HIV Drug Interactions and Antiretroviral (ARV) Therapeutic Drug 5.8 Monitoring (TDM) Registry: Attaining Compliance With Clinical Laboratory Improvement Act (CLIA) and the Health Insurance Portability and Accountability Act (HIPAA) J. Slish, L. Catanzaro, L. Esch, F. Lliguicota, R. DiFrancesco, G. Morse Laboratory for Antiviral Research School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, The State University of New York Abstract Methods HIV Drug Interactions Concentrations versus Drug Interactions and HIV Drug Interactions and Antiretroviral (ARV) Therapeutic Drug and Antiretroviral TDM Antiretroviral TDM Data Report Monitoring (TDM) Registry: Attaining Compliance With Clinical HIPAA Mandated Exclusion Laboratory Improvement Act (CLIA) and the Health Insurance Portability and Accountability Act (HIPAA). Identifiers Registry Form J. Slish, L. Catanzaro, L. Esch, F. Lliguicota, R. DiFrancesco, G. Morse. Laboratory for Antiviral Research, University at Buffalo (UB) Site Registers on HIV School of Pharmacy and Pharmaceutical Sciences, New York, USA. • Names • Certificate/license number Pharmacotherapy Key Words: Therapeutic Drug Monitoring, Antiretrovirals, Drug • Geographic info (city,• VIN and Serial number Network Interactions, CLIA, and HIPAA state, zip) • License plate number (www.hiv.buffalo.edu) • Elements of dates • Device identifiers Background: The HIV Drug Interactions and TDM Registry is a clinical research initiative designed to examine adherence, drug • Web URLs interactions and antiretroviral (ARV) plasma concentrations in H IV- • Telephone number • IP address number infected subjects. The Clinical Laboratory Improvement Act (CLIA ) • Fax number Site obtains informed • Biometric identifiers and Health Insurance Portability and Accountability Act (HIPAA) mandate that such operations follow a standard set of guidelines. • E-mail address • Full face photo image consent and registers • Social Security • Comparable photo images subject Methods: The UB Laboratory for Antiviral Research (UBLAR) has developed a laboratory program to measure and report ARV number • Unique identifying number concentrations that is compliant with CLIA regulations. The validation of the method was executed in accordance with the FDA Guidance for • Medical record Lab sends kit to site, Chromatographic Methods (2001). UBLAR also established a secure , Later goal database -driven Internet application to provide users a mechanism for • Prescription number site returns sample for data collection and allow submission of plasma samples while • Health plan assay maintaining HIPAA compliance. Specimens and the associated data collected do not contain any of the 18 patient identifiers mentioned in beneficiary number Pharmaco - the HIPAA regulations. Specimens are uniquely identified by a • Account number genetics combination of a random, confidential clinician code and a sample accession number. To comply with HIPAA regulations and ensure Viral genetics patient confidentiality and data protection, UBLAR has implemented Lab provides assay policies and procedures that will reduce the probability of data corruption on both personal and networked computer systems. A result and interpretation retrospective analysis of the initial 2 2 0 subjects was performed to of PK result assess the site registration, data entry and lab results components -1 between 2-11 -99 and 10 -2002. Samples were collected at trough or at designated times post-dosing. HIPAA Compliant Results: From 220 subjects (158 male, 50 female, and 12 unknown), Database for 302 plasma samples and 10 cerebral spinal fluid samples were submitted for analysis by 11 sites. Subject demographics (%) were Form Population Analyses Caucasian (42), African American (30), Hispanic (8), Asian (1), Native American (2) and other (18). Median plasma concentrations (mcg/mL) are as follows: amprenavir 1.83, efavirenz 3.29, indinavir • Specimens and the associated data collected 3.19, lopinavir 1.48, nelfinavir 2.01, saquinavir 0.638, and ritonavir do not contain any of the 18 patient identifiers 0.192 (ritonavir boosting regimens only). Laboratory inspections mentioned in the HIPAA regulations. conducted in November 2002 have yielded a two -year certification period. • Specimens are uniquely identified by a Conclusion: The Registry has been successfully implemented and the site registration, data entry and ARV assay mechanism are well combination of a random, confidential clinician CLIA Methods Individual Antiretroviral integrated. CLIA and HIPAA compliance have been achieved. code and a sample accession number. Improvements in database and software design have been made to safeguard the integrity of the data. Results • All laboratory operations are conducted in accordance with the Clinical Laboratory Improvement Act (CLIA) requirements as Antiretrovirals (n) Concentration Range Median Concentration mcg/mL mcg/mL applied to the Therapeutic Drug Monitoring (n<LOQ) sections. Objectives • As such, procedures, processes and actions within the laboratory must be executed with APV (64) 0.073 -13.13 (5) 1.83 the following components in place: • Establish a confidential website for site EFV (53) 0.157 -13.00 (4) 3.29 registration. • Proficiency Testing • Calibration and • Develop a CLIA-compliant assay and a Program Control HIPAA-compliant registration mechanism • Procedures for Procedures IDV (56) 0.061 -16.15 (3) 3.19 • Implement a limited-center pilot program to Specimen • Remedial Action Summary test outcomes of the TDM process. Submission and Policies • Develop a reporting process so that sites Drug Interactions and Handling • Required LPV (76) 0.111 -12.06 (24) 1.48 • CLIA and HIPAA compliance have been receive TDM results with a limited • Procedures for All Personnel achieved for the confidential website pharmacologic assessment. TDM Data Collection Form Records and Test Qualifications registry. Reports • Documented NFV (19) 0.344 -7.32 (2) 2.01 • Standardize an approach to collect adherence and concurrent medications • Test Requisition Personnel • Currently, twenty-six sites have registered information. Requirements Responsibilities to participate. RTV (114) 0.117 -7.54 (47*) 0.192* • Test Method/ • Patient Test Equipment/ Management • Antiretroviral plasma concentrations were Instrumentation/ Procedures measured for PIs and efavirenz. SQV (3) 0.140 -4.37 (0) 0.638 Reagents/ Materials • Comparison of Standard Operating Test Results to • Some early patients had TDM Procedures Reference concentrations below assay detection Background: • Quality Control and Methods Total Assays reported (385) * ritonavir boosting regimens only indicating the need to intensify adherence Policy interventions. The HIV Drug Interactions and TDM Registry is a • Personnel clinical research initiative designed to examine • Procedure Manual Assessment adherence, drug interactions and antiretroviral • Performance Program Summary of samples collected over prescribed dosing (ARV) plasma concentrations in HIV-infected Specifications, • Communications intervals subjects. The Registry goals and objectives Equipment and Complaint were presented at the 3rd International Workshop Maintenance, and Investigation on Clinical Pharmacology of HIV Therapy. This Function Checks Procedures presentation further defines the details required to make the Registry operational within regulatory realms. The UBLAR has established Results Patient Demographics the HIV Pharmacotherapy Network Website (www.hiv.buffalo.edu) as a means of fostering a multicenter exchange of information and the Race Caucasian African Hispanic Asian Native Unreported Conclusions American American performance of clinical research. • The Registry has been successfully Percent The Clinical Laboratory Improvement Act (CLIA) 42 30 8 1 2 17 implemented and the site registration, data (%) and Health Insurance Portability and entry and antiretroviral assay mechanisms Accountability Act (HIPAA) mandate that such are well integrated. Percent operations follow a standard set of guidelines. 33 20 6 1 2 12 Male • Improvements in database and software The CLIA standards promote good laboratory design have been made to safeguard the practices and assure reliable laboratory results Percent integrity of the data. 9 10 2 0 0 5 and documentation/records. Regulations under Female • Additional adherence interventions have these guidelines define requirements for personnel, procedures, and policies. A been incorporated prior to TDM sampling to avoid measuring undetectable laboratory performing assays and reporting specimens. results, which are used to treat, diagnose, or manage a patient’s care, require certification by CLIA. Drug Interactions And TDM Data Report Form • A network of clinical sites is evolving that will provide a larger patient database to facilitate population modeling. HIPAA standards are designed to ensure the privacy of individually identifiable health • To comply with HIPAA regulations and ensure patient confidential ity and data protection, • The registry has been utilized to apply for information by establishing conditions for its use UBLAR has implemented policies and procedures that will reduce the probability of data additional funding to support expanded and disclosure by a health plan, healthcare corruption on both personal and networked computer systems. research involving drug interactions and clearinghouse, and certain healthcare providers. TDM of antiretrovirals. Eighteen identifiers have been named which must be excluded from transfer of data outside protected source documentation.
Pages to are hidden for
"HIV Drug Interactions and Antiretroviral (ARV) Therapeutic Drug"Please download to view full document