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Based on interview, record review and policy review the hospital failed to ensure that:
- There were clear policies and procedures that outlined staff responsibility for informing, retrieving, and documenting Advance Directive (AD, a legal document where the patient can direct their medical care wishes should the patient become unable to make their own decisions) information for three current patients (#6, #23 and #24) of 14 current patients, and three discharged patients (#28, #31 and #32) of three discharged patient records reviewed for AD's. (A-0132)
- Physicians responsible for the care of the patient renewed an order for four point restraints (medical cuffs applied to both arms and both legs to prevent someone form causing harm to themselves or others) according to hospital policy, for two discharged patients (#35 and #36) of two discharged patients reviewed. (A-0171)
- Staff followed their policy and completed a face-to-face assessment within one hour after four-point restraints (medical cuffs applied to both arms and both legs to prevent someone form causing harm to themselves or others) were placed on two discharged Emergency Department (ED) patients (#35 and #36), of two discharged ED patients reviewed for restraints. (A-0178)

These deficient practices resulted in the hospital's non-compliance with specific requirements found under 42 CFR 482.13 Condition of Participation: Patient's Rights. The hospital census was 16.

Based on interview, record review and policy review, the hospital failed to follow their own policies and procedures that outlined staff roles for informing, retrieving, assisting with formulation, and documenting Advance Directive (AD, a legal document where the patient can direct their medical care wishes should the patient become unable to make their own decisions) information for three current patients (#6, #23 and #24) of 14 current patients, and three discharged patients (#28, #31 and #32) of three discharged patient records reviewed for AD. These failures had the potential to affect all patients who presented to the hospital seeking care. The hospital census was 16.

Findings included:

1. Review of the undated hospital document given to patients upon admission titled, "Patient Guide (information pamphlet given to patients on admission)," showed that one of the most important decisions you can make about your care is to fill out an AD in case you can no longer make medical decisions for yourself. AD's are documents that let others know your wishes about the type of medical care you want. They will only be used if you become unconscious or too ill to communicate yourself. Check with your admissions department or nurse if you have questions.

Review of the hospitals policy titled, "Advance Directives," dated 12/2021, showed the following:
- The AD would provide a clear and convincing chart record of an individual's wishes regarding the use of life-prolonging procedure or treatment choices through a living will, durable power of attorney (DPOA, a legal document that lets a person name someone else to make decisions about their health care in case they were not able to make those decisions themselves), or health care directive.
- At the time of admission as a hospital inpatient, outpatient, or resident of a skilled nursing facility, the individual will be provided with written information (Patient Guide) concerning their rights under state law, both statutory and case law, to make decisions concerning such medical care, including the right to accept or refuse medical or surgical treatment, and the right to formulate AD's.
- There shall be documentation in the individual's medical record on the patient admission assessment form, whether the individual had executed any ADs. Copies shall be made a permanent part of the individual's medical record.
- AD's include a living will, DPOA, health care directives, any other written documentation executed by the individual, signed and dated that expresses the individual's health care treatment decisions, and an oral statement made by the patient, documented in the medical records.
- In the event that an individual does not have an AD, but would like information, hospital staff may provide the patient a copy of Center for Practical Bioethics, "Caring Conversations."
- If an individual is being readmitted as inpatient, and has previously provided copies of AD's, they shall apply as a valid document after being verified by the individual.
- The nurse may request a copy of a previous AD's from the patient's past chart by contacting the Medical Records Department or reviewing electronic documents. It will be provided as AD documentation for the current chart after it has been verified as current by the patient or family. If previous documentation is not available, the family will be contacted in an attempt to obtain the directive. Attempts to obtain AD's will be documented in the chart. Resources for assistance are spiritual care and case management; however the nurse providing the care for the patient is responsible to ensure AD's are on the chart.
- Any oral AD's given to personnel other than the attending physician shall be documented in the individual's medical record, and the attending physician notified.
- Any employee who knowingly fails to comply with an individual's AD or revocation that is in the patient's medical record, or has actual knowledge to the existence of the document, shall be subject to existing hospital disciplinary actions.

Review of Patient #6's medical record showed the following:
- He was an 83 year old male admitted to the hospital on 10/02/22 for respiratory failure (condition in which not enough oxygen passes from the lungs into the blood) secondary to pneumonia (infection in the lungs), and sepsis (life threatening condition when the body's response to infection injures its own tissues and organs).
- Patient Demographic Information dated 10/02/22, showed that Patient #6 did not have an AD.
- Physician documentation on 10/02/22 at 11:42 PM, showed that Patient #6 had a DPOA with a name and phone number listed.
- Nursing documentation on 10/03/22 at 1:58 PM, showed that Patient #6 did not have a DPOA.
-The family did not receive information about ADs.

