CHECK LIST . An integrated LIS can help laboratories struggling with staffing challenges. For decades, experts have predicted genomic technology would transform patient care. Next generation sequencing: What it means for patient care. Denos su opinin sobre sus experiencias con las instalaciones, el personal, la comunicacin y los servicios del DSHS. Resources: 04-JUN-2020 . You will be subject to the destination website's privacy policy when you follow the link. To assess compliance with FDAs regulations governing the conduct of clinical and nonclinical trials, including regulations for informed consent and ethical review. README.TXT contains descriptions of the codes in the database. The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before. How much time a lab needs depends on its complexity and the volume of instrumentation it uses. (b) General requirements. All laboratories issued a CLIA. SAs (PDF)process CLIA applications (PDF), renewals, updates, and requests for certificate copies. Compliance and Inspection Survival Advice for CLIA, The Joint Commission, CAP and COLA Successful Strategies and Specific Applications of the Regulations 2021, 274 pages, 11" by 9" workbook format, wire coil binding ISBN 1-886958-35-1 ISBN-13 978-1-886958-35-7 List price: $80.00 REVISED. "The inspection process is designed to be collaborative," shares Bakken. It's an opportunity for improvement.". You can verify receipt of your forms by calling 503-693-4125 or by e-mailing LC.info@odhsoha.oregon.gov. Sign up for our CLIA Communications Email List with the link below: https://public.govdelivery.com/accounts/USCMS/subscriber/new?topic_id=USCMS_12461. Although CLIA is a federal program, State Agencies (SAs) are responsible for laboratory oversight and maintaining CLIA laboratories certification records. Should an accredited laboratory fail to be in compliance with one or more condition-level requirements, it is subject to a full review by CMS; should a CLIA-exempt laboratory fail to be in compliance with one or more condition-level requirements, it is subject to appropriate enforcement actions under the approved state licensure program. website belongs to an official government organization in the United States. Working with a consultant with expertise in CLIA inspection preparation can help resolve concerns before they become deficiencies or, worse, put a laboratory in immediate jeopardy. Instructions on how to apply for a clinical laboratory registration or license and federal CLIA certificate for waived, provider performed microscopy procedures, moderate or high complexity testing are found on the Laboratory Field Services (LFS) Clinical Laboratory Facilities webpage. % and will assist you in preparing for. CLIA INSPECTION GUIDANCE DOCUMENT 2013 5 In 1991, Congress passed Public Law (Pub. Share sensitive information only on official, secure websites. By using this site you agree to our use of cookies as described in our UPDATED . Use this list only as a guide to prepare your laboratory. Consulting companies can also provide in-person or ongoing remotesupport with monthly or quarterly assistance to help clinicians stay prepared for any type of inspection. The Joint Commission standards require compliance with the personnel qualifications specified in the Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA). Transcripts . Check out our article, CLIA 101: Answers to your most common questions about CLIA waived tests. hb```u ea0'CP7HQ"Kl]o#+-}GGcEGG3j``@*` %X,AA{*w8|>09c3Qg/s^Fv;! L 70@.:H30(g yd`=;x 0 Y7 In total, CLIA covers approximately 320,000 laboratory entities. If you identify any errors with your logs, it's important to develop and document your own corrective plan of action. If facilities have concerns, having a consultant involved can help with their CLIA inspection preparation process. New laboratories are assigned to a specific cycle based on when their application is submitted for review. All information these cookies collect is aggregated and therefore anonymous. February 2022. Permit personnel to be observed performing all phases of the testing process. The CLIA eCompliance module is a self-paced, easy way for you and your staff to become inspection-ready and up-to-date on CLIA regulations. 