Request for Information – Laboratory Information System (LIS) Application

Posted on January 2, 2008 By Corinne Jones Bid Opportunities

Laboratory Information System (LIS) Application for Haiti

Issued December 28, 2007

Responses due by January 24, 2008

International Training and Education Center on HIV (I-TECH)

University of Washington

Seattle, WA

Purpose. The purpose of this Request for Information (RFI) is to assess interest among companies and other organizations in supplying and implementing a laboratory information system (LIS) to support both clinical care and population health monitoring of HIV-positive persons in Haiti. This RFI is also intended to gather information which may be used to develop a Request for Proposals (RFP) to meet LIS needs in Haiti. Responding to this RFI does not obligate any organization to respond to any subsequent RFP, nor will a response to this RFI be required in order to respond to any subsequent RFP.

Background. I-TECH through funding from a cooperative agreement with the U.S. Department of Health and Human Services, Health Resources and Services Agency (HRSA) and in collaboration with the U.S. Centers for Disease Control and Prevention (CDC), Global AIDS Program (GAP) is supporting the President’s Emergency Plan for AIDS Relief (PEPFAR). PEPFAR has set the following goals for the first five years of the program in 15 focus countries that have a high burden of HIV/AIDS.

· Treatment of 2 million persons living with HIV/AIDS

· Prevention of 7 million HIV infections

· Palliative care for 10 million people (including orphans) living with HIV/AIDS

In order to reach these goals, the U.S. Government has established collaborations with a broad range of partners to implement the many initiatives required to strengthen health system capacity and services in the focus countries. Strong laboratory infrastructure and quality testing is critical to the success of PEPFAR initiatives. This RFI solicits information from qualified information technology software providers that may be used in a subsequent RFP to strengthen LIS in the public health laboratories of Haiti. I-TECH, working together with the Haiti Ministry of Health, the National Public Health Laboratory (NPHL), CDC/GAP and CDC/GAP/Haiti, identified 4 laboratories (Phase 1: HUEH in Port au Prince; Phase 2: HIC in Les Cayes, HUJ in Cap-Haitien, and HSM in Jacmel) in which to implement a pilot phase of the LIS in Haiti. The NPHL as the National reference lab and the head of the laboratory network in the country ensuring both the monitoring and quality control of the laboratory sector will have access to all data and reports generated by the system from phase 1 of the project. The number of laboratories that potentially would have LIS implemented in a national rollout is over 100 and this initial phase of the project will enable development of an effective model for the installation of LIS in all public laboratories, assuring technical, human resource, support and financial issues are properly evaluated and addressed in a national plan. The 4 laboratories proposed for the pilot phase of the project are, Hopital Universitaire d’Etat d’Haiti (HUEH – a teaching/tertiary hospital in Port au Prince), Hopital Justinien (a teaching/tertiary hospital in Cap-Haitien), Hopital St. Michel (a departmental/secondary hospital in Jacmel), and Hopital Immaculee Conception (a teaching/tertiary hospital in Les Cayes).

I-TECH visited Haiti earlier this year to initiate evaluation of the laboratory system related to an implementation of an LIS in the pilot laboratories. The activities of the evaluation team are noted here.

· Evaluated the 4 pilot laboratories, met key stakeholders, and described standard laboratory services and current LIS capacity in the public health sector of Haiti;

· Visited other governmental, private, and NGO (non-government organization) laboratories to compare sample flow procedures and to understand how samples are processed within those laboratories;

· Facilitated discussions on laboratory information system (LIS) requirements with Haiti government and health officials, as well as CDC Haiti staff; and

· Developed an action plan for the implementation of an LIS in Haiti and to gather specific information needed for the development of an RFP for the purchase of an LIS application.

General Technical Specifications

I-TECH is considering supporting the acquisition and implementation of a LIS to be placed in the 4 pilot project laboratories for the purpose of improving quality and efficiency within the laboratory and to provide timely population data to the Haitian Ministry of Health to address strategic and operational concerns in combating HIV/AIDS and other diseases throughout Haiti. The following areas are of particular interest, and we welcome information on achieving these goals:

(1) The LIS selected for Haiti should support a standards-based, bidirectional interface with the electronic medical record (EMR) system developed by I-TECH and University of Washington collaborators. This patient monitoring system is already established in Haiti and will continue to grow in usage through the country.

