JULY 27, 2015 UNDERSTANDING LABORATORY INFORMATION SYSTEMS COMPLIANCE COPYRIGHT © 2015 BC SOLUTIONS, LLC. ALL RIGHTS RESERVED. AUTHOR: SUDHA POOSA BC SOLUTIONS, LLC. Understanding Laboratory Information Systems Compliance It is critical to properly implement Laboratory Information Systems not just from an information technology perspective but with a clear vision of creating a safe and compliant interaction with all other hospital systems. To achieve that goal, the expertise of IT specialists must be complemented by the experience of clinical professionals. This helps create a system that not only complies with the letter of the law, but also fulling integrates the Laboratory while improving patient safety, ordering, results, and billing. BC Solutions has compiled and presented current regulations and recommendations by the agencies tasked with governing this section of the healthcare industry. The goal is to provide a roadmap that can be used by all levels of your implementation team, regardless of their level of laboratory or compliance experience. This common understanding of who the stakeholders are, what governing bodies are involved, as well as what steps should be taken to achieve compliance can be the difference between having a fully integrated functioning system rather than a stand-alone software implementation. Presented by: 16815 S. Desert Foothills Pkwy, #130 ● Phoenix, AZ 85048 480.346.7011 ● www.bcsolutionsrfn.com 2 Contents Introduction ............................................................................................................................................................ 5 Safe Compliant LIS ............................................................................................................................................ 6 Laboratory Departments .................................................................................................................................... 7 Microbiology ....................................................................................................................................................... 8 Chemistry ............................................................................................................................................................. 8 Hematology ......................................................................................................................................................... 9 Transfusion Services/Immunology ........................................................................................................... 9 Laboratory Stakeholders ................................................................................................................................. 10 Physicians and Nurses ................................................................................................................................. 10 Laboratory directors .................................................................................................................................... 10 Administrative technologists .................................................................................................................... 11 Compliance Officer ........................................................................................................................................ 11 Technologies Included ..................................................................................................................................... 12 Laboratory Information System............................................................................................................... 12 Electronic Medical Record and Electronic Health Record ............................................................. 13 Health Information Exchange ................................................................................................................... 16 Meaningful Use ............................................................................................................................................... 18 Standards and Coding .................................................................................................................................. 19 HL7 –Health Level Seven ........................................................................................................................ 20 ICD - International Classification of Disease ................................................................................... 20 CPT - Current Procedural Terminology ............................................................................................ 21 LOINC - Logical Observation Identifiers Names and Codes ..................................................... 21 SNOMED CT - Systematized Nomenclature of Medicine ............................................................ 21 IHE – Integrating the Health Enterprise ............................................................................................... 22 3 Interface Engines ........................................................................................................................................... 22 Specimen Management................................................................................................................................ 23 Computerized Provider Order Entry (CPOE) ...................................................................................... 24 Billing / Revenue Cycle Management .................................................................................................... 24 Medical Device Interfaces (MDI).............................................................................................................. 25 Laboratory Governing bodies, Regulations, Applicable Laws .......................................................... 26 AABB ................................................................................................................................................................... 26 CLIA ..................................................................................................................................................................... 27 CLIA and EHR .............................................................................................................................................. 29 CAP ...................................................................................................................................................................... 30 FDA ...................................................................................................................................................................... 33 TJC ........................................................................................................................................................................ 37 HIPAA ................................................................................................................................................................. 40 Steps to achieve compliance .......................................................................................................................... 44 Implementing written policies, procedures and standards of conduct .................................... 45 Designating a compliance officer and compliance committee ..................................................... 45 Conducting effective training and education ...................................................................................... 46 Developing effective lines of communication ..................................................................................... 47 Conducting internal monitoring and auditing .................................................................................... 47 Enforcing standards through well-publicized disciplinary guidelines ..................................... 47 Swift action against offenses and breaches ......................................................................................... 48 References ............................................................................................................................................................. 48 4 Introduction Clinical laboratory testing plays an increasingly critical role in quality healthcare delivery. Test results guide more than 70% of all medical decisions made by healthcare providers and the information entered into and generated from Laboratory Information Systems (LIS) must be closely monitored. As established in the Institute of Medicine report To Err Is Human: Building a Safer Health System (1999), it is essential to use information systems as one of the primary means to help improve the quality, safety, efficiency and effectiveness of health care delivery. Subsequently, there currently are several federal mandates and incentive programs that promote wide‐spread and more systematic use of electronic data sharing in the healthcare sector to better support health care delivery and public health goals. The exchange of clinical data can happen in numerous ways between the laboratories, physicians, health plans, Health Information Exchanges (HIE), and other authorized recipients. With the vast applications of clinical data and integrated LIS, the importance of compliance requirements and regulations cannot be over emphasized. This paper sheds light on several key aspects related to laboratory compliance and regulatory needs. Topics discussed here include: Which regulatory agencies