11/23/2009   4:35 am

Department of Health (601)

Local Laboratory and Pharmacy Services (601 440 17)

Laboratory and pharmacy services are essential to enable local health departments to diagnose and effectively treat communicable diseases, monitor other reportable conditions, as well as to diagnose and treat chronic diseases, and to respond to public health emergencies. The capacity and complexity of both of these support services varies based on the volume and complexity of laboratory tests and prescriptions and also resources available to local health departments. All local health departments maintain core competencies in inventory and proper storage of drugs and biologicals; ordering, and dispensing pharmaceuticals; provision of immunizations; specimen collection of human fluids or tissue: milk and food sampling; animal head collection for rabies testing; water sample collection; and processing and transporting of specimens for testing by private sector laboratories. These competencies are available in every locality to support prevention, diagnosis, and treatment of reportable diseases; assurance of prenatal and post partum care; wellness in infants and children; performance of environmental health assessments, assuring safe food and drinking water, and disposal of human waste.

All laboratory activities are performed in accordance with the Local Health Department’s Clinical Laboratory Improvement Amendments certificate and all pharmacy activities comply with the Virginia Board of Pharmacy regulations and the Virginia Department of Health policies and procedures. The local health director is responsible for assuring their lab and pharmacy services comply.

Local Laboratory Services

The vast majority of local health departments (97 of 119 Local Health Departments) do only simple tests such as urinalysis and blood hemoglobin in support of services such as well-child examinations and basic communicable disease testing. These types of routine tests are best provided on-site in the interest of timely care for the clients. Additional lab testing not performed by these Local Health Department's are purchased from private sector labs under state contract.

Those local health departments with moderate and high complexity labs (22 of 119) perform more extensive testing in support of clinical programs such as Sexually Transmitted Disease diagnosis and prenatal care. Such labs tend to be located in local health departments who have historically had large clinical programs such as primary care for adults.

More specialized testing, such as identification of uncommon pathogens in outbreaks, testing of animals for rabies, the newborn screening program and testing of specimens for tuberculosis are conducted at the Division of Consolidated Laboratories in Richmond. As a highly specialized laboratory, Division of Consolidated Laboratory Services does not conduct the simple, routine tests that can be done by Local Health Department's or contract laboratories. The testing done in Local Health Department's and by Division of Consolidate Laboratory Services complement one another and are not duplicative. In addition, the Local Health Department's are reimbursed by Medicaid based on Virginia Department of Health's status as a provider of clinical services. Division of Consolidate Laboratory Services is not eligible to bill Medicaid.

All public and private sector laboratories are regulated through the Clinical Laboratory Improvement Amendments of 1988 administered by the federal Centers for Medicare and Medicaid Services. Laboratories subject to Clinical Laboratory Improvement Amendments regulation are those designated as moderate or high complexity based on the types of tests that are performed. The inspection of these labs is carried out by the Office of Quality Health Care and Consumer Services under contract to Centers for Medicare and Medicaid Services. As of 2003 (most recent data) the 97 Local Health Department's that perform few lab tests of low complexity are not subject to Clinical Laboratory Improvement Amendments and are considered ‘waived’ labs.

Local Pharmacy Services

All 119 local health departments can provide some minimal level of prescription drug dispensing, such as contraceptives and Sexually Transmitted Disease treatment, under protocols established by local health directors and the Virginia Department of Health, Central Pharmacy located in Richmond. Each local health department is also capable of dispensing and administering vaccines and medications in the event of an emergency as declared by the Governor.

Seven local health departments operate full service pharmacies that comply with all Board of Pharmacy Regulations. These Local Health Department's employ pharmacisits who fill prescriptions for clients who seek health care services in the health department clinics. These pharmacies do not provide services to the community at large, but only to patients who receive services from local health departments.

As a government agency, Virginia Department of Health purchases prescription drugs through federal contracts and multi-state purchasing compacts at prices that are substantially lower than average wholesale prices. As a condition of this preferential pricing, public health facilities are prohibited from competing against public retail entities for non-public health treatments under the federal Robinson-Patman Act. Subject to available staff, Local Health Departments assist indigent patients to gain access to free medications available through patient assistance programs operated by pharmaceutical companies.

Local Health Department's that have full-service pharmacies are those that have historically have operated large primary care clinics for indigent adults or who provide specialized services to such populations as children with special health care needs and newcomers to this country who are at risk for communicable diseases such as tuberculosis. As with laboratory services, such Local Health Department's must have the resources available to support such an operation. Inspections of these pharmacies are conducted by the Board of Pharmacy.

For the majority of Local Health Department's that do not operate pharmacies in the Local Health Department, the prescription needs of their patients are met through the Virginia Department of Health, Central Pharmacy. These services include: treatment or support for sexually transmitted and communicable diseases, prenatal services, family planning, provision of vaccines to all local health departments under the Virginia Vaccines for Children Program, provision of pharmaceuticals to HIV infected patients under the AIDS Drug Assistance Program; provision of pharmaceuticals in support of the Children Specialty Services Program; provision of pharmaceuticals in support of the Hemophilia Program; provision of vaccines to local health departments that do not have a pharmacy to support immunization for foreign travel; provision of pharmaceuticals in response to natural emergencies, national emergencies, and bioterrorism related events; and provision of guidance and information to local health departments on State and Federal laws that pertain to the storage, distribution, and dispensing of medications.

