Laboratory of Pathology - Staff

LP Personnel  Policies

Sexual harassment is not tolerated at the NIH.

Organization Chart

Laboratory of Pathology Organization Chart

The Chief of the Laboratory of Pathology (LP) has designated the Clinical Manager, Section Head for Clinical Operations to perform duties related to responsibilities for reviewing laboratory-wide polices and implementing regulatory standards. Please see the Medical Director’s Delegation of Authority for defined roles and responsibilities of LP's clinical section heads.

Medical Director Responsibilities

In accordance with standards established by the Clinical Laboratory Improvement Amendments (CLIA) and adopted by the College of American Pathologists (CAP), the Medical Director for the Laboratory of Pathology, CCR, NCI has authority and the responsibility to implement and maintain standards of the CAP and CLIA. The LP Medical Director is responsible for the overall operation and administration of the LP clinical services, including all aspects of personnel management, technical and administrative operations, quality management, procurements and budgets. The LP Medical director will ensure:

• Testing systems in the laboratory provide quality services in all aspects of test performance, i.e., the pre-analytic, analytic, and post-analytic phases of testing and are appropriate for the NIH/LP patient population;
• Physical and environmental conditions of the laboratory are adequate and appropriate for the testing performed;
• The environment for employees is safe from physical, chemical, and biological hazards and safety and biohazard requirements are followed;
• Technical and/or general supervisors (high complexity testing) are available to provide day-to-day supervision of all testing personnel and reporting of test results as well as provide on-site supervision for specific minimally qualified testing personnel when they are performing high complexity testing;
• Sufficient numbers of appropriately educated, experienced, and/or trained personnel to provide appropriate consultation, properly supervise, and accurately perform tests and report test results in accordance with the written duties and responsibilities;
• New test procedures are validated and reviewed/approved prior to performing patient testing, and new tests are included in the procedure manual and followed by personnel;
• All laboratory tests are enrolled in proficiency testing or perform alternate proficiency surveys, and proficiency testing policies are adhered to;
• Quality assessment and control programs are established, assessed and maintained;
• Deviations from LP's established performance characteristics are investigated and remedial actions implemented and issue(s) resolved prior to resuming patient testing - i.e., root-cause-analysis, QA investigative reports, instrument troubleshooting;
• Each employee’s responsibilities and duties are specified in writing, and employees are trained and competency assessed to perform their duties; and,
• Established and engaged continuing education program for all professional and technical staff; 

Medical Director Delegation of Authority

In accordance with standards established by the Clinical Laboratory Improvement Amendments (CLIA) and adopted by the College of American Pathologists (CAP), the Medical Director for the Laboratory of Pathology, NCI, CCR has delegated responsibilities and authority to Section Directors / Technical Supervisors (Section Heads) and General Supervisors, meeting the CLIA qualifications for the specialties supervised.  Each section's Laboratory Personnel Evaluation Roster must be reviewed at least annually by the section Technical Supervisor as delegated authority, and updates must be made on the CAP's Organization website when new professional and technical staff are hired. 

Clinical Services Roles and Responsibilities

Section Heads (Section Director / Technical Supervisors) must meet the Clinical Laboratory Improvement Amendments (CLIA) qualifications for the specialties supervised and must fulfill the following responsibilities. All section heads for LP's clinical services meet the CLIA requirements for supervising high-complexity testing, and are identified on the sections' Laboratory Personnel Evaluation Roster.  Authorized roles and responsibilities for Technical and General Supervisors include:

• Ensuring availability to the laboratory section as needed for on-site, telephonic or electronic consultation.
• All technical and regulatory compliance for the assigned discipline or service. 
• Implement and maintain CAP standards, selection of equipment and methodologies, validation and implementation of new methods and instruments, communication of laboratory data, and resolution of technical problems and ensuring remedial actions are taken when necessary.
• Ensuring policies and standard operating procedures (SOPs) are relevant and appropriate, and SOPs are reviewed biennially. 
• Ensuring enrollment in Proficiency Testing programs for all analytes, and ensuring compliance with Quality Assurance, Quality Control, and Performance Improvement programs.
• Personnel Management: ensuring staff qualifications, training, competency, and continuing education requirements are met.
• All Technical Directors/Supervisors identify training needs, and have authority to train and competency assess technical and administrative staff that support patient-care responsibilities in their clinical sections. 

General Supervisors have delegated authority to: perform training and competency assessment in their disciplines, but must meet the general supervisor qualifications for high complexity testing if assessing staff performing high-complexity testing; monitor test performance; and ensure remedial actions at taken when test systems deviate from established performance specifications.

Clinical consultants must meet the CLIA qualifications for the specialty (e.g. board certified anatomic pathologist). The clinical consultant must be available to provide and ensure that consultation is available on test ordering, and interpretation of results relating to specific patient conditions, and for matters relating to the quality of test results reported. The clinical consultant must also ensure that patient reports include pertinent information required for interpretation. 