1-833-4CA4ALL lock CLIA Regulation and GuidanceThe Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). How to leverage point-of-care testing to help improve patient care & generate revenue. Here is a basic guide to help you prepare for a CLIA inspection. The CLIA inspection regulations are found in Subpart Q of the Code of Federal Regulations, which addresses both basic and specific inspection requirements. Bakken explains that clinicians should encourage their personnel to respond to an inspector's questions honestly and provide answers on the items or records in question. CMS or its representatives may conduct subsequent inspections on a biennial basis or with such frequency as necessary to ensure compliance. NEW Checklist Requirements Requirement Effective Date MIC.11075 09/17/2019 MIC.22635 06/04/2020 MIC.32150 06/04/2020 MIC.32170 06/04/2020 MIC.65145 09/17/2019 MIC.65620 06/04/2020 REVISED Checklist Requirements . To contact the Los Angeles Use this list only as a guide to prepare your laboratory. Learn more about MedSol >. You can decide how often to receive updates. /Filter /FlateDecode Welcome to the Illinois Clinical Laboratory Improvement Amendments (CLIA) Program. Heres how you know. Requests for other OSI records may be submitted to the FDA under the Freedom of Information Act (FOIA). The CLIA inspection regulations are found in Subpart Q of the Code of Federal Regulations, which addresses both basic and specific inspection requirements. 2021; 2020; 2019; 2018; 2017; 2016; News by Topic SUBSCRIBE TO RSS FEED XML. The cost of the certificate is $180.00 every two years. To Apply for a Certificate of Compliance or Certificate of Accreditation Labs NOT located in Oregon: Find your state agency and mail forms to them (pdf) CLIA Fees and Application CLIA CMS-116 application form (pdf) The Division of ClinicalLaboratory Improvement & Quality, within the Quality, Safety & Oversight Group, under the Center for Clinical Standards and Quality (CCSQ) has the responsibility for implementing the CLIA Program. Further, a laboratory must provide (upon request) all information and data necessary for CMS or its representatives to make a determination of the laboratory's compliance. or 1 Its purpose is to protect patient safety and make sure laboratories maintain quality standards at the federal level. An official website of the United States government EXPANDED. To contact the Los Angeles LFS Office please call (213) 620-6160. The latest edition currently provided by the Illinois Department of Public Health; Compatible with most PDF-viewing applications. The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. CDC provides clinical and public health laboratories with training and technical assistance to help them achieve the highest-quality laboratory science while ensuring the safety of laboratory professionals and the communities where they work. Those predictions are now becoming a reality as providers adopt next generation sequencing-based tests. SetTest! January 19, 2021 Intelligence: Late-Breaking Lab News MAJOR CHANGES ARE HAPPENING IN THE COMPETITIVE MARKET for CLIA accreditation of hospital laboratories. lock Consult with the appropriate professionals before taking any legal action. CMS 116 CLIA Application. accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists . hbbd```b`` 3@$A Review Board The first 2 digits of your ASHI laboratory accreditation number indicate what region (non-geographic) you are in. Before sharing sensitive information, make sure you're on a federal government site. clia inspection checklist 2021 The fda received infectious wastes must be reverified at fda blood bank inspection checklist was not considered high risk management systems inspected by using the final responsibility. and gathering the appropriate information to successfully meet the inspector. CLIA-exempt and accredited laboratories must permit validation and complaint inspections. zhuri james net worth 2021 / low carb ground beef and spinach recipes / low carb ground beef and spinach recipes /Creator (thunderhead.com) December 2021. requested, for a two-year period prior to the survey, or from the date of the last survey/ CMS CLIA inspection. Please take this short survey. . Participants usually need to register well in advance,so clinicians should allow plenty of time to complete proficiency testing well before inspection time, Personnel competency binders can help organize staff training documentation. All Rights Reserved. regulations for CLIA under Title 42, Code of Federal Regulations (CFR) Part 493. b. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. 