(2) I-TECH and Haiti are considering all LIS options – including open source software. We welcome information as to the cost, quality, and sustainability of both commercial and open-source options.

(3) Responding organizations should consider a formal partnership with a local IT support team to enable Haiti to manage the system long-term with minimal dependence on external resources, addressing issues of technology transfer. We welcome information in support of such a partnership, as well as cogent arguments against such a partnership.

(4) The Association of Public Health Laboratories has developed guidelines for LIS implementation in resource poor settings (http://www.aphl.org/programs/Global_Health/current_initiatives/Documents/Guidebook_Implementing_LIS.pdf ). We welcome information as to the applicability of these guidelines in Haiti

While none of the following general specifications is an absolute requirement, these specifications represent preferences for an LIS application based on the existing analysis of the laboratory network structure in Haiti and representative sample flow:

While the purpose and objective of this LIS implementation within Haiti laboratories is to ensure that the laboratories can provide timely and accurate services and information to support treatment and prevention of HIV/AIDS, it is recognized that these same laboratories must also respond to service and information requests for other diseases – some of which are and some not associated with HIV/AIDS. Consequently, any LIS application should have the capability of capturing and reporting data for the range of clinical diagnostic tests associated with diseases of public health concern.
The official language in use in the Haiti laboratories is French. Therefore application screens, documentation and training materials may be most effective when presented in this language.
This LIS application should be considered a laboratory-oriented, sample-centric application as opposed to a patient-centric, patient management application. While there are many patient-centric applications that have laboratory components, the primary purpose of this application is to collect and manage laboratory data within the laboratory and facilitate generation of reports. Sample-centric applications should permit linkage of samples to individual patient for epidemiological purposes.
For the purpose of this RFI, installations in laboratories should be considered as separate individual installations. While there may be an advantage to consolidating data from several laboratories into a “central server,” the communications infrastructure presents challenges. Each installation should have the ability to manage its data at the laboratory site. However, the ability to communicate or transfer that data to other entities (eg, the Ministry of health or national laboratory), regardless of the reliability of the communication pathway, must be a part of the application. Applications that have the flexibility to move toward central data management in the future are preferred.
At this time, web-oriented technology is strongly preferred over those which are client-server based. Flexibility for updating and expansion are extremely important and will be a major consideration in choice of the application. It is understood that the NPHL as the hub of the Haitian laboratory network will have access from their facilities to all data and reports generated by the sites.
Applications should be designed to run in a Windows-based environment on PCs running Windows XP and servers running Windows Server 2003 (if necessary). The type of database employed by the application needs to be a modern, relational database, widely supported by current technology. If a commercial database is required, MS-SQL is preferable over Oracle, Sybase, Informix, and other databases.
While adherence to PHIN-compliant (Public Health Information Network) protocols are not required, applications which have the ability to create and transmit data files in HL7 format and have the potential to achieve PHIN compliance are preferred.
Vendors can assume that a local LAN will be in place and functional in each laboratory prior to installation of the application. In addition, vendors can assume that each laboratory will have access to the internet through broadband and that the access will be available through the local LAN installed in the laboratory.
Vendors can assume that sufficient PCs running Windows XP will be available to run the application software in each laboratory prior to the installation of the application software.
The vendor will be required to set up single-PC, non-networked versions of the software at locations that cannot be hooked into the LAN. Provisions for the download of data from these single-instance PCs to a manual device (i.e., memory stick) must be made, along with provisions for the upload of the same data into the LAN.
Vendors can assume that bar code printers and scanners (if necessary) along with a sufficient number of networked system printers required by the selected application will be available prior to the installation of application software. For those vendors that have the ability to supply this type of hardware, the option to bid this equipment and installation is a possibility.
Vendors should keep in mind that this RFI is designed to gather information for a possible RFP for the purchase and installation of application software (and hardware, if applicable) in the 4 pilot laboratories only. However, if the installation at the pilot sites is successful, there is anticipation of expanding installation of the same software to peripheral laboratories throughout the country. Vendors can assume that the additional peripheral laboratories will exhibit similar characteristics and provide essentially the same instrumentation present at the pilot sites.
Vendors will be expected to bid a LIS application package that includes the following for each of the 4 installations: all software required to make the LIS viable, hardware not already available in the laboratory, initial user training at the laboratory facility on the software as provided, installation and initial customization of the software for use in Haiti laboratories, one (1) year minimum of software maintenance (updates, patches, etc.), one (1) year minimum of software support (for user questions, help desk, etc.). Plans and prices for the continuation of software maintenance and support can be addressed at a later date, as well as any costs associated with software customization following initial installation. To reiterate – we would like potential vendors to consider the opportunity for a formal partnership with a local IT support team for technology transfer purposes to enable Haiti to manage the system long-term with minimal dependence on external resources.
Questions regarding general functional specifications or technical aspects of the application described in this RFI must be directed in writing preferably via email to Roges Lamothe (rogeslamothe@itech-haiti.org).

