Basics of Antibiotic resistance: Focus on Carbapenem-resistant Enterobacteriaceae

Similar documents
Taking Action to Prevent and Manage Multidrug-resistant Organisms and C. difficile in the Nursing Home: Part 1 Reviewing the organisms

CONTAGIOUS COMMENTS Department of Epidemiology

Antimicrobial Susceptibility Testing: Advanced Course

Prevention, Management, and Reporting of Carbapenem-Resistant Enterobacteriaceae

2015 Antibiotic Susceptibility Report

2016 Antibiotic Susceptibility Report

Florida Health Care Association District 2 January 13, 2015 A.C. Burke, MA, CIC

Understanding the Hospital Antibiogram

Concise Antibiogram Toolkit Background

What is an Antibiotic Stewardship Program?

Antibiotic. Antibiotic Classes, Spectrum of Activity & Antibiotic Reporting

5/4/2018. Multidrug Resistant Organisms (MDROs) Objectives. Outline. Define a multi-drug resistant organism (MDRO)

Mercy Medical Center Des Moines, Iowa Department of Pathology. Microbiology Department Antibiotic Susceptibility January December 2016

Safe Patient Care Keeping our Residents Safe Use Standard Precautions for ALL Residents at ALL times

The β- Lactam Antibiotics. Munir Gharaibeh MD, PhD, MHPE School of Medicine, The University of Jordan November 2018

9/30/2016. Dr. Janell Mayer, Pharm.D., CGP, BCPS Dr. Lindsey Votaw, Pharm.D., CGP, BCPS

2012 ANTIBIOGRAM. Central Zone Former DTHR Sites. Department of Pathology and Laboratory Medicine

CONTAGIOUS COMMENTS Department of Epidemiology

Antimicrobial Susceptibility Patterns

CONTAGIOUS COMMENTS Department of Epidemiology

Suggestions for appropriate agents to include in routine antimicrobial susceptibility testing

The Basics: Using CLSI Antimicrobial Susceptibility Testing Standards

New Opportunities for Microbiology Labs to Add Value to Antimicrobial Stewardship Programs

GENERAL NOTES: 2016 site of infection type of organism location of the patient

Intrinsic, implied and default resistance

a. 379 laboratories provided quantitative results, e.g (DD method) to 35.4% (MIC method) of all participants; see Table 2.

Antimicrobial Stewardship:

Antimicrobial Stewardship Programs The Same, but Different. Sara Nausheen, MD Kevin Kern, PharmD

Antibiotic Stewardship in the LTC Setting

1/30/ Division of Disease Control and Health Protection. Division of Disease Control and Health Protection

Antimicrobial Susceptibility Testing: The Basics

Antimicrobial Update. Alison MacDonald Area Antimicrobial Pharmacist NHS Highland April 2018

THE NAC CHALLENGE PANEL OF ISOLATES FOR VERIFICATION OF ANTIBIOTIC SUSCEPTIBILITY TESTING METHODS

Educating Clinical and Public Health Laboratories About Antimicrobial Resistance Challenges

Help with moving disc diffusion methods from BSAC to EUCAST. Media BSAC EUCAST

BACTERIAL SUSCEPTIBILITY REPORT: 2016 (January 2016 December 2016)

MICRONAUT MICRONAUT-S Detection of Resistance Mechanisms. Innovation with Integrity BMD MIC

New Drugs for Bad Bugs- Statewide Antibiogram

Aberdeen Hospital. Antibiotic Susceptibility Patterns For Commonly Isolated Organisms For 2015

Antibiotic Resistance. Antibiotic Resistance: A Growing Concern. Antibiotic resistance is not new 3/21/2011

Antimicrobial Stewardship Strategy: Antibiograms

Bad Bugs. Pharmacist Learning Objectives. Antimicrobial Resistance. Patient Case. Pharmacy Technician Learning Objectives 4/8/2016

Similar to Penicillins: -Chemically. -Mechanism of action. -Toxicity.