7500 Security Boulevard, Baltimore, MD 21244, An official website of the United States government, Clinical Laboratory Improvement Amendments (CLIA). Cookies used to make website functionality more relevant to you. These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. CLIA - PRE-INSPECTION . Checklists This section contains copies of the parameter/method/technology checklists used by NC WW/GW Laboratory Certification auditors during the on-site inspections of laboratories. A CLIA-exempt laboratory and a laboratory that requests, or is issued a certificate of accreditation, must permit CMS or a CMS agent to conduct validation and complaint inspections. CMS's policy for inspections includes an announced initial and biennial recertification inspection and unannounced complaint and follow-up inspections. After extraction, you will have two files: CLIIL.TXT and README.TXT. They help us to know which pages are the most and least popular and see how visitors move around the site. Centers for Medicare and Medicaid Services. McKesson cannot be held responsible for the continued currency of or for any errors or omissions in the information. March 2022. If you have any questions concerning the content of the Clinical Investigator Inspection List, please contacttheOffice of Scientific Investigations. lock CLIIL.TXT contains investigator names, addresses, inspection dates and other coded information gathered from inspections. CREDIT CARD PAY INSTRUCTIONS (with different CLIA/CAP numbers) to provide a final, reportable result for the originally-ordered test. The clinical investigator inspections were conducted as part of the Food and Drug Administration'sBioresearch Monitoring Program (BIMO) within the Center for Drug Evaluation and Research (CDER). The program's mission is to ensure the highest quality of laboratory testing is performed in the state through the use of education and enforcement of state and federal CLIA regulations. Determine if the laboratory is operated and testing is performed in a manner that does not constitute an imminent and serious risk to public health. Documentation The Clinical Laboratory Improvement Amendments of 1988 (CLIA) establish quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. The objective of the CLIA program is to ensure quality laboratory testing. /Producer (thunderhead.com) An official website of the United States government We take your privacy seriously. A federal government website managed and paid for by the U.S. Centers for Medicare & Medicaid Services. Some states also have laboratory licensing laws separate from the CLIA regulations, so please check with your SA before your laboratory begins testing. These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. The New Jersey Department of Health (NJDOH), under contract with the Federal Centers for Medicare & Medicaid Services (CMS), administers the Clinical Laboratory Improvement Amendments of 1988 in New Jersey to ensure quality laboratory testing. means youve safely connected to the .gov website. Under CLIA, FDA categorizes in vitro diagnostic (IVD) tests by their degree of complexity: waived, moderate complexity, and high complexity. Occasionally, if an inspector uncovers missing competencies, concerns with QC or other deficiencies, they may interview lab personnel to better understand their testing knowledge or related background.5. A completed CMS-116 and any required supporting documents must be submitted to the OLS CLIA Section via email, mail or fax. Here's how. MFk t,:.FW8c1L&9aX: rbl1 Running a mock inspection can help laboratories find and mitigate issues before the real thing. CLIA Laboratory Program Mail check to: CLIA Laboratory Program, P.O. MS 0500 These cookies may also be used for advertising purposes by these third parties. Compile the manuals, documents and information listed in this section and have them ready and retrievable for the survey. Be advised that information contained herein is intended to serve as a useful reference for informational purposes only and is not complete clinical information. Permit CMS or its representative access to all areas encompassed under the certification, including, but not limited to: Specimen procurement and processing areas, Storage facilities for specimen reagents, supplies, records, and reports. According to Bakken, the facility should perform a mock inspection about three months before an expected CLIA inspection. lock A federal government website managed and paid for by the U.S. Centers for Medicare & Medicaid Services. Commissioners are listed in the above link by region. Point-of-care testing with in-office labs can help generate more revenue for your health system, create better patient outcomes and set you apart from competitors. 