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Based on observation, interview, and record review, the GB failed to assume full responsibility for determining, implementing, and monitoring the policies governing all hospital functions as evidenced by the failure to ensure a new telemetry order set was approved by the GB before it was implemented. This created an increased risk of substandard healthcare for their patients.

Findings:

Review of the hospital's Amended and Restated Bylaws dated 3/7/13, showed the Board of Trustees shall require the person responsible for each basic and supplemental medical service cause written P&Ps to be developed and maintained and such policies shall be approved by the Board of Trustees.

The hospital's P&P titled Policy and Procedure; Writing dated 3/17 showed the purpose of the P&P is to specify a single comprehensive system for the development, approval, distribution, organization, and maintenance of P&Ps at the hospital. The P&P also showed the Hospital Administration and GB shall review and approve all P&Ps every three years or more often as necessary.

On 4/2/19 at 1321 hours, an observation in the Orthopedic unit was conducted accompanied by Manager 10. A sheet of paper was observed to be taped on a computer screen and showed a new telemetry order set would go live on 3/26/19. Manager 10 stated an inservice of the new telemetry order set was provided to the nursing staff.

Review of the hospital's document showed a new process for telemetry orders would go live on 3/26/19. This was a new workflow for telemetry monitoring centered on a new telemetry order set which asked the provider to choose a duration-based telemetry monitor order; a "new nursing DC Telemetry Assessment" would be attached to the time-limit 1-Day and 2-Day telemetry monitoring orders. The nursing staff will complete this assessment to evaluate if the patient meets the clinical criteria for ending the telemetry monitoring for the duration ordered.

Review of the hospital's P&P titled Telemetry Monitoring in Non-Critical Care Area showed the section of "Clinical Policy & Procedure Committee," "Nursing Leadership Team," "...Departmental Approval," and "Administrative Approval" was dated as of 2/19. The sections of "Policy and Procedure Committee," "Cardiology Committee," and "Reviewed/Revised" was dated as of 2/17. Further review showed the "Discontinue Telemetry Assessment" Intervention will turn pink on the RN's intervention list; if the patient's criteria to discontinue telemetry, and an order was placed by the RN to discontinue the telemetry monitoring using a secondary order source.

On 4/4/19 at 1340 hour, an interview and concurrent review of Patient 30's medical record was conducted with Manager 7. Patient 30 was admitted to the hospital on 4/2/19 at 1909 hours. The physician's orders dated 4/2/19 at 1256 hours, showed "Telemetry Monitor 2 Days AS DIRECTED," "Nursing to DC tele after 2 days if patient meets DC criteria...." The DC Telemetry Assessment dated 4/4/19 at 1230 hours, documented by an RN, had the section of "Patient Meets Criteria To Remove Telemetry Monitoring" documented as "Safe to Remove Telemetry."

On 4/4/19 at 0915 hours, during a group QAPI interview, it was disclosed the P&P for telemetry monitoring , or telemetry order set had been approved through the Medical Staff Committee and there had been "lots of discussion" with the Medical Staff before this policy was implemented. However, it was confirmed the hospital was already applying the telemetry policy, or a telemetry order set before it was approved by the GB.

On 4/4/19 at 1050 hours, during a group GB interview, the CMO stated he considered it a failure that the telemetry policy, or the telemetry order set was implemented before the GB's approval.

Based on interview and record review, the GB failed to ensure the contracted services provided in the hospital were evaluated. This failure created the increased risk of substandard services being provided.

Findings:

Review of the hospital's Amended and Restated Bylaws dated 3/7/13, showed in part: "...Article VI Board of Trustees ...the powers of the ministry shall be exercised, its property controlled and its affairs conducted by or under the direction of the Board of Trustees ...Article VII Committees ...Each committee shall be organized and function pursuant to a charter approved by the Board of Trustees. Such committees shall include at minimum the following committees: executive, community benefit, quality, and finance ...Article X Quality of Professional Services ...The Board of Trustees shall further require, after considering the recommendations of the Medical Staff, the conduct of specific review and evaluation activities to assess, preserve and improve the overall quality and efficiency of patient care in the ministry ...Article XI Contracts and Banking...All binding obligations of the corporation shall be consistent with...accreditation standards, relevant law..."

The hospital's FY 2018-Performance Improvement Plan showed in part: "...Hospital is committed to an ongoing performance improvement process that will best ensure all services and activities are provided in a manner consistent with our Mission, Vision, Core Values and Strategic Plan ...objectively and systematically plan, assess and evaluate the quality of patient care, to improve patient care and safety, and to continuously seek and act on opportunities to improve the quality and value of our services ..."

Review of the hospital's contracted services list was conducted on 4/4/19, and was found to be incomplete.

During an interview with the CMO on 4/4/19 at 1445 hours, he stated the contracted services were reviewed by each department, but could not provide evidence the GB reviewed the contracted services for quality and safety.

Based on interview and record review, the GB failed to ensure a complete list of all contracted services provided in the hospital was maintained. This created the increased risk of substandard services being provided.

Findings:

On 4/4/19, the hospital's contracted services list was reviewed. The contracted services list included all contracts for clinical services but the non-clinical vendors were not listed.

During an interview with the CMO on 4/4/19 at 1445 hours, he stated the contracted services were reviewed by each department; however, there was no documented evidence the GB reviewed the contracted services for quality and safety. The CMO was unable to provide a complete list of contracted services.

Based on observation, interview, and record review, the hospital failed to ensure the personal privacy was maintained during the continuous video monitoring in the MICU. In addition, no documented guidelines were developed for the use of the video monitoring in the MICU. These failures created the risk of violating the patients' rights to receive full visual privacy and considerate and respectful care.

Findings:

During the MICU tour on 4/2/19 at 1410 hours with Manager 11, a monitor screen at the nursing station above the secretary's desk showed four patients' rooms. The monitor screen was able to be viewed by the staff at the nursing station and personnel who were not involved in the direct care of the patients such as other health care providers and EVS staff. When asked, Manager 11 stated the patient's privacy was maintained by closing the privacy curtains during hygiene care. However, observation of Rooms A and B showed the cameras were installed in the ceiling inside the privacy curtains. Further observation showed there was a patient in Room A and no patient in Room B.

On 4/2/19 at 1420 hours, RN 8 was interviewed in the presence of Manager 11. RN 8 stated she took care of the patient in Room A and the patient required total care from the staff. When asked, RN 8 closed the privacy curtains in Room A and Manager 11 closed the privacy curtains in Room B. After the privacy curtains were closed in Rooms A and B, the monitor screen was viewed and showed the patients' beds were visible even with the privacy curtains closed. When asked, Manager 11 stated the video monitoring did not have the ability to be turned on and off to protect the patient's privacy when personal hygiene and care were being provided tot the patients. When asked if the hospital had a P&P addressing this video monitoring including how the patient's privacy would be afforded, Manager 11 stated no. Manager 11 verified the patients in Rooms A and B could be visible in the monitor screen during hygiene and care even with the privacy curtains closed.

Based on observation, interview, and record review, the hospital failed to ensure the temperature and humidity levels in the surgical area were tracked and trended when they were out of the acceptable range. In addition, the hospital failed to ensure the terminal cleaning in the L&D OR was performed as per the hospital's P&P. These failures created an unsafe environment for the patients who received services from those areas.

