Inspector Information
Laboratory Information
TABLE OF CONTENTS
Topic / Page / InspectorInformation / Laboratory
Information /
Introduction……………………………………………………………. / 4 / · / ·
Inspection Objectives………………………………………………... / 5 / · / ·
Standards for Laboratory Accreditation……………………………….. / 5 / · / ·
Checklists……………………………………………………………. / 5 / ·
Commission Philosophies……………………………………………… / 8 / ·
Peer Review…………………………………………………………… / 8 / ·
Thoroughness………………………………………………………….. / 8 / ·
Judgment………………………………………………………….…… / 8 / ·
Disputes………………………………………………………………... / 9 / ·
Sexual Harassment…………………………………………………….. / 9 / ·
Solicitation…………………………………………………………….. / 9 / ·
Confidentiality…………………………………………………….…… / 9 / ·
Conflict of Interest…………………………………………………….. / 10 / ·
Applying to the CAP Laboratory Accreditation Program……………. / 11 / ·
Prerequisites…………………………………………………………… / 11 / ·
Application…………………………………………………………….. / 11 / ·
Pre-Inspection Phase: Preparation of Application Materials…….…. / 13 / ·
Inspection Checklists…………………………………………………... / 13 / ·
Application Demographics Form………………………………..…….. / 13 / ·
Supplemental Materials………………………………………………... / 14 / ·
AABB Coordination…………………………………………………… / 14 / ·
Returning the Application…………………………………………… / 14 / ·
Preparing for the Inspection……………………………………………. / 15 / ·
Inspection Team Leader Assignment………………………………... / 15 / ·
Inspection Team Leader Qualifications……………………………... / 15 / ·
Inspector Inspection Packet……………………………………….…… / 16 / ·
Laboratory Disciplines………………………………………………… / 17 / ·
Inspection Team……………………………………………………….. / 17 / ·
Arranging the Inspection Date…………………………………….… / 17 / ·
Requests for Inspection Delays……………………………………… / 18 / ·
AABB Coordinated Inspection……………………………………… / 18 / ·
Unprepared Laboratories………………………………………….…… / 18 / ·
Conducting the Inspection: Meetings and General Principles……… / 20 / ·
Meeting with the Laboratory Director…………………………….… / 20 / ·
Meeting with the Hospital Administrator……………………………… / 20 / ·
Meeting with a Representative of the Medical Staff………………… / 20 / ·
Meetings with Direct Healthcare Providers……………………….… / 21 / ·
Meetings with Clients of Independent Laboratories………………… / 21 / ·
Inspecting the Laboratory Sections…………………………………….. / 22 / ·
Laboratory General……………………………………………….…… / 22 / ·
Conducting the Safety Inspection…………………………………… / 25 / ·
Hematology and Coagulation………………………………………….. / 31 / ·
Clinical Chemistry, Special Chemistry, Toxicology………………… / 33 / ·
Inspecting the Laboratory Sections (Continued)
Urinalysis and Clinical Microscopy…………………………………… / 34 / ·
Microbiology…………………………………………………………... / 36 / ·
Transfusion Medicine………………………………………………….. / 38 / ·
Immunology and Syphilis Serology……………………………….… / 39 / ·
Anatomic Pathology…………………………………………………… / 39 / ·
Cytopathology…………………………………………………….…… / 41 / ·
Cytogenetics…………………………………………………………… / 43 / ·
Histocompatibility…………………………………………………… / 44 / ·
Flow Cytometry……………………………………………………….. / 44 / ·
Molecular Pathology………………………………………………… / 44 / ·
Point of Care Testing …………………………………………….…… / 44 / ·
Inspecting Other Types of Laboratories……………………………….. / 46 / · / ·
Special Function Laboratories…………………………………….…… / 46 / · / ·
Affiliated Laboratories………………………………………………… / 46 / · / ·
System Inspection Option…………………………………………… / 46 / · / ·
Satellite Laboratories………………………………………………….. / 47 / · / ·
Staff Inspected Laboratories………………………………………… / 47 / · / ·
Limited Service Laboratory……………………………………….… / 47 / · / ·
The Summation Conference…………………………………………… / 49 / ·
Pre-Summation Team Meeting……………………………………… / 49 / ·
Summation Conference……………………………………………… / 49 / ·
Concluding the Inspection…………………………………………… / 50 / ·
The Inspection Report…………………………………………………… / 52 / ·
Inspector’s Summation Report (ISR)………………………………….. / 52 / ·
Expense Reimbursement………………………………………….…… / 52 / ·
Continuing Medical Education (CME)……………………………… / 52 / ·
Return of Inspection Packet…………………………………………… / 53 / ·
Post-Inspection Phase……………………………………………….…… / 54 / ·
Laboratory Inspection Packet………………………………………….. / 54 / ·
Packet Review…………………………………………………….…… / 55 / ·
Immediate Review Criteria………………………………………….. / 55 / ·
Accreditation………………………………………………………… / 56 / ·
Denial/Revocation…………………………………………………… / 56 / ·
Appeals………………………………………………………………… / 56 / ·
Post Inspection Critique………………………….……………….…… / 57 / ·
Maintaining Accreditation………………………………………………. / 58 / ·
Proficiency Testing Participation and Satisfactory Performance……. / 58 / ·
Self-Evaluations……………………………………………………….. / 58 / ·
Anniversary of Accreditation…………………………….………..… / 58 / ·
Implications of Accreditation …………………………………….…… / 58 / ·
Non-Routine Inspections………………………………………………… / 60 / ·
Change in Location, Director, or Ownership………………………... / 60 / ·
Added Discipline………………………………………………….…… / 60 / ·
Secondary On-Site Inspection…………………………………….…. / 60 / ·
Complaint Investigation……………………………………………….. / 61 / ·
Appendix A: CAP Checklist Usage………………………………….…… / 62
Appendix B: Guidelines for Determining Test Volume………………… / 65
Appendix C: Quality Improvement………………………………………. / 66