During an interview on 10/03/22 at 1:50 PM, Patient #6 and his family stated that no one had talked with them about a DPOA, or asked them if Patient #6 had a DPOA. Family did not know what a DPOA was or how to get one. Patient #6's daughter-in-law asked for information on a DPOA, and stated that they would really like information about a DPOA.

During an interview on 10/03/22 at 3:00 PM, Staff O, Registered Nurse (RN), stated that the physicians often asked the patient who their emergency contact was and then documented them in the history and physical as the DPOA. She did not know why the physicians did that, and an emergency contact should not be documented as a DPOA.

Review of Patient #24's medical record showed the following:
- He was an 83 year old male admitted to the hospital on 10/03/22, after presenting to the ED via Emergency Medical Services (EMS) from a skilled nursing facility after a fall. The patient was cognitively impaired.
- The SNF did send a copy of the DPOA to the ED.
- Patient Demographic Information showed that it was unknown if Patient #24 had an AD.
- ED nursing documentation on 10/03/22 at 4:22 PM, showed the patient was a "no code" under AD.
- A patient preferences for life sustaining treatment form (nurse checklist to ask about Advance Directives) dated 10/03/22 at 9:30 PM, showed that Patient #24's DPOA was his son.
- Physician documentation on 10/03/22, showed that Patient #24's son was the DPOA.
- Staff X, Case manager, documented on 10/04/22, Patient #24's son was his DPOA, and she requested paperwork be brought in to the hospital. The son told Staff X that he did not have the paperwork, but his mother was also the DPOA and she could get the paperwork. Staff X called Patient #24's wife who told her that the paperwork had been brought in the previous month when he was in the hospital, and it should be on file.

During an interview on 10/04/22 at 9:40 AM, Staff X, Case Manager, stated that Patient #24 had a guardian (a person appointed by a judge to take care of and manage the property and rights of a person who is considered incapable of administering his or her own affairs). A DPOA and a guardian were the same thing. There was no paperwork in the medical record indicating there was a DPOA or a guardian, but the son would be bringing in the paperwork. She did remember the son bringing the paperwork before, but she was not able to look into the scanned documents and did not have access to them in the medical record. When she saw a patient had a DPOA that meant the patient had a guardian, and any other case manager would think the same thing.

During an interview on 10/04/22 at 4:15 PM, Patient #23, stated that staff did not ask her if she had a DPOA or an AD and she was not given information about AD's. She did request information regarding a DPOA.

During an interview on 10/04/22 at 10:30 AM, Staff V, Chief Quality Officer (CQO), stated that a guardian and a DPOA were the same thing.

During an interview on 10/04/22 at 12:23 PM, Staff AA, Director of Case Management, stated that DPOA's and guardians were not the same thing and she would expect case management to know the difference.

During an interview on 10/04/22 at 10:25 AM, Staff Z, RN, stated that a DPOA and a guardian were not the same thing, a DPOA only went into effect if the patient was not able to make decisions. All staff were responsible for obtaining DPOA information, nursing staff would document a DPOA or guardian under the observation tab in the medical record.

During an interview on 10/05/22 at 9:50 AM, Staff JJ, Health Information Director, stated that there was no paperwork on file for Patient #24 having either a guardian or a DPOA. When they received DPOA or any AD paperwork they scanned it into the medical record and saved it so it would be readily available upon future admissions. Patients did not need to bring a new copy of AD paperwork upon each hospital admission, unless there were changes made to the paperwork.

Review of Patient #32's medical record showed the following:
- She was a 64 year old female admitted to the hospital on 04/02/22 from Hospital B for sepsis (life threatening condition when the body's response to infection injures its own tissues and organs), altered mental status (mental functioning ranging from slight confusion to coma) and low blood pressure.
- Patient Demographic Information showed that it was unknown if Patient #32 had an AD.
- Referral information from Hospital B showed that Patient #32 had an AD, which was included.
- On 04/03/22 at 9:27 AM, the Case Manager documented that she contacted Patient #32's DPOA due to the patient's cognition to discuss the discharge plan.
- On 04/04/22 at 9:45 AM, a transfusion of blood and blood components consent form indicated that Patient #32 gave verbal consent for blood or blood products.
- On 04/04/22 at 11:52 AM, a consent form for surgery indicated that Patient #32 gave verbal consent to surgery as she was unable to sign the form.
- On 04/15/22 at 2:24 PM, a Case Manager documented that she continued to be in contact with Patient #32's DPOA to discuss the discharge plan and placement back to the skilled nursing facility.