Findings:

During the observation, interview, and record review on 4/2 and 4/3/19, the following was identified:

* The temperature and humidity levels were not maintained in the surgical areas as per the hospital's P&P. In addition, there was no action taken when the temperature and humidity levels were out of acceptable range as per the hospital's P&P. Cross reference to A0951, example #1.

* The patient care environment in the Surgical and L&D areas were not maintained in a state of cleanliness and sanitary condition for as per the hospital's P&P. Cross reference to A0951, example #2.

On 4/3/19 at 1453 hours, an interview with Director 1 and Manager 15 was conducted. When asked, Director 1 and Manager 15 provided Environmental Service Report for the first, second, third, and fourth quarters of 2018. These reports were provided to the Infection Control Committee.

Review of the Terminal Cleaning Operating Rooms, Cath lab & C-sections of the Environmental Service Reports showed all terminal cleaning were performed by the EVS staff using the attached checklist and records were available for review. However, Director 1 and Manager 15 were not aware the terminal cleaning in the L&D OR was not performed as per the hospital's P&P; and there was no documentation to show the EVS supervisors' rounding.

The above concerns were shared with Manager 1 on 4/4/19 at 1213 hours.

Based on observation, interview, and record review, the hospital failed to ensure the medical staff enforced the bylaws and P&Ps adopted by the facility as evidenced by:

1. The hepatitis B and flu vaccine status were not tracked for six physicians (MDs 1, 2, 3, 4, 5, and 6).

2. The pre-anesthesia assessments were not completed for two of 31 sampled patients (Patients 2 and 5).

3. The anesthesia record was not completed accurately for one of 31 sampled patients (Patient 5).

These practices increased the risk of poor health outcomes to the patients in the hospital.

Findings:

Review of the hospital's Amended and Restated Bylaws dated 3/7/13, showed in part: "...The Board of Trustees shall require: (a) that the Medical and Administrative Staffs prepare and maintain adequate and accurate medical records for all patients, and (b) that the person responsible for each basic and supplemental medical service cause written policies and procedures to be developed and maintained and that such policies be approved by the Board of Trustees..."

Review of the hospital's Medical Staff Bylaws dated 12/6/18, showed the Bylaws are adopted to provide a framework for self-government for the organization of the hospital's Medical Staff that permits the Medical Staff to discharge its responsibilities in matters involving the quality of patient care, treatment and services, to govern the orderly resolution of issues and the conduct of Medical Staff functions supportive of those purposes, and to account to the Governing Body for the effective performance of Medical Staff responsibilities. Each Medical Staff Member, and each practitioner exercising temporary privileges, shall continuously meet all of the following responsibilities ...Abide by the Medical Staff Bylaws and Rules and all other lawful standards, policies, and rules of the Medical Staff and of the Hospital. A medical 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.

1. According to the CDC's Guidelines for Infection Control in Health Care Personnel, 1998, showed in part: "...Prevention of Nosocomial Transmission of Selected Infections...Bloodborne pathogens, general recommendation ...a. Hepatitis B. 1) Administer hepatitis B vaccine to personnel who perform tasks involving routine and inadvertent (e.g., as with housekeepers) contact with blood, other body fluids (including blood-contaminated fluids), and sharp medical instruments or other sharp objects ..."

According to the APIC Position Paper: Influenza Vaccination Should Be a Condition of Employment for Healthcare Personnel, Unless Medically Contraindicated dated 2011, showed "...APIC recommends that acute care hospitals, long term care, and other facilities that employ healthcare personnel require annual influenza immunization as a condition of employment unless there are compelling medical contraindications..."

On 4/4/19 at 1300 hours, review of the credential files for six physicians (MDs 1, 2, 3, 4, 5, and 6) showed no documented evidence the hepatitis B and flu vaccine status were tracked for these six physicians. During a concurrent interview, the credentialing staff confirmed the findings.


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2. Review of the hospital's P&P titled Pre-Anesthesia Period reviewed/revised 5/17 showed a pre-anesthesia evaluation of each patient for whom anesthesia is contemplated must be completed. The pre-anesthesia evaluation of the patient and the pre-anesthesia record entry shall be the responsibility of the anesthesiologist. This evaluation includes the gathering of information necessary to determine the capacity of the patient to undergo anesthesia and formulate an anesthesia plan. The pre-anesthesia evaluation includes the review of pertinent information and the patient's physical status including a focused physical examination. The determination of an appropriate candidate to undergo the planned anesthesia is to be based on a review of the patient's condition immediately prior to the administration of anesthesia and the results of the pre-anesthesia evaluation

a. On 4/2/19 at 1005 hours, Patient 2 was observed in the preop area ready for the procedure.

Review of Patient 2's medical record showed the patient was admitted to the hospital on 4/2/19.

The Anesthesia Preop Evaluation authenticated by MD 8 on 4/2/19 at 0853 hours, showed Patient 2 was evaluated on 4/2/19 at 0852 hours. The patient was classified as ASA 2. The section for Anesthesia Review/Physical Exam showed "Vital signs reviewed." However, the section for General/Vital Information showed the HR, BP, RR, SpO2, temperature, and ASA Class Reason were left blank.

During a concurrent interview with RN 9, she stated the preop RN checked the patient's vital signs and documented in the hospital's EMR, and the patient's vital signs should be automatically transferred to the anesthesia preop evaluation.

Further review of Patient 2's medical record showed the patient's vital signs were entered into the patient's medical record on 4/2/19 at 0918 hours, 25 minutes after the Anesthesia Preop Evaluation was signed by MD 8.


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b. Patient 5's medical record was reviewed on 4/2/19. The medical record showed Patient 5 was admitted to the hospital on 4/2/19.

Review of the H&P examination dated 4/1/19, showed Patient 5 had three known drug allergies. However, review of the Anesthesia Preop Evaluation dated 4/2/19 at 0645 hours, showed Patient 5 had no know allergies and Patient 5 was classified as ASA 4.

In addition, further review of the Anesthesia Preop Evaluation showed the following areas were left blank:

* Body Mass Index (BMI)
* Height and weight
* HR, BP, RR, SpO2, temperature
* ASA class reason

Review of the Vital Signs record dated 4/2/19 at 0612 hours, showed Patient 5's temperature was 98.2 degrees F, the HR was 50 bpm, the BP was 137/64 mmHg, and the SpO2 was 98% on room air.

On 4/4/19 at 0900 hours, an interview and concurrent medical record review was conducted with MD 9. The MD stated a patient who was very sick and had a great risk of dying or going to die without any medical intervention would be classified as ASA 4. MD 9 verified the Anesthesia Preop Evaluation was incomplete including the ASA class reason and vital signs.

3. Patient 5's medical record was reviewed on 4/2/19. Patient 5 was admitted to the hospital on 4/2/19.

a. Review of the Perioperative Clinical Record dated 4/2/19, showed general anesthesia was provided to Patient 5 during the procedure; the anesthesia gases/agents (oxygen, FGF nitrous oxide, and FGF air) was documented as "0" (zero) throughout the procedure; and propofol (an anesthesia or sedative) was used during the procedure.

The Perioperative Clinical Record dated 4/2/19 at 0822 hours, showed the following:

* The procedure end time
* Spontaneous ventilation
* Oropharynx suctioned
* Extubation criteria met
* ETT/LMA removed intact atraumatically
* Teeth in pre-anesthetic condition

However, further medical record failed to show documentation of the intubation for the general anesthesia.

