Medical Technologist

BRENDA POPE, MT (ASCP)

**** ********* **** *****: 410-***-****

Odenton, MD 21113 Email: **********@*****.***

Business Owner and Director of Operations

A top-performing, dedicated, dynamic, innovational, and well respected Business Owner, Home Health Care Provider, and Consumer Safety Officer credited with combining compassion, technical savvy, team development, and government regulation expertise to deliver substantial educational, public safety, client care, and compliance assurance in highly technical sectors. Highly accomplished in consumer safety, collaboration and coordination, and in the ability to build and maintain strong relationships.

Areas of Expertise

Public Trust Security Clearance

Quality Control

Strategic Planning/Analysis

Industry Collaboration

Customer Service

Inspections/Audits

Clinical Laboratory Scientist

Business Owner

Compliance

Quality Improvement

Home Health Care

Government Regulations

Recruiting/Hiring

Data Review

Marketer

Professional Experience

COMFORCARE SENIOR SERVICES, Glen Burnie, MD 2008 – 2015

Owner and Director of Operations

Conducted all aspects of opening this Home Healthcare Agency including locating office space and negotiating lease, organizing files as per State requirements, successfully passing State licensing inspection, recruiting staff, and marketing for clients; established billing and payroll rates.

Wrote policy and procedure manuals which included guidelines for opening and closing the office, staffing new cases, ordering supplies, performing background checks, and conducting payroll and billing services.

Supervised RN unannounced and announced site visits; performed budget audits for administrative and marketing department. Secured county contracts with the Departments of Aging in Anne Arundel, and Carroll Counties. Secured additional government programs including Medicaid Waiver Older Adults, and Medicaid Waiver Living at Home.

Continued to grow the business by conducting sales efforts that emphasized the establishment and nurturing of meaningful and productive referral sources that provided ongoing and consistent clients. Supervised a staff of 50 caregivers, 2 RNs, 2 Administrative Assistant, a Marketing Specialist, and a support staff that included an Accountant, and a Computer Technician.

Coordinated daily client and caregiver schedules; performed staffing responsibilities that included emergency staffing, coordinating monthly availability of field staff, responding to customer requests, briefing new employees about client care plans for initial visits, and initiating disciplinary actions as required for employees.

Synchronized payroll and billing services, employee flow sheets with client schedules, data entry of billing and payroll data into software system, and follow-up with field staff who were delinquent with required paperwork.

Recruited, screened, interviewed, processed, and oriented employees. Orientation training included HIPAA regulations, transfer, and infection control training.

Sold profitable agency

FOOD AND DRUG ADMINISTRATION, Rockville, MD 2006 – 2008

Consumer Safety Officer, Department of Enforcement (Public Trust Security Clearance)

Enforced compliance of the Food and Drug and Cosmetic Act; Reviewed and evaluated evidence submitted by the District Offices for actions including warnings, untitled letters, import detention, and injunctions; Developed warning and untitled letters for promotion and advertising violations, recalls and manufacturing deficiencies.

Participated in the inspections of Class III medical device companies; Issued inspectional guidance to the district; Reviewed Establishment Inspections Reports (EIR) from the district inspectors; Collaborated with members of other centers and agencies to include the Office of Criminal Investigations (OCI), Center for Biologics (CBER), and the Department of Justice (DOJ) based on the inspection reports.

Reviewed and evaluated the manufacturing section of Pre-Market Approval (PMA) Applications including procedures, corresponding supplements, and site change requests.

Reviewed and classified 25 recalls; Prepared two Health Risk Assessments, nine Health Hazard Evaluations, and chaired two Health Hazard Evaluations which included doctors, engineers and lawyers from the Office of Device Evaluation, Office of Surveillance and Biometrics, and the Office of Science and Engineering Laboratories.

DEPARTMENT OF THE ARMY, WALTER REED ARMY MEDICAL CENTER, Washington, DC 2005 – 2006

Supervisor, Medical Technologist

Served as the immediate rater and supervisor of Medical Technologists, and Medical Laboratory Technicians in the Stem Cell Transplant and Bone Marrow Processing Laboratories. Collected and processed Peripheral Blood Autologous Stem Cells; assisted and processed bone marrow transplants, and performed testing on peripheral blood and body fluids for Complete Blood Counts (CBC), and manual differential of White Blood Cells (WBC).

Participated in the quality improvement program that monitored multiple aspects of patient care. Revised the procedures manual, and added step-by-step guidelines for specimen collection and processing, data entry, instrument maintenance, and quality control.

Took part in inspections by regulatory agencies including College of American Pathologists (CAP), Foundation for the Accreditation of Cellular Therapy (FACHT), and the Joint Commission on the Accreditation of Healthcare Organization (JCAHO).

Performed quality control, correlations, and/or calibration on various Hematology and Coagulation instruments. Consulted with manufacturers to test and provide feedback on test kits, reagents, and new instruments before they were released commercially.

Coordinated with vendors to secure equipment recommendation bids; negotiated cost proposals including equipment costs, start-up costs for supplies, and warranty costs.

Developed Corrective and Preventive Actions for out-of-specification equipment, incomplete procedures, improperly trained staff, incomplete or missing quality control, patient records, and outdated technology.

Collaborated with patient care physicians in discussing the interpretation of test results and other suggested test procedures that helped answer clinical problems. Handled unusual test requests, identified and resolved inconsistent test results, and the occurrence of unusual events.

DEPARTMENT OF THE ARMY, WALTER REED ARMY MEDICAL CENTER, Washington, DC 2004 – 2005

Medical Technologist

Performed testing on peripheral blood and body fluids for CBC, and manual differential of WBC. Conducted hands-on training for Medical Laboratory Technicians (MLT), and Medical Technologist (MT) students.

Consulted with manufacturers to test and provide feedback on their tests kits, reagents, and new instruments before they were commercially released. Managed unusual test requests, identified and resolved inconsistent test results, and the occurrence of unusual events

Maintained compliance standards and prepared for inspections by agencies including CAP and JCAHO. Performed quality control, validations, correlations, and calibration on multiple Hematology and Coagulation instruments.

PREVIOUS PROFESSIONAL EXPERIENCE INCLUDES: DEPARTMENT OF THE ARMY, KIMBROUGH AMBULATORY CARE CENTER, Ft. Meade, MD, 2000 – 2002, Section Supervisor, Medical Technologist; KAISER PERMANENTE, Clinton, MD, 1994 – 2002, Lead Technologist (PRN Medical Technologist).

Education

(In progress) Master of Health Science Administration (MHSA), Strayer University

Bachelor of Science, Biology, Morgan State University

Medical Laboratory Technician, US Air Force, US Army Reserves

FDA & Military Training

Medical Device Law Course

Corrective and Preventive Action (AAMI)

Basic Food and Drug Law Course

Process Validation (AAMI)

Quality Systems Requirement (AAMI)

Advance Topics Regulatory Issues (Recalls)

Anatomy & Physiology (Reviewer)

Device Packaging (AAMI)

Air Force Reserves, Staff Sergeant (SSGT), Mobilized in support of Desert Storm

Air Force, Sergeant (SGT), Decontamination procedures of chemical warfare and field medical procedures

Army Reserves

Professional Affiliation

Medical Technologist (American Society of Clinical Pathologists) - MT (ASCP)

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