About Us

Founded in 1985, the BDC Laboratory of the Baltimore City Health Department (BCHD) holds a Federal license to operate a Highly Complex Independent Laboratory and maintains a State of Maryland Laboratory Permit. Our voluntary inspection agency is the Commission on Laboratory Accreditation (COLA), which presented the BDC Laboratory with an Award for Laboratory Excellence.

Laboratory Client Base

BDC Laboratory provides diagnostic support to BCHD Adolescent, Family Planning, Chest (TB) and STD Clinics, which compromise six geographically-separate locations. Also the BDC Laboratory provides testing services for three BCHD mobile vans and eight Community-Based Organizations (CBOs) allied with BCHD.

BDC Laboratory is a referral facility for sites offering Rapid HIV Testing. The Laboratory performs HIV-1 Western blot supplemental testing to confirm initial Rapid HIV Positive test results. The samples are referred from two BCHD STD Clinics, four Hospital Emergency Departments, and three CBOs throughout the metropolitan Baltimore area.

Who Does the Testing?

All Medical Technologists at BDC Laboratory are health care professionals with a BS degree in Medical Technology, which includes a formal internship in a full-service medical laboratory.

Medical Technologists working in the Clinical Laboratory use specialized instrumentation and techniques to analyze blood and urine samples for detecting, treating, and monitoring disease.

Because they produce test results with a significant impact on health care, Medical Technologists are specially educated and highly trained for the functions they perform and, in most cases, have certification for their position. The BDC Laboratory Administrator (also a Medical Technologist with a health care graduate degree) has over 30 year of laboratory experience to oversee the testing being performed in the Laboratory. The Laboratory Administrator also ensures that strict quality control practices and quality management systems are followed to produce reliable and accurate test results.

Laboratory Regulations and Quality Assurance

Key participants in the quest for laboratory quality have been the Federal and State governments and the laboratory professional community.

The Federal government under the Clinical Laboratory Improvement Amendments (CLIA) regulates clinical labs in the United States.

Passed by Congress, CLIA established quality standards for laboratory testing to ensure that results are accurate, reliable, and timely. CLIA regulations include standards for the education and training of lab personnel so that our clients can be confident in their ability to report accurate results.

The Department of Health and Mental Hygiene (DHMH) also licenses laboratories in Maryland.

Regulatory Agencies Overseeing BDC Laboratory

• Federal Government - All laboratories that perform tests on "specimens derived from humans for the purpose of providing information for the diagnosis, prevention, and treatment of disease" fall under the Clinical Laboratory Improvement Amendments (CLIA). This means that if a clinician wants a patient’s blood or urine analyzed, then CLIA will influence how these samples are handled and how the tests are performed.
• State Government – Maryland has additional requirements that are more stringent than those outlined in CLIA. In this case, the State, not the Federal government, assumes primary responsibility for oversight of laboratory practices.
• Laboratory Professional Organizations - The first line of defense for accurate results is Federal regulation, but the foundation for this regulatory system is the voluntary accrediting systems developed by laboratory personnel and their professional organizations.
• The Commission on Laboratory Accreditation (COLA) accredits BDC Laboratory. COLA is a voluntary professional organization whose mission is to help laboratories operate accurate and efficient testing facilities. By earning accreditation through COLA, laboratories also meet Maryland and Federal CLIA requirements.

The Commission on Laboratory Accreditation (COLA) accredits BDC Laboratory. COLA is a voluntary professional organization whose mission is to help laboratories operate accurate and efficient testing facilities. By earning accreditation through COLA, laboratories also meet Maryland and Federal CLIA requirements.

Specimen Requirements

The clinical usefulness and accuracy of laboratory testing are limited by the quality and correctness of the sample used for analysis. However, specimen quality depends in large part upon those submitting the specimens. Your actions in collecting and submitting samples influence the outcome of test results.