Testing Personnel performing moderate- and/or high-complexity testing (e.g. Pathologists Assistants) must meet the CAP and CLIA requirements for the complexity testing performed. Each LP staff has a Personnel Qualification Verification Form completed by the Section's General Supervisor or Clinical Manager upon hire to designate type of testing the staff is authorized to perform. 

Personnel Policies and Records

All personnel policies for the NIH are located on the NIH Office of Human Resources Web site. Job descriptions define qualifications and duties for each position. Personnel records contain the job description, qualifications, references, and performance evaluations. The supervisor of the section maintains continuing education and competency records for each employee. All records must be easily available with the exception of health records, which are maintained in the Occupational Medical Service (OMS) and are only reviewed or released with consent of the employee. OMS will test technical personnel who perform laboratory tests requiring color discrimination for visual discrimination. This does not mean that visually color-impaired technical personnel cannot be employed, only that they be tested with job assignments and responsibilities evaluated accordingly.

Section personnel folders for testing and supervisory staff, and other laboratory personnel include the following elements:

1. Copy of academic diploma, transcript, or primary source verification (PSV) report confirming credentials
2. Laboratory personnel license, if applicable
3. Summary of training and experience (can be resume)
4. Certification, if applicable
5. Description of current duties and responsibilities as specified by the laboratory director - can be the Position Description or Performance Management and Appraisal Plan (PMAP) that addresses:
    a) procedures the individual is authorized to perform
    b) Whether supervision is required for specimen processing, test performance or result reporting,
    c) Whether supervisory or section director review is required to report patient test results
6. Records of continuing education
7. Dates of employment - hire date identified is appropriate

Note: Work-related incident and/or accident records are only maintained in Occupational Medical Service (OMS)

Time and Attendance

• All employees must complete his/her work requirement during the hours of duty specified in their tour of duty. Changes in tour of duty must meet program goals, properly balance workload, and be approved in writing by their supervisor and the Chief, LP. Changes must be in accordance with HHS and OPM policies, and federal regulations. Examples include: alternative work schedules, flexible work.

• Schedules, uncommon tours of duty, compressed work schedule, dual pay, differential pay, telecommuting, and work periods outside the 6:00 AM to 6:00 PM (M-F) time band.

• Telecommuting and/or performing work in the employee's home or living quarters are not permitted without prior written approval from the Chief, LP. Furthermore, the Assistant Secretary for Personnel Administration, HHS, must approve overtime outside the work unit.

Meal Periods and Breaks

      https://policymanual.nih.gov/2300-610-5

1. Meal Periods –
   1. A meal period must be provided if the employee is scheduled to work 8 or more hours a day. Employees on an alternative work schedule, e.g., flexible and compressed work schedules to include variable day, variable week, and/or maxiflex schedule, must have a meal period if they work 8 or more hours a day.
   2. A meal period may be provided if the employee is scheduled to work more than 5 but less than 8 hours a day.
   3. A meal period is usually not provided if the employee is scheduled to work 5 or fewer hours a day, however; the employee's request for one may be granted at management's discretion.
   4. A meal period may not be skipped at the discretion of the employee in order to shorten the length of the work day.
   5. Employees who are required by their supervisors to work through their meal period must be given a meal period later in the same workday, be dismissed from duty an equivalent period of time at the end of the workday, or be compensated for working during the meal period.
2. Breaks –
   1. Are granted at the discretion of management and as such are an employee benefit, not an entitlement.
   2. May not be scheduled immediately before or after meal periods or at the start or end of the workday.
   3. May not be accumulated for use in lieu of leave.

                Work Break - A brief period of paid work time, e.g., 15 minutes or less, set aside at management's discretion for the efficiency, health,
                or safety of employees.

                Meal Period - a minimum of one-half hour of unpaid time set aside for eating. A meal period is not considered to be part of the basic
                workweek/work requirement, except in those situations when the supervisor requires the employee to perform his or her regular
                duties while eating.

NIH Leave Policies

        https://hr.nih.gov/benefits/leave/nih-leave-guide-civilian-employees

LP Leave Instructions

To ensure compliance with the NCI and NIH Leave Guidance, this notice is to communicate the procedures for requesting and obtaining leave approval when you have a need to be absent from the workplace.

Scheduled Absence: A request for approval for a scheduled absence from work for 2 days or less, must be submitted to your immediate supervisor via email at least 2 business days in advance of the date you are requesting approval to be absent. Requests for approval to be absent from work for more than 2 days must be submitted to your immediate supervisor via email at least 5 business days in advance of the start date of the period you are requesting approval to be absent. Please note that when requesting approval to be absent you must also indicate what type of leave you are requesting, such as annual leave, sick leave, or leave without Pay (LWOP). If your absence is approved, you must submit a leave request in the Integrated Time and Attendance System (ITAS). Examples of scheduled leave are scheduled doctor appointments for you or a family member, vacation, etc.

