RFP_AHRQ-16-10013_-_Amendment_2.pdf

Amendment #2

AHRQ-16-10013:

The Continuation of the Medicare Patient Safety Monitoring System (MPSMS) – Analysis of 2015 and 2016 Data

Amended RFP Modification Summary

Changes are listed below and are highlighted in the attached amended RFP.

Item no.

Section Description Page No.

1 Section J Sample Small Business Subcontracting Plan added to the Solicitation List of Attachments

2 Section L Section L.9.B Small Business Subcontracting Plan is revised to indicate that the Sample Small Business Subcontracting Plan is included as Attachment K to this solicitation

Request for Proposal (RFP) – Amendment #2 AHRQ-16-10013 Changes Listing Page i

Request for Proposal No. AHRQ-16-10013

PART I - THE SCHEDULE

SECTION A - SOLICITATION FORM

Date Issued: March 23, 2016 Date Questions Due: March 29, 2016 Please Note: All questions and inquires will be processed on a non-attribution basis.

Date Notice of Intent Due: April 13, 2016 Date Proposals Due: Tuesday May 3, 2016, NLT 11:00 AM, EST

You are invited to submit a proposal to the Agency for Healthcare Research and Quality (AHRQ) for Request for Proposal (RFP) No. AHRQ-16-10013 entitled “The Continuation of the Medicare Patient Safety Monitoring System (MPSMS) – Analysis of 2015 and 2016 Data.” Your proposal must be developed and submitted in accordance with the requirements and instructions of this RFP.

Please note: Mandatory Qualification Criteria shall be demonstrated by the PRIME offeror before the proposal will receive a full evaluation.

The mandatory criteria are as follows:

1) Offerors shall be a CMS Quality Innovation Network-Quality Improvement Organization (QIN-QIO) or a Beneficiary and Family Centered Care Quality Improvement Organization (BFCC-QIO) prime contractor, or an approved subcontractor of the QIN-QIO or BFCC-QIO prime contractor; and

2) Offerors shall demonstrate that the offeror has current access to the CMS Health Care

Quality Information Systems (HCQIS) portal.

Offerors shall submit two completed forms to demonstrate that they meet each of these criteria.

The forms that shall be used to assure these characteristics are attached to this RFP, and shall be submitted as Appendix C with the Technical Proposal.

CMS, in consultation with AHRQ, will verify that all offerors who submit proposals are legitimate QIN-QIOs, BFCC-QIOs, or qualifying subcontractors that have the requisite HCQIS access.

Request for Proposal v. Jun-15; FAC 80 AHRQ-16-10013

Solicitation Information: Please review the table of contents and refer to the appropriate section of this RFP for requirements, proposal instructions and evaluation information. The Government intends to award this contract without negotiations, so it is imperative that all questions are addressed during the solicitation phase, and that all proposals submitted include the required information and accept the terms and conditions as stated. Failure to comply with proposal instructions or submit required information may result in the removal of a proposal from consideration for award. Please review Section L carefully.

Proposal Intent: If you intend to submit a proposal in response to this solicitation, please inform the Contracting Officer of your intent by completing the Proposal Intent Response Form (See section L.10 and Attachment A) and send it to the Contracting Officer no later than 11:00am EST on April 13, 2016. You may mail it to the address below; fax it to 301-427-1740, Attention:

Lisa Slavin, Contract Specialist/Contracting Officer or email it to Lisa.Slavin@ahrq.hhs.gov.

Questions: All Questions regarding this solicitation shall be received in this office no later than the date shown above. All questions shall be submitted electronically by e-mail to Lisa Slavin, Contract Specialist/Contracting Officer, at the following email address:

Lisa.Slavin@ahrq.hhs.gov. Subject line shall read: Proposal Questions RFP No. AHRQ-16- 10013. Answers to questions and all solicitation amendments will be posted to the Federal Business Opportunities web page: www.fbo.gov. It is your responsibility to monitor the web site.

Additional Information:

• A cost plus fixed fee contract is contemplated for a base period of six (6) months, an option period of twelve (12) months, and an additional option period of eight (8) months.

• The Government anticipates awarding one contract from this solicitation on or about September 20, 2016.

• Proposals submitted in response to this solicitation must state that they are valid for a period of at least 120 days (reference FAR clause 52.215-1 in Section L of this document.

• The NAICS code for this requirement is 541990 with a size standard of $15,000,000.00.

Proposal Submission: The proposal shall be signed by an authorized official to bind your organization and must be received in our Contracts Office by the due date specified above.

Your proposal must be mailed to the following address:

Agency for Healthcare Research and Quality Division of Contracts Management 5600 Fishers Lane, Mailstop 06N34B Rockville, Maryland 20857 Attn: Lisa Slavin, (301) 427-1824 http://www.fbo.gov/

Hand carried proposals may be dropped off at the above location. However, please allow ample time as proposals cannot be accepted until they have gone through security. We will not be held responsible for any delays that may be incurred getting your proposal through security.

NOTE: The U.S. Postal Service’s “Express Mail” does not deliver to our Rockville, Maryland address. Packages delivered via this service will be held at a local post office for pick-up. The Government will not be responsible for picking up any mail at a local post office. If a proposal is not received at the place, date, and time specified herein, it will be considered a “late proposal.”

