Laboratory of Pathology - Staff

5.  Flow Cytometry

Overview:

The Flow Cytometry Laboratory directly receives diagnostic specimens from in-house patients for evaluation (i.e., they do not go through Histology). Flow cytometric analysis provides critical diagnostic information that is used in treatment decisions. We therefore must assure that these specimens are appropriately handled so that diagnoses can be rendered on an emergency basis when needed and to avoid destruction of the specimen. The resident on-call may be notified concerning a specimen for flow cytometric analysis. This has occurred in the past and is expected in the future. You therefore need to be aware of the proper procedure for handling these specimens. If you have any questions concerning the proper procedure for handling a flow cytometry specimen, please contact Dr. Maryalice Stetler-Stevenson or Dr. Jeffrey Schrager.

Contact either Dr. Maryalice Stetler-Stevenson or Dr. Jeffrey Schrager when you first hear about a flow specimen:

Dr. Maryalice Stetler-Stevenson:

• Pager:  104-4075- 7
• Office/Lab:  301-402-1424 or 301-402-1716

• Pager:  104-5345
• Office/Lab:  301-496-4709

We have answering machines at home and at the office. If you don't reach one of us you should leave a message on all 4 of these machines, including the phone number you can be reached at. Do not simply accept specimens without attempting to contact us. We will try to stain cells on the weekend when possible. We can also store specimens in a manner using techniques that can not be done by the novice.

                               OR

• Keep us informed if procedure is canceled.
  
  
• Optimal results are obtained with fresh material. Inform the clinician of this and tell them to schedule specimen collection during weekdays, if possible. However, as leukemic patients can have emergencies on Friday night and during the weekend, we will have to receive specimens during this time period.
  
  
• Instruct clinician how to obtain and store specimen for immunophenotyping as follows (Do not simply ask if they know how to, instruct them in our method).

Bone Marrow Aspirates:  Prepare the following Transport Media:

1. Place 15 ml RPMI with 10% fetal calf serum in a 50 ml conical tube. RPMI without fetal calf serum is acceptable. If RPMI is not available, PBS can be used.
2. Add 50,000 units of heparin in 5 ml PBS to final volume of 2,500 units/ml.
3. Use sterile heparin to rinse out the syringe and needle before aspiration (sterile heparin is available from the Nurses Station).
4. Immediately post-aspiration, place 3-5 ml of bone marrow aspirate for Flow Lab in Transport or Storage Media. Cap tightly and mix by inverting 5-6 times.
5. Have the bone marrow technologist prepare 2 unstained smears of the bone marrow for Pathology. This is critical so stress this to the clinical fellow. Failure to provide smears may make it impossible to do a TDT.
6. Label all specimens with patient name and unit number, date, type of specimen.

Peripheral Blood:

1. Peripheral bloods can be kept at room temperature overnight. As the temperature in the NIH Clinical Center is so variable, we recommend placing the peripheral blood in an empty styrofoam container with a lid (the type routinely used to ship specimens on ice). There is a container outside of Room 6N-109 for this purpose.
   
   
2. If you have contacted the Flow Lab staff, you will have been told where to put the specimen and it is your responsibility to make sure that it gets to the location you are told. If you have not successfully contacted anyone, leave a message on the home and work answering machines of Catherine McCoy, Gregory Jasper, and Dr. Maryalice Stetler-Stevenson. Include the name and pager number of the clinical fellow who is on-call and covering the patient. We will contact the fellow concerning the specimen. The clinical fellow should call the Flow Lab first thing on Monday morning.

Ordering and Reporting Procedures for Immunohistochemistry:

Immunohistochemical staining is an integral component of modern pathologic diagnosis. A high proportion of cases will require immunohistochemical stains for sign-out. It is the resident's responsibility to see that immunostains are ordered, and cases signed out in a timely manner.

Requests for immunohistochemical staining should be brought directly to Room 2B58. Request forms must be filled out completely; otherwise they may be returned. It is also essential that requests be entered with the SoftPath computer system.

• Do not order stains that are not on the Immunohistochemistry Request Form without speaking to Dr. Raffeld.
  
  
• The resident is responsible to ensure that paraffin blocks or unstained sections prepared on coated or charged slides are available for staining when submitting a request on submitted material.
  
  
• All cases are stained within 24 hours of receiving appropriate unstained slides from the Histology Lab or directly from the submitter.
  
  
• In cases where no unstained slides are available from Histology, the Immunohistology technologists prepare and stain the slides within 72 hours of receipt of the staining request and block.
  
  
• Rush cases must be brought to the laboratory before 10:00 AM to have the slides returned on the same day.
  
  
• The slides are then reviewed daily by the Immunohistochemistry unit professional staff for quality control, and distributed to the attending resident and attending staff for final interpretation.
  
