RFP_AHRQ-18-10003_Final_(01-18-18).pdf

Request for Proposal v. Jan-17; FAC 93 AHRQ-18-10003 The Continuation of the Medicare Patient Safety Monitoring System (MPSMS) Page 1 of 123

Request for Proposal No. AHRQ-18-10003

PART I - THE SCHEDULE

SECTION A - SOLICITATION FORM

Date Issued: Thursday, January 18, 2018 Date Questions Due: Thursday, January 25, 2018 Please Note: All questions and inquires will be processed on a non-attribution basis.

Date Notice of Intent Due: Friday, February 9, 2018 at 10:00 AM, EST Date Proposals Due: Thursday, February 22, 2018 at 10:00 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-18-10003 entitled “The Continuation of the Medicare Patient Safety Monitoring System (MPSMS)”. 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 confirm that the offeror meets the mandatory criteria attached to this RFP, and shall be submitted as Appendix 2 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.

Please note: This requirement contains Human Subject Research. Please refer to Section L.5 for offeror instructions.

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

The Continuation of the Medicare Patient Safety Monitoring System (MPSMS) Page 2 of 123 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 Thursday, February 15, 2018. You may mail it to the address below; fax it to 301-427-1740, Attention: Lisa Slavin, Contract Specialist 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, at the following email address: Lisa.Slavin@ahrq.hhs.gov. Subject line shall read: Proposal Questions RFP No. AHRQ-18-10003. 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. A cost plus fixed fee contract is contemplated for a period of one year, with four one-year options.

b. The Government anticipates awarding one contract from this solicitation on or about September 9, 2018.

c. 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.)

d. The NAICS code for this requirement is 541990 with a size standard of $15M.

Proposal Submission: The proposal shall be signed by an authorized official to bind your organization and must be received by the due date specified above. The proposal shall be submitted to the following address:

Agency for Healthcare Research and Quality (AHRQ)* Division of Contracts Management* 5600 Fishers Lane* Mail Stop 06N34B* Rockville, Maryland 20857* Attn: Lisa Slavin, (301) 427-1824*

*All boxes must be clearly labeled with this information.

Please read this section carefully. Some mail and package delivery procedures have changed due to security controls. All mail and packages are screened at a local offsite facility before being delivered to 5600 Fishers Lane.

The U.S. Postal Service’s “Express Mail” does not deliver to our Rockville, Maryland address.

Please do not use this means of delivery for proposal submission.

http://www.fbo.gov/

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Proposals delivered by commercial package delivery company (example: Fedex, UPS, DHL, etc.):

Submit and label as instructed above. These companies are familiar with the delivery procedures at 5600 Fishers Lane.

Hand carried or hand carry courier service: The 5600 Fishers Lane building security does not allow packages to be delivered directly to the building. Hand carried or courier delivered proposals shall be labeled as instructed above, however they must be delivered directly to the offsite screening facility at 12225 Wilkins Avenue Rockville MD 20852. Please note that anyone who arrives at the Fishers Lane location with a delivery will be directed to the screening facility, however this will cause delay. Packages will be accepted and date/time stamped at the screening facility. Please allow ample time, as proposals cannot be date/time stamped until they have gone through security.

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 shall 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-18- 10003.

http://www.sam.gov/

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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

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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)”. 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 $ $ $ Option Period 3 Severable $ $ $ Option Period 4 Severable $ $ $

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

OPTION TASKS

SOW Task Services Estimated Cost Fixed Fee Total

Optional Task A

Non-severable

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Optional Task B

Severable

Optional Task C

Non-severable

Optional Task D

Non-severable

Optional Task E

Severable

Optional Task F

Non-severable

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

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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 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."

No funding or expenditures will be 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.

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

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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 Statement of Work (September 2018 – September 2019)

Base Period Task 1: Determination of Injury/Harm Rates for Specified Conditions using Medicare Patient Safety Monitoring System (MPSMS)

1.1 Analyze MPSMS Data and Produce Adverse Event Rates (Base Year)

The Government will provide to the Contractor patient-identified abstracted data from the Centers for Medicare & Medicaid Services (CMS) Clinical Data Abstraction Center (CDAC) for 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 measures of events or conditions (listed below). The Contractor shall deliver quarterly and annual rates, based on Calendar Year (CY) 2017 inpatient charts (single hospital-stay medical records). The CY 2017 MPSMS sample of charts consists of approximately 30,000 charts, of which approximately 20,000 will come from four sets of 5,000 charts per quarter, consisting of approximately 1000-1500 charts per quarter from each of four patient groups (“four conditions”).

