congestion, missing outlet covers, stained ceiling tiles, trip hazards, etc.)

• Nonconformity

NC

• Requirement that was not met:

• Evidence that the requirement was not met:

• Opportunity for Improvement

OFI

• OFI:

• Noteworthy Effort:

NE

• Description of what it is the auditee is doing well

• Comments:

Competency, Training, and Awareness (7.2)

• Are there any certifications, licenses, or training requirements for team members who perform these tasks?<br>

  Yes

  No

  N/A

• Team member HR file:

Team Member

• Team member initials:

• This team member is required to maintain a license or certification.

  Off

  On

• Is the team member's license/certification valid?

  Yes

  No

  N/A

• What steps are being taken to address the situation?

• This team member is not required to maintain a license or certification to perform his/her job duties.

  Off

  On

• How does the department ensure that the team member has adequate experience or training for his/her position?

• On-the-job (OTJ) experience/training can be considered adequate if there is a skills/competency evaluation.

• Comments:

• Orientation checklists, licenses, annual competencies, certifications can verify required training was completed

• Nonconformity

NC

• Requirement that was not met:

• Evidence that the requirement was not met:

• Opportunity for Improvement

OFI

• OFI:

• Noteworthy Effort:

NE

• Description of what it is the auditee is doing well

• Comments:

Policy (7.3)

• Can you explain the SRH Quality Policy?

• How do you and your department demonstrate the values of the Quality Policy?

• (The Quality Policy is located on page 15 in the Quality Manual)

• Explain the Preventive Maintenance schedule, according to department policy.

• Nonconformity

NC

• Requirement that was not met:

• Evidence that the requirement was not met:

• Opportunity for Improvement

OFI

• OFI:

• Noteworthy Effort:

NE

• Description of what it is the auditee is doing well

• Comments:

General Documentation Requirements (7.5)

• Are there any documents are required for this process?<br>(Policies, Procedures, Forms, Electronic Maintenance Records)

  Yes

  No

  N/A

• Examples:

• Are all required documents maintained on the Intranet (SharePoint)?

  Yes

  No

  N/A

• Review of Policies/Procedures

Policy/Procedure

• [Date Ranges: Policies=3yrs, Forms=6yrs, External Documents: Annually, Order Sets= 2yrs (QSP-SRH-0001)]

• Policy/Procedure Title and Number:

• Formulated/Publish date:

• Revision level:

• Is the document compliant with review/revision dates?

  Yes

  No

  N/A

• Nonconformity

NC

• Requirement that was not met:

• Evidence that the requirement was not met:

• Opportunity for Improvement

OFI

• OFI:

• Noteworthy Effort:

NE

• Description of what it is the auditee is doing well

• Comments:

Operation

Process Walk-through and Explanation

• Summary of the process:

• (This may require walking through a department or work area and may require PPE)

• (Ensure fire extinguishers and electrical panels are not blocked, O2 cylinders are secured when not in use, Bio-hazard containers are secured.)

• Notes:

• Additional Process questions

Question

• Question:

• Answer:

• Nonconformity

NC

• Requirement that was not met:

• Evidence that the requirement was not met:

• Opportunity for Improvement

OFI

• OFI:

• Noteworthy Effort:

NE

• Description of what it is the auditee is doing well

Customer Communication (8.2.1)

• Is there a process for obtaining and responding to feedback from customers/patients? <br>

  Yes

  No

  N/A

• (Customers may be other departments or team members)

• Nonconformity

NC

• Requirement that was not met:

• Evidence that the requirement was not met:

• Opportunity for Improvement

OFI

• OFI:

• Noteworthy Effort:

NE

• Description of what it is the auditee is doing well

Externally Provided Products and Services (8.4)

• Are any related operations performed by an outside entity (Vendor or Contract Service)?

  Yes

  No

  N/A

• Has the outside entity been validated by the organization?<br>

  Yes

  No

  N/A

• (Contract evaluation, extension, or renewal can verify this)

• Comments:

• Nonconformity

NC

• Requirement that was not met:

• Evidence that the requirement was not met:

• Opportunity for Improvement

OFI

• OFI:

• Noteworthy Effort:

NE

• Description of what it is the auditee is doing well

Control of Production and Service Provision (8.5)

• Are controls in place to verify that the intended outcome/result of this process is achieved?<br>

  Yes

  No

  N/A

• Example:

• (Examples are policies & procedures, protocols, order sets, forms, etc.)

• Are there controls in place to prevent human error?

  Yes

  No

  N/A

• Example of control:

• (Color coding, segregation, incompatibility of connectors, verification, etc. )

• This process involves patient-related products (8.5.2)

  Off

  On

• (Patient-related products can be narcotics, implants, surgical sponges, etc.)

• Is there a procedure for providing identification and traceability of patient-related products?

  Yes

  No

  N/A

• Explanation of process:

• Nonconformity

NC

• Requirement that was not met:

• Evidence that the requirement was not met:

• Opportunity for Improvement

OFI

• OFI:

• Noteworthy Effort:

NE

• Description of what it is the auditee is doing well

Preservation of Products or Services (8.5.4)

• Is test equipment currently within calibration date and specifications?

• Nonconformity

NC

• Requirement that was not met:

• Evidence that the requirement was not met:

• Opportunity for Improvement

OFI

• OFI:

• Noteworthy Effort:

NE

• Description of what it is the auditee is doing well

• Comments:

Control of Nonconforming Outputs (8.7)

• Is there a process for addressing product failures (equipment, supplies, services)?

  Yes

  No

  N/A

• Describe the process:

• What steps are taken when a piece of test equipment is found to be out of calibration specifications?

• What actions are taken for equipment that was tested by out-of-calibration test equipment?

• What is done when equipment cannot be located to perform preventive maintenance?

• Is there a process for handling customer complaints/grievances?

  Yes

  No

  N/A

• Explain this process:

• Nonconformity

NC

• Requirement that was not met:

• Evidence that the requirement was not met:

• Opportunity for Improvement

OFI

• OFI:

• Noteworthy Effort:

NE

• Description of what it is the auditee is doing well

Performance Evaluation (9)

• Are there any defined department performance goals? (Yes or N/A)

  Yes

  No

  N/A

• Explain how any goals are set and measured:

• If goals are not being met, what corrective actions are taken?

• Are the results reported to higher levels for review?

  Yes

  No

  N/A

• Where are the results reported to?

• (PIC, PEC, MEC, Board Review, Management Review, etc.)

• Nonconformity

NC

• Requirement that was not met:

• Evidence that the requirement was not met:

• Opportunity for Improvement

OFI

• OFI:

• Noteworthy Effort:

NE

• Description of what it is the auditee is doing well

Improvement (10)

• Are opportunities for improvement identified and addressed?

  Yes

  No

  N/A

• Example(s) or procedures:

• Is feedback solicited from team members on how a task could be improved or streamlined?

  Yes

  No

  N/A

• Example(s) or methodology:

• Suggestion box, leader engagement, idea board, etc.

• Nonconformity

NC

• Requirement that was not met:

• Evidence that the requirement was not met:

• Opportunity for Improvement

OFI

• OFI:

• Noteworthy Effort:

NE

• Description of what it is the auditee is doing well

After the audit is complete:

• Other Applicable Notes/Comments:

• Auditor Name and Signature

Auditor

• Name

• Add signature

  Sign