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Based on observation, staff interview, medical record review, and review of facility documents, it was determined the facility failed to ensure the rights of each patient is protected.

Findings include:

1. The facility failed to order blood, emergently, for a neonate with a critical hemoglobin level. (Cross refer to Tag A-144).

Based on staff interview, review of facility policy and procedure, facility document review, and review of one (1) of one (1) medical record of a neonate requiring an emergency blood transfusion, it was determined the facility failed to ensure care was provided in adherence with facility policy.

Findings include:

Reference: Facility policy, Blood Administration (Transfusion), states, "... C. Emergency Release of Blood ... II. Procedure: A. Emergency Release of Blood: ... [bullet] Emergency blood unit can be ready in 5 minutes. ..."

1. A review of Medical Record #1 revealed the patient delivered a baby (Patient #2) at 17:38 via cesarean section. The obstetrician's report; "Unscheduled OpNote" states, "... It was a [male/female] infant, which appeared extremely pale. The umbilical cord was clamped and cut and the baby was handed over to the neonatologist. The umbilical cord was short, and cord blood was obtained. The blood appeared to be somewhat diluted. ... The placenta appeared abnormal, friable, pink and hydropic. ..."

2. A review of Medical Record #2 revealed the following:

a. A neonatology consult note states, "... The child was stable on the continuous positive airway pressure (CPAP) with 60% oxygen, saturating at 98-100%, with occasional desaturation. I got the hemoglobin report by 6:17 p.m., reported from the lab. It was 3.7, so I called for the blood transfusion. Consent was obtained at 6:48 p.m. I got the message from [name of obstetrician] that the Kleihauer-Betke fetomaternal hemorrhage (KB/FH) test, fetal blood loss was 375 milliliters, that is 7.5% of the fetal blood in the mother's body. Since there was difficulty in intravenous access, we called for umbilical venous (UV) line consult, obtained at 7:34 p.m. The umbilical venous (UV) line was placed at 8:00 p.m. Still the child was unstable on continuous positive airway pressure (CPAP) plus 60% oxygen. ... At this time, acute fetal-maternal transfusion was considered. We are waiting for the packed red blood cells (RBCs) to come in. ... The blood arrived, and we are preparing to transfuse. Since the heart rate started going down and desaturating, we requested the parents to leave the room. The code was called at 8:52 p.m. ... [He/she] got 1.5 milliliters of epinephrine through the endotracheal tube 1 time. After that, epinephrine 1.5 milliliters was given via the umbilical venous line, so the baby got a total of 8 milliliters of epinephrine from 8:50 p.m. to 9:11 p.m. ... The blood transfusion was started at 9:06 p.m., because it was originally planned to give this through the peripheral line over 3 hours. ..."

(i) The first unit of packed RBC's was initiated two (2) hours and 49 minutes after the neonatologist became aware of Patient #2's critical hemoglobin level.

b. Laboratory result documentation indicated the critical hemoglobin result of 3.7 was conveyed to nursing staff at 18:36 on 2/23/21.

c. An "IV [intravenous] Start/In Place PEDS (Peripheral) on 2/23/21 at 19:09 states, "Insert Date: Tue, 23 Feb 2021 IV type: Peripheral ... Descriptn [sic]: patent; no signs of IV complications observed. ... tolerated well ..."

d. A "TIME OUT VERIFICATION CHECKLIST" states the time of verification for the UV line was 2000 on 2/23/21.

e. A nursing "Neonatal Resuscitation" note states, "... 3.5 Fr UV line placed at 2015 by [name of Neonatologist] under sterile technique. ... Placement confirmed by Xray. PRBC's received at 2030. ... More Epi given via UV line as per Cardiopulmonary Arrest Flowsheet. ..."

3. A review of Blood Bank documentation for Patient #2 revealed the following:

a. The neonatologist signed the first order for PRBC's on 2/23/21 at 18:48. The blood was not ordered emergently.

b. The blood was available for release from the blood bank at 19:22, 34 minutes after the physician ordered the first unit of PRBC's.

c. The "BLOOD CLAIM SLIP & TRANSFUSION RECORD" indicates the blood was released from the Blood Bank on 2/23/21 at 20:38 PM, one (1) hour and 16 minutes after the blood bank documented it was available for release.

