IMPACTA is a polyclinic authorized by the Ministry of Health that has the level of care and Reference Center for Sexually Transmitted Infections and HIV (CERITS). HITS provides medical services for diagnosis, treatment and monitoring of STIs and HIV in their headquarters of Barranco and San Miguel.


The staff of medical specialists in sexually transmitted infections and HIV with experience in handling vulnerable populations allow the whole process to be efficient clinical care and quality.


If you wish to contact our clinics can do it for free IMPACTA line or ask a specialist on the contact page or else visit us at one of our two locations.


Phlebotomy (taking and / or sample collection) is one of the most important stages in the clinical laboratory work.


On the one hand represents the first contact between the laboratory and its participants and from the point of view of the blood sample, the enormous importance of dealing with a sample collected properly, the safety of your home and proper labeling, packaging and transport are factors fundamental in the evaluation and reporting of tests to be performed.

 

That is why the Impacts Laboratory have qualified staff that performs the collection of the blood sample and perform rapid tests for HIV, syphilis, pregnancy and urine and the results are delivered in a period not exceeding 30 minutes.


The Sampling area is the first contact of the clinical laboratory with participants and this is why the staff working in this area, this always has the right deal to the participant, providing information and trust as we work always included in international biosafety standards. This allows us to ensure the quality of our results and provide the best service to our participants.


This area has a panel of diagnostic tests, such as ELISA for Viral Hepatitis B, Herpes 1 and 2 with reagents FDA (Food and Drug Administration) approved. Confirmatory testing is also performed as Western Blot for HIV and Syphilis MHATP. All these tests are performed under the standards of quality and certification of the Quality Control Program External College of American Pathologists (CAP).


Serology in the area is counted with the Sysmex XS-1000i analyzer using fluorescent flow cytometry and advanced cell counting method. The measurements taken are RBC / PLT-conductance with hydrodynamic flow, flow cytometry WBC-semiconductor laser, HGB-colorimetric method (SLS), CBC and differential WBC 5 parts.


Further counting is performed CSF cytology. These tests are conducted under the standards of quality and certification of the Quality Control Program External College of American Pathologists (CAP).


Flow Cytometry (CPM): The CPM is a simple technique that is applied in the daily routine of many clinical and research laboratories, capable of providing fast results that are used in the diagnosis. This technique, due to its high specificity is able to distinguish between several different cell populations, and detect a cell population in a sample of predominantly majority other cell populations.


Absolute count of CD4 and CD8 lymphocytes is important for studying the immune status of patients infected with HIV-1 virus. The progressive reduction of CD4 + T lymphocytes is highly associated with the severity of HIV.


In our laboratory test performed flow cytometry (MFC) for recuentro of CD3, CD4 and CD8, test done in a flow cytometer FACSCount following international quality standards and is certified by UK NEQAS the United UK (United Kingdom National Quality Assessment Service Esternal).


Provides clinical analysis with high quality and secure information accurately in less time. Our professional staff is qualified CAP standards of methodological validation, internal quality control and external evaluation programs.
We have an automatic analyzer Vitros 250 whose main features are the different tests 1-6 with 50 ul of sample. Processing 250 tests per hour.

 

Two types of reading simultaneously, and Potentiometric REFLECTOMETRY. From 7-30 different tests with 150 samples. Minor evidence inventory management, caching 5000 patients with up to 30 tests per patient. Ability to generate workload statistics per test. Automatic Dilution with individual toes, ready multiplied by the dilution factor.

 

The fully validated test menu we process is: Glucose, Urea Nitrogen (BUN), creatinine, sodium, potassium, chloride, CO2, phosphorus, cholesterol, triglycerides, LDL, VLDL, direct HDLC, total protein, albumin, AST, ALT, ALKP, total bilirubin, conjugated bilirubin, and amylase. These tests are conducted under the standards of quality and certification of the Quality Control Program External College of American Pathologists (CAP).


Our professionals are trained and qualified for processing, isolation, enumeration and cryopreservation of mononuclear cells (lymphocytes) from peripheral blood to assess and measure immune response. We have high technology equipment and facilities to ensure optimum results.


