Quality Improvement Organization Manual 
Chapter 13 - Management 
 
 
Table Of Contents 
(Rev. 32, 04-12-19) 
 
Transmittals for Chapter 13 
 
INTERNAL QUALITY IMPROVEMENT PROGRAM (IQIP) 
 
13000 - Purpose and Objectives of the Internal Quality Improvement Program (IQIP) 
13010 - IQIP Requirements, Control Process, and Reporting 
 
DOCUMENTATION AND RECORD RETENTION 
 
13100 - Introduction 
13110 - QIO Documentation 
13115 - Timeframes for Retaining QIO Review Documentation 
13125 - Timeframes for Retaining Patient Medical Records 
13130 - Electronic Data Retention Requirements 
13140 - Contractor Records Retention 
13150 - Disposal of Records 
 
    INTERNAL QUALITY IMPROVEMENT PROGRAM (IQIP) 
 
13000 - Purpose and Objectives of the Internal Quality Improvement 
Program (IQIP) 
(Rev. 23, Issued: 12-03-15, Effective: 12-03-15, Implementation; 12-03-15) 
 
Each QIO must develop and maintain an Internal Quality Improvement Program (IQIP), 
also known as an Internal Quality Control (IQC) program or a Continuous Internal 
Quality Improvement Program (CIQIP), in accordance with provisions in its QIO 
contract.  The purpose of the IQIP requirement is to support and foster an environment of 
continuous quality improvement within the QIO through ongoing assessment and 
improvement in areas that are critical for successful contract performance.  The 
objectives of the contractual requirements for an IQIP are to: 
 
  Demonstrate continuous improvement in the quality of services provided by QIOs in 
support of the performance objectives, functions, tasks, and subtasks identified in 
QIO contracts 
 
  Develop and implement a plan that ensures all aspects of QIO activities run 
efficiently, comply with the contract, and are consistent with CMSs goals and 
objectives for the QIO contract 
 
  Document and share with CMS, other QIOs, providers, or key stakeholders, its 
lessons learned in carrying out its functions to help advance the quality and 
effectiveness of the QIO program 
 
  Improve the reliability, accuracy, consistency, and timeliness of data analysis and 
reporting, and case review processing and decision-making 
 
  Provide contract services that consider and meet the needs of customers, and result in 
high levels of customer satisfaction 
 
  Identify opportunities to enhance internal and external customer satisfaction, 
including but not limited to the need for and development of additional provider, 
practitioner, beneficiary, or family/caregiver education regarding QIO review 
processes and criteria 
 
  Ensure the support, understanding, and participation of all beneficiaries, practitioners, 
providers, and other constituencies that are affected by QIO activities 
 
  Ensure compliance with the requirements of statutes, regulations, policy, and the QIO 
contracts 
 
13010 - IQIP Requirements, Control Process, and Reporting 
(Rev. 23, Issued: 12-03-15, Effective: 12-03-15, Implementation; 12-03-15)   
Every QIO shall document and implement an IQIP that encompasses the tasks, subtasks, 
major activities, deliverables, reporting, and contract administrative functions such as 
financial management defined in its contract with CMS. 
 
IQIPs must address the following requirements, and each QIO must implement internal 
quality control processes that strengthen performance of the work identified in its QIO 
contract: 
 
  Identify tasks, subtasks, and/or activities that are included 
 
  Identify measures and/or monitors of performance for each of the tasks, subtasks, 
and/or activities 
 
  Identify plans for how the QIO will meet goals and targets 
 
  Implement control measures that enable the QIO to determine if performance is 
proceeding acceptably during the course of the contract to enable the QIO to adjust 
course when necessary and  meet intermediate and/or process goals or targets that the 
QIO has set for identified tasks, subtasks, and/or activities and evaluation targets 
specified in the contract 
 
  At least quarterly, or more often as performance indicates or as otherwise directed, 
use measures, results, and other information to assess whether the QIO is likely to 
meet goals and targets. Analyze any causes of failure and propose and implement 
changes in the process(es) that the QIO believes will improve performance 
 
  Maintain documentation of: 
  Measures, thresholds, measurement timeframes 
o
  Results of measurement 
o
  Method(s) used to analyze causes of failure and results of the analysis 
o
  Proposed and selected process improvements that address the causes of failure 
o
  Implementation of improvement actions and their impact 
o
  Communication of results and actions  
o
 
  Assess whether improvements were successful and make adjustments to the process, 
if needed 
 
When requested by CMS, QIOs shall report and make available documentation of the 
QIOs continuous internal quality improvement process controls including 
measurements, monitoring, plan, results, improvement actions, and lessons learned for all 
tasks, subtasks, and major activities. 
     
