Marcia regs and requirements by James Rhymer

3/27/2015

Regulations and Other Requirements Affecting Infection Prevention and Control Programs in Ambulatory Surgery Centers Marcia Patrick, MSN, RN, CIC Infection Prevention and Control Consultant and Educator marcia.patrickip@gmail.com

Objectives  Identify three agencies that produce regulations or other requirements related to infection prevention programs in the ASC  Describe three requirements that have an impact on your organization  Describe strategies for complying with these three requirements  State two emerging national regulatory trends that impact ASCs

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Types of Requirements Terminology may be confusing; it is important to know the difference! Know the Source of the Requirement!

Regulation (Government Agencies) Mandatory

Accrediting Standards Voluntary, unless required by State

Best or Recommended Practices; Other Guidance Voluntary, but may become standard of care

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Regulatory Agencies Not all government agencies issue regulations. It is essential to know those that do!

 Occupational Safety & Health Admin. (OSHA)  Centers for Medicare & Medicaid Services (CMS)  Environmental Protection Agency (EPA)  Department of Transportation (DOT)  Food and Drug Administration (FDA)  State and local health departments  Note: Some state/local regulations may be more

stringent than federal; follow the most stringent

Occupational Safety & Health Administration (OSHA)  Federal agency under U.S. Department of Labor  Occupational Safety & Health Act adopted by

Congress in 1970  Formed to protect health of workers  By helping employers and employees reduce on‐the‐

job injuries, illnesses and deaths

 22 states have their own Occupational Safety

and Health Plans http://www.osha.gov/dcsp/osp/

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OSHA‐Approved State Plans Alaska

Indiana

Nevada

Puerto Rico

Arizona

Iowa

New Mexico South Carolina

California

Kentucky New Jersey*

Vermont

Conn.*

Maryland New York*

Washington Wyoming

Hawaii

Michigan

North Carolina

Tennessee

Illinois*

Minn.

Oregon

Utah

Virgin Islands* Virginia

*these states cover public employees only

OSHA Bloodborne Pathogens (BBP) Standard  29 CFR Part 1910.1030. Occupational

Exposure to Bloodborne Pathogens; Final Rule; 12/6/91  http://www.osha.gov/pls/oshaweb/owadis

p.show_document?p_table=STANDARDS& p_id=10051

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OSHA Bloodborne Pathogens Standard: Exposure Control Plan (1)  Requires Bloodborne Pathogens

Exposure Control Plan (ECP) that must include the following:  Purpose  Scope  Definitions  Exposure Determination

OSHA Bloodborne Pathogens Standard: Exposure Control Plan (2) Hierarchy of Control Methods (OSHA)   

Engineering Controls Work Practice Controls Personal Protective Equipment (PPE)

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OSHA Bloodborne Pathogens Standard: Exposure Control Plan (3) Engineering Controls  Safety built into device  Safety needles  Safety scalpels  Sharps containers  Mylar‐wrapped capillary tubes  Plastic specimen tubes

http://blog.peanutsafesyringe.com/hospital‐staff‐and‐injection‐safety‐dr‐baby‐manoj‐p‐p/

OSHA Bloodborne Pathogens Standard: Exposure Control Plan (4) Work Practice Controls  Reduce likelihood of exposure  Alter manner in which task

performed   

e.g., no eating, drinking, applying lip balm in work area No recapping of needles Most difficult to enforce

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OSHA Bloodborne Pathogens Standard: Exposure Control Plan (5) Personal Protective Equipment (PPE)  Gloves  Gowns  Masks  Respirators  Face shields  Etc.

OSHA Bloodborne Pathogens Standard: Exposure Control Plan (6)  Hepatitis B Vaccination or written

declination  Post Exposure Evaluation and Follow‐up  Sharps Injury Log  Training and Education  Recordkeeping

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OSHA BBP Standard 1/18/01 revision • Safer sharps requirements added: – Modified definitions of engineering controls – Requires annual review and revision of Exposure Control Plan – Requires employee input on selection of sharps safety devices, PPE – Additional recordkeeping

• 29 CFR Part 1910.1030. Occupational Exposure to Bloodborne Pathogens; Needlestick and Other Sharps Injuries; Final Rule. Effective April 18, 2001

Strategies for Complying with OSHA BBP Standard (1)  Ensure availability of Exposure