General Functional Specifications

The general functional specifications listed below are meant to be a guide for vendors in responding to this RFI and to ensure that vendors understand the specific data which needs to be collected and communicated within the Haiti laboratories. Consequently, they are somewhat general in nature and represent the minimum of data points to be collected. Once an application has been selected, specific data, specific screen design and modification of the software to meet logistical laboratory requirements can be negotiated. The description of the system which follows is a general example of the sample flow and the requirements of an LIS in a typical laboratory.

Process Overview. Patients who require laboratory services must be referred for those services by a doctor, nurse or other clinician. Consequently, patients must see one of these individuals before laboratory services can be performed. These clinicians see patients in a variety of places, although for hospitals, most of the initial contact occurs there. Typically, the clinician orders laboratory tests by filling out a sample request form. While the data required by the form is essentially the same, the format of the form may vary. The patient takes the form to the sample collection area where the sample is taken. Typically, these sample collection areas are a part of the laboratory reception, although that is not necessarily always the case and the physical orientation of the hospital and the logistics of the laboratory often determine where the sample collection takes place. In addition, some samples are taken external to the hospital (i.e., at home for stool samples) and brought to the laboratory. Regardless of where the sample is taken, however, the sample request must be logged into the LIS, along with required demographic information, and matched with the resulting sample. There is a preference for using a unique sample identifier for each sample (or sample number) which can be placed on the sample and the sample request form generated through the LIS. The form and type of identifier is open to negotiation and the use of bar code printers and scanners to produce and read sample data is the preferred method of utilizing this data. Whether multiple samples are logged under the sample identifier or whether each sample receives its own unique identifier is also open to negotiation.

Once the samples have been logged into the LIS, work lists for technicians performing tests should be made available. These work lists may be available electronically within the LIS application or by physically printing the lists. The format and presentation of these lists is negotiable.

Every effort should be made to decrease the amount of data entry required for technicians. Data which has been previously entered into the LIS should not have to be re-keyed for any reason. Data required by analytical instrumentation to ensure sample identification and to meet QA/QC requirements should be uploaded into the instrument if the instrumentation supports it. In addition, results of analyses should be subsequently downloaded into the LIS along with identifying information if possible. When automatic uploading and/or downloading of data are not possible, steps should be introduced to simplify and automate the transmission of data into or from the LIS application.

Once the requested test has been completed and result data entered into the LIS, a printed report of analysis should be produced for dissemination to the clinician and client. In addition, data required to reproduce the report in the future must be stored within the application.

Because one of the major purposes of this project is to collect laboratory data in a timely fashion in order to facilitate allocation of resources, data produced in the laboratory must be made available to the Ministry of Health or other organizations as required. Consequently, the data should be made available to transmit electronically in a format required by the country. Because that format has yet to be designed, the application must be flexible enough to allow users with sufficient training to create these data files from within the LIS and make them available electronically to other systems.

Sample Submission Form. The sample submission form or requisition form used by hospitals and clinicians to request laboratory analyses is in the process of being standardized throughout the country. The following data taken from these forms will be required:

· Lab Number (Specimen Identification Number) – a unique sample identifier which should be generated in the laboratory at the time of sample receipt and used to identify a specific sample.

· Date Received/Time Received – Date and time the sample was received by the laboratory

· Patient Name/ID Number – Name of patient or patient identifier if the sample is collected without name.

· Patient Sex – Sex of the patient.

· Patient’s Date of Birth (Age) – Patient’s birth date, calculation of age

· NID – National Patient Identifier, if available.