DOCUMENTATION AND RECORD RETENTION 
 
13100  Introduction 
(Rev. 23, Issued: 12-03-15, Effective: 12-03-15, Implementation; 12-03-15) 
 
QIOs shall maintain complete and accurate documentation of all QIO activities in a 
manner that ensures that: 
 
  QIO activities can be validated during auditing procedures 
 
  Documentation is available to verify performance of all quality improvement and 
case review functions as defined in each QIO contract 
 
  Activities and documentation are handled in a manner that ensures the 
confidentiality of all QIO data in accordance with 42 CFR Part 480 
 
13110 - QIO Review Documentation 
(Rev. 32, Issued: 04-12-19, Effective: 05-13-19, Implementation: 05-13-19) 
 
The term Medicare beneficiary identifier (Mbi) is a general term describing a 
beneficiarys Medicare identification number. For purposes of this manual, Medicare 
beneficiary identifier references both the Health Insurance Claim Number (HICN) and 
the Medicare Beneficiary Identifier (MBI) during the new Medicare card transition 
period and after for certain business areas that will continue to use the HICN as part of 
their processes. 
 
QIOs shall maintain file records and establish internal control systems that at a minimum 
enable it to perform the following functions as required under the contract: 
 
  Provide an accurate and complete record of all in-progress and completed activities, 
correspondence, and analyses, including a record of times and dates, in connection 
with every individual case review effort 
 
  Identify all individuals, roles, responsibilities, and determinations made as part of 
every individual case review effort 
 
  Identify all quality improvement activities in-progress and completed, to include 
provider/practitioner improvement plans and points of contact for each quality 
improvement activity 
 
  Furnish complete and accurate documentation to CMS and authorized third parties 
upon request 
    Comply with requirements for protection of all data and records in accordance with 
CMS security and privacy policies (see QIO Manual Chapters 8 and 10, and 42 CFR 
Part 480) and procedures identified in the QIO contract 
 
  Transfer to CMS, or to a successor QIO contractor as directed by CMS, any records 
and files, including patient medical records, necessary to perform the business 
functions of the QIO that are identified in the QIO contract 
 
Case Review Documentation Requirements 
 
At a minimum, QIO case review documentation must include: 
 
  Case identifiers (e.g., Medicare beneficiary identifier) 
 
  Determinations (outcomes) of each review (e.g., approval, denial, coding decision, 
quality concern) 
 
  Medical review criteria used in the review 
 
  Verification that appropriate review was performed 
 
  Name and title of each reviewer who contributed to the determination (e.g., review 
coordinator, physician advisor) 
 
  Dates of each review function that demonstrate compliance with review timeframes 
(e.g., date case was identified for review, dates records requested and received, dates 
review initiated and completed, dates notices issued, if applicable) 
 
  Any referrals to other QIOs or external agencies 
 
Denial Determinations, Diagnostic Related Group (DRG) Assignment Changes, and 
Confirmed Quality Concerns 
 
If the QIO determination results in an initial or technical denial, DRG assignment change, 
or confirmed quality concern, the review documentation must also include: 
 
  The detailed basis (e.g., all documentation already in your possession for the case) for 
the denial determination (including limitation on liability determinations and 
documentation errors), DRG assignment change, or confirmed quality concern 
 
  A copy of the notice that was sent to all parties, identification of each party, and the 
date the notice was mailed or delivered 
 
  The returned envelope and notice, if the notice was subsequently returned as 
undeliverable or receipt refused 
  Reconsideration and/or Provider Request for a Review of a QIO DRG 
Determination 
 
If the QIO conducts a reconsideration or review of the QIO DRG determination, its 
review documentation must also include: 
 
  Documentation of the reconsideration or review request 
 
  The detailed basis for the reconsideration (including the limitation on liability 
determination) or review determination 
 
  A copy of the reconsideration or review determination letter that was sent to all 
parties, identification of each party, and the date on which the notice was mailed or 
delivered 
 
  The returned envelope and notice, if the notice was subsequently returned as 
undeliverable or receipt refused 
 
Format of QIO Case Review Documentation 
 
QIOs shall retain case review documentation in an easily retrievable format such as hard 
copy, electronic file record, or as specified in its contract. 
 