The four conditions include 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 10,000) 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 aged 18 years and older, and without being limited to payment by Medicare, i.e., the five MPSMS samples described above for CY 2017 are “all-payer.” Additional information on the medical records requested from hospitals by CMS is available at the CMS website for the Inpatient Prospective Payment System (IPPS) Final Rule for 2017 (https://www.cms.gov/Medicare/Medicare-Fee-for-Service- Payment/AcuteInpatientPPS/FY2017-IPPS-Final-Rule-Home-Page.html)

Quarterly data for the combined four condition charts shall be delivered by email to the AHRQ Contracting Officer’s Representative (COR) in both of the following 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 https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2017-IPPS-Final-Rule-Home-Page.html https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/FY2017-IPPS-Final-Rule-Home-Page.html

The Continuation of the Medicare Patient Safety Monitoring System (MPSMS) Page 9 of 123 groups in the 2017 MPSMS four-condition sample. Additionally, the annual data shall be provided to the COR in the same two ways. The annual composite data shall also be analyzed 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 2017 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 to be submitted to the COR 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 1.4.

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

• 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 (by email) 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. The annual data on each type of adverse

The Continuation of the Medicare Patient Safety Monitoring System (MPSMS) Page 10 of 123 event shall also be delivered to the COR in graphical form* that shows the stepwise intermediate reduction of the patients exposed to each adverse event, and the number of patients that eventually experienced the adverse event. Annual data shall also include tables* indicating the length of stay and inpatient mortality for each MPSMS measure in CY 2017, 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: Attachment E to this RFP includes intermediate data related to the potential development of an MPSMS adverse event for a sample MPSMS measure in CY 2015.

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

Attachment G to this RFP includes a summary of all the MPSMS Measure Definitions and Descriptions.

The raw Q1 2017 data from the Clinical Data Abstraction Center (CDAC) will be immediately available to the Contractor within two weeks of contract award. Analysis of quarterly data for Q1 2017 data shall be delivered to the COR within 60 days of award. The Government will provide the data to the Contractor as a Microsoft 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 2017 data after Q1 2017 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 2017 data will be transferred from the CDAC, and will be delivered within three months of award, and will be due within two months of receipt. 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 Access files using confidential file transfer methods to be specified during the contract period.

1.2 Reporting of Selected "Sub-Events" (Base Year)

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 2017 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 adverse events. 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.

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1.3 National Injury/Harm Rate (Base Year)

The Contractor shall develop a composite formula for calculating a national patient safety adverse event rate based on the 2017 samples. Using this formula, the Contractor shall calculate a national patient safety adverse event rate for 2017. The rate shall 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 stays; 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. The Contractor shall include an additional modified National Injury/Harm Rate that includes up to three measures based on Quality and Safety Review System (QSRS) data (e.g., inpatient opioid-associated adverse events and up to two other types of adverse event present in QSRS, but not in MPSMS). See base period Task 2 for information on QSRS.

1.4 Develop a Method to Combine 4-Condition and “Global” Charts in the CY 2017 MPSMS

Sample into a Single Composite Rate

The Contractor shall develop methods to be used to combine the data from these two sets of charts to produce data and information that is representative of the U.S. inpatient population and to provide data on the 21 MPSMS adverse events, and a composite MPSMS adverse event rate with all of the charts. The methods used shall be developed in consultation with the AHRQ COR before implementation, and may draw upon prior work sponsored by AHRQ in this area.

1.5 Compare MPSMS Data and Measure Definitions to CDC National Healthcare Safety

Network Data, and AHRQ Quality and Safety Review System (QSRS) Data

The Contractor shall 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), and the AHRQ Quality and Safety Review System (QSRS) that will be run concurrently with MPSMS for CY 2017 through 2019 data, and is presently being run concurrently for CY 2016. The review and cross reference of MPSMS and NHSN data shall be based on publically available NHSN data, and shall 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 2019 data and fully transition to QSRS for national chart-review-based patient safety measurement, while maintaining the ability to track and trend adverse event or HAC rates to prior years, including to 2010 for the current sample, and for a selected Medicare only and age 65 and older subsample.

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 CY 2016 and 2017 MPSMS and QSRS data, 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 10,000 that may be exposed to a common adverse event type, or included in a condition-group or one or more combined condition groups).