Antibiotic Stewardship Program (ASP) CHRISTUS SETX

Infection Prevention Highlights for the Medical Staff. Pamela Rohrbach MSN, RN, CIC Director of Infection Prevention

Other Beta - lactam Antibiotics

Infection Control of Emerging Diseases

European Committee on Antimicrobial Susceptibility Testing

Antimicrobial Resistance Strains

Service Delivery and Safety Department World Health Organization, Headquarters

Approach to pediatric Antibiotics

Available online at ISSN No:

ESBL- and carbapenemase-producing microorganisms; state of the art. Laurent POIREL

Antimicrobial Stewardship Program

Antimicrobial Stewardship/Statewide Antibiogram. Felicia Matthews Senior Consultant, Pharmacy Specialty BD MedMined Services

2015 Antibiogram. Red Deer Regional Hospital. Central Zone. Alberta Health Services

PRACTIC GUIDELINES for APPROPRIATE ANTIBIOTICS USE

EARS Net Report, Quarter

Interactive session: adapting to antibiogram. Thong Phe Heng Vengchhun Felix Leclerc Erika Vlieghe

European Committee on Antimicrobial Susceptibility Testing

Appropriate antimicrobial therapy in HAP: What does this mean?

2017 Antibiogram. Central Zone. Alberta Health Services. including. Red Deer Regional Hospital. St. Mary s Hospital, Camrose

Antibiotic Resistance in the Post-Acute and Long-Term Care Settings: Strategies for Stewardship

Prevalence of Metallo-Beta-Lactamase Producing Pseudomonas aeruginosa and its antibiogram in a tertiary care centre

ESBL Producers An Increasing Problem: An Overview Of An Underrated Threat

Mechanism of antibiotic resistance

Challenges Emerging resistance Fewer new drugs MRSA and other resistant pathogens are major problems

03/09/2014. Infection Prevention and Control A Foundation Course. Talk outline

جداول میکروارگانیسم های بیماریزای اولویت دار و آنتی بیوتیک های تعیین شده برای آزمایش تعیین حساسیت ضد میکروبی در برنامه مهار مقاومت میکروبی

Infectious Disease 101: Helping the Consultant Pharmacist with Stewardship Principles

Multi-Drug Resistant Organisms (MDRO)

Pharmacology Week 6 ANTIMICROBIAL AGENTS

Table 1. Commonly encountered or important organisms and their usual antimicrobial susceptibilities.

Antimicrobial Stewardship Program 2 nd Quarter

Medicinal Chemistry 561P. 2 st hour Examination. May 6, 2013 NAME: KEY. Good Luck!

Core Elements of Antibiotic Stewardship for Nursing Homes

RCH antibiotic susceptibility data

January 2014 Vol. 34 No. 1

Super Bugs and Wonder Drugs: Protecting the One While Respecting the Many

EUCAST recommended strains for internal quality control

2016 Antibiogram. Central Zone. Alberta Health Services. including. Red Deer Regional Hospital. St. Mary s Hospital, Camrose

Childrens Hospital Antibiogram for 2012 (Based on data from 2011)

Taking Action to Prevent and Manage Multidrug-resistant Organisms and C. difficile in the Nursing Home: Part 2 Understanding the spread

Multi-drug resistant microorganisms

Multidrug-Resistant Organisms: How Do We Define them? How do We Stop Them?

ADC 2016 Report on Bacterial Resistance in Cultures from SEHOS and General Practitioners in Curaçao

General Approach to Infectious Diseases

Microbiology. Multi-Drug-Resistant bacteria / MDR: laboratory diagnostics and prevention. Antimicrobial resistance / MDR:

Do clinical microbiology laboratory data distort the picture of antibiotic resistance in humans and domestic animals?

Cell Wall Weakeners. Antimicrobials: Drugs that Weaken the Cell Wall. Bacterial Cell Wall. Bacterial Resistance to PCNs. PCN Classification

Routine internal quality control as recommended by EUCAST Version 3.1, valid from

Preventing and Responding to Antibiotic Resistant Infections in New Hampshire

INCIDENCE OF BACTERIAL COLONISATION IN HOSPITALISED PATIENTS WITH DRUG-RESISTANT TUBERCULOSIS

ANTIMICROBIAL RESISTANCE SURVEILLANCE FROM SENTINEL PUBLIC HOSPITALS, SOUTH AFRICA, 2014

Int.J.Curr.Microbiol.App.Sci (2017) 6(3):

Preserve the Power of Antibiotics

Using Web-Based Instruction Modules to Improve Practitioner Knowledge at Yale New Haven Hospital on the Prevention of Antimicrobial Resistance and

