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Based on interview and record review, the Governing Body failed to provide oversight and ensure there was a contracted agreement between the hospital and an outside facility (Pavilion surgery center) for surgical equipment loaning services provided. This had the potential for the necessary surgical equipment to not be available for use for surgical patients.

Finding:

Review of the hospital's Bylaws titled Amended and Restated Bylaws dated 2/28/13, showed in part: "Purposes of the Corporation. This corporation is operated as a ministry established for the purposes set forth ...for the purposes of delivering health services to the people of Orange County and surrounding areas ...These services shall include inpatient and outpatient care, educational programs, research activities and participating in any activity designed and carried on to promote the general health, rehabilitation and social needs of the community ..."

Review of the hospital's FY (Fiscal Year) 2018-Performance Improvement Plan showed the Board of the hospital "has overall responsibility for the quality and safety of patient care provided and strives to assure that quality by requiring and supporting the establishment and maintenance of an effective center-wide performance improvement program ...As a Subcommittee of the Board, the Quality & Safety Committee is delegated the responsibility by the Board of Trustees for the monitoring of/ and performance improvement for clinical and service quality, patient safety, environment of care and regulatory compliance policies of the Organization ..."

Review of the hospital's Delineation of Privileges ObGyn Core Privileges Form undated showed in part: " ...The following is a list of core procedures for the specialties within the Department of Obstetrics and Gynecology ...Hysteroscopy (a procedure by using an instrument to inspect the inside of the womb and treat the abnormalities) diagnostic and operative..."

Review of the hospital's worksheet for preference card titled Hysteroscopy OP/D&C/Polypectomy dated 1/18/18, showed a list of equipment and supplies including " ...blade morecellor 2.9 mm rotary truclear incisor for Morcellator ...blade morecellor 4 mm rotary truclear incisor pus for Morcellator (a surgical instrument used for division and removal of large masses of tissues during a surgery)..."

On 6/27/18 at 1100 hours, during an interview with the Manager- Main OR, the Manager stated any surgical equipment that was not available in the hospital's main OR was to be borrowed from the Pavilion surgery center. The Manager stated the "Morcellator and supplies are kept at Pavilion but are available if scheduled appropriately and requested by physician in an adequate time."

On 6/27/18 at 1320 hours, the Executive Director, Regulatory Readiness/Quality Management stated the hospital had no contracted agreement for the surgical equipment loaning services with Pavilion surgery center.

Based on interview and record review, the hospital failed to ensure the IM letter was provided timely as per the hospital's P&P for two of 31 sampled patients (Patients 18 and 26). This posed the risk for these patients to not be aware of their rights and not able to exercise their rights to appeal the discharge.

Findings:

The hospital's P&P titled Medicare Discharge Appeal Rights (IM Letter) dated 6/17 showed the following:

* All hospital inpatients who are Medicare beneficiaries are covered by the regulation CMS-4105-F, "Notification of Hospital Discharge Appeal Rights."

* IM Delivery Requirements for Initial Copy:

- Delivered within two calendar days of admission or at preadmission, but not more than seven calendar days before admission.

- Signed and dated by the beneficiary (or beneficiary representative if beneficiary unable to sign).

* IM Delivery Requirements for Follow-up Copy:

- Copy of initial signed IM will be delivered to the patient/representatives far in advance as possible before discharge, but no more than two calendar days before the day of discharge. Delivery cannot be routinely on day of discharge, so as to allow beneficiary time to consider rights.

- Hospital must document delivery.

1. On 6/26/18 at 1525 hours, an interview and concurrent review of Patient 18's medical record was conducted with the Manager, Risk Management.

Patient 18 was admitted to the hospital on 6/10/18, and discharged on 6/13/18.

Review of the scanned documents in the electronic medical record showed an uploaded IM letter.

Review of the uploaded IM letter showed Patient 18 signed the letter; however, there was no date or time on the letter.

On 6/26/18 at 1555 hours, the Manager, Risk Management acknowledged since the IM letter for Patient 18 was not dated, it could not be determined if it was issued to the patient within the required time frame as per the hospital's P&P.

2. On 6/27/18 at 0935 hours, an interview and concurrent review of Patient 26's medical record was conducted with the Manager, Risk Management.

Patient 26 was admitted to the hospital on 3/10/18, and discharged on 3/13/18.

Review of the scanned documents in the electronic medical record showed Patient 26 was issued the initial IM letter on 3/9/18, while the patient was in the emergency department. Further review of the medical record showed no documented evidence showing Patient 26 received the follow-up copy of the IM letter within 48 hours of discharge.