  
• The final interpretation of the immunohistochemical stains is performed by the attending staff pathologist and resident responsible for the case. The immunohistochemical results are incorporated into the surgical pathology report.
  
  
• In the event that a case has been signed out prior to receipt of the immunohistochemistry stains, a supplemental report must be generated.
  
  
• ALL IMMUNOSTAINS MUST BE DOCUMENTED IN YOUR REPORTS.
  

8.  In Situ Hybridization

The In Situ Hybridization Unit provides the resident with practical experience using diagnostic and research tools that are applicable to biomedical research in cancer and other fields. The In Situ Hybridization Unit is responsible for clinical testing for Epstein Barr viral (EBV) sequences using the EBER RNA probe. Results of EBV in situ hybridization are reviewed by the resident, and these data are integrated into the surgical pathology or molecular diagnostic report. The resident also reviews test slides to determine the preservation of RNA in the clinical sample.

9.  Laboratory Management

Duration

Goals and Objectives:

1. Patient Care
   1. The resident will understand laboratory administration skills relevant for the practice of pathology.
   2. The resident will learn to provide appropriate and effective administrative guidance of the laboratory for the management of a patient service.
   3. The resident develops a good working knowledge of the overall organization of the clinical laboratory and the role of the pathologist as the service chief and/or medical director.
   4. The resident will develop an understanding of various concepts and models of organizational structure and their interdependencies with the environment, drivers of change, change management concepts, and strategic planning as it impacts patient care.
   5. The resident will learn to apply the principles of quality control, quality management, (including proficiency testing), continuous quality improvement, and risk management.
   6. The resident understands the importance of and the process of laboratory and general health care institutional accreditation, compliance issues, and regulations. This includes knowledge of the unique roles of professional organizations, regulatory bodies, and governmental agencies (e.g., CAP, AABB, JCAHO, FDA, CMS, ACGME, CLIA, CFR, OSHA, etc.) in the accreditation process.
      
      
2. Medical Knowledge
   
   1. The resident will learn to integrate his/her medical knowledge with models, tools, and concepts to develop managerial problem solving and decision making skills.
   2. The resident has a working knowledge of statistical analysis relevant to clinical laboratory management decisions as it relates to therapeutic implications of common disease states; and the societal impact and preventative aspects of common diseases.
   3. The resident understands the principles of and can interpret the results of new method and instrument validation studies.
   4. The resident will learn to effectively apply his/her general and focused medical knowledge when analyzing administrative situations to make reasonable decisions related to work flow and process management.
      
      
3. Practice-Based Learning and Improvement
   
   1. The resident will discover his/her style of leadership in the context of laboratory settings, and understand the leadership skills necessary to effectively lead, facilitate, and accomplish change.
   2. The resident will review case studies to develop an understanding of how to balance multiple responsibilities of planning, organizing, implementing, and controlling situations and priorities in laboratory management.
   3. The resident will participate in leadership discussions, conferences, lectures, and reading of the literature (texts, journals, and other medical databases) to inform her/his day-to-day practice of pathology, and in the development and resolution of management issues.
   4. The resident develops an understanding of the significance of and process of billing for clinical laboratory and pathology services, including the general approach to providing CPT and ICD-9 codes to maximize reimbursement.
   5. The resident has an understanding of the role of informatics in pathology practice and health care delivery.
   6. The resident will learn how to update the Accreditation Council for Graduate Medical Education (ACGME) online resident case logs.
   7. The resident has a working knowledge of the different types of clinical information systems, including their major components and how the components are organized.
   8. The resident understands the concept of interfacing of different information systems.
   9. The resident has a general knowledge of the process of evaluating and purchasing a laboratory information system.
   10. The resident understands the regulatory requirements for management of laboratory information systems.
   11. The resident understands the different means of requesting laboratory tests, providing laboratory data, test results, and pathology reports using electronic media, including Web-based reporting systems.
   12. The resident has a working knowledge of digital image production and how digital images can be embedded into laboratory or pathology reports.
   13. The resident has a working knowledge of the use of information systems for case searching, data mining, and clinical database management.
   14. The resident will learn how to use the SoftPath™ Laboratory Information System (LIS) to check pending cases, track turnaround time and manage cases so they are processed on a timely basis.
       
       
4. Interpersonal and Communication Skills
   
   1. The resident will learn to communicate effectively and courteously with health care providers, laboratory staff members, administrators, patients, and other individuals in the course of her/his practice.
   2. The resident will learn to work as an effective member of the health care team in the course of his/her daily practice. The resident must strive to perform her/his tasks in a responsible and timely fashion, facilitate the tasks of other team members, and be cooperative in his/her interactions with team members.
   3. The resident will develop an understanding of process design, workflow, staffing, teamwork, and group effectiveness.
   4. The resident has a general knowledge of the principles of laboratory staffing and human resource management.
   5. The resident will learn techniques for effective communication among caregivers and teams and become aware of potential communication issues or barriers.
   6. He/she will learn to practice communications appropriate for collaboration, debriefing, team work and conflict resolution.
      