Our professionals carry out their activities with the highest standards of quality and that are certified by the International Program Quality Assurance (IQA) of the Duke Human Vaccine Institute, Duke University, Durham.


This area is equipped with high-tech equipment that allow the realization of different tests, among which are:


Viral load for HIV-1:


This procedure starts performing DNA or RNA extraction, amplification and automated quantification of the genetic material present in the sample and is intended to accompany the response monitoring antiretroviral therapy for infections caused by HIV-1 virus.


Viral load tests performed in the laboratory of the Civil Partnership Impacts are with technology and Biomerieux Abbott Real time (in-house method of the Laboratory of Virology at the University of Washington), this technique is the latest technology, where results can be quantified and analyzed simultaneously by monitoring the fluorescence emitted during amplification.

 


Viral load for Human Papillomavirus (HPV):


This procedure starts performing DNA extraction, amplification and real-time quantification of genetic material whose purpose is to detect genotype genotypes 16 and 18 which are considered high risk.
Women infected with HPV 16 and / or HPV 18 have an increased risk of progression to dysplasia and cervical cancer compared with women infected with other genotypes of high-risk HPV.

 


Automatic Sequencing of HIV-1 Virus:


Automatic sequencing of the genome of the HIV virus to study the resistance or susceptibility to antiretroviral drugs used in the treatment of patients infected with HIV. This test is performed in order to establish an appropriate therapeutic approach. For these tests are employing ViroSeq kit, which is constantly updated and allows analysis of the obtained sequences compared against existing libraries.


These tests are Certified by VQA (Virology Assessment Program) Rush Presbyterian - St. Lukes Medical Center Chicago, Illinois.

 

In the Laboratory of our headquarters in San Miguel team has continuous access automated molecular diagnostic tests GenXpert working real-time PCR in which the tests were validated influenza A-H1N1 Influenza B 2009 (Xpert FLU ) and detection of Mycobacterium tuberculosis rifampin resistance + (MTB / RIF) which allows us to get results the same day of receipt of the sample.


In this area are currently implemented testing direct examination, fungal culture and identification. Addition is done to Cryptococcus neoformans Indian ink tests in CSF and CSF latex agglutination and serum.


These tests are conducted under the standards of quality and certification of the Quality Control Program External College of American Pathologists (CAP).


Our professionals are trained and certified in the handling and transportation of biological samples for shipment at Room Temperature with Dry Ice and Liquid Nitrogen by the International Air Transport Association (IATA) and approved by the International Civil Aviation Organization (ICAO).

 

Our main international destinations are United States, Australia, Brazil, Argentina, among other destinations.


The Laboratory of IMPACTA is one of the resource units that make up the institution. This is composed of a Central Laboratory Biosafety Level 2 located in the District of Barranco, a satellite laboratory sampling and processing of rapid tests located at our headquarters in San Miguel District and a Biosafety Level 3 Laboratory located in the Third floor of our headquarters in San Miguel District.

 

 

The laboratory is directed by a medical professional, specializing in Anatomic Pathology and Clinical Pathology, under his direct supervision are the Laboratory Manager, the Supervisor of QC / QA, Clinical Laboratory consultancy, and all other members of staff .



The work done in this area under the responsibility of the Supervisor QA / QC includes:

 

1) Route cause analysis for all laboratory events.

2) Evaluation and monitoring productivity indicators such as TAT, EQA performance, shipping errors, test failure, Safety and Biosafety incidents.

3) Developing and / or updating of Standard Operating Procedures (SOPs).

4) Optimization activities QA / QC set out in the Management Plan Quality Laboratory.

 

Additionally is responsible for overseeing the training and assessment of competence of personnel, review of compliance with preventive maintenance activities, daily review of the quality control tests and parallel tests for new lots, reagents and controls and validation of new equipment, the latter including the evaluation of test performance parameters (analytical precision, linearity, reference intervals and analytical specificity tests without FDA approval).


In this area one of the tools we use is the LDMS (Laboratory managemt System) which is a software created by Frontier Science laboratory, able to optimize the administrative control of the samples collected in our various offices, it also allows the entry, handling and monitoring of samples, test results (viral load), storage and delivery of information to the different networks of the NIH (National Institute of Health in the United States of America), such as ACTG and HVTN.

