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Based on observation, interview, and record review, the hospital's Governing Body did not ensure that the hospital (Hospital A) had a separate surgery service independent of Hospital B. The two hospitals utilized the same physical space for operating room (OR) services, sterile processing services as well as the nursing staff working by contract in both hospitals. This resulted in the inability of the hospital to ensure that it had the capability to independently provide surgical services and to provide separate space and staffing for all patients requiring surgical services in a universe of 564 patients. (Refer to A-0940)

The cummulative effect of these deficient practices resulted in the Condition of Participation for Governing Body not being met.

Based on observation and interview the hospital failed to ensure the personal privacy of patients, Patient 52 and patients on unit 9100 and unit 8100, in a universe of 564 patients, when medical information about the patients was easily viewed from the public hallway. This failure had the potential for the patient's personal information to be used in a way not authorized by the patients.

Findings:

1. During a tour on October 13, 2015 at 9:00 AM, of unit 7200, there were 3 computer screens facing out toward the unit hallways where patients, visitors and staff walk by. One computer screen displayed laboratory tests and results that had been performed on Patient 52. This computer screen was easily seen from the unit hallway and anyone passing by could have seen the patient's lab information, the patient name and medical record number.

In a concurrent interview with accompanying Regulatory Specialist (RG), RG stated that the computer screens had a built-in privacy screen and the patient information could not be seen by someone standing to the side of the computer screen. RG stated someone left it (the patient information) on the screen when they got up and that information could be seen by someone passing by. RG acknowledged the staff person that left the screen should have logged off of the patient information before leaving the computer.


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2. During a tour on October 12, 2015 at 11:15 AM on the unit of 9100, there was 1 computer screen facing out toward the unit hallways where patients, visitors and staff walk by that did not have a privacy screen. This computer was used to access and input patient information. The computer screen was easily viewed from the unit hallway and anyone passing by could have seen the patient's medical information, patient name and medical record number.

During a concurrent interview with the Unit Director (UD), UD verified the computer did not have a privacy screen.


3. During a tour on October 12, 2015 at 11:35 AM on unit 8100, there were 2 computer screens facing out toward the unit hallways where patients, visitors and staff walk by that did not have a privacy screen. The computer screens displayed patient information. The computer screens were easily viewed from the unit hallway and anyone passing by could have seen the patient's medical information , the patient name and medical record number.

During a concurrent interview with the accompanying Unit Director, the UD verified 1 of the computers did not have a privacy screen, and 1 did have a privacy screen, but a staff member who was currently working with the computer removed it for better visualization.

4. During a tour on October 13, 2015 at 9:00 AM, of unit 7100, there was 1 computer screen facing out toward the unit hallways where patients, visitors and staff walk by without a privacy screen. The computer screen displayed patient information. This computer screen was easily seen from the unit hallway and anyone passing by could have seen the patient's medical information, the patient name and medical record number.

During a concurrent interview with the accompanying Unit Manager, the UM stated that most of the computers had a built-in privacy screens but this computer did not have a privacy screen.

Based on interview and record review, the hospital's Medical Record Department did not have a separate and distinct department for all individuals, both inpatients and outpatients evaluated or treated in the Loma Linda University Medical Center (Hospital A) to meet the scope and complexity of services at Loma Linda University Medical Center when it failed to:

a). Employ separately designated staff to maintain and store medical records for Loma Linda University Medical Center (Hospital A). (Refer to A-0432)

b).Ensure a separate space was designated to store the medical records for Loma Linda University Medical Center (Hospital A). (Refer to A-0432).

The cumulative effect of these systemic practices had the potential for patient information to be lost due to the University Medical Center (Hospital A) filing together medical records with the Childrens Hospital (Hospital B) records. These findings were not in compliance with the Condition of Participation for Medical Record Services.

Based on interview and record review, the hospital's Medical Record Department did not have a separate and distinct department for all individuals, both inpatients and outpatients evaluated or treated in the Loma Linda University Medical Center (Hospital A) to meet the scope and complexity of services at Loma Linda University Medical Center when it failed to:

a). Employ separately designated staff to maintain and store medical records for Loma Linda University Medical Center (Hospital A).

b).Ensure a separate space was designated to store the medical records for Loma Linda University Medical Center (Hospital A).

These findings had the potential for patient information to be lost due to the University Medical Center (Hospital A) filing together medical records with the Childrens Hospital (Hospital B) records.

