2025-01-13T09:28:13-06:00 2024-06-30 231980475 KREISCHER MILLER 100 WITMER ROAD SUITE 350 HORSHAM PA 190442369 990 2023-07-01 237089361 CLINICAL AND LABORATORY STANDARDS INSTITUTE CLIN 6106880100 1055 WESTLAKES DRIVE 300 BERWYN PA 19312 CECILIA PORTO VP, FINANCE AND ACCOUNTING 6106880100 2025-01-13 1 1 CHRISTOPHER M PEKULA P00734965 2154414600 2023 2024-10-15 13:58:12Z CECILIA PORTO 1055 WESTLAKES DRIVE 300 BERWYN PA 19312 24402313 0 X WWW.CLSI.ORG X 1969 PA DEVELOP CLINICAL AND LABORATORY PRACTICES AND PROMOTE THEIR USE WORLDWIDE. 16 16 40 2000 0 0 2531195 1386575 4299669 4304669 295573 2784720 2840088 2398990 9966525 10874954 0 0 0 0 4828306 5060277 0 0 0 4003353 3457885 8831659 8518162 1134866 2356792 19023956 20006390 3641782 3398564 15382174 16607826 X SEE SCHEDULE O 0 0 4526357 5732194 THE DEVELOPMENT OF THE ORGANIZATION'S INTERNATIONAL OUTREACH INSTITUTE 23-7089361 CLINICAL AND LABORATORY STANDARDS INITIATIVE, THE GLOBAL HEALTH PARTNERSHIPS PROGRAM: CLSI STAFF AND VOLUNTEERS PROVIDE TRAINING AND EDUCATION SERVICES AND HANDS-ON SUPPORT OF LABORATORIES IN RESOURCE-CONSTRAINED COUNTRIES, HELPING THEM ACHIEVE SUSTAINABLE QUALITY WITH SYSTEMS TO BETTER DIAGNOSE AND TREAT PATIENTS WITH INFECTIOUS DISEASES. THROUGH PARTNERSHIPS WITH THE US GOVERNMENT, UNIVERSITIES, AND OTHER NONPROFIT ORGANIZATIONS, CLSI HAS WORKED IN MORE THAN 20 COUNTRIES IN AFRICA, CENTRAL ASIA, CENTRAL AMERICA AND EASTERN EUROPE FOR OVER 50 YEARS, OUR MEMBERS, VOLUNTEERS AND CUSTOMERS HAVE MADE CLSI A RESPECTED, TRANSFORMATIVE LEADER IN THE DEVELOPMENT AND IMPLEMENTATION OF CLINICAL AND LABORATORY TESTING STANDARDS. THROUGH OUR UNIFIED EFFORTS, WE WILL CONTINUE TO SET AND UPHOLD THE STANDARDS THAT DRIVE QUALITY TEST RESULTS, ENHANCE PATIENT CARE DELIVERY, AND IMPROVE THE PUBLIC'S HEALTH AROUND THE WORLD. 4526357 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 1 1 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 31 0 1 40 1 0 0 0 0 0 0 0 0 0 0 X 16 16 0 0 0 0 1 1 0 1 1 0 0 1 1 1 1 1 1 1 1 0 PA FL X X BARBARA JONES CEO 6106880100 1055 WESTLAKES DRIVE SUITE 300 BERWYN PA 19312 RANDALL T HAYDEN BOARD MEMBER 1.00 X 0 0 0 BARBARA L ZIMMER BOARD MEMBER 1.00 X 0 0 0 COLLETTE FITZGERALD BOARD MEMBER 1.00 X 0 0 0 GARY PROCOP PRESIDENT ELECT 1.00 X X 0 0 0 JOSEPH PASSARELLI TREASURER 1.00 X X 0 0 0 JAMES NICHOLS PRESIDENT 1.00 X X 0 0 0 LEONTHENA CARRINGTON BOARD MEMBER 1.00 X 0 0 0 LORALIE J LANGMAN BOARD MEMBER 1.00 X 0 0 0 LORIN BACHMANN BOARD MEMBER 1.00 X 0 0 0 PAULA VAGNONE SECRETARY 1.00 X X 0 0 0 TANIA MOTSCHMAN EX OFFICIO NON-VOTING MEMBER 1.00 X 0 0 0 SUSAN SHARP BOARD MEMBER 1.00 X 0 0 0 VICTOR WADDELL IMMEDIATE PAST PRESIDENT 1.00 X X 0 0 0 BARBARA J JONES CEO AND BOARD MEMBER 40.00 X X 470726 0 27014 DEBRA KUEHL BOARD MEMBER 1.00 X 0 