College of American Pathologists Cancer Protocols and Checklists Upper Aerodigestive Tract (Including Salivary Glands)Updated November 16, 2006 http://www.cap.org/apps/docs/cancer_protocols/2005/upperaero05_ckw.doc

The College of American Pathologists (CAP) is the primary professional organization accrediting clinical medical laboratories. The CAP bases their accreditation standards on scientific evidence that links best practices to best outcomes. The following is a list of the CAP Accreditation Checklist standards that have emanated from clinical research published by Dr. Novis and his coworkers.

COMMISSION ON LABORATORY ACCREDITATION

Laboratory Accreditation Program

All Checklists are ©2005. College of American Pathologists. All rights reserved

LABORATORY GENERAL CHECKLIST

GEN.20316             Phase II                                                              N/A   YES   NO

Are key indicators of quality monitored and evaluated to detect problems and opportunities for improvement?

NOTE:  Key indicators are those that reflect activities critical to patient outcome, that affect a large proportion of the laboratory’s patients, or that have been problematic in the past. The laboratory must document that the selected indicators are regularly compared against a benchmark, where available and applicable.  The benchmark may be a practice guideline, CAP Q-PROBES data, or the laboratory’s own experience.  New programs or services should be measured to evaluate their impact on laboratory service.  The number of monitored indicators should be consistent with the laboratory’s scope of care.  Special function laboratories may monitor a single indicator; larger laboratories should monitor multiple aspects of the scope of care commensurate with their scope of service.  (However, there is no requirement that an indicator(s) be assessed in every section of the laboratory during every calendar year.)

Examples of key indicators include, but are not limited to the following.  (Indicators related to CAP patient safety goals include numbers 1, 4, 7, 8 and 9.)

1.      Patient/Specimen Identification.  May be any of the following:  percent of patient wristbands with errors, percent of ordered tests with patient identification errors, or percent of results with identification errors.

2.      Test Order Accuracy.  Percent of test orders correctly entered into a laboratory computer.

3.      Stat Test Turnaround Time.  May be collection-to-reporting turnaround time or receipt-in-laboratory-to-reporting turnaround time of tests ordered with a stat priority.  May be confined to the Emergency Department or intensive care unit if a suitable reference database is available.  Laboratories may monitor mean or median turnaround time or the percent of specimens with turnaround time that falls within an established limit.

4.      Critical Value Reporting.  Percent of critical values with documentation that values have been reported to caregivers

5.      Customer Satisfaction.  Must use a standardized satisfaction survey tool with a reference database of physician or nurse respondents.

6.      Specimen Acceptability.  Percent of general hematology and/or chemistry specimens accepted for testing.

7.      Corrected Reports General Laboratory.  Percent of reports that are corrected.

8.      Corrected Reports Anatomic Pathology.  Percent of reports that are corrected.

9.      Surgical Pathology/Cytology Specimen Labeling.  Percent of requisitions or specimen containers with one or more errors of pre-defined type.

10.  Blood Component Wastage.  Percentage of red blood cell units or other blood components that are not transfused to patients and not returned to the blood component supplier for credit or reissue.

11.  Blood Culture Contamination.  Percent of blood cultures that grow bacteria that are highly likely to represent contaminants.

While there is no requirement that the specific key quality indicators listed above be monitored, these indicators have been field-tested and shown to be measurable in a consistent manner, to demonstrate variability from laboratory-to-laboratory, and to be important to clinicians and to patient care.  For the above indicators, performance should be compared with multi-institutional performance surveys that have been conducted within ten years of the laboratory s most recent measurement, where such surveys are available (see references below).  Action plans should be developed for any indicator in which laboratory performance falls below the 25^th percentile (i.e., 75% or more of the other laboratories in the study perform better).  Use of the indicators listed above does not require enrollment in any quality monitoring product.

4) Novis DA, et al.  Biochemical markers of myocardial injury test turnaround time.  Arch Pathol Lab Med. 2004; 128:158-164;

10) Novis DA, et al.  Quality indicators of fresh frozen plasma and platelet utilization. Arch Pathol Lab Med. 2002; 126:527-532\

GEN.20348             Phase II                                                                N/A   YES   NO

Are preanalytic variables monitored?

