HospitalInspections.org

Based on observation, interview and record review, the facility failed to ensure that the Condition of Participation for Surgical Services was met as evidenced by:

1. The facility failed to provide adequate and safe care of a patient with vaginal (an opening in a woman's body that goes back to her uterus [a pear-shaped organ in the reproductive system of people assigned female at birth ]) and uterine (uterus) packing inserted in the operating room (OR) for one (1) of thirty (30) sampled patients (Patient 1) as evidence by Labor and Delivery (L&D) Laborist (an obstetrician/gynecologist who specializes in caring for women in labor and delivering babies) 2 (OBGYN 2) did not verify all packings from the uterus and the vagina, were removed as indicated on the Operative and Procedure Report. (Refer to A 0951).


2. The facility failed to provide adequate and safe care of a patient with vaginal and uterine acking inserted in the OR for one (1) of thirty (30) sampled patients (Patient 1) by L&D nurse in the operating room (OR) did not complete the Patient 1's Orifice Packing Hand-Off Communication and Tracking Tool. The record did not indicated packing in the uterine. The record under Section III which addresses the packing removal, was blank with no date/time of removal indicated, no healthcare staff signature or date confirming removal of packing. (Refer to A 0951).

These systemic deficient practices resulted in the failure of the facility to deliver surgical services that safeguard the health of the patients.

Based on interview and record review the facility failed to provide adequate and safe care of a patient with vaginal (an opening in a woman's body that goes back to her uterus [a pear-shaped organ in the reproductive system of people assigned female at birth ]) and uterine (uterus) packing inserted in the operating room (OR) for one (1) of thirty (30) sampled patients (Patient 1)as evidence by:

1. Labor and Delivery (L&D) Laborist (an obstetrician/gynecologist who specializes in caring for women in labor and delivering babies) 2 (OBGYN 2) did not verify all packings from the uterus and the vagina, were removed as indicated on the Operative and Procedure Report.

2.. L&D nurse in the operating room (OR) did not complete the Patient 1's Orifice Packing Hand-Off Communication and Tracking Tool. The record did not indicated packing in the uterine. The record under Section III which addresses the packing removal, was blank with no date/time of removal indicated, no healthcare staff signature or date confirming removal of packing.

The deficient practice resulted to Patient 1 going to General Acute Care Hospital 2 (GACH 2) emergency department on 10/26/23 (20 days after discharged from GACH 1) due to pain with urination, foul odor from her vaginal and was diagnosed with endometritis and retained vaginal foreign body (gauze packing found in the vagina).

On 11/15/2023 at 4:10 p.m., an IJ was called for Surgical Services regarding facility's failure to provide adequate and safe care for Patient 1, who had vaginal(an opening in a woman's body that goes back to the uterus [a pear-shaped organ in the reproductive system of people assigned female at birth ]) packing and intrauterine (inside the uterus) in the presence of the Chief Nursing Officer (CNO), Quality Director (QD), Chief Operating Officer (COO), Interim Director of Regulatory, and Chief Medical Officer (CMO).

On 11/16/2023, at 2:35 p.m., the IJ was removed in the presence of CNO, CMO, QD, COO, Interim Director of Regulatory ad Director of Patient Safety and Risk management. The surveyors onsite verified, the implementation of the facility's IJ removal plan.

The facility's IJ removal plan was as follows:

1. The attached form "Uterine and/or Vaginal Packing Hand-off Communication and Tracking Tool" has been revised to include:

a. Verification that packing pieces are intact.

b. Dual signature verification by the physician and Labor & Delivery (L&D) RN of insertion and removal packing.

c. Ultrasound verification that all packing has been removed.

2. Once the packing has been removed and the quantity verified, the physician will verify by ultrasound imagining that all packing has been removed.

3. A Labor and Delivery (L&D) nurse must be present when uterine and/or vaginal packing is removed by the physician.

4. An L&D nurse will visually assess vaginal and/or uterine packing and document in the medical record every shift.

5. OB (OB, a field of medicine dealing with the care women and their children during pregnancy, childbirth, and postnatal periods) physicians and OB staff members will be educated on:

a. The use and process for the form "Uterine and/or Vaginal Packing Hand-off Communication and Tracking Tool."

b. The need for signature verification of insertion and removal packing pieces.

c. The presence of an L&D nurse when packing is removed.

d. Verification and documentation that all packing pieces were removed via ultrasound (machine use high frequency sound waves that makes images so that organs inside the body can be examined).