National Clinical Guideline Centre Pneumonia Diagnosis and management of community- and hospital-acquired pneumonia in adults

number Done by Corrected by Doctor Dr.Malik

INFECTIOUS DISEASES DIAGNOSTIC LABORATORY NEWSLETTER

Transcription:

Basics of Antibiotic resistance: Focus on Carbapenem-resistant Enterobacteriaceae Nimalie Stone, MD, MS Division of Healthcare Quality Promotion December 9, 2015

Provide exceptional compassionate clinical care that treats the whole person Strive to prevent problems and treat when necessary. Change Package Strategies and Prevent Healthcare Acquired Infections Change Bundle (Attachment 4): https://www.lsqin.org/wp-content/uploads/2015/03/nh- ChangePackage-032615-Final-508.pdf 2

Presentation Objectives Review common bacteria identified in nursing homes and antibiotics used to treat them Describe mechanisms for antibiotic resistance to develop in bacteria including carbapenemresistance Discuss ways your laboratory can provide information about antibiotic resistance to your facility

Basics on bacteria Gram Stain Positive (purple) Gram Stain Negative (pink/red) Bacteria have different characteristics that allow us to identify them in the lab Shape, size, gram stain, growth patterns, etc. We often use these characteristics to develop antibiotics

Common bacteria in healthcare Gram positive Many are cocci, round bacteria Examples are Streptococci, Staphylococci, Enterococci Clostridium difficile (C. diff) is an anaerobic, Gram positive rod Gram negative Most are bacilli, rod-shaped bacteria Examples are: E. coli, Klebsiella, Enterobacter, Proteus, Pseudomonas, Acinetobacter

Important gram-negative bacteria Genus Common species Enterobacteriacea Escherichia sp. E. coli Urine Common culture sites Klebsiella spp. K. pneumoniae and K. oxytoca Urine, resp. Not Enterobacteriacea Enterobacter spp. E. cloacae and E. aerogenes Pseudomonas sp. Pseudomonas aeruginosa Urine Urine, resp., wound Acintobacter sp. A. baumannii Urine, resp.

Antibiotics 101 Antibiotics are drugs that treat and kill bacteria They are grouped into classes based on their structure and activity Narrow-spectrum target a few specific bacteria Broad-spectrum can kill a wide variety of bacteria Antibiotic resistance = when the bacteria are no longer fully killed by the antibiotic Bacteria with resistance can cause patients to have more severe infections which are harder and more costly to treat Infection prevention programs track certain bug-drug combinations for resistance

Antibiotics: Beta Lactam classes Penicillin, methicillin, amoxicillin and ampicillin Extended spectrum agents: piperacillin, ticarcillin Can be combined with a drug to help them overcome bacterial resistance Amoxicillin + Clavulante = Augmentin; Ampicillin + Sulbactam = Unasyn Piperacillin + tazobactam = Zosyn Cephalosporins More gram positive activity: Cephalexin, Cefazolin More gram negative activity: Ceftriaxone, Ceftazidime, Cefepime New broader spectrum, including MRSA: Ceftaroline

Antibiotics: Carbapenems Extremely broad-spectrum, among the most powerful antibiotics we currently have available Spectrum includes Streptococci, susceptible Staphylococci, Enterobactericeae, Pseudomonas, Acinetobacter sp., and anaerobic bacteria Drug Imipenem Meropenem Ertapenem Doripenem Route of Administration IV IV IM, IV IV

Antibiotics : Gram positive agents Vancomycin Treats methicillin-resistant Staphylococcus aureus (MRSA) Oral form is NOT absorbed from gut; only used to treat C difficile IV form will get good systemic levels - used to treat all other infections Daptomycin Covers resistant gram-positive organisms: MRSA and Va n co m ycin -resistant Enterococci (VRE) Only available as IV formula Linezolid Cove rs MRSA an d VRE Both oral and IV forms available and get good systemic levels

Antibiotics: Gram negative agents Fluoroquinolones (oral and IV forms) Ciprofloxacin: Mostly gram negative activity Commonly used for UTI treatment Levofloxacin/Moxifloxacin: Broader activity Also used for treating UTIs and infections from gramnegative bacteria Also covers Streptococcus pneumoniae and other respiratory bacteria Aminoglycosides (only IV) Examples: Gentamicin, Tobramycin, Amikacin Excellent gram negative drugs especially for urinary tract Limited use because of toxicity (kidney, hearing/balance)