NOTE:  Preanalytic (i.e., pre-examination) variables include all steps in the process prior to the analytic phase of testing, starting with the physician s order.  Examples include accuracy of transmission of physicians’ orders, specimen transport and preparation, requisition accuracy, quality of phlebotomy services, specimen acceptability rates, etc.  This list is neither all-inclusive nor exclusive.  The variables chosen should be appropriate to the laboratory’s scope of care.

13) Dale JC, Novis DA. Outpatient phlebotomy success and reasons for specimen rejection. A Q-Probes study. Arch Pathol Lab Med. 2002;126:416-419;

GEN.20364             Phase II                                                                                             N/A   YES   NO

Are postanalytic variables monitored?

NOTE:  Postanalytic (i.e., post-examination) variables include all steps in the overall laboratory process between completion of the analytic phase of testing and results receipt by the requesting physician.  Examples are accuracy of data transmission across electronic interfaces, reflex testing, turnaround time from test completion to chart posting (paper and/or electronic), and interpretability of reports.  This list is neither all-inclusive nor exclusive, providing the variables chosen are appropriate to the laboratory’s scope of care.

1) Novis DA, Dale JC. Morning rounds inpatient test availability. A College of American Pathologists Q-Probes study of 79 860 morning complete blood cell count and electrolyte test results in 367 institutions. Arch Pathol Lab Med. 2000;124:499-503;

4) Jones BA, Novis DA. Nongynecologic cytology turnaround time. A College of American Pathologists Q-Probes study of 180 laboratories. Arch Pathol Lab Med. 2001;125:1279-1284

point-of-care testing CHECKLIST

POC.03200             Phase II                                                                         N/A   YES   NO

Is the POCT program enrolled in the appropriate available graded CAP Surveys or a CAP approved alternative proficiency testing program for the patient testing performed?

COMMENTARY:

The POCT program must participate in a CAP Surveys or CAP approved program of graded interlaboratory comparison testing appropriate to the scope of the laboratory, if available.  This must include enrollment in surveys with analytes matching those for which the laboratory performs patient testing (e.g., patient whole blood glucose testing requires enrollment in CAP survey WBG or approved equivalent).  Laboratories will not be penalized if they are unable to participate in an oversubscribed program.

6) Novis DA, Jones BA. Interinstitutional comparison of bedside glucose monitoring. Characteristics, accuracy performance, and quality control documentation: a College of American Pathologists Q Probes study of bedside glucose monitoring performed in 226 small hospitals. Arch Pathol Lab Med. 1998;122:495-502

POC.03225             Phase II                                                                  N/A   YES   NO

For tests for which CAP does not require PT, does the laboratory at least semiannually  1) participate in external PT, or 2) exercise an alternative performance assessment system for determining the reliability of analytic testing?

NOTE:  Appropriate alternative performance assessment procedures may include:  participation in ungraded proficiency testing programs, split sample analysis with reference or other laboratories, split samples with an established in-house method, assayed material, regional pools, clinical validation by chart review, or other suitable and documented means.  It is the responsibility of the Laboratory Director to define such alternative performance assessment procedures, as applicable, in accordance with good clinical and scientific laboratory practice.

COMMENTARY:

For analytes where graded proficiency testing is not available, performance must be checked at least semi annually with appropriate procedures such as:  participation in ungraded proficiency surveys, split sample analysis with reference or other laboratories, split samples with an established in house method, assayed material, regional pools, clinical validation by chart review, or other suitable and documented means.  It is the responsibility of the Laboratory Director to define such procedures, as applicable, in accordance with good clinical and scientific laboratory practice.

2) Novis DA, Jones BA. Interinstitutional comparison of bedside glucose monitoring. Characteristics, accuracy performance, and quality control documentation: a College of American Pathologists Q Probes study of bedside glucose monitoring performed in 226 small hospitals. Arch Pathol Lab Med. 1998;122:495-502;

POC.03500             Phase II                                                  N/A   YES   NO

Does the point-of-care testing program have a written QC/QM program?

