Quality Improvement - pSMILE



|Non-Smile Contributor |

|Author: |Document Number: |Doc10-03 |

|R,Kibaya | | |

| |Effective (or Post) Date: |6-March-09 |

|Document Origin |Company: |US Army Research Center |

| |SMILE Approved by: |Jackie Madden |

|Heidi Hanes |Mandana Godard |Review date |10-Feb-20 |

|SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your lab’s specific processes and/or specific protocol|

|requirements. Users are encouraged to ensure compliance with local laws and study protocol policies when considering the application of this document. If you|

|have any questions contact SMILE. |

Quality Improvement SOP

| |Copy Number |SOP No: |

|Standard Operating Procedure | |Supercedes: N/A |

| | |Effective Date: |

|Title: Quality Improvement SOP |

| |SIGNATURE |DATE |

|PREPARER | | |

|QA UNIT AUTHORITY | | |

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|REVIEWING AUTHORITY | | |

|APPROVAL AUTHORITY | | |

This SOP has been read and understood by:

NAME SIGNATURE DATE

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|2. | | |

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1. PURPOSE/ APPLICABILITY:

1. Purpose: To provide a description of the processes used for support and implementation of a continuous quality improvement (CQI) program for (Your Laboratory). It also describes all aspects of CQI, and how each part relates to the other to create a functioning quality system.

2. Scope: The scope of CQI applies to all personnel and supporting laboratories (clinical and research) assigned or attached to areas within (Your Laboratory).

2. TERMS AND ABBREVIATIONS:

1. (TQM)- Total quality management

1. CRC – Clinical Research Center

2. CQI – Continuous Quality Improvement

3. QA – Quality Assurance

4. HIV – Human Immunodeficiency Virus

5. CAP – College of America Pathologist

6. QI – Quality Improvement

7. SOP – Standard operating Procedure

8. CA – Corrective Action

3. EQUIPMENT AND MATERIALS: N/A

4. RESPONSIBILITIES

1. Administrative responsibilities are addressed by laboratory supervisory staff and the Administrative personnel including the HIV Laboratory Director.

2. Laboratory specific issues (i.e., weekly control data review, result review, etc.) are the responsibility of the supervisor of each laboratory and their personnel.

3. (Your Laboratory) Laboratory Officer is responsible for supervision of the program and assurance of compliance.

5. PROCEDURE

1. GENERAL POLICY

1. CQI is an essential part of a total quality management (TQM) system.

2. TQM directs the following actions:

a. Generates team-based effective decision making

b. Supports current and anticipates future needs

c. Sustains ongoing assessment of quality improvement

d. These three “actions” provide the basis for the process that supports CQI.

3. CQI can systematically maximize laboratory efficiency, effectiveness, and adaptability by offering supervisors and personnel a means to readily identify problems and/or issues relating to the laboratory. This process requires that the performance of laboratory personnel, equipment and materials be periodically monitored and provides a system for the consistent documentation of all aspects of laboratory management. CQI also ensures compliance with established regulations, policies, and applicable accreditation standards (e.g., CAP).

4. The CQI program will support the following efforts:

a. Improve the quality of subject result reports/patient care by identifying problems in a timely manner and confirming, by documentation of corrective action, that such problems have been resolved.

b. Provide continuous staff education and training to include competency assessment and verification. In addition, individual employee files/notebooks will be kept to document all continuing education.

c. Compliance with established policies and standards (i.e., internal polices, CAP, NCCLS).

2. QI Committee meetings

1. In order for laboratory employees to feel they are a part of the CQI, employees must recognize that they are “empowered” to take part in the process. QI meetings allow employees on all levels to participate in the decision making process through discussion of pertinent issues.

2. The purpose of the QI meeting is to receive and evaluate reports from all laboratory sections and implement corrective action or active review of issues.

3. Membership:

a. Department Chiefs

b. Lab Director or designee.

c. Laboratory Supervisor or designee.

d. Laboratory Personnel

e. (Your Laboratory) Laboratory Officer

NOTE: All laboratory personnel must attend and participate in the monthly QI meetings.

4. For personnel information refer to (Your Laboratory Personnel and Equipment Listings SOP) – (Your Laboratory) and Supporting Areas.

5. Meeting frequency: The QI meeting will be held on the 2nd Thursday of each month or as scheduled by the Committee Chairpersons.

3. Reporting: Copies of QI meeting minutes will be generated reviewed and filed in QI meeting file. Follow-up of issues is performed at the next scheduled meeting and evaluated as to status, i.e., resolved or unresolved.

4. Corrective and preventative action

1. These actions relate to the laboratory management process, both administrative and specific laboratory issues (i.e., result reports, equipment maintenance, QA/QC, safety/accident reports, etc.).

2. Corrective Action (CA) – immediate action taken to resolve problems or issues in a timely manner.

3. Preventative Action (PA) – preventative action is taken in anticipation of potential problems or issues.

NOTE: Preventative action is always more desirable than corrective action.

4. Both preventative and corrective actions must be addressed and documented as soon as possible, with issues relating to subject results; other, less pressing issues, should be addressed within 2 weeks if possible. Standardized forms should be used whenever possible to document incidents requiring corrective or preventative actions.

5. Depending upon the severity of the problems or issues, the generation of a formal CA report may be necessary. This type of CA report should include a complete description of events, as well as, supporting documentation copies of discrepant reports, accident reports, should be attach.