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1.6 Other Special Analyses/Study of MPSMS Data (Base Year)

The Contractor shall prepare (and deliver to the COR), at least one report on a special analysis of MPSMS data based on CY 2016 and prior year data. For example, a study could be 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, such as knee replacement surgery and hip replacement surgery. This study should be performed so that they can serve as the basis for a paper to be submitted for publication in a peer-reviewed scientific journal.

1.7 Compare 2017 Data to Prior Years of Data (2009-2016) (Base Year)

The Contractor shall compare 2017 MPSMS adverse event rates to 2009 through 2016 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 1.3), and risk-adjusted data that may take into account factors such as patient age and comorbidity information in the MPSMS data, geographical location, and hospital size and accreditation status, etc. Data from 2009-2016 will be provided by the Government. The report from the Contractor providing the comparison information to the government shall be transmitted via email to the COR.

1.8 Trend Risk-Adjusted Data from 2010 and 2014 to 2017, with Provisions to Continue

Trending Through 2019 (Base Year)

The Contractor shall develop methods to allow risk-adjusted trends based on MPSMS adverse events to be tracked from 2010 to 2019, and from 2014 to 2019, and implement the methods for the 2017 data. The same method may or may not be appropriate for use for the latter period as for the former period. This approach shall be determined in consultation with the COR.

1.9 Activities in Support of Potentially Correcting or Improving CY 2018 MPSMS Measures

(Base Year)

Based on direction from the COR, or COR-approved suggestions from the Contractor for appropriate areas of focus, the Contractor shall perform analyses in support of necessary ad hoc modifications or updates of MPSMS measures for the CY 2018 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 shall edit the measure technical specifications, and provide information to the Government necessary to allow modifications to the MedQuest data collection tool at the CDAC.

Base Period Task 2: Analyze Quality and Safety Review System (QSRS) Data

2.1 Perform Quality and Safety Review System (QSRS) Data Analyses (Base Year)

Unlike MPSMS, the QSRS software produces data on the rates of adverse events (numbers of types of adverse events, and numbers of patients that were subject to, or exposed to, the type of adverse event) without requiring additional analyses after the abstractors at the CMS CDAC

The Continuation of the Medicare Patient Safety Monitoring System (MPSMS) Page 13 of 123 have reviewed a set of charts using the QSRS software. This removes the need for initial analyses to determine the rates of QSRS adverse events. The QSRS software is also arranged in eleven modules, which contain the data on the types of adverse events within each module.

The modules are as follows: Birth-Maternal, Birth-Neonatal, Blood, Device, Fall, Hospital-acquired Infection (HAI), Medication, Pressure Ulcer, Surgery, Venous Thromboembolism, and Other Outcomes of Interest (OOOI).*

*Note: Attachment H to this RFP includes two recent Event Descriptions for the adverse events included in two of these QSRS modules, as samples.

Additional information on QSRS is available on-line at:

https://www.ahrq.gov/professionals/quality-patient-safety/qsrs/index.html, https://www.psoppc.org/psoppc_web/DLMS/downloadDocument?groupId=628&pageNa me=for%20developers%20and%20vendors, https://www.psoppc.org/psoppc_web/DLMS/downloadDocument?groupId=627&pageNa me=for%20developers%20and%20vendors, and https://www.psoppc.org/psoppc_web/DLMS/downloadDocument?groupId=626&pageNa me=for%20developers%20and%20vendors.

The Contractor shall regularly receive data from the Government (no less frequently than on a monthly or quarterly basis) and review and analyze quarterly QSRS data for CY 2016 and the first three quarters of CY 2017 to determine if there are clinical, technical, or statistical issues that suggest that the results are inaccurate or otherwise problematic or invalid in some way.

MPSMS and other sources of patient safety data may be used to augment these reviews.

2.2 Analyze QSRS Data to Produce Adverse Event Rates in Support of the HHS Partnership for Patients 3.0 Program and National HAC Rate (Base Year)