Antibiotics: Miscellaneous Trimethoprim/Sulfamethoxazole (Bactrim): Mainly given in oral form must watch renal function Considered narrow spectrum, but has activity against both Gram negative and Gram positive bacteria Commonly used to treat UTIs Also used for MRSA skin infections Azithromycin: Commonly given in oral dose pack called Z-pack Considered narrow spectrum, used for respiratory/sinus infections Metronidazole (Flagyl) (oral and IV form) A primary treatment for C. difficile infections Oral form can cause nausea and stomach upset

Understanding multidrug-resistance Multidrug-resistant organisms (MDROs) are a group of bacteria with important resistance patterns Sometimes just one key drug will define a MDRO Methicillin-resistance in Staphylococcus aureus Va n co m ycin -resistance in Enterococcus sp. Gram-negative bacteria can develop resistance to multiple classes of antibiotics Resistance elements travel together so one bacteria can become resistant to many classes: Penicillins, cephalosporins, carbapenems, fluoroquinolones, aminogylcosides Seen in Enterobacteriaceae, Pseudomonas and Acinetobacter

ABCs of MDROs Bacteria Abbrev. Antibiotic Resistance Staphylococcus aureus MRSA Methicillin-resistance Enterococcus (faecalis/faecium) VRE Vancomycin-resistance Enterobacteriaceae ESBL Extended spectrum penicillins and cephalosporin resistance Enterobacteriaceae CRE Carbapenem-resistance Pseudomonas/ Acinetobacter MDR Multiple drug-resistance

Mechanisms of antibiotic resistance Production of proteins that destroy antibiotics Beta-lactamases Cephalosporinases Carbapenemases Change their cell structure Blocks binding and function of antibiotics Reduce exposure Pump antibiotics out Increase cell barriers to block entry http://bioinfo.bact.wisc.edu/themicrobialworld/bactresanti.html

Case scenario 70 year old admitted from hospital to nursing home Treated with Ceftriaxone for catheter-associated UTI x7 days before transfer Catheter still in place recently transferred Repeat urine culture ordered by MD prior to removing catheter Organism: E. coli, >10 5 cfu Drug Amikacin Ampicillin Amp/Sulbactam Aztreonam Cefazolin Cefepime Ceftazidime Ceftriaxone Cefuroxime Gentamicin Levofloxcin Meropenem Piperacillin/Tazobactam Tobramycin Trimethoprim/Sulfa Result Susceptible Susceptible Susceptible Susceptible

Penicillin and cephalosporin resistance in gram-negative bacteria Innate: Resistance genes present in bacterial chromosomes (Example: AmpC) Bacteria already had the capability to be resistant Resistance was uncovered with overexpression of the gene Consider in bugs like Serratia, Pseudomonas, Acinetobacter Acquired: Resistance genes entered bacteria through mobile genetic elements, called plasmids Example: Extended spectrum Beta-lactamases (ESBLs) Consider in E. Coli, Klebsiella Now we see both types of cephalosporin-resistance expressed in gram-negative bacteria

Case scenario #2 70 year old admitted from hospital to nursing home Had complicated history including surgery, ICU care, ventilator-weaning On transfer, has tracheostomy, PEG tube, urinary catheter and large sacral pressure ulcer MD sends culture from tracheostomy secretions Organism: Klebsiella pneumoniae, >10 5 cfu Drug Amikacin Ampicillin Amp/Sulbactam Aztreonam Cefazolin Cefepime Ceftazidime Ceftriaxone Cefuroxime Gentamicin Levofloxcin Meropenem Piperacillin/Tazobactam Tobramycin Trimethoprim/Sulfa Result Intermediate

Carbapenem-resistance in gramnegative bacteria Carbapenems are reserved for severe, complicated infections with multiple and often resistant bacteria Recall: Extremely broad-spectrum Resistance significantly limits treatment options for lifethreatening infections No new antibiotics in development for gram-negative bacteria Emerging resistance mechanisms can be spread Carbapenemases are found on mobile genetic elements