During an interview on 10/05/22 at 9:50 AM, Staff JJ, Health Information Director, stated that there was no DPOA paperwork on file for Patient #32. Health information staff did scan in patient DPOA's, when they received them. DPOA's were easy to find in the medical record and all staff had access to see them in the medical record.

Review of Patient #28's medical record showed the following:
- Patient #28 was a 70 year old female who presented to the Emergency Department (ED) on 08/07/22 via Emergency Medical Services (EMS, emergency response personnel, such as paramedics, first responders, etc.) with a chief complaint of ankle pain.
- Patient #28 was admitted to the hospital on 08/07/22. ED nursing documentation showed that when Patient #28 was admitted to the hospital, family was with her. No specific family member that was present on admission was identified in the documentation.
- The patient preferences for life sustaining treatment form, dated 08/07/22, showed that Patient #28 listed her first cousin as her DPOA. There was no contact information obtained for the DPOA.
- The hospital had no record of asking for Patient #28's DPOA paperwork to be given to them.
- Staff HH, Case Manager, documented on 08/09/22 that she was unable to reach Patient #28's family but left a message.
- Staff X, Case Manager, documented on 08/13/22, that she had made numerous attempts to call Patient #28's daughter, but all previous calls were to a non-working number. Patient #28 was cleared for discharge and accepted to another hospital for continuation of care. Patient #28's daughter called the hospital and Staff X updated her on Patient 28's discharge plan.
- There was no documentation that the person named by Patient #28 as her DPOA was ever contacted or that staff inquired about her contact information, even though the patient named her as the DPOA.

During an interview on 10/05/22 at 10:07 AM, Staff HH, Case Manager, stated that case managers asked patients if they had a DPOA or guardian. They used the emergency contact on the patient's face sheet (a one-page summary of important information about a patient) if the patient was unable to state whether or not they had a DPOA or guardian or if there was no contact information for the DPOA or guardian. The only emergency contact information the hospital had for Patient #28 was for her daughter. There was no contact information for a DPOA for Patient #28.

During an interview on 10/05/22 at 10:40 AM, Staff X, Case Manager, stated that when Patient #28 was admitted, Staff X tried to call Patient #28's daughter and left several messages for her. Patient #28's daughter called the hospital to get an update on how Patient #28 was doing, and Staff X was able to talk with her and asked if Patient #28 had a DPOA. Patient #28's daughter told Staff X that Patient #28 did not have any DPOA paperwork, Patient #28 would make her own decisions, and that Patient #28's daughter would make decisions if Patient #28 became incapacitated.

During an interview on 10/05/22 at 9:50 AM, Staff JJ, Health Information Director, stated that there was no DPOA or AD paperwork on file for Patient #28

Review of Patient #31's medical record showed the following:
- She was a 93 year old female admitted to the hospital on 09/17/22 from a skilled nursing facility for abdominal pain.
- Past medical history included Alzheimer's dementia (a chronic brain disorder characterized by gradual loss of memory, decline in intellectual ability and deterioration in personality).
- A copy of the DPOA paperwork was dated 01/11/19, and provided the DPOA information.
- The patient preferences for life sustaining treatment form was completed on 09/17/22 at 10:45 PM, the section for further information or who to contact on behalf of the patient was left blank next to the DPOA, guardian and living will.
- Admission information showed unknown for AD's.

During an interview on 10/04/22 at 10:05 AM, Staff Y, Administrative Assistant, stated that it was the responsibility of nursing staff to ask and obtain information regarding AD's from patients.

During an interview on 10/03/22 at 1:50 PM, Staff N, RN, stated that the admission department was responsible for obtaining AD information from patients, and they were also responsible for providing the information to patients regarding an AD.

During an interview on 10/03/22 at 3:20 PM, Staff P, Registrar, stated that admission staff did ask patients if they had an AD or DPOA, but they did not discuss with patients what a DPOA was or explain what an AD was.

During an interview on 10/04/22 at 9:15 AM, Staff X, Case Manager, stated that admission staff were responsible for searching through the medical record for an AD, and were to let nursing staff know that the patient had an AD on file.