The Contractor shall analyze data furnished by the Government from QSRS to produce summary adverse event rates in eleven specific areas, as follows: 1) adverse drug events (anticoagulant events, hypoglycemic agent events, and opioid events); 2) catheter-associated urinary tract infections; 3) central-line associated urinary tract infections; 4) Clostridium difficile infections; 5) falls, 6) hospital-acquired pneumonias, including those subsequent or concurrent to ventilator use; 7) obstetric adverse events (including neonatal and maternal events); 8) pressure ulcers; 9) venous thromboembolisms (deep vein thromboses and pulmonary embolisms); 10) surgical site infections; and 11) all other adverse event types combined, such as those associated with devices and blood, etc. These eleven rates shall be calculated and reported to the Government by the Contractor separately, and as a composite rate. Rates shall be calculated and reported for each quarter of CY 2016, for the first three quarters of 2017, and for the CY 2016 data year. This task shall also include, similarly to Task 1.4 above for MPSMS, the development of a method to produce information from QSRS that is representative of the U.S. inpatient population (with and without obstetric patients) based on the CY 2017 sample of charts (4-condition and global charts as described above in Task 1.1). This can be based on the method developed above for MPSMS data, but will need to be able to provide data on the two birth-related modules and adverse events. Unlike MPSMS, QSRS contains childbirth-related adverse event measures.

2.3 Develop a Method to Track and Trend Annual QSRS Adverse Event Data (Base Year)

The Contractor shall develop a method that risk adjusts for key patient characteristics and key hospital characteristics based on CY 2016 or CY 2017 data as a baseline (CY selected in https://www.ahrq.gov/professionals/quality-patient-safety/qsrs/index.html https://www.psoppc.org/psoppc_web/DLMS/downloadDocument?groupId=628&pageName=for%20developers%20and%20vendors https://www.psoppc.org/psoppc_web/DLMS/downloadDocument?groupId=628&pageName=for%20developers%20and%20vendors https://www.psoppc.org/psoppc_web/DLMS/downloadDocument?groupId=627&pageName=for%20developers%20and%20vendors https://www.psoppc.org/psoppc_web/DLMS/downloadDocument?groupId=627&pageName=for%20developers%20and%20vendors https://www.psoppc.org/psoppc_web/DLMS/downloadDocument?groupId=626&pageName=for%20developers%20and%20vendors https://www.psoppc.org/psoppc_web/DLMS/downloadDocument?groupId=626&pageName=for%20developers%20and%20vendors

The Continuation of the Medicare Patient Safety Monitoring System (MPSMS) Page 14 of 123 consultation with the COR) for the remainder of calendar years to be analyzed, which is expected to be through CY 2021 for QSRS data, if all contract options are exercised. The method shall be developed and implemented to support analyses of both quarterly and annual QSRS adverse event data.

2.4 Compare MPSMS and QSRS Rates of Similar or Related Events (Base Year)

The Contractor shall review the rates and definitions of the MPSMS and QSRS adverse events on the same general topics; for example, for falls, pressure ulcers, selected HAIs, selected medication events, etc., and produce a report on whether the differences in rates are appropriate, i.e., due to differences in how the MPSMS and QSRS measures are defined, or are inappropriate, e.g., the measures are defined similarly in MPSMS and QSRS, but the data are notably inconsistent between the two systems. Specific areas of focus for this contract year will be determined in consultation with the COR. Findings and data from this Task may to contribute to Task 2.6, and support the transition from MPSMS to QSRS as the primary source of data for computing a National HAC Rate.

2.5 Produce an MPSMS- and QSRS-based Adverse Drug Event (ADE) Rate (Base Year)

The Contractor shall develop a preliminary 2017 adverse drug event rate based on MPSMS adverse events for hypoglycemic agent adverse events, anticoagulant medication adverse events, digoxin adverse events, plus QSRS partial CY 2017 data on opioid-associated adverse events and other types of medication events included in QSRS, but not MPSMS.

2.6 Perform Analyses and Develop Methods to Support the Transition from MPSMS to QSRS Data (Base Year)

The Contractor shall develop and implement methods to be able to continue to trend AHRQ data on the rates of adverse events in the National HAC rate going back to CY 2010 (see AHRQ web page on existing MPSMS-based method: https://www.ahrq.gov/professionals/quality-patient-safety/pfp/index.html). Methods implemented would include the development of a National HAC Rate calculation based solely on QSRS data, and for QSRS data for 2019 to 2021 to be compared to MPSMS data from 2010 to 2019, for the purposes of trending changes in the national rates of HACs from 2010 to 2021, 2014 to 2021, and for other time periods of interest. This shall include analyses in support of comparing MPSMS and QSRS rates for similar specific types adverse events, and for a composite total adverse event rate (such as the National HAC Rate), to enable trending of specific rates and a composite rate to continue without interruption after MPSMS is discontinued after the CY 2019 data year.

