§264.2450. Quality Assurance and Improvement

a)         A birth center shall implement a quality improvement program consistent with the requirements of the accrediting body and is encouraged to participate in quality improvement projects implemented by the Department's Administrative Perinatal Centers and other Department-supported perinatal quality improvement projects. (Section 35 of the Act)

 

b)         The birth center shall adopt, implement, and enforce a written quality assurance and improvement program that includes all health and safety aspects of client care for both pregnant or postpartum persons and infant.

 

c)         The ongoing monitoring and evaluation of the quality and accessibility of care and services provided by the birth center or under contract shall include, but not be limited to:

 

1)         Admission of clients appropriate to the capabilities of the birth center;

 

2)         Client satisfaction, complaints, and grievances;

 

3)         Review of the clinical records;

 

4)         Incidences of morbidity and mortality of postpartum person and infant;

 

5)         Postpartum infections;

 

6)         All transfers to a referring hospital for delivery, care of infant, or postpartum care of birthing person;

 

7)         Incidents, problems, and potential problems identified by staff of the birth center, including infection control;

 

8)         Any issues of unprofessional conduct by any member of the birth center's staff (including contractual staff);

 

9)         The integrity of surgical instruments, medical equipment, and client supplies;

 

10)       Client referrals and consultations;

 

11)       Appropriateness of medications prescribed, dispensed, or administered in the birth center;

 

12)       Problems with compliance with any federal or State laws;

 

13)       At least an annual review of protocols, policies and procedures relating to maternal and newborn care;

 

14)       Appropriateness of the risk criteria for determining eligibility for admission to and continuation in the birth center program of care;

 

15)       Appropriateness of diagnostic and screening procedures;

 

16)       Quarterly meetings of clinical practitioners to review the management of care of individual clients and to make recommendations for improving the plan of care;

 

17)       Regular review and evaluation of all problems or complications of pregnancy, labor and postpartum and the appropriateness of the clinical judgment of the clinical practitioner in obtaining consultation and attending to the problem; and

 

18)       Evaluation of staff on ability to manage emergency situations by unannounced periodic drills for fire, maternal/newborn emergencies, power failure, etc.

 

d)         The birth center shall identify and address quality assurance issues and implement corrective action plans as necessary.  The outcome of any corrective action plans shall be documented.  The outcome of the remedial action shall be documented.

 

e)         The QAPI shall include, but not be limited to:

 

1)         Routine testing of the efficiency and effectiveness of all equipment (e.g., sphygmomanometer, dopplers, sterilizers, resuscitation equipment, transport equipment, oxygen equipment, communication equipment, heat source for newborn, smoke alarms, and fire extinguishers);

 

2)         Routine review of housekeeping procedures and infection control; and

 

3)         Evaluation of maintenance policies and procedures for heat, ventilation, emergency lighting, waste disposal, water supply and laundry and kitchen equipment.

 

f)         The QAPI program shall monitor and promote quality of care to clients and the community through an effective system for collection and analysis of data, which includes, but is not limited to:

 

1)         Outcomes of care provided:

 

A)        Spontaneous abortions;

 

B)        Neonatal morbidity;

 

C)        Maternal morbidity;

 

D)        Persons registered for admission for care;

 

E)        Antepartum transfers;

 

F)         Persons admitted to birth center for intrapartum care;

 

G)        Intrapartum transfers;

 

H)        Number of births in the birth center;

 

I)         Percentage of breastfeeding persons;

 

J)         Births occurring en route to the birth center;

 

K)        Postpartum transfers;

 

L)        Newborns transferred;

 

M)       Type of delivery; normal spontaneous vaginal delivery or other;

 

N)        Third and fourth degree lacerations;

 

O)        Infants with birth weight less than 2500 grams or greater than 4500 grams;

 

P)         Apgar scores less than 7 at five minutes;

 

Q)        Neonatal mortality; and

 

R)        Maternal mortality.

 

2)         Reasons for transfer:

 

A)        Antepartum;

 

B)        Intrapartum;

 

C)        Postpartum; and

 

D)        Newborn.

 

g)         Clinicians, or their clinical representative, attending persons in labor at the birth center shall attend morbidity and mortality reviews that occur at the receiving birthing hospital on their clients, when invited, at a mutually agreeable time.  This includes, but is not limited to, maternal and neonatal clients transferred to the receiving birthing hospital. (Section 35 of the Act)