During an interview on 10/05/22 at 3:10 PM, Staff D, Chief Nursing Officer, CNO, stated that it was the responsibility of all staff to obtain DPOA information. Nursing staff did not have access to scanned and saved files in the patient's medical record and that was an issue because they were not able to see saved AD information from previous hospitalizations.




46856

Based on interview, record review, and policy review the hospital failed to ensure that the physician responsible for the care of the patient renewed an order for four point restraints (medical cuffs applied to both arms and both legs to prevent someone form causing harm to themselves or others) according to hospital policy, for two discharged patients (#35 and #36) of two discharged patients reviewed with restraints. This failure had the potential to cause poor outcomes for all patients placed in restraints. The hospital census was 16.

Findings included:

1. Review of the hospital's policy titled, "Restraint and Seclusion," revised 07/2021, showed the following:
- Physicians with a working knowledge of hospital policy, are authorized to order a restraint.
- Orders should be for each use of the restraints and related to a specific episode of the patient's behavior and not for an unspecified future time or episode.
- In emergency application situation, a registered nurse (RN) who has documented restraint and seclusion competency may initiate the application of restraint or seclusion prior to obtaining an order from a physician. In this event the order must be obtained either during the emergency application of the restraint or seclusion or immediately (within a few minutes) after the restraint or seclusion has been applied.
- Orders for restraint or seclusion used for the management of violent or self-destructive behavior that jeopardized the immediate physical safety of the patient or staff member may be renewed in accordance with the following limits for up to a total of 24 hours- every four hours for adults 18 years and older, and every two hours for children and adolescents nine to 17 years old.
- As the time frame is about to expire (four hours for adults 18 years and older, two hours for children nine to 17 years old), the RN must contact the physician, report the results of the latest assessment and request that the order be renewed, not to exceed the required time limits. The physician may determine if an onsite assessment is required in conjunction with the RN who is over-seeing the care of the patient.

Review of Patient #35's medical record showed the following:
- She was a 16 year old female who presented to the ED via private vehicle on 09/24/22 with complaints of suicidal ideation (SI, thoughts of causing one's own death).
- On 09/25/22 at 2:15 PM, there was a physician's telephone order for Patient #35 to be placed in four point restraints for being a danger to herself and others, signed by the physician on 09/22/22 at 2:10 PM, and would require a new physician order after two hours.
- Nursing documentation showed Patient #35 remained in four point restraints from 2:30 PM until 7:30 PM, when she was released from bilateral leg restraints, but remained in bilateral arm restraints until 9:15 PM (requiring another physician order at 8:30 PM).
- There were no additional physician orders for four point restraints, and no physician documentation in the medical record indicating a physician had seen Patient #35 for the date of 09/25/22.

Review of Patient #36's medical record showed the following:
- He was a 20 year old male who presented to the ED via ambulance on 09/05/22, after being found in a stairwell acting bizarre and aggressive.
- Physician orders for four point restraints for being a danger to himself and others, were obtained at 9:05 AM, 12:45 PM and 5:00 PM (four hours and fifteen minutes after the previous order).
- Restraint and seclusion observation records showed that Patient #36 was placed in four point restraints on 09/05/22 at 9:05 AM, and was taken out of four point restraints at 6:30 PM.

During an interview on 10/05/22 at 3:00 PM, Staff V, Chief Quality Officer (CQO), stated that an order for four point restraints were to be renewed every four hours for adults, and every two hours for children nine to 17 years of age.

During an interview on 10/05/22 at 3:10 PM, Staff D, Chief Nursing Officer (CNO), stated that there should have been three physician orders for restraints for Patient #35.

Based on interview, record review and policy review the hospital failed to follow their policy and complete a face-to-face assessment within one hour after four-point restraints (medical cuffs applied to both arms and both legs to prevent someone form causing harm to themselves or others) were placed on two discharged Emergency Department (ED) patients (#35 and #36), of two discharged ED patient reviewed. This had the potential to affect all patients when restraint or seclusion were used. The hospital census was 16.

Findings included:

1. Review of the hospital policy titled, "Restraint and Seclusion," revised 07/2021, showed that a physician must perform an in person, face-to-face assessment within one hour of the initiation of restraint or seclusion used for violent or self-destructive behavior, even if the restraint or seclusion is discontinued in less than one hour. A telephone call or telemedicine methodology is not permitted when completing the face-to-face assessment of the patient. The in person evaluation must include an evaluation of the patient's immediate situation, the patient's reaction to the intervention, the patient's medical and behavioral condition, a review of systems, a review and assessment of the patient's history, drugs and medications, most recent lab and other diagnostic test results, and the need to continue or terminate the restraint or seclusion.