System for Award Management: In accordance with Federal Acquisition Regulation, all contractors must be registered in the System for Award Management (SAM) database in order to conduct business with the government [See Section I - FAR clause 52.204-7 System for Award Management]. Access the System for Award Management (SAM) at http://www.sam.gov.

Reminder: The Procurement Integrity Act prohibits the unauthorized disclosure of, inquiry about, or acceptance of procurement information. Communications with any other individual outside the AHRQ contracting office may result in rejection of an offeror’s proposal. All requests for any information concerning this RFP should be referred to Lisa Slavin, (301) 427-1824 or e-mail: Lisa.Slavin@ahrq.hhs.gov. Please note e-mail requests should state subject as RFP

AHRQ-16-10013.

http://www.sam.gov/

Table of Contents

PART I - THE SCHEDULE

SECTION A - SOLICITATION FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATION/WORK STATEMENT

SECTION D - PACKAGING AND MARKING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II – CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES

PART III- LIST OF DOCUMENTS, EXHIBITS AND ATTACHMENTS

SECTION J – SOLICITATION LIST OF ATTACHMENTS

PART IV– REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS AND NOTICES TO OFFERORS

SECTION M- EVALUATION FACTORS FOR AWARD

Request for Proposal v. Jun-15; FAC 80 AHRQ-16-10013 The Continuation of the Medicare Patient Safety Monitoring System (MPSMS) – Analysis

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

“The Continuation of the Medicare Patient Safety Monitoring System (MPSMS) – Analysis of 2015 and 2016 Data”

See Section C for a complete description.

B.2 ESTIMATED COST AND FIXED FEE

a. The Estimated Cost (exclusive of fees) for performance of the work under the base period of this contract, including direct and indirect costs is $ To Be Determined (TBD).

b. The Fixed Fee for the base period of this contract is $TBD. The fixed fee shall be paid in installments based on the percentage of completion of work, as determined by the Contracting Officer. Payment shall be subject to the withholding provisions of the Clause ALLOWABLE COST AND PAYMENT and FIXED FEE incorporated herein.

c. The total contract value, represented by the sum of the estimated cost plus the fixed fee for the base period is $TBD.

Period of Performance

Services Estimated Cost Fixed Fee Total

Base Period Severable $ $ $

B.3 OPTION COSTS

If the Government exercises its option(s) pursuant to the option article in Section H of this contract, the Government’s total contract amount represented by the sum of the estimated cost and fixed fee will be revised as follows:

Period of Performance Services Estimated Cost Fixed Fee Total Option Period 1 Severable $ $ $

Option Period 2 Severable $ $ $

The base period and each option are separate and distinct from one another for accumulation of costs and billing purposes.

B. 4 PROVISIONS APPLICABLE TO DIRECT COSTS

a. Items Unallowable Unless Otherwise Provided

Notwithstanding the clauses, ALLOWABLE COST AND PAYMENT, and FIXED FEE, incorporated into this contract, unless authorized in writing by the Contracting Officer, the costs of the following items or activities shall be unallowable as direct costs:

(1) Acquisition, by purchase or lease, of any interest in real property;

(2) Rearrangement or alteration of facilities;

(3) Purchase or lease of any item of general purpose-office furniture or office equipment regardless of dollar value. (General purpose equipment is defined as any items of personal property which are usable for purposes other than research, such as office equipment and furnishings, pocket calculators, etc.);

(4) Accountable Government property;

(5) Travel to attend general scientific meetings;

(6) Foreign Travel;

(7) Any costs incurred prior to the contract's effective date;

(8) Rental of meeting rooms not otherwise expressly paid for by the contract;

(9) Any formal subcontract arrangements not otherwise expressly provided for in the contract;

(10) Consultant fees;

(11) Information Technology hardware or software;

(12) Food and Beverages; and

(13) No funding or expenditures are authorized under this contract for travel or meeting expenses of any person that is not an employee of the contractor or approved subcontractor in accordance with the terms of the contract. See 31 USC § 1345 for appropriations restrictions.

Note: Food and Beverages are unallowable costs. Contracting Officer Authorization for Food and Beverages will be only made as specifically authorized by statute, which is extremely rare. The contractor shall not provide food or beverages of any type. The

Request for Proposal v. Jun-15; FAC 80 AHRQ-16-10013 The Continuation of the Medicare Patient Safety Monitoring System (MPSMS) – Analysis contractor shall not accept food or beverages, even if included in, or provided ‘free’ as part of a meeting/conference ‘package.’

b. Travel Costs

This contract is subject to the provisions of Public Law (P.L.) 99-234 which amends the

Office of Federal Procurement Policy Act to provide that contractor costs for travel, including lodging, other subsistence, and incidental expenses, shall be allowable only to the extent that they do not exceed the amount allowed for Federal employees. The Contractor, therefore, shall invoice and be reimbursed for all travel costs in accordance with Federal Acquisition Regulations (FAR) 31.205-46.

The following applies to Educational Institutions: The Contractor shall invoice and be reimbursed for all travel costs in accordance with OMB Circular A-21 - "Cost Principles for Educational Institutions."

B.5 CONTRACTING OFFICER AUTHORIZATION

Other provisions of this contract notwithstanding, approval of the following items within the limits set forth is hereby granted without further authorization from the Contracting Officer.