Test Requested	Appropriate Sample for Testing
Chlamydia/GC Screen by Nucleic Acid Amplification Test (NAAT)	Urine tube, Vaginal, Urethral, Throat or Rectal Swab in Lab-supplied collection kit
Complete Blood Count (CBC)	Lavender Top Blood Tube (5-7ml)
Gonorrhea Culture	GC Culture Plate (incubated at 35C)
HIV-1 Antibody Screen	Red Top Blood Tube (7-10ml)
Syphilis Serology Screen* (RPR Card Test)	Red Top Blood Tube (7-10ml)
Quantiferon (QTF TB Blood Test)	Set of three QTF Blood Tubes

*Screening tests automatically reflex to Confirmation Assays if initial test is Positive and there is sufficient sample available for the additional testing.

HIV-1 antibody Positive samples are tested with HIV-1 Western blot supplemental assay.

Syphilis Serology Positive samples are tested with RPR Titer and FTA-ABS Confirmation assay.

Specimen Labeling

Mislabeled and inadequate laboratory samples have been identified as a source of medical errors and can jeopardize patient safety.

Correct specimen collection and labeling are beneficial for all involved. For the Laboratory, it ensures quality test results, compliance with regulations, and meets diagnostic test manufacturers’ sample acceptance criteria. For the clinician, it avoids delays in detecting infections, and possible anxiety and inconvenience for the patient.

Two labeling protocols exist for specimens submitted to BDC Laboratory:

OPTION ONE

To properly identify the sample(s) submitted for testing, use a label with two identifiers such as patient’s printed name and date of birth (DOB) or unique number (e. g. Medical Record).

The printed name must match exactly as shown on the Laboratory Test Request Form submitted with the sample(s). Place the Test Request Form and labeled sample(s) in the same plastic specimen transport bag and forward to BDC Laboratory. The sample(s) will be identified further by barcodes placed onto the sample and Test Request Form by BDC Laboratory staff.

OPTION TWO

Place a portion of a specific barcode label on the sample, and use a pre-printed label or print the patient’s name on the sample. The second part of the barcode label is placed on the Laboratory Test Request Form.

Send the information to the BDC Laboratory in an electronic file format to request tests.

See following Table the in next section for Barcode Groups and tests they will initiate.

    BARCODE GROUPS AT BDC LABORATORY

Prefix	Barcode Color	Test Ordered	Comments
FA	Light Blue	FTA-ABS	Syphilis Confirmation
GC	Dark Blue	CT/GC	Chlamydia/Gonorrhea by NAAT
GO	Green	GC Culture	Gonorrhea Culture
HP	Gray	Hematology Profile	Also known as Complete Blood Count (CBC)
QF	Salmon	Quantiferon© (QTF TB)	TB Blood Test
SO	Brown	Syphilis Serology	Automatic Confirmation Tests if Positive
XO	Orange	HIV-1 Antibody	Automatic Confirmation Tests if Positive

Getting Test Results

BDC Laboratory is staffed to provide rapid and cost-efficient test results. The Laboratory operates in accordance with the City of Baltimore Holiday Schedule and is open Monday-Friday from 8am to 4pm.

Most tests are performed the day the specimens are received in the Laboratory. Some tests are assayed on highly automated instrumentation that performs testing overnight. Samples must be in the Laboratory by 2:30pm to get tested the same day as received.

Results are generally available in two working days. Confirmation testing may take up to four days to complete. Results are provided to clients electronically or in written format. Depending on your facility, results may be uploaded to an electronic medical record (EMR) at your location or returned via courier in a sealed envelope marked "Laboratory Reports-Confidential".

Test Results of Public Health Importance

To comply with Code of Maryland Regulations (COMAR 10.06.01.03c), laboratory test results indicating infectious or communicable diseases are reported to the Central Office of BCHD.

At the Central Office, the laboratory test results are used for disease surveillance programs, patient/partner notification, and follow-up confirmation for disease treatment.

Reference Ranges and Results

Reference ranges (sometimes called "Normal" or "Expected Ranges") are provided with all test reports. Abnormal results are flagged with an asterisk (*) indicating the result falls outside of the expected parameters for that test. Any comments pertinent to a specimen and the test results obtained (e.g. lipemic sample, hemolysis, clotted CBC, etc.) are displayed in a text comment as part of the laboratory test results.