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Based on interview and record review, the facility failed to follow its policy and procedure when three of 9 sampled employees (EVS 1, RN 1 and CLS 1) did not have a completed pre-employment background check prior to their date of hire. This failure had the potential to affect the patients' overall health and safety in a universe of 6 patients.

Findings:

On August 21, 2015 at 8:10 AM, an interview with the Human Resources Generalist (HRG) and a concurrent review of the employee's files was conducted and HRG confirmed the following:

1. Environmental Services Technician (EVS) - Date of hire: March 7, 2011. The background check was completed on March 10, 2011 (3 days after date of hire).

2. Registered Nurse (RN 1) - Date of hire: October 7, 2011. The The background check was completed on October 18, 2011 (11 days after date of hire).

3. Clinical Laboratory Scientist (CLS) - Date of hire: October 31, 2011. There was no documented evidence of a verification of CLS' social security and past employment/reference.

A concurrent review of the facility's policy and procedure titled "Post Offer Background Check Policy," Revised date 4/16/2012, revealed, "Purpose. Employment at (name of hospital) is contingent on successfully completing a post-offer, pre-employment background check...Policy...All background and reference checks are conducted after an offer of employment has been accepted and will be completed prior to an employee starting work with (name of hospital) ... An outside vendor is contracted to gather background information on: criminal history, national wants and warrants, driving record, previous employer verification, sexual predator, and social security verification. This information gathering is for all newly hired employees. The Human Resources department may conduct: professional license verification, O.I.G. name search, reference checks, and previous employer verification for applicants who are offered and accept a position..."

Based on observation, interview and record review, the facility failed to conduct pharmacy oversight for monitoring drugs and biological's for all OB (Obstetrical) patients in the Perinatal Department including Labor and Delivery, Post Partum (after childbirth) and Nursery. This failure had the potential to cause harm to patients if they received the wrong medications or dosages for patients receiving perinatal services.

Findings;

During an observation on August 18, 2015, at 4:45 PM with the OB Manager (RN 3), a Pyxis (automated medication dispensing machine) was noted in the medication room.

During a concurrent interview with RN 3, when asked how orders were entered into the Pyxis system, she stated the OB Department is not on MAC (a computer physician order entry system), orders are handwritten by the physician. After the physician writes the order, the nurse will place the orders in the Pyxis, then the medications can be accessed.

During an interview on March 20, 2015 at 8:30 AM with the Pharmacy Manager (PH 1), when asked if the pharmacy had medication oversight in the Perinatal Department, she stated no, the physicians handwrote the order, then the nurses enter the order in Pyxis. When asked if pharmacy reviews the orders retrospectively, she stated they do not.

During an interview on March 20, 2015 at 3:00 PM with Pharmacist 2 (Ph 2), when asked to review the policy "Review of Medication Orders" dated October 12, 2011, she stated, according to policy the Perinatal Department should have pharmacy oversight.

The facility policy and procedure titled "Review of Medication Orders" dated October 12, 2011, indicated Scope / Applicability: All inpatient medication orders generated at [The Facility]...", "... the pharmacist must conduct a retrospective review of the order as soon as he or she is available..."

Based on observation, interview, and record review, the facility failed to follow its policy and procedure on checking crash carts daily (a cart containing supplies used for emergency situation) at the Family Medicine Outpatient Clinic and on the Perinatal (Labor and Delivery, Post Partum and Nursery) Units for two out of six crash carts inspected. This finding had the potential to affect the health and safety of all patients receiving emergency services at the Family Medicine Outpatient Clinic and on the Perinatal Units.

Findings:

1. On August 19, 2015 at 9:10 AM, an inspection of the crash cart at the Family Medicine outpatient clinic and a concurrent interview with Registered Nurse (RN 7), in the presence the Educator Coordinator, was conducted.

A concurrent review of the "Crash Cart Daily Checklist" for August 2015 revealed initials that indicated the crash cart was not checked daily by the staff members. RN 7 confirmed the contents of the cart was not checked by the staff member on August 1, 2015.

A review of the facility's policy and procedure titled "Crash Cart Checks," dated November 4, 2014, indicated, "Departments that has a crash cart must perform daily checks."

2. During an observation on August 18, 2015 at 4:45 PM with the Obstetrical (OB) Manager (RN 3), the Perinatal crash cart logs dated July 4, 17,18,19, August 4, 7, and 13 were missing the daily checks.

During a concurrent interview with RN 3, she stated that the checks should have been documented on the Crash Cart log, but she had created another log titled "Perinatal Daily Assignment Sheet" (PDAS) and nurses note on that form if the crash cart has been checked. When asked if the PDAS had all elements of a crash cart check, she stated no, it just indicates that it had been done.

When asked if the Perinatal Department is ever closed, she stated it is not.

The facility policy and procedure titled "Crash Cart Checks" dated November 4, 2014 indicated "Each of the six departments that has a crash cart must perform daily ...checks: Daily (except days when that particular department is closed) a staff member will note the following, document it in the crash cart's daily log and record their initials: Monitor is charging, battery is full, hourglass (a shape) is flashing, check defibrillator (a machine used to shock a heart back to a normal rhythm) cable and pads, monitor paper is present, suction pump is charging, outer plastic lock is in place, Oxygen tank is adequate."

Based on observation, interview, and record review, the facility failed to ensure all essential patient-care equipment were maintained in safe operating condition when the preventative maintenance (PM - maintenance to ensure its safe and reliable operation) for multiple devices and equipment located at the radiology department, physical and occupational therapy clinic, orthopedic clinic, women's health clinic, family medicine clinic, and the intensive care unit, were noted to be not updated.
This failure had the potential to lead to misdiagnosis if the readings or values were not correct or cause harm to patients if the equipment was not performing as expected for all patients requiring diagnostic and therapeutic services being serviced by the hospital.

Findings:

1. During a tour of the outpatient Physical Therapy/Occupational Therapy Clinic with the Educator Coordinator on August 19, 2015, an inspection of the medical devices and equipment was conducted. During an interview with the Orthopedic/Rehabilitation Manager on August 19, 2015 at 8:15 AM and a concurrent inspection of the weighing scale, the Orthopedic/Rehabilitation Manager confirmed the weighing scale did not have a documented evidence to indicate a PM was performed.

During an interview with Biomedical Technician (Biomed Tech 1) and Biomed Tech 2 on August 19, 2015 at 2:30 PM, they confirmed the most recent PM performed on the weighing scale was on September 26, 2013 (approximately 2 years and 11 months ago); they stated the PM should have been performed yearly.

2. During a tour of the outpatient Orthopedics Clinic with the Educator Coordinator on August 19, 2015, an inspection of the medical devices and equipment was conducted. During an interview with the Orthopedic/Rehabilitation Manager on August 19, 2015 at 8:30 AM and a concurrent inspection of the medical device and equipment, the Orthopedic/Rehabilitation Manager confirmed the following:

a. Two pulse oximeter devices (measures the oxygen saturation level in the blood) had a "sticker" that indicated the PM was performed on May 21, 2014 and the next PM was due to be performed on May 2015 (approximately three months ago).

b. A blood glucose meter (a meter that tests blood sugar levels) had a "sticker" that indicated the PM was performed on June 26, 2014 and the next PM was due to be performed on June 2015 (approximately two months ago).

During an interview with Biomedical Technician (Biomed Tech 1) and Biomed Tech 2 on August 19, 2015 at 2:30 PM, they confirmed the PM for the two pulse oximeter devices should have been performed on May 2015, and the PM for the blood glucose meter was performed on June 30, 2015 but was mislabeled (the sticker indicated the PM wrong date).

3. During a tour of the outpatient the Women's Health Clinic with the Educator Coordinator on August 19, 2015, an inspection of the medical devices and equipment was conducted.

During an interview with Registered Nurse (RN 7) on August 19, 2015 at 9:35 AM and a concurrent inspection of the medical device and equipment, RN 7 confirmed two Blood Pressure monitor device (BP-tests pressure of the blood) did not have a documented evidence to indicate performance of a preventative maintenance on the devices.

During an interview with Biomedical Technician (Biomed Tech 1) and Biomed Tech 2 on August 19, 2015 at 2:30 PM, they confirmed the Clinical Engineering Department (Biomed department) did not "track" and calibrate blood pressure monitor devices. They explained that when the nursing staff noted the "needle is out (needle on the gauge fails to point to zero to indicate calibration)," the staff would determine whether to request and obtain a new BP monitoring device or continue its use.

A review of the manufacturer's guide on calibration check of the device, it revealed a recommendation of a full check of calibration every two years.

3. During a tour of the outpatient the Family Medicine Clinic with the Educator Coordinator on August 19, 2015, an inspection of the medical devices and equipment was conducted. During an interview with the Family Medicine Clinic Manager on August 19, 2015 at 9:10 AM and a concurrent inspection of the medical device and equipment, the Family Medicine Clinic Manager confirmed the photodynamic therapy device (used for skin problems; uses a particular type of light) did not have a documented evidence that a PM was performed.

During an interview with Biomedical Technician (Biomed Tech 1) and Biomed Tech 2 on August 19, 2015 at 2:30 PM, they confirmed the photodynamic therapy device "was not on the (Biomed's medical device/equipment tracking) system." They both confirmed they had no knowledge the device was in the clinic and was being used for the patients, of who and of when the device was received by the clinic staff, and whether the device was hospital-owned or not. They confirmed the device "shouldn't have been up there (in the clinic)."

When asked what the facility's process was on preventative maintenance of the medical devices and equipment, Biomed Tech 1 and Biomed Tech 2 explained whenever a device or an equipment was purchased by the facility, it would be delivered to the Clinical Engineering (Biomed) department. The Biomed technicians would assign a PM procedure for the device or the equipment, information including the serial number and its location would be documented, and a PM sticker and a control number would be assigned. A "risk assessment" on patient safety would be initiated, and procedures or tasks would be performed on each device or equipment according to the manufacturer's recommendation, before it would be delivered to the appropriate department.