Control Plan (ECP)  Must contain all required

elements and a copy of the BBP Standard

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Strategies for Complying with OSHA BBP Standard (2)  Provide documentation of following: • Exposure determination required by paragraph (c)(2) • Schedule and method of implementation for: • •

•

• •

(d) Methods of Compliance (e) HIV and HBV Research Laboratories/Production Facilities (may not be applicable) (f) Hepatitis B Vaccination and Post‐Exposure Evaluation and Follow‐up (g) Communication of Hazards to Employees (h) Recordkeeping, for this standard

Strategies for Complying with OSHA BBP Standard (3) • Annually document consideration of safer

medical devices designed to eliminate or minimize occupational exposure (safety sharps) • Annual review of Exposure Control Plan • Required orientation and annual training • Required HBV vaccination or declination

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Strategies for Complying with OSHA BBP Standard (4)  Ensure personal protective equipment (PPE)

is available and used properly, consistently  Must be universal for same task

 Ensure sharps safety devices available  and used properly  Evaluate new safety sharps products if they

fill a niche where there are exposures  Refer to OSHA BBP Compliance Directive https://www.osha.gov/pls/oshaweb/owadisp.show_document ?p_table=DIRECTIVES&p_id=270

Strategies for Complying with OSHA BBP Standard (5)  eTools:  http://www.osha.gov/dts/os

ta/oshasoft/index.html

 Hospital eTool: see

“Surgical Suite”  http://www.osha.gov/SLTC/e

tools/hospital/index.html

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Other OSHA Rules Affecting Infection Prevention & Control Programs  OSH ACT “General Duty Clause”  Hazard Communication (29 CFR

1910.1200)  Occupational Injury and Illness Recording and Reporting (29 CFR 1904)

OSHA Inspections (1)  Some planned; many

unannounced in response to:  Catastrophes and fatal accidents  Complaints (employee or patient)

 Non compliance can result in

citation, fines, and adverse publicity

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OSHA Inspections (2)  Inspection process includes:  Request to see specific personnel  Review documents & records  Inspect site (walk around)  Interview employees  Evaluate compliance  Issue written findings

Centers for Medicare & Medicaid Services (CMS)  Federal agency that administers:  Medicare and Medicaid  HIPAA (Healthcare Insurance Portability and

Accountability Act of 1996)

 Enforces federal quality standards for

various healthcare settings

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Centers for Medicare & Medicaid Services (CMS)  Maintains oversight of ASCs, hospitals, long

term care facilities, home health agencies, intermediate care facilities, mental health facilities, long‐term acute care, and rehabilitation facilities  Administers Quality Improvement Organizations (QIOs) at state level  QIOs work to enforce CMS requirements

CMS Regulations  Prescribed rules  written in broad, general terms

 CMS Interpretive Guidelines support implementation and enforcement of regulations  Noncompliance results in citation, disqualification from Medicare, other penalties, closure  CMS regulations described as Conditions for Participation (e.g. hospitals) or Conditions for Coverage (e.g. ASCs)

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What is an Ambulatory Surgical Center or ASC (per CMS)?  Any distinct entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization and in which the expected duration of services would not exceed 24 hours following an admission.  The entity must have an agreement with CMS to participate in Medicare as an ASC and must meet the ASC Conditions for Coverage (42 CFR 416.2 – 416.52)

What is Surgery per CMS? (1)  Procedure performed for purpose of

structurally altering the human body by incision or destruction of tissues  Also: diagnostic or therapeutic treatment of conditions or disease processes by any instruments causing localized alteration or transposition of live human tissue which include lasers, ultrasound, ionizing radiation, scalpels, probes, and needles

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What is Surgery per CMS? (2)  Also: Injection of diagnostic or therapeutic substances into body cavities, internal organs, joints, sensory organs, and the central nervous system

CMS Conditions for Coverage: Ambulatory Surgical Centers (ASC) (1)  ASC Conditions for Coverage (CfCs)  effective since May 18, 2009

 Interpretive Guidelines for CfCs available  Include CfC on “Infection Control”

 Search CMS CfCs & Interpretive

Guidelines

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Interpretive Guideline Example (Ref:S&C‐08‐04)  Centers for Disease Control & Prevention

(CDC) has defined “infection control professional” as “a person whose primary training is in either nursing, medical technology, microbiology, or epidemiology and who has acquired specialized training in infection control.”