Review of Patient #35's medical record showed the following:
- She was a 16 year old female who presented to the ED via private vehicle on 09/24/22 with complaints of suicidal ideation (SI, thoughts of causing one's own death).
- On 09/25/22 at 2:15 PM, there was a physician's telephone order for Patient #35 to be placed in four point restraints for being a danger to herself and others.
- There was no physician documentation within one hour of the patient being placed in violent restraints indicating it was a one hour face-to-face that included the patient's immediate situation, the patient's reaction to the intervention, the patients history, drugs and medications, most recent lab or other diagnostic test results, or the need to continue or terminate the restraint.
- There was no physician documentation in Patient #35's medical record for the date of 09/25/22.

Review of Patient #36's medical record showed the following:
- He was a 20 year old male who presented to the ED via ambulance on 09/05/22, after being found in a stairwell acting bizarre and aggressive.
- On 09/05/22 at 9:05 AM, 12:45 PM and 5:00 PM, there were physician orders for the patient to be placed in four point restraints for being a danger to himself or others. He was released from four point restraints at 6:30 PM.
- On 09/05/22 at 11:20 PM, there was a physician order for Patient #36 to be placed back into four point restraints.
- On 09/05/22, nursing documentation showed that Patient #36 was placed in four point restraints from 11:20 PM until 12:10 AM.
- There was no physician documentation within one hour of the patient being placed in four point restraints, for either incident, indicating it was a one hour face-to-face, that included the patient's immediate situation, the patient's reaction to the intervention, the patients history, drugs and medications, most recent lab or other diagnostic test results, or the need to continue or terminate the restraint.

During an interview on 10/05/22 at 3:00 PM, Staff V, Chief Quality Officer (CQO), stated that there was no one hour face-to-face documented for Patient #35, and there should have been.

During an interview on 10/05/22 at 3:10 PM, Staff D, Chief Nursing Officer, (CNO), stated that there was no one hour face-to-face documented for Patient #36, and there should have been.

Based on observation, interview, record review, and policy review, the hospital failed to:
- Adequately implement, monitor and enforce action plans after a sentinel event of a retained surgical instrument in one discharged patient (#33). (A-0951)
- Ensure staff counted instruments correctly during surgical procedures according to hospital policy for one current patient (#34) of eight current patient medical records reviewed and three discharged patients (#30, #31 and #33) of six discharged patient medical records reviewed. (A-0951)
- Ensure a current roster listing each practitioner's specific surgical privileges and restricted surgical privileges was available in the surgical suite and the area where the scheduling of surgical procedures was done. (A-0945)

The cumulative effect of these failures resulted in non-compliance with 42 CFR 482.51 Condition of Participation: Surgical Services. The hospital performed approximately 245 surgeries per month. The hospital census was 16.

Based on observation, interview, record review and policy review, the hospital failed to ensure a current roster listing each practitioner's specific surgical privileges and restricted surgical privileges was available in the surgical suite and the area where surgical procedures were scheduled. This failed practice had the potential to compromise the safety and health of all patients undergoing surgical procedures if these procedures were performed by physicians without surgical privileges or restricted privileges. The hospital performed approximately 245 surgeries per month. The hospital census was 16.

Findings included:

1. Review of the hospital's policy titled, "Surgical Privileges," dated 01/2022, showed the purpose of surgical privileges as to advise and acquaint nursing personnel, in the surgical services department, of surgeons who have been authorized to perform procedures and to identify their subspecialties. The unit director will verify the Surgeon's Privilege list is up to date and available for reference.

Observation on 10/03/22 at 1:45 PM, in the Surgical Services scheduling area showed no roster listing each practitioner's specific surgical privileges and restricted privileges.

During an interview on 10/03/22 at 2:15 PM, Staff II, Surgical Services Registered Nurse (RN), stated that she was unsure how to find a surgeon's surgical privileges, and there was no list of the physicians' surgical privileges in the surgical suites.

During an interview on 10/04/22 at 12:30 PM, Staff CC, Surgical Services RN, stated that she was not aware of how to access surgeons' surgical privileges online, and that there was no paper list available in the surgical suites.

During an interview on 10/04/22 at 1:45 PM, Staff A, Surgical Services Director, stated that there was a site on the hospital's intranet homepage that staff could access physician privileges, but it was not functioning.