A concurrent review with Biomed Tech 2 of the facility's policy and procedure titled "Medical Device Equipment Management Policy," Revised date 4/25/14, it revealed under Procedure, "The Biomed Department Shall: ... Test and ensure the operating safety of clinical equipment utilized (at the clinic locations) ... Maintain a facility "Equipment Inventory List" for the devices specified above ...Perform and document all required safety, corrective and preventative maintenance actions for the devices specified above ...Provide documentation upon request, to each area detailing all work accomplished and the equipment status...Inspect all Medical Devices prior to their initial use and at intervals to be identified utilizing a "Risk Factor" evaluation system...Provide a quality assurance program to validate the performance of the Clinical Engineering program...Continually review, monitor and when appropriate, address any and all pertinent regulatory changes..." It further revealed, "Incoming inspections (Hospital owned equipment): All hospital owned equipment that directly supports patient care, or that is located within the patient care setting, regardless of acquisition methods, is inspected prior to initial use. Equipment is inspected to assure physical condition, functionality, accuracy, patient/operator safety, electrical safety, and proper documentation. All equipment is equipped with a "Biomed Control ID Number," and is included in the computerized maintenance system inventory. Operator and service manuals are maintained on file in the Clinical Engineering Department, or in the department that will be responsible for the technical support of the equipment..."

During an interview with the Family Medicine Clinic Manager in the presence of the Education Coordinator on August 19, 2015 at 3:15 PM, she confirmed the photodynamic device, which was delivered to the clinic from "purchasing department" on November 20, 2014, was being used for the patients who had skin issues. The Family Medicine Clinic Manager she was not part of the "protocol of receiving the equipment" in the clinic and she did not know who set-up the equipment.

A review of the "Dermatology" (pertains to the skin) patient list revealed eight patients, from January 9, 2015 to February 19, 2015, had received treatment using the photodynamic device.






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4. During an observation on August 18, 2015 at 3:50 PM during a tour of the Emergency Room (ER) with the ER Manager (RN 8), an X-ray machine was noted in the Trauma room attached to the ceiling. No PM sticker was present indicating when the PM was last done or due to be done.

During an interview with the RM on August 19, 2015 at 9:30 AM, he stated the last PM on the ER X-Ray Machine was completed on June 4, 2013. He stated the PM should be done annually, and he needed to call the company to schedule the PM.

During an interview with the RM on August 20, 2015, the RM stated the reason the PM was missed in 2014 was because it was not on the contracted company's list to do the work.

During the same interview, when asked how often the ER X-Ray machine was used , he stated it was used a lot, especially during trauma events.

When asked what the outcome of not having PM done annually on an X-Ray machine would be, he stated if not enough radiation was emitted, the diagnostics may be wrong, and if too much radiation was emitted, it could release dangerous levels of radiation.

The facility policy and procedure titled "B001 Medical Device Equipment Management Policy", dated April 25, 2014 indicated, "If scheduled maintenance is being handled by an outside vendor, the Clinical Engineering Department will notify the vendor and schedule the PM service."

5. During an observation on August 19, 2015 at 7:30 AM, in the Intensive Care Unit (ICU), Pulse Oximeter 4 was noted to have a green tag that said "Last serviced July 2014, Inspection due July 2015."

During a concurrent interview with RN 4, she stated the PM should have been done last month.

During an interview on August 10, 2015 at 2:00 PM with Biomed Tech 2, when asked about the PM on Pulse Oximeter 4, he stated that it was on the PM list to do, but the machine could not be located.

The facility failed to ensure that the Condition of Participation for Organizational Structure was met when the facility failed to do the following:

1. Failed to identify that Undercooked unpasteurized shelled eggs were routinely served to patients who requested and received over easy eggs (fried on both sides, but the yolk stays runny). The dietary staff who prepared the eggs was not aware of the requirement to cook the eggs until congealed (solid) or to a temperature of 145 °F for 15 seconds. This lack of staff knowledge of safe handling of the eggs put the highly susceptible population of patients at the facility at greatly increased risk for food borne illness. (Refer to C-278)

An Immediate Jeopardy situation was declared on August 20, 2015 at 12:40 PM, in the presence of the facility's Chief Executive Officer (CEO), the Chief Nursing Officer (CNO) and the Clinical Quality Coordinator of Patient Safety and Risk (CQC), they were verbally notified of the facility's failure to ensure unpasteurized eggs were cooked so that all parts of the egg were congealed (solid) or ensure they were cooked to a safe temperature to eliminate the risk salmonella infection.

On August 21, 2015, at 7:30 AM, the Immediate Jeopardy situation was lifted in the presence of the CEO, CNO, CQC and the Registered Dietitian (RD) when the survey team approved the facility's Corrective Action Plan after observations, interviews and record review confirmed that the dietary staff was knowledgeable on safe handling of unpasteurized eggs. In addition, an updated policy regarding pasteurized eggs was correct and approved by the governing body. The Corrective Action Plan included the following components:

a. The facility's "Egg Storage and Preparation" policy was revised to include safe handling of unpasteurized eggs and was approved by the governing body.

b. The RD in-serviced all present dietary staff on safe handling of unpasteurized eggs. All dietary staff not present would be inserviced before starting their next shift.

c. Compliance with the new policy would be monitored daily via food temperature logs by the DS or his designee. The logs would be reviewed quarterly by the Performance Improvement Committee.

d. Pasteurized shelled eggs were ordered for delivery on August 21, 2015.

2. The facility's policies and procedures were approved by the Governing Board. (Refer to C-0241)

3. The facility's policies and procedures were reviewed annually. (Refer to C-272).

4. The Preventative Maintenance (PM - multiple medical devices and equipment were noted maintenance to ensure its safe and reliable operation) for multiple devices and equipment located at the radiology department, physical and occupational therapy clinic, orthopedic clinic, women's health clinic, family medicine clinic, and the intensive care unit, were updated and performed on time. (Refer to C-0336)

5. Failed to ensure pharmacy department had oversight in the Perinatal Department, including Labor and Delivery, Post Partum, and Nursery. This lack of oversight had the potential to affect the health and safety of all patients receiving obstetrical services in the Perinatal Department. (Refer to C-203).

The cumulative effect of these systemic problems had the possibility to result in increasing the risk of substandard quality healthcare for all facility patients in a universe of 6 patients. The facility failed to deliver care in compliance with the Condition of Participation for Organizational Structure.

Based on interview and record review, the facility failed to ensure that the Governing Board had approved the facility policies and procedures, specifically the new policy titled "Receiving Sterile Supplies brought in by Vendors into the Peri-operative Area." This deficient practice had the potential to result in increased the risk of a policy and procedure being implemented before it was evaluated and approved by the governing body.

Findings:

During an interview with the CNO, on August 19, 2015, at 9:45 AM, the CNO was asked for documentation of the policy approval process, through the Quality, Medical Executive Committee (CME) and Governing Board Committees, for the new policy "Receiving Sterile Supplies brought in by Vendors into the Peri-operative Area, dated June 18, 2015." The CNO was unable to comply, instead, the CNO provided a copy of the Board of Directors Meeting Minutes, dated February 21, 2013, and a facility policy and procedure titled "SMHD Policy, Procedure, Guideline, or Protocol Review and Approval Process," dated November 13, 2014.

The facility policy and procedure titled "Receiving Sterile Supplies brought in by Vendors into the Peri-operative Area," dated June 18, 2015, indicated "Approved by: [Name of CEO] (Chief Executive Officer) designated representative of SMHD Board...Sterility of implants will be verified first by examination of transport container to ascertain that it is a sealed container with sterile implants inside..."

A review of the Board of Directors Meeting Minutes, dated February 21, 2013, indicated "Delegation of Approval of Policies to the Chief Executive Officer and Medical Executive Committee: Discussion and Possible Action...this review and research supports the delegation of approval of policies to the CEO by the Board of Directors, subject to limitations."

During an interview with the Governing Board and the CEO, on August 20, 2015, at 9:15 AM, Board Member 1 stated that the Governing Board delegated policy approval to the CEO. The CEO confirmed that he was delegated the responsibility to approve facility policies by the Governing Board.

During an interview with the CNO, on August 20, 2015, at 11:35 AM, she stated that the Governing Board voted to rescind (take back) their delegation of policy approval to the CEO, and starting with the next Governing Board meeting, the Governing Board will adopt a more conservative process and they will vote to approve facility policies.

During an interview with the CNO, on August 19, 2015, at 11:15 AM, she was asked if the policy and procedure titled "SMHD Policy, Procedure, Guideline, or Protocol Review and Approval Process," dated November 13, 2014, indicated "the complete policy approval process? Are there other places the policies must be discussed and approved before they become effective?" The CNO stated, "No." She was then asked, " what about Quality?" The CNO answered, "Quality doesn't have to see the policy before approval."

The facility policy and procedure titled "SMHD Policy, Procedure, Guideline, or Protocol Review and Approval Process," dated November 13, 2014, indicated two routes of policy approval. One route was for "Clinical Policy, Guideline or Protocol" and the second route was for "Non-Clinical Policy." The Clinical policy route indicated that the final policy approval was to be given by the Medical Executive Committee (MEC). The Non-clinical Policy route indicated that final policy approval was given by the "Appropriate Committee..." Neither of these routes to policy approval, according to the policy, included the Governing Board or the CEO.

During an interview with the CNO, on August 20, 2015, at 7:15 AM, the CNO was asked to describe in detail, the facility policy approval process. The CNO stated, "If it was a surgical policy, the policy would go to the Surgery Committee for approval. Once the policy was approved by the appropriate Committee, the policy would go to the Medical Executive Committee (MEC) for approval. The CEO (Chief Executive Officer) is on the MEC and gives the final blessing." The CNO stated, "He's clinical, so he has been given the final say. He is a Physical Therapist by trade, he has a clinical sense of things." When asked, "Why do you do it that way?" According to the CNO, the Governing Board, in the past, has asked, "Why they were signing policies?" The CNO stated that a Governing Board member said, "I have a degree in English." The Governing Board wanted to make sure that the Medical Staff and the CEO were aware of the policy. The CNO stated, "That's our process." The CNO was asked, "Is the CEO a Governing Board member?" The CNO stated, "No."

During a review of the meeting minutes of the Governing Board and the MEC for 2015, indicated no documented evidence that the Governing Board or the MEC approved the facility policy and procedure titled "Receiving Sterile Supplies brought in by Vendors into the Peri-operative Area," dated June 18, 2015.

The Bylaws of the [Name of Healthcare District], dated May 15, 2014, indicated "Powers of Directors...To control and be responsible for the management of all operations and affairs of the District, and be the Governing Board of the Facilities operated by the District...To adopt resolutions and ordinances establishing policies or rules for the operation of this District and any of it's Facilities...Duties of Administrator...Carry out all policies established by the Board and the Medical Staff...All committees shall be advisory only to the Board unless otherwise specifically designated and authorized by the Board."

