Public Health Laboratories and Health System Change . Site Visit Protocols

10/06/1997

Public Health Infrastructure And The Private Sector: Public Health Laboratories And Managed Care

Draft Site Visit Protocol

Questions for Public Health Laboratory Interviewees

State Public Health Laboratory Infrastructure

Laboratory Size, Organization, and Funding:

Briefly describe the size and organization of the public health laboratory.

How many branch offices are there?

How many FTEs?

What is the percent breakdown by labor category?

What is the organization of the public health laboratory with respect to the larger state public health infrastructure?

Do you have an organizational chart?

Can you provide a financial summary of the public health laboratory?

What is the annual budget?

Please describe the revenues and costs.

What are the sources of funding and what is the percentage of funding by source?

State

Federal funds

User fees

Which of these sources provide funds specific to particular laboratory functions (e.g., PCR testing, testing/surveillance of emerging infections)

What is the budget for laboratory equipment including laboratory information systems?

Over the past 2-3 years, has the public health lab budget increased, decreased, or remained the same?

What are some of the key reasons for changes in funding?

What effect, if any, have funding changes had on the number of FTEs or other lab resources?

How have other changes in the public health infrastructure affected public health laboratory resources?

Have you made any capital acquisitions for the lab during the last 2-3 years?

How, if at all, has the level of capital acquisitions been affected by health market changes?

Scope of Laboratory Services/Core Laboratory Functions:

What are the types of lab services provided/core functions of the public health lab today?

Which tests does the lab perform the most (by volume)?

List of tests performed by the public health laboratory?

Common tests such as: Syphilis, HIV, Gonorrhea, Chlamydia, TB, drug sensitivity for TB, Enteric pathogens (typing issue)

Actual figures for volume of tests performed or specimens processed? If not why?

Do core functions include screenings for chronic diseases or conditions?

Cancers

Hyperlipidemia

Newborn screenings

Does the lab provide reference testing for other labs?

For what particular pathogens?

Does the lab provide testing services for environmental quality?

Please give some examples of typical environmental tests performed by the public health laboratory.

As part of the core functions, does the laboratory engage in laboratory improvement activities or research?

What is the public health laboratory's role with regard to CLIA?

Have public health infrastructure changes affected the role of the public health laboratory?

Which changes in particular?

Which functions have they affected?

Have they had an affect on testing volume for specific tests?

Does state law mandate providers to send specimens to the state public health lab for initial testing or reference testing purposes?

For which tests are these submissions mandated?

Does state law mandate providers to report the incidence of specific diseases to the public health lab?

For which diseases?

Over the past 2-3 years, have the types or volume of testing increased, decreased, or remained the same?

What are some of the key reasons for the changes?

Could you provide us with specific data to support the changes in volume?

Is the lab involved with any research or training activities (use of new technology)?

Does your state have Medicaid Managed Care?

If yes, what impact (general and specific) has Medicaid Managed Care had on the core functions public health laboratory?

How has overall testing volume been affected?

For which tests has the public health lab seen increases/decreases in testing volume?

Have any tests been discontinued?

Public Health Laboratory's Role with regard to Emerging Infections:

Please describe the public health laboratory's role in detecting and controlling for emerging infections, e.g., E.coli, Mycobacterium tuberculosis, Salmonella, Borrelia burgdorferi (Lyme disease), Cryptosporidium, Hepatitis A, Cryptococcus (Meningitis).

Are independent reference laboratories or hospital laboratories required to submit isolates of specimens containing these pathogens to the public health laboratory for confirmation?

What is the process for identification and reporting of emerging infections to the state health agency?

How are these pathogens generally detected in your state?

Usually by the public health laboratory?

. Usually by hospital based laboratories?

. Usually by independent reference laboratories?

Has the volume of emerging infection isolates submitted for confirmation to the public health laboratories changed in recent years, and what types of evidence suggests this (quantitative, anecdotal)?

Laboratory Information System Resources/Process Automation:

What planning or strategy exists within the state public health lab for data infrastructure development?

How are laboratory testing results conveyed back to the customers (i.e., electronically through LIS or paper form)?

What electronic connectivity do you have with MCOs?

To what extent, if any, is your results reporting system designed to help MCO customers comply with HEDIS requirements?

What laboratory information system do you have in place currently?

How many requisitions are entered into your database daily?

Does your LIS have any relational databases?

What is your process of disease reporting to public health officials?

Do you have any electronic connectivity to the state epidemiology office?

What information system connectivity do you have with the Centers for Disease Control (CDC), e.g., PHLIS?

If you use PHLIS, what types of information are transmitted to CDC, and for which diseases, e.g., salmonella?

What system(s) do you use to code tests electronically, e.g., LOINC, SNOMED?

If you do have an LIS, has it resulted in any cost savings? If so, how much?