Appendix D: Sample of Inspection Confirmation Letter to Lab
Director…………………………………………………… / 68
Appendix E: Resources………………………………………………….. / 70
Appendix F: Site Coordinators Manual………………………………….. / 74
Appendix G: Retention Guidelines……………………………………….. / 86
Appendix H: Glossary of Terms…………………………………………. / 88
College of American Pathologists Laboratory Accreditation Manual
Page 1
Inspector Information
Laboratory Information
INTRODUCTION
The College of American Pathologists (CAP) has established and directs four separate accreditation programs. These programs were created with the primary objective of improving the quality of clinical laboratory services throughout the United States, through voluntary participation, professional peer review, education and compliance with established performance standards. Since their creation, these programs have become widely acknowledged as programs of excellence. In all, the College accredits over 6,000 laboratories. The Laboratory Accreditation Program (LAP), for all clinical laboratories, was established in 1961. The Forensic Urine Drug Testing (FUDT) accreditation program was established in 1988 and the Athletic Drug Testing Program (ADT), in 1992. The Reproductive Laboratory Program (RLAP), directed jointly with the American Society of Reproductive Medicine (ASRM), was established in 1993.
The accreditation programs examine all aspects of quality control and quality improvement in the laboratory, including test methodologies, reagents, control media, equipment, specimen handling, procedure manuals, test reporting, and internal and external proficiency testing and monitoring, as well as personnel, safety, and overall management practices that distinguish a quality laboratory.
Management and operation of the four accreditation programs are the responsibility of the Commission on Laboratory Accreditation (CLA), except the responsibility for the RLAP is shared with the ASRM. The CLA is a group of specially qualified pathologists appointed by the president of the CAP and is composed of a chair, a vice chair, and regional and special commissioners. The CLA meets three times each year to develop standards, guidelines, and policies for the LAP, to make accreditation decisions and to consider relevant issues.
Each Regional Commissioner has responsibility for a specific geographic region. The Regional Commissioners are assisted by Deputy and State Commissioners. Other commissioners oversee the revision of the inspection Checklists, develop inspector training materials, address state and federal legislative and regulatory issues, and edit the Laboratory Accreditation Newsletter. In addition, the Commission uses the expertise of numerous CAP scientific resource committees to keep the program and its requirements current.
State and Division Commissioners are responsible for identifying and assigning inspectors in their geographic regions. They must make sure that inspections are conducted on a timely basis and in accordance with Commission policy. Following the on-site inspections, the Regional Commissioner, in conjunction with the CAP technical staff, reviews the inspection data and conducts any follow-up necessary to reach an accreditation decision.
The Laboratory Accreditation Department at the CAP headquarters in Northfield, Illinois is staffed by technical and administrative personnel who carry out the policies and procedures of the CLA and handle administrative details of the accreditation process.
The inspectors who conduct the on-site laboratory inspections are the lifeblood of the program. Typically, the inspection team leader is a board-certified pathologist who has been trained by attending an inspector training seminar or evening symposium.
Three documents are fundamental to the inspection process: the Standards for Laboratory Accreditation, the Checklists, and the Inspector’s Summation Report (ISR). The inspector’s role is to interpret the Standards, in the spirit of peer review, using the Checklists and ISR. The inspector collects and records the information upon which the CLA will base the accreditation decision. The inspection is a peer review educational process designed to achieve improvement of patient care activities in participating laboratories. During the course of the inspection, inspectors often will share experiences which will enhance the quality of the laboratory’s service, and inspection team members find ideas that can be implemented in their own laboratories.
Inspection Objectives:
In the course of an inspection, the inspector should learn to :
1. Describe how to evaluate the operating practices of a particular laboratory, by reviewing technical procedures and related materials for quality control and quality improvement.
- Use the Standards for Laboratory Accreditation and the Inspection Checklists as tools for the assessment of unfamiliar laboratory practices for compliance and consistency with good laboratory practice.
- Describe knowledge about new methods and technology or approaches enhanced through the inspection process.