The facility failed to ensure that the Condition of Participation for Provision of Services was met when it failed to ensure the following:

1. The facility failed to have a system in place for identifying, investigating and controlling infections of patients when:

a. Unpasteurized shelled eggs (eggs that have not been through a process of killing harmful bacteria before eating) ) were not cooked to ensure all parts of the egg were congealed (solid) or ensure they were cooked to a safe temperature to eliminate the risk salmonella infection (salmonella is a bacteria and a common cause of food borne illness, sometimes called "food poisoning.") (Refer to C-278).

An Immediate Jeopardy situation was declared on August 20, 2015 at 12:40 PM, in the presence of the facility's Chief Executive Officer (CEO), the Chief Nursing Officer (CNO) and the Clinical Quality Coordinator of Patient Safety and Risk (CQC), they were verbally notified of the facility's failure to ensure unpasteurized eggs were cooked so that all parts of the egg were congealed (solid) or ensure they were cooked to a safe temperature to eliminate the risk salmonella infection. (refer C -278)

On August 21, 2015, at 7:30 AM, the Immediate Jeopardy situation was lifted in the presence of the CEO, CNO, CQC and the Registered Dietitian (RD) when the survey team approved the facility's Corrective Action Plan after observations, interviews and record review confirmed that the dietary staff was knowledgeable on safe handling of unpasteurized eggs. In addition, an updated policy regarding pasteurized eggs was correct and approved by the governing body. The Corrective Action Plan included the following components:

a. The facility's "Egg Storage and Preparation" policy was revised to include safe handling of unpasteurized eggs and was approved by the governing body.

b. The RD in-serviced all present dietary staff on safe handling of unpasteurized eggs. All dietary staff not present would be inserviced before starting their next shift.

c. Compliance with the new policy would be monitored daily via food temperature logs by the Dietary Supervisor (DS) or his designee. The logs would be reviewed quarterly by the Performance Improvement Committee.

d. Expired foods, nutritional supplements and enteral formula (liquid nutritional used with tube feeding directly into the digestive tract) were stored in the dietary services.

c. There was a lack of staff knowledge regarding the proper immersion time in the sanitizer solution for the three compartment sink, and

d. The ice machine in the cafeteria, used for patients, staff and visitors, was not clean.
These failures had the potential to result in food borne illness in the staff, visitors and a highly susceptible patient population. (refer C 278)

e. Pasteurized shelled eggs were ordered for delivery on August 21, 2015.

2. The facility failed to employ a qualified dietary services supervisor as required by the California Health & Safety Code 1265.4. This occurred when the facility dietitian was not full time running the day to day operations of the dietary services. Also, the Dietary Supervisor (DS) did not satisfy any of the seven pathways to qualify as a Dietary Services Supervisor as required in the code. In addition, the job description for the Registered Dietitian (RD) failed to include mandatory oversight of the dietary services by the RD as required by the same code. These failures contributed to unsafe dietary practices, including an Immediate Jeopardy situation, which put patients at risk for food borne illness in a universe of 6 patients. (Refer to C- 279)

3. The facility failed to conduct pharmacy oversight for all patients in the Perinatal Unit (Labor and Delivery Unit, Post-partum, and Nursery Units) This failure had the potential to cause harm to patients if they received the wrong medications or dosages. (Refer to C -203)

4. The facility failed to review its policies and procedure annually.
This deficient practice increased the risk of substandard health care for all facility patients in a universe of 6 patients. (Refer to C-272).

5. The facility failed to follow its policy and procedure on checking crash cart daily at the Family Medicine Outpatient Clinic and on the Perinatal Units. This finding had the potential to affect the health and safety of all patients receiving emergency services at the Family Medicine Outpatient Clinic and on the Perinatal Units. (Refer to C-276)
6. The facility failed to ensure competency of staff when there was no documented evidence that Registered Nurse (RN 1) had received adequate training in the use of the photodynamic device (used for skin problems; uses a particular type of light) and ensure that all nursing staff had completed competencies in mixing IV medications. These failures had the potential to affect the overall health and safety of all patients requiring photodynamic treatment and for all patients requiring IV medications to be mixed after pharmacy hours by the nursing staff. (Refer to C-294)

7. The facility failed to implement a Care Plan for pain for one of six patients (Patient 7). This failure had the potential for Patient 7"s pain not being relieved. (Refer to C-298).

The cumulative effect of these systemic problems had the possibility to result in food borne illness in the staff, visitors and a highly susceptible patient population and patients receiving incorrect medications or medication dosages with increasing the risk of infection if medications were not mixed using sterile techniques. The facility failed to deliver care in a safe setting in order to be in compliance with the Condition of Participation for Provision of Services.

Based on interview and record review, the facility failed to ensure that:

1. Facility policies and procedures were reviewed annually.

This deficient practice increased the risk of substandard health care for all facility patients in a universe of 6 patients.

Findings:

1. During an interview with the Chief Executive Officer (CEO) on August 21, 2015, at 12:45 PM, he volunteered documentation of approval of facility policies and procedures by the Governing Board. He provided a facility "Emergency Department Policy Manual Approval Sheet" at that time.

A review of the facility document titled "Emergency Department Policy Manual Approval Sheet," dated November 16, 2012, indicated that Governing Board member 1 signed approval of the policy manual on November 16, 2012. There was no documented evidence that the policy manual had been reviewed since November 16, 2012.

a. During a review of the Medical/Surgical Policy Manual on August 21, 2015 at 8:30 AM with the Clinical Quality Coordinator of Patient Safety and Risk (CQC), the Review and Approval Sheet was noted to have final approval by the CEO on November 4, 2013.

During a concurrent interview with the Quality Manager (QM) she verified the last review for the Medical/Surgical policies was in 2013 and policies are to be reviewed annually.

The facility policy and procedure titled "Policy and Procedure Development and Maintenance" dated October 27, 2011 indicated, "Renewal/Review...Most state and federal mandated policies require timely reviews to ensure policies are current and relevant."

2. During an interview with the CNO, on August 19, 2015, at 9:45 AM, the CNO was asked for documentation of the policy approval process, through the Quality, Medical Executive Committee (MEC) and Governing Board Committees for the new policy titled "Receiving Sterile Supplies brought in by Vendors into the Peri-operative Area ( the areas patients receive care before, during and after surgery)," dated June 18, 2015. The CNO was unable to comply.

During a review of the meeting minutes of the Governing Board and the MEC for 2015, indicated there was no documented evidence that the Governing Board or the MEC approved the facility policy and procedure titled "Receiving Sterile Supplies brought in by Vendors into the Perioperative Area, dated June 18, 2015."

During an interview with the CNO, on August 19, 2015, at 11:15 AM, she was asked if the policy and procedure titled "[Facility] Policy, Procedure, Guideline, or Protocol Review and Approval Process," dated November 13, 2014, indicated "the complete policy approval process? Are there other places the policies must be discussed and approved before they become effective?" The CNO stated, "No." She was then asked, "What about Quality?" The CNO answered, "Quality doesn't have to see the policy before approval."

Based on observations, interviews and record reviews, the facility failed to have a system in place for identifying, investigating and controlling infections of patients when:

1. Unpasteurized shelled eggs were not cooked to ensure all parts of the egg were congealed (solid) or ensure they were cooked to a safe temperature to eliminate the risk salmonella infection (salmonella is a bacteria and a common cause of food borne illness, sometimes called "food poisoning"), in a universe of 6 patients.

2. Expired foods, nutritional supplements and enteral formula (liquid nutritional used with tube feeding directly into the digestive tract) were stored in the dietary services. This failure had the potential to result in food borne illness in the staff, visitors and a highly susceptible patient population of 6.

3. There was a lack of staff knowledge regarding the proper immersion time in the sanitizer solution for the three compartment sink. This failure had the potential to result in food borne illness in the staff, visitors and a highly susceptible patient population of 6.

4. The ice machine in the cafeteria, used for patients, staff and visitors, was not clean.
This failure had the potential to result in food borne illness in the staff, visitors and a highly susceptible patient population of 6.

5. The facility did not ensure that the Quat disinfectant cleaner, after it was diluted, was labeled with an expiration date, per manufacturer's instructions. This practice increased the risk of the spread of infection in a universe of 6 patients.

6. The facility did not ensure that one Endotracheal tube (ET tube-tube placed in throat to help patient breath during surgery) and ten Laryngeal Airway Masks (LMA's- placed to help patient breath during surgery) were stored in a sealed package in the OR. This practice increased the risk of infection for all patients utilizing surgical services, in a universe of 6 patients.

These deficient practices resulted in an Immediate Jeopardy Situation when unpasteurized eggs were being served to patients, staff and visitors with other Infection Control breaches that had the potential to affect the health and safety of all patients serviced in the hospital in a universe of 6 patients.

Findings:

1. During a tour of the kitchen in the Dairy reach-in refrigerator (#2) on August 20, 2015, at 8:48 AM, a case of 15 dozen shelled eggs was observed. The shell of the eggs did not contain the red "P" stamp to indicate they were pasteurized (pasteurized eggs are distinguishable from unpasteurized eggs by a red "P" stamped on the shell). The label on the box also did not indicate that they were pasteurized. Approximately 8 - 10 eggs were missing from the box.

During a concurrent interview with the Dietary Supervisor (DS), he stated that the grocery company that delivers the eggs recently started sending unpasteurized eggs instead of pasteurized eggs.

During a concurrent interview with Cook 1, she stated that they served the eggs however the patients request them: scrambled, over easy (fried on both sides, but the yolk stays runny) or hard boiled. She clarified that she cooked over easy eggs so that the yolk of the egg was still runny. She further stated that she made two over easy eggs for patients for breakfast that morning from the box that was in the Dairy refrigerator #2.

During an observation of Patient # 7's breakfast tray the same day at 8:15 AM it was noted that the patient's two eggs were cooked so that the egg was not completely congealed. The eggs were cooked over easy.

During a follow-up interview with the DS the same day, at 10:15 AM, he stated that the facility had been receiving unpasteurized eggs for a couple of months. He stated that the cooks were not alerted to the change in eggs. He did not instruct the cooks on safely cooking the unpasteurized eggs to prevent salmonella infection.

During a concurrent interview with the Registered Dietitian (RD), she stated that she was not aware that they were using unpasteurized shelled eggs to cook over easy eggs.

During a follow-up interview with Cook 1 the same day, (8/20/15), at 11:14 AM, she stated that whenever she cooked the over easy or soft cooked eggs, she did not take the temperature of the egg. She stated, "I just cook it the way the patient asks for it." She stated that she didn't do anything special to the eggs because they were unpasteurized.