NOTE:  The QM/QC program for POCT  must be clearly defined and documented.  The program must ensure quality throughout the preanalytic, analytic, and post-analytic (reporting) phases of testing, including patient identification and preparation; specimen collection, identification, and processing; and accurate result reporting.  The program must be capable of detecting problems and identifying opportunities for system improvement.  The laboratory must be able to develop plans of corrective/preventive action based on data from its QM system.

COMMENTARY:

The quality control (QC) and quality management (QM) program in POCT should be clearly defined and documented.  The program must ensure quality throughout the preanalytic, analytic, and post-analytic (reporting) phases of testing, including patient identification and preparation; specimen collection, identification, and processing; and accurate result reporting.  The program must be capable of detecting problems and identifying opportunities for system improvement.  The POCT program must be able to develop plans of corrective/preventive action based on data from its QM system.

Before patient results are reported, QC data must be judged acceptable.  The Laboratory Director or designee must review QC data at least monthly.  Beyond these specific requirements, a laboratory may (optionally) perform more frequent review at intervals that it determines appropriate.  Because of the many variables across laboratories, the CAP makes no specific recommendations on the frequency of any additional review of QC data.

5) Novis DA, Jones BA. Interinstitutional comparison of bedside glucose monitoring. Characteristics, accuracy performance, and quality control documentation: a College of American Pathologists Q Probes study of bedside glucose monitoring performed in 226 small hospitals. Arch Pathol Lab Med. 1998;122:495-502

POC.08800             Phase II                                                           N/A   YES   NO

For QUANTITATIVE tests, are control materials at more than one concentration (level) used for all tests at least daily?

NOTE:  For coagulation tests under CLIA 88, 2 different levels of control material are required during each 8 hours of patient testing, and each time there is a change in reagents.  For blood gas testing under CLIA-88, a minimum of 1 quality control specimen for pH, pCO2 and pO2 is required during each 8 hours of patient testing.

COMMENTARY:

For quantitative tests, an appropriate quality control (QC) system must be in place.

The daily use of 2 levels of instrument and/or electronic controls as the only QC system is acceptable only for unmodified test systems cleared by the FDA and classified under CLIA 88 as “waived” or “moderate complexity.”  The laboratory is expected to provide documentation of its validation of all instrument reagent systems for which daily controls are limited to instrument and/or electronic controls.  This documentation must include the federal complexity classification of the testing system and data showing that calibration status is monitored.

6) Novis DA, Jones BA. Interinstitutional comparison of bedside glucose monitoring. Characteristics, accuracy performance, and quality control documentation: a College of American Pathologists Q Probes study of bedside glucose monitoring performed in 226 small hospitals. Arch Pathol Lab Med. 1998;122:495-502

TRANSFUSION MEDICINE CHECKLIST

TRM.20000             Phase II                                          N/A   YES   NO

Does the transfusion medicine section have a written quality management/quality control (QM/QC) program?

NOTE:  The QM/QC program in the transfusion medicine section must be clearly defined and documented.  The program must ensure quality throughout the preanalytic, analytic, and post-analytic (reporting) phases of testing, including patient identification and preparation; specimen collection, identification, preservation, transportation, and processing; and accurate, timely result reporting.  The program must be capable of detecting problems in the laboratory s systems, and identifying opportunities for system improvement.  The laboratory must be able to develop plans of corrective/preventive action based on data from its QM system.

All QM questions in the Laboratory General Checklist pertain to the transfusion medicine section.

9) Novis DA, et al. Quality indicators of blood utilization. Three College of American Pathologists Q-probes studies of 12, 288, 404 red blood cell units in 1639 hospitals. Arch Pathol Lab Med. 2002;126:150-156;

10) Novis DA, et al. Quality indicators of fresh frozen plasma and platelet utilization. Three College of American Pathologists Q-probes studies of 8 981 796 units of fresh frozen plasma and platelets in 1639 hospitals. Arch Pathol Lab Med. 2002;126:527-532;

11) Novis DA, et al. Operating room blood delivery turnaround time. A College of American Pathologists Q-Probes study of 12 647 units of blood components in 466 institutions. Arch Pathol Lab Med. 2002;126:909-914.