Unscheduled Absence: Occasionally, the need to take leave cannot be anticipated, such as for illness, emergency, or inclement weather. When this happens, you must email your immediate supervisor at least 1 hour prior to the start of your tour of duty to request and obtain approval to be absent from work. Please note that when requesting approval to be absent you must also indicate what type of leave you are requesting, such as annual leave, sick leave, or LWOP and your anticipated return date.  

Late Arrival/Early Departure: There may be an occasional incident which results in a need for a late arrival or early departure from the office. In the event that you are unable to report for duty on time, you must email your immediate supervisor at least 1 hour prior to the start of your tour of duty to request and obtain approval to be late to work. There may be an occasional incident for which you need to leave work prior to the end of you tour of duty, due to illness or an emergency. If this occurs, you are required to email your immediate supervisor to request and obtain approval prior to leaving the office. In the event that your supervisor is unavailable, and you do not receive a response from your supervisor within 10 minutes, you must forward the email requesting approval to leave work to the person designated by your supervisor to approve absences in such instances.  

Medical Certification: Absences due to illness in excess of 3 consecutive work days, will require medical certification to support approval of the continuing absences. The medical certification must be personally signed by a licensed healthcare provider, on his/her letterhead or stationary, and specify that you are under the provider’s care and are incapacitated/or unable to report to work. Other administratively acceptable evidence to support the use of leave may be submitted, such as a hospital or healthcare facility certification.

Leave Entry Into ITAS: Be advised that approval of an absence must be granted by your supervisor before submission of a leave request in ITAS can be approved. All approved leave requests must be entered into ITAS by noon on the second Thursday of the pay period. You are also required to verify your timecard in ITAS by noon on the second Thursday of the pay period.

Requirement to Comply with Instructions for Approval of Absences: Be advised that failure to request and obtain approval of an absence or late arrival/early departure in accordance with the instructions above may result in charges of absence without leave (AWOL). Failure to follow these instructions and/or repeated charges of AWOL can be the basis for proposing a disciplinary action.

Designated Official for Approval of Early Departures When Immediate Supervisor is Unavailable: In the event your immediate supervisor is not available, either the Lead Section Technologist or Staff Scientist, Branch Chief, Deputy Branch Chief, or Clinical and Scientific Operations Manager (in this order of priority) should be notified for requests for early departure. Notify your immediate supervisor by email who provided approval of the early departure request prior to leaving the work area.

Exceptions

Any exception to the above must be approved with reasonable written justification by the appropriate supervisor

• All exceptions must be in compliance with current policy and federal regulation.

• The Chief, LP, must approve changes, which last for a period of time longer than one pay period.

• Leave Policies

Emergency Employees - Refer to Emergency Plan page.

• Refer to the Emergency Management Plans page. 

• OPM Guidelines for Dismissal or Closure Procedures

Tier Designation – LP clinical staff are to be established as Tier 1 employees

EMERGENCY TIER DESIGNATIONS (ETD)ETDs are tiered in three categories based on the activities/functions performed that support the NIH/IC mission and if the employee has an approved NIH telework agreement. The methodology applies a series of tests to determine which functions are necessary to operate the NIH during an array of emergencies. All NIH employees must be assigned to a specific Tier. This same rationale can be applied to NIH contractors. The Contracting Officer Technical Representatives (COTRs)/Project Officers should work with IC leadership and procurement to ensure that all contract awards reflect necessary emergency requirements.

Signature Lines in Business Emails

Government office equipment and technology resources are primarily available for NIH work. Employees should use government office equipment/resources responsibly and appropriately. In this regard, the signature block of an e-mail is meant to serve business purposes and should only contain your name, job title, contact information, or other pertinent information.

As a matter of policy, employees should not include other content in the signature block unrelated to your official business; e.g., statements or quotes of a religious or political nature, or annotations intended for comic effect. Not everyone may share an employee’s views, and the imposition of an employee’s beliefs or opinions on others may create an unwelcome intrusion and feeling of discomfort. Please respect the diverse views shared by LP personnel and our society.

The NIH Ombudsman provides the following excerpt from the NIH EEOC Guidance that is relevant to this policy:

We interpret the line “Employers must take steps to prevent religious harassment of their employees” to mean while we respect people’s rights to hold differing beliefs and opinions, we don’t allow them to voice them or display them in ways that are likely to make others uncomfortable. Conversely, we won’t prohibit all forms of expression (wearing of religious jewelry, having an ideological totebag, keeping a bible on their desk) just because someone else might be upset by it. The line is typically drawn by how personal the expression is versus how public and unavoidably present to others.