To Be Determined

SECTION C - DESCRIPTION/SPECIFICATION/WORK STATEMENT

Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work as follows:

Statement of Work

Base Period: Six (6) Months from Date of Award

Task 1 Determination of Injury/Harm Rates for Specified Conditions

1.1 The Government will provide to the contractor identified abstracted data from the CMS

Clinical Data Abstraction Center (CDAC) for further data analysis to detect adverse events as identified from medical records acquired through the CMS Inpatient Quality Review (IQR) program or related initiatives. The Contractor shall use previously developed protocols, which will be provided by the Government, to determine the injury rate for each of the 21 Medicare Patient Safety Monitoring System (MPSMS)-specified events or conditions (listed below). The Contractor shall deliver quarterly rates and annual rates, based on Calendar Year (CY) 2015 inpatient charts (single hospital-stay medical records). The (CY) 2015 MPSMS sample of charts consists of approximately 29,700 charts, of which approximately 19,200 will come from four sets of 4,800 charts per quarter consisting of approximately 1,200 charts per set from four patient groups (aka “four conditions”): those patients with a principal diagnosis of 1) Acute Myocardial Infarction (AMI), 2) Congestive Heart Failure (CHF), 3) Pneumonia, and 4) those receiving an inpatient surgical procedure included in the set of procedures encompassed by the Surgical Care Improvement Project (SCIP). The remaining charts (approximately 10,500) will come from charts that are selected for being representative of the general hospital inpatient population, which has been referred to as a “global” population in the operation of MPSMS activities. All charts are selected only from patients age 18 years and older, and without being limited to payment by Medicare, i.e., the five MPSMS samples described above for CY 2015 are “all-payer.” Additional information is available at the CMS website for the Inpatient Prospective Payment System (IPPS) Final Rule for 2015 (https://www.cms.gov/Medicare/Medicare-Fee-for-Service- Payment/AcuteInpatientPPS/FY2015-IPPS-Final-Rule-Home-Page.html)

Quarterly data for the combined four condition charts shall be delivered by email to the Contracting Officer’s Representative (COR) in two ways: 1) based on the combined quarterly charts, as provided by the CMS Clinical Data Abstraction Center (CDAC)

Request for Proposal v. Jun-15; FAC 80 AHRQ-16-10013 The Continuation of the Medicare Patient Safety Monitoring System (MPSMS) – Analysis https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2015-IPPS-Final-Rule-Home-Page.html https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2015-IPPS-Final-Rule-Home-Page.html during the year as representing each calendar year quarter, regardless of the condition/diagnosis of the patients in the combined sample; and 2) based on a special composite of the samples that equally balances the contribution of each of the four condition groups in the 2015 MPSMS four-condition sample. The annual data shall be delivered by email to the COR in two ways: 1) based on the combined final annual chart data provided by the CDAC, regardless of the condition/diagnosis of the patients in the combined four condition sample; and 2) based on a special composite of the samples that equally balances the contribution of the four conditions in the 2015 MPSMS four condition sample. The annual composite data shall be delivered by email to the COR in two ways: 1) using the same methods as required above for the quarterly data, and 2) using advanced statistical methods, such as repeated resampling and “bootstrapping” to provide MPSMS rate data that equally balances the contribution of the four conditions/diagnosis-groups in the 2015 MPSMS sample described above. Quarterly and annual summary data shall be delivered by email to the COR in multiple Excel files.

The “global” charts shall be analyzed similarly to, but separately from, the four-condition charts. Quarterly and annual data are required deliverables (also by email), but no special efforts to combine, isolate, or analyze MPSMS rates within different groups of patients in the sample are envisioned, except as noted below under Task 1.11.

The 21 specific adverse events or hospital-acquired conditions (HACs) included in MPSMS are the following:

• Clostridium difficile Infections after Inpatient Antibiotics

• Digoxin Adverse Drug Events

• Insulin Adverse Drug Events

• Intravenous Heparin Adverse Drug Events

• Low Molecular Weight Heparin Adverse Drug Events

• Warfarin Adverse Drug Events

• Falls

• Pressure Ulcers

• Adverse Events after Femoral Artery Puncture for Angiography

• Adverse Events after Hip Replacement

• Adverse Events after Knee Replacement

• Contrast Nephropathy Associated with Contrast Dye

• Mechanical Adverse Events Associated with Central Venous Catheter Placement

• Post-Operative Cardiac Events (in cardiac and non-cardiac surgery patients)

• Post-Operative Venous Thromboembolism Events

• Catheter-Associated Urinary Tract Infections (CAUTI)

• Central-line Associated Bloodstream Infections

Request for Proposal v. Jun-15; FAC 80 AHRQ-16-10013 The Continuation of the Medicare Patient Safety Monitoring System (MPSMS) – Analysis

• Methicillin-resistant Staphylococcus aureus Infections in a Sterile Site

• Post-Operative Pneumonias

• Vancomycin-resistant Enterococcus Infections in a Sterile Site

• Ventilator-Associated Pneumonias

The Contractor shall report all summary data directly to the COR. Quarterly and annual rates shall be delivered to the COR in summary Excel spreadsheets with the summary numerators (total cases of MPSMS adverse events) and denominators (total exposures to MPSMS adverse events) during the time period. Annual data on each type of adverse event shall also be delivered to the COR in graphical form*. Annual data shall also include tables* indicating the length of stay and inpatient mortality for each MPSMS measure in CY 2015, as well as a table providing demographic, comorbidities, and other information about patients exposed to each MPSMS measure, with columns summarizing information on the patients that did and did not experience adverse events.