      
5. Professionalism
   
   1. The resident develops a courteous and collegial demeanor in all interactions while demonstrating professional responsibilities with enthusiasm in an effective and a timely fashion.
   2. The resident has a working knowledge of the concept of client service, including test result turnaround time management, client relations, management of client complaints, etc.
   3. The resident will identify important ethical and legal issues in pathology and apply the principles and policies of ethics and clinical research when faced with moral dilemmas, conflicts of interest, release of human biological materials, processing medicolegal requests, and releasing patient information.
      
      
6. Systems-Based Practice
   
   1. The resident acquires knowledge of practice and health care delivery systems and an awareness of the role of pathology in the context of the greater health care system.
   2. The resident has a general knowledge of the principles of budgeting for the clinical laboratory, including the elements of operating budget, capital budget, direct costs, indirect costs, test fee analysis, and “profit” margin.
   3. The resident understands the elements of laboratory safety.
   4. The resident will learn about guidelines, laws, and regulations pertaining to human resources, understand job analysis, performance management, competency modeling, professional development, interviewing techniques, and factors involving employee retention and motivation, and levels of learning.
   5. The resident will understand the basics fundamentals of financial management, financial ratios, cost/benefits analysis, effective budgeting, and healthcare reimbursement.
   6. The resident will develop an awareness of and responsiveness to the health care system, both at the National Institutes of Health, and in the broader national community.
   7. The resident will develop the ability to effectively call on system resources to provide care that is of optimal value.
   8. The resident will understand concepts in marketing and strategic planning.
   9. The resident will learn career planning techniques and develop attributes for professional development.
   10. The resident will be exposed to inventory management techniques.

Cost-Effective Use of the Laboratory

Personnel Issues

Residents are encouraged to discuss personnel issues with the appropriate manager, members of the clinical staff, supervisor, or section chief as individual issues arise. The core values that define the organizational culture include respect of the contributions and diversity of the people in our workplace and a commitment to a high-quality work life.

Residents are encouraged to develop management acumen in personnel issues, including skills of staff motivation, leading change, leading people, building accountability and continuous quality improvement, building coalitions, time management and productivity. Residents are expected to understand NCI policies found at http://camp.nci.nih.gov/admin.htm. They should understand regulations regarding equal opportunity and affirmative action, become familiar with the principles of performance management and conduct actions, organizational development, staffing, and basic supervision of employees. Questions regarding policies or personnel issues may directed towards the Administrative Manager, Administrative Officer for the Laboratory of Pathology (LP), the Clinical Laboratory Manager, or the Chief of LP.

Budget Preparation

The National Cancer Institute (NCI) prepares a budget plan, which is provided directly to the President of the United States for formulating the budget request for Congress. The NCI 2013 budget request may be reviewed at http://www.cancer.gov/aboutnci/budget_planning_leg/plan-2013/2013budgetrequest. Funds are allocated to a Resident Central Account Number (CAN) each fiscal year. The resident's expenses are charged to this CAN. The Administrative Resource Center (ARC) reports monthly obligations to the Chief of LP and the Chief Resident to monitor budget variances and be good stewards of resources. Questions regarding the budget process may be directed towards the Administrative Officer for LP, the Clinical Laboratory Manager, or the Chief of LP.

The chief resident mediates procurement of large purchases such as microscopes and computers with the Chief of LP. He/she also oversees purchase of consumables for residents through central stores and outside vendors.

Residents may also elect to take courses on financial and procurement management such as the Budget Execution, Budget Formulation, or Federal Budget Process. The schedule for these courses can be found at http://trainingcenter.od.nih.gov. The charge for each class can be charged to the Resident CAN, if approved by the Chief of LP.

Regulatory Agencies

The Laboratory of Pathology (LP) maintains a stringent, quality-oriented accreditation by the Joint Commission of Accreditation for Hospitals (JCAHO) and the College of American Pathologists (CAP).

The lab also maintains compliance with multiple regulatory codes, including the Clinical Laboratory Improvements Act (CLIA), Occupational Health and Safety Act (OSHA), Health Insurance Portability and Accountability Act (HIPPA) and the Code of Federal Regulations (CFR). Residents are required to participate in at least one CAP inspection and participate in the preparation of one JCAHO inspection during their training.

Residents are made aware of CLIA, OSHA, HIPPA, and CFR during their training, by review of laboratory policy and interaction with medical and administrative staff, and must be familiar with these regulations. Questions regarding regulatory agencies may be directed towards the Clinical Laboratory Manager.