Do you have any funding, either from the federal or state government, for capital investments in laboratory information systems?

Please describe lab processes for a typical testing episode, from collecting the specimen to reporting test results.

What is the typical turnaround time?

To what extent is this dependent on the type of test being performed?

Provide examples of tests with shorter/longer turn around times.

Which parts of this process are automated?

What differences (if any) are there in the approach towards lab process automation between public health labs and private sector labs?

Differences in level of resources?

Differences in priority?

Importance of customer service?

Managed Care and Public Health Labs

Relationships between Public Health Labs and Managed Care Organizations:

Does the state public health lab have any contracts with MCOs (for-profit or not-for-profit) to provide testing services?

If so, please describe the arrangement(s).

For which services?

How were these contracts developed?

How, if at all, is the state public health lab reimbursed for these services?

Are there any plans to develop these relationships?

What have been some barriers to developing state public health lab/MCO relationships?

Does the state public health lab have any other interactions with for-profit or not-for-profit MCOs?

Is there a memorandum of understanding to share information on lab-related issues?

Are there any collaborative arrangements between public health laboratories and MCOs?

What is the nature of these arrangements?

Are future collaborations being considered?

What are some of the areas where public health labs and MCOs can work together?

What are some areas of need?

What are areas where there is duplication of functions between MCOs and public health laboratories?

Impact of Managed Care on State Public Health Lab

What is the market penetration of managed care organizations in the state?

What is the status of Medicaid managed care in the state?

Has the presence of public or private managed care programs affected the volume/types of services provided by public health labs?

Which of the services have been affected and how?

Has there been a decrease in per-capita clinical chemistry testing?

Has there been an increase in environmental testing?

Has there been a decrease/increase in other testing services?

Have any services been discontinued/started because of these effects?

What effect has public or private managed care had on public health laboratory's revenue supply?

Have they affected the amount of users' fees generated by the state public health lab? If so, how significantly?

Have they affected the level of capital acquisitions by the public health laboratory?

What trends have you seen in disease reporting in the state in light of managed care (i.e., quality and volume of reporting)?

What do you see as some of the possible impacts of these trends?

Lab Stakeholder Interactions in the State

Please describe the relationships between the various lab stakeholders in general:

State public health laboratory

State health department (including Medicaid/Medicare)

Other public health labs (county, federal labs)

Other labs: commercial, hospital, MCO, physician office, home testing labs

Federal health agencies (e.g., CDC, FDA, NIH)

Users of public health labs: providers, managed care organizations (MCOs)

Is the interaction between the state public health lab and clinical labs collaborative in nature or competitive?

For what types of tests do the state public health labs compete with the private clinical labs?

Which types of tests are only performed by the state public health lab?

Which are the types of tests that have been historically performed by state public health labs that are now being performed by other competing labs?

Are you exploring new areas of service in response to some of the competitors, or emphasizing certain types of services?

Please describe the roles of and relationships between the various lab stakeholders in terms of disease reporting responsibilities:

State public health lab

State health department

Local health departments

Other public health labs (county, federal labs)

Other labs: commercial, hospital, MCO, physician office, home testing labs

Federal health agencies (e.g., CDC, FDA, NIH)

Users of public health labs: providers, MCOs

Please describe the roles of and relationships between the various lab stakeholders during a disease outbreak:

State public health lab

State health department

Local health departments

Other public health labs (county, federal labs)

Other labs: commercial, hospital, MCO, physician office, home testing labs

Federal health agencies (e.g., CDC, FDA, NIH)

Users of public health labs: providers, MCOs

 

Other Issues Involving Health Market Change and Public Health Labs

Have hospital consolidations affected lab testing capabilities and capacity?

Has there been an increase/decrease in specific tests?

Have certain services been started/discontinued?

Have there been changes in the way specimens are processed?

With regards to the types of tests performed?

With regards to the focus of resources?

How have health market changes affected the development of laboratory information systems and other health information laboratory technologies?

Has the privatization, or the threat of privatization, affected your lab's operations?

Public-Private Collaborations in Clinical Laboratory Services

Is the state public health lab involved in any collaborative efforts with private laboratories or other private organizations (e.g., drug, computer, device companies)?

What are the terms of the arrangement(s)?

Are new arrangements being considered?

What are some of the areas where public health labs and other private organizations can work together?

What are the primary barriers to overcome for successful public-private collaboration?

What are some potential areas for public and private collaboration in lab-related issues?

In the area of disease reporting?

In the area of clinical laboratory standards?