On 4/4/19 at 0900 hours, an interview and concurrent medical record reviewed with MD 9 was conducted. MD 9 stated MD 10 most likely used an ETT during general anesthesia instead of LMA if the oropharynx was suctioned prior to extubation. However, MD 9 stated as he further reviewed the Perioperative Clinical Record, Patient 5 was not intubated or extubated during the procedure because no anesthesia gases were administered. MD 9 stated Patient 5 received IV anesthesia. MD 9 verified the Perioperative Clinical Record regarding extubation was inaccurate.

b. On 4/2/19 at 1030 hours, an interview with Manager 12 was conducted. Manager 12 stated a patient who had TAVR procedure could be directly admitted to DSU if the patient was not intubated during the procedure and was stable after the procedure from the Cath Lab. Manager 12 stated Patient 5 arrived at the DSU without any arterial line or femoral sheath.

Review of the Perioperative Clinical Record dated 4/2/19 at 0727 hours, showed the arterial line was placed in Patietn 5's left radial artery. However, there was no documentation to show the arterial line was removed from Patient 5. In addition, there was no documentation to show the site, where the arterial line was placed or removed, was assessed.

On 4/4/19 at 0900 hours, an interview and concurrent medical record review was conducted with MD 9. MD 9 verified the artery line removal was not documented in the patient's medical record.

Based on observation, interview, and record review, the hospital failed to ensure the nursing care was provided to meet the needs of the patients as evidenced by:

1. The hospital failed to ensure the nursing staff followed the hospital's P&P on restraint application for one of 31 sampled patients (Patient 15).

2. The hospital failed to ensure the patients who were on telemetry monitor in the DSU and DSU overflow, were continuously monitored as per the hospital's standard of practice for the DSU.

3. The hospital failed to ensure the nursing staff identified the abnormal heart rhythm for one of 31 sampled patients (Patient 5) and documented the heart rhythms every four hours for two of 31 sampled patients (Patients 6 and 23).

4. The hospital failed to ensure the alarm volume of the fetal heart monitor was maintained at a safe level.

5. The nursing staff failed to ensure contact and droplet precautions were implemented for one of 31 sampled patients (Patient 9).

These failures created the increased risk of substandard care provided to the patients.

Findings:

1. Review of the hospital's P&P titled Restraints and Seclusion revised 6/18 showed the following:

* Violent or self destructive behavioral restraint is used only in an emergency or in a crisis situation. Use must be limited to the duration of the emergency situation regardless of the length of the order.

* For violent or self destructive behavioral restraint or seclusion, the patient will be monitored at least every 15 minutes or more frequently if necessary.

* Each written order for violent or self destructive behavioral restraint is time limited to four hours.

On 4/3/19 at 1425 hours, during a tour of the DSU with Manager 12, Patient 15 was observed in bed with a chest restraint.

On 4/3/19 at 1430 hours, an interview and concurrent review of Patient 15's medical record was conducted with Manager 12. Patient 15 was admitted to the hospital on 4/1/19.

a. Review of the Physician's Order dated 4/2/19 at 2300 hours, showed to apply hard restraints to the left and right lower extremities and upper extremities due to violent acting out for four hours.

Review of the nurse's notes dated 4/2/19 at 2300 hours, showed the hard restraints were applied to the patient's left and right upper and lower extremities due to impulsive and restless behaviors.

Review of the Psychiatric Progress Note dated 4/2/19 at 2306 hours, showed the psychiatrist ordered 5 mg of Haldol (an antipsychotic), 2 mg of Ativan (a medication used for anxiety), and 25 mg of Benadryl (a medication used for allergy or sedation) due to the patient resisting security and continuously escalating.

Review of Care Plan Problem Restraints Violent form under the section Violent Behaviors showed the following:

* On 4/2/19 at 2315 hours, RN 10 documented Patient 15 showed restless and impulsive behavior.
* At 2319 hours, Patient 15 received 2 mg of Ativan.
* At 2330 hours, Patient 15 showed restless and impulsive behavior.
* At 2335 hours, Patient 15 received 25 mg of Benadryl.
* At 2336 hours, Patient 15 received 5 mg of Haldol.
* At 2345 hours, Patient 15 showed the patient was "sleeping," "impulsive," and "quiet."

However, review of the physician's order on 4/3/19 at 0000 hours, showed the physician ordered again to apply the hard restraints to Patient 15's the left and right upper and lower extremities due to violent acting out for four hours.

b. Review of the Care Plan Problem Restraints Violent showed the following:

* On 4/2/19, RN 10 documented Patient 15 showed restless and impulsive behavior at 2315 and 2330 hours. At 2345 hours, documentation showed sleeping, impulsive, and quiet behavior.

* On 4/3/19 at 0000, 0015, 0030 and at 0045 hours, documentation showed sleeping, impulsive, and quiet behavior.

Review of the Care Plan Problem Restraint Violent dated 4/3/19, showed the following:

* At 0500 hours, left lower extremity hard restraint was removed.
* At 0510 hours, right lower extremity hard restraint was removed.
* At 0520 hours, left upper extremity hard restraint was removed.
* At 0536 hours, right upper extremity hard restraint was removed.

Further medical record review showed no documented evidence the patient was assessed and monitored at least every 15 minutes for four hours and 36 minutes (from 0100 hours to 0536 hours) on 4/3/19.

c. Review of the Restraint Justification Violent 18 + Years dated 4/3/19 at 0400 hours, showed Patient 15 did not meet the criteria for reorder. However, the restraint was not completely removed until 0536 hours (or six hours and 36 minutes after the restraints was initiated).

Manager 12 verified the above findings.

2. Review of the hospital's Scope of Services/ATD-Definitive Step-Down Unit (DSU) reviewed/revised 5/16 showed the mission is to serve the healthcare needs of the critically ill, providing a bridge between MICU/CVICU and the Telemetry and Med/Surg units. DSU patients are those who require less care than intensive care, but more than that which is available from the medical/surgical care. The number of staff on duty is determine by the census and patient acuity. The primary nurse is a model used for care delivery. The ratio of patient to nurse is 3:1 depending on the patient's acuity and level of care needed.

Review of the Cardiovascular System section of the hospital's P&P titled Definitive Step-Down Unit (DSU/SDU) Standards of Practice reviewed/revised 9/16 showed all patients in the DSU/SDU will have cardiac monitoring, unless otherwise ordered by the physicians or if the patient has orders to transfer to an unmonitored bed.

On 4/2/19 at 1330 hours, during the tour of the DSU, a charge nurse was observed leaving the nursing station. No one was observed in the two nursing stations in the DSU.

On 4/2/19 at 1445 hours, a tour of the telemetry hub was conducted. In the telemetry hub, TT 1 and TT 2 were observed monitoring the patients on telemetry monitor for the following units: pulmonary/renal, oncology, medical telemetry, general surgery, and orthopedic. However, there were no patients who were physically located in the DSU, were monitored by TT 1 or TT 2 in the telemetry hub.

On 4/3/19 at 0900 hours, during an observation of the DSU, Secretary 1 was observed to turn off the alarm of the telemetry monitor and leaving the nursing station. No one was observed in the two nursing stations in the DSU. When asked, Secretary 1 stated her shift was from 0900 hours to 2130 hours, and she was trained to read the EKG rhythm. When asked if the night shift had a secretary after 2130 hours, she stated no.

