Statutes, codes, and regulations
Delaware Administrative Code
Title 16 - Health and SafetyDepartment of Health and Social ServicesDivision of Health Care Quality
Regulations Governing Dialysis Centers
Section 3330-16.0 - Quality Assessment and Performance Improvement

16 Del. Admin. Code § 3330-16.0

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Current through Register Vol. 28, No. 5, November 1, 2024
Section 3330-16.0 - Quality Assessment and Performance Improvement
16.1 The dialysis center must develop, implement, maintain, and evaluate an effective, ongoing facility-wide, data driven, interdisciplinary QAPI program.
16.2 The QAPI program shall reflect the complexity of the dialysis center's organization and services, including those services furnished under contract or arrangement, and must focus on indicators related to improved health outcomes and the prevention and reduction of medical errors.
16.2.1 There must be an operationalized, written plan describing the QAPI program scope, objectives, organizations, responsibilities of all participants, and procedures for overseeing the effectiveness of monitoring, assessing and problem solving activities.
16.3 The QAPI program shall include:
16.3.1 An ongoing review of key elements of care using comparative and trend data to include aggregate patient data;
16.3.2 Identification of areas where performance measures or outcomes indicate an opportunity for improvement;
16.3.3 Appointment of an interdisciplinary team to:
16.3.3.1 Identify, measure, analyze and track indicators for variation from desired outcomes;
16.3.3.2 Create and implement improvement plan(s);
16.3.3.3 Evaluate the implementation of the improvement plan(s); and
16.3.3.4 Continuously monitor performance, take actions that result in performance improvements and track performance to ensure that improvements are sustained over time.
16.3.4 Establishment and monitoring of quality indicators related to improved health outcomes and the identification and reduction of medical errors. For each quality assessment indicator, the facility shall establish and monitor a level of performance consistent with current professional knowledge. These performance components shall influence or relate to the desired outcomes themselves. At a minimum, the following indicators shall be measured, analyzed, and tracked on a monthly basis:
16.3.4.1 Water and dialysate quality;
16.3.4.2 Dialysis equipment repair and maintenance;
16.3.4.3 Dialysis adequacy;
16.3.4.4 Nutritional status;
16.3.4.5 Mineral metabolism and renal disease bone management;
16.3.4.6 Anemia management;
16.3.4.7 Fluid and blood pressure management;
16.3.4.8 Vascular and/or peritoneal dialysis access;
16.3.4.9 Patient modality choice and transplant referral;
16.3.4.10 Personnel qualifications and issues;
16.3.4.11 Infection prevention and control;
16.3.4.12 Medical errors and medical injuries;
16.3.4.13 Adverse occurrences;
16.3.4.14 Patient satisfaction and grievances;
16.3.4.15 Physical plant safety audits;
16.3.4.16 ESRD Network 4 relationship and communications; and
16.3.4.17 Morbidity and mortality.
16.4 The dialysis center must set priorities for performance improvement, considering prevalence and severity of identified problems and giving priority to improvement activities that affect clinical outcomes or patient safety.
16.5 The dialysis center shall immediately correct any identified problems that threaten the health and safety of patients.
16.6 The Department may review the dialysis center's QAPI activities to determine compliance with these requirements.

16 Del. Admin. Code § 3330-16.0

22 DE Reg. 853( 4/1/2019) (final)