~ Chair, Commission on Laboratory Accreditation

Similar documents
College of American Pathologists 325 Waukegan Road, Northfield, Illinois Advancing Excellence

Standards for Forensic Drug Testing Accreditation

CAP Most Frequent Deficiencies and How to Avoid Them. March 11, 2015

Standards for Laboratory Accreditation

Standards for Biorepository Accreditation

6/28/2016. Questions? Workshop 6 CAP Inspection Preparation Thursday, June 23, 2016

COMMISSION ON LABORATORY ACCREDITATION. Laboratory Accreditation Program TEAM LEADER ASSESSMENT OF DIRECTOR & QUALITY CHECKLIST

CAP Forensic Drug Testing Accreditation Program Standards for Accreditation

Medicare Program; Announcement of the Approval of the American Association for

Medicare Program; Announcement of the Reapproval of the Joint Commission as an

Policy Subject Index Number Section Subsection Category Contact Last Revised References Applicable To Detail MISSION STATEMENT: OVERVIEW:

Heart of America POC Group Quality Management Making it Meaningful

CE Update [generalist compliance/regulation management/administration and training] COLA Accreditation An Educational Experience

IQCP. Ensuring Your Laboratory s Compliance With Individualized Quality Control Plans. November/December 2016

TESTIMONY OF THOMAS HAMILTON DIRECTOR SURVEY & CERTIFICATION GROUP CENTER FOR MEDICAID AND STATE OPERATIONS CENTERS FOR MEDICARE & MEDICAID SERVICES

Personnel. From RLM, COM, GEN and TLC Checklists

Catholic Health Initiatives

CAP Accreditation and Checklists Update. Lyn Wielgos, MT(ASCP) Checklist Editor, CAP Accreditation Programs

PROGRAM GUIDE - UNIVERSITY CLIA REGISTERED LABORATORIES COMPLIANCE COMMITTEE

Massachusetts General Hospital Point of Care Testing Program

College of American Pathologists. Senior Director, Legislation and Political Action Position Profile October 2012

APPLICATION FOR HISTOCOMPATIBILITY LABORATORY MEMBERSHIP ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK (OPTN)

Participant Handbook

Laboratory Accreditation Manual Edition Editor: Francis E. Sharkey, MD, FCAP

Protecting, Maintaining and Improving the Health of Minnesotans

Danette L. Godfrey, MS, MT (ASCP) Senior Product Manager, Accreditation Programs cap.org

Best Practices for Equipment Calibration and Analytical Controls in the Diagnostics Laboratory

Laboratory Accreditation Manual

IQCP January Is Coming Fast What Do I Do?!? Jean Ball Bold, MBA, MT(HHS), MLT(ASCP

Drug and Medical Device Registration FAQ

Individualized Quality Control Plan (IQCP) Frequently Asked Questions Date: May 5, 2015 (last updated 08/21/2017)

Improving Your POC Program: An Upside Down Map. Sheila K. Coffman MT(ASCP)

PURPOSE: This policy provides an overview of SHANDS Jacksonville Laboratory s commitment to the care and safety of the patients we serve.

The CAP Inspection Process

PROTECTING, MAINTAINING AND IMPROVING THE HEALTH OF ALL MINNESOTANS

The Lab General Checklist

The CLIA regulations..

Quality Laboratory Practice and its Role in Patient Safety

Change 142 Manual of the Medical Department U.S. Navy NAVMED P Oct 2012

Agency for Health Care Administration

The Future is Now: Global Application of CLSI and ISO:15189 Quality Management Systems

ASSEMBLY BILL No. 940

Aetna Better Health Hospital Credentialing Packet Table of Contents

Quality Assurance Program For Hospital Based Point of Care Testing. Presented by: Jeanne Mumford, MT(ASCP) Pathology Supervisor, QA Specialist

International Organization for Standardization (ISO) 15189

A COLA White Paper: FEDERAL GOVERNMENT QUESTIONS QUALITY IN WAIVED TESTING.

CLIA Regulations Update 2015

MEDICARE/MEDICAID CERTIFICATION AND TRANSMITTAL. PART I - TO BE COMPLETED BY THE STATE SURVEY AGENCY Facility ID: 00719

PERSONNEL REQUIREMENTS. March 9, 2018

US ): [42CFR ]:

Centers for Medicare and Medicaid Services (CMS) Survey and Certification Group (SCG) Mission:

. s%rwcu ~,+ *+ % %vd3a 7 Food and Drug Administration. Center for Devices and

MEDICARE/MEDICAID CERTIFICATION AND TRANSMITTAL. PART I - TO BE COMPLETED BY THE STATE SURVEY AGENCY Facility ID: 00695

Karen W. Dyer MT(ASCP), DLM Director, Division of Laboratory Services Centers for Medicare & Medicaid Services CLIA