On 4/3/19 at 1030 hours, Manager 12 stated the ratio of patient to nurse for the DSU unit was 3:1. Manager 12 also stated each nurse had to sign on the Relief List when going to a meal break for 30 minutes. When asked who monitored the patient's telemetry monitor, Manager 12 stated it was everyone's responsibility to respond to the audible alarm. When asked, Manager 12 stated there was no telemetry technician in the DSU.

On 4/3/19 starting at 1040 hours, eight RNs were interviewed. Eight of eight RNs stated if there was no break nurse available, the charge nurse covered the meal breaks or a nurse paired up with another nurse would cover each other's meal break. Seven of the eight RNs stated they had covered another nurse's assignment during their meal breaks. One of the eight RNs stated there would be no break record if the nurses covered for each other's break. When asked how the patient's heart rhythm was monitored, the RNs stated the heart rhythm of the patients with telemetry monitor will show in the screen located in the nurses station. When asked how the patient's heart rhythm could be monitored if the nurse was in the medication room or talking to the physician or family members, and there was no staff in the nurses station, the RNs were not able to answer.

Review of the DSU Relief List showed the following shifts did not have documentation of any meal break:

* On 3/23, 3/29, 3/30, and 4/1/19, there was no meal break assignment record for the night shift.

* On 3/24, 3/25, 3/26, and 3/31/19, there was no meal break assignment records for the day and night shifts.

Review of the DSU Assignment Sheet showed there was no relief nurse available for the meal breaks on the above dates. During the meal breaks, one nurse was responsible for the nursing care for more than three patients.

On 4/4/19 at 1200 hours, Manager 12 was interviewed. Manager 12 stated there was no telemetry technician in the DSU overflow. When asked who relieved a meal break for the nurses in the DSU overflow, Manager 12 stated the charge nurse of the DSU had to come and relieve the meal break. The two RNs in the DSU overflow were responsible for the nursing care of six DSU patients and the telemetry monitoring as well.

3. Review of the Cardiovascular System section of the hospital's P&P titled Definitive Step-Down Unit (DSU/SDU) Standards of Practice reviewed/revised 9/16 showed the cardiac monitoring is continuous with rhythm strips documented every four hours (4 a.m., 8 a.m., 12 p.m., 4 p.m., 8 p.m., 12 a.m.) and as needed if any rhythm changes occurs. The tracing will include the patient's name, time, date, rate, and evaluation of the rhythm. The patient's EKG rhythms will be recorded on printer paper each shift.

a. During a tour of the DSU nursing station with Manager 12 on 4/2/19 at 1330 hours, a telemetry monitor was observed showing Patient 5's cardiac rhythm had 11 PVCs per minute. The alarm of the telemetry monitor was activated when there were more than 10 PVCs per minute.

On 4/2/19 at 1340 hours, CC 3 was interviewed. CC 3 stated the nurses could save the heart rhythm strips electronically or print them out every four hours.

On 4/3/19 at 0925 hours, an interview and concurrent review of Patient 5's medical record was conducted with Manager 12. Patient 5 was admitted to the DSU on 4/2/19 at 0835 hours, after the procedure in the Cath Lab.

Review of the EKG dated 3/27/19, showed Patient 5 had a sinus rhythm.

Review of the H&P examination dated 4/1/19, showed the Physical Exam section showed Patient 5 had regular rate and rhythm.

Review of the Cardiopulmonary Exam section of the Anesthesia PreOp Evaluation dated 4/2/19 at 0645 hours, showed Patient 5 had positive systolic ejection murmur. However, PVC was not identified during the preop evaluation.

Review of the Bedside Report/Rounding Report dated 4/2/19, showed Patient 5 had PVCs during the procedure.

Review of the Alarm Review Report for Patient 5 showed Patient 5's heart rhythm were evaluated and documented on 4/2/19 at 0902, 1213, and 1544 hours. The three heart rhythms showed Patient 5 had less than 10 PVC per minute.

The heart alarm review dated 4/2/19, showed the following:

* At 1301 hours, Patient 5 had 11 PVCs per minute.
* At 1307, 1315, and 1329 hours, Patient 5 had more than 10 PVCs per minute.
* At 1404 hours, Patient 5 had 15 PVCs per minute.

However, the above abnormal heart rhythms were not documented in Patient 5's medical record. When asked if the RN identified and notified the physician about the abnormal heart rhythms, Manager 12 was not able to locate any documentation. Manager 12 verified the abnormal heart rhythms were not identified.

During an interview with Executive Director 5 and Manager 6 on 4/4/19 at 1423 hours, Manager 6 stated the patient would have PVCs during the procedure because the patient's heart was stimulated by wires. Manager 6 also stated once the procedure was complete and all the wires removed, there should be no more PVC present.

b. On 4/2/19 at 1350 hours, an interview and concurrent review of Patient 6's medical record was conducted with Manager 12.

Patient 6's medical record showed the patient was admitted to the hospital on 3/18/19, and was transferred to DSU on 3/23/19 at 2209 hours, from MICU.

Further medical record review showed the first heart rhythm evaluation was performed on 3/24/19 at 0728 hours. However, there was no heart rhythm evaluation performed on 3/24/19 at 0000 and 0400 hours. Manager 12 verified the above findings.


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c. On 4/3/19 at 1432 hours, a tour of the Orthopedic Unit was conducted accompanied by Manager 10. At the nurses station, a telemetry monitor was observed showing Patient 23's heart rate and heart rhythm. Manager 10 stated the telemetry assessments were done every four hours.

On 4/3/10 at 1445 hours, an interview and concurrent review of Patient 23's medical record was conducted with Manager 10. Manager 10 stated Patient 23 was on telemetry monitoring.

Review of Patient 23's medical record showed the patient was admitted to the hospital on 3/21/19.

Review of the physician's order dated 3/21/19 at 2158 hours, showed "Cardiac Telemetry Monitoring."

Review of the telemetry assessments from 3/30/19 at 2040 hours through 4/3/19 at 1200 hours, showed there was no documented evidence the telemetry assessments were done every four hours as follow:

- On 3/31/19, from 0019 hours through 0553 hours (five hours and 34 minutes);

- On 3/31/19, from 0800 hours through 1300 hours (five hours);

- On 4/1/19, from 1600 through 2104 hours (five hours and four minutes);

- On 4/2/19, from 0400 through 1007 hours (six hours and seven minutes); and

- On 4/2/19, from 1437 through 2041 hours (six hours and four minutes).

Manager 10 acknowledged the above findings.


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4. On 4/2/19 at 0910 hours, a tour of the Labor and Delivery unit was conducted with Executive Director 1 and Manager 3. When viewing the Fetal Heart Monitoring system, the alarm for this system was heard to be at a very low level. CN 1 was asked if the alarm was at a low level and she confirmed the alarm volume of the fetal heart monitoring system was low. When viewed, there was no numeric indicator to show what the alarm volume level of the fetal heart monitoring system would be. The volume level appeared to be in the range of 20-25%.

During an interview with Manager 3 on 4/2/19 at 1445 hours, Manager 3 stated the alarm volume of the fetal heart monitor had been lowered and they were at full volume now.