During an interview with Patient #7, in his room the same day at 11:45 AM, he stated that he received fried eggs on his breakfast tray that morning. He stated the eggs were not completely cooked hard; there was yolk that was still runny.

During an interview with the Infection Preventionist the same day (8/20/15), at 12:20 PM, she stated that she performed sanitation surveillance in the kitchen every month. She stated that she was not aware that the cook was using unpasteurized eggs to fry eggs that were not cooked so that they were completely congealed. She didn't know that the dietary department was purchasing unpasteurized shelled eggs.

According to the 2013 Food and Drug Administration Food Code, raw animal foods such as eggs and foods containing raw animal foods, shall be cooked to heat all parts of the food to a temperature and for a time that complies with the following method: 145 °F (degrees Fahrenheit) or above for 15 seconds for raw eggs that are broken and prepared in response to a consumer's order and for Immediate service. And, a partially cooked food such as soft cooked eggs may be served or offered for sale upon consumer request or selection in a ready-to-eat form if the food establishment serves a population that is not a highly susceptible population.

According to the Code, highly susceptible population means persons who are more likely than other people in the general population to experience foodborne disease because they are: (1) Immunocompromised; preschool age children, or older adults; and (2) Obtaining food at a facility that provides services such as custodial care, health care, or assisted living, such as a child or adult day care center, kidney dialysis center, hospital or nursing home, or nutritional or socialization services such as a senior center.

Also, according to the Centers for Disease Control (CDC), to avoid Salmonella, you should never eat raw or lightly cooked (runny whites or yolks) eggs. Cooking reduces the number of Salmonella bacteria present in an egg. However, a lightly cooked egg with a runny egg white or yolk still poses a greater risk than a thoroughly cooked egg. Lightly cooked egg whites and yolks have both caused outbreaks of Salmonella infections. Although anyone can get a Salmonella infection, older adults, infants, and people with impaired immune systems are at increased risk for serious illness. In these people, a relatively small number of Salmonella bacteria can cause severe illness.

An Immediate Jeopardy situation was declared on August 20, 2015 at 12:40 PM, in the presence of the facility's Chief Executive Officer (CEO), the Chief Nursing Officer (CNO) and the Clinical Quality Coordinator of Patient Safety and Risk (CQC), they were verbally notified of the facility's failure to ensure unpasteurized eggs were cooked so that all parts of the egg were congealed (solid) or ensure they were cooked to a safe temperature to eliminate the risk salmonella infection.

On August 21, 2015, at 7:30 AM, the Immediate Jeopardy situation was lifted in the presence of the CEO, CNO, CQC and the Registered Dietitian (RD) when the survey team approved the facility's Corrective Action Plan after observations, interviews and record review confirmed that the dietary staff was knowledgeable on safe handling of unpasteurized eggs. In addition, an updated policy regarding pasteurized eggs was correct and approved by the governing body. The Corrective Action Plan included the following components:

a. The facility's "Egg Storage and Preparation" policy was revised to include safe handling of unpasteurized eggs and was approved by the governing body.

b. The RD in-serviced all present dietary staff on safe handling of unpasteurized eggs. All dietary staff not present would be in-serviced before starting their next shift.

c. Compliance with the new policy would be monitored daily via food temperature logs by the DS or his designee. The logs would be reviewed quarterly by the Performance Improvement Committee.

d. Pasteurized shelled eggs were ordered for delivery on August 21, 2015.

2. During a tour of the kitchen in the Dairy refrigerator (#2) on August 20, 2015, at 8:40 AM, a five pound container of cottage cheese was noted to have a manufacturer's best by date of August 10, 2015. Also noted on the container was a handwritten open date of August 12, 2015. The container was approximately one third full.

During a concurrent interview with the Dietary Supervisor (DS), he stated that the open date was the date that the staff opened the container. He stated that the two thirds of cottage cheese that was missing from the container had been served after the manufacturer's best by date. He further stated that the facility's policy was to use the manufacturer's best by as the expiration date. He could not explain why the cottage cheese had not been discarded on August 10, 2015.

Also observed in the kitchen storage closet the same day, (8/20/15), at 9:00 AM, were five, eight ounce bottles of Ensure Plus (a liquid nutritional supplement) with a manufacturer's expiration date of February 1, 2015, and 11 one liter bottles of enteral formula with a manufacturer's expiration date of April 1, 2015.

During a concurrent interview with the DS, he stated that he checked for expired products in the kitchen daily. He could not explain why the liquid nutritional supplement and the enteral formula had expiration dates from four and a half to six and a half months old.

A review of the facility's policy titled, "Food Storage", revised date April, 2012, indicated "All foods shall be discarded upon the elapse of its expiration date."

3. During an interview with Cook 2 on August 20, 2015, at 8:20 AM, she stated that when washing dishes manually in the three compartment sink, the process was to wash in soapy water, rinse in plain water and dip the dishes in the third sink which contained a sanitizer solution. She stated that she dipped the rinsed dishes in the sanitizer for less than one minute.

On August 20, 2015 at 8:30 AM, it was observed that posted directions on the wall above the three compartment sink, dishes must be immersed in the sanitizer for one to two minutes for it to be effective.

A review of the facility's policy titled, "Manual Ware Washing", revised date June, 2012, indicated washing directions that included, "Immerse items in the third sink filled with chemical-sanitizing solution. Items must be immersed for 60 seconds."

4. During a tour of the kitchen and cafeteria on August 20, 2015, at 9:17 AM, the ice machine in the cafeteria was inspected. The ice machine was a dispenser type model that had a drain pan where excess or spilled ice accumulated. This drain pan was noted to not be clean and had a significant accumulation of a black brown residue.

During a concurrent interview with the Maintenance Technician, he stated that it was both housekeeping and maintenance's responsibility to clean the drain pan to prevent this build up. He could not explain why the drain pan was not clean.

A review of the facility's policy titled, "Equipment Condition and Safety", dated May 13, 2915, indicated "Procedure for all equipment: The overall appearance of the item must be up to departmental standards. The interior and exterior of the equipment must be free of rust, corrosion, solutions, lint, dents and deposits."





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5. During an observation on August 18, 2015, at 4:20 PM, in the Operating Room (O.R.) area, one spray bottle of diluted Quant disinfectant, used to clean the Operating Room (O.R.) area, was observed. The spray bottle was not marked with an expiration date, for the diluted solution inside the bottle. During a concurrent interview with Staff #3, she agreed that the spray bottle should have been labeled with an expiration date.

The manufacturer's instructions titled "3M Quat Disinfectant Cleaner Concentrate 5L and 5H," dated August 2012, indicated "Dispense 3M Quat Disinfectant Cleaner Concentrate 5L/5H using the 3M Twist'n Fill dispenser into a properly labeled bottle or mop bucket...Always use clean, properly labeled containers when diluting this product."

6. During an observation on August 18, 2015, at 3:40 PM, in Operating Room (O.R.) two, ten LMA's and one ET tube were observed to be in unsealed packages, stored in the anesthesia provider cart. During a concurrent interview with Staff #3, she agreed that the LMA's and ET tube should be in sealed packages and removed the unsealed packages from the O.R.

Based on interviews and record reviews the facility failed to employ a qualified dietary services supervisor as required by the California Health & Safety Code 1265.4. This occurred when the facility dietitian was not full time running the day to day operations of the dietary services. In addition, the Dietary Supervisor (DS) did not satisfy any of the seven pathways to qualify as a Dietary Services Supervisor as required in the code. In addition, the job description for the Registered Dietitian (RD) failed to include mandatory oversight of the dietary services by the RD as required by the same code. These failures contributed to unsafe dietary practices, that contributed to an Immediate Jeopardy situation, which put patients at risk for food borne illness in a universe of 6 patients. (refer C -278)

Findings:

According to the California Health & Safety Code 1265.4(a) A licensed health facility, as defined in subdivision(a), (b), (c), (d), (f), or (k) of Section 1250, shall employ a full-time, part-time, or consulting dietitian. A health facility that employs a registered dietitian (RD) less than full time, shall also
employ a full-time dietetic services supervisor who meets the requirements of subdivision (b) to supervise dietetic service operations. The dietetic services supervisor shall receive frequently
scheduled consultation from a qualified dietitian.
(b) The dietetic services supervisor shall have completed at least one of the following educational requirements:
(1) A baccalaureate degree with major studies in food and nutrition, dietetics, or food management and has one year of experience in the dietetic service of a licensed health facility.
(2) A graduate of a dietetic technician training program approved by the American Dietetic Association, accredited by the Commission on Accreditation for Dietetics Education, or currently registered by the Commission on Dietetic Registration.
(3) A graduate of a dietetic assistant training program approved by the American Dietetic Association.
(4) Is a graduate of a dietetic services training program approved by the Dietary Managers Association and is a certified dietary manager credentialed by the Certifying Board of the Dietary Managers
Association, maintains this certification, and has received at least six hours of in-service training on the specific California dietary service requirements contained in Title 22 of the California Code of Regulations prior to assuming full-time duties as a dietetic services supervisor at the health facility.
(5) Is a graduate of a college degree program with major studies in food and nutrition, dietetics, food management, culinary arts, or hotel and restaurant management and is a certified dietary manager
credentialed by the Certifying Board of the Dietary Managers Association, maintains this certification, and has received at least six hours of in-service training on the specific California dietary
service requirements contained in Title 22 of the California Code of Regulations prior to assuming full-time duties as a dietetic services supervisor at the health facility.
(6) A graduate of a state approved program that provides 90 or more hours of classroom instruction in dietetic service supervision, or 90 hours or more of combined classroom instruction and instructor
led interactive Web-based instruction in dietetic service supervision.
(7) Received training experience in food service supervision and management in the military equivalent in content to paragraph (2), (3), or (6).
(c) Pursuant to Section 1276, the State Department of Public Health may grant a program flexibility request to the facility to modify the requirements in subdivision (b) for any individual who has
at least five years experience prior to January 1, 2009, as a dietetic services supervisor in a health facility specified in subdivision (a) to allow that individual to function as a dietetic services supervisor for a period not to exceed 18 months, as long as the individual is enrolled in a program that meets the requirements listed in subdivision (b). The department may extend the program flexibility request for a period not to exceed six months if the individual can demonstrate to the department that the coursework could not otherwise be completed within the original 18-month period. Program flexibility requests shall be submitted not later than December 31, 2009.