710 0 obj <>stream Laboratory Field Services. Topics for 2020 Checklist Update, Cont'd All Common Checklist (COM) o Proficiency Testing o Comparability of Instruments and Methods-Nonwaived Testing o Reagents o Instruments and Equipment o Test Method Validation and Verification Discipline-specific checklist changes (ANP, CHM, IMM, MIC, POC, TRM) CAP resources to identify changes 5 Clinical Lab Improvement Amendments (CLIA), CMS: Individualized Quality Control Plan (IQCP), CMS: Individualized Quality Control Plan (IQCP) Workbook, CMS: List of CPT-4 and HCPCS Codes Non-waived Tests subject to edits (CMS), FDA: CLIA - Test Complexity Determination, IL Secretary of State Corporation/LLC Search, IRS: Not-for-profit (federal 501(c)(3) tax determination letter, Medicare Provider Enrollment and Certification, CLIA Regulations How do they Affect my Lab (CDC), Verifications of Performance Specifications (CDC), Calibration and Calibration Verification (CDC), Equivalent Quality Control Procedures (CDC), Proficiency Testing - DOs and DON'T's (CDC), How to Perform Lab Personnel Competency Assessments (CDC), Individualized Quality Control Plan - IQCP (CDC & CMS), Ready? Image source: /content/dam/soi/en/web/idph/files/images/clia-photo1.jpg. https:// The following list of required laboratory practices and documents is an overview of what the on-site survey inspection may consist off; however, please know that additional documents may be required by the surveyor. Drug Approvals and Databases, Recalls, Market Withdrawals and Safety Alerts, Resources for Information | Approved Drugs, Clinical Investigator Inspection List (CLIIL), Clinical Investigator Inspection List (Search), Clinical Investigator Inspection List Zip File, Clinical Investigator Inspection List (CLIL) Database Codes, Clinical Investigations Compliance & Enforcement, To protect the rights, safety, and welfare of human research subjects, To verify the accuracy, reliability, and integrity of clinical and nonclinical trial data submitted to FDA. Official websites use .govA Amendments (CLIA) Certificate of Waiver. This process involves compliance with the federal Clinical Laboratory Improvement Amendments (CLIA) of 1988, which requires that all laboratories testing human specimens be certified by the federal government. Subsequent inspections are based on compliance history. Secure .gov websites use HTTPSA The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). The Clinical Investigator Inspection List (CLIIL) database contains information on clinical investigator inspections conducted since October 1, 2008, and that have a final classification. The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. The time required to complete this information collection is estimated to average one hour per response, including the time to review instructions, search existing data resources, gather the data needed, *1 J "6DTpDQ2(C"QDqpIdy~kg} LX Xg` l pBF|l *? Y"1 P\8=W%O4M0J"Y2Vs,[|e92se'9`2&ctI@o|N6 (.sSdl-c(2-y H_/XZ.$&\SM07#1Yr fYym";8980m-m(]v^DW~ emi ]P`/ u}q|^R,g+\Kk)/C_|Rax8t1C^7nfzDpu$/EDL L[B@X! Patient Testing is Important. In general, CLIA inspectors give two weeks' notice for announced initial and renewal inspections although an unannounced visit could occur at any time. 101(a), which exempted VHA from CLIA and stated that the Secretary of Veterans Affairs would, in consultation with the Secretary of HHS, publish regulations that would "establish number. . Permit interviews of all personnel concerning the laboratory's compliance. April 2022. These records should be identified and the location communicated to the relevant staff. CLIA Statistical Tables/Graphs. Again, make sure to document any errors or omissions in a corrective action plan. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. Laboratories that utilize these strategies can be inspection-ready at all times. The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). N.J.S.A. Complete all forms in the Pre-Survey Packet prior to the survey. Additionally, see the Temporary COVID-19 Testing Sites (PDF) infographic, which advises those receiving laboratory services of things to be aware of to ensure they are receiving quality laboratory testing. These inspections may occur any time during the laboratory's hours of operation and may include review of PPM testing. The data are updated quarterly. CLIA 101: Answers to your most common questions about CLIA waived tests, https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/cliaback.pdf, https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/howobtaincertificateofwaiver.pdf, https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/cliabrochure.pdf, https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493/subpart-Q/section-493.1773, How to prepare for a CLIA certification inspection, Representatives from any regulatory agency could show up unannounced for follow-up or look into complaints between