• Factors Impacting the Products and/or Services:
  A downturn in the economy may increase the demand for services if there is an increase in the number of
  underinsured or uninsured citizens, who turn to the local health department for services.
  
  
  Maintenance of trained staff is challenging as competition from private sector for trained pharmacy staff
  increases and proficiency requirements for laboratory staff increase.
  
  
  Immunization of foreign born non-English speaking persons and world travel creates more diagnostic and
  treatment burden to local health departments.
• Anticipated Changes to the Products and/or Services
  Availability of pharmaceutical supplies (example: flu vaccine) will vary and affect product and service
  availability.
  
  
  Availability of enhanced laboratory testing can dramatically increase the accuracy and timeliness of
  disease detection.
  
  
  Existence of anthrax screening devices in large postal facilities will necessitate the ability to quickly
  respond to predicted number of false positives.
  
  
  Increasing demand for affordable medications requires local Health Department staff to provide more
  linkages to needed resources.
• Listing of Products and/or Services
  • Diagnosis of Organism or Medical Condition: Collection of human and environmental specimens Processing, transporting, and evaluating specimens Reporting laboratory results to Clinicians, Nurses, and Environmental Health Specialists Collectively analyzing reportable disease for surveillance and tracking
  • Consultation and Education: Counseling patients on the meaning of laboratory results Educating private providers on interpretation of laboratory results Educating the public on the significance of laboratory reports Educating providers on how to manage outcomes based on laboratory findings Training of Nurses, Physician Assistants, and other health care providers
  • Treatment: Dispensing medications by licensed clinicians or pharmacists Administering pharmaceuticals to prevent disease Educating patients about side effects and adverse reactions Linking citizens to affordable pharmaceuticals for chronic disease management in the private sector
  • Rapid Emergency Response: Maintenance of documentation of reports and chain of custody of specimens Provide prophylaxis to exposed contacts of communicable disease outbreaks Collaborate with partners to ensure capacity for rapid response to identify/diagnose suspected biological or chemical agent and to provide mass immunizations or treatments

• Assure access to quality pharmaceutical services in support of public health
  Objective Description
  Local health departments assure citizens local access to needed immunizations and pharmaceuticals to promote the health of pregnant women and children, and treat and prevent diseases. The Virginia Board of Pharmacy regulates all local health department pharmacies and conducts periodic inspections to assure adherence to statutory regulations contained in the Code of Virginia. Local health directors and Pharmacist in Charge will assure that their respective pharmacies adhere to all regulatory requirements, and comply with quality standards.
  Objective Strategies
  • Community Health Services will collaborate with the Central Pharmacy to institute a statewide and standardized incident reporting process for all service area customers who experience an "error" in pharmaceutical dispensing and develop a feedback mechanism to assure quality improvement.
  • All dispensing will comply with the Virginia Department of Health policies and procedures and Board of Pharmacy regulations.
  Objective Measures
  • Dispensing error rate
    Measure Class:

    Other

    Measure Type:

    Outcome

    Measure Frequency:

    Annual

    Preferred Trend:

    Down

    Measure Baseline Value:

    .003

    Date:

    7/1/2006

    Measure Baseline Description: Errors per 1,000 filled prescriptions

    Measure Target Value:

    .75

    Date:

    6/30/2010

    Measure Target Description: Errors per 1,000 filled prescriptions

    Data Source and Calculation: 2005 the Virginia Deparment of Health Risk Management data. Error rate = Number of incident reports/number of prescriptions filled

  • Percent of stand alone pharmacies compliant with Board of Pharmacy (BOP) standards.
    Measure Class:

    Other

    Measure Type:

    Outcome

    Measure Frequency:

    Annual

    Preferred Trend:

    Up

    Measure Baseline Value:

    75

    Date:

    12/31/2006

    Measure Baseline Description: Percent

    Measure Target Value:

    100

    Date:

    6/30/2010

    Measure Target Description: Percent

    Data Source and Calculation: BOP inspection reports will be provided to VDH by the local health department pharmacist in charge, and will be usesd to calculate the percentage of compliant stand-alone pharmacies.

• Laboratory services within local health departments will meet the quality standards established by Clinical Laboratory Improvement Amendments with no repeat citations on audit or inspection
  Objective Description
  Local health directors will assure that their respective laboratories maintain a Clinical Laboratory Improvement Amendments Certificate of Compliance. Regular inspections will assure compliance with quality standards. A statewide inventory will be developed that compiles data on Clinical Laboratory Improvement Amendments certification and citations for the laboratories within local health departments to share best practices.
  Objective Strategies
  • Survey Laboratories regarding their current Clinical Laboratory Improvement Amendments certification (high, moderate or waived), including most recent inspection reports and citations. The survey will identify laboratories in need of technical assistance to meet certification requirements. Virginia Department of Health personnel in local health departments that have no repeat findings will provide technical assistance and consultation to those in need of compliance assistance.
  Objective Measures
  • Repeat Clinical Laboratory Improvement Amendments Citations in The Virginia Department of Health Laboratories
    Measure Class:

    Other

    Measure Type:

    Outcome

    Measure Frequency:

    Annual

    Preferred Trend:

    Up

    Measure Baseline Value:

    100

    Date:

    12/31/2006

    Measure Baseline Description: Percent of labs with no repeat violations

    Measure Target Value:

    100

    Date:

    6/30/2010

    Measure Target Description: Percent of labs with no repeat violations

    Data Source and Calculation: The Virginia Department of Health has 16 labs. They are inspected on a three-year cycle.

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