CMS Conditions for Coverage: ASC  416.51(b): Infection control program  Designed to prevent, control and investigate

infections and communicable diseases  Based on nationally recognized guidelines  Led by licensed individual who has training in principles and methods of infection prevention and control

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CMS Conditions for Coverage: ASC  416.51(b): Infection control program  Must be integral part of ASC’s quality assessment and performance improvement (QAPI) program  Provides plan of action for preventing, identifying, and managing infections and communicable diseases and for immediately implementing corrective and preventive measures that result in improvement

Strategies for Complying with CMS Conditions for Coverage  Review Conditions for Coverage and

Interpretive Guidelines  Base your infection surveillance, prevention

and control program strategies on interpretive guidelines

 Self assessment: Use CMS IC Surveyor’s

Worksheet

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The CMS Survey for ASCs  Will determine if ASC complies with:  Definition of an ASC  ASC general conditions and

requirements  Conditions for coverage (CfCs)

 Certification accomplished through:  Observations, tours, interviews  Document and record reviews

No “drive by” CMS surveys!

CMS Survey Process:  Focus on staff that do procedures  Use case tracer methodology  Surveyors required to follow at least one

patient from admission, through surgery and recovery, to discharge  Observe for compliance with multiple CfCs, particularly at transition points and in OR

 Use Infection Control Survey Tool

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Clinical Laboratory Improvement Amendments (CLIA)  CMS regulates all laboratory

testing (except research) performed on humans in United States through CLIA program  A facility MUST obtain CLIA Certificate to perform any point of care testing (e.g. glucose blood screening)

Full Survey

Validation Survey

Your Facility

Complaint Survey

Remember: If you are performing point of care (POC) testing you must be able to produce your CMS CLIA Certificate. If you do not have a CMS CLIA Certificate, you may have a follow up CLIA survey!

CLIA Survey

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What type of survey was it?

Many CMS Quality Initiatives: Public Reporting and Pay for Performance  Nursing Home Quality Initiative  Requires reporting of infection rates

 Hospital Quality Initiatives  CMS linking payment with performance by

requiring hospitals to submit data on quality measures  Program has been expanding

 Performance data posted on CMS website

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CMS Quality Reporting Program for ASCs (ASCQR) (Reporting for Performance)

 CMS implemented ASCQR program in 2012*  Beginning with Jan. 1, 2014 services, ASCs that do not successfully meet ASCQR Program requirements subject to payment reduction  Program being phased in *OPPS/ASC Final Rule (CMS‐1525‐FC) http://www.gpo.gov/fdsys/pkg/FR‐2011‐11‐30/pdf/2011‐ 28612.pdf

CMS ASCQR Measures Related to Infection Prevention  ASC‐5: Prophylactic Intravenous (IV) Antibiotic Timing for SSI Prevention*  data submission began Oct 1, 2012

 ASC‐8: Influenza Vaccination Coverage Among Healthcare Personnel  data submission began Oct. 1, 2014

 Being considered for future reporting:  Surgical Site Infections *OPPS/ASC Final Rule (CMS‐1525‐FC)

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Surgical Care Improvement Project (SCIP)  Initiated in 2003 by CDC and CMS  National partnership of organizations focused on improving surgical care quality by reducing surgical complications Started as voluntary but…. • Many SCIP measures have been

incorporated into mandatory and public reporting program requirements at Federal and State levels

SCIP Core Measures Applicable to ASCs  Prophylactic antibiotic: • initiated within one hour prior to surgical

incision • appropriate antibiotic selection for specified surgical procedures

 Surgery patients with appropriate hair

removal

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CMS ASC‐5: Prophylactic Intravenous (IV) Antibiotic Timing ASCs must submit to CMS one of these codes:  G8916: Patient with preop order for IV antibiotic surgical site infection (SSI) prophylaxis, antibiotic initiated on time  G8917: Patient with preop order for IV antibiotic SSI prophylaxis, antibiotic not initiated on time  G8918: Patient without preoperative order for IV antibiotic SSI prophylaxis

CMS ASC‐8: Flu Vaccine Reporting Requirement to CMS via NHSN  ASCs participating in CMS ASCQR Program

must report:  Surveillance for healthcare personnel (HCP)

influenza vaccination: data collection started Q4 2014 (Oct.‐Dec.) to monitor influenza vaccination rates (percentages) among HCP  http://www.cdc.gov/nhsn/ambulatory‐ surgery/hcp‐vaccination/index.html