CYTOPATHOLOGY CHECKLIST

CYP.00800             Phase II                                                 N/A   YES   NO

Is there a clearly defined and documented quality management program in cytopathology?

NOTE:  Laboratories should consistently review activities and monitor their effectiveness in improving performance.  Each laboratory should design a program that meets its needs and conforms to appropriate regulatory and accreditation standards.

6) Jones BA, Novis DA. Cervical biopsy-cytology correlation. A College of American Pathologists Q-Probes study of 22439 correlations in 348 laboratories. Arch Pathol Lab Med. 1996;120:523-531;

CYP.07569             Phase II                                   N/A   YES   NO

Is an effort made to correlate gynecologic cytopathology findings with available clinical information?

NOTE:  Methods of clinical correlation should be documented in the laboratory procedure manual, and selected reports can be reviewed to confirm practice.  Possible mechanisms may include:  focused rescreening of cases based on clinical history, history of bleeding, or previous abnormality; correlation of glandular cells with hysterectomy status, age of patient, and last menstrual period; review of previous or current biopsy material.  Documentation of clinical correlation may include policies, problem logs with resolution, or notes in reports.

COMMENTARY:

An effort must be made to correlate gynecologic cytopathology findings with available clinical information.

3) Jones BA, Novis DA. Follow-up of abnormal gynecologic cytology. A College of American Pathologists Q-Probes study of 16 132 cases from 306 laboratories. Arch Pathol Lab Med. 2000;124:665-671;  .

CYP.07690             Phase I                                                                                               N/A   YES   NO

Are 90% of reports on routine non-gynecologic cytology cases completed within 2 working days of receipt by the laboratory performing the evaluation?

NOTE:  This question is primarily concerned with the majority of routine specimens, and applies to all laboratories.  Longer reporting times may be allowed for specimens requiring special processing or staining (e.g., immunohistochemistry or other molecular analysis), or for screening (as opposed to diagnostic) specimens (for example, urines).  If the laboratory has certain classes of specimens, patient types, etc., for which longer turnaround times are clinically acceptable, these must be identified, together with reasonable target reporting times, for Inspector review.  Documentation may consist of continuous monitoring of data or periodic auditing of reports by the laboratory.  In lieu of this documentation, the Inspector may audit sufficient reports to confirm turn around time.

Jones BA, Novis DA. Nongynecologic cytology turnaround time. A College of American Pathologists Q-Probes study of 180 laboratories. Arch Pathol Lab Med. 2001;125:1279-1284.

LIMITED SERVICE LABORATORY CHECKLIST

LSV.37050             Phase II                                                                   N/A   YES   NO

Are routine and STAT results available within a reasonable time?

NOTE:  A reasonable time for routine daily service, assuming receipt or collection of specimen in the morning is 4 to 8 hours. Emergency or STAT results that do not require additional verification procedures should be reported within 1 hour after specimen receipt in the laboratory.

COMMENTARY:

Routine and stat results must be available within a reasonable time.  A reasonable time for routine daily service, assuming receipt or collection of specimen in the morning, is 4 to 8 hours.  Emergency or stat results that do not require additional verification procedures should be reported within 1 hour after specimen receipt in the laboratory.

2) Steindel SJ, Novis DA. Using outlier events to monitor test turnaround time. A College of American Pathologists Q-Probes study in 496 laboratories. Arch Pathol Lab Med. 1999;123:607-614;

HEMATOLOGY – COAGULATION CHECKLIST

HEM.23150             Phase II                                       N/A   YES   NO

Are routine and STAT results available within a reasonable time?