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5. Review of the hospital's P&P titled Isolation Practices dated 2/19 showed barrier protection equipment includes gloves, masks, and gowns. Barrier protection equipment must be put on before entering an isolation patient's room and removed and discarded before exiting the room. Masks are worn to protect the wearer and prevent the transmission of some infections that are spread by direct contact with mucous membrane. Gowns are intended to protect the clothing of the healthcare personnel from soiling with blood and other body substances. Gloves are worn to reduce the possibility that the wearer will come in contact with infectious agents from the patients, to reduce the likelihood of transmitting organisms to the patients, and to prevent the colonization of organisms on healthcare personnel who could then transfer the organisms to other patients.

Review of the hospital's P&P titled Contact Precautions dated 9/17 showed contact precaution is used to reduce the risk of transmission of infections from patients who were known or suspected to be infected or colonized with infectious agents by direct contact with the patient (hand or skin-to-skin contact that occurs during performance of patient care) or indirect contact (touching) with environmental surfaces or patient care items. The precaution procedures include placing "contact precaution" sign at the patient's room entrance indicating the category and specific isolation precaution that are required; proper hand washing; wearing a clean, non-sterile gown when entering the patient's room; wearing clean, non-sterile gloves when entering the patient's room; changing gloves during patient care after contact with infectious material; removing of gown before leaving the patient's room; removing of gloves before leaving the patient's room and washing hands immediately; ensuring hands do not touch potentially contaminated surfaces or items in the patient's room; washing hands again outside of the patient's room.

Review of the hospital's P&P titled Droplet Precautions dated 9/17 showed droplet precaution is used to reduce the risk of droplet transmission of patients with known or suspected respiratory infections by coughing, sneezing, or talking. The precaution procedures include placing "Droplet Precautions" sign at the patient's room entrance indicating the category and specific isolation precautions that are required; and wearing a surgical mask upon entering the patient's room.

Review of the Student Orientation Manual 2018-19 provided by the hospital's Clinical Education Department, showed in part: Infection Prevention and Control, patients are at a much higher risk of becoming infected due to underlying disease, surgical wounds, and tubes in their bodies. Small numbers of organisms that would not affect a healthy person, may be life threatening to a patient. Students are to wear protective barriers when it is indicated and observe infection control and safety procedures consistently; to wear a mask for close contact with patients exhibiting signs of respiration infection.

On 4/2/19 at 1350 hours, a tour of the Medical Telemetry Unit was conducted with Manager 10 and CN 4. An isolation cart with a precaution sign showing contact and droplet isolation instructions was observed outside of Patient 9's room. A nursing student and the nursing student's instructor were observed standing at Patient 9's bedside. The nursing student was wearing a gown and gloves; however, the nursing student was not wearing a mask. The nursing student's instructor was wearing a gown; however, the nursing student's instructor was not wearing mask or gloves. CN 4 stated Patient 9 was in both contact and droplet isolation precautions. CN 4 further stated both the nursing student and nursing student's instructor should be wearing a gown, gloves, and mask while in Patient 9's room. When asked if the nursing student was providing care to other patients on the unit, CN 4 stated yes. CN 4 stated the nursing student and the nursing student's instructor received a report about the patients' conditions and plans of care at the beginning of the shift prior to providing care. Manager 10 stated it was the nurse's responsibility to ensure the care and safety of the patients were provided.

On 4/3/19 at 0915 hours, an interview and concurrent document review was conducted with CN 5. CN 5 stated the nursing student assigned to provide care to Patient 9 on 4/2/19, was also assigned to provide care to two other patients on the unit.

On 4/3/19 at 1000 hours, an interview and concurrent review of Patient 9's medical record was conducted with CC 4. CC 4 stated Patient 9 was admitted to the facility on 3/12/19, and transferred to the Medical Telemetry unit on 3/30/19 at 1830 hours. CC 4 further stated Patient 9 was on droplet precautions for pneumonia and contact precautions for a positive C-difficile culture.

Based on observation, interview, and record review, the hospital failed to ensure the nursing care of each patient was provided in accordance to the patient's needs as evidenced by:

1. Patients with telemetry monitoring who were not physically located in the medical telemetry unit, were not staffed as per the unit's scope of services and state regulation and were not assigned to a RN who had the same requirement as the telemetry RNs.

2. Competency evaluation for restraint was not completed for RN 10.

3. The hospital failed to ensure the DSU was staffed with the nursing aide as per the DSU staffing matrix.

These failures created the increased risk of substandard care provided to the patients.

Findings:

1. On 4/2/19 at 0910 hours, a tour of the General Surgery Unit was conducted accompanied by Manager 10, Manager 7, and CC1. At the nurses station, a telemetry monitor screen was observed showing Patient 11's heart rate and heart rhythm. Review of the daily assignment sheet dated 4/2/19, showed RN 1 was assigned to care for five patients including Patient 11.

On 4/2/10 at 1000 hours, an interview and concurrent review of Patient 11's medical record was conducted with RN 1. Review of Patient 11's medical record showed the patient was admitted to the hospital on 3/7/19. The patient was transferred to the General Surgery Unit on 3/25/19 at 1019 hours. Review of the physician's order dated 3/24/19 at 1313 hours, showed transfer level of care to: "Med/Surgical with Tele." RN 1 stated she was assigned to care for five patients including Patient 11 who was on the telemetry monitor.

On 4/2/19 at 1035 hour, a tour of the Orthopedic Unit was conducted accompanied by Manager 10 and CN 3. At the nurses station, a telemetry monitor screen was observed showing Patients 10, 20, and 23's heart rates and heart rhythms.

Review of the daily assignment sheet dated 4/2/19, showed RN 2 was assigned to care for five patients including Patient 10.

On 4/2/10 at 1100 hours, an interview and concurrent review of Patient 10's medical record was conducted with RN 2. Review of Patient 10's medical record showed the patient was admitted to the hospital on 4/1/19. Review of the physician's order dated 4/1/19 at 2006 hours, showed to admit as inpatient with "Level of Care: Med/Surgical with Tele." RN 2 stated she was assigned to care for five patients including Patient 10 who was on the telemetry monitor.

On 4/4/19 at 1005 hours, a meeting with the GB members was conducted. When asked what the level of care would be expected and to be provided to the patient when the physician ordered to admit or transfer the patient to medical/surgical or orthopedic with telemetry monitor. The COS stated the expectation was the patient would receive the same level of care as a patient with telemetry level of care or higher level of care.

a. Pursuant to Title 22, Section 70217(a)(10), commencing January 1, 2008, the licensed nurse-to-patient ratio in a telemetry unit shall be 1:4 or fewer at all times. "Telemetry unit" is defined as a unit organized, operated, and maintained to provide care for and continuous cardiac monitoring of patients in a stable condition, having or suspected of having a cardiac condition or a disease requiring the electronic monitoring, recording, retrieval, and display of cardiac electrical signals.

Review of the Scope of Services/Admission Transfer and Discharges for Orthopedic Unit updated 3/3/17 showed, "...Patients that require telemetry monitoring will be assigned 1:4..."

During an interview with CN 3 on 4/2/19 at 1058 hours, CN 3 stated the nurse-to-patient ratio on the orthopedic unit was one nurse to five patients. When asked about the nurse-to-patient ratio for patients with telemetry monitoring on the orthopedic unit, CN 3 stated the nurse-to-patient ratio remained the same, one nurse to five patients.

b. Review of the Department Specific Requirements-Medical Telemetry showed the Clinical Nurse II Minimum Requirement was "current ... RN License... Current American Heart Association Basic Life Support (BLS) for Healthcare Provider....current American Heart Association Advanced Cardiac Life Support (ACLS).