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CMS: “Infection Control” Breaches Requiring Reporting to Public Health Authorities  Using same needle for more than one individual  Using same syringe, pen or injection device for more than one individual  Re‐using a needle or syringe which has already been used to administer medication to an individual for use on another individual  Using lancing/fingerstick device for more than one individual  Effective May 28, 2014

Environmental Protection Agency (EPA)  Regulates:

 Disinfectants used on inanimate

objects and environmental surfaces  Medical waste incinerators Reminder # 1: make sure your disinfectants are EPA‐ registered as hospital disinfectant products and are being used correctly. Reminder # 2: bleach solution is acceptable disinfectant when used correctly; make sure it is EPA registered as hospital disinfectant Reminder # 3: read and follow the label!

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Food and Drug Administration  Regulates:

 High‐level disinfectants & sterilants  Medical devices, including reuse  Issues recall notices and safety alerts  Publishes guidance; answers questions  Issues drug and device approvals and clearances Subscribe to FDA Med Watch email alerts at http://www.fda.gov/Safety/MedWatch/default.htm

A few words about Single Use Devices (SUDs)…  SUD, also known as a disposable device, is intended to be used on one patient during a single procedure. Not intended to be reprocessed (cleaned, disinfected / sterilized) and used on another patient.*  Can be reprocessed by third‐party reprocessor approved by

FDA  Healthcare facilities cannot meet stringent FDA requirements as reprocessor *FDA. Enforcement Priorities for Single‐Use Devices Reprocessed by Third Parties and Hospitals. http://www.fda.gov

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Department of Transportation (DOT)

 Regulates packaging and

transport of regulated (infectious) medical waste

If you ship specimens, you need to have IATA as well as DOT certification Does not apply for your laboratory specimens which are picked up by a lab service.

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State & Local Regulations  Include:  Requirements for infection surveillance,

prevention and control programs  Notifiable disease reporting (all States)  Medical waste handling & processing  Food safety and sanitation  State occupational safety & health

State Mandatory and Public Reporting  In addition to CMS, many states require

reporting:

 Many require reporting of HAI related data  Some have public reporting

 Reporting indicators differ by state  Know your state reporting requirements  APIC legislative map: www.apic.org  click on “Public Policy” and “State Legislation”  http://www.cdc.gov/hai/stateplans/required‐ to‐report‐hai‐NHSN.html#wa

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Several States Have Requirements for HAI Reporting in ASCs States requiring SSI reporting*:       

Colorado Missouri Nevada New Hampshire Texas Massachusetts New Jersey *As of Jan. 1, 2014

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Accreditation Standards  Must be met to receive accreditation  Not regulations, but standards often reflect

CfCs used by CMS  ASC accrediting agencies with deemed status:  Accreditation Association for Ambulatory Health Care (AAAHC)  The Joint Commission (TJC)  American Association for Accreditation of Ambulatory Surgical

Facilities (AAAASF)  American Osteopathic Association (AOA)  Healthcare Facilities Accreditation Program (HFAP)

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and be ready for a CMS visit, too!

How to Prepare for an Accreditation Survey…  Know standards and requirements related to

surveillance, prevention, and control of infection  Conduct self assessment  Use forms and checklists  Conduct mock survey

 Prepare documents for review  Educate self, staff and administration  Network with colleagues

Recommended Practices and Guidelines  Not regulations BUT may be incorporated

into regulations  Often cited by accrediting agencies  May become “Standard of Care”  Based on scientific research (or consensus, if research is limited)  May be graded by level of evidence

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Guidance Documents Developed by Various Agencies & Organizations Here are just a few examples ....

 Centers for Disease Control and Prevention (CDC)  Association for periOperative Registered Nurses (AORN)  Facilities Guidelines Institute [formerly American Institute of    

Architects (AIA)] Association for Professionals in Infection Control and Epidemiology (APIC) Association for the Advancement of Medical Instrumentation (AAMI) Advisory Committee on Immunization Practices (ACIP) Society for Healthcare Epidemiology of America (SHEA)

Centers for Disease Control and Prevention (CDC)  Division of Healthcare Quality Promotion

(DHQP)  Healthcare Infection Control Practices

Advisory Committee (HICPAC)  National Healthcare Safety Network (NHSN)

 National Institute for Occupational Safety

and Health (NIOSH)  www.cdc.gov

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Just Some of the CDC Guidelines . . .(1)  Hand Hygiene (2002)*  Isolation Precautions (2007)*  Infection Prevention Checklist for Outpatient

Settings: Minimum Expectations for Safe Care (2011)  Environmental Infection Control (2003)* • Disinfection and Sterilization in Healthcare Facilities (2008)* *http://www.cdc.gov/hai/ Remember, if your IC Plan states that you follow a guideline, the CMS surveyor will look for evidence that you actually do.

