§264.2200. Clinical Records  


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  • a)         Each birth center shall adopt, implement, enforce, and maintain a clinical record system to assure that the care and services provided to each client are completely and accurately documented and systematically organized to facilitate the compilation and retrieval of information.

     

    b)         Each birth center shall maintain accurate and complete clinical records for each client, and all entries in the clinical record shall be made at the time when care, treatment, medications, consultations, or other medical services are given.  The record shall include, but not be limited to, the following:

     

    1)         Client-identifying information;

     

    2)         Name of the client's birth attendants, and the name of all other birth assistants;

     

    3)         Initial risk assessment in accordance with Section 264.1550(f);

     

    4)         A disclosure statement and informed consent that is signed by the client that explains the benefits, limitations, and risks of the services available at the center, and that describes the collaborative arrangements that the center has with physicians and with referral hospitals;

     

    5)         Record of antepartum (prenatal) care;

     

    6)         History and physical examination of the client;

     

    7)         Laboratory tests, ultrasounds, procedures and results;

     

    8)         Written progress notes, signed and dated by the person rendering the service, and incorporated into the client record within 24 hours after services;

     

    9)         Medication list and medication administration record, if applicable;

     

    10)       Intrapartum care;

     

    11)       Newborn assessment and care, including, but not limited to:

     

    A)        Apgar scores;

     

    B)        Maternal-newborn interaction;

     

    C)        Prophylactic procedures;

     

    D)        Accommodation to extra-uterine life;

     

    E)        Blood glucose when clinically indicated;

     

    F)         Supplemental oxygen;

     

    G)        Newborn screening required per the Hearing Screening and Vision Screening administrative codes and the Newborn Metabolic Screening and Treatment Code.

     

    12)       Postpartum care;

     

    13)       Allergies and medication reactions;

     

    14)       Documentation of consultation;

     

    15)       Refusal of the client to comply with advice or treatment;

     

    16)       Discharge summary, to include postpartum person and infant;

     

    17)       Discharge plan and instructions to the client;

     

    18)       Arrangements for newborn follow-up screening and testing it the newborn is discharged prior to the 48 hours;

     

    19)       Authentication of entries by the physician or physicians, birth attendants and birth assistants who treated or cared for the client and newborn;

     

    20)       A copy of the transport form if the client or newborn was transferred to the referral hospital; and

     

    21)       Documentation that a birth certificate was filed or, if applicable, a death certificate was filed.

     

    c)         The birth center shall maintain all original medical records, either paper or electronic, for a period of not less than 10 years.  If the birth center has been notified in writing by an attorney before the expiration of the 10 year retention period that there is litigation pending in court involving the record of a particular client as possible evidence and that the client is their client or is the person who has instituted such litigation against their client, then the birth center shall retain the record of that client until notified in writing by the plaintiff's attorney, with the approval of the defendant's attorney of record, that the case in court involving such record has been concluded or for a period of 12 years from the date that the record was produced, whichever occurs first in time.

     

    d)         Records shall be stored in a manner that will assure safety from water, fire or other sources of damage and will safeguard the records from unauthorized access.

     

    e)         The birth center shall develop a policy for maintenance and confidentiality of all original records or copies of those records, in accordance with State and federal laws.

     

    f)         If a birth center closes, inactive records shall be preserved to ensure compliance with this Section.  The birth center shall send the Department written notification of the reason for closure, the location of the client records, and the name and address of the client record custodian.  If a birth center closes with an active client roster, a copy of the active client record shall be transferred with the client to the receiving birth center or other health care facility to assure continuity of care and services to the client.