 

Additionally Impacts on Civil Association has developed laboratory information software, Syslab, used as tool and results reporting income such as hematology, flow cytometry, biochemistry, serology, immunology, and molecular biology, with this tool achieves tracking of all visits of our participants in the different studies running the institution, helping in the documentation of the chain of custody.


In response to the increasing number and complexity of protocols of the DAIDS research networks, the IMPACTA PERU CTU has responded by developing an in-house, secure and role-based informatics tool named Clinical Trials Unit Enterprise Information System (CTU-ES).  This provides opportunities for better management, accountability and performance measurements of all the CTU components.

 

To optimize key CTU operations, to improve CRS capacity, and to reduce administrative costs, the Biostatistics, Informatics, Data Management and System Resource Unit (BIDS RU) designed, developed and implemented an innovative web-based tool named CTU-ES. 

 

This tool has evolved from individual modules, created to satisfy the local protocol-based implementation of the HPTN 039, CIPRA PE 002 and 003 studies, to an integrated information system. 

 

This system supports sharing information across all CTU components to keep pace with the increasingly complex interplay between CRSs and multiple DAIDS research networks. 

This development is compliant with FDA's 21 CFR Part 11 and the HIV/AIDS Network Coordination IT Best Practices.6,137

 

This system provides access to timely and quality information about CTU-implemented clinical trials. The CTU-ES supports the full life cycle of protocols, from protocol management, clinical site monitoring to management of laboratory and pharmacy operations. Figure 1.5 depicts the logic architecture design of the CTU-ES composed of 5 integrated modules: a) Clinical Research Management System (CRMS); b) Laboratory Information System (LIS); c) Learning Management System (LMS); d) Protocol Regulatory Tracking (PRT); and e) Case Report Form (CRF) and Computer Assisted Self-Interview (CASI) Builder.

 


The CRMS handles comprehensive study participant specific information that includes: a) study scheduled visits; b) visit windows; c) participant protocol identification number (PTID/PID) and study ID (SID); d) study product prescription and dispensation at each study visit; and e) CRS personnel roles at each study. 

 

With information provided, a clinical tracking sheet is generated as an electronic checklist to monitor the timing and completion of every study procedure. 

 

Additionally, the CRMS handles electronic prescription of investigational products.  Outputs of this module include: a) Screening Log; b) Enrollment Log; c) Study Product Accountability Form; and d) Monthly Error Report. Also, it sends alerts to CRS personnel (Figure 1.6) about missed visits and data transmission deadlines.

 

Sistema de Citas - Impacta Perú

 


This service includes the provision of advice, guidance and operational assistance for your company.

 

We develop for you advice and management activities combined (multidisciplinary) planning, organization, operation, internal control assessment process, management information flows and management of these, among others.


Information from the Laboratory Processing Charts is entered into the LIS.  This information includes: a) test performed at each visit; b) material required for each test; c) vials to be stored and storage conditions after test processing; and d) shipping date for each vial stored, if needed. 

 

With information provided, a Laboratory Tracking Sheet is generated as an electronic checklist to monitor timing and completion of laboratory procedures. 

 

Outputs from the LIS include: a) laboratory workload for each staff; b) laboratory results; and c) turn-around time report.

This system sends alerts to laboratory personnel about non-performed tests, shipping deadlines, or laboratory values out of the reference range.

SISLAB icon


Venue and Equipment Laboratory Human

 

Laboratory Impacts Civil Association is one of the resource units that make up the institution. This is made by a Central Laboratory Biosafety Level 2 located in the district of Barranco, Satellite laboratory sampling and processing of rapid tests located at our headquarters in San Miguel District and Biosafety Level 3 Laboratory located in the Third floor of our headquarters of the district of San Miguel.


The Clinical Laboratory is comprised of a multidisciplinary team of physicians, medical technologists, biologists and highly qualified technicians. It is directed by a medical professional, specializing in Pathology and Clinical Pathology are under their direct supervision of the Laboratory Manager, Supervisor QC / QA Laboratory clinical consultant, and all other members of staff.