those two years, An unannounced visit doesn't replace a license renewal inspection, Clinicians who know their license expires within six months can expect an inspection any time within that window, Documenting any errors in a corrective action plan is essential, Laboratory proficiency testing is another area that inspectors will frequently cite. Decrease, Reset Quality, Safety & Oversight - Certification & Compliance, Clinical Laboratory Improvement Amendments (CLIA), How to Apply for a CLIA Certificate, Including International Laboratories, Accreditation Organizations/Exempt States, Certification Boards for Laboratory Directors of High Complexity Testing, CLIA Regulations and Federal Register Documents, CLIA Related Hearing Decisions and Compliance Topics, Individualized Quality Control Plan (IQCP), State Agency & CLIA Operations Branch Contacts, CME Courses for Laboratory Directors of Moderate Complexity Laboratories, CLIA Historical Numbers - January 2022 (PDF), CLIA Top Ten Deficiencies in the Nation - 2021 (PDF), CLIA Update Statistics - March 2023 (PDF), Laboratories By Facility Type Under CLIA - March 2023 (PDF), Certificate of Compliance Laboratories By CLIA Certificate Schedule - March 2023 (PDF), Total CLIA Laboratories Registered - March 2023 (PDF), Percent of CLIA Laboratories By Certificate Type - March 2023 (PDF), Physician Office Laboratories Under CLIA - March 2023 (PDF), Laboratories By Certificate Type Under CLIA - March 2023 (PDF), CLIA Accredited Laboratories - March 2023 (PDF). CLIA INSPECTION CHECKLIST & GUIDANCE FOR LRN-C LABORATORIES 1 No collaboration or communication is allowed between laboratories (or testing sites for those laboratories with multiple testing sites) until after the PT reporting date. Rate of disparity means the percentage of sample validation inspections for a specific accreditation organization . The Mock Inspection (Section 8.1) that follows is applicable to all inspections (CLIA, The Joint Commission, CAP, COLA, etc.) Clia - Pre-inspection Check List - Illinois. The CMS 116 CLIA Applications may be completed for any changes. Official websites use .govA BioAgilytix for Large Molecule Drug Development Under CLIA. Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities. 0 As a result of that inspection, Department examiners determined that your laboratory is not in compliance with the requirements specified in the Health and Safety Code section 101160 and/or California Code of Regulations, title 17, sections 1078 and 1083. Therefore, laboratories should always take steps to maintain accurate and consistent quality control (QC) records. The CLIA top ten deficiencies information in the Downloads section is from the CMS CLIA database in 2021. See the Consumer Complaints FAQ (PDF) on how to file a complaint. This option is available every other survey cycle (a two-year period). A laboratory must have all records and data accessible and retrievable within a reasonable amount of time during the inspection. The program is also responsible for inspection of over 200 laboratories with a CLIA certificate of waiver annually. While laboratories issued a certificate of waiver or certificate for provider performed microscopy are not subject to biennial inspections, CMS or its representatives may conduct inspections at any time during the laboratory's hours of operation to: Waived and PPM laboratories must comply with all of the basic inspection requirements. 2021, c. 454 as amended by P.L. In general, CAP has more specialty-specific quality standards than other accreditation organizations. CDC, in partnership with CMSand FDA, supports the CLIA program and clinical laboratory quality. Collect information regarding the appropriateness of tests specified as waived or provider performed microscopy. You can now pay online with your CLIA number and the amount due. The CMS 116 CLIA Application and Enclosure A Disclosure of Ownership is completed for change of ownership and Tax ID. Self-inspect your laboratory. CMS inspects CLIA laboratories every two years and, occasionally, upon complaints. NJ CLIA Program. CMS or its representative may re-inspect a laboratory at anytime to evaluate the laboratory's ability to provide accurate and reliable test results. How to Apply for a New CLIA Certificate 1. Recently, CLIA laboratories owned and operated by Flow Health have been inspected in California, Georgia . Unexpected DocumentServiceException: error.content.DocServiceError Access CAP Home The valid OMB control number for this information collection is 0938-0581. "Anytime you find an error or something done inappropriately, it's not necessarily punitive. @Rt CXCP%CBH@Rf[(t CQhz#0 Zl`O828.p|OX Sacramento, CA 95899-7377, For General Public Information: Ambulatory Surgery Center Inspection Form . Laboratories are required to permit CMS or its representatives to conduct an inspection. Use this 16-item fire marshal inspection form to check all residential/rental properties for fire hazards and ensure that the property remains compliant with local fire safety requirements. 