Based on observation, interview, record review, and policy review, the hospital failed to adequately implement, monitor and enforce action plans (Did not revise count sheet, did not revise the policy "Count Policy: Prevention of Retained surgical items" and did not finalize what high risk patients would receive an automatic x-ray) after a sentinel event of a retained surgical instrument in one discharged patient (#33), and ensure staff counted instruments correctly during surgical procedures according to hospital policy for one current patient (#34) of eight current patient medical records reviewed and three discharged patients (#30, #31 and #33) of six discharged patient medical records reviewed. These failed practices had the potential to compromise the safety and health of all patients undergoing surgical procedures at the hospital. The hospital performed approximately 245 surgeries per month. The hospital census was 16.

Findings included:

1. Review of the hospital's policy titled, "Count Policy: Prevention of Retained Surgical Items," dated 04/2018, showed that:
- The Registered Nurse (RN) Circulator (role performed by a registered nurse who ensures the patient's safety during all phases of a surgical procedure) and the scrub person will perform initial count of sponges and sharps (a term used for devices with sharp points or edges that can puncture or cut the skin) before the start of the procedure.
- A count should be performed by the RN Circulator and scrub person when new sponges or sharps were added to the operative field.
- A count should be performed by the RN Circulator and scrub person when wound closure begins.
- Instruments were to be counted on all procedures in which a cavity (thorax, abdomen, and organs) were entered.
- A count should be performed by the RN Circulator and scrub person at skin closure.
- A count sheet or a count board that was visible to all team members was to be used.
- The RN Circulator had the primary responsibility for accurately accounting for items placed on the sterile field.
- The scrub person had the primary responsibility for accounting for items used during the procedure in the surgical wound and the immediate surgical field and tables.
- The surgeon and assistants were responsible for items placed inside a surgical wound.
- When wound closure begins, the surgeon will remove items not needed for closure or completion of the procedure and will visually and manually examine the operative site.
- The total number of individual parts of an instrument were accounted for in the count.
- The RN Circulator reports the results of the surgical counts to the surgical team.
- Each level of count will be documented as it pertains to the procedure, baseline, closure of a cavity, closure of the procedure site, and skin closure.
- If a surgical count was incorrect an X-Ray will be obtained to rule out any retained surgical item.

Review of the hospital's policy titled, "Safety," dated 01/2022, showed that the policy provided safety steps for department employees to decrease the chance of patient injury. The circulating and scrub nurse/technician will account for all sponges, instruments, needles and sharps before the surgery begins, when items are added to the field, when a cavity is closed and at the time of skin closure with Surgicount system (machine that counts surgical sponges) in addition to manual counts. The circulating nurse will document on the operative record the outcome of all final counts.

Review of the hospital's document titled, "Situation, Background, Assessment, Recommendation (SBAR, a tool used to provide a framework for communication between members of the health care team) Safety Alert: Retained Surgical Instrument," dated 09/07/22, showed that one of the recommendations to prevent the incident from reoccurring, was the surgical count sheet had been revised to include a "working" count column prior to the final count column.

Review of discharged Patient #33's medical record showed that she was a 26 year old female that presented to the ED by ambulance on 08/11/22 for complaints of abdominal pain and shortness of breath. Because she was 21 weeks pregnant she was taken directly to the Obstetrical Unit (OB, the unit dedicated to childbirth and caring for and treating women in or in connection with childbirth). She was placed on tocometry (a machine that measured and recorded uterine contractions) to evaluate her for preterm labor. No uterine contractions were measured so she was transferred to the ED for evaluation of her shortness of breath. In the ED she had a computed tomography (CT, a combination of x-rays and a computer to create pictures of organs, bones, and other tissues, which shows more detail than a regular x-ray) of the abdomen and an ultrasound (a test that uses sound waves to create images of structures within the body). The CT showed an abnormal collection of blood in the abdomen. The ultrasound showed a live fetus with a normal heart rate. Because she was in hemorrhagic shock (a condition of reduced tissue perfusion due to inadequate delivery of oxygenated blood) and hypotensive (low blood pressure) she was taken to surgery for an exploratory laparotomy (surgery to open up the belly area to find the cause of bleeding or pain). A uterine rupture (spontaneous tearing of the uterus) was identified and repaired. The fetus was no longer viable and was delivered via Cesarean Section (removing a baby through a surgical incision). The hospital's document titled, "Surgical Count Sheet," dated 08/11/22, showed an initial count and second count of instruments. There was no final count of instruments documented. She was an inpatient for six days after surgery, and then discharged to her home. On 08/26/22, she returned to the ED with complaints of abdominal pain. A CT of her abdomen was obtained which showed the presence of a retained foreign body which appeared to be a surgical instrument. Staff BB, General Surgeon, evaluated her in the ED and scheduled her for surgery to remove the retained surgical instrument. She called the next day to inform Staff BB that she had changed her mind and was going elsewhere for treatment.