2.7 Other Special Analyses/Study of QSRS Data (Base Year)

The Contractor shall prepare (and deliver to the COR), at least one report on a special analysis of QSRS data based on CY 2016 and/or CY 2017 data. For example, a study could be on inpatient opioid administration and adverse event rates, including the use of Naloxone, and demographic and related data on various aspects of opioid usage and adverse event rates.

Another potential topic is the extent to which hospital-acquired pneumonias, as measured by QSRS should be considered adverse events rather than consequences of an underlying illness or condition that may result in pneumonia cases, even if properly treated by physicians and other clinicians. This study or these studies shall be performed so that they can serve as the basis for papers to be submitted for publication in a peer-reviewed scientific journal.

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

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2.8 Activities in Support of Potentially Revising or Enhancing QSRS Measures (Base Year) appropriate areas of focus, the Contractor shall perform analyses in support of necessary ad hoc modifications or updates of QSRS abstractor instructions (including software help text) or measures for the CY 2018 data year. Examples of potential modifications would be those necessary to correct errors in the measures that have been identified as being associated with QSRS adverse events being under-counted (false negatives) or over-counted (false positives) based on the existing Event Descriptions. If any changes are recommended, the Contractor shall provide information to the Government to allow modifications to the QSRS Event Descriptions and software. These changes may include recommendations for new modules, for example for measuring adverse events in pediatric patients; or new content for existing modules, for example for measuring the rates of adverse events associated with non-steroidal anti-inflammatory drugs or other types of medications not explicitly included in QSRS.

Base Period Task 3: Administrative Support for the Medicare Patient Safety Monitoring System (MPSMS) and for Quality and Safety Review System Analyses

The Contractor shall provide administrative and technical support for the on-going operation, analysis, and maintenance of the MPSMS, and for the analysis of QSRS data. The Contractor shall coordinate monthly, one-hour progress teleconferences with an AHRQ-identified working group comprised of the COR for this contract, the COR for the QSRS software contract, the AHRQ MPSMS-QSRS management team, and AHRQ-identified representatives of other Department of Health and Human Services (HHS) agencies or contractors.

3.1 Schedule and Develop Agendas for Monthly Teleconferences (Base Year)

The Contractor shall schedule and develop agendas for monthly teleconferences, and 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.

3.2 Deliver a Monthly Progress Report (Base Year)

The Contractor shall deliver a monthly progress report to the COR on ongoing MPSPS- and QSRS-related activities, and provide to the COR as Word and pdf files 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, and similar status updates on QSRS analyses shall be included, as appropriate.

3.3 Finalize Project Work Plan for the Base Period for Review and Approval by the COR (Base Year)

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 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 Task 3.1.

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3.4 Facilitate Publication/Author Groups (Base Year)

The Contractor shall facilitate publication/author groups to write at least two articles for publication on findings from MPSMS and QSRS data and information. This shall include the following:

• Participate in, or lead author groups;

• Set up conference calls for author groups; and

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

3.5 Prepare and Provide an MPSMS Annual Report (Base Year)

The Contractor shall prepare and provide an annual report that contains annual (new CY 2017) 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.).

3.6 Prepare and Provide a QSRS Annual Report (Base Year)

The Contractor shall prepare and provide an annual report that contains all analyses delivered on QSRS data for CY 2016 and CY 2017. The Annual Report shall be delivered to the COR as three (3) hard copies and three (3) CDs, with the identical material also provided electronically over email (in appropriate formats: Word, pdf, Excel files, etc.).

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Option Year 1 Statement of Work (September 2019 – September 2020)

Option Year 1 Task 1: Determination of Injury/Harm Rates for Specified Conditions Using Medicare Patient Safety Monitoring System (MPSMS)

1.1 Analyze MPSMS data and Produce Adverse Event Rates (OY1)

The Government will provide to the Contractor identified, abstracted data from the Centers for Medicare & Medicaid Services (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 (see Task 1.1 from the Base Period). The Contractor shall deliver quarterly rates and annual rates, based on Calendar Year (CY) 2018 inpatient charts (single hospital-stay medical records). The Contractor shall plan to perform activities with the CY 2018 data that are consistent with those described in Task 1.1 for the Base Period of the contract and CY 2017 data. The required activities for CY 2018 data may not be identical to those for CY 2017, but will be very similar in scope and complexity.

1.2 Reporting of Selected "Sub-Events" (OY1)

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 2018 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 adverse events. 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.