On 4/4/19 at 1440 hours, an interview and concurrent review of RNs 1 and 2's personnel files was conducted with Executive Director 4, Educator 1, and Manager 14.

* Review of RN 1's personnel file showed RN 1's job title was RN II. The Department Specific Requirements-Medical Surgical showing the Clinical Nurse II Minimum Requirement were "current California RN License" and "Current American Heart Association Basic Life Support (BLS) for Healthcare Provider." There was no requirement of ACLS certification for Clinical Nurse II or RN 1. Further review of RN 1's personnel file showed RN 1 did not have ACLS certification.

* Review of RN 2's personnel file showed RN 2's job title was RN II. The Department Specific Requirements-Orthopedic showing the Clinical Nurse II Minimum Requirement were "current California RN License" and "Current American Heart Association Basic Life Support (BLS) for Healthcare Provider." There was no requirement of ACLS certification for Clinical Nurse II or RN 2. Further review of RN 2's personnel file showed RN 2 did not have ACLS certification.

Executive Director 4, Educator 1, and Manager 14 confirmed RNs 1 and RN 2 did not have the ACLS certificate. Executive Director 4 stated RNs 1 and 2 were not required to have the ACLS certification.

Executive Director 4, Educator 1, and Manager 14 were informed RNs 1 and 2 who had no ACLS certification, were assigned to care for patients who were transferred or admitted to the general surgical or orthopedic unit and were required to be on telemetry monitoring. Educator 1 stated the physician ordered telemetry monitor for patients who were in the general surgical unit or orthopedic unit, and these patients were not required the telemetry level of care. Executive Director 4, Educator 1, and Manager 14 were informed the physician's expectation was to provide a telemetry level of care or higher to the patients when the physician ordered telemetry monitor for the patients. Executive Director 4 was asked what was the requirement for a nurse who would be assigned to provide care to a patient who required telemetry monitor in the telemetry unit. Executive Director 4 stated the requirements included RN license, BLS and ACLS certifications.


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2. Review of the hospital's P&P titled Restraints and Seclusion revised 6/18 showed all appropriate direct care staff that have direct patient contact, will have ongoing education and training as indicated by the department's scope of services in the proper and safe use and application of restraints and seclusion with emphasis on prevention and alternatives to restraint use. Direct patient care staff will receive ongoing training and demonstrate competencies in identifying behavioral emergencies and choosing the least restrictive intervention based on an individualized assessment of the patient's medical, or behavioral status or condition.

The nursing staff did not implement the hospital's P&P related to the restraint application for Patient 15. Cross Reference to A 0395, example # 1.

On 4/4/19 at 1440 hours, an interview and concurrent review of RN 10's personnel file was conducted with Executive Director 4, Educator 1, and Manager 14.

Review of RN 10's competency for restraints and hard restraints showed RN 10 met the standard competency outcome. However, the section of evaluator signature and date were left blank.

Executive Director 4, Educator 1, and Manager 14 verified the above finding.

3. Review of the Staffing Matrix for CV-SDU (or DSU overflow) showed for the day shift, one nurse aide should be staffed when there are six patients.

Review of the Hybrid CVICU (DSU overflow) Assignment Sheet dated 3/23/19 for the day shift, showed there were six patients and two RNs. However, there was no nurse aide staffed on 3/23/19, for day shift as per the staffing matrix.

On 4/4/19 at 1200 hours, Manager 12 verified the above findings.

Based on interview and record review, the hospital failed to ensure the medications were administered and monitored as per the hospital's P&P or protocol for two of 31 sampled patients (Patients 11 and 3) as evidenced by:

1. The use of heparin (an anticoagulant) was not monitored timely for the potential of adverse effects for Patient 11.

2. The nursing staff did not document when titrating norepinephrine (medication used for low BP) for Patient 3.

These failures created the increased risk of inappropriate care provided to these patients.

Findings:

Review of the hospital's P&P titled Medication/IV Administration reviewed/revised 9/17 showed all medications administered will be documented in the medical record to include the date and time. Patients will be monitored for parameters specified in the medication order, per the IV Administration Guidelines in Lexicomp (an online drug reference), or per other approved procedure or guideline.

1. Review of the hospital's Heparin Intravenous Infusion Protocol & Guideline revised 2/18 showed the pharmacist will assume the responsibility for dosing and monitoring therapy as specified in this protocol upon receipt of an order for "Heparin per pharmacy." The pharmacist will contact the physician when there are reports or documentation of clinically significant signs of thrombosis (clotting of the blood) or bleeding or other adverse effects. The pharmacist note/order will be documented in the patient's medical record at the initiation of therapy and on a daily basis. Information may include but is not limited to pertinent laboratory/diagnosis results; orders, plans/recommendations for providing or modifying the anticoagulation therapy.

According to Lexi-comp, thrombocytopenia (an abnormal low platelet count) is one of the adverse effects from the use of heparin.

Review of Patient 11's medical record was initiated on 4/2/19. The patient was admitted to the hospital on 3/7/19.

Review of the physician's order dated 3/12/19 at 1740 hours, showed heparin drip per pharmacy.

Review of the medication administration record showed heparin drip was started for Patient 11 on 3/12/19 at 2005 hours.

Review of the laboratory report showed Patient 11's platelet counts was 333 K/uL (normal range is from 150 to 450 K/ul) on 3/9/19 at 0255 hours, 237 K/ul on 3/10/19 at 0637 hours, 158 K/ul on 3/13/19 at 0824 hours, and 109 K/ul on 3/14/19 at 0613 hours.

There was no documented evidence to show the pharmacist intervened or notified the physician when Patient 11's platelet count was decreased to 109 K/ul on 3/14/19 at 0613 hours.

On 4/4/19 at 1205 hours, an interview and concurrent review of Patient 11's medical record was conducted with Manager 16 and the Medication Safety Officer. Manager 16 and the Medication Safety Officer confirmed the finding.


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2. Patient 3's medical record was reviewed on 4/2/19. Patient 3 was admitted to the hospital on 4/1/19.

Review of the Physician's Order dated 4/1/19 at 2251 hours, showed to administer norepinephrine IV per the following protocol:

* Starting rate at 4 mcg/min.

* Titrate up 2 mcg/min every five minutes to maintain MAP > 65 mmHg.

* Titrate down 2 mcg/min every five minutes and call MD if HR is equal to or greater than 120 bpm.

* Maximum rate is 30 mcg/min.

Review of the Care Activity-Assessments showed on 4/2/19, the norepinephrine was administered to Patient 3 as follow:

* At 0800 hours, norepinephrine was infusing at 15 mcg/min.

* At 0915 hours, Patient 3's MAP was 50 mmHg. RN 8 titrated the norepinephrine up to 17 mcg/min.

* At 0930 hours, Patient 3's MAP was 74 mmHg.

* At 0945 hours, Patient 3's MAP was 87 mmHg.

* At 1000 hours, the norepinephrine was infusing at 10 mcg/min.

However, there was no documented MAP at 0920 hours to evaluate the effectiveness of the increased norepinephrine infusion after titrating the norepinephrine up to 17 mcg/min from 15 mcg/min at 0915 hours. In addition, there was no documentation to show why the nursing staff titrated down the norepinephrine infusion from 17 mcg/min to 10 mcg/min in accordance to the physician's order.

On 4/2/19 at 1445 hours, an interview with RN 8 was conducted in the presence of Managers 11 and 12. RN 8 stated she did not document every time she titrated the norepinephrine. Managers 11 and 12 verified the norepinephrine titration was not documented.

