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Based on observation, interview, and document review, the hospital's Governing Body failed to ensure that daily operation of the Children's Hospital (Hospital A) was conducted in an effective, safe, and organized manner when it failed to ensure the following:

Findings:

1. The hospital's Governing Body failed to ensure that the Children's Hospital (Hospital A) had a separate and distinct surgery service independent of the Medical Center (Hospital B). The two hospitals have the same physical space for their operating rooms (OR) ( Nine ORs (1, 2, 3, 8, 9, 10, 14, 15, and 16) were used exclusively by hospital B. Five ORs (4, 5, 6, 7, 12) were used exclusively by the surveyed hospital (A) and two OR rooms were jointly used (11, 13). All surgical services were performed on the same floor as well as having contracted nursing staff from the Medical Center (Hospital B), and sterile processing services. This resulted in the inability of Hospital A, to ensure that it had the capability to independently provide surgical services to all pediatric patients and to provide a separate space and separate staffing services without contracting from the Medical Center (Hospital B). for those patients. These deficient findings resulted in Hospital A not providing independent oversight that might possibly place patients at risk affecting their health and safety and their needs not being met. (Refer A-0941).

2. The hospital's Governing Body failed to ensure that Hospital A's pharmaceutical services were separate, independent, and exclusive from Hospital B for all Children's Hospital patients when it failed to do the following:

a). Store medications according to manufacturer's directions. (Refer to A-0491)

b). Ensure sufficient pharmacy staff personnel, exclusive to the needs of the hospital's patients, and independent from the University Medical Center (Hospital B) pharmacy staff personnel, to ensure quality pharmaceutical service for all Children's Hospital patients. (Refer to A-0493)

c). Ensure that all compounding, packaging, and dispensing of drugs was performed independently from the University Medical Center pharmacy department, exclusive to the needs of the hospital's patients, and consistent with State law. (Refer to A-0501)

d). Ensure that multiple expired and unusable medications were not available for patient use. (Refer to A-505)

3. Ensure that Medical Records Services were being met by failing to employ separately designated staff to maintain and store medical records for the Children's Hospital (Hospital A). This failure had the potential to increase the risk of medical records mixing with other facility's medical records. (Refer to A-0432)

The cumulative effect of these systemic problems resulted in the failure of Hospital A to deliver care in a safe setting and be in compliance with the Condition of Participation for Governing Body.

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

a). Employ separately designated staff to maintain and store medical records for the Children's Hospital (Hospital A). (Refer to A-0432)

b).Ensure a separate space was designated to store the medical records for the Children's Hospital (Hospital A). (Refer to A-0432).

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

Based on interview and record review, the facility failed to provide a separate and distinct electronic medical record (EMR), Health Information Management (HIM) department and closed medical record storage department for the Children's Hospital (Hospital A) This failure had the potential to increase the risk of delayed access to closed medical records, and to increase the risk accessing protected healthcare information to employees who were not granted authorization to access the medical record.

Findings;

On September 16, 2015, at 11:00 AM, an interview was conducted with the Medical Records Executive Director (MRED) of Company C. (which is a contracted agency for medical records)). When asked if the medical records department employees were employed by Hospital A, she stated that the medical records employees are employed by Company C and are not employees of Hospital A. She stated that Company C is contracted to maintain and store all of Hospital A's closed medical records once a patient is discharged. She also stated that Company C contracts with all hospitals under the same corporation storing all of their medical records in the same location filed together.

The MRED was asked if the medical records from Hospital A were stored separately from other contracted hospital's medical records. She stated they were electronically stored separately, but the paper portions of the medical record were mixed with other hospital records after scanning them into the EMR.

The MRED was asked if the medical record employees' of Company C are hired to process only Hospital A's medical records, the MRED stated that all of the employees of Company C work on all medical records for all contracted hospitals of the corporation, of which three hospitals were identified during the interview.