Risk Management

The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) accredits the NIH Clinical Center and the Laboratory of Pathology, CCR. The JCAHO has risk management standards that have been implanted with the overriding goal to reduce risk through a coordinated effort to continuously improve quality improvement. The Medical Executive Committee (MEC) of the NIH Clinical Center is the governing body responsible for hospital risk management, risk identification, and risk reduction functions. The bylaws of the Medical Staff may be reviewed at http://www.cc.nih.gov/ccc/aboutcc/msh/laws.html

Clinical cases fulfilling the requirements set forth in the pre-established "Criteria for Selection of Cases for Surgical Case Review Committee" ( Appendix A9) are reported to the Surgical Case Review Committee through the Quality Improvement Committee whenever anatomic pathology section chiefs submit referrals based on the above-mentioned criteria. A pathology resident attends the Quality Improvement Committee meetings as a "resident member" on a rotational basis.

Laboratory Safety

• On an annual basis, each resident reads and signs the Laboratory Safety Manual and the NIH Clinical Center Emergency Plans, attends Fire Safety/Evacuation training and participates in a Fire Drill.
• All residents are required to participate in the Occupational Medical Services (OMS) Tuberculosis (TB) Surveillance Program. OMS may be contacted by calling 6-4411.
• Residents must maintain a valid CPR certification. Residents may review a CPR study guide at http://www.nih.gov/od/ors/ds/oms/cprstudy.htm .CPR training is scheduled by calling 6-4411.
• All residents are required to take the Blood Borne Pathogens training offered via the Clinic Research Informatics System (CRIS) on an annual basis. Residents review the universal precautions information in the Laboratory Safety Manual, then take the test on the CRIS system and print a certificate at the end of the session.
• Residents who work with radioactive materials or radiation, must register for the basic radiation safety class at http://www.nih.gov/od/ors/ds/rsb/rregist.html.
  
  
• All residents are required to complete the safety training requirements outlined in the Laboratory Safety Manual?.  See tab 6 or the LP Policy manual for details.  Training includes:
  
  
  • New Employee Orientation checklist,
  • Universal Precautions and Tuberculosis training,
  • Annual Fire Safety and Fire Evacuation Drills, and,
  • Radiation Safety Orientation (online computer-based training).

Quality Improvement Activities

The Quality Improvement (QI) Program is designed to continually evaluate the quality of clinical services generated throughout the Laboratory of Pathology (LP). This is accomplished by monitoring and evaluating quality improvement indicators for the Laboratory of Pathology and assisting each individual laboratory unit in the identification of areas that can be improved upon to maximize the quality of service and of patient care provided. The autopsy pathology resident attends the QI Committee meetings as a "resident member" during their service months for the purpose of providing an education experience and an opportunity to contribute to the ongoing improvement efforts of the QI Committee. The complete program, procedures and data are available for review by the chair of the QI Committee. Residents are also encouraged and asked to volunteer as needed for committees for the purposes of strategic planning, process improvements, organizational evaluation, and policy development, etc.

Requests for Human Biological Materials

The Laboratory of Pathology (LP) Tissue Research Committee (TRC) is charged with the development and implementation of a process through which basic science observations and translational pathology studies will be prioritized and executed within the LP. The TRC also reviews requests for human biological materials from the pathology archives to ensure that these materials meet ethical guidelines.

The senior resident participates in reviewing tissue requests in concert with a staff pathologist. As part of this process they are trained in the guidelines that govern the research use of human tissues. The complete TRC procedure can be obtained through the Clinical Laboratory Manager.

Principles and Practice of Clinical Research

The residents are encouraged to take the "Introduction to the Principles and Practice of Clinical Research" offered through the NIH Clinical Center, in the second or third year of the Residency Training Program. This 32-session course covers epidemiological methods, ethical issues and regulation of human subjects research, monitoring patient-oriented research and regulatory issues, and preparing and funding a clinical research study. Sessions usually start each January and end in May. Schedule and registration information is located at http://www.cc.nih.gov/OD/corecourse/index2.html

Laboratory Information Systems

The Laboratory of Pathology? uses the SoftPath™ Laboratory Information System (LIS) to accession, process, and manage patient cases. Resident education in medical informatics occurs as they learn the LIS. The LIS is used for, but not limited to,  case management and data management, including ordering additional cuts or special stains on cases, reviewing the history of patients scheduled for operating room procedures or for the tumor board, looking up the case status or diagnosis of a patient, printing case status logs, generating case reports, tracking physician notification, printing worksheets, recording outgoing consultations, exporting data to MS Access for direct research, etc. Residents will gain user experience with all aspects of the pathology information system. A LIS user manual is located in the resident's office and in each section of the laboratory and contains instructions for all LIS procedures as well as the disaster or system failure protocol.