*Note: Intermediate data related to the potential development of MPSMS adverse events for most measures can be viewed in Attachment F to this RFP.

Attachment G to this RFP includes examples of tables indicating the length of stay and inpatient mortality for each MPSMS measure in CY 2015, as well as a table providing demographic, comorbidities, and other information about patients exposed to each MPSMS measure, with columns summarizing information on the patients that did and did not experience adverse events.

The raw Q1 2015 data from the Clinical Data Abstraction Center (CDAC) will be immediately available to the Contractor once confidentiality of data transfer methods has been assured. Analysis and delivery of quarterly data for Q1 2015 data is required within 30 days of award and assurance of confidentiality of data transfer methods. The Government will provide the data to the Contractor as an MS Access file, after data is abstracted from paper and electronic versions of patient records at the CDAC using the MPSMS measures as implemented with the MedQuest software tool for data collection.

Calendar year 2015 data after Q1 2015 may be supplied by the Government, via the CDAC monthly or quarterly, and reports to AHRQ are to be based on CY quarters and annual CYs. Q2, Q3, and Q4 2015 data will be transferred from the CDAC, and will be delivered within one month of award (and assurance of confidentiality of data transfer methods), and will be due within two months of award and assurance of confidentiality of data transfer methods. Due dates for all quarterly and annual data are provided in the Deliverable Schedule. The existing protocols for analyzing the data and producing the MPSMS adverse event rates and related information are in the SAS programming language, and will be provided to the contractor by the Government within one week of contract award. All annual MPSMS data files shall also be provided in SAS, Excel, and

Request for Proposal v. Jun-15; FAC 80 AHRQ-16-10013 The Continuation of the Medicare Patient Safety Monitoring System (MPSMS) – Analysis

Access files using confidential file transfer methods to be specified during the contract period.

Note: Attachment H to this RFP includes the MPSMS data dictionary and abstractors’ manual, which includes additional information on the MPSMS measures and related topics.

1.2 Activities in Support of Potentially Correcting MPSMS Measures.

The Contractor shall perform analyses in support of necessary ad hoc modifications or updates of MPSMS measures for the CY 2016 data year. Examples of potential modifications would be those necessary to correct errors in the measures that have been identified as being associated with MPSMS adverse events being under-counted (false negatives) or over-counted (false positives). If any changes are necessary, the contractor will edit the measure technical specifications, and provide information to the Government necessary to allow modifications to the Medquest data collection tool at the CDAC. Medical record review by the contractor may be necessary, and if the Government deems it necessary, the contractor shall plan for no more than 50 charts needing to be acquired from the Clinical Data Abstraction Center to be reviewed by the contractor for potential instances of false positives or false negatives.

1.3 Reporting of Selected "Sub-Events"

The Contractor shall develop standardized population summary reports in tabular form, which shall be available to identify incidence and rates of all specific "sub-events" measured by MPSMS in the 2015 data year. For some MPSMS measures, these may be displayed as separate numerical values and findings (counts of sub-events) as well as summed up to generate the overall rate of the MPSMS measures. For example, the report shall include the number of cases and rate of CAUTI and major bleeding/hematoma among the adverse events that occur after hip replacement and after knee replacement surgeries, and the cases and rates of fractures, subdural hematomas, and lacerations requiring sutures occurring in inpatients that fall.

*Note: Attachment F provides four examples of MPSMS adverse event measures with “sub-events” indicated. For example, in the Warfarin adverse event, various outcomes are listed as associated with the adverse event (ranging from “new hematoma” to “death”), and for the Venous Thromboembolic Event (VTE) adverse event, both Pulmonary Embolus (PE) and Deep Vein Thrombosis (DVT) cases are identified. The pressure ulcer measure provides data on patients with and without pressure ulcers on admission. This type of capability is to be continued in the 2015 and 2016 data. For the 17 other MPSMS measures not shown in Attachment F the requirements are similar in quantity and complexity as for the four shown, which are one hospital acquired infection, Request for Proposal v. Jun-15; FAC 80 AHRQ-16-10013 The Continuation of the Medicare Patient Safety Monitoring System (MPSMS) – Analysis one adverse drug event, one post-operative adverse event, and one general adverse event.

1.4 National Injury/Harm Rate

The Contractor shall develop a composite formula for calculating a national patient safety adverse event rate based on the 2015 sample. Using this formula, the Contractor shall calculate a national patient safety adverse event rate for 2015. The rate must be able to specify both the rate of patients that experience one or more events, e.g., 15 percent of patients admitted experience one or more events; and the harm or injury rate per admission, e.g., 180 events per 1,000 admissions (this per-admission measure allows for multiple adverse events experienced by an individual patient to be counted toward the total rate). This rate must exclude double-counts of single adverse events in the same patients and hospital stay; for example, a case of post-operative pneumonia that occurs as a ventilator-associated pneumonia (both as defined in MPSMS) should not be counted twice in the patient safety adverse event rate.

1.5 Healthcare Acquired Infection (HAl) Rates

The Contractor shall prepare a report on HAIs based on 2015 data. For the purposes of this study, MPSMS HAl measures include: Catheter-Associated UTI, CVC-Associated BSI, MRSA Infection in a Sterile Site, Post-Op Pneumonia, VRE Infection in a Sterile Site, Ventilator-Associated Pneumonia, and C. difficile Infection after Inpatient Antibiotics. A consolidated rate that includes all HAIs, excluding double-counts, shall be included in the report. The Contractor shall produce a consolidated rate that includes C.

difficile Infection after Inpatient Antibiotics and an additional rate that excludes this particular measure. The Contractor shall provide data and assistance with regard to understanding the data to Federal or Federal Contractor personnel identified by AHRQ as associated with the HHS HAl National Action Plan as needed and requested by

AHRQ.

