HospitalInspections.org

Based on interview and record review, the hospital failed to maintain a complete and accurate list of contracted services. This failure had the potential for the hospital to be unaware of which contracted services were in effect.

Findings:

During an interview with the Director of Quality and Risk (DQR), and review of the Contracted Services list, on 8/29/19, at 2:33 PM, she stated the hospital contracts with a teleradiology (radiologists review medical images from another location) group. The DQR verified she was unable to find the teleradiology group listed on the 2019, Contracted Services list.

During an interview with the Imaging Director (ID), and review of the Contracted Services list, on 8/30/19, at 3:36 PM, he stated the hospital has contracts with two companies which lease or service radiology equipment. The ID reviewed the 2019, Contracted Services list and was unable to find the two companies listed.

Based on observation, interview, and record review, the hospital failed to follow its Informed Consent policy and procedure for four of 38 sampled patients (Patient 7, Patient 12, Patient 13, and Patient 14) when;

1. Registered Nurse (RN) 2 documented her witness signature prior to the patient signing two informed consents.

2. The anesthesia consent did not indicate the patient was consenting to a labor epidural for (a regional anesthetic used to reduce the pain level during labor and delivery) or name the anesthesia provider.

3. The RN failed to sign as witnessing a patient's signature.

4. The RN failed to verify informed consent was given by the provider prior to patients signing informed consent documents.

These failures had the potential for patients not to be fully informed of the procedure before giving consent.

Findings:

1. During an observation and interview with RN 2, and review of the clinical record for Patient 7, on 8/28/19, at 3:55 PM, in the pre-operative holding room (room where each patient was prepared to go into the operating room); RN 2 was at Patient 7's bedside with Anesthesiologist 1. Anesthesiologist 1 explained how he planned to administer anesthesia for Patient 7's upcoming procedure. RN 2 documented her witnessing Patient 7's signature prior to Patient 7 signing "Consent for Anesthesia." RN 2 also documented her witness signature on the "Authorization For and Consent to Surgery or Special Diagnostic Procedure/Treatment [consent for partial amputation of the right foot]" prior to Patient 7 documenting his consent. RN 2's signature on the surgical consent was documented at 4:15 PM. When RN 2 was requested to copy the surgical consent, she stated, "Well, he hasn't signed it yet." Patient 7 signed the surgical consent after his surgeon spoke to him, the time of his signature documented by the patient as 4:25 PM.

During an interview with RN 2 and the Clinical Concurrent Reviewer Registered Nurse (CCRRN), on 8/29/19, at 11 AM, RN 2 stated, "I always document my signature before the patient signs because I am at the bedside when the doctors explain and the patient agrees. It saves time. If the patient ends up not signing the consent after I witnessed it, I just tear up the consent."

During an interview with the CCRRN, on 8/29/19, at 2:10 PM, she stated "I heard [RN 2] say that. She should not document 'Witness Signature' before it is signed by the patient." The CCRRN acknowledged RN 2 should not destroy any part of patients' medical record.



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2a. During a review of the clinical record for Patient 12, The Authorization for Consent for Administration of Anesthesia, dated 8/28/19, at 1 AM, indicated Patient 12 consented to having anesthesia, the type of anesthesia was not documented and the provider was not named. The OB (Obstetrician) Anesthesia Record, dated 8/28/19, at 7:14 AM, indicated Patient 12 received a labor epidural placed by Anesthesiologist 2.

2b. During a review of the clinical record for Patient 13, The Authorization for and Consent for Administration of Anesthesia, dated 8/28/19, at 6:20 AM, indicated Patient 13 consented to having anesthesia, the type of anesthesia was not documented and the provider was not named. The Anesthesia Record, dated 8/28/19, indicated Patient 13 received a labor epidural at 6:42 AM.

During an interview with RN 1, on 8/29/19, at 2:44 PM, she confirmed the anesthesia consents did not name epidurals as the specific type of anesthesia the OB patient is signing for or did not name the anesthesia provider.

The hospital policy and procedure titled "Informed Consent/Consent Forms" dated 3/18, indicated "The facility policy and procedure titled, "Informed Consent/Consent Form" dated 3/18, indicated "PURPOSE: To provide information to the patient regarding their health status, diagnoses, prognosis and appropriate care, treatment and services options allowing the patient to make an informed choice, as well as, to provide guidelines for completing and witnessing consent forms. . . Authorization for and Consent to Surgery or Special Diagnostic Procedure/Treatments: 1. List the exact procedure as stated by the physician's written order. . .2. List the first and last name(s) of the physician(s) performing the procedure(s). . . Anesthesia Consent Form:. . . 2. Specific written consent id required for independent diagnostic and therapeutic anesthesia procedures such as therapeutic nerve blocks."

3. During a review of the clinical record for Patient 14, The Authorization for and Consent to Surgery or Special Diagnostic Procedure/Treatment, dated 8/28/19, at 1:01 AM indicated Patient 14 signed a consent for "Induction of labor [IOL using medication to cause labor], vaginal delivery, possible repair of laceration or/and episiotomy" with the provider named OB 2 "or on call MD [Medical Doctor]". Patient 14's signature was not witnessed by a staff member.

During an interview with RN 1, on 8/29/19, at 2:44 PM, she confirmed there was no witnessing signature on Patient 14's IOL consent.