 

Quality of Laboratory Testing

 

The Laboratory of Civil Association serves Impacts committed to seeking continuous improvement of care, health and quality of life for our participants. For this we have a team of highly qualified professionals, the laboratory has state of the art equipment for the development of their daily activities.
We are committed to maintaining the quality of the results issued 100% reliable and timely, thus contributing to the welfare of individuals and society.

 

Our vision is to be recognized as Clinical Diagnostics Laboratory global leader in the field of Clinical Research results provide services and framed to the highest quality standards.


 

IMPACTA, provides training services and virtual modalities (through its training system LMS) in the following areas:


• Good Clinical Practice
• Protection of Human Subjects
• Risk Reduction Counseling
• Data Management


All online courses are developed through SISDOC system is management software training and documentation to access this page you need to go to the intranet page (intranet.impactaperu.org)


The PRT software monitors the progress of regulatory approvals. 

Regulatory steps include approvals from Peruvian regulatory bodies, and protocol registrations and site activation.  The PRT provides monthly, or on-demand, reports about regulatory status of protocols.

 

It alerts regulatory CTU staff (CTU PI, CTU Coordinator, CRS Leader, CRS Coordinator and Study Coordinator) when a timeframe for a regulatory process is approaching or exceeding the expected date of completion.

PRT icon


 

The multidisciplinary team of Biostatistics, Computing, Data Management and Systems (BIDS) of the Civil Partnership Impacts Health and Education, specializes on providing quality and efficiency of the implementation of clinical and epidemiological studies to the highest quality standards, both national and hospitalizations. BIDS is an example of multidisciplinary work in different professions (Medicine, Biostatistics, Obstetrics, Psychology, Systems engineering, computing and technology) to generate the necessary harmonic gear with different areas of Impacts.


Each of the offices of BIDS, mutually exclusive, but highly cohesive allow performance data capture in the research process meet the quality standards set needed to become science.

 

Thus the effort of data managers is supported by information technology and systems not only help those BIDS but other research centers outside of Lima, allowing access to Web Services Cloud Impacts. Mention web systems are developed by BIDS, unique in its kind and technology in the country and has positioned the institution internationally, making collecting data from 3 continents in 8 different languages and 12 clinical research units around the world.


Currently, this advance in experience and innovation has not stopped, and this research unit, key Impacta, is working to better integrate with the community researchers, a challenge that goes far beyond technology.


The LMS is used for training and documentation management and allows role-based access (trainee, trainer, or administrator). It provides current status for each staff member in a Monthly Training Status Report. 

 

It automatically sends alerts when a deadline for course completion or documents review is approaching or exceeded. 

 

The LMS facilitates online training by providing web-based content, with immediate evaluations, alerting supervisors about failing evaluations. 

 

Documents posted at the LMS include: a) institutional SOPs; b) CTU SOPs; c) protocol documentation; d) meeting minutes; e) protocol regulatory documents; and f) certificates of required courses (Section 9.4).  It manages documents versions and alerts about new versions.

SISDOC icon


Audit services IMPACTA offers are designed to guide them meet the challenges involved in managing risk, resources and information, helping them identify their contingencies and how to address them successfully.

 

Similarly, use tools "in-house" appropriate to the nature and circumstances of your business, to monitor its operations, providing security and reliability to information your institution.


The CRF and CASI Builder is web-based software that captures participant information by using CRFs or CASI.  The web-based CASI is integrated into our CRMS software using role-based staff access.  

 

Its design includes: a) management of controlled medical vocabulary (i.e. MedDRA); b) fast CRF and CASI design; c) integrated validations or warnings for quality control (QC), like missing or invalid data); and d) easy exportation of data to SPSS or MS Excel formats. 

 

This system has been used with success in many projects, including CIPRA PE 002 and 003, HPTN 039, HVTN 914 and iPrEx protocols. The iPrEx CASI collected data from eleven CRS in four languages (English, Spanish, Portuguese, and Thai) on 4 continents.

SISQUAL icon


IMPACTA, has experience and technical capacity for conducting research consultancies:


Qualitative Research


Quantitative Research


• Operations Research


• Epidemiological investigation

        or transverse Design
        or Case Control Design
        o Design Cohort


• Clinical Trials Research