Carbapenem-resistance: Mechanisms There are different ways that gram-negative bacteria become resistant to Carbapenems. Some bacteria have to make lots of changes to become resistant. Step 1: Acquire or produce a cephalosporinase (to break down betalactam antibiotics Step 2: Lose a porin protein in the cell wall to prevent carbapenems from getting into the cell. Step 3: Gain a pump to remove the carbapenem from the cell Others acquire resistance by a plasmid, which carries the genes for carbapenem resistance, carbapenemases Examples include: KPC, NDM, VIM, OXA-48

Why focus on carbapenemases? The genetic material creating carbapenemases sits on highly mobile elements These resistance elements can be shared between different bacteria very easily Similar to concern with ESBL spreading cephalosporinresistance Two carbapenemases getting lots of attention Klebsiella pneumoniae carbapenemase (KPC) New Delhi metallo-beta-lactamase (NDM-1) Identifying/containing bacteria which produce carbapenemase will prevent the spread of resistance to other people and other organisms

Microbiology 101: Identification Growing the bacteria Traditional culture, use gram stain and biochemical reactions for identification Selective culture media (e.g., CHROMagar) Examining parts of the bacteria Molecular diagnostic tests which identify specific fragments of DNA/RNA of organisms Nucleic acid amplification tests (NAAT); Polymerase chain re action (PCR) Matrix-assisted laser desorption/ionization (MALDI-TOF) Very new technology: Uses mass spectrometry to identify bacteria based on weight and charge of ions

Microbiology 101: Susceptibility Testing the growth in the presence of antibiotic Determining the minimum inhibitory concentration (MIC) lowest amount of drug needed to stop growth Broth micro-dilution, Disk diffusion, E-test strips Identifying resistance genes Molecular diagnostic tests detect presence of specific resistance genes (NAAT, PCR)

Microbiology 101: Automated testing Systems with identification and susceptibility in one platform Special growth panels contain biochemicals for identification and antibiotics for susceptibility testing Bacteria of interest are innoculated onto panels and placed into system Computer will identify organism and susceptibility interpretation Uses pre-programmed algorithms based on growth patterns of bacteria on the panel Example systems (trade names): Microscan, Walkaway, VITEK 2, Phoenix, Sensititre

Can laboratories identify carbapenemases? Labs look for susceptibility to carbapenems by manual or automatic testing methods Challenges: Identification of carbapenem-resistance varies by which carbapenem is used for susceptibility testing Low-levels of carbapenem resistance may not be detected by automated testing Even if carbapenem resistance is detected it may not mean the bacteria produce a carbapenemase

Lab strategies to confirm carbapenemase Modified Hodge test production Create a plate of susceptible E coli Place a Carbapenem disc in center Negative control has clear zone of inhibition; zone gets distorted when carbapenemase is present Molecular detection of resistance genes Nucleic acid amplification tests (NAAT); Polymerase chain reaction (PCR) Positive control Negative Control Described by Lee K et al. Clinical Microbiology and Infection 7: 88-102, 2001.

What does it all mean? Microbiology labs may use different strategies for identifying carbapenem-resistance Detection of carbapenemase production can vary by testing method being used Labs may NOT do the additional confirmatory testing to determine if resistance is from a carbapenemase Requires additional knowledge, supplies/resources, time and technology Understanding the testing methods in your laboratory helps you interpret carbapenem-resistance reported in your facility True burden may be over or under-estimated depending on testing methods and lab reporting

Starting the conversation with your lab Talk with the director of microbiology for your laboratory Share your interest in understanding the carbapenem resistance in gram-negative bacteria identified in your facility Ask what methods are used for identification and antibiotic susceptibility Is it an automated method? Can they easily flag organisms with carbapenem-resistance? Ask whether they can perform confirmatory testing for carbapenemase-production (e.g., modified Hodge) Could this be done if requested? Discuss a strategy for notifying your facility when a carbapenem-resistant bacteria is identified

Snapshot of resistance patterns: Facility antibiograms A yearly summary of the common bacteria from facility cultures and their susceptibility patterns to antibiotics Can be developed by your laboratory to show trends in resistance over time

Take Home Points Antibiotic resistance is a growing problem across all healthcare settings; Carbapenem resistance results in infections which cannot be treated with current antibiotics Understand the common bacteria causing infections among residents and the most frequently prescribed antibiotics in your facility The microbiology laboratory is a key partner in identifying and communicating when resistant organisms are isolated