Unique Value of the Public Health Labs

Would you agree or disagree that the unique value of public health labs are evident in the following functions?

provision of laboratory services with the public's interest in mind (i.e., there may be inherent conflict of interest in private labs providing public health services)

population level disease surveillance

response to disease outbreaks

performing tests unrelated to individuals treatment, but significant for public health reasons (e.g., serotyping of certain bacteria)

testing for diseases without commercial viability (e.g., orphan tests)

quality assurance for all clinical labs

evaluating and monitoring success/failure of public health programs through testing (e.g., childhood lead levels and lead abatement programs)

. serving as a conduit for transfer of new lab technologies to private sector

. serving as a reservoir for collection of important disease data

What public health lab core functions do you see remaining and disappearing in the next five years?

What are the implications of these core functions on size and resources devoted to public health laboratories?

How do you think the relationship between public health labs and MCOs will change in the future?

Questions for Independent Clinical Laboratory Interviewees

Market Environment for Clinical Laboratory Services

What is the number and market share of different types of private clinical labs in the state?

physician office labs

hospital-based labs

independent reference labs

how have the numbers and types of labs changed over time; what are the trends?

What is your estimate of the scope of services offered by each type of clinical lab?

For what types of tests do the state public health labs compete with the private clinical labs?

Which types of tests have historically been performed by state public health labs and are now being performed by other competing labs?

Which types of tests are only performed by the state public health lab?

Are there state mandates requiring specific tests to be conducted by the public health lab?

For which tests?

Are there state mandates requiring the reporting of certain findings to the state public health labs?

For which diseases/conditions?

Is the lab exploring new areas of service in response to some of the competitors, or emphasizing certain types of service?

What are some of the trends in the clinical laboratory market in the state?

Have these trends positively, negatively, or not affected the type/volume of services provided by public health labs?

Has the emergence of large, commercial labs affected the market for lab services in the state? If yes, how?

What effect has the presence of large commercial laboratories (e.g., SmithKline, LabCorp, Quest Diagnostics) had on the clinical laboratory market?

With respect to the tests performed by a typical clinical laboratory?

With respect to disease reporting?

What effect has the development of managed care organizations had on the clinical lab market?

Has testing volume for certain tests increased/decreased?

Have certain tests been started/discontinued?

What has been the effect of MCOs on disease reporting practices?

 

Public-Private Collaborations in Clinical Laboratory Services

Is the state public health lab involved in any collaborative efforts with your laboratory?

What are the terms of the arrangement(s)?

What are the primary barriers to overcome for successful public-private collaboration between public health labs and clinical labs?

What are some potential areas for public health lab and clinical laboratory collaboration in lab-related issues?

In areas of disease reporting?

In maintaining/monitoring clinical lab standards?

Is the interaction between the state public health lab and clinical labs collaborative in nature or competitive?

 

Lab Stakeholder Interactions in the State

1. Please describe the relationships between the various lab stakeholders in general:

state public health lab

state health department (including Medicaid/Medicare)

other public health labs (e.g., county, federal labs)

other labs: commercial, hospital, MCO, physician office, home testing labs

federal health agencies (e.g., CDC, FDA, NIH)

users of public health labs: providers, managed care organizations (MCOs)

2. Is the interaction between the state public health lab and clinical labs collaborative in nature or competitive?

For what types of tests do the state public health labs compete with the private clinical labs?

Which types of tests are only performed by the state public health lab?

Which types of tests have historically been performed by state public health labs and are now being performed by other competing labs?

Are you exploring new areas of service in response to some of the competitors, or emphasizing certain types of services?

3. Please describe the roles of and relationships between the various lab stakeholders in terms of disease reporting responsibilities:

state public health lab

state health department

local health departments

other public health labs (e.g., county, federal labs)

other labs: commercial, hospital, MCO, physician office, home testing labs

federal health agencies (e.g., CDC, FDA, NIH)

users of public health labs: providers, MCOs

4. Please describe the roles of and relationships between the various lab stakeholders during a disease outbreak:

state public health lab

state health department

local health departments

other public health labs (e.g., county, federal labs)

other labs: commercial, hospital, MCO, physician office, home testing labs

federal health agencies (e.g., CDC, FDA, NIH)

users of public health labs: providers, MCOs

Lab Practices and Resources

General Activities/Capabilities:

What services does your lab provide?

Can you tell us the list of services you provide?

How many FTEs do you have?

FTEs only involved in testing?

FTEs involved in disease reporting?

FTEs involved in providing other services (e.g., courier)?

Who are your major customers?

Hospitals/SNFs?

Physician Offices?

MCOs?

How are you generally reimbursed (capitation or FFS)?

What is your budget for capital investment for lab equipment, including lab information systems?

Laboratory Information System Resources/Process Automation

What planning or strategy exists within the laboratory for data infrastructure development?

Do you have plans to provide customers with information-driven services?

How are laboratory testing results conveyed back to the customers (i.e., electronically through LIS or paper form)?

To what extent, if any, is your results reporting system designed to help MCO customers comply with HEDIS requirements?