0 0 MICHAEL LOEFFELHOLZ BOARD MEMBER 1.00 X 0 0 0 JENNIFER ADAMS VP STANDARDS & QUALITY 40.00 X 224349 0 22642 CECILIA PORTO VP, FINANCE AND ACCOUNTING 40.00 X 217028 0 25912 PATRICK MATETA VP GLOBAL HEALTH PARTNERSH 40.00 X 216488 0 10219 MELISSA MEEKS DIRECTOR, EDUCATION AND DE 40.00 X 139949 0 6600 CATHERINE BARNETT DIRECTOR, MEMBERSHIP 40.00 X 141099 0 11273 DAVID STERRY DIRECTOR, STANDARDS DEVELO 40.00 X 128783 0 27006 KATHARINE CASTAGNA DIRECTOR, STANDARDS DEVELO 40.00 X 114317 0 27006 LISA ARONE VP, GLOBAL COMMUNICATIONS & BRAND 40.00 X 137371 0 20772 1790110 0 178444 9 0 1 0 0 25000 1361575 1386575 MEMBERSHIP DUES 541900 4116950 4116950 GLOBAL HEALTH PROGRAM INCOME 541900 171518 171518 EDUCATIONAL PROGRAM INCOME 541900 16201 16201 4304669 416204 416204 971465 971465 15767969 13399453 2368516 2368516 2368516 1555431 127906 1427525 1427525 10874954 5732194 0 3756185 X 1282982 1282982 2859644 2203010 656634 121005 56872 64133 501459 235686 265773 295187 138738 156449 7403 7403 35581 35581 969422 526557 442865 250145 250145 300149 155451 144698 504331 242114 262217 81199 41898 39301 1147115 847141 299974 53075 28570 24505 45219 24342 20877 DUES AND SUBSCRIPTIONS 36869 543 36326 EDUCATION PROGRAM EXPEN 25435 25435 BAD DEBT RECOVERY 1942 1942 8518162 4526357 3991805 0 23 23 3350766 2269222 135455 107975 307187 303852 36217 76957 331213 299265 0 0 0 0 14763838 16890914 75257 58182 24000 0 19023956 20006390 1000144 1038695 2641638 2359869 3641782 3398564 X 15382174 16607826 15382174 16607826 19023956 20006390 2356792 -1131140 0 X X 0 1 X 1 1 1 X 1220704 2235915 4357350 2531195 1386575 11731739 5795732 6228325 6673452 5940813 5860100 30498422 7016436 8464240 11030802 8472008 7246675 42230161 0 0 0 42230161 385016 397667 499620 1661580 1387669 4331552 385016 397667 499620 1661580 1387669 4331552 170000 206863 376863 7571452 9068770 11530422 10133588 8634344 46938576 0.89970 0.91310 0.09230 0.06800 X RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED 0 X 9871720 -1131140 127906 -1003234 10874954 0 10874954 8646068 127906 127906 8518162 0 8518162 PART X, LINE 2: THE ORGANIZATION IS QUALIFIED AS A TAX EXEMPT ORGANIZATION UNDER EXISTING PROVISIONS OF THE INTERNAL REVENUE CODE SECTION 501(C)(3) AND, THEREFORE, HAS MADE NO PROVISION FOR FEDERAL OR STATE INCOME\ TAXES IN THE ACCOMPANYING FINANCIAL STATEMENTS. THE ORGANIZATION IS ANNUALLY REQUIRED TO FILE A FORM 990 RETURN OF ORGANIZATION EXEMPT FROM INCOME TAX WITH THE INTERNAL REVENUE SERVICE AND HAS NOT FILED FORM 990-T, UNRELATED BUSINESS INCOME TAX. THE ORGANIZATION IS NO LONGER SUBJECT TO U.S. FEDERAL OR STATE INCOME TAX EXAMINATIONS BY TAX AUTHORITIES FOR YEARS BEFORE 2020. THE ORGANIZATION DOES NOT ANTICIPATE SIGNIFICANT CHANGES IN ITS TAX POSITIONS OVER THE NEXT 12 MONTHS. PART XI, LINE 2D - OTHER ADJUSTMENTS: COST OF GOODS SOLD 127,906. PART XII, LINE 2D - OTHER ADJUSTMENTS: COST OF GOODS SOLD 127,906. 