On 6/27/18 at 0900 hours, an interview was conducted with the Director of Care Management. When asked when and how the IM letter was issued to Medicare beneficiaries, the Director stated the admitting department issued the initial IM letter to the patient upon admission to the hospital. The follow-up IM letter was issued no sooner than two days before the discharge, but typically it was issued four to 24 hours before discharge. The Director further stated the Care Management department is responsible for issuing the follow-up letter, and it should be issued far enough in advance of the discharge so the patient had the opportunity to appeal.

On 6/27/18 at 1000 hours, the Manager, Risk Management confirmed there was no documentation in the medical record to show the follow-up copy of the IM letter was issued to Patient 26.

Based on interview and record review, the hospital failed to ensure the hospital's P&P related to Informed Consent was implemented for one of 31 sampled patients (Patient 9) when the patient did not sign on the patient's signature section for the proposed procedure. This could result in the patient's lack of knowledge when receiving care.

Finding:

Review of the hospital's P&P titled Informed Consent dated 4/17 showed the Consent to Operate, Diagnostic or Therapeutic Procedure, Administration of Anesthesia, and Blood Transfusion should be completed to include the competent patient's signature, date, and time.

On 6/26/18 at 1010 hours, an interview and concurrent review of Patient 9's medical record was conducted with the Manager-Step Down Unit and Manager-Orthopedic Unit.

Patient 9's medical record showed the patient was admitted to the hospital on 6/20/18 at 1745 hours. The patient had a surgery on 6/21/18.

The Orthopedic Surgery Prog (Progress) Note dated 6/21/18 at 0741 hours, showed Patient 9 was alert and oriented.

Review of the Consent for Surgery or Special Diagnostic or Therapeutic Procedure showed the following:

* On the first page of the form was the section for "Signature: (Patient, Legal Representative):__________" for the proposed surgery. However, this section was not signed by Patient 9.

* The second page of the form showed Patient 9 signed on 6/21/18 at 1725, for the authorization and consent to blood transfusion.

The Managers confirmed the Consent for Surgery or Special Diagnostic or Therapeutic Procedure was not completed.

Based on observation, interview, and record review, the hospital failed to ensure the hospital's P&P related to the use of the RSM to promote the rights to personal privacy was implemented for two of 31 sampled patients (Patients 16 and 17) and two nonsampled patients (Patients A and B) as evidenced by:

1. The electronic privacy screen was not initiated for four patients (Patients 16, 17, A, and B) to ensure the patients' physical privacy during the medical or nursing treatments when the RSMs were utilized for these patients.

2. The use of the RSM was not reevaluated for Patient 17 on 6/23/18, during the night shift. In addition, there was no documented evidence to show Patient 17 or the patient's family member was informed about the use of the RSM until four days later.

These failures had the potential for the patients' personal privacy to not be protected.

Findings:

Review of the hospital's P&P titled Remote Safety Monitoring dated 12/17 showed the following:

* The patient's right for privacy should be respected at all times. The room/bed surveillance should be placed into privacy mode during such as activities including, but not limited to, personal hygiene and physician/provider request during rounds and/or examination.

* The Clinical Coordinator or Charge Nurse completes the Clinical Safety Assessment in the medical record for initiation and reevaluation of the RSM use at least once a shift.

* The Primary Nurse assess that the patient is appropriate for physical or remote monitoring with the Clinical Coordinator or Charge Nurse, reevaluates the need for the RSM at least every four hours or more frequently, and document the continued RSM needs.

* The RSA initiates the electronic privacy curtain upon request from the clinical staff and sets the timer each time it is done.

* The patient and family will be informed that the RSM will be utilized to ensure patient safety; educate on the intervention and criteria for the initiation and discontinuation; and will be given a copy of the educational material. This education shall be documented in the medical record.

1. On 6/26/18 at 1055 hours, a tour of Telemetry Medical floor was conducted with the Manager-Step Down Unit. The following was identified:

* A wound care cart was observed to be parked in the hallway in front of Room A. A sign was posted outside Room A indicating the RSM was in use in this room.

* In a room where the RSM station was located, RSA 1 was observed sitting in front of a big screen monitor. The big screen had six sections and each section showed one room or one patient being monitored by using the RSM. Patients 16, 17, A, and B were observed being monitored. Patients 16, 17, and B were observed on the big screen monitor being provided care by the staff. Patient A was observed standing up with exposed back and used a walker with the staff standing next to him. There was no privacy screen observed when the staff provided care to Patients 16, 17, A, and B.