Thank you!! Email: nstone@cdc.gov with questions/comments For more information please contact Centers for Disease Control and Prevention 1600 Clifton Road NE, Atlanta, GA 30333 Telephone, 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348 E-mail: cdcinfo@cdc.gov Web: www.cdc.gov The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. National Center for Emerging and Zoonotic Infectious Diseases Division of Healthcare Quality Promotion

Minnesota Resources Minnesota Antimicrobial Stewardship Program Toolkit for Long-Term Care Facilities: http://www.health.state.mn.us/divs/idepc/dtopics/antibioticresistance/asp/ltc/index. html Recommended nursing-driven core elements Identify a stewardship champion (i.e. Consider nursing leadership or IPs) Identify a committee/team to incorporate stewardship (e.g. QA, infection control, nursing team meetings) Measures antimicrobial use & regularly shares findings with all stakeholders (e.g. EMR, pharmacy records) Incorporate relevant clinical guidelines (e.g. Loeb et al, SHEA, IDSA) into policies & protocols Provide stewardship-related training to all healthcare personnel & empower all to recognize their role Communicate stewardship-related messages to residents, families, & visitors Develop clinical algorithms to cue appropriate diagnostic testing, antimicrobial timing, & review of results Conduct infection surveillance that is rooted in resident signs and symptoms (e.g. 2012 Stone et al criteria) Assess nursing process for 1) recognizing, 2) assessing, 3) communicating, and 4) documenting a resident s change in condition 32

Minnesota Resources Core Tools Action Steps and Strategies for Implementing Antimicrobial Stewardship http://www.health.state.mn.us/divs/idepc/dtopics/antibioticresistance/asp/ltc/apxb.pdf Antimicrobial Stewardship Gap Analysis Tool http://www.health.state.mn.us/divs/idepc/dtopics/antibioticresistance/asp/ltc/apxc.pdf Nursing and Provider Antibiotic Use Attitudes and Beliefs Survey http://www.health.state.mn.us/divs/idepc/dtopics/antibioticresistance/asp/ltc/apxd.pdf Antimicrobial Use Assessment http://www.health.state.mn.us/divs/idepc/dtopics/antibioticresistance/asp/ltc/apxe.pdf Nursing Process Evaluation Tool Resident Change in Condition http://www.health.state.mn.us/divs/idepc/dtopics/antibioticresistance/asp/ltc/apxf.pdf Supplemental Tools: Nursing communication tools, infection surveillance tools, clinical decision-making tools, education modules for nurses and nursing assistants, nursing skills fair questions, antimicrobial stewardship presentations, flyers, table tents, quizzes (see main page above) 33

Michigan and Wisconsin Resources Michigan Antibiotic resistance Reduction Coalition (MARR) Page: http://mi-marr.org/ Michigan Long-Term Toolkit: http://mi-marr.org/ltc_toolkit.php Wisconsin Antibiotic Resistance Page: https://www.dhs.wisconsin.gov/disease/aro.htm Wisconsin Healthcare-Associated Infections in Long-Term Care Coalition Resources (including stewardship) https://www.dhs.wisconsin.gov/regulations/nh/hai-resources.htm Wisconsin Guidelines for Prevention and Control of Antibiotic Resistance Organisms in Health Care Settings: https://www.dhs.wisconsin.gov/publications/p4/p42513.pdf 34

National Resources from Centers from Disease Control and Prevention (CDC) All long-term care resources http://www.cdc.gov/longtermcare/index.html The Core Elements of Antibiotic Stewardship for Nursing Homes http://www.cdc.gov/longtermcare/prevention/antib iotic-stewardship.html 35

Contact the Lake Superior Quality Innovation Network Michigan: MPRO Kathleen Lavich 248-465-7399 klavich@mpro.org Minnesota: Stratis Health Kristi Wergin 952-583-8561 kwergin@stratishealth.org Wisconsin: MetaStar Liz Domiguez 608-441-8271 ldomiguez@metastar.com 36

This material was prepared by the Lake Superior Quality Innovation Network, under contract with the Centers for Medicare & Medicaid Services (CMS), an agency of the U.S. Department of Health and Human Services. The materials do not necessarily reflect CMS policy. 11SOW-MI/MN/WI-C2-15-226 120815