Findings:

A review of Patient 1's "Face Sheet'' print date/time 10/03/2023, indicated Patient 1 was admitted to the GACH 1's obstetrics (OB - a field of medicine dealing with the care women and their children during pregnancy, childbirth, and postnatal periods) unit for 39 weeks pregnant rule out labor on 10/02/23 at 12:15 P.M.

A review of Patient 1's History and Physical dated 10/2/2023, indicated that Patient 1 was G 2 P 1 (Gravida 2 Para 1; 2 pregnancies but only 1 survived to gestational age of 20 weeks or more and or is still pregnant) at 39 weeks, presenting with chief complaint as "Contractions since 6 a.m." Laborist 1 (OBGYN 1) assessed and noted that Patient 1 was presenting with regular contractions every eight (8) minutes, positive fetal movement with baseline at 145 beats per minute (BPM), and category 1 (a normal fetal heart rate tracing during labor is between 110 BPM to 160 BPM).

During a concurrent interview with the L&D Manager (LDM) and record review of Patient 1's Operative and Procedure Reports, dated 10/2/2023, on 11/15/2023, at 9:18 A.M., LMD stated Patient 1 had no prenatal history and OBGYN 1 scheduled Patient 1 for a Cesarean Section (c-section or cesarean birth; a surgical delivery of a baby through an incision made in the mother's abdomen and uterus) due to high risk of uterine rapture (a life threatening complication common in people who have had a c-section where the uterine walls tear open.) Patient 1's c-section was uneventful however Patient 1 was found to have placenta accreta (a condition where placenta grows into the uterine wall during pregnancy posing a major risk of severe vaginal bleeding after delivery). Patient 1 was stabilized and sent to recovery.

1. During an interview with OBGYN 1 and Chief Medical Officer (CMO), on 11/13/2023 at 3:45 P.M., OBGYN 1 stated Patient 1's continued bleeding post c-section and was taken back to L&D Operating Room (OR) for Dilation and Curettage (D&C, a procedure to remove tissue from inside your uterus). OBGYN 1 proceeded to pack both the uterus and the vagina with gauze packing to control the bleeding before transferring Patient 1 to Intensive Care Unit (ICU) due to consumption coagulopathy (also known as Disseminated Intravascular Coagulation (DIC, a life-threatening condition where blood is prevented from clotting normally). OBGYN 1 added that Patient 1 was given two (2) cranberry wrist bands to indicate two (2) orifice gauze packings, with orders remove packing after 48 hours.

During a concurrent interview LDM and record review of Patient 1's the Operative and Procedure Reports, dated 10/2/2023, on 11/15/2023, at 9:18 A.M., LMD confirmed OBGYN 1 noted full length of vaginal packing was used, one placed in the uterus and another in the vagina to apply pressure and control bleeding. LDM also added, during L&D morning rounds, on 10/4/2023, Patient 1's packing removal was discussed with Laborist 2 (OBGYN 2), who stated they would remove the packing but declined the suggested help of an L&D RN, who are competent in the orifice packing removal procedure.

During an interview with OBGYN 1 and CMO, on 11/13/2023 at 3:45 P.M., CMO stated there is no facility policy or procedure on removal of orifice packing but in practice, orifice packing was removed by a physician and refence to the "Packing Hand-off Communication and Tracking Tool," was done to reconcile the count in presence of a L&D RN.

During an interview with OBGYN 2 and CMO, on 11/14/2023 at 10:33 A.M., OBGYN 2 stated Patient 1's gauze packing was removed in the ICU after pelvic ultrasound (a diagnostic exam that produces images used to assess organs and structures within the female pelvis) confirmation of its presence and location on post-op day 2 as ordered. OBGYN 2 added, the main concern was Patient 1 was no longer bleeding and upon removal of gauze packing, OBGYN 2 was called away for an emergency. OBGYN 2 remembered coming back to assess Patient 1 later that day, but OBGYN 2 did not visually check nor order any radiography studies to confirm all the orifice packing was removed.