1.6 Adverse Drug Event (ADE) Rates

The Contractor shall prepare (and deliver to the COR) a report on ADEs based on current year and prior year data. For the purposes of this study, MPSMS ADE measures include: Clostridium difficile Infections after Inpatient Antibiotics, Digoxin Adverse Drug Events, Insulin Adverse Drug Events, Intravenous Heparin Adverse Drug Events, Low Molecular Weight Heparin Adverse Drug Events, and Warfarin Adverse Drug Events. A consolidated rate that includes all ADEs, excluding double-counts, shall be included in the report. The Contractor shall produce a consolidated rate that includes C. difficile Infection after Inpatient Antibiotics and an additional rate that excludes this particular measure. The Contractor shall provide data and assistance with regard to understanding the data to Federal or Federal Contractor personnel identified by AHRQ as associated with National Action Plan for ADE Prevention as needed and requested by AHRQ.

1.7 Compare MPSMS Data and measure definitions to AHRQ Patient Safety Indicator and Healthcare Cost and Utilization Project Data, CDC National Healthcare Safety Network Data, and AHRQ Quality and Safety Review System Data Review and cross-reference MPSMS measures with similar measures in the current versions of other measurement systems, such as the CDC National Healthcare Safety Network (NHSN), the AHRQ Patient Safety Indicators (PSIs) and related Healthcare Cost and Utilization Project administrative data (such as Clostridium difficile or pressure ulcer data), and the AHRQ Quality and Safety Review System (QSRS) that will be run concurrently with MPSMS for CY 2015 data and was run partially concurrently (with 2,000 overlapping hospital charts only) for CY 2014 data. The review and cross reference of MPSMS, PSI, HCUP, and NHSN data will be based on publically available PSI, HCUP, and NHSN data, and will focus primarily on summary data. The review and cross reference of MPSMS and QSRS measures and data shall support AHRQ and HHS efforts to suspend the use of MPSMS after the analysis of CY 2016 data and transition to QSRS while maintaining the ability to track and trend adverse event or HAC rates to prior years, including to 2009 for the current sample, and for a selected Medicare only and age 65 and older sample. The analysis of MPSMS and QSRS data may include confidential MPSMS and QSRS data in Limited Data Set or other similar formats. Analyses may include use of summary data on partial year or other subsets of the 2015 data as well as for the complete data year of CY 2015, and data on specific individual patients, small groups of patients (for example, dozens to hundreds within a subgroup of patients that may be exposed to a rare adverse event type), and large groups of patients (for example, approximately 1,000 to 20,000 that may be exposed to a common adverse event type, or included in a condition-group or one or more combined condition groups).

1.8 Other Special Analyses/Study of MPSMS Data

The Contractor shall prepare (and deliver to the COR), at the request of the COR, and in concert with AHRQ personnel identified by the COR, one report on a special analysis of MPSMS data based on 2015 and prior year data. For example, a study on inpatient antibiotic use and exposure (as indicated by the data acquired in support of the MPSMS Clostridium difficile measure) and the relationships to other patient or provider characteristics, or a combined study of adverse events among patients exposed to procedures that have become increasingly common in recent years: knee replacement surgery and hip replacement surgery. This study should be performed at a sufficient level of quality so as to potentially be adapted for papers to be submitted for publication in a peer-reviewed scientific journal.

1.9 Compare 2015 data to prior years of data (2009-2014)

The contractor shall compare 2015 MPSMS rates to 2014 through 2009 rates to support the understanding of trends in patient safety (adverse event rates). These comparisons will compare raw data, patient safety adverse event rate data (as described above in Task 1.4), and risk-adjusted data that takes into account factors such as patient age and comorbidity information in the MPSMS data, geographical location (state), and hospital size and accreditation status, etc. Data from 2009-2014 will be provided by the

Request for Proposal v. Jun-15; FAC 80 AHRQ-16-10013 The Continuation of the Medicare Patient Safety Monitoring System (MPSMS) – Analysis

Government. The report from the contractor providing the information to the government shall be transmitted via email to the COR.

Task 2 Administrative Support for the Medicare Patient Safety Monitoring System

(MPSMS)

The Contractor shall provide administrative and technical support for the on-going operation and maintenance of the MPSMS. The Contractor shall coordinate monthly, one hour progress teleconferences with an AHRQ-identified working group comprised of the AHRQ COR, AHRQ MPSMS management team, and AHRQ-identified representatives of other Department of Health and Human Services (HHS) agencies. The Contractor shall also coordinate a monthly, one hour teleconference with the COR that may also include other participants as identified by the COR.

The Contractor shall perform a range of tasks including:

2.1 Schedule and develop agendas for monthly teleconferences. The Contractor shall produce meeting minutes within five (5) working days of the teleconferences. Meeting minutes shall be transmitted as Word and pdf files to the COR by email.

2.2 Deliver a monthly progress report to the COR on ongoing activities, and provide to the COR as Word and pdf file via email. In months when new quarterly or annual data are available, the monthly report shall include updated data on the MPSMS measures listed in Task 1.1.