1 SUB-SAHARAN AFRICA 0 23 PROGRAM SERVICES SEE PART V FOR DESCRIPTION 1361575 SUB-SAHARAN AFRICA 0 0 PROGRAM SERVICES SEE PART V FOR DESCRIPTION 21272 CENTRAL AMERICA AND THE CARIBBEAN 1 0 PROGRAM SERVICES SEE PART V FOR DESCRIPTION 138947 EAST ASIA AND THE PACIFIC 0 0 PROGRAM SERVICES SEE PART V FOR DESCRIPTION 11299 0 23 0 23 0 46 1533093 0 1533093 0 0 0 0 0 0 PART I, LINE 2: THE ORGANIZATION USES AN ACCOUNTING SYSTEM THAT IDENTIFIES GRANT EXPENSES BY PROJECT AND COST CATEGORY. GRANT EXPENSES MUST FOLLOW THE ORGANIZATION APPROVAL PROCESS, BUDGETS ARE APPROVED BY THE FUNDING AGENCY AND BUDGET VERSUS ACTUAL REPORTS ARE MONITORED ON A REGULAR BASIS. SCHEDULE F, PART I, LINE 3, COLUMN (E) SPECIFIC TYPES OF SERVICES IN REGION: THROUGH ITS GLOBAL HEALTH PARTNERSHIPS (GHP) PROGRAM, CLSI IS DEDICATED TO BUILDING INDIGENOUS LABORATORY CAPACITY AND IMPLEMENTING QUALITY IMPROVEMENTS IN RESOURCE-CONSTRAINED COUNTRIES THROUGH ASSESSMENTS, TRAINING, AND MENTORSHIPS BASED ON CRITICAL NEEDS AND LABORATORY BEST PRACTICES. ADDITIONALLY, CLSI SUPPORTS BROADER COUNTRY GOALS OF ENHANCING THE ENTIRE NATIONAL LABORATORY SYSTEM, WHICH PLAYS A PIVOTAL ROLE IN THE FOUNDATION OF A COUNTRY'S HEALTHCARE NETWORK. LABORATORY DATA ESSENTIAL FOR CLINICIANS TO ACCURATELY ASSESS THE STATUS OF PATIENTS' HEALTH, MAKE ACCURATE DIAGNOSES, FORMULATE TREATMENT PLANS, AND SUBSEQUENTLY, MONITOR THE EFFECTS OF TREATMENT. THE CLINICIAN MUST HAVE CONFIDENCE IN THE ACCURACY OF THE TEST RESULTS FROM THE LABORATORY TO USE THEM FOR CLINICAL DIAGNOSIS AND TREATMENT. SINCE 2005, THE U.S. PRESIDENT'S EMERGENCY PLAN FOR AIDS RELIEF (PEPFAR) HAS BEEN FUNDING LABORATORY CAPACITY-BUILDING PROGRAMS IN RECOGNITION OF THE VITAL ROLE OF LABORATORIES IN COMBATING THE AIDS EPIDEMIC. CLSI HAS WORKED IN AFRICA, CENTRAL AND SOUTHEAST ASIA, AND EASTERN EUROPE FOR OVER FIFTEEN YEARS WITH FUNDING FROM PEPFAR TO HELP RESOURCE-CONSTRAINED COUNTRIES IMPROVE THE QUALITY OF THEIR LABORATORY NETWORKS, AND THE EFFICIENCY AND ACCURACY OF THEIR LABORATORY RESULTS. PEPFAR'S INVESTMENT IN IMPROVING LABORATORY CAPACITY HAS PAID OFF SIGNIFICANTLY. MORE PATIENTS ACCURATELY DIAGNOSED AS HIV-POSITIVE HAVE RESULTED IN MORE PEOPLE RECEIVING THE TREATMENT THEY NEED. THIS NOT ONLY HELPS THE PATIENTS LIVE LONGER, HEALTHIER LIVES, BUT ALSO CAN PROTECT THEIR HIV-NEGATIVE PARTNERS FROM CONTRACTING THE DISEASE. IN ADDITION, CORRECTLY DIAGNOSING A PREGNANT WOMAN AND STARTING HER ON ANTIRETROVIRAL TREATMENT CAN PREVENT HER CHILDREN FROM BEING BORN HIV-POSITIVE. IMPROVED LABORATORY SYSTEMS ALSO INCREASE ACCESS TO RELIABLE, QUALITY DIAGNOSTIC SERVICES FOR TUBERCULOSIS AND