What laboratory information system do you currently have in place?

How many requisitions are entered into your database daily?

Does your LIS have any relational databases?

What electronic connectivity do you have with MCOs?

What system(s) do you use to code tests electronically (e.g., LOINC, SNOMED)?

What is your process for reporting test results to public health officials?

Do you have any electronic connectivity to the state epidemiology office?

What information system connectivity do you have with the Centers for Disease Control (CDC), e.g., PHLIS?

If you use PHLIS, which diseases/conditions (e.g., salmonella) and what types of information are transmitted to CDC?

If you do have an LIS, has it resulted in any cost savings? How much?

Please describe how the lab processes a typical testing episode from collecting the specimen to reporting test results:

What is the typical turn around time?

To what extent is the process dependent on the type of test being performed?

Please give examples of tests with shorter/longer turn-around times.

Which parts of this process are automated?

Unique Value of the Public Health Labs

Would you agree or disagree that the unique value of public health labs are evident in the following functions?

provision of laboratory services with the public's interest in mind (i.e., there may be inherent conflict of interest in private labs providing public health services)

population level disease surveillance

response to disease outbreaks

performing tests unrelated to individuals treatment, but significant for public health reasons (e.g., serotyping of certain bacteria)

testing for diseases without commercial viability (e.g., orphan tests)

quality assurance for all clinical labs

evaluating and monitoring success/failure of public health programs through testing (e.g., childhood lead levels and lead abatement programs)

serving as a conduit for transfer of new lab technologies to private sector

serving as a reservoir for collection of important disease data

What public health lab core functions do you see remaining and disappearing in the next five years?

What are the implications of these core functions on size and resources devoted to public health laboratories?

How do you think the relationship between public health labs and MCOs will change in the future?

Questions for Managed Care Organization Interviewees

Managed Care and Laboratory Services

What laboratory services are included in your enrollee benefits?

Does your MCO have internal laboratories?

What tests do they perform themselves?

What tests do they outsource, and why?

Does your MCO have contracts with clinical laboratories?

What services are generally covered under these contracts?

What is the typical mechanism for reimbursing clinical laboratory contractors?

What are the criteria your MCO uses when deciding how to choose laboratory service providers?

Automated processes?

Courier services?

Short turn-around-time?

Sophisticated information systems?

Are you connected electronically with your laboratory service contractors for purposes of information transfer?

To what extent does information connectivity with laboratory contractors help you comply with HEDIS requirements?

What do you think is the role of laboratory services in terms of the benefits you provide to your enrollees?

Purely for diagnosing disease conditions?

Broader purposes?

Managed Care and Public Health Laboratories

Relationships between Public Health Labs and Managed Care Organizations

Does the state public health lab have any contracts with your MCO (for-profit or not-for-profit) to provide testing services?

For which services?

Is the public health laboratory reimbursed for providing these services?

Is the reimbursement mechanism capitated or FFS-based?

If the state public health lab does not have any contracts with your MCO, are there any plans to develop these relationships?

What have been some barriers to developing state public health lab/MCO relationships?

Are there any state requirements (by law or contract) mandating MCOs to submit specimens for specific tests to the public health lab?

How is the mandate established?

For which specimens?

Are there any requirements (by law or contract) mandating MCOs to report the results of particular tests to the public health laboratory?

How is the mandate established?

For which specimens?

Does the state public health lab have any other interactions with your MCO (e.g., signing a memorandum of understanding to share information on lab-related issues)?

Managed Care Environment in the State:

What is the market penetration of MCOs in the state?

How (if at all) has the advent of Medicaid managed care affected your organization?

How has providing services to the Medicaid population changed your practices with regard to laboratory testing or disease reporting?

Has there been an increase in MCO offerings of preventive services and surveillance services that overlap traditional public health responsibilities?

What trends have you seen in disease reporting in the state in light of managed care (i.e., quality and volume of reporting)?

What do you see as some of the possible impacts of these trends?

Unique Value of the Public Health

Would you agree or disagree that the unique value of public health labs are evident in the following functions?

provision of laboratory services with the public's interest in mind (i.e., there may be inherent conflict of interest in private labs providing public health services)

population level disease surveillance

response to disease outbreaks

performing tests unrelated to individuals treatment, but significant for public health reasons (e.g., serotyping of certain bacteria)

testing for diseases without commercial viability (e.g., orphan tests)

quality assurance for all clinical labs

evaluating and monitoring success/failure of public health programs through testing (e.g., childhood lead levels and lead abatement programs)

serving as a conduit for transfer of new lab technologies to private sector

serving as a reservoir for collection of important disease data

What public health lab core functions do you see remaining and disappearing in the next five years?

What are the implications of these core functions on size and resources devoted to public health laboratories?

How do you think the relationship between public health labs and MCOs will change in the future?