Empanelment of Event Management and Public Relations (PR) Organisations

Center for Medicaid and State Operations/Survey and Certification Group

Record or Document Type Retention Period Relevant Legal Citation(s) IRB Records: Training Records;

Standards, Guidelines, and Regulations

Topic: CAP s Legislative Proposal for Laboratory-Developed Tests (LDT) Date: September 14, 2015

MEDICARE/MEDICAID CERTIFICATION AND TRANSMITTAL. PART I - TO BE COMPLETED BY THE STATE SURVEY AGENCY Facility ID: 00166

MEDICARE/MEDICAID CERTIFICATION AND TRANSMITTAL PART I - TO BE COMPLETED BY THE STATE SURVEY AGENCY

COMPLIANCE WITH THIS PUBLICATION IS MANDATORY

Cheryl Johnson, HFE NEII


Internal Lab Inspections: Are You Inspection Ready? Presented by: Jeanne Mumford, MT(ASCP) Manager, Point of Care Testing, JHM

CLIA S NEW IQCP SEABB. March 19, Linda Sigg, MT(ASCP)SBB,CQA(ASQ) Staff Lead Assessor, Accreditation, AABB

07/23/ /21/2013 (L20)

CLOSE OUT VISIT REPORT (NO CRF TO MONITOR)

Protecting, Maintaining and Improving the Health of Minnesotans

TABLE OF CONTENTS DELEGATED GROUPS

Inspections, Compliance, Enforcement, and Criminal Investigations

AHP Online Guide Contact Changes Sponsor or Member

SUWANNEE COUNTY TOURIST DEVELOPMENT COUNCIL LOCAL EVENT MARKETING PROGRAM APPLICATION

STANDARDS & MANUALS. Accreditation Revised February 2015 Interim Changes Highlighted

Request for Information: Revisions to Personnel Regulations, Proficiency Testing

Center for Clinical Standards and Quality /Survey & Certification

ACEN Accreditation Manual POLICIES. A publication of the Accreditation Commission for Education in Nursing

Request for Proposal PROFESSIONAL AUDIT SERVICES. Luzerne-Wyoming Counties Mental Health/Mental Retardation Program

Office of the Vice Chancellor for Research Supervisory Responsibilities of Clinical Investigators

MEDICARE/MEDICAID CERTIFICATION AND TRANSMITTAL. PART I - TO BE COMPLETED BY THE STATE SURVEY AGENCY Facility ID: 00351

Three Steps to Streamline Laboratory Operations:

Protecting, Maintaining and Improving the Health of Minnesotans. Re: Enclosed Follow-up Survey Results - Project Number SL

BLSFR SERVICE UPDATE CHECKLIST

Discover the DLO difference. Go with. Clinical Resource Guide

Accreditation Commission Policy and Procedure Manual

The Safety Audit. Safety Audits Why Bother? Oh no.. 4/26/2017. I need some help but where can I get it????? Does it really matter? I hate metrics!

Optima Health New Provider Application Packet

The Mammography Quality Standards Act Final Regulations Document #2

GUIDELINES FOR MARKETING AND ADVERTISING HEALTH PLAN ACCREDITATION. Table of Contents

UNITED STATES DEPARTMENT OF EDUCATION FEDERAL STUDENT AID SCHOOL ELIGIBILITY CHANNEL SCHOOL PARTICIPATION TEAM ATLANTA TEAM

HOSPICE CONTRACTING CHECKLIST FOR INPATIENT SERVICES, RESPITE CARE AND VENDOR AGREEMENTS

Policy Number: Title: Abstract Purpose: Policy Detail:

Dear Targeted Small Business (TSB) Applicant:

James Anderson, State Fire Marshall

Patricia Halverson, Unit Supervisor

MEDICARE/MEDICAID CERTIFICATION AND TRANSMITTAL PART I - TO BE COMPLETED BY THE STATE SURVEY AGENCY

MEDICARE/MEDICAID CERTIFICATION AND TRANSMITTAL. PART I - TO BE COMPLETED BY THE STATE SURVEY AGENCY Facility ID: 00940

What is HIPAA? Purpose. Health Insurance Portability and Accountability Act of 1996

MEDICARE/MEDICAID CERTIFICATION AND TRANSMITTAL PART I - TO BE COMPLETED BY THE STATE SURVEY AGENCY 3. NAME AND ADDRESS OF FACILITY

Delegation Oversight 101: How to Pass Oversight Audits Session Code: TU01 Time: 8:00 a.m. 9:30 a.m. Total CE Credits: 1.5 Presenter: Angela Dorsey,

Transcription:

...................... PATHOLOGISTS COLLEGE of AMERICAN :!:... ~ : ~. C ~:::; : :: A p~.~.: : ' ACCREDITED COllEGE of AME~ICAN PA1,..,OLOGISTS The College of American Pathologists certifies that the laboratory named below United Clinical Lab Maquoketa Wyoming, Iowa CAP Number: 9300676 AU-IO: 1770134 CLiA Number: 1602053125 has met all applicable standards for accreditation and is hereby accredited by the College of American Pathologists' Laboratory Accreditation Program. Reinspection should occur prior to June 1, 2018 to maintain accreditation. Accreditation does not automatically survive a change in director, ownership, or location and assumes that all interim requirements are met. ~ Chair, Commission on Laboratory Accreditation 44~#4~ President, College of American Pathologists

To tailor this release for your organization contact media@cap.org for an electronic version For Immediate Release Contact: Tailor to your organization August2,2016 UNITED CLINICAL LAB MAQUOKETA RECEIVES ACCREDITATION FROM COLLEGE OF AMERICAN PATHOLOGISTS The Accreditation Committee of the College of American Pathologists (CAP) has awarded accreditation to United Clinical Lab Maquoketa, Wyoming, Iowa based on results of a recent on-site inspection as part of the CAP's Accreditation Programs. The facility's director,, was advised of this national recognition and congratulated for the excellence of the services being provided. United Clinical Lab Maquoketa is one of more than 7,700 CAP-accredited facilities worldwide. "Insert quote from Laboratory Director here, " said Dr. X. Organization's ChiefExecutive Officer (or other leader), upon learning of the laboratory's accreditation, said: "Insert quote here." The U.S. federal government recognizes the CAP Laboratory Accreditation Program, begun in the early 1960s, as being equal-to or more-stringent-than the government's own inspection program. During the CAP accreditation process, designed to ensure the highest standard of care for all laboratory patients, inspectors examine the laboratory's records and quality control of procedures for the preceding two years. CAP inspectors also examine laboratory staff qualifications, equipment, facilities, safety program and record, and overall management. About the College of American Pathologists As the leading organization with more than 18,000 board-certified pathologists, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. The CAP's Laboratory Improvement Programs, initiated 65 years ago, currently have customers in more than 100 countries, accrediting 7, 700 laboratories and providing proficiency testing to 20,000 laboratories worldwide. Find more information about the CAP at cap.org. Follow CAP on Twitter: @pathologists. PRESSREL2

...... COLLEGE of AMERICAN..... PATHOLOGISTS CAP #: 9300676 AU-ID: 1770134 July 29, 2016 United Clinical Lab Maquoketa 307 E Webster Street Wyoming, Iowa 52362 Dear Dr. Timmerman: I completed my review of the College of American Pathologists (CAP) inspection findings of your laboratory by Jean Ball, MBA,MT(HHS),ML T(ASCP on June 2, 2016. The documentation provided demonstrates the correction of all deficiencies cited during the inspection. I recommend accreditation for your laboratory. Congratulations on the excellent services that your laboratory is providing for your community and the efforts that you have made towards accreditation. We value your participation in the CAP's Accreditation Programs. Sincerely, /Y)llAf~~ Mary J. Reznicek, MD North Central Regional Commissioner CAP Accreditation Programs DEFREC 325 Waukegan Rd. Northfield, IL 60093 cap,org

........... COLLEGE of AMERICAN..... PATHOLOGISTS United Clinical Lab Maquoketa 307 E Webster Street Wyoming, Iowa 52362 CAP#: 9300676 AU-ID: 1770134 August 2, 2016 Dear Dr. Timmerman: The College of American Pathologists (CAP) is pleased to advise you that the medical laboratory you direct, United Clinical Lab Maquoketa, in Wyoming, Iowa, has successfully met the Laboratory Accreditation Program Standards for Accreditation in the area(s) listed on the attached sheet. Please retain this letter and list of accredited services in your records, as this is your official notification of accreditation. Your Certificate of Accreditation is enclosed. Accreditation is valid for two-years and is maintained through continuous compliance with the Terms of Accreditation contained in the attached document. The Accreditation Committee congratulates you on the accreditation of the laboratory under your direction and the excellence of the services you are providing. Please remember CAP accreditation is not a substitute for continuous in-depth monitoring by the laboratory and its personnel to maintain a safe and properly functioning laboratory. We look forward to working with you in the future and commend your achievement of the "gold standard" of laboratory accreditation. Sincerely, ~~~/Afj? Paul Bachner, MD Chair, Accreditation Committee cc: Richard M. Scanlan, MD, Chair, Commission on Laboratory Accreditation LAPACCLTR 325 Waukegan Rd. Northfield. IL 60093 cap.org