1.3 National Injury/Harm Rate (OY1)

The Contractor shall implement the composite formula developed in the base period for calculating a national patient safety adverse event rate based on the CY 2017 samples with CY 2018 samples. Using this formula, with any necessary modifications, the Contractor shall calculate a national patient safety adverse event rate for 2018. The rate shall 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 stays; 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. The ability to include an additional modified National Injury/Harm Rate that includes up to four measures based on QSRS data (e.g., inpatient opioid-associated adverse events and up to

The Continuation of the Medicare Patient Safety Monitoring System (MPSMS) Page 18 of 123 three other types of adverse event present in QSRS, but not MPSMS) shall be included in this task.

1.4 Implement Method to Combine 4-condition and “Global” Charts in the CY 2018 MPSMS Sample into a Single Composite Rate (OY1)

The Contractor shall implement the methods, developed in the base period with CY 2017 data, to combine the data from the two sets of CY 2018 charts. Prior to starting this work, the contractor shall review with the COR the methods used for the 2017 data to ensure that no modifications are necessary to accommodate the 2018 data. The method shall use available MPSMS data and information to produce MPSMS adverse event data that is maximally representative of the U.S. inpatient population for each of the 21 specific MPSMS measures.

The method shall also support the development of a composite combined MPSMS adverse event rate that is based on all 21 MPSMS measures.

1.5 Compare MPSMS Data and Measure Definitions to CDC National Healthcare Safety Network Data, and AHRQ Quality and Safety Review System (QSRS) Data (OY1)

The contractor shall 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), and the AHRQ Quality and Safety Review System (QSRS) that will be run concurrently with MPSMS for CY 2018 through 2019 data. The review and cross reference of MPSMS and NHSN data shall be based on publically available NHSN data, and shall 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 2019 data and fully transition to QSRS for national chart-review-based patient safety measurement, while maintaining the ability to track and trend adverse event or HAC rates to prior years, including to 2010 for the current sample, and for a selected Medicare only and age 65 and older subsample. The analysis of MPSMS and QSRS data may include confidential MPSMS and QSRS data in Limited Data Sets or other similar formats. Analyses may include use of summary data on partial year or other subsets of the CY 2016 and 2017 MPSMS and QSRS data, 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 10,000 that may be exposed to a common adverse event type, or included in a condition-group or one or more combined condition groups).

1.6 Other Special Analyses/Study of MPSMS Data (OY1)

The Contractor shall prepare (and deliver to the COR at least one report on a special analysis of MPSMS data based on CY 2017 and prior year data. This study shall be performed so that it can serve as the basis for a paper to be to be submitted for publication in a peer-reviewed scientific journal.

1.7 Compare 2018 Data to Prior Years of Data (2009-2017) (OY1)

Based on the work done in the base period that considered MPSMS data through CY 2017, the Contractor shall compare 2018 MPSMS adverse event rates to 2017 through 2009 rates to support the understanding of trends in patient safety (adverse event rates). These comparisons

The Continuation of the Medicare Patient Safety Monitoring System (MPSMS) Page 19 of 123 will compare raw data, patient safety adverse event rate data (as described above in Task 1.3), and risk-adjusted data that takes into account factors such as patient age and comorbidity information in the MPSMS data, geographical location, and hospital size and accreditation status, etc. The report from the Contractor providing the information to the government shall be transmitted via email to the COR, and may be based in part on prior work sponsored by AHRQ.

1.8 Trend Risk-Adjusted Data from 2010 and 2014 to 2018, with Provisions to Continue Trending through 2019 (OY1)

The Contractor shall implement through the CY 2018 data year the methods developed in the base period to allow risk-adjusted trends based on MPSMS adverse events to be tracked from 2010 to 2019 and from 2014 to 2019. Prior to starting this work, the contractor shall review with the COR the methods used for the 2017 data to ensure that no modifications are necessary to accommodate the 2018 data.

1.9 Activities in Support of Potentially Correcting or Improving CY 2019 MPSMS Measures

(OY1)

Similarly to the work performed in Task 1.9 in the base period, the Contractor shall perform analyses in support of necessary ad hoc modifications or updates of MPSMS measures for the CY 2019 data year.

Option Year 1 Task 2: Analyze Quality and Safety Review System (QSRS) Data

2.1 Perform Quality and Safety Review System (QSRS) Data Analyses (OY1)

Similarly to the work performed in the Base Period, the Contractor shall regularly receive data from the Government (no less frequently than on a monthly or quarterly basis) and review and analyze quarterly QSRS data for the fourth quarter of CY 2017 and the first three quarters of CY 2018 to…