Based on observation, interview, and record review, the hospital failed to ensure the surgical services areas were maintained per the hospital's P&Ps as evidenced by:

1. The temperature and humidity levels were not maintained in the surgical areas as per the hospital's P&P. In addition, the surgical staff failed to initiate corrective actions when the temperature and humidity levels were out of range as per the hospital's P&P.

2. The Surgical and L&D areas were not maintained in a state of cleanliness and sanitary condition as per the hospital's P&P.

3. The surgical scrubbing was not timed and monitored in the Main OR.

These failures created an unsafe environment for the patients and surgical services staff.

Findings:

1. Review of the hospital's P&P titled Temperature, Humidity, and Pressure Relationship Monitoring for Procedure Suites reviewed/revised 5/16 showed the following:

* This P&P is to provide guidelines for temperature, humidity, and pressure relationship values in procedural suites which includes Surgical Services, and L&D.

* The temperature, humidity, and pressure relationship in each procedural suite will be monitored and recorded on days of operation. The recommended Relative Humidity is between 30-60%. The recommended optimal suite temperature is between 68-73 degree F with adjustments made to the temperature for optimal patient care.

* The temperature, humidity, and pressure relationship is recorded for every suite in the department on days of operation by a designated person. A log book is kept in each department.

* If the temperature recording is out of range at the time of the daily check, adjust the thermostat to 68-73 degrees F. If the temperature remains out of range call engineering immediately.

* If the humidity recording is out of range at the time of the daily check, call engineering immediately. If the humidity remains out of range prior to the start of the first case, reassign cases to a procedural suite where relative humidity is between 30-60% when possible; if humidity range is between 20-29% perform the low Relative Humidity Risk Assessment Steps.

* If either temperature, humidity, and/or pressure relationship are out of range at the time of daily checks and appropriate phones calls or actions have been taken, recheck the room suite in approximately 30-60 minutes to confirm whether or not the corrected range has returned.

* Document actions taken on the "CORRECTIVE ACTION" log sheet

* At any time during daily operations the temperature (unless indicated for optimal patient care), humidity, and/or pressure relationship is identified to be out of the acceptable range, the above actions should be initiated without interruptions of ongoing cases.

On 4/3/19 at 1430 hours, the Temperature, Humidity, Pressure Relationship Log Sheet for the month of March 2019 was requested and reviewed.

Review of the Temperature, Humidity, Pressure Relationship Log Sheets for the month of March for the ORs, CV ORs, L&D ORs, Sterile Closet in the L&D, SPD Decontamination area, SPD sterilization/storage area and OR Core/Bone/Tissue Bank Cart showed the instructions as follow:

* For temperature out of range, adjust the thermostat to range. If no thermostat available, call 15000.

* For humidity and/or room pressure out of range, call 15000 immediately.

* Recheck in approximately 30-60 minutes, if still out of range call 15000.

* Do not use the room until ranges are within normal limits; document all corrective actions on the corrective actions log sheet attached.

* The humidity range is 30-60%.

* The temperature range is 68-73 degree F for the ORs, CV ORs, L&D ORs, Sterile Closet in the L&D, SPD sterilization/storage area and OR Core/Bone/Tissue Bank Cart.

* The temperature range is 65 to 73 degrees F for the SPD decontamination area.

Further review of the Temperature, Humidity, Pressure Relationship Log Sheets showed the following:

a. The temperature levels were out of range on multiple dates in different ORs and CVORs. For example:

* On 3/15/19, the temperature levels were documented as 59 degrees F for CVOR 24; 60 degrees F for CVOR 23; 66 degrees F for OR 5; and 67 degrees F for OR 2.

* On 3/27/19, the temperature levels were documented as 67 degrees F for OR 2 and CVOR 25; 66 degrees F for ORs 3, 4, 6, 7, 9 and CVOR 23; and 64 degrees F for CVOR 24.

b. The humidity levels were below 30% on multiple days in different ORs, CVORs, L&D OR 4, SPD decontamination area, and SPD sterilization/storage area. For example:

* On 3/14/19, the humidity levels were documented as 19% for L&D OR 4; 20% for OR 4; 25% for OR 7 and SPD Decontamination area; and 21% for CVOR 24 and SPD sterilization/storage area.

* On 3/15/19, the humidity levels were documented as 24% for L&D OR 4 and SPD Decontamination area; 23% for SPD sterilization/storage area, CVORs 24 and 21; 21% for OR 5; and 20% for ORs 6, 7, 9, 11, 12, and CVOR 25.

* On 3/27/19, the humidity levels were documented as 23 % for OR 4; 28% for OR 7; 22% for OR 15; and 23 % for CVOR 24.

c. On 3/28/19, the sections for the temperature and humidity levels for CVOR 25 were left blank.

On 4/3/19 at 1253 hours, an interview and concurrent record review was conducted with Executive Director 3 and Manager 5. After reviewing the hospital's P&P and the Temperature, Humidity, Pressure Relationship Log Sheets, Executive Director 3 and Manager 5 stated the staff should report and act on the issues when the temperature and humidity levels were out of range, and document the actions on the Corrective Action Log. However, Executive Director 3 and Manager 5 could not locate documented evidence of the actions taken by the staff when the temperature and humidity levels were out of range. Executive Director 3 and Manager 5 stated they were not aware the temperature and humidity levels were out of range and did not receive reported events of any interruption of the surgery services related to the temperature or humidity level being out of range.

2. Review of the hospital's P&P titled Surgical and Specialized Area Cleaning reviewed/revised 7/16 showed the following:

* The policy is to establish the pre/post-case and terminal cleaning procedures to ensure an aseptically clean environment for the patients and staff in all the surgical suites in the Main Hospital Surgical Area, Labor and Delivery C-Section Rooms where the invasive procedures are completed. The patient care environment will be maintained in a state of cleanliness that meets professional standards in order to protect the patients and health care personnel from potentially infectious organisms.

* The EVS department will adhere to establish a terminal cleaning schedules and procedures to ensure aseptically clean environment for the patients and staff in the sterile surgical and procedural areas of the hospital.

* The room turnover (between case cleaning) procedures includes

- Removing the trash.

- Starting with the OR table by wiping the joints and table attachment, wiping sides of the mattress by using a minimum of one microfiber cloth and allow drying for a minimum of three minutes.

- Cleaning and disinfecting patient transfer devices, mayo stands, and the high touch objects such as telephone.

- Cleaning and disinfecting the floors and walls of the operating and procedure rooms after each surgical or invasive procedure if soiled or potentially soiled.

* Unused rooms should be cleaned once during each 24 - hour period during the regularly scheduled work week because personnel entering unused rooms and moving equipment and supplies in and out of the room can increase the risk of environmental contamination.

* The terminal room cleaning procedure include paying special attention to the air exhaust and intake vent as they must be kept free of lint and dust.

* Documentation includes to document in the Terminal Cleaning Logs.

a. On 4/3/19 at 0921 hours, a tour of the L&D ORs was conducted with Executive Director 1, Manager 3, and Educator 2. The following was identified:

* In L&D OR 2, EVS 1 was observed performing a turnover cleaning.