6. CA and PA reports should be secured in an appropriate “problem log/notebook” and kept in each laboratory area.

7. Both the administrative and laboratory specific CA logs must be inspected monthly, signed and dated, to verify that all CA reports were resolved. Confirmation of monthly CA log review should be verified by signatures and dates regardless of whether or not CA reports were filed

5. Monthly result review

1. The Laboratory Officer will enter applicable laboratory areas monthly and randomly select 5 clinical result reports. Each report will be examined for completeness and accuracy by comparison of raw data to final result reports and by review of quality control parameters. Once complete, results will be documented in the Laboratory note book

2. Verbal Communications: Problems/issues relating to testing and/or result reports (i.e., unacceptable sample material, panic value reports, etc.) requiring verbal communication must be documented in the laboratory Accident log/notebook to include:

a) Time and date

a. Description of problem,

b. Name of individual contacted,

c. Name of the individual reporting the problem.

d. This log/notebook must also be inspected monthly by the laboratory supervisor, signed and dated to verify review and ensure that corrective action was taken and the problem was resolved

6. SOPs

1. SOPs - All current laboratory SOPs are reviewed and approved annually by Laboratory officer and the Laboratory Supervisor or designate and each laboratory specific SOP is reviewed annually by all laboratory personnel. Individual SOP signature sheets are initialed and dated by all applicable laboratory personnel.

2. Document Control – Quality System Documentation (Refer to your Laboratory SOP) provides instructions for creation and revision of SOPs and supporting documents. This instruction also ensures that new and revised SOP documents have been reviewed by personnel and those laboratory personnel changes are implemented.

3. Copies of all revised or cancelled SOP documents are kept in a separate Section of the laboratory set aside for retired SOPs for a minimum of 2 years, after the discontinuation of the performed testing.

7. Personnel

1. Personnel files/folder will be kept for each employee as defined in (Your Laboratory SOP).

2. Personnel Training Folders will be kept as defined in (Your Laboratory SOP)

3. While much of the information is duplicated between the folders, the Training documentation folder must be available for inspection, while the personnel folders are not required to be available for inspection

8. Safety policy review

1. Review and implement safety related issues/policies as required.

2. Refer to (Your Laboratory Safety SOP) and CRC Safety Manual for a complete description of safety practices

9. Regulatory/Standards review: Review guidelines of accrediting and standards agencies (e.g., CAP, NCCLS) and implement policies when required.

10. Equipment Maintenance (refer to Equipment calibration and maintenances SOPs for complete process descriptions)

1. The responsibility of equipment maintenance, (Your Laboratory) has in-Country service contracts for the major equipment in the lab; and annually the Medical Maintenance Team from (Your Laboratory Maintenance Team) for verification and certification.

2. All laboratory equipment is included in this program (e.g., centrifuges, refrigerators, etc.), with the exception of thermometers, pipettes, and timers. The laboratory personnel are responsible for calibration of these devices.

11. Annual Appraisal of QI Program: Annual appraisal of the QI Program involves review and assessment of QA achievements for the year and defines strategies for continued improvement during the following year.

12. Change of Director/Section Chief

1. In the event that the Director/Section Chief of (Your Laboratory) should change, the new Director/Section Chief shall immediately oversee the QI program and other related issues.

2. All SOPs must be reviewed and signed by the new Director/Section Chief within 3 months of assignment.

12. Quality Assessment Program

1. External: The (Your Laboratory) participates in the following external quality assessment programs: (List appropriate EQA)

1. College of American Pathologists (CAP) – Hematology, Flow cytometry, HIV Serology, Chemistry, Serum Carry over, Instrument Survey 1

2. BBI HIV RNA PCR

3. HIV Serology

4. UK NEQAS – Flow cytometry

5. CD Chex/Streck – Flow cytometry

6. QASI – Flow Cytometry

7. VQC/NRL – HIV RNA

2. Internal:

1. Daily performance of Quality Controls.

2. Regular preventative maintenance of all equipment.

3. When available controls and maintenance will be performed in accordance with manufacturer’s recommendations.

5. APPENDIES:

1. Corrective Action Log.

2. Training Documentation File

7.0 REFERENCES:

7.1 Package insert for the External quality assessment program.

7.2 QI committee documentation minutes

7.3 Individual Assay SOPs

8.0 VERSION TABLE:

|Original: N/A |Dated: |SOP No.: |No. |

|Version 1: Quality Improvement SOP |Dated: |SOP No.: |No. |

| | | |Pages 9 |

|Version 2: |Dated: |SOP No.: |No.: |

|Version 3: |Dated: |SOP No.: |No. |

|Version 4: |Dated: |SOP No.: |No. |

CORRECTIVE ACTION LOG.__________________

|DATE |INCIDENT |INITIALS |DATE |ACTION |INITIALS |

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Supervisor _________________________ Date _______________

SOP Review and Updating Logs

|ANNUAL REVIEW |

|REVIEWER SIGNATURE |DATE |REVIEWER SIGNATURE |DATE |

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DOCUMENT COPY CONTROL

|DATE PRINTED: |NUMBER OF COPIES: 6 |

|SOP DISTRIBUTION |

|1. QA OFFICE |2. |3. |4. |

|5. |6. |7. |8. |

By Initialing and dating below I understand and approve of the changes to the attached SOP.

SOP CHANGES

| |Initials/Date |

|Date/Initials |Nature of Change |QA |LAB |INVEST |

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Training Documentation Log for SOP Files

|Site Name |Copy Number |SOP No: Supersedes: N/A |

| | |Effective Date: |

|Title: Quality Improvement SOP |

|Trained by: |Date: |

|Approved by: |Date: |

|Date: |Printed Name |Signature |Date: |Printed Name |Signature |

|00-MON- 11 | | |00-MON- 11 | | |

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