1.0 Accreditation-Quality Assurance


Title of Manual: Specimen Collection

Version No: 1.0

Title: Accreditation/Quality Assurance

Effective Date: 11/01/09
Revised Date: 06/23/14

Document #: GPA.SPC.1.0


I. PURPOSE

Greensboro Pathology Associates, participates in proficiency evaluation programs in conformance with the Clinical Laboratory Improvement Act (CLIA) as well as the proficiency testing programs of the College of American Pathologists.

II. MATERIALS

Reagents

Supplies

Equipment


III. PROCEDURE

QUALITY ASSURANCE PROGRAMS

Our Quality Management program includes proficiency testing / external audits and a documented operational plan covering all aspects of laboratory services. To assess its effectiveness, the Quality Management program is regularly evaluated by the Laboratory Director(s). In addition, our board certified pathologists and technical personnel serve as inspectors for other accredited laboratories.

Histology

Key quality indicators (including preanalytical and postanalytic variables) are monitored and compared to benchmarks where available and applicable. A designated pathologist is responsible for quality indicator monitoring and reporting; pathologists are also directly responsible for coordination with other medical and administrative staff members through various divisional, departmental and institutional committee meetings. Our quality control policies include clearly defined goals for monitoring analytic performance, tolerance limits, procedures and corrective action. Our quality variance reporting system is designed to identify and correct problems that may interfere with patient care services.

Cytology

Each of our cytotechnologists are ASCP certified. All slides are initially screened by a qualified cytotechnologist. Cases interpreted as “Unsatisfactory” are re-screened by a senior cytotechnologist that has three or more years of experience. All patients that are considered to be high-risk for developing cervical cancer as indicated on the Pap test requisition or LIS are also re-screened by a senior cytotechnologist. At least ten percent of the cases interpreted as normal by the cytotechnologist are quality control selected for senior cytotechnologist re-screening. Re-screening is performed prior to issuing a final report. All other cases with abnormal cellular findings, including reactive/typical repair are evaluated by a board certified pathologist for final diagnosis.

Clinical

Key quality indicators (including preanalytical and postanalytic variables) are monitored and compared to benchmarks where available and applicable. The Clinical manager/designee is responsible for quality indicator monitoring and reporting. Our quality control policies include clearly defined goals for monitoring analytic performance, tolerance limits, procedures and corrective action. Our quality variance reporting system is designed to identify and correct problems that may interfere with patient care services.

IV. QUALITY CONTROL

V. CALCULATIONS/CALIBRATION

VI. INTERPRETATIONS

VII. METHOD PERFORMANCE SPECIFICATIONS

VIII. REFERENCES

IX. RELATED DOCUMENTS

X. DOCUMENT HISTORY

MINOR REVISION
(Laboratory Director’s Signature on Original Subsequent Document Attached)

X - MAJOR REVISION
(Requires Laboratory Director & Department Director Signature - where applicable)

Reason for Change

6/23/14 Added Clinical department information.



Laboratory Director

(Signature)

Date

Natalie Depcik-Smith, MD
(Print)



Department Director

(Signature)

Date


(Print)



Designee

Date

(Print)

(Signature)

(Print)

(Signature)

(Print)

(Signature)

(Print)

(Signature)

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(Signature)



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