(i) The "Transfusion Start Date/Time" on the Blood Claim Slip & Transfusion Record is documented as "2/23/21 @ [at] 2030." This was eight (8) minutes prior to the documented time the blood was released from the Blood Bank and 36 minutes prior to the time the neonatologist documented the blood transfusion was initiated, as stated above.

(ii) Patient #2's blood type was documented as "Recipient Group O Rh +". The donor blood type was documented as "Donor Group O Rh neg [negative]". This indicated that Patient #2 received O negative blood for the first transfusion. However, the blood was not ordered emergently.

4. During an interview with the Neonatologist, Staff #13, on 5/12/21 at 11:15 AM, he/she stated he/she was unaware of the Emergent Blood Release order form. Staff #13 stated Patient #2 could have been given O negative blood in accordance with the Emergency Blood Release Order, but he/she did not know it was available. Staff #13 stated he/she communicated to the nurse that the blood was needed STAT [immediately] and he/she completed the order form, as far as quantity, but the nurse filled out the order form. Staff #13 confirmed he/she signed the order for PRBC's.

5. During an interview on 5/12/21 at 11:21 AM, Staff #4, the Chief Medical Officer, stated there was not a specific order for O negative blood and it would have to be written on the "PHYSICIAN'S ORDERS: BLOOD COMPONENT" sheet.

a. During an interview on 5/12/21 at 11:35 AM, Staff #15, a registered nurse for Staff Development, presented the Emergency Blood Release Order form and confirmed it could be used for any patient, including a neonate. Staff #15 stated the form had been updated recently. At 11:55 AM, Staff #4 stated he/she was unaware of the Emergency Blood Release order form.

6. During an interview on 5/12/21 at 12:05 PM, Staff #16, an Anesthesiologist, stated he/she was unaware of the Emergency Blood Release order form.

7. On 5/12/21 at 12:20 PM, Staff #15 provided education regarding the emergency release of blood. Staff #15 stated the form had gone through revision by the Blood Utilization Committee in May of 2019. Staff #15 provided education on the Emergency Release of Blood and the Massive Transfusion protocol that was provided to nursing and support staff following the revisions. Staff #15 confirmed the maternal/newborn health staff would have received this education. Staff #15 stated his/her department was not responsible for educating the physicians regarding the revisions.

8. A review of Medical Executive Committee meeting minutes dated 11/12/19, revealed, "... D. Policy Review ... b. Emergency Release/Massive Transfusion Protocol: Policy was reviewed. Committee voted unanimously in favor of approval of the policy as presented. ..." Staff #4 is documented as being in attendance at this meeting.

9. During an interview on 5/13/21 at 10:10 AM, with Staff #18 and in the presence of Staff #4, Staff #18 was asked regarding the process for disseminating changes in policy to the physicians. Upon request, Staff #18 could not provide evidence that all physicians received information regarding the Emergent Blood Release order form after it was revised, in May 2019. Staff #4 stated he/she was "not sure we did get education out to everybody" and stated the policy was not differentiated from the Massive Transfusion Protocol, which may have impacted which physicians received the education.

Based on review of physician credential files, medical staff bylaws, facility documents, and staff interview, it was determined the facility failed to ensure all physicians are credentialed in accordance with medical staff bylaws.

Findings include:

1. The facility failed to ensure physician's privileges are current. (Cross refer to Tag A-341)

Based on one (1) of three (3) physician credential files reviewed (Staff #13), staff interview, review of medical staff bylaws, and review of facility documents, it was determined the facility failed to ensure all physicians are credentialed in accordance with medical staff bylaws.

Findings include:

Reference #1: Facility "Bylaws of the Medical Staff", approved 10/23/2018, states, "... 5.5 Reappointment ... Recommendations for biennial reappointments shall be made by the President of the Medical Center or designee and the Selection and Credentials and Medical Executive Committees of the Medical Staff after consultation with the appropriate Department Chairperson. They shall evaluate each member for satisfactory completion of requirements for Staff membership, as detailed in the Credentials Manual of the Medical Staff, and in Article 5.2 and this Article 5.5 of these Bylaws of the Medical Staff. Applications for reappointment shall also include the appropriate Department Chairperson's review and approval of professional and clinical performance, as well as adherence to the rules and regulations of the Medical Staff, a statement of satisfactory health status, and if requested by the Selection and Credentials and/or Medical Executive Committees reasonable evidence thereof, attestation of completion of continuing medical education credit hours over a three two year [sic] period; and a peer reference designed to evaluate the applicant's ability to function with other practitioners and health care personnel in such a way that patient care is not compromised. ..."