Review of discharged Patient #33's medical record from Hospital B showed that she presented to the hospital requesting removal of a retained foreign body from her abdomen. She had surgery at Hospital B on 08/27/22, during the surgery a three inch wide malleable retractor (a bendable retractor used to protect tissue or organs while closing an incision) was removed from her abdominal cavity. An X-Ray during the surgery showed no evidence of any other retained foreign bodies. On 08/31/22 her pain was tolerable with oral pain medications, she was walking, her bowels were working, and she was able to eat and drink without nausea or vomiting, so she was discharged to her home.

During an interview on 10/04/22 at 12:30 PM, Staff CC, RN Circulator, stated that:
- She was called in for an emergency exploratory laparotomy on 08/11/22, for Patient #33.
- When she arrived at the hospital, she set up the operating room for the surgery and completed an initial count of sponges, needles, and instruments with the scrub person.
- All surgical retractors were grouped together on the count sheet and were counted as a group instead of being counted individually by name.
- If an instrument was being used and placed in the abdomen it was up to the surgeon and scrub person to keep track of it.
- The surgery was stressful because the patient was losing a lot of blood and was 21 weeks pregnant. Staff CC had to leave the OR many times during the procedure to retrieve instruments needed for the surgery.
- She did not think of getting an X-Ray at the time but now looking back she thought it would have been a good idea.
- After this incident the surgery department had added a third instrument count.

During an interview on 10/04/22 at 1:00 PM, Staff DD, Surgical Technician, stated that:
- She was called in for an emergency exploratory laparotomy on 08/11/22, for Patient #33.
- When she arrived she prepared the operating room and counted sponges, sharps, and instruments with Staff CC, RN Circulator.
- She felt that it would be safer to split out the retractors by name instead of lumping them together as a group on the count sheet.
- There were two instrument counts completed with the circulating nurse, one before the patient entered the OR room and then as fascia was being closed.
- If at any time staff felt uncomfortable with the sponge or instrument count an X-Ray could be ordered. She did not think about getting an X-Ray for this procedure.
- The surgery department had added a third instrument count, she thought this would help to prevent a reoccurrence of a retained instrument.

During an interview on 10/05/22 at 2:30 PM, Staff BB, General Surgeon, stated that:
- He operated emergently on Patient #33 for what he thought was a ruptured spleen, Patient #33 was unstable due to the blood she was losing internally.
- After the incision was made it was discovered she had a uterine rupture not a ruptured spleen. The OB doctor scrubbed in to assist with the uterine repair and delivery of a nonviable fetus.
- During closure of the fascia, the counts were reported to him as correct. At the time of the final instrument count he was still using the malleable retractor.
- On 08/26/22, he was called to the ED to review an X-Ray of Patient #33's abdomen where he saw a retained surgical instrument.
- He spoke with Patient #33 and she decided she would go home and come back the next day to have surgery to remove the retained surgical instrument, however she called the next day to let him know she had decided to go elsewhere for the surgery.

During an interview on 10/05/22 at 8:30 AM, Staff EE, Doctor of Osteopathy, (DO, a physician that practices and treats medical disorders with an emphasis on manipulation and massage of the bones, joints, and muscles) Chief of Surgery, stated that:
- He heard about the incident of a retained surgical instrument about three days after the event, he felt this case would have warranted an X-Ray after fascia closure to make sure there were no retained items.
- Because the surgery was stressful, she had a large body mass, multiple surgeons were working, there was a baby involved, the patient was requiring massive transfusions of blood to stabilize her, and it was an after-hours case factored into the instrument being missed on the instrument count.
- He felt like following the count policy by counting initially, a second count with closure of fascia, and final count at skin closure would help prevent this from happening in the future.
-The surgeons were going to meet to discuss when an X-Ray post operatively would be indicated.