During an interview on October 6, 2015 at 10:30 AM, with the Quality and Patient Safety Specialist (QPSS), when asked if the electronic medical records of Hospital B could be accessed by Hospital A's employees, she stated they could be accessed on a view only basis, but Hospital A's staff would not be able to alter the records of Hospital B. She further stated access was designed to allow Hospital A to have access to the Emergency Department (ED) records of Hospital B for pediatric patients who were transferred from the ED of Hospital B to Hospital A.

The QPSS was asked if Hospital A had a medical records department in Hospital A's building, the QPSS stated, "No". She then said the Health Information Management Department (HIM) for Hospital A was located at Hospital B.

On October 6, 2015, a review of Hospital A's policy and procedure titled, " Medical Records: Composition, Management, and Access " dated November, 2014 stipulated, " ...Original paper Medical Record documentation shall be sent to the Health Information Management Department (HIM)."

The hospital failed to ensure that the Condition of Participation: CFR 482.25 Pharmaceutical Services was met by failing to:

1) Store medications according to manufacturer's directions. (Refer to A-0491)

2) Have sufficient pharmacy staff personnel, exclusive to the needs of the hospital's patients, and independent from the University Medical Center's pharmacy staff personnel, to ensure quality pharmaceutical service for all Children's Hospital patients. (Refer to A-0493)

3) Ensure that all compounding, packaging, and dispensing of drugs was performed independently from the Loma Linda University Medical Center pharmacy, exclusive to the needs of the hospital's patients, and consistent with State law. (Refer to A-0501)

4) Ensure that multiple expired and unusable medications were not available for patient use. (Refer to A-505)

The cumulative effect of these systemic practices resulted in the failure of the hospital to meet the pharmaceutical needs of the hospital's patients in accordance with the Condition of Participation: Pharmaceutical Services.

Based on observation, interview, and record review, the hospital failed to ensure that the pharmacy was administered in accordance with State of California regulation which requires that adequate equipment and supplies be available for the provision of pharmaceutical services in the hospital. All compounding, packaging, and dispensing of drugs was performed independently from the University Medical Center pharmacy department, exclusive to the needs of the hospital's patients, and was consistent with State law. This failure had the potential for medications to be dispensed and/or administered to patients in a manner that may not be accurate or timely due to the facility not having proper equipment or adequate supplies of medications to prepare and dispense pharmaceuticals to the patients. Medications that are not dispensed or administered accurately or timely can lead to medication errors that may contribute to patient harm or death in a universe of 214 patients.


Findings:

During an inspection of the 5th floor Children's Hospital (Hospital A) pharmacy on September 8, 2015, at 9:40 AM, the pharmacy was noted to be approximately 200 square feet. It contained one laminar flow hood (equipment used to prepare sterile IV (intravenous - in the vein) medications) that could accommodate only one pharmacy person. The pharmacy was not set up to be capable of preparing TPNs (total parenteral nutrition medications that require multiple medication ingredients and multiple manipulations) or chemotherapy (medications used to treat cancer). It was observed that there was no dedicated area to prepare large numbers of oral solution medications, (commonly used in pediatric patients) or solid oral medications (tablets/capsules). Medications were stored on all sides of the pharmacy room. A relatively small supply of solid oral medications (less than 100 tablets/capsules of each medication) were stored in plastic bags in alphabetical order. A relatively small supply of IV medications (less than 50 vials of each medication) were stored in plastic bins. A relatively small supply of liquid oral medications (less than 2 bottles of 480mL (milliliter)) were stored on the pharmacy shelves.