Reference #2: Facility "Credentialing Manual", states, "... Chapter 6 - Expedited Credentialing ... Procedure: 2. Applications and requests for Clinical Privileges shall be forwarded to the appropriate Department/Division Chair, APP Committee Chairperson (if applicable) for review and recommendation to the Selection & Credentials Committee 3. Applications and requests for clinical privileges shall be reviewed to ensure it fulfills the established requirements for membership and clinical privileges, The applicant and their request for clinical privileges shall be presented to the Selection & Credentials Committee for review and recommendation. 4. If the Selection & Credentials Committee recommends approval for expedited processing, the Chair of the Selection & Credentials Committee shall sign the Expenditure Credentialing Form. The Form will be forwarded to the Chairperson of the Medical Executive Committee for their recommendation and signature and to the Expedited Committee of the Board of Trustees for their final action. 5. If the expedited process is recommended: a. The recommendation of the Department/Division Chair, APP Committee, and Selection & Credentials Committee are forwarded to two (2) voting members of the Board of Trustees who are delegated the authority to render decisions and approve applications and clinical privileges on behalf of the Board of Trustees. b. The applicant shall be notified of appointment or reappointment and clinical privileges once approved by the Board of Trustees delegates. ..."

1. Review of Staff #13's physician credential file, in the presence of Staff #4 and Staff #31, revealed an undated application for privileges that was signed by the applicant (Staff #13) but does not contain documentation of approval or denial of the privileges requested. This was confirmed with Staff #31 on 5/13/21 at 3:13 PM. Staff #4 stated that privileges are renewed every two (2) years.

a The previous application for privileges was signed by Staff #13 on 9/14/16 and was approved as follows:

(i) By the Department Chair on 10/9/16.

(ii) By the Selection and Credentials Committee Chair (not dated)

(iii) By the Medical Executive Committee Chair on 11/8/16.

b. A letter from the Board of Trustees dated 11/19/15, states, "... I am pleased to inform you that the Board of Trustless of Hunterdon Medical Center, at their meeting on 11/19/2015, approved your reappointment to the Active Staff in the Department of Pediatrics with clinical privileges in Neonatology, for the period beginning 11/19/15 through 11/18/2017. ..." Upon request, a more recent letter could not be provided.

c. Upon request on 5/13/21, Staff #4 and Staff #31 could not provide a completed application for privileges for Staff #13 after his/her privileges were due for renewal in October/November 2018.

2. A review of Selections & Credentials Committee meeting minutes dated 10/1/20 and 10/9/20 revealed "... REAPPOINTMENTS ... E. [Staff #13], active with Waiver, Pediatrics *Pending chair signature ..."

3. A review of Medical Executive Committee meeting minutes dates 10/13/20, revealed, "... Reappointments ... G. [Staff #13] Active with Waiver, Pediatrics ..."

4. On 5/13/21 at 3:57 PM during an interview with Staff #9,din the presence of Staff #4 and Staff #31 the above findings were confirmed. Staff #9 stated the 2016 application for privileges is the last time the privileges were approved and signed by the Department Chair. It was also confirmed that the Selections & Credentials Committee meeting minutes dated 10/1/20 and 10/9/20, indicate Staff #13's privileges were approved pending the signature of the Department Chair and that the application lacks evidence of the Department Chair's signature.

Based on one (1) of one (1) medical record reviewed (Medical Record #1) for a contraction stress test, review of facility policy, and staff interview, it was determined the facility failed to ensure the facility developed and implemented a policy and procedure for contraction stress tests.

Findings include:

Reference: Facility policy titled, "Induction and Augmentation of Labor", states, "... Policy: It is the policy of Hunterdon Medical Center to achieve a labor pattern that produces cervical dilation while ensuring fetal and maternal safety. I. Definitions: A. Induction - use of methods to begin labor in a woman who is not spontaneously laboring B. Augmentation - use of methods to restart or strengthen labor after it has begun C. Cervical Ripening - process of preparing the cervix for induction ..."