NOTE:  A reasonable time for routine daily service, assuming receipt or collection of specimen in the morning, is 4-8 hours.  For common hematology and coagulation tests, emergency or STAT results that do not requir

Summary of Projects

CONSULTING

Dr. Novis assists clients directly, and as a subcontractor for other consulting companies with providing laboratory and pathology services. Dr. Novis has:

For hospital administrators:

• Evaluated the adequacy and quality of pathology services,
• Designed models for delivery of pathology service and pathologist reimbursement
• Conducted recruitment searches for a laboratory medical director and sub specialty pathologists.
• Conducted billing, utilization, and compliance audits

For private laboratories

• Secured CLIA certification and CAP accreditation
• Evaluated delivery of pathology services
• Addressed sales teams of customer preferences
• Presented webinars on applying lean production techniques to reduce errors
• Implementing lean techniques resulting in a 20% reduction in billing audit completion times.

For pathology organizations and support vendors:

• Performed national and international accreditation inspections
• Provided governance functions
• Advised defense attorneys on matters relating to laboratory quality, CLIA and CAP compliance, and laboratory oversight
• Authored articles on pathology and laboratory service delivery
• Authored manual on launching tissue laboratories

For physicians

• Advised community hospital pathologists on practice organization, service delivery, quality assessment
• Wrote pathology service proposal
• Analyzed scientific literature.

MEDICAL PRACTICE, MANAGEMENT, ADMINISTRATION

Courtagen Life Sciences, Woburn, MA.
Since 2011, Dr. Novis has been the CLIA Laboratory Director of Courtagen Life Sciences a privately held clinical laboratory that performs next generation sequencing (NGS) technology to diagnose mitochondrial disease in children and adults. Dr. Novis

• Assisted Courtagen in receiving CLIA certification and state licensures.
• Authored laboratory procedures
• Developed quality control and quality assurance systems.
• Advised management in all aspects of laboratory management and service 

Oxford Diagnostic Laboratories (ODL), Marlborough, MA
Since 2008, Dr. Novis has been the Medical Director of ODL. ODL is a privately held clinical laboratory that performs TSpot-TB test, a cutting edge blood test for the diagnosis of Tuberculosis that is replacing the antiquated TB skin test., Dr. Novis has

• Assisted ODL in receiving CLIA certification, CAP accreditation, and state licensures.
• Authored laboratory procedures
• Developed quality control and quality assurance systems.
• Advised management in all aspects of laboratory management and service
• Served as a resource and troubleshooter for ODL clients.

Young Novis PA (YNPA)
For 25 years, YNPA provided anatomic and clinical pathology services to two community hospitals, the University of New Hampshire Student Heath Center laboratory, and Path Lab Inc, a regional private laboratory. As managing partner of YNPA, Dr. Novis :

• Introduced practice innovations including:
• Computerized anatomic pathology and cytology records (1981)
• Non-physician assistants (1982)
• Template diagnostic reporting (1983)
• Computer generated graphics (1992)
• Internet-based reporting (2002).
• Delivered 8% revenue growth/year over 25 years, 31% revenue growth in last 4 years of practice with greater than 50% of pre-collection gross revenues realized to net income.
• Demonstrated consistently high rate of customer satisfaction.
• Demonstrated consistently high metrics of quality; recognized by hospital Performance Improvement Committee as a high quality provider.

Northeast New England Pathology Associates (NENEPA)
For 10 years, NENEPA, a consortium of four pathology practices provided anatomic and clinical pathology services to regional and national laboratories in the Seacoast region on New Hampshire and Southern Maine. As founding partner and President, Dr. Novis

• Organized four competing practices to work cooperatively and embrace concepts of partnering and value generation.
• Ensured profitability: during its last 3 years of operation (2001-2005), third party reimbursement revenues increased  over 150%, realizing revenues of 4.6 million.

Physicians Professional Management Company. (PPMC) www.ppmcbilling.com
PPMC is a physicians billing and practice management company serving office-based and hospital practices in Massachusetts, Maine, and New Hampshire. As Founding Partner and Director, Dr. Novis participated in:

• Strategic planning resulting in conversion of the company from a co-operative consortium to a private for-profit entity, targeting of markets, developing new product lines, and fostering growth.
• Realization of 31% growth in last four years with revenues exceeding 5 million dollars annually.