13115 - Timeframes For Retaining QIO Review Documentation 
(Rev. 23, Issued: 12-03-15, Effective: 12-03-15, Implementation; 12-03-15) 
 
Retain copies of all case review documentation as follows: 
 
Approved Reviews 
 
Retain all review documentation for 12 months from the date review is completed. 
Approved reviews, as used in this instruction, refer to initial reviews of medical 
necessity, quality, or appropriateness of healthcare services conducted by a QIO review 
associate and/or a physician peer reviewer in which there are no confirmed issues at the 
completion of the reviews identified in 42 CFR 476.71. 
 
Negative Determinations 
 
In accordance with regulations at 42 CFR 476.94(e), retain all review documentation of 
initial denial determinations and DRG assignment changes for six years from the date the 
services in question are furnished. In addition, retain all review documentation of 
confirmed quality concerns for six years from the date the services in question are 
furnished. 
 
DRG Review Determinations 
  Retain all review documentation of DRG assignment change review determinations, 
including re-reviews, for six years from the date the services in question are furnished. 
 
Reconsideration Determinations 
 
In accordance with regulations at 42 CFR 478.36, retain all review documentation of 
reconsideration determinations for four years after the date on the notice of the QIOs 
reconsidered determination, or until litigation is completed and the time period for filing 
all appeals has passed, whichever is later. 
 
Audits 
 
Ensure that the documentation is readily retrievable within 10 working days for any 
auditing process that may be required by CMS. If an audit is conducted by CMS, retain 
all review documentation for three years from the date of the audit or the timeframes for 
retaining documentation specified in this Manual, whichever is later. 
 
13125 - Timeframes for Retaining Patient Medical Records 
(Rev. 23, Issued: 12-03-15, Effective: 12-03-15, Implementation; 12-03-15) 
 
Retain copies of patient medical records as follows: 
 
Approved Reviews 
 
Retain patient medical records for at least 90 days from the date review is completed. 
 
Negative Determinations 
 
Retain patient medical records for initial denial determinations, DRG assignment 
changes, and confirmed quality concerns for 12 months from the date review is 
completed. 
 
Reconsideration Determinations 
 
Retain patient medical records for at least four years after the date of the QIO 
reconsideration determination notice  or the time period for completion of litigation and 
for filing all appeals whichever is the later as defined in 42 CFR 478.36. 
 
13130 - Electronic Data Retention Requirements 
(Rev. 1, 05-23-03) 
 
Retain for 18 months, records of any sampling universe records electronically supplied 
by CMS.  Sampling records include the universe for sampling, identification of each 
sample selected for review with information sufficient to identify an individual case, and 
the category of review for which the case was selected. 
  13140 - Contractor Records Retention 
(Rev. 1, 05-23-03) 
 
In addition to SOW requirements, the Federal Acquisition Regulations (FAR) require that 
all other documents (e.g., outreach activities) related to contracts entered into by 
negotiation be retained for 3 years after final payment under the contract. 
 
The Comptroller General of the United States or duly authorized representatives from the 
General Accounting Office (GAO) have access to and the right to examine directly any of 
the contractor's pertinent books, documents, papers, or other records involving 
transactions related to the contract. 
 
For any subcontracts under a negotiated contract, the GAO has access to and the right to 
examine any of the subcontractor's pertinent books, documents, papers, or other records 
involving transactions related to the subcontract for 3 years after final payment under the 
subcontract.  Subcontracting records do not include purchase orders not exceeding 
$10,000 and subcontracts or purchase orders for public utility services. 
 
13150 - Disposal Of Records 
(Rev. 1, 05-23-03) 
 
Ensure that confidential records are destroyed when appropriate.  In accordance with 42 
CFR 480.115(e), destroy and dispose of records in a manner that ensures that confidential 
information cannot be retrieved. 
 
If you subcontract with a private company to destroy records, use prudent business 
standards. 
  Transmittals Issued for this Chapter 
 
Rev #  Issue Date  Subject  Impl Date  CR# 
R32QI  04/12/2019  Update to Publication (Pub.) 100-10 to  05/13/2019 11206 
Provide Language-Only Changes for the New 
Medicare Card Project 
R23QIO  12/03/2015  QIO Manual Chapter 13  Management  12/03/2015 N/A 
R01QIO  05/23/2003  Initial Release of Chapters 2,8,13 and 15  N/A  N/A 
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