OTHER OPPORTUNISTIC INFECTIONS. FOR OVER FIFTEEN YEARS, CLSI'S GHP STAFF, CONTRACTORS AND VOLUNTEERS HAVE PROVIDED HUNDREDS OF WORKSHOPS IN 20+ COUNTRIES REACHING THOUSANDS OF LABORATORY PROFESSIONALS. THESE WORKSHOPS HAVE COVERED A BROAD RANGE OF TOPICS, INCLUDING QUALITY MANAGEMENT SYSTEMS, STRATEGIC PLANNING, QUALITY CONTROL AND QUALITY ASSURANCES, VERIFICATION AND VALIDATION, AND LABORATORY ASSESSOR AND MENTOR TRAINING. CLSI MENTORS HAVE PROVIDED OVER 5,000 HOURS OF SIDE-BY-SIDE MENTORING IN AFRICAN, CENTRAL AMERICA, AND ASIAN LABORATORIES, ASSISTING OVER 60 LABORATORIES IN THEIR BID FOR ACCREDITATION TO INTERNATIONALLY RECOGNIZED STANDARDS. CLSI HAS COLLABORATED ON PROJECTS WITH A RANGE OF NONPROFIT PARTNERS. X X X X 0 0 0 0 0 1 0 0 0 BARBARA J JONES CEO AND BOARD MEMBER 395726 0 75000 0 0 0 0 0 27014 0 497740 0 0 0 JENNIFER ADAMS VP STANDARDS & QUALITY 187207 0 37142 0 0 0 0 0 22642 0 246991 0 0 0 CECILIA PORTO VP, FINANCE AND ACCOUNTING 182028 0 35000 0 0 0 0 0 25912 0 242940 0 0 0 PATRICK MATETA VP GLOBAL HEALTH PARTNERSH 180472 0 36016 0 0 0 0 0 10219 0 226707 0 0 0 LISA ARONE VP, GLOBAL COMMUNICATIONS & BRAND 137371 0 0 0 0 0 0 0 20772 0 158143 0 0 0 DAVID STERRY DIRECTOR, STANDARDS DEVELO 117137 0 11646 0 0 0 0 0 27006 0 155789 0 0 0 CATHERINE BARNETT DIRECTOR, MEMBERSHIP 129254 0 11845 0 0 0 0 0 11273 0 152372 0 0 0 PART I, LINE 6 CLSI'S BONUS POLICY STATES THAT THE PAYMENT CALCULATION IS TO BE BASED ON ORGANIZATION, TEAM, AND INDIVIDUAL GOALS. ONE OF THE ORGANIZATION'S GOALS IS TO MEET BUDGET. FORM 990, PART III, LINE 1, DESCRIPTION OF ORGANIZATION MISSION: THE MISSION OF CLINICAL AND LABORATORY STANDARDS INSTITUTE (CLSI) IS TO "DEVELOP CLINICAL AND LABORATORY PRACTICES AND PROMOTE THEIR USE WORLDWIDE." WORKING TOGETHER, CLSI STAFF AND VOLUNTEER EXPERTS GUIDE THE DEVELOPMENT AND PROMOTE THE USE OF VOLUNTARY LABORATORY STANDARDS AND GUIDELINES WITHIN THE US AND INTERNATIONAL HEALTH CARE COMMUNITIES. CLSI FACILITATES A UNIQUE PROCESS OF DEVELOPING THESE TESTING STANDARDS BASED ON INPUT FROM AND CONSENSUS AMONG INDUSTRY, GOVERNMENT, AND HEALTH CARE PROFESSIONALS. IMPROVING THE QUALITY OF PATIENT CARE BY FOSTERING EXCELLENCE IN LABORATORY MEDICINE IS THE DRIVING FORCE BEHIND THE CREATION OF EVERY CLSI PRODUCT AND PROGRAM. FOUNDED IN 1968 AS A FOR-PROFIT STANDARDS DEVELOPMENT MEMBERSHIP ORGANIZATION, CLSI HAS EARNED THE CONFIDENCE AND RECOGNITION OF GOVERNMENT REGULATORY BODIES SUCH AS THE US FOOD AND DRUG ADMINISTRATION, CENTERS FOR DISEASE CONTROL AND PREVENTION, AND ORGANIZATIONS SUCH AS THE CENTERS FOR MEDICARE AND MEDICAID SERVICES THAT EITHER DIRECTLY ACCREDIT OR AUTHORIZE DEEMED STATUS ACCREDITATION STATUS. CLSI, ON BEHALF OF THE AMERICAN NATIONAL STANDARDS INSTITUTE, HAS SERVED FOR OVER 25 YEARS AS THE