During an interview with the Dietary Supervisor (DS) on August 20, 2015, at 10:15 AM, he stated that he did not meet the requirements of the California Health & Safety Code 1265.4, subdivision (b). He stated that he took and passed the ServeSafe course (safe food handling manager course) in June, but is not a qualified dietary services supervisor according to the code.

During the survey, an Immediate Jeopardy situation was identified when undercooked unpasteurized (eggs that have not been through a process of killing harmful bacteria before eating) ) were not cooked to ensure all parts of the egg were congealed (solid) or ensure they were cooked to a safe temperature to eliminate the risk salmonella infection (salmonella is a bacteria and a common cause of food borne illness, sometimes called "food poisoning.") shelled eggs were routinely served to patients who requested and received over easy eggs (fried on both sides, but the yolk stays runny). The dietary staff who prepared the eggs was not aware of the requirement to cook the eggs until congealed (solid) or to a temperature of 145 °F for 15 seconds. This put the highly susceptible population of patients at the facility at greatly increased risk for food borne illness. (refer C 278)

During a concurrent interview with the RD, she stated that it was not part of her job description to provide oversight of the dietary services department. She was not required to conduct regular inspections of the dietary services for sanitary conditions related to safe food handling. She further stated that she was not aware that the facility was serving unpasteurized eggs to the patients.

According to the 2013 Food & Drug Administration Food Code, raw animal foods such as eggs and foods containing raw animal foods, shall be cooked to heat all parts of the food to a temperature and for a time that complies with the following method: 145 °F or above for 15 seconds for raw eggs that are broken and prepared in response to a consumer's order and for Immediate service. And, a partially cooked food such as soft cooked eggs may be served or offered for sale upon consumer request or selection in a ready-to-eat form if the food establishment serves a population that is not a highly susceptible population.

According to the Code, highly susceptible population means persons who are more likely than other people in the general population to experience foodborne disease because they are: (1) Immunocompromised (a weak immune system); preschool age children, or older adults; and (2) Obtaining food at a facility that provides services such as custodial care, health care, or assisted living, such as a child or adult day care center, kidney dialysis (a method to remove excess fluids and waste from the blood stream) center, hospital or nursing home, or nutritional or socialization services such as a senior center.

Also, according to the Centers for Disease Control (CDC), to avoid Salmonella, you should never eat raw or lightly cooked (runny whites or yolks) eggs. Cooking reduces the number of Salmonella bacteria present in an egg. However, a lightly cooked egg with a runny egg white or yolk still poses a greater risk than a thoroughly cooked egg. Lightly cooked egg whites and yolks have both caused outbreaks of Salmonella (a bacteria) infections. Although anyone can get a Salmonella infection, older adults, infants, and people with impaired immune systems are at increased risk for serious illness. In these people, a relatively small number of Salmonella bacteria can cause severe illness. (Cross refer C 278)

During a review of the DS employee file, the Job Description for the position of Dietary Supervisor, date of hire (for this position) August 12, 2013, did not require a qualified dietary services supervisor as defined in the California Health & Safety Code 1265.4, subdivision (b). Also, there was no evidence that the DS was qualified according to this code.

During a review of the employee file for the RD, date of hire July 6, 2015, the Job Description for the position of Registered Dietitian, undated, indicated a Job Summary, "The Registered Dietitian (RD) shall participate in the provision of nutrition therapy assessment and counseling to inpatients and outpatients as referred by their provider. The RD plans and directs preparation of diets as prescribed and consults and counsels patients and relatives on special diet requirements. The RD may also assist in projects related to the food services program and provide supervisory support." There was no requirement for the RD to provide frequent scheduled consultation and oversight of the dietary services to ensure safe food handling as was required in the California Health & Safety Code 1265.4.

Based on observation, interview and record review, the facility failed to;

1. Ensure competency of the staff when there was no documented evidence that Registered Nurse (RN 1) had received adequate training in the use of the photodynamic device (used for skin problems; uses a particular type of light).

2. Ensure that 42 of 68 registered nurses currently employed had completed competencies in mixing IV (Intravenous) medications.
This failure had the potential to affect the overall health and safety of all patients requiring photodynamic treatment and for all patients requiring IV medications to be mixed after pharmacy hours by the nursing staff.

Findings:

1. During a tour of the outpatient the Family Medicine Clinic with the Educator Coordinator on August 19, 2015, an inspection of the medical devices and equipment was conducted.
During an interview with the Family Medicine Clinic Manager on August 19, 2015 at 9:10 AM and a concurrent inspection of the photodynamic therapy device the Family Medicine Clinic Manager confirmed the photodynamic therapy device was used for the patients.

A review of the "Dermatology" (pertains to the skin) patient list dated January 9, 2015 to February 19, 2015, revealed eight patients had received treatment using the photodynamic device.

During an interview with RN 1 on August 19, 2015 at 3:40 PM, when asked if she had received any training on the use of the photodynamic device, RN 1 stated a representative of the company had been present each time the device was used. RN 1 explained that while RN 1 was assisting with the procedure, the representative provided RN 1 with onsite "coaching and training" including the application of the medication, how the medication worked, the use of the light, expected reactions to the medications and the light, aftercare, patient teaching/education, and the use of the device. When asked to provide a documented evidence of such training, RN 1 stated there was no "official" documentation and was unable to provide one. RN 1 was essentially assisting the physician and assisting the company representative during the procedure, but did no provide any evidence that she (RN 1) was formally trained in operating the photodynamic device on her own.

A review of the photodynamic device's operating manual revealed, "WARNING: All personnel should read and understand the instructions in this manual before the system is used. Failure to do so may result in improper operation of the system."

A review of the facility's policy and procedure titled "Description of Direct Services," Effective Date 5/22/2014, it revealed, "Responsible Department.. Implementation, training, and monitoring compliance with this policy are the responsibilities of Medical Director and Clinic Manager."


2. During an interview with the Pharmacy Manager (Ph 1) on March 20, 2015 at 8:30 AM, when asked what the Pharmacy hours were, she stated they were open 8:00 AM to 6:30 PM, and on-call twenty-four hours per day seven days per week.

During the same interview, when asked how IV mixtures were prepared after hours, she stated she would come in if the nurse requested, but the nurses could mix IV medications. When asked what training was required for the nurses to compound (mixing) medications, she stated all of the registered nurses were shown a video on IV mixing and took a post test in 2011 and 2012, but since then the training has been done by the Nursing Department.

During an interview with RN 2 on March 20, 2015 at 10:15 AM when asked if she was the nurse who provided education / orientation to new nurses, she stated yes. When asked if she provided IV medication mixing competency training to new Registered Nurses as part of their orientation, she stated she did not, and stated she thought that was part of the Pharmacy orientation.

During an interview with RN 6 on March 21, 2015 at 7:10 AM when asked when how she accesses IV medications after the pharmacy is closed, she stated if they have not been mixed by pharmacy, she would pull the medication and saline (a solution) from the Pyxis and mix it herself, or call the Pharmacist if the medication ordered was complicated.

During the same interview with RN 6, when asked what training she had on mixing IV medications, she stated when training with her preceptor, the nurse showed her how to pull the medication and saline from the Pyxis (an automated medication dispensing system) and to mix the medications in the medication room. When asked if she watched a video and took a quiz on mixing medications she stated that she did not.

During a concurrent interview with RN 5, she stated she was given a directive via email from the Medical Surgical RN Manager (RN 10) which was originally sent to him from the Pharmacist with instructions on how to mix a Banana Bag (a mixture of vitamins and minerals in intravenous solution).

During a review of the training "Aseptic Preparation of Parenteral Products Training" dated 2011 and 2012 provided by the Pharmacist and the current list of registered nurses currently on staff, 26 of the current 68 nurses now on staff last completed the competency in 2011 and 2012.

The facility policy and procedure titled "Drug Compounding and Dispensing" dated March 12, 2014 indicated "A part of the initial orientation, all Registered Nurses (RN's) will complete a program in the preparation and administration of IV medication. A special video will be provided by the Pharmacy Department to ensure that each nurse had adequate knowledge of proper medication admixture must be viewed and post-test passed. Also this video will be shown yearly at a monthly nursing staff meeting and a test given to ensure continued competency".

The facility failed to provide the video training to new registered nurses when hired, and to provide reeducation to all registered nurses annually to ensure continued competency.

Based on observation, interview and record review, the facility failed to implement a Care Plan for pain for one of six patients (Patient 7). This failure had the potential for Patient 7"s pain not being relieved in a timely manner.

Findings;

During an observation on August 20, 2015 at 8:05 AM with RN 2 (Registered Nurse), in Patient 7's room, Patient 7 was observed requesting pain medication.

A review of the Physician orders dated August 18, 2015 indicated Hydrocodone (Norco a pain medication) 10 mg ( milligrams - a unit of measurement) every six hours as needed for moderate to severe pain, Norco 5 mg by mouth every six hours for mild pain, Morphine (a pain medication) 2 mg IVP (given through an Intravenous line) every 2 hours as needed for mild pain. Morphine 5 mg every 2 hours as needed for severe pain.

During a review of the Medication Administration Record (MAR) Patient 7 received pain medication as follows with the corresponding pain scale, 0 is no pain and 10 is the worst pain;

August 19, 2015:

12:22 AM Norco 5 mg for pain scale of 4.
2:29 AM Morphine 2 mg IVP for a pain scale of 5.
8:34 AM Norco 10 mg for a pain scale of 5.
3:13 PM Norco 5 mg for a pain scale of 4.
8:34 PM Norco 10 mg for a pain scale of 5.

August 20, 2015:

2:06 AM Norco 10 mg for a pain scale of 6.
8:33 AM Norco 10 mg for a pain scale of 7.
3:28 PM Norco 5 mg for a pain scale of 5.
9:24 PM Norco 10 mg pain scale of 7.

During a review of Patient 7's Care plan on August 21, 2015 at 9:55 AM with RN 9, pain was not listed on the problem list.

During a concurrent interview with RN 9 when asked why pain was not initiated on the Care Plan, she stated that pain was not the primary problem and that unless the patient had extensive pain, that she would not add it to the care plan.

The facility policy and procedure titled "Nursing Care Plan" dated May 25, 2012, indicated "This care plan shall be individualized, initiated... and documented in the patient's medical record."

Based on interview and record review, the facility failed to ensure that there was documented evidence of a current medical license for one of seven physicians (MD 5) credential files reviewed. This deficient finding increased the risk of a poor surgical outcome for all patients receiving surgical services in the hospital in a universe of 6 patients.