1. A review of Medical Record #1 revealed the following:

a. An obstetrician's (OB) "Unscheduled Admit Note" dated 2/23/21 at 1939, states, "HISTORY OF PRESENT ILLNESS: The patient is a 30-year-old gravida 2, para 0-0-1-0, sent from the office for induction of labor at 38 weeks 1 day of gestation for persistent decreased fetal movement. ... PLAN: 1. I discussed with the patient that the likelihood of fetal tolerance to labor is low, therefore I will not start cervical ripening but perform a contraction stress test with oxytocin. We will decide on cesarean delivery if the baby fails the stress test. ..."

b. An untimed OB physician's progress note dated 2/23/21, states, "... patient had a spontaneous ctx [contraction] at 12:16 pm with a decel down to the 90's for 2 min another ctx at 13:16 with a decel down to the 60's for - [sic] 4 min ... Findings discussed with patient. high possibility of fetal intolerance to labor [sic] will proceed with contraction stress test Consent for c/section obtained OR is open. Start oxytocin ..."

(i) An additional OB physician's progress note at 15:30 states, "... there is a low likelihood of baby tolerating labor and a higher chance of emergent c-section if we proceed with induction of labor. ..."

c. A review of Labor and Delivery nursing monitoring notes and the corresponding fetal monitoring strip from 2/23/21 revealed that pitocin was initiated at 14:05.

2. During an interview with Staff #3, Staff #4, Staff #5 and Staff #6, on 5/11/21 at 11:20 AM, Staff #3 stated that the facility does not do contraction stress testing and that he/she "would not stress test a baby with a decel [deceleration]".

3. Upon request on 5/11/21, the facility policy for induction of labor was provided and Staff #3 stated there was not a policy for contraction stress tests.

4. During an interview on 5/13/21 at 12:24 PM, Staff #36 stated that Patient #1 had been sent to the hospital from the physician's office for an induction of labor. Staff #36 stated Patient #1 did not have a favorable cervix for induction so a contraction stress test was performed to determine if the baby could tolerate labor. Staff #36 stated he/she did not initiate an induction of labor because the contraction stress was failed. Staff #36 stated a contraction test is clinical judgment and it is performed often.

5. During an interview on 5/13/21 at 2:13 PM, it was confirmed with Staff #2, Staff #3, and Staff #5, that the facility did not have a policy for contraction stress tests, that was separate from the induction of labor policy, to guide nursing practice.

Based on review of one (1) of one (1) Medical Record (#10), staff interview, review of facility policy and procedure, and facility documents, it was determined the facility failed to ensure implementation of it's policy and procedure for patients receiving continuous intravenous paralytic medications.

Findings include:

Reference: Facility policy titled, "Peripheral Nerve Stimulator" states, " ... Patients receiving paralytic medications will have their state of paralysis checked every 8 hours and one hour after any changes in the amount of medication being administered. ... The presence of 3 twitches in response to Train of Four stimulation indicates a reasonable level of neuromuscular blockade for most critically ill patients. This level of blockade is usually sufficient to achieve respiratory muscle relaxation and improved gas exchange."

1. On 5/13/21, during a tour of the Intensive Care Unit, Patient #10 was identified as a mechanically ventilated patient receiving a continuous infusion of Cisatricurium (Nimbex), a neuromuscular blocking agent.

a. Upon interview, Staff #29 stated a Train of Four (TOF) assessment is conducted every eight (8) hours and one (1) hour after a change in the amount of medication.

b. Review of Medical Record #10 indicated that on 5/9/21 at 1930 [7:30 PM] a change in rate occurred. The rate went from 3 mcg/kg/min to 4 mcg/kg/min. there was no reassessment documented one hour after the change in rate.

2. Review of Train of Four assessments revealed the following:

a. On 5/10/21 the last TOF assessment was at 5:30 AM, the next TOF assessment was documented at 8:00 PM, fourteen and a half (14 1/2) hours after the last assessment.

b. On 5/11/21 the last TOF assessment was at 6:00 AM, the next TOF assessment was documented on 5/12/21 at 9:00 PM. One (1) day and fifteen (15) hours after the last assessment.

3. The above findings were confirmed with Staff #5 and Staff #29 at the time of discovery.

A. Based on two (2) of (2) medical records reviewed (#1 and #2) and staff interview, it was determined the facility failed to ensure medical records were accurately written.