Just Some of the CDC Guidelines . . .(2)  Prevention of Surgical Site Infections (1999)*  Prevention of IV Catheter‐Related Infections

(2011)*  Prevention of CAUTI (2009)*  Management of Multidrug‐resistant Organisms (2006)*  Management of Occupational Exposures to HIV (2013) *http://www.cdc.gov/hai/ Remember, if your IC Plan states that you follow a guideline, the CMS surveyor will look for evidence that you actually do.

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Association of periOperative Registered Nurses (AORN)  Guidelines for Perioperative

Practice, 2015  Noted on IC Surveyor Worksheet for CMS ASC survey www.aorn.org

Association for Advancement of Medical Instrumentation  Consensus organization founded in 1967  Manufacturers and users of medical devices

Provides: Standards and Guidelines for decontamination and sterilization for healthcare facilities. Key resource for steam sterilization (ANSI/AAMI ST79) and High Level Disinfection (ST58) practices.

www.aami.org

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Association for Professionals in Infection Control and Epidemiology (APIC)  Original research, position papers, peer

reviewed journal – and more!  Extensive resources specific to infection prevention in ambulatory care  e‐newsletter  On‐line education programs & webinars  Annual educational conference & meeting

Other Guidelines & Standards  American Society for Gastrointestinal

Endoscopy (ASGE)  Multisociety Guideline for Reprocessing Scopes

 American Academy of Ophthalmology  American Society of Anesthesiologists  American Association of Nurse Anesthetists  American Academy of Pediatrics  “Red Book” for pediatric infectious diseases

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Other Guidelines & Standards  Society of Gastroenterology Nurses and

Associates (SGNA)  http://www.sgna.org  Produces guidelines, standards, and position papers  American Academy of Cataract and Refractive Surgery  Intravenous Nurses Society (INS)

60/67

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How Can We Ensure Compliance? (1)  Know requirements applicable to our

setting  Obtain and disseminate copies of regulations, standards, and guidelines  Educate self, administration and staff

How Can We Ensure Compliance? (2)  Monitor new and changing requirements  Use APIC and other professional

organizations; network with colleagues; monitor websites; receive electronic alerts

 Assist during surveys and inspections  Serve as leader or member of

performance improvement teams

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How Can We Ensure Compliance? (3)  Assess compliance by observation,

checklists, rounds, interviews  Involve stakeholders

 Develop and implement action plan

if:  new or changing requirements  non‐compliance  infection rates unacceptable

Summary  An ASC’s infection surveillance, prevention and control program (ISPC) must comply with a variety of requirements:  government regulations, accrediting agency

standards, and guidelines produced by various organizations  We have discussed strategies that can be used to assist an ASC meet these requirements  The Infection Preventionist plays a critical role in developing and implementing an effective IPSC Program

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References  29 CFR Part 1910.1030. Occupational Exposure to Bloodborne Pathogens; Needlestick and Other Sharps Injuries; Final Rule. April 18, 2001 http://www.osha.gov/pls/oshaweb/owadisp.show_do cument?p_id=16265&p_table=FEDERAL_REGISTER  CPL 02‐02‐069. OSHA Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens (Compliance Directive) http://www.osha.gov/pls/oshaweb/owadisp.show_do cument?p_table=DIRECTIVES&p_id=2570

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References  CMS Clinical Laboratory Improvement Amendments (CLIA) https://www.cms.gov/Regulations‐and‐ Guidance/Legislation/CLIA/index.html?redirect=/clia/ 03_interpretive_guidelines_for_laboratories.asp  National Healthcare Safety Network (NHSN) Manual: Healthcare Personnel Influenza Vaccination http://www.cdc.gov/nhsn/ambulatory‐surgery/hcp‐ vaccination/index.html

References  CMS Memorandum, May 28, 2014: Infection Control Breaches Which Warrant Referral to Public Health Authorities

http://www.cms.gov/Medicare/Provider‐Enrollment‐ and‐ Certification/SurveyCertificationGenInfo/Downloads/S urvey‐and‐Cert‐Letter‐14‐36.pdf

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