Findings:

During a review of the credential file for MD 5, there was no documented evidence of a current medical license in the credential file. During an interview with the MSC (Medical Staff Coordinator), on August 21, 2015, at 7:10 AM, she reviewed the credential file for MD 5 and was unable to find documentation of a current medical license.

The facility's Hospital Medical Staff Bylaws, dated May 21, 2015, stipulated, "Membership on the Medical Staff and privileges shall be extended only to practitioners who are professionally competent and continuously meet the qualifications, standards, and requirements set forth in the Medical Staff Bylaws. Medical Staff membership shall be limited to practitioners who are currently licensed...Physicians must be licensed to practice medicine by the Medical Board of California..."

Based on interview and record review, the facility failed to ensure the following:

1. A Pre-anesthesia assessment form was present in Patient 1's medical record before the start of surgery.

2. A Post-anesthesia assessment form was completed for two surgical patients (Patients 10 and 12).

These deficient practices increased the risk of a poor surgical outcome and a premature discharge for all post-surgical patients receiving surgical services in the hospital in a universe of 6 patients.

Findings:

1. During an observation on August 18, 2015, at 7:15 AM, in the Pre-operative holding area and in the Operating Room (OR), the quality of care provided to Patient 1 was observed.

In the Pre-operative area, the Pre-Anesthesia Assessment form, in Patient 1's medical record, it was noted to be completely blank. During a concurrent interview with Nurse 1, she confirmed there was no evidence of a written Pre-operative assessment for Patient 1 in the clinical record.

During an interview with Anesthesia Provider 1, in the OR, he was asked if there was "A written Pre-operative assessment?" He stated, "No written Pre-op (Pre-operative) assessment yet. I'll write it after this." After administering a medication to Patient 1, Anesthesia Provider 1 provided a "Blank" Pre-Anesthesia Assessment form.

A review of the facility's policy and procedure form, titled "Assessment Prior to Induction of Anesthesia," dated June 28, 2011, stipulated, "The patient will be evaluated by the anesthesiologist/anesthetist prior to provision of sedation and/or anesthesia services, with the results of the evaluation documented on the pre-anesthesia evaluation record."

2. During a review of the clinical record for Patient 12, the Anesthesia Post-Operative Evaluation form, dated August 12, 2015, indicated an area for the patient's post-operative vital signs to be recorded (e.g. temperature, heart rate). The area to record the vital signs was found blank. There was an area to record the patient's "Mental Status" - it was found blank. There was an area to record the patient's post-operative "Pain" - it was found blank. There was an area to record the patient's post-operative "Nausea/vomiting" - it was found blank.

A review of the Anesthesia Record form, dated August 12, 2015, indicated "To OR-2 for postpartum hemorrhage (life threatening bleeding after childbirth)..." During a concurrent interview with Staff 1, on August 21, 2015, at 9:00 AM, she confirmed that the areas mentioned above on the Post-Operative Evaluation form were found blank for Patient 12.

During a review of the clinical record for Patient 11, the Anesthesia Post-Operative Evaluation form was reviewed and found to be entirely blank. All areas to record Post-Operative information for Patient 11 were left blank, including the area for vital signs, mental status, pain, complications, airway, nausea/vomiting and hydration status.

During a concurrent interview with Staff 1, on August 21, 2015, at 9:00 AM, she confirmed that the entire Anesthesia Post-Operative Evaluation was left entirely blank for Patient 11.

The facility's policy and procedure form, titled "Assessment & Reassessment-Surgical Patient," dated June 28, 2011, stipulated, "The patient's postoperative status is reassessed upon admission, throughout the patient's stay and upon discharge from the Post Anesthesia Care Unit (PACU)...The data is available on the patient's medical record to provide collaborative interdisciplinary care for the patient's optimal and expedient recovery."

The Condition of Participation for Provision of Services was not met when the facility failed to ensure that opportunities for quality improvement were identified during routine monitoring of hospital services. The facility failed to ensure the following:

1. The findings from the quality assurance activities were used to identify multiple opportunities for improvement when the facility failed to identify that Undercooked unpasteurized shelled eggs were routinely served to patients who requested and received over easy eggs (fried on both sides, but the yolk stays runny). The dietary staff who prepared the eggs was not aware of the requirement to cook the eggs until congealed (solid) or to a temperature of 145 °F for 15 seconds. This lack of staff knowledge of safe handling of the eggs put the highly susceptible population of patients at the facility at greatly increased risk for food borne illness. (Refer to C-278)

An Immediate Jeopardy situation was declared on August 20, 2015 at 12:40 PM, in the presence of the facility's Chief Executive Officer (CEO), the Chief Nursing Officer (CNO) and the Clinical Quality Coordinator of Patient Safety and Risk (CQC), they were verbally notified of the facility's failure to ensure unpasteurized eggs were cooked so that all parts of the egg were congealed (solid) or ensure they were cooked to a safe temperature to eliminate the risk salmonella infection.

On August 21, 2015, at 7:30 AM, the Immediate Jeopardy situation was lifted in the presence of the CEO, CNO, CQC and the Registered Dietitian (RD) when the survey team approved the facility's Corrective Action Plan after observations, interviews and record review confirmed that the dietary staff was knowledgeable on safe handling of unpasteurized eggs. In addition, an updated policy regarding pasteurized eggs was correct and approved by the governing body. The Corrective Action Plan included the following components:

a. The facility's "Egg Storage and Preparation" policy was revised to include safe handling of unpasteurized eggs and was approved by the governing body.

b. The RD in-serviced all present dietary staff on safe handling of unpasteurized eggs. All dietary staff not present would be inserviced before starting their next shift.

c. Compliance with the new policy would be monitored daily via food temperature logs by the DS or his designee. The logs would be reviewed quarterly by the Performance Improvement Committee.

d. Pasteurized shelled eggs were ordered for delivery on August 21, 2015.

2. The facility policies and procedures were approved by the Governing Board. (Refer to C-0241)

3. The facility policies and procedures were reviewed annually. (Refer to C-272).

4. Documented evidence of a current medical license for one of seven physicians was in the credential file. (Refer to C-0321)

5. The Operating Room (OR) Register contained the age of each surgical patient. (Refer to C-0334)

6. Patient medical records included a history and physical examination. (Refer to C-0334)

7. Surgical patient medical records included a pre-and post-anesthesia assessment. Refer to C-0334)

8.a. The bottle of diluted disinfectant was labeled with the expiration date. (Refer to C-0278)

8.b. The Endotracheal tube (ET tube-tube placed in throat to help patient breath during surgery) and ten Laryngeal Airway Masks (LMA's- placed to help patient breath during surgery) were stored in a sealed package in the OR. This practice increased the risk of infection for all surgical patients. (Refer to C-0336)

9. The Preventative Maintenance (PM - multiple medical devices and equipment were noted maintenance to ensure its safe and reliable operation) for multiple devices and equipment located at the radiology department, physical and occupational therapy clinic, orthopedic clinic, women's health clinic, family medicine clinic, and the intensive care unit, were updated. (Refer to C-0336)

10. Lack of pharmacy oversight in the Perinatal Department, including Labor and Delivery, Post Partum, and Nursery. This lack of oversight had the potential to affect the health and safety of all patients receiving obstetrical services in the Perinatal Department. (Refer to C-203).

The cumulative effect of these systemic problems had the possibility to result in increasing the risk of substandard quality healthcare for all facility patients in a universe of six patients. The facility failed to deliver care in compliance with the Condition of Participation of Periodic Evaluation and Quality Assurance Review.

Based on interview and record review, the facility failed to ensure the following:

1. A complete History and Physical (H & P) was present in the clinical record for two surgical patients (Patient 10 & 12).

2. The Operating Room Register contained the age of each surgical patient.

These deficient practices increased the risk of a poor surgical outcome for all patients requiring surgical services in a universe of 6 patients.

Findings:

During a review of the clinical record for Patient 10, the Obstetrical Provider History and Physical form, dated August 1, 2015, indicated a box to check if the patient's Physical Exam was "normal" or "abnormal" and a place to write in comments. There was an area for "General" - it was left blank. "HEENT" (head and neck) - it was left blank. "CV" (cardiovascular- heart exam) - it was left blank. "Lungs" - it was left blank. "Abd" (abdomen) - it was left blank. "Extr" (arms and legs) - it was left blank. "Neuro" (neurological - brain and spinal cord) - it was left blank. "Skin - it was left blank. A review of the Anesthesia Record, dated August 2, 2015, indicated "Operation:C-Section (Cesarean Section- delivery of a baby through an abdominal incision). During a concurrent interview on August 21, 2015, at 9:00 AM with Staff 1, she confirmed the multiple blank areas noted above on the History and Physical form for Patient 10.

During a review of the clinical record for Patient 12, the Obstetrical Provider History and Physical form, dated August 11, 2015, indicated a box to check if the patient's Physical Exam was "normal" or "abnormal" and a place to write in comments. There was an area for "General" - it was left blank. "HEENT" (head and neck)- it was left blank. "CV" (cardiovascular- heart exam) - it was left blank. "Lungs" - it was left blank. "Abd" (abdomen) - it was left blank. "Neuro" (neurological- brain and spinal cord) - it was left blank. A review of the Anesthesia Record, dated August 12, 2015, indicated "Operation: D&C (Dilation & curettage-removal of debris from the inside of the uterus to stop bleeding after childbirth); Uterine Pack (a pack placed to stop excessive blood loss) Bakri Balloon placement (to stop excessive blood loss)/taken out." During a concurrent interview on August 21, 2015, at 9:00 AM with Staff 1, she confirmed the multiple blank areas noted above on the History and Physical form for Patient 12.

The facility was asked to provide a policy that described the contents of a complete History & Physical. The facility was unable to provide the information requested.

2. During a review of the Operating Room (OR) register, on August 20, 2015, at 2:50 PM, it was noted that the register did not include the age of each surgical patient. During a concurrent interview with the CQC, she confirmed that the age of each surgical patient was missing from the OR register.

The facility policy and procedure titled "Surgical Logbook," dated November 19, 2014, indicated "A copy of the operative record of all procedures done in the operating room or done in another area of the hospital by Surgical Services personnel will be maintained in the Surgical Logbook. The following information will be included for all procedures ...Date of birth" (from which patient age can be calculated).