Findings:

During an interview with the Medical Records Executive Director (MRED) on October 12, 2015 at 10:00 AM, when asked if the Medical Records Department employees are employed by Hospital A, she stated that the medical records employees are employed by Company C and are not employees of Hospital A. The MRED stated that Company C is contracted to maintain and store all of Hospital A's closed medical records once a patient is discharged. She also stated that Company C contracts with other hospital's under the same Hospital Corporation and stores all of the Corporations closed medical records.

The MRED was asked if the medical records from Hospital A were stored separately from the other contracted hospital's medical records. She stated they were electronically stored separately, but the paper portions of the charts were stored in batches with the other hospital's records after scanning them into the Electronic Medical Record (EMR).

The MRED was asked if the medical record's employees of Company C are hired to only process Hospital A's medical records, the MRED stated that all of the employees of Company C work on all records for Hospital A and Hospital B under the Corporation. The MRED also stated that Company C's employees may work alternately with Hospital A and Hospital B's medical records during the same shift.

Based on observation, interview, and record review, the hospital failed to ensure that outdated medications were not available for immediate patient use. This failure had the potential for medications to be used past their expiration date and for the patient to receive a medication that may not provide the full treatment benefit as intended by the manufacturer and prescriber which could lead to patient harm in a universe of 564.

Findings:

1. During a tour of the Operating Room (OR) Surgical services floor on October 12, 2015, at 4:10 PM, a storage room with medications was inspected. The room was labeled as "EESR South 2739". Hospital personnel were not able to define what "EESR" stood for. Observed to be stored in the storage room were 4 bags of 0.9% Sodium Chloride (normal saline - a medication used to hydrate patients) 1 Liter solution for injection. One bag had an expiration date of "Mar 13" (March 2013), another bag had an expiration date of "Sep 15" (September 2015), and the other 2 bags had expiration dates of "Aug 15" (August 2015).

During a concurrent interview with the Director of Pharmacy, he confirmed that the medication bags had expired and indicated that he would make sure the pharmacist reviewed this room during their monthly storage inspections. Hospital personnel then removed the expired bags from the storage area.

A review of facility policy & procedure titled "Medication Storage in Patient Care Areas", coded "R-23", with an effective date of "05/2013", states, "1.4 Medications that are outdated, deteriorated........shall be placed in separate, designated storage area for return to Pharmacy".

2. During a tour of the PACU (post anesthesia care unit) on October 12, 2015, at 4:25 PM, a opened and used vial of vial of Humalog insulin (a medication used to reduce high blood sugar) was observed to be stored in the medication refrigerator. The vial was labeled by hospital personnel with an expiration date of "10/10/15".

During a concurrent interview with the PACU Registered Nurse, she confirmed the vial was opened, used, and expired. She stated she would have the vial removed from the unit and replaced by Pharmacy.

A review of facility policy & procedure titled "Medication Storage in Patient Care Areas", coded "R-23", with an effective date of "05/2013", states, "1.4 Medications that are outdated, deteriorated........shall be placed in separate, designated storage area for return to Pharmacy".

Based on observation, interview, and document review, the hospital's Governing Body did not ensure that the hospital (hospital A) had a separate surgery service independent of hospital B. The two hospitals utilized the same physical space for operating room (OR) services, sterile processing services as well as the nursing staff working by contract in both hospitals. This resulted in the inability of the hospital to ensure that it had the capability to independently provide surgical services and to provide separate space and staffing for all patients requiring surgical services in a universe of 564 patients.

1. The hospital's Governing Body did not ensure that the hospital (hospital A) had a separate surgery service independent of hospital B. see tag A-0941


2. The hospital did not ensure that an adequate Physical Exam was documented in the medical record for 2 out of 3 patients undergoing foot surgery. See tag A-0952


The cummulative effect of these deficient practices resulted in the Condition of Participation for Surgical Services to be not met.

Based on observation, interview, and document review, the hospital's Governing Body did not ensure that the hospital (hospital A) had a separate surgery service independent of hospital B. The two hospitals provided surgical services on the same floor for operating room (OR) services as well as utilizing the same sterile processing services and contracted nursing staff to Hospital B. This resulted in the inability of the hospital to ensure that it had the capability to provide surgical services to patients and to provide separate space and staffing for all patients requiring Surgical Services in a universe of 564 patients.