Findings include:

1. During an interview with the Neonatologist, Staff #13, on 5/12/21 at 10:45 AM, Staff #13 stated he/she felt the cesarean section was emergent because the fetal heart rate was dropping.

2. During an interview with the Anesthesiologist, Staff #16, on 5/12/21 at 12:01 PM, Staff #16 stated he/she considers all cesarean sections that are not scheduled, to be emergent.

3. During an interview with the obstetrician, Staff #36, on 5/13/21 at 12:24 PM, Staff #36 stated this was not an emergency cesarean section.

B. Based on two (2) of (2) medical records reviewed (#1 and #2), review of facility policy, and staff interview, it was determined the facility failed to ensure that non-emergent cesarean deliveries are accurately documented in the medical record.

Findings include:

Reference: Facility policy, Cesarean Section Emergency states, "... PROCEDURE: 1. When a physician makes a decision that an emergency cesarean section is needed, the physician notifies the Anesthesiologist and the Neonatologist/Pediatrician on call for Obstetrics. ..."

1. A review of Medical Record #1 revealed the following:

a. A progress note written by the obstetrician, on 2/23/21 at 15:30, states, "... We discussed that she is remote from delivery, unfavorable cervix, and there is a low likelihood of baby tolerating labor and a higher chance of emergent c-section if we proceed with induction of labor. Patient and husband agreed to have delivery via c-section. Oxytocin was stopped. FHR [fetal heart rate] is reassuring at present. Per anesthesia will proceed at 17:00 Since [sic] she ate at 11am. Will continue monitoring. Consent for procedure already discussed [and] signed. ..." The obstetrician note does not indicate that an emergent cesarean section was to be performed.

b. An "Anesthesia Record" dated 2/23/21 states, "... Surgical Procedure ... Emergency cs [cesarean section] ..." This was not different than the obstetrician note which does not indicate the cesarean section was to be performed emergently.

2. A review of Medical Record #2, the neonate, revealed a neonatology admission note dated 2/23/21, which states, "... HISTORY: ... delivered by primary cesarean (C) section for fetal intolerance of labor and nonreassuring fetal heart rate, under epidural anesthesia. ... MATERNAL HISTORY: ... At one point, there was a fetal intolerance deceleration, so she was taken for emergency cesarean section. ..." This was different than the obstetrician's note, which does not indicate the cesarean section was to be performed emergently.

3. During an interview with the Neonatologist, Staff #13, on 5/12/21 at 10:45 AM, Staff #13 stated he/she felt the cesarean section was emergent because the fetal heart rate was dropping.

4. During an interview with the Anesthesiologist, Staff #16, on 5/12/21 at 12:01 PM, Staff #16 stated he/she considers all cesarean sections that are not scheduled to be emergent.

5. During an interview with the Obstetrician, Staff #36, on 5/13/21 at 12:24 PM, Staff #36 stated that this was not an emergency cesarean section.

C. Based on review of one (1) of one (1) medical record of a neonate who received a blood transfusion (Medical Record #2), review of facility policy, and staff interview, it was determined the facility failed to ensure that an accurate medical record is maintained for all patients.

Findings include:

Reference: Facility policy Nursing Documentation Format, states, "... PROCEDURE: ... a. Documentation will reflect the nursing process- time specific assessment, interventions, outcome/evaluation of the patient's status. ..."

1. A review of Medical Record #2 revealed the following:

a. A neonatology consult note states, "... The blood transfusion was started at 9:06 PM, because it was originally planned to give this through the peripheral line over 3 hours. Because of the code acute situation, 42 milliliters of blood was pushed through the umbilical venous (UV) line in 40 minutes. ..."

b. The "BLOOD CLAIM SLIP & TRANSFUSION RECORD" indicates the blood was released from the Blood Bank on 2/23/21 at 20:38 PM and documented evidence on the form indicated the "Transfusion Start Date/Time" was "2/23/21 @ [at] 2030." The transfusion start time was documented as eight (8) minutes prior to the time the blood was released from the Blood Bank and 36 minutes prior to the time the neonatologist documented the blood transfusion was initiated.

(i) Documented evidence indicates that vital signs were obtained "15 mins [minutes] After Start" at 20:45. This was 21 minutes prior to the neonatologist documenting the transfusion was initiated.