The hospital policy and procedure titled, "Informed Consent/Consent Form" dated 3/18, indicated "PURPOSE: To provide information to the patient regarding their health status, diagnoses, prognosis and appropriate care, treatment and services options allowing the patient to make an informed choice, as well as, to provide guidelines for completing and witnessing consent forms. . . B. Consent forms will be witnessed by hospital staff within the scope of their practice".

4a. During a review of the clinical record for Patient 12, the face sheet (part of the medical record with patient's personal information) dated, 8/28/19, indicated Patient 12 was admitted to the hospital on 8/28/19, at 12:07 AM. The Authorization for and Consent to Surgery or Special Diagnostic Procedure/Treatment, dated 8/28/19, at 1:01 AM indicated Patient 12 signed a consent for "vaginal delivery with possible episiotomy [incision made during delivery] and repair" with the provider named Obstetrician 1 "or on call physician".

4b. During a review of the clinical record for Patient 13, the face sheet, dated 8/28/19, indicated Patient 13 was admitted to the hospital on 8/28/19, at 4:58 AM. The Authorization for and Consent to Surgery or Special Diagnostic Procedure/Treatment, undated, indicated Patient 13 signed a consent for "vaginal delivery with repair of laceration and for episiotomy" with the provider named OB 1 "or MD on call".

During an interview with RN 1 and Women and Infants Nurse Manager (WINM), on 8/29/19, at 2:44 PM, they reviewed the clinical record for Patient 12 and Patient 13. RN 1 stated the process is for the nurse to have the patient sign consents for procedures including vaginal delivery, IOL, augmentation of labor (using medication to speed up the labor process for women already in labor), and epidural anesthesia, early in the admission process. RN 1 stated she was not sure where the provider documents giving informed consent in the medical record. She was unable to find documentation of informed consent in the medical record for Patient 12. The WINM verified the process used in her department is for the RNs to consent patients upon admission to the hospital, without verifying the informed consent was given by the provider. She verified the findings for consents for Patient 12 and Patient 13.

The hospital policy and procedure titled, "Informed Consent/Consent Form" dated 3/18, indicated "PURPOSE: To provide information to the patient regarding their health status, diagnoses, prognosis and appropriate care, treatment and services options allowing the patient to make an informed choice, as well as, to provide guidelines for completing and witnessing consent forms. . . 1. Informed consent is obtained after a competent patient (or person legally authorized to make health care decisions on the patient's behalf) is given sufficient information by the treating physician to make an informed choice, understands the information, and voluntarily agrees to be treated (consent) or not be treated (refusal), thus protecting the patient's fundamental right to autonomy. . . 1. Informed consent is an agreement between the patient and physician /provider and will be recorded in writing, and witnessed. . . B. Consent forms will be witnessed by hospital staff within the scope of their practice. . . 2. The physician treating the patient will be responsible for obtaining the patient's informed consent. . . 3. The role of the hospital will be limited to obtaining verification that the patient's informed consent has been obtained by the physician before the physician is permitted to perform the procedure. . . PROCEDURE. . . 3. Documentation of the informed consent is required. Recording the conversation in a signed note in the progress notes provides the best documentation which includes: A. Witnesses present B. Location of procedure of surgical site C. Date and time D. Content of discussion. . .CONSENT FORMS:. . . Authorization for and Consent to Surgery or Special Diagnostic Procedure/Treatments. . . 6. Verify the signature of the patient scheduled for the procedure and sign the consent as a witness. . .Anesthesia Consent Form:. . . 3. Witness patient's signature AFTER the anesthesiologist has given the patient information including risks and benefits."

Based on observation, interview, and record review, the facility failed to follow its Universal Protocol policy and procedure for one of 38 sampled patients (Patient 3). This failure had the potential for the surgical team to miss critical patient information regarding the pending surgery.

Findings:

During an observation on 8/29/19, at 9:35 AM, in the operating room (OR), Registered Nurse (RN) 3 began the time out process (a pause conducted prior to the starting of surgery involving everyone in the room to verify the identification of the patient and the planned procedure with the surgical team). During the Time Out process, the Surgical Technologist (ST) was observed assisting Surgeon 1 putting on his sterile gown. The Operating Room Manager (ORM) was observed waving her hands at the surgeon and the ST, and the surgeon stopped putting on his gown.

During an interview with the ORM, on 8/30/19, at 8:40 AM, she was asked why she was waving her hands, she stated, "I wanted to signal everyone to pay attention to time-out."

During a review of the facility policy and procedure titled "Universal Protocol" dated 2/17, it indicated "Purpose: To enhance patient safety by correctly identifying the patient, the appropriate procedure, and the correct site of the procedure. . . 3. Time-out Verification Process: 1. The time-out is conducted immediately prior to starting the procedure and is initiated by the proceduralist/surgeon with a designated member of the team reviewing all elements of the verification process in the pre-procedure checklist. B. The entire team pauses for verification. C. Time-out involves interactive verbal communication between all team members. Any team member is able to express concern about the procedure verification. D. During the time-out, all other activities are suspended to the extent possible without compromising patient safety, so that all relevant members of the team are focused on the active confirmation of the correct patient, procedure, site and other critical elements included in the safety checklist. . . G. If the entire team agrees, the surgery/procedure commences."