The Manager confirmed the above observations. The Manager stated the wound care staff was providing care to Patient 16's wound; the staff was inserting an IV line to Patient B; and the physician was examining Patient 17.

On 6/27/18 at 0955 hours, an interview was conducted with RSA 2 and the Manager-Step Down Unit. The RSA stated she was able to initiate the privacy screen when it was requested. When asked what activities would be required for the the privacy screen, the RSA stated when the patient needed to be changed or bathed and when the family was talking to the patient.

2. Review of the Remote Safety Monitoring Patient Request Form showed the RSM was initiated for Patient 17 on 6/21/18.

Review of the Remote Safety Monitoring: Intervention Log from 6/21/18 to 6/26/18, showed the RSM was used for Patient 17, starting on 6/21/18.

Review of Patient 17's medical record was initiated on 6/26/18. The patient was admitted to the hospital on 6/18/18.

Review of the Clinical Safety Assessment from 6/22/18 to 6/26/18, showed the RSM was utilized for Patient 17 on 6/22/18 at 0042, 0800, and 2000 hours; on 6/23/18 at 0000, 0503, and 1600 hours; on 6/24/18 at 1200 hours; on 6/25/18 at 0000 and 0800 hours; and on 6/26/18 at 0600 and 1257 hours.

a. Review of the Education Adult document dated 6/21/18 at 0800 hours, 6/22/18 at 1900 hours, 6/23/18 at 0900 hours, 6/24/18 at 0800 hours, 6/25/18 at 0726 hours, and 6/25/18 at 2220 hours, failed to show Patient 17 or the patient's family member was informed or educated about the use of the RSM as per the hospital's P&P.

Review of the Education Adult document dated 6/26/18 at 1200 hours (or four days later), showed Patient 17 and the patient's family was educated about the purpose of the use of the RSM and the educational flyer and information were provided to the patient and the family member.

On 6/26/18 at 1350 hours, an interview and concurrent review of Patient 17's medical record was conducted with the Manager-Step Down Unit. The Manager stated the RSM was initiated for Patient 17 on 6/22/18 at 0042 hours, and was used for the patient until this time. When asked whether Patient 17 or the patient's family member was informed about the use of the RSM, the Manager was unable to find documented evidence to show the patient and/or the patient's family member were informed of the RSM use until 6/26/18 at 1200 hours, or four days later.

On 6/27/18 at 1010 hours, an interview was conducted with RN 2 and the Manager-Step Down Unit. When asked about notifying the patient and/or the patient's family member about the use of RSM, RN 2 stated the patient and/or the patient's family member would be notified about the use of the RSM right away.

b. There was no documented evidence to show the nursing staff reevaluated the use of RSM from 6/23/18 at 16000 hours to 6/24/16 at 0800 hours, or on 6/23/18 at the night shift as per the hospital's P&P.

On 6/27/18 at 0850 hours, an interview and concurrent review of Patient 17's medical record was conducted with the Manager-Step Down Unit. The Manager confirmed there was no documented evidence to show the nursing staff reevaluated the use of RSM for Patient 17 on 6/23/18, during the night shift as per the hospital's P&P. The Manager stated it should be done.

Based on interview and record review, the hospital failed to ensure the H&P examination was completed as per the Medical Staff Bylaws for one of 31 sampled patients (Patient 8). This failure could create the risk of substandard healthcare outcomes to this patient.

Finding:

Review of the hospital's Medical Staff Bylaws dated 12/7/17, showed a history and physical examination must be completed and documented for each patient no more than 30 days before or 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services. An updated examination of the patient, including any changes in the patient's condition, must be completed and documented within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services, when the medical history and physical examination are completed within 30 days before admission or registration.

On 6/26/18 at 0930 hours, an interview and concurrent review of Patient 8's medical record was conducted with the Manager-Step Down Unit and RN 1.

Patient 8's medical record showed the patient was admitted to the hospital on 6/25/18 at 0523 hours. The patient had a surgery on 6/25/18. The anesthesia was started at 0743 hours. The surgery was started at 0806 hours.

Review of the Physician Pre-Procedure Documentation Informed Consent/H&P Update form signed by the physician on 6/25/18 at 0720 hours, showed under the section titled H&P Interval Note (update), the bullet point indicating "Upon interview and examination of the patient, there are no significant interval changes to previous H&P" was circled.

However, review of the Patient Encounter Note created on 6/13/18, reviewed and signed by the physician on 6/24/18, failed to show the physician listed the patient's past surgical history, allergies, home medications, and social history.

The Manager and RN 1 confirmed the finding.