Based on observation, interview, and record review, the facility failed to ensure that the Quality Assurance Program provided opportunities for quality improvement during routine monitoring of problems identified . The facility failed to ensure the following:

1. The findings from the quality assurance activities were used to identify multiple opportunities for improvement when the facility failed to identify that Undercooked unpasteurized shelled eggs were routinely served to patients who requested and received over easy eggs (fried on both sides, but the yolk stays runny). The dietary staff who prepared the eggs was not aware of the requirement to cook the eggs until congealed (solid) or to a temperature of 145 °F for 15 seconds. This lack of staff knowledge of safe handling of the eggs put the highly susceptible population of patients at the facility at greatly increased risk for food borne illness.

An Immediate Jeopardy situation was declared on August 20, 2015 at 12:40 PM, in the presence of the facility's Chief Executive Officer (CEO), the Chief Nursing Officer (CNO) and the Clinical Quality Coordinator of Patient Safety and Risk (CQC), they were verbally notified of the facility's failure to ensure unpasteurized eggs were cooked so that all parts of the egg were congealed (solid) or ensure they were cooked to a safe temperature to eliminate the risk salmonella infection.

2. The facility policies and procedures were approved by the Governing Board.

3. The facility policies and procedures were reviewed annually.

4. Documented evidence of a current medical license for one of seven physicians was in the credential file.

5. The Operating Room (OR) Register contained the age of each surgical patient.

6. Patient medical records included a history and physical examination.

7. Surgical patient medical records included a pre-and post-anesthesia assessment.

8.a. The bottle of diluted disinfectant was labeled with the expiration date.

8.b. The Endotracheal tube (ET tube-tube placed in throat to help patient breath during surgery) and ten Laryngeal Airway Masks (LMA's- placed to help patient breath during surgery) were stored in a sealed package in the OR. This practice increased the risk of infection for all surgical patients.

9. The Preventative Maintenance (PM - multiple medical devices and equipment were noted maintenance to ensure its safe and reliable operation) for multiple devices and equipment located at the radiology department, physical and occupational therapy clinic, orthopedic clinic, women's health clinic, family medicine clinic, and the intensive care unit, were updated.

These deficient practices resulted in an ineffective Quality Assurance Program in evaluating the quality of care provided to all patients receiving care in the hospital, in a universe of 6 Patients.

Findings:

1. During a tour of the kitchen in the Dairy reach-in refrigerator (#2) on August 20, 2015, at 8:48 AM, a case of 15 dozen shelled unpasteurized eggs was observed.

During a concurrent interview with the Dietary Supervisor (DS), he stated that the grocery company that delivers the eggs recently started sending unpasteurized eggs instead of pasteurized eggs. During a concurrent interview with Cook 1, she stated that they served the eggs however the patients request them: scrambled, over easy (fried on both sides, but the yolk stays runny) or hard boiled. She further stated that she made two over easy eggs for patients for breakfast that morning from the unpasteurized eggs. She further stated that she did not take the temperature of the egg.

During a follow-up interview with the DS the same day, at 10:15 AM, he stated that the facility had been receiving unpasteurized eggs for a couple of months. He stated that the cooks were not alerted to the change in eggs. He did not instruct the cooks on safely cooking the unpasteurized eggs to prevent salmonella infection. During a concurrent interview with the Registered Dietitian (RD), she stated that she was not aware that they were using unpasteurized shelled eggs to cook over easy eggs.

During an interview with the Infection Preventionist the same day at 12:20 PM, she stated that she was not aware that the cook was using unpasteurized eggs to fry eggs that were not cooked so that they were completely congealed. She didn't know that the dietary department was purchasing unpasteurized shelled eggs.

According to the 2013 Food and Drug Administration Food Code, eggs shall be cooked to heat all parts of the food to 145 °F or above for 15 seconds for raw eggs. And, a partially cooked food such as soft cooked eggs may be not served or offered to a highly susceptible population (such as hospitalized patients).

Also, according to the Centers for Disease Control (CDC), to avoid Salmonella, you should never eat raw or lightly cooked (runny whites or yolks) eggs. Lightly cooked egg whites and yolks have both caused outbreaks of Salmonella infections. Although anyone can get a Salmonella infection, older adults, infants, and people with impaired immune systems are at increased risk for serious illness. In these people, a relatively small number of Salmonella bacteria can cause severe illness.

During an interview with the Chief Executive Officer (CEO), the Chief Nursing Officer (CNO) and the Clinical Quality Coordinator of Patient Safety and Risk Management (CQC) on August 21, 2015, at 10:00 AM, it was stated that the facility had not identified this high risk practice of undercooking unpasteurized eggs for the patients. This quality committee was not aware of the practice or the lack of dietary staff knowledge on safe handling of unpasteurized eggs.









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2. During an interview with the CNO, on August 19, 2015, at 9:45 AM, the CNO was asked for documentation of the policy approval process, through the Quality, Medical Executive Committee (MEC) and Governing Board Committees, for the new policy titled "Receiving Sterile Supplies brought in by Vendors into the Peri-operative Area, dated June 18, 2015." The CNO was unable to comply.

The facility policy and procedure titled "SMHD Policy, Procedure, Guideline, or Protocol Review and Approval Process," dated November 13, 2014, indicated two routes of policy approval. One route was for "Clinical Policy, Guideline or Protocol" and the second route was for "Non-Clinical Policy." The Clinical policy route indicated that the final policy approval was to be given by the Medical Executive Committee (MEC). The Non-clinical Policy route indicated that final policy approval was given by the "Appropriate Committee... " Neither of these routes to policy approval, according to the policy, included the Governing Board or the CEO.

3. During an interview with the Chief Executive Officer (CEO) on August 21, 2015, at 12:45 PM, he volunteered documentation of approval of facility policies and procedures by the Governing Board. He provided a facility "Emergency Department Policy Manual Approval Sheet" at that time.

The facility document titled "Emergency Department Policy Manual Approval Sheet," dated November 16, 2012, indicated that Governing Board member #1 signed approval of the policy manual on November 16, 2012. There was no documented evidence that the policy manual had been reviewed since November 16, 2012.

4. During a review of the credential file for MD5, there was no documented evidence of a current medical license in the credential file. During an interview with the MSC, on August 21, 2015, at 7:10 AM, she reviewed the credential file for MD5 and was unable to find documentation of a current medical license.

The facility Hospital Medical Staff Bylaws, dated May 21, 2015, indicated "Membership on the Medical Staff and privileges shall be extended only to practitioners who are professionally competent and continuously meet the qualifications, standards, and requirements set forth in the Medical Staff Bylaws. Medical Staff membership shall be limited to practitioners who are currently licensed ...Physicians must be licensed to practice medicine by the Medical Board of California ... "

5. During a review of the Operating Room (OR) register, on August 20, 2015, at 2:50 PM, it was noted that the register did not include the age of each surgical patient. During a concurrent interview with the CQC, she confirmed that the age of each surgical patient was missing from the OR register.

The facility policy and procedure titled "Surgical Logbook," dated November 19, 2014, indicated "A copy of the operative record of all procedures done in the operating room or done in another area of the hospital by Surgical Services personnel will be maintained in the Surgical Logbook. The following information will be included for all procedures ...Date of birth " (from which patient age can be calculated).

6. During a review of the clinical record for Patient #10, the Obstetrical Provider History and Physical form, dated August 1, 2015, indicated a box to check if the patient's Physical Exam was "normal" or "abnormal" and a place to write in comments. There was an area for "General"- it was left blank. "HEENT" (head and neck) - it was left blank. "CV" (cardiovascular- heart exam)- it was left blank. " Lungs " - it was left blank. " Abd " (abdomen)- it was left blank. "Extr" (arms and legs) - it was left blank. "Neuro" (neurological- brain and spinal cord) - it was left blank. "Skin"- it was left blank. A review of the Anesthesia Record, dated August 2, 2015, indicated "Operation: C-Section (Cesarean Section- delivery of a baby through an abdominal incision). During a concurrent interview on August 21, 2015, at 9:00 AM with Staff #1, she confirmed the multiple blank areas noted above on the History and Physical form for Patient #10.

During a review of the clinical record for Patient #12, the Obstetrical Provider History and Physical form, dated August 11, 2015, indicated a box to check if the patient's Physical Exam was "normal" or "abnormal" and a place to write in comments. There was an area for "General" - it was left blank. "HEENT" (head and neck)- it was left blank. "CV" (cardiovascular- heart exam) - it was left blank. "Lungs" - it was left blank. "Abd" (abdomen) - it was left blank. "Neuro" (neurological- brain and spinal cord) - it was left blank. A review of the Anesthesia Record, dated August 12, 2015, indicated "Operation: D&C (Dilation & curettage-removal of debris from the inside of the uterus to stop bleeding after childbirth); Uterine Pack (a pack placed to stop excessive blood loss) Bakri Balloon placement (to stop excessive blood loss)/ taken out." During a concurrent interview on August 21, 2015, at 9:00 AM with Staff #1, she confirmed the multiple blank areas noted above on the History and Physical form for Patient #12.

The facility was asked to provide a policy that described the contents of a complete History & Physical. The facility was unable to comply.

7a. During an observation on August 18, 2015, at 7:15 AM, in the Pre-operative holding area and the Operating Room (OR), the quality of care provided to Patient #1 was observed. In the Pre-operative area, the Pre-Anesthesia Assessment form was noted to be completely blank. During a concurrent interview with Nurse #1, she confirmed there was no written Pre-operative assessment for Patient #1 in the clinical record.

During an interview with Anesthesia Provider #1, he was asked if there was a written Pre-operative assessment. He stated, "No written Pre-op (Pre-operative) assessment yet. I'll write it after this." At that moment, Anesthesia Provider #1 reached over and gave Patient #1 medication into his I.V. (intravenous- in the vein). He then showed the surveyor the blank Pre-Anesthesia Assessment form.

The facility policy and procedure titled "Assessment Prior to Induction of Anesthesia," dated June 28,2011, indicated "The patient will be evaluated by the anesthesiologist/anesthetist prior to provision of sedation and/or anesthesia services, with the results of the evaluation documented on the pre-anesthesia evaluation record."

7.b. During a review of the clinical record for Patient #12, the Anesthesia Post-Operative Evaluation form, dated August 12, 2015, indicated an area for the patient's post-operative vital signs to be recorded (e.g. temperature, heart rate). The area to record the vital signs was left blank. There was an area to record the patient's "Mental Status" - it was left blank. There was an area to record the patient's post-operative "Pain" - it was left blank. There was an area to record the patient's post-operative "Nausea/vomiting"- it was left blank. A review of the Anesthesia Record, dated August 12, 2015, indicated "To OR-2 for postpartum hemorrhage (life threatening bleeding after childbirth)..." During a concurrent interview with Staff #1, on August 21, 2015, at 9:00 AM, she confirmed that the areas mentioned above on the Post-Operative Evaluation form were left blank for Patient #12.