SECRETARIAT FOR THE INTERNATIONAL ORGANIZATION FOR STANDARDIZATION TECHNICAL COMMITTEE (TC 212) THAT AUTHORS GLOBAL STANDARDS FOR THE MEDICAL LABORATORY. CLSI IS FUNDED BY MEMBERSHIP DUES, THE SALES OF ITS PRODUCTS AND SERVICES, SPONSORSHIPS, AND GRANTS. CLSI STAFF, CONTRACTORS AND VOLUNTEERS PROVIDE SERVICES AND HANDS-ON SUPPORT TO LABORATORIES IN RESOURCE CONSTRAINED COUNTRIES, HELPING THEM ACHIEVE SUSTAINABLE QUALITY WITH SYSTEMS TO BETTER DIAGNOSE AND TREAT PATIENTS WITH INFECTIOUS DISEASES. THROUGH PARTNERSHIPS WITH THE US GOVERNMENT, UNIVERSITIES, AND OTHER NONPROFIT ORGANIZATIONS, CLSI HAS WORKED IN MORE THAN 20 COUNTRIES IN AFRICA, CENTRAL ASIA, SOUTH AMERICA, AND EASTERN EUROPE. FOR OVER 50 YEARS, OUR MEMBERS, VOLUNTEERS, AND CUSTOMERS HAVE MADE CLSI A RESPECTED, TRANSFORMATIVE LEADER IN THE DEVELOPMENT AND IMPLEMENTATION OF CLINICAL AND LABORATORY TESTING STANDARDS. THROUGH OUR UNIFIED EFFORTS, WE WILL CONTINUE TO SET AND UPHOLD THE STANDARDS THAT DRIVE QUALITY TEST RESULTS, ENHANCE PATIENTCARE DELIVERY, AND IMPROVE THE PUBLIC'S HEALTH AROUND THE WORLD. FORM 990, PART VI, SECTION A, LINE 1A CLSI'S EXECUTIVE COMMITTEE IS COMPRISED OF THE OFFICERS OF THE BOARD OF DIRECTORS. THEY MEET ON A MONTHLY BASIS AND CAN MAKE DECISIONS ON BEHALF OF THE BOARD UNLESS WHERE IT IS EXPLICITLY NOTED THAT THE FULL BOARD MUST APPROVE/VOTE PER OUR BY-LAWS. FORM 990, PART VI, SECTION A, LINE 6 ALL ORGANIZATIONS PAYING MEMBERSHIP DUES ARE CONSIDERED MEMBERS OF CLSI FORM 990, PART VI, SECTION A, LINE 7A POWER TO ELECT OR APPOINT ONE OR MORE MEMBERS OF THE GOVERNING BODY FORM 990, PART VI, SECTION B, LINE 11B INDEPENDENT AUDITORS PREPARE THE ANNUAL FORM 990 AND THE FORM IS SENT TO THE BOARD OF DIRECTORS FOR REVIEW PRIOR TO SUBMISSION. FORM 990, PART VI, SECTION B, LINE 12C OFFICERS AND MEMBERS OF THE BOARD ARE REQUIRED TO COMPLETE A DISCLOSURE OF INTEREST FORM AND IT IS A STANDING AGENDA ITEM AT ALL BOARD MEETINGS FOR UPDATES TO EACH MEMBER'S. FORM 990, PART VI, SECTION B, LINE 15 INDUSTRY COMPARABILITY DATA AND OTHER ANALYSIS IS USED TO DETERMINE APPROPRIATE COMPENSATION FOR THE CEO AS WELL AS OTHER OFFICERS AND KEY EMPLOYEES. THE CEO'S SALARY IS APPROVED BY THE PRESIDENT OF THE BOARD OF DIRECTORS. FORM 990, PART VI, SECTION C, LINE 19 ALL GOVERNING DOCUMENTS, POLICIES AND PROCEDURES, FINANCIAL STATEMENTS AND COPIES OF FORM 990 ARE AVAILABLE FOR PUBLIC INSPECTION UPON REQUEST. FORM 990, PART IX, LINE 11G PROFESSIONAL FEES: PROGRAM SERVICE EXPENSES 526,557. MANAGEMENT AND GENERAL EXPENSES 442,865. FUNDRAISING EXPENSES 0. TOTAL EXPENSES 969,422. FORM 990, PART XII, LINE 2C CLSI HAS A FINANCE COMMITTEE WHICH TAKES RESPONSIBLITY FOR OVERSIGHT OF THE ANNUAL FINANCIAL STATEMENT AUDIT. THERE WERE NO CHANGES TO THIS PROCESS FROM PRIOR YEARS.