QUALITY
College of American Pathologists (CAP) www.cap.org
The CAP is the professional organization of pathologists. Dr. Novis has served as Vice Chair of the Quality Practices Committee and is a laboratory inspector for the CAP s Laboratory Accreditation Program

• Designed, planned, and monitored approximately 100 national studies of quality outcomes, benchmarking and best practices in Pathology and Laboratory medicine.
• Studies purchased by over 1000 institutions worldwide generating 1 million dollars of revenue annually.
• Wrote quality outcome summary reports and analyses for customer distribution.
• Published articles in peer reviewed journals.
• Presented data at national society meetings.
• Reviewed manuscripts dealing with quality practices for several medical journals.
• Provided data by which the College of American Pathologists Laboratory Accreditation Program established standards of performance.

Wentworth Douglass Hospital (WDH) www.wdhospital.com
WDH is the largest of five acute care community hospital, serving a population of 100,000 people residing in the Seacoast region of New Hampshire and Southern Maine.

Advised hospital Performance Improvement Committee; work cited for excellence by the JCAHO.

HOSPITAL GOVERNANCE AND PLANNING
Wentworth Douglass Hospital  (WDH) www.wdhospital.com
WDH is the largest of five acute care community hospitals serving a population of 100,000 people residing in the Seacoast region of New Hampshire and Southern Maine. WDH maintains a full service cancer diagnostic and treatment facility and owns The Works Family Health and Fitness Center,  one of the largest health and fitness centers in New Hampshire. For 10 years, Dr. Novis was a Hospital Trustee, serving on the Strategic Planning and Community Benefits Committees. He was Chairman of the Board of The Works.

• Sole or major contributor to projects including:
• Development of outcome-based dashboards for strategic planning and governance.
• Designing a system for educating and orienting Trustees.
• Implementing a system that provided financial assistance to under served citizens: 4.2 million dollars worth of assistance distributed yearly to over 3700 citizens while maintaining levels of operating margin, operating cash, and days cash on hand that exceeded national benchmarks.
• Establishing a dental clinic providing care to 2500 under served citizens within first  6 months of operation.
• Providing medication assistance of 2.5 million dollars annually to under served citizens.
• Developed strategic and master plan for hospital-owned health and fitness center.  The design included a 7.5 million dollar, 40,000 sq. ft. facility expansion which allowed the creation of a community family program. In the first 2 years of operation, revenues increased from 3 to 4.5 million, membership increased from 5,000 to 9,000, and health system utilization was increased through health screenings which referred members into other hospital services—all done while maintaining a net operation margin of 22%.
• Contributor to projects:
  • Cancer Center expansion
  • Extension of primary care services into secondary markets
  • Hospitalist and Intensivist programs
  • Physician succession plan
  • Expansion of physical plant
  • Joint ventures with staff physicians (MRI, Sleep Lab)
  • Design and development of system of to assess implementation of burgeoning technology.

PROFESSIONAL ACTIVITIES
College of American Pathologists (CAP) www.cap.org; Clinical Laboratory Management Association (CLMA) www.CLMA.org); American Society of Cytopathology  (ASC) www.cytopathology.org; Northeast Medical Association (NEMA) www.nemaonline.com

Dr. Novis has served on the CAP’s Quality Practices, Education and Cancer Committees and is the New Hampshire Representative to the House of Delegates.

The ASC is the is the professional organization of pathologists and technologists sub-specializing in the field of Cytopathology. Dr. Novis headed the ASC s task force on membership, and was a member of their Strategic Planning Committee.

NEMA is a multi-specialty medical society devoted to studying advance in outdoor medicine and sports-related injuries. Dr. Novis has served as NEMA’s Secretary-Treasurer and President.

As a member of these organizations, Dr. Novis has:

• Designed and conducted membership preference surveys and produced a plan for increasing the ASC’s membership.
• Authored the ASC mission statement and strategic plan, including outcome metrics.
• Designed a concept for CAP Internet-based learning and professional consultation. .
• Authored CAP cancer diagnostic protocols.
• Provided performance criteria for CAP Laboratory Accreditation Program.
• Designed planned and conducted 10 NEMA’s national and international scientific symposia.
• Evaluated best practice studies (CLMA).