- Explain how interaction with administration, physicians and staff enhanced the inspector’s knowledge of current management issues and solutions.
Standards for Laboratory Accreditation
The Standards are the basis for the accreditation decision. Each of the four-accreditation programs has its own Standards. The Standards, which have evolved through years of study and continuous review by the CLA, are approved by the CAP Board of Governors. The inspector must be familiar with each standard and its interpretation. A copy of the Standards for Laboratory Accreditation is included with each inspection packet. The Standards should be reviewed before the inspection of the laboratory. The inspector is considered the on-site authority for the interpretation of the Standards.
Checklists
Detailed Checklists were developed, based on the requirements of the Standards. The Checklist format permits a comprehensive evaluation of a laboratory’s compliance with the Standards.
The Checklists are organized by specific laboratory disciplines and/or important management operations:
· Laboratory General
· Hematology and Coagulation
· Automated/General Chemistry
· Urinalysis and Clinical Microscopy
· Toxicology
· Special Chemistry
· Microbiology
· Transfusion Medicine
· Immunology and Syphilis Serology
· Anatomic Pathology
· Cytopathology
· Cytogenetics
· Histocompatibility
· Flow Cytometry
· Molecular Pathology
· Limited Service Laboratory
· Blood Gas Laboratory
· Point-of-Care Testing
The Checklists are available in hard copy format by calling 800-323-4040, extension 6055 or 847-832-7000, extension 6055 or at the CAP Website (www.cap.org). To download Checklists from the Web page follow these directions. From the Laboratory Improvement icon, view the dropdown menu and click on Laboratory Accreditation Program. From the Laboratory Improvement screen click Download checklists. The download library screen will appear, scroll until you reach LAP Checklist. Click on LAP Checklists and the list of all Checklists will appear listing two formats. To obtain a copy of a checklist, click the download format. The HTML format will allow you to view only. These Checklists are revised periodically and consist of approximately 3,200 questions, many of which are the same item in each of the section-specific Checklists. During the inspection, the Checklist questions are used to evaluate whether or not a laboratory meets the LAP Standards. Each of the questions is uniquely numbered, worded and designed to produce: a “Yes” response, which means that the lab is compliant; a “No” response, which means the lab does not comply; or N/A which means that the question does not apply in this testing situation. Each of the questions bears a designation of Phase I (deficiency) or Phase II (deficiency).
Phase I deficiencies do not seriously affect the quality of patient care or significantly endanger the welfare of a laboratory worker. Phase I deficiencies require documented responses.
Phase II deficiencies are major deficiencies that may seriously affect the quality of patient care or may affect the health and safety of hospital or laboratory personnel. All Phase II deficiencies must be corrected and the correction documented to the satisfaction of the CLA before accreditation will be granted. Correction requires both a plan of action and additional evidence that the plan has been implemented.
College of American Pathologists Laboratory Accreditation Manual
Page 1
Inspector Information
COMMISSION PHILOSOPHIES
Peer Review
Purpose: Improve laboratory performance through objective evaluation and constructive criticism.
The inspector can enhance the spirit of peer review and educational benefit of the inspection process by keeping in mind the following items:
· Inspectors are representatives of the accreditation program and the CAP; they must strive for an objective and fair review. There may be more than one way to respond to a requirement and be in compliance.
· The inspection team leader should be a peer of the medical director and serve as a guest consultant to the laboratory.
· If a deficiency can be corrected to the inspector’s satisfaction while the inspector is on site, that deficiency should not be cited in the Inspector’s Summation Report.
· Deficiencies should be presented factually with recommendations for improvement.
· A negative, unduly critical, or punitive attitude should be avoided.
· Deficiencies cited by the inspection team may be challenged. Dialogue between the medical director and the inspection team leader strengthens the program and can provide insight to both to the director and the team leader. Such discourse may lead to changes to Checklist questions or clarification of requirements. The director is encouraged to respond in writing to the CAP about any disputed citation. Supporting documentation should be included in the any response. The Regional Commissioner, in conjunction with the entire Commission, will adjudicate the challenge. An inspector should encourage the appeal process, if necessary, to avoid conflict at the Summation Conference.
Thoroughness
Participating laboratories expect a thorough, detailed, and fair inspection. All pertinent items in the Checklist should be considered. Most laboratories spend considerable time and effort preparing for the inspection; they appreciate and deserve a comprehensive inspection.
Overlooking seemingly minor deficiencies does not do anyone a favor.
Judgment
The Commission relies upon the inspector’s judgment more than any other attribute in the assessment of a laboratory. This attribute is, however, the most difficult to standardize. There will be occasions when a conscientious inspector will have difficulty deciding whether a Checklist item should be answered “Yes” or “No” or N/A. Many of these situations involve partial compliance with the wording in the question. The inspector must be as detailed as possible in the description of a deficiency in the Inspector’s Summation Report (ISR). In some cases, there may be doubt as to whether the item actually applies to the specific laboratory inspected.