2.3 Finalize project work plan for the Base Period for review and approval by the COR.

Within one (1) month of the contract award, the Contractor shall deliver to the

COR an electronic project plan including all deliverables, tasks, and schedules.

The Contractor shall be expected to update the project plan and actual resource usage by task on a monthly basis, and deliver the plan to the COR via email for review during the monthly teleconference specified in 2.1.

2.4 Facilitate Publication/Author Groups to write articles for publication on findings from

MPSMS data and information.

• Participate in, or lead two to three (2 to 3) author groups. The contractor will not be responsible for identifying potential co-authors.

• Set up conference calls for author groups

• Provide administrative and technical support for the review, editorial and publication processes.

2.5 Prepare and provide an Annual Report that contains annual (new 2015) data on MPSMS measures, a complete set of reports delivered, and a complete collection of other final documents associated with all contract tasks required above. The Annual Report shall be delivered to the Government as three (3) hard copies and three (3) CDs, with the identical material also provided electronically (in appropriate formats: Word, pdf, Excel files, etc.).

Option Year 1: Twelve (12) Months

Task 1 Determination of Injury/Harm Rates for Specified Conditions

OY1.1.1 The Government will provide to the Contractor identified abstracted data from the

CMS Clinical Data Abstraction Center (CDAC) for further data analysis to detect adverse events as identified from medical records acquired through the CMS Inpatient Quality Review (IQR) program or related initiatives. The Contractor shall use previously developed protocols, which will be provided by the Government, to determine the injury rate for each of the 21 MPSMS-specified events or conditions (listed below). The Contractor shall deliver quarterly rates and annual rates, based on Calendar Year (CY) 2015 inpatient charts (single hospital-stay medical records).

The (CY) 2016 MPSMS sample is not yet known, but the Contractor shall plan for a sample that is the same as the CY 2015 sample, as described Task 1.1 in the Base Year.

Quarterly data for the combined four condition charts shall be delivered to the COR in two ways: 1) based on the combined quarterly charts, as provided by the CMS Clinical Data Abstraction Center (CDAC) during the year as representing each calendar year quarter, regardless of the condition/diagnosis of the patients in the combined sample; and 2) based on a special composite of the samples that equally balances the contribution of each of the four condition groups in the 2015 MPSMS four-condition sample. The annual data shall be delivered to the COR in two ways:

1) based on the combined final annual chart data provided by the CDAC, regardless of the condition/diagnosis of the patients in the combined four condition sample; and

2) based on a special composite of the samples that equally balances the contribution of the four conditions in the 2015 MPSMS four condition sample. The annual composite data shall be delivered to the COR in two ways: 1) using the same methods as required above for the quarterly data, and 2) using advanced statistical methods, such as repeated resampling and “bootstrapping” to provide MPSMS rate data that equally balances the contribution of the four conditions/diagnosis-groups in the 2015 MPSMS sample described above.

Request for Proposal v. Jun-15; FAC 80 AHRQ-16-10013 The Continuation of the Medicare Patient Safety Monitoring System (MPSMS) – Analysis

Quarterly and annual summary data shall be delivered to the COR by email in multiple Excel files. All annual MPSMS data files shall also be provided in SAS, Excel, and Access files using confidential file transfer methods to be specified during the contract period.

The “global” charts shall be analyzed similarly to, but separately from, the four-condition charts. Quarterly and annual data are required deliverables, but no special efforts to combine, isolate, or analyze MPSMS rates within different groups of patients in the sample are envisioned, except as noted below under Task

OY1.1.1 The 21 specific adverse events or hospital-acquired conditions (HACs) included in

MPSMS are expected to be the same as in the Base Year.

The Contractor shall report all summary data directly to the COR. Quarterly and annual rates shall be delivered by email from the contractor to the COR in summary Excel and pdf formatted spreadsheets with the summary numerators (total cases of MPSMS adverse events) and denominators (total exposures to MPSMS adverse events) during the time period. Annual data on each type of adverse events shall also be delivered by the contractor to the COR in graphical form*. Annual data shall also include tables* indicating the length of stay and inpatient mortality for each MPSMS measure in CY 2015, as well as a table providing demographic, comorbidities, and other information about patients exposed to each MPSMS measure, with columns summarizing information on the patients that did and did not experience adverse events.

*Note: Intermediate data related to the potential development of MPSMS adverse events for most measures can be viewed in Attachment F to this RFP. Attachment G to this RFP includes examples of tables indicating the length of stay and inpatient mortality for each MPSMS measure in CY 2015, as well as a table providing demographic, comorbidities, and other information about patients exposed to each MPSMS measure, with columns summarizing information on the patients that did and did not experience adverse events.

The Government will provide the data to the Contractor as an Access file, after data is abstracted from paper and electronic versions of patient records at the CDAC using the MPSMS measures as implemented with the MedQuest software tool for data collection. Q1 2016 data will become available in January 2017, Q2 2016 data will become available approximately on March 31, 2017, with Q3 data expected to become available in June 2017, and Q4 data expected to become available no later than September 2017.