During an interview on 10/04/22 at 1:45 PM and 10/05/22 at 9:15 AM, Staff A, Surgical Services Director, stated that:
- On 08/11/22, she was notified by Staff D, Chief Nursing Officer (CNO), that Patient #33 was in the ED, there were two other emergency situations going on and requested she come in to assist.
- She was only present to help with the setup of the surgery, she did not help with the counts. She left shortly after the patient's incision was made.
- After the hospital found out Patient #33 had a retained instrument, she had a mandatory staff meeting on 09/08/22. Staff initially recommended that another column be added to the count sheet to include working instruments. Since then, it was decided that staff would do a third and final count at closure of skin.
- The policy was confusing and open for interpretation. After reviewing the policy, it did look like it said to do three counts of instruments, but they had only been doing two instrument counts for the last 20 years. She planned to amend the policy to make it more clear.
- The Surgical Count Sheet had not been revised yet. She had not made any policy changes to reflect the new process.
- All surgical staff had been educated on the new process of performing a third count of items and instruments at skin closure.

During an interview on 10/05/22 at 9:50 AM, Staff FF, Risk Manager Director, stated that:
- After learning of the event she reviewed Patient #33's medical record and organized a root cause analysis (RCA, a tool to help sturdy events where patient harm or undesired outcomes occurred in order to find the root cause) meeting.
- She reviewed the policy, which stated that three instrument counts should have been performed.
- She held the RCA meeting and recommendations to keep this from happening again were documented.
- The Surgical Services Director did provide education on counting to the surgical staff at a mandatory staff meeting. Surgical staff were also to complete online modules by 10/31/22 and 11/30/22, but she felt it should have been done sooner.

Review of discharged Patient #30's medical record, showed that he was a five year old male that came to the hospital on 05/09/22 for a long spiral fracture of the right femur (broken thigh bone). An open reduction internal fixation (ORIF, surgery to fix severely broken bones) of the right femur was performed on 05/09/22 at 5:24 PM. Page one of the hospital's document titled, "Operative Record Set," dated 05/09/22, showed the initial count completed. There was no other count documented.

Review of discharged Patient #31's medical record showed that she was a 93 year old female admitted to the hospital on 09/17/22 for complete intestinal obstruction. On 09/19/22 at 11:01 PM, the patient had an exploratory laparotomy with lysis of adhesions (a procedure that cuts bands of tissue that form between organs, often caused by scar tissue) and segmental small bowel resection (to remove part of an organ) left in discontinuity. The fascia (a thin casing of connective tissue that surrounds and holds every organ, blood vessel, bone, nerve fiber and muscle in place) was closed and a wound vacuum assisted closure (wound vac, a device that decreases air pressure on a wound to help it heal more quickly) device was applied to the open portion of the incision to assist with closure of the surgical wound. The hospital's document titled, "Surgical Count Sheet," dated 09/19/22, showed an initial count and second count of items and instruments. There was no final count of items or instruments documented.

Review of current Patient #34's medical record showed that she was a 69 year old female that came to the hospital on 10/04/22 for a laparoscopic (a type of surgical procedure that allows a surgeon to access the inside of the abdomen and/or pelvis without making a large incision) gallbladder removal at 7:49 AM. Page one of the hospital's document titled, "Operative Record Set," dated 10/04/22, showed one initial count, there was no other count documented.

During an interview on 10/04/22 at 11:00 AM, Staff U, RN, stated that she was responsible for documenting the counts on page one of Patient #34's operative record sheet. She recalled a second count was completed, but she forgot to write it down. She recently received education regarding the importance of surgical counts and the surgical department changed the process of counting instruments on open abdominal cases. The surgical staff now do an instrument count at the beginning of the procedure, closing of fascia and at skin closure. Prior to the retained instrument incident, there was only an instrument count at the beginning of the case and at closing of fascia.

During an interview on 10/04/22 at 10:55 AM, Staff F, Surgical Services Clinical Coordinator, stated that a second count should have been documented on Patient #34's operative record set.

During an interview on 10/03/22 at 2:00 PM, Staff F, Surgical Services Clinical Coordinator, stated that since the retained surgical instrument incident occurred, she had been auditing surgical counts during procedures that required instruments to be counted. The audits started the beginning of September and she had completed three audits. She was not sure how many audits she needed to be doing.

During an interview on 10/05/22 at 3:10 PM, Staff D, CNO, stated that she was made aware of the incident of the retained surgical instrument by Staff FF, Risk Management Director and she attended the RCA meeting. She stated that she felt there was still room for improvement in surgical counts being performed in the hospital's operating rooms and she expected the surgical staff to follow the hospital's count policy. She was disappointed that surgical staff would not document a count after all that had happened.





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