· Department – Name of department where the sample was collected

· Commune – Name of commune where the sample was collected

· Name of Institution – institution (hospital or clinic) where the sample was collected

· Unit or Service – Unit or service (if sample was collected in a hospital)

· Patient File Number – Chart number of hospital patient

· Collection Date – Date sample was collected

· Sample Type – Type of sample presented for analysis

· Receipt Number – Receipt number for patients who have paid for the analysis

· Amount Paid – The amount paid by the patient for the test

· Test Requested

· Requested by – Name of person requesting test

· Date requested – Date the test was requested

· Comments about sample(s)

Tests. The following list, which is not exhaustive, represents potential tests that could be analyzed in the laboratory and should be included in any LIS application. Not all laboratories will have the capability of performing all these tests and there may be other tests performed that are not on this list. This list, however, represents the majority of tests performed in Haiti laboratories:

Parasitology	Parasite identification
	Blood smear – malaria, microfilaria
	Stools – methylene blue
	Stools – ZN coccidioides
	Stools O+P – wet mount
Clinical Chemistry
	Acid Phosphatase
	ALAT
	Albumin
	Alkaline Phosphatase
	Amylase
	ASAT
	Bilirubin direct
	Bilirubin indirect
	Bilirubin total
	Calcium
	Chloride
	Cholesterol
	Creatinine
	Fasting blood sugar
	Gamma GT
	Globulin
	Glucose tolerance test
	HDL
	Iron
	LDL
	Potassium
	Protein total
	Random blood sugar
	Sodium
	Triglyceride
	Urea
	Uric Acid
Hematology
	Bleeding time
	Blood Grouping
	Clotting time
	Differential Count
	Basophils
	Eosinophils
	Lymphocytes
	Monocytes
	Neutrophils
	ESR
	HB
	HB Electrophoresis phenotypic profile
	MCH
	MCHC
	MCV
	P.T.T.
	PCV
	Platelets
	Prothrombin time
	RBC Total
	Reticulocytes
	Sickle Cell Test (hb S)
	Smear comments
	WBC Total
Serology
	AFP
	CD4
	CD8
	CEA
	Dengue
	Extended Widal
	FSH
	HCG
	Helicobacter pylori
	Hep A Antigen
	Hep B Antigen
	Hep C Antigen
	HIV – ELISA
	HIV – Viral Load (PCR)
	HIV – Western Blot
	HIV Screen (Rapid Tests)
	LH
	Malaria
	Pregnancy Test
	Progesterone
	Prolactin (PRL)
	PSA
	RA Test
	Rubella (HUEH – covered by CAREC)
	Salm Typhil O
	Sam Typhil H
	T3
	T4
	Testosterone
	Total CD3
	TPHAASPT
	TSH
	VDRL
Bacteriology
	Macroscopic
	Bacterial Count
	Biochemical testing
	Culture Identification
	Gram stain
	India ink
	Isolate identified
	Wet mount
	ZN
	Resistance/Sensitivity
	Cefuroxime
	Chloramphenical
	Ciprofloxacin
	Cloxacillin
	Co- trimoxazole
	Erythromycin
	Gentamicin
	Nalidixic Acid
	Nitrofurantoin
	Penicillin
	Tetracycline

Instrumentation. The table below outlines the instrumentation available in each of the 4 proposed pilot laboratories in Haiti. Each instrument listed should be interfaced to the LIS directly for uploading and downloading of data if possible:

CD4

PointCare

Hematology

Sysmex KX-21N

HumaCount

Blood Chemistry

Reflotron

Organizational information to be included with RFI.

Full legal name and any “doing business as” or d/b/a names used by the organization likely to respond to the RFP.
Authorized representative of the organization likely to respond to the RFP.
Phone, fax and e-mail address.
Business mailing address.

Responses may be sent to I-TECH by e-mail attachment in MSWord or PDF format to psutton@u.washington.edu, attention of Perri Sutton, Country Program Manager, and I-TECH. E-mail responses should be received at the I-TECH office by 5 pm PST on January 24, 2008. Submitters will receive a confirmation of receipt.

I-TECH will review all letters of information received by the response deadline and follow-up by February 8, 2008. Respondents to the RFI should address their willingness to work with Haiti to achieve the best possible LIS solution for long-term sustainability.

by Corinne Jones

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