OY1.1.2 National Health Care Quality and Disparities Report (QDR) The data on specified measures for injury rates are used as a major input for the

AHRQ Quality and Disparities Report (QDR). The Contractor shall provide the data required for these reports as requested by AHRQ based on the 21 measures listed above. Data shall be delivered to the COR, as necessary, to ensure that the measures are as comparable as possible with prior data sets; for example, for 2009-2014 data based on samples of non-Medicare patients, or special analyses limiting the information to Medicare patients aged 65 and over within the annual samples. The Contractor shall deliver to the COR data tables and measure specifications to the QDR team. The timing of the data submission by the Contractor will be tied to publication timelines.

OY1.1.3 Reporting of Selected "Sub-Events" The Contractor shall develop standardized population summary reports in tabular form, which shall be available to identify incidence and rates of all specific "sub-events" measured by MPSMS in the 2015 data year. For some MPSMS measures, these may be displayed as separate numerical values and findings (counts of sub-events) as well as summed up to generate the overall rate of the MPSMS measures. For example, the report shall include the number of cases and rate of CAUTI and major bleeding/hematoma among the adverse events that occur after hip replacement and after knee replacement surgeries, and the cases and rates of fractures, subdural hematomas, and lacerations requiring sutures occurring in inpatients that fall.

*Note: Attachment F provides four examples of MPSMS adverse event measures with “sub-events” indicated. For example, in the Warfarin adverse event, various outcomes are listed as associated with the adverse event (ranging from “new hematoma” to “death”), and for the VTE adverse event, both PE and DVT cases are identified. The pressure ulcer measure provides data on patients with and without pressure ulcers on admission. This type of capability is to be continued in the 2015 and 2016 data. For the 17 other MPSMS measures not shown in Attachment F the requirements are similar in quantity and complexity as for the four shown, which are one hospital acquired infection, one adverse drug event, one post-operative adverse event, and one general adverse event.

OY1.1.4 National Injury/Harm Rate The Contractor shall develop a composite formula for calculating a national patient safety adverse event rate based on the 2015 sample. Using this formula, the Contractor shall calculate a national patient safety adverse event rate for 2015. The rate must be able to specify both the rate of patients that experience one or more

Request for Proposal v. Jun-15; FAC 80 AHRQ-16-10013 The Continuation of the Medicare Patient Safety Monitoring System (MPSMS) – Analysis events, e.g., 15 percent of patients admitted experience one or more events; and the harm or injury rate per admission, e.g., 180 events per 1,000 admissions (this per-admission measure allows for multiple adverse events experienced by an individual patient to be counted toward the total rate). This rate must exclude double-counts of single adverse events in the same patients and hospital stay; for example, a case of post-operative pneumonia that occurs as a ventilator-associated pneumonia (both as defined in MPSMS) should not be counted twice in the patient safety adverse event rate.

OY1.1.5 Healthcare Acquired Infection (HAl) Rates The Contractor shall prepare a report on HAIs based on 2015 and 2016 year data.

For the purposes of this study, MPSMS HAl measures include: Catheter-Associated UTI, CVC-Associated BSI, MRSA Infection in a Sterile Site, Post-Op Pneumonia, VRE Infection in a Sterile Site, Ventilator-Associated Pneumonia, and C. difficile Infection after Inpatient Antibiotics. A consolidated rate that includes all HAIs, excluding double-counts, shall be included in the report. The Contractor shall produce a consolidated rate that includes C. difficile Infection after Inpatient Antibiotics and an additional rate that excludes this particular measure. The Contractor shall provide data and assistance with regard to understanding the data to Federal or Federal Contractor personnel identified by AHRQ as associated with the HHS HAl National Action Plan as needed and requested by AHRQ.

OY1.1.6 Adverse Drug Event (ADE) Rates The Contractor shall prepare (and deliver to the COR) a report on ADEs based on

2015 and 2016 data. For the purposes of this study, MPSMS ADE measures include: Clostridium difficile Infections after Inpatient Antibiotics, Digoxin Adverse Drug Events, Insulin Adverse Drug Events, Intravenous Heparin Adverse Drug Events, Low Molecular Weight Heparin Adverse Drug Events, and Warfarin Adverse Drug Events. A consolidated rate that includes all ADEs, excluding double-counts, shall be included in the report. The Contractor shall produce a consolidated rate that includes C. difficile Infection after Inpatient Antibiotics and an additional rate that excludes this particular measure. The Contractor shall provide data and assistance to Federal or Federal Contractor personnel identified by AHRQ as associated with National Action Plan for ADE Prevention as needed and requested by AHRQ.

OY1.1.7 Review and Update Base Year Final Report Comparing MPSMS Data to PSI Data, NHSN Data, and QSRS Data Review and cross-reference MPSMS measures with similar measures in the current versions of other measurement systems, such as the CDC National Healthcare Safety Network (NHSN), the AHRQ Patient Safety Indicators (PSIs) and related Healthcare Cost and Utilization Project administrative data (such as Clostridium difficile or pressure ulcer data), and the AHRQ Quality and Safety Review System (QSRS) that will be run concurrently with MPSMS for CY 2015 and 2016 data and

Request for Proposal v. Jun-15; FAC 80 AHRQ-16-10013 The Continuation of the Medicare Patient Safety Monitoring System (MPSMS) – Analysis was run partially concurrently (with 2,000 overlapping hospital charts only) for CY 2014 data. The review and cross reference of MPSMS, PSI, HCUP, and NHSN data will be based on publically available PSI, HCUP, and NHSN data, and will focus primarily on summary data. The review and cross reference of MPSMS and QSRS measures and data shall support AHRQ and HHS efforts to suspend the use of MPSMS after the analysis of CY 2016 data and transition to QSRS while maintaining the ability to track and trend adverse event or HAC rates to prior years, including to 2009 for the current sample, and for a selected Medicare only and age 65 and older sample. The analysis of MPSMS and QSRS data may include confidential MPSMS and QSRS data in Limited Data Set or other similar formats.