- EVS 1 used a blue towel with Oxycide (a disinfectant) solution to clean the PANDA baby warmer. EVS 1 wiped the top of the mattress pad of the baby warmer, turned over the pad, wiped the back of the mattress pad and put the mattress pad back immediately to the baby warmer. EVS 1 used the same blue towel to wipe the wall mounted telephone set and the mayo stand. Then with a new blue towel with Oxycide solution, EVS 1 cleaned and disinfected the patient's transfer roll board that was placed on top of the OR pad. After wiping the transfer roll board with the blue towel with Oxycide solution, EVS 1 immediately placed it back on top of the OR pad.

- EVS 1 then cleaned the floor with a mop. EVS 1 used the mop to push the trash that was on the OR floor to the entrance door, used a broom and a dustpan to pick up the trash, dump the trash to the EVS cart, placed a yellow "Wet" warning stand, and left the OR. The floor was observed not being wet after being mopped.

- Two minutes after EVS 1 left L&D OR 2, Vendor 1 and AT 1 went inside L&D OR 2.

During a concurrent interview with EVS 1, she stated she used Oxycide solution to clean all the surfaces and the wet time (or contact time) for the Oxycide would be five (5) minutes.

During a concurrent interview with Vendor 1, Vendor 1 stated the L&D nurses would advice him if the OR was not available for him to go in; otherwise, he could access any ORs.

Manager 3 confirmed all of the surfaces that EVS 1 had wiped or mopped, were not wet for five minutes as per the manufacturer's recommendation.

* In L&D OR 4, the following was identified:

- Two air exhaust vents were dusty.

- Trash was observed on the OR floor.

- There was trash in the trash can.

- The surfaces of the anesthesia cart was observed with rust and missing paints.

According to Manager 3, L&D OR 4 was a clean OR and ready to be used for a procedure.

* In L&D OR 3, the following was identified:

- The air exhaust vents were not cleaned thoroughly.

- A used medication vial was found on the floor next to a sharps container.

- The mattress pad on the OR table was observed with small cracks.

- The OR table frame had accumulate of dust.

According to Manager 3, L&D OR 3 was a smaller OR, and was not used very often. Manager 3 did not have the information when L&D OR 3 was last used or cleaned. Manager 3 stated the EVS staff should report to her the cracked mattress pad.

* In the soiled utility room of the L&D, there was a hopper in the room. The following was observed:

- The hopper had built up dark red, brown, and yellow colored discharges in the bowl.

- There were beef red spots on the rim of the hopper.

- There were dark black and dark red spots on the wall and floor next to the hopper.

A concurrent interview was conducted with OBT 1. OBT 1 stated she used this room to store dirty C-section instrument trays and cases cart. OBT 1 stated the EVS staff was responsible for cleaning this room.

Manager 15 checked the soiled utility room and stated the EVS Supervisor should have checked the soiled utility room during the morning rounds.

b. During the tour of the L&D ORs on 4/3/19 at 0921 hours, with Executive Director 1, Manager 3, and Educator 2, Manager 3 stated they had four ORs in the L&D and all the L&D ORs could be used for C-section cases and other emergency procedures in any given time; L&D OR 3 was a smaller room and often used for D&C procedures, but this room still could be used for C-section cases if needed. Executive Director 1 stated the EVS staff was responsible in cleaning the L&D ORs; the EVS evaluated their own works; the L&D staff did not oversee or evaluate the EVS; and the L&D staff could verbally communicate with the EVS Supervisor if there were concerns with the cleaning.

* AT 1 was observed wearing a bunny suit and entering each L&D ORs with a supply cart containing anesthesia supplies and medication cassettes. During the concurrent interview with AT 1, he stated he and the other ATs were responsible in changing/adding anesthesia supplies in the L&D ORs anesthesia carts weekly. Two minutes later, Vendor 1 was observed wearing a bunny suit and entered L&D OR 2 to change the sharps containers. During the concurrent interview, Vendor 1 stated the contracted services were to change and replace the sharps containers weekly.

Review of the L&D OR surgery schedule showed L&D OR 2 was used on 3/12/19, for a procedure; and L&D OR 3 was used on 3/15/19, for a procedure.

On 4/3/19 at 1453 hours, the Daily Operating or Procedure Terminal Cleaning Checklist for the month of March 2019 was reviewed with Director 1, Manager 15, and INFs 1 and 2.

Review of the Daily Operating or Procedure Terminal Cleaning Checklist showed documentation of the daily terminal cleaning for the L&D ORs (L&D ORs 1, 2, 3 and 4). Further review showed the following:

* For L&D OR 3, the terminal cleaning was done on 3/13/19. However, there was no documented evidence to show the terminal cleaning was completed for the rest of March 2019. There was no documentation a terminal cleaning was done after L&D OR 3 was used on 3/15/19.

* For L&D OR 1, there was no documentation a terminal cleaning was done 3/12 and 3/14/19.

* For L&D OR 2, there was no documentation of terminal cleaning was done after it was used on 3/12/19. In addition, there was no documentation a terminal cleaning was done on 3/25 and 3/26/19.

* For L&D OR 4, there was no documentation a terminal cleaning was done on 3/1, 3/2, 3/3, 3/4, 3/5, and 3/14/19.

Director 1, Manager 15, and INFs 1 and 2 confirmed the findings.

According to Manager 15, each EVS staff had to clean the OR after each use and perform a terminal cleaning when all the cases were done. The OR would not be cleaned if it was not used for that day. Everyday, the EVS staff would complete the cleaning tasks and mark the daily cleaning log with their initials. The daily cleaning log were reviewed and signed off by a supervisor. In addition, the supervisor were to conduct an inspection to ensure the cleaning was done properly. Manager 15 received reports from the supervisors and would review for the completion of all daily cleaning log. Director 1 colleted the data from Manager 15 and reported to the Infection Control Committee quarterly.

Manager 15 stated they were not aware of the for the days the clearing was missed. hospital's P&P requiring the cleaning of any unused OR once during each 24 hour period; and confirmed they did not do it. Manager 15 stated he did not document, track, and trend the daily terminal cleaning logs and did not see documented report of the supervisor's rounding. Manager 15 did not have a system to track and trend any identified concerns of the EVS services in the L&D OR area.

c. On 4/2/19 at 1038 hours, a surgical procedure was observed in the main hospital's OR 7. The following was identified:

- The air exhaust vents were dusty.

- The OR's floor seams were not intact.

- Outside of OR 7, there were two rubber drainage floor mats located under the two scrub sinks. The back of the rubber drainage floor mats were observed with accumulated lint and debris.

During a concurrent interview with Manager 15, the Manager stated he was not aware of the lint and debris underneath the rubber drainage floor mats. Manager 15 stated the EVS staff mopped the floor underneath of the mats but they did not clean or wash the rubber drainage floor mats.

3. On 4/2/19 at 1026 hours, a tour of the Main OR was conducted. The following was observed:

- There was a sign posted next to the scrub sink outside of OR 7 showing to hand scrub for six (6) minutes. MD 7 and PA 1 were observed scrubbing for a surgery; however, there was no timer set for six minutes for the scrubbing time.

During the concurrent interview, MD 7 stated the timer would be on when the water was running, and the timer would be interrupted when the water was turned on and off. MD 7 stated the MD only needed the water for rinsing hands therefore the water was not turned on or running all the time.

- Next to OR 6, the timer for the scrub sink was checked. The timer could not be turned on when checked. Executive Director 3 and Manager 4 confirmed there was no alternative method for the surgical personnel to time the six minutes when scrubbing for a surgery.