Findings:

1. The Executive Director of Perioperative Services for both hospitals A and B was interviewed on 9/8/15 at 9:50 AM. He described that the hospital (A) surgical services had a separate and independent director who reported up to the Executive Director. He also explained that there were 16 ORs in the surgical suite that was situated in an area of overlap of the physical plant between the two hospitals. Nine ORs (1, 2, 3, 8, 9, 10, 14, 15, and 16) were used exclusively by hospital A. Five ORs (4, 5, 6, 7, 12) were used exclusively by hospital (B) and two OR rooms were jointly used (11, 13). These two "flex" rooms could be used by either surgical service, every day on a case by case basis. In addition, the common areas of the surgical suite, hallways, storage, and other areas, were also used by both hospitals. All of the ORs were owned by the parent corporation for both hospitals. Surgical scheduling was also performed for both hospitals by one group of scheduling staff in a shared space in hospital B. It was also explained that the ambulatory surgical center was leased to the hospital (B) but used also by hospital A. The space was used by only one hospital on any particular day

2. A policy entitled "Operating Policy" and subtitled "Allocation of Operating Rooms" was reviewed. It stated that five operating rooms in the main perioperative suite shall be dedicated to the hospital (4, 5, 6, 7, and 12). OR 11 and 13 may be used ....under the following conditions: a. Rooms are assigned by block time by service, b. The OR supervisor (or designee) will adjust which hospital's cases will be performed (in OR 11 and 13) based on criteria below: patient condition, surgical procedure, equipment needed, room size, length of case.

3. A policy entitled "Operating Policy" for the hospital (A), subtitled General Management, Scheduling, Utilization and Allocation of Block Time was reviewed. It stated "Operations shall be scheduled ...at the Outpatient Surgery Center on Monday and Wednesday."

4. The Ambulatory Surgical Center (ASC) was toured on 9/10/15 at 9:05 AM. The Director of Surgical Services for the hospital (A) explained that the ASC was on both hospitals licenses and was owned by the corporation.

5. The sterile processing area in the surgical suite of both hospitals was toured on 8/9/15 at 9:00 AM. The service was one integrated service for both hospitals. The Director of Perioperative services for the hospital (A) explained that this service was provided under contract to hospital B. The instrument storage room was inspected. Instruments for hospital A and B were grouped separately but stored in the same room without any form of separation.

The Executive Director for Surgical Services (EDSS) was interviewed again on 10/14/15 at 9:55 AM. He provided and explained the utilization of the operating rooms (ORs). The total number of cases performed in the 16 ORs over a 9 month period is 8392, of which 5087 were for hospital A and 3305 for hospital B. These figures were converted into monthly averages. The average daily volume of the combined OR suite over the last 9 months was 932 cases of which 565 (60.6% of cases) were Hospital A cases (adults) and 367 (39.4% of cases) were Hospital B cases.

Based on interview and document review, the hospital did not ensure that an adequate Physical Exam was documented in the medical record for 2 out of 3 patients (Patients 19 and 20) undergoing foot surgery. This resulted in the possibility that surgery and sedation/anesthesia was performed in the presence of unrecognized medical problems that might have been identified by a more in depth physical examination, and possible harm to all patients requiring Surgical Services in a universe of 564.

Findings:

1. Closed surgical electronic records were reviewed on 10/13/15 at 9:05 AM. Health Information Specialist A was present. Three records were reviewed for adult patients undergoing foot surgery at the Outpatient Surgery Center of the Hospital (A). The record for Patient 19 indicated the surgery was performed by a Medical Doctor (A). The physical exam documented information from observing the patient and minimal exam, including general appearance, good capillary refill, pulse palpable, observational neurological exam, and an in depth exam of the foot. There was no documentation that the heart or lungs were actually examined by either auscultation (listening with a stethoscope) or palpation (putting hands on the chest). The record for Patient 20 indicated the surgery was performed by a Doctor of Podiatric Medicine (DPM) A. Only vital signs and a foot exam were documented in the Physical Exam section.

2. The Executive Director for Surgical Services (EDSS), Executive Director of Health Information Management (HIM) and the Director of Record Integrity were interviewed October 13, 2015 at 3:30 PM. They confirmed that there was no other Physical Examination documented in the electronic records for Patients 19 and 20. The EDSS stated that the Bylaws of the Medical Staff required a physical examination pertinent to the procedure.

3. The Chairman and Chief of Surgery was interviewed on October 13, 2015 at 4:45 PM. He agreed with the findings in the medical records and stated that this is how it was done at the hospital. He further stated that there had been a lot of discussion among the medical staff and that it was agreed for the anesthesiologists to perform the physical examinations and documentation. All patients went preoperatively to the Pre-anesthesia Clinical Evaluation (PACE) clinic before admission to surgery. The preoperative History and Physical was performed at that clinic. The anesthesiologists were to decide how much of a physical examination should be performed. He agreed that the examination should be a little more in depth.