2. A review of Patient 1's "Orifice Packing Hand-Off Communication and Tracking Tool" (a facility tracking tool used to enhance communication among care providers when there is orifice packing in place to assist in the prevention of retained packing), indicates that two (2) radiopaque gauze bandage packing placed in obstetrical operating room in vagina on 10/3/2023 at 12:15 A.M., signed and acknowledged by L&D Registered Nurse (RN) who placed 2 cranberry armbands and receiving intensive care unit (ICU, unit for critically ill patients) RN on 10/3/2023 at 1:30 A.M. The record indicated, under Section 1: "Placement of Packing Material," the site of orifice packing mark was, "Vagina." The record did not indicated packing in the uterine. The record under Section III which addresses the packing removal, was blank with no date/time of removal indicated, no healthcare staff signature or date confirming removal of packing.

During an interview with LDM , on 11/13/2023 at 12:40 p.m., LDM stated facility's orifice packing policy, staff must give cranberry wrist bands for packing. LDM stated the patient will have the same number of cranberry wrist bands as packing inserted for staff know how much packing was place inside a patient. LDM stated Patient 1 had vaginal and uterine packaging and had two (2) cranberry wrist band place during intra-operative (during surgery). LDM stated Patient 1 was transferred to ICU during night shift and on the day shift (7 a.m. to 7 p.m. shift), Patient 1 had bands on (two cranberry bands, two packing [vaginal and uterine]).

During an interview with OBGYN 2, on 11/14/2023 at 10:30 a.m., OBGYN 2 was called away for an emergency after removing Patient 1's packings (vaginal and uterine. OBGYN 2 remembered coming back to assess Patient 1 later that day, but OBGYN 2 did not visually check nor order any radiography studies to confirm all the orifice packing was removed. OBGYN 2 stated not being aware of the form (Orifice Packing Hand-Off Communication and Tracking Tool) being used and did not know if it (the form, Orifice Packing Hand-Off Communication and Tracking Tool) was a physician's responsibility to fill/complete.

During an interview with facility Quality Director, Interim Director of Regulatory, Chief Nursing Officer, Chief Medical Officer, and Director of Patient Safety and Risk Management, on 11/16/2023 at 9:05 a.m., and concurrent record review of Patient1's Orifice Packing Hand-Off Communication and Tracking Tool, dated 10/3/2023, all verified Patient 1's Orifice Packing Hand-Off Communication and Tracking Tool under Section 1: "Placement of Packing Material," the site of orifice packing mark was, "Vagina." The record did not indicated packing in the uterine. The record under Section III which addresses the packing removal, was blank with no date/time of removal indicated, no healthcare staff signature or date confirming removal of packing.

A review of Patient 1's GACH 2 Emergency Provider Report dated 10/26/2023, Emergency Medical Doctor (EMD) noted Patient 1 come in with complaint of pain with walking and urination, and vaginal discharge with foul smell. EMD noted a large amount of foul purulent discharge and removed several feet of packing gauze from Patient 1's vaginal canal. Patient 1's genital culture tested positive for Escherichia coli (E. Coli - a type of bacteria). EMD ordered antibiotics (medicine to fight infections caused by bacteria) and transferred Patient 1 to a higher level of care GACH under the care of an OBGYN with clinical diagnosis of endometritis (an irritation of the lining of the uterus due to infection) and retained vaginal foreign body.

A review of the facility's Administrative Procedure titled Prevention of Retained Surgical Items (PRSI), effective 3/21/2023, indicates intra-operative orifice packing is usually used in the setting of hemorrhage. The packing is removed in the post-operative period when the patient has left the OR. Only radiopaque gauze packing material was used. A provider places the radiopaque packing, writes an order providing instruction on management of the packing and its removal. The type, amount and location of the packing was documented by the RN circulator on the Packing Hand-off Communication and Tracking Tool or the designated post-operative care management plan in the Electronic Medical Record (EMR). RN Circulator places a cranberry "packing" armband on the patient, performs a verbal handoff to post procedure RN caring for the patient, includes the packing information in that handoff.