Terms of Accreditation A laboratory that is accredited by CAP or that has applied for accreditation must cooperate in any CAP investigation or inspection and promptly notify the CAP if the laboratory becomes: a. The subject of an investigation by a government entity (including federal, state, local, or foreign), or b. The subject of a validation inspection, or c. The subject of adverse media attention. Promptly notify the CAP if the laboratory discovers actions by laboratory personnel that appear to violate federal, state, or local laws that regulate laboratories. Have a written procedure for employees to communicate concerns about quality and safety to management and for management to investigate employee complaints. Incorporate corrective or preventive actions into the laboratory Quality Management Plan. Provide a trained inspection team comparable in size and scope to that required for its own inspection if requested by the regional and/or state commissioner at least once during the two-year accreditation period. Participate annually in a CAP accepted proficiency testing program, if applicable and, if subject to US CLiA regulations, meet the proficiency testing requirements in subpart H of the US CLiA regulations. Promptly notify the CAP and, if subject to US CLiA regulations, the US Department of Health and Human Services (HHS), in writing 30 days prior to any changes in the following: directorship, location, ownership, name, insolvency or bankruptcy. Promptly notify the CAP when there is a change in the laboratory's test menu prior to beginning that testing or the laboratory permanently or temporarily discontinues some or all testing. Authorize the CAP to release its inspection and proficiency testing data and other information required by law to the appropriate regulatory or oversight agencies such as CMS, Department of Veterans Affairs, Department of Defense, Joint Commission, HFAP(AOA), UNOS, or state/provincial agencies. If the laboratory is subject to US CLiA regulations: - Make available on a reasonable basis the laboratory's annual PT results upon request of any person; - Allow HHS or its agent to perform a validation or complaint inspection at any time during the laboratory's hours of operation and permit HHS to monitor the correction of any deficiencies found through such an inspection; - Obtain a CLiA Certificate of Accreditation and pay all applicable fees as a CLiA-certified laboratory if it will use CAP accreditation to meet CLiA certification requirements. Submit a completed Self-Inspection Verification Form in the interim year. Accept and adhere to the Certification Mark Terms of Use/Agreement for CAP Accredited Mark and Design, if the laboratory is/or will use the CAP Certification Mark of accreditation. The Agreement may be downloaded and printed from the CAP web site. Submit only documentation and other materials to CAP that have been de-identified of all protected health information (PHI) in accordance with the requirements of the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations unless the laboratory must submit PHI to CAP in order to respond to a deficiency or patient complaint. Refrain from copying or distributing the CAP Checklists or any content thereof except for use by inspectors in conducting a CAP inspection and by the laboratory in preparing for such an inspection. LAPACCLTR

.............. COLLEGE of AMERICAN PATHOLOGISTS MEMORANDUM TO: FROM: DATE: RE: Joe Schramm Director, Enterprise Communications August2,2016 News Release and Certification Mark for Your Accredited Laboratory CAP # : 9300676 AU 10: 1770134 News Release. Congratulations on your recent accreditation from the College of American Pathologists (CAP). The CAP encourages you to share this news and consider the following news release distribution options: 1. Share internally with your organization's: a. Communications/public relations (PR) department, b. Newsletter, c. Patient magazine, d. Web site, and e. Social Media outlets. 2. Share externally with: a. Local newspaper(s), b. Television station(s), and c. Community newsletters and publications. *Note: Your internal communications/pr department may want to manage external distribution. If you would like to tailor the release, for example, with a quote from your organization 's chief executive officer, please contact me at media@cap.org for an electronic version. Certification Mark. You may use the CAP Certification Mark to promote your CAP Accreditation via your: 1. Web site, 2. Advertisements, 3. Posters, Fliers, and Announcements, and 4. Displays in patient and others areas of your organization. To obtain access to the Certification Mark: 1. Log into "e-lab Solutions 1M /CAP Accredit2tion/CAP Accreditation Certification Mark" at cap.org, or 2. E-mail contactcenter@cap.org to have the Certification Mark files sent electronically. If you have any questions, please contact me at 800-323-4040 ext. 7445, 847-832-7445 or jschramm@cap.org. Thank you for making the commitment to quality and patient safety as a CAPaccredited site. PRESSREL 325 Waukegan Rd. Northfield, IL 60093 cap.org

United Clinical Lab Maquoketa LAP Number: 9300676 AU 10: 1770134 The above Laboratory is accredited by the College of American Pathologists Laboratory Accreditation Program for the following services: All Common Director/Organizational Assessment Laboratory General Point of Care Testing - Waived This accreditation is valid for the period ending June L 2018. PLEASE RETAIN THIS DOCUMENT IN YOUR RECORDS.