Analyses may include use of summary data on partial year or other subsets of the 2016 data as well as for the complete data year of CY 2016, and data on specific individual patients, small groups of patients (for example, dozens to hundreds within a subgroup of patients that may be exposed to a rare adverse event type), and large groups of patients (for example, approximately 1,000 to 20,000 that may be exposed to a common adverse event type, or included in a condition-group or one or more combined condition groups).

OY1.1.8 Other Special Analyses of MPSMS Data The Contractor shall prepare (and deliver to the COR), at the request of the COR, and in concert with AHRQ personnel identified by the COR two reports on a special analysis of MPSMS data based on 2015 and prior year data. For example, a study on inpatient antibiotic use and exposure (as indicated by the data acquired in support of the MPSMS Clostridium difficile measure) and the relationships to other patient or provider characteristics, or a combined study of adverse events among patients exposed to procedures that have become increasingly common in recent years: knee replacement surgery and hip replacement surgery. These studies should be performed at a sufficient level of quality so as to potentially be adapted for papers to be submitted for publication in a peer-reviewed scientific journal.

OY1.1.9 Compare 2016 data to prior years of data (2009-2015) The contractor will compare 2016 MPSMS rates to 2015 and prior year rates to support the understanding of trends in patient safety (adverse event rates). This comparisons will compare raw data, patient safety adverse event rate data (as described above in Task 1.4), and risk-adjusted data that takes into account factors such as patient age and comorbidity information in the MPSMS data, geographical location (state), and hospital size and accreditation status, etc. Data from 2009- 2014 will have been be provided by the government during the Base Period.

OY.1.10 Contribute to Government Data Analysis of “Global” MPSMS data The Contractor shall contribute to Federal Government analysis of the 2010-2015

PFP National HAC rate data that is based on the MPSMS rates and also data from the AHRQ Patient Safety Indicators (for obstetric adverse events and others) and from the CDC's National Healthcare Safety Network (for Surgical Site Infections), as well as analyses using annual AHRQ HCUP data on hospital discharges. This may

Request for Proposal v. Jun-15; FAC 80 AHRQ-16-10013 The Continuation of the Medicare Patient Safety Monitoring System (MPSMS) – Analysis include developing and implementing a new or modified method for computing a National HAC rate that includes MPSMS data from the CMS Inpatient Quality Review patient records for "global" and other diagnosis groups. To date, these other diagnosis groups have been drawn and analyzed with MPSMS only in CYs 2012- 2014, but may be used extensively or exclusively in future patient safety measurement efforts beginning with 2015, 2016 or other data years, and may allow better insight into HAC rates in patients other than those admitted for major surgery (Surgical Care Improvement Project patients), acute myocardial infarction, congestive heart failure, and pneumonia, which have been included in all MPSMS samples since 2009. Use of the global sample may necessitate the use of methods such as limiting the contribution of certain subsets of charts in the analysis, and statistical methods such as risk adjustment to compensate for the unanticipated demographic or other changes in the global sample from year to year.

OY1.1.11 Analyze National HAC Rate Data

The Contractor shall perform analyses to determine if the National HAC Rate (based primarily on MPSMS data, but including other data sources) has changed in a statistically significant way from data year 2009 through to data year 2016, and prepare a report on this topic. In addition to providing findings on the overall HAC rate in the report, this report shall include findings on the seven combined MPSMS measures that are included in the MPSMS National HAC rate, and on each measure individually, and the 10 combined MPSMS measures that are included in the PfP's "all-other" HACs category, as well as data from other non-MPSMS sources included in the PfP National HAC Rate, as described above in OY1.11.

See the AHRQ PfP web site (http://www.ahrq.gov/professionals/quality-patient-safety/pfp/index.html) for information on the PfP National HAC Rate and how it is computed.

The Contractor shall provide administrative and technical support for the on-going operation and maintenance of the MPSMS. The Contractor shall coordinate one-hour monthly progress teleconferences with an AHRQ-identified working group comprised of the AHRQ COR, AHRQ MPSMS management team, and AHRQ-identified representatives of other Department of Health and Human Services (HHS) agencies. The Contractor shall also coordinate a monthly one-hour teleconference with the COR that may also include other participants as identified by the COR.

http://www.ahrq.gov/professionals/quality-patient-safety/pfp/index.html http://www.ahrq.gov/professionals/quality-patient-safety/pfp/index.html

The Contractor shall perform a range of tasks including:

OY1.2.1 Schedule and develop agendas for monthly teleconferences. The Contractor shall produce meeting minutes within five (5) working days of the teleconferences.

Meeting minutes shall be transmitted as Word and pdf files to the COR by email.

OY1.2.2 Deliver a monthly progress report to the COR on ongoing activities, and provide to the COR as Word and pdf file via email. In months when new quarterly or annual data are available, the monthly report shall include updated data on the MPSMS measures listed in Base Period Task 1.1.

OY1.2.3 Facilitate Publication/Author Groups to write articles for publication on findings from

• Participate in, or lead two to three (2 to 3) author groups.