664 0 obj <> endobj And though it's true that laboratories holding a Certificate of Waiver (CoW) and running CLIA waived laboratory procedures aren't routinelyinspected, inspectors can still make unannounced visits to investigate any possible complaints.3. WOULD YOU LIKE TO RECEIVE EMAIL UPDATES FROM CLIA? Clinical Laboratory Improvement Advisory Committee (CLIAC), Centers for Disease Control and Prevention. Provide feedback on your experience with DSHS facilities, staff, communication, and services. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. or endobj Based on their license renewal cycle, clinicians running moderate and high complexity testing laboratories will undergo Clinical Laboratory Improvement Amendment (CLIA) inspections every two years. Included is a series of videos on how inspections are scheduled; records required for the survey; and how to respond to deficiencies. Learn more about CLIA. Inspection. The CLIA inspectors review each lab's policies and procedures to help improve quality and compliance. The list below is not all-inclusive, but represents the basic items required. /CreationDate (D:20200514090514-05'00') ( The Division of Laboratory Improvement implements state and federal laboratory licensure laws, which apply to Pennsylvania's over 9,000 clinical laboratories. The laboratories involved may perform . Home Fire Hazard Inspection Check List - Scottsdale, Arizona, Clia Certificate Type Change Form - Illinois, DNR Form 542-0269 Iowa DNR Public Water System Security Inspection Check List - Iowa, Form DLT-L-129 Electric Elevator Inspection Check List - Rhode Island, Form DLT-L-133 Escalator Inspection Check List - Rhode Island, Form DLT-L-130 Hydraulic Elevator Inspection Check List - Rhode Island, Attachment C Mixing Valve Inspection Check List - Sample - South Carolina, Attachment G Hvac Inspection Check List - Sample - South Carolina, Attachment F Generator Inspection Check List - Sample - South Carolina. Download Free Template. The mission of the Clinical Laboratory Improvement Amendments (CLIA) section of Laboratory Field Services is to ensure compliance with State and federal clinical laboratory laws and regulations by performing biannual onsite inspections to ensure accuracy and reliability of laboratory test results and conducting review of laboratory performed proficiency testing results. Laboratories issued a registration certificate must permit an initial inspection to assess the laboratory's compliance with the regulations before issuance of a certificate of compliance. ) "Sometimes it's worth it to invest in working with experts who can bring peace of mind throughout the process," says Bakken. (1-833-422-4255). CDC twenty four seven. Laboratories perform their own mock inspections, but some facilities and physician offices may opt to contract this out, either for a stand-alone mock inspection or for ongoing support. To contact the Los Angeles LFS Office please call (213) 620-6160. The Checklists used for inspection by the College of American Pathologists' Accreditation Programs have been created by the CAP and are copyrighted works of the CAP. The goals of the BIMO program are: An official website of the United States government, : July 2022. To contact the CLIA Program you may contact us by email at CLIA@health.mo.gov or by telephone at 573-751-6318. 2 >> Test samples, including proficiency testing, or perform procedures. Want to get in touch to learn how we can help support your lab? Tests that are waived by regulation under 42 CFR. V E,2 ~" V f?@$W ~DI(3^)";Z&,L`B w+#:mt"30T0 Vx 2022, c.44 . The CLIA program performs routine inspections of over 800 laboratories and validations of 36 accredited facilities each year. CE Checklist; Dispensing Tech in Training Certification of 500 Hours; . CMS's objectives in developing an outcome-oriented survey process were to not only determine the laboratory's regulatory compliance but to assist laboratories in improving patient care by emphasizing those aspects that have a direct impact on the laboratory's overall test performance. Legal Disclaimer: The information provided on TemplateRoller.com is for general and educational purposes only and is not a substitute for professional advice.