During a review of the clinical record for Patient #11, the Anesthesia Post-Operative Evaluation form was reviewed and found to be entirely blank. All areas to record Post-Operative information for Patient #11 were left blank, including the area for vital signs, mental status, pain, complications, airway, nausea/vomiting and hydration status. During a concurrent interview with Staff #1, on August 21, 2015, at 9:00 AM, she confirmed that the entire Anesthesia Post-Operative Evaluation was left entirely blank for Patient #11.

The facility policy and procedure titled "Assessment & Reassessment-Surgical Patient," dated June 28, 2011, indicated "The patient's postoperative status is reassessed upon admission, throughout the patient's stay and upon discharge from the Post Anesthesia Care Unit (PACU)...The data is available on the patient's medical record to provide collaborative interdisciplinary care for the patient ' s optimal and expedient recovery."

8.a. During an observation on August 18, 2015, at 4:20 PM, in the Operating Room (O.R.) area, one spray bottle of diluted Quant disinfectant, used to clean the Operating Room (O.R.) area, was observed. The spray bottle was not marked with an expiration date, for the diluted solution inside the bottle. During a concurrent interview with Staff #3, she agreed that the spray bottle should have been labeled with an expiration date.

The manufacturer's instructions titled "3M Quat Disinfectant Cleaner Concentrate 5L and 5H," dated August 2012, indicated "Dispense 3M Quat Disinfectant Cleaner Concentrate 5L/5H using the 3M Twist 'n Fill dispenser into a properly labeled bottle or mop bucket ...Always use clean, properly labeled containers when diluting this product."

8.b. During an observation on August 18, 2015, at 3:40 PM, in Operating Room (O.R.) two, ten LMA's and one ET tube were observed to be in unsealed packages, stored in the anesthesia provider cart. During a concurrent interview with Staff #3, she agreed that the LMA's and ET tube should be in sealed packages and removed the unsealed packages from the O.R.

During the Quality group interview, on August 21, 2015, at 10:30 AM, when the Chief Executive Officer (CEO) was asked if the specific concerns about the Dietary and Pharmacy services had been previously identified by the Quality Assurance (QA) committee, the CEO stated, "QA had not heard of these concerns before you identified them."



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9.a. During a tour of the outpatient Physical Therapy/Occupational Therapy Clinic with the Educator Coordinator on August 19, 2015, an inspection of the medical devices and equipment was conducted. During an interview with the Orthopedic/Rehabilitation Manager on August 19, 2015 at 8:15 AM and a concurrent inspection of the weighing scale, the Orthopedic/Rehabilitation Manager confirmed the weighing scale did not have a documented evidence to indicate a PM was performed.

During an interview with Biomedical Technician (Biomed Tech 1) and Biomed Tech 2 on August 19, 2015 at 2:30 PM, they confirmed the most recent PM performed on the weighing scale was on September 26, 2013 (approximately 2 years and 11 months ago); they stated the PM should have been performed yearly.

9.b. During a tour of the outpatient Orthopedics Clinic with the Educator Coordinator on August 19, 2015, an inspection of the medical devices and equipment was conducted. During an interview with the Orthopedic/Rehabilitation Manager on August 19, 2015 at 8:30 AM and a concurrent inspection of the medical device and equipment, the Orthopedic/Rehabilitation Manager confirmed the following:

a. Two pulse oximeter devices (measures the oxygen saturation level in the blood) had a "sticker" that indicated the PM was performed on May 21, 2014 and the next PM was due to be performed on May 2015 (approximately three months ago).

b. A blood glucose meter (a meter that tests blood sugar levels) had a "sticker" that indicated the PM was performed on June 26, 2014 and the next PM was due to be performed on June 2015 (approximately two months ago).

During an interview with Biomedical Technician (Biomed Tech 1) and Biomed Tech 2 on August 19, 2015 at 2:30 PM, they confirmed the PM for the two pulse oximeter devices should have been performed in May 2015, and the PM for the blood glucose meter was performed in June 30, 2015 but was mislabeled (the sticker indicated the PM wrong date).

9.c. During a tour of the outpatient the Women's Health Clinic with the Educator Coordinator on August 19, 2015, an inspection of the medical devices and equipment was conducted.

During an interview with Registered Nurse (RN 7) on August 19, 2015 at 9:35 AM and a concurrent inspection of the medical device and equipment, RN 7 confirmed two Blood Pressure monitor device (BP - tests pressure of the blood) did not have a documented evidence to indicate performance of a preventative maintenance on the devices.

During an interview with Biomedical Technician (Biomed Tech 1) and Biomed Tech 2 on August 19, 2015 at 2:30 PM, they confirmed the Clinical Engineering Department (Biomed department) did not "track" and calibrate blood pressure monitor devices. They explained that when the nursing staff noted the "needle is out (needle on the gauge fails to point to zero to indicate calibration)," the staff would determine whether to request and obtain a new BP monitoring device or continue its use.

A review of the manufacturer's guide on calibration check of the device, it revealed a recommendation of a full check of calibration every two years.

9.d. During a tour of the outpatient the Family Medicine Clinic with the Educator Coordinator on August 19, 2015, an inspection of the medical devices and equipment was conducted. During an interview with the Family Medicine Clinic Manager on August 19, 2015 at 9:10 AM and a concurrent inspection of the medical device and equipment, the Family Medicine Clinic Manager confirmed the photodynamic therapy device (used for skin problems; uses a particular type of light) did not have a documented evidence that a PM was performed.

During an interview with Biomedical Technician (Biomed Tech 1) and Biomed Tech 2 on August 19, 2015 at 2:30 PM, they confirmed the photodynamic therapy device "was not on the system;" they both confirmed they had no knowledge the device was in the clinic and was being used for the patients, who and when the device was received by the clinic staff, and whether the device was hospital-owned or not; the device "shouldn't have been up there (in the clinic)." When asked what the facility's process was on preventative maintenance of medical devices and equipment, Biomed Tech 1 and Biomed Tech 2 explained that whenever a device or an equipment was purchased by the facility, it would be delivered to the Clinical Engineering (Biomed) department. The Biomed technicians would assign a PM procedure for the device or the equipment, information including the serial number and its location would be documented, and a PM sticker and a control number would be assigned. A "risk assessment " on patient safety would be initiated, and procedures or tasks would be performed on each device or equipment according to the manufacturer's recommendation, before it would be delivered to the appropriate department.

A concurrent review with Biomed Tech 2 of the facility's policy and procedure titled "Medical Device Equipment Management Policy," Revised date 4/25/14, it revealed under Procedure, "The Biomed Department Shall: ... Test and ensure the operating safety of clinical equipment utilized (at the clinic locations)... Maintain a facility "Equipment Inventory List" for the devices specified above...Perform and document all required safety, corrective and preventative maintenance actions for the devices specified above...Provide documentation upon request, to each area detailing all work accomplished and the equipment status...Inspect all Medical Devices prior to their initial use and at intervals to be identified utilizing a "Risk Factor" evaluation system...Provide a quality assurance program to validate the performance of the Clinical Engineering program...Continually review, monitor and when appropriate, address any and all pertinent regulatory changes..." It further revealed, "Incoming inspections (Hospital owned equipment): All hospital owned equipment that directly supports patient care, or that is located within the patient care setting, regardless of acquisition methods, is inspected prior to initial use. Equipment is inspected to assure physical condition, functionality, accuracy, patient/operator safety, electrical safety, and proper documentation. All equipment is equipped with a "Biomed Control ID Number," and is included in the computerized maintenance system inventory. Operator and service manuals are maintained on file in the Clinical Engineering Department, or in the department that will be responsible for the technical support of the equipment..."

During an interview with the Family Medicine Clinic Manager in the presence of the Education Coordinator on August 19, 2015 at 3:15 PM, she confirmed the photodynamic device, which was delivered to the clinic from "purchasing department" on November 20, 2014, was being used for the patients who had skin issues. The Family Medicine Clinic Manager she was not part of the "protocol of receiving the equipment" in the clinic and she did not know who set-up the equipment.

A review of the "Dermatology" (pertains to the skin) patient list dated January 9, 2015 to February 19, 2015, revealed eight patients had received treatment using the photodynamic device.

During an interview with Biomedical Technician (Biomed Tech 1) and Biomed Tech 2 on August 19, 2015 at 2:30 PM, Biomed Tech 1 and Biomed Tech 2 stated their department would only oversee and perform PM on medical devices and equipment that were "in-house" (all devices or equipment in the facility except for those in the laboratory and the medical imaging department). They explained that the devices and equipment in the laboratory and the medical imaging department, were considered to be under the "third party" services, in which PM for those devices or equipment would be performed by the manufacturers; the department's manager would be responsible to ensure the PM was performed by the "third party" services accordingly and timely as recommended.

An interview with Biomed Tech 1, the Biomed Tech 2, and the Chief Nursing Officer (CNO) on August 19, 2015 at 4:50 PM was conducted. A concurrent review with Biomed Tech 2 of the facility's policy and procedure titled "Medical Device Equipment Management Policy," Revised date 4/25/14, it revealed,"...Equipment Preventative Maintenance Inspections and Compliance: ... If scheduled maintenance is being handled by an outside vendor, the Clinical Engineering Department (Biomedical Technicians department) will notify the vendor and schedule the PM service..." During a concurrent interview, Biomed 2 stated, "That's true but not 100% true," because their department was not aware of the PM schedule for the devices and equipment in the laboratory and the medical imaging department so, "Typically, it goes back to the department managers so we're not included in that."

During a concurrent interview with the CNO, CNO stated the facility's policy and procedure needed to be changed to exclude areas (laboratory and the medical imaging departments) that biomedical technicians were not responsible in calling the vendors for PM scheduling. CNO confirmed she provided oversight of the department managers, who were responsible to ensure timely PM services for the devices and equipment in the laboratory and the medical imaging department. When asked how she performed the oversight, CNO stated she met with the department managers monthly during a safety meeting and she would check with them. She, however, confirmed there was no documented evidence of this meeting. When asked if she knew about the X-Ray machine in the ER trauma room with no PM since 2013 she confirmed she did not know about it.