During a concurrent interview with the Director of Pharmacy and Pharmacist 1, the Director of Pharmacy stated that the 5th floor pharmacy was responsible for providing pharmaceutical services to all hospital patients on the 2nd floor, 4th floor, and 5th floors, and patients on the Labor & Delivery units of the 3rd floor. Based on hospital bed licensing, the 5th floor pharmacy is responsible for a potential maximum of approximately 250 patients. Pharmacist 1 was asked how the 5th floor pharmacy provided medications to their patients. She stated that pharmacists in the 5th floor pharmacy dispensed the first dose of IV (intravenous - in the vein), solid oral (tablets and capsules) medications, and oral solution (liquid) medications. She also stated that they provided any immediate need medications that were not located in their Accudose machines (automated dispensing cabinets located on patient care units for storage and dispensing of immediate need medications), such as missing doses. She further stated that subsequent doses of routine IV, oral tablets/capsules, and oral solutions for the patients of Hospital A, were dispensed from the University Medical Center (Hospital B) pharmacy. Hospital B's pharmacy is licensed by the Board of Pharmacy and is located on the 2nd floor. Hospital B's pharmacy is contracted to provide medications to Hospital A patients.

During an inspection of the 3rd floor NICU (Neonatal Intensive Care Unit) pharmacy on September 8, 2015, at 2:00 PM, the pharmacy was noted to be approximately 150 square feet. The pharmacy contained one laminar flow hood (equipment used to prepare sterile IV (intravenous - in the vein) medications) that could accommodate only one pharmacy person. The pharmacy was not set up to be capable of preparing TPNs (total parenteral nutrition medications that require multiple medication ingredients and multiple manipulations) or chemotherapy (medications used to treat cancer). It was observed that there was no dedicated area to preparing large numbers of oral solution medications. The Children's Hospital (Hospital A) has contracted TPNs and Chemotherapy Medications from the University Medical Center (Hospital B) for these types of Intravenous medications as needed. A relatively small supply of liquid oral solution medications (typically observed as 2 bottles of 480mL (milliliter) or less) were stored on the pharmacy shelves. A relatively small supply of IV medications (less than 50 vials of each medication) were stored in plastic bins.

During a concurrent interview with the Pharmacy Quality Management Coordinator (PQMC) and Pharmacist 2 on September 8, 2015, at 2:00 PM, the PQMC confirmed that the 3rd floor NICU (neonatal intensive care unit) pharmacy was responsible for 3rd floor NICU patients. Based on hospital bed licensing, the 3rd floor pharmacy is responsible for a potential maximum of over 80 critically ill neonatal patients. Pharmacist 2 was asked how the 3rd floor NICU pharmacy provided medications to their patients. He described a similar system of providing first doses of new orders. Subsequent doses of routine orders came from the 2nd floor University Medical Center's (Hospital B) Pharmacy department. The University Medical Center (Hospital B) has a contract with the Children's Hospital (Hospital A) to provide medications to Children's Hospital patients.

During an interview with the Executive Director of Pharmacy Services and the Director of Pharmacy on September 16, 2015, at 9:00 AM, they were asked what was the percentage of drugs dispensed to the University Children's Hospital patients came from the University Medical Center pharmacy department. They stated that approximately 15% of drug purchased by the Medical Center (contracting) pharmacy is dispensed to Children's Hospital patients. They added that out of the total drugs dispensed to Children's Hospital patients, 75% of this total was prepared using Medical Center pharmacy space and equipment resources (with whom they have a contract). This included the Medical Center IV room, Medical Center pharmacy oral solution preparation area, and the Medical Center pharmacy "Robot" (an automated packaging machine that prepares solid oral (tablets/capsules) medications in unit dose packaging for dispensing to patient care units).

During the interview with the Executive Director of Pharmacy Services and Director of Pharmacy on September 16, 2015, at 9:00 AM, they were asked if the Children's Hospital pharmacy had adequate equipment and supplies to provide all pharmaceutical service medications to all Children's Hospital patients without the use of Medical Center pharmacy equipment and supplies. They answered, "No, not immediately." They indicated that they could increase purchasing and storage to meet the needs of their patients within several hours. They would utilize outpatient pharmacy areas such as their Pediatric Oncology outpatient pharmacy (PONC), which was offsite, to prepare and dispense TPNs and chemotherapy medications. In addition, they would set up an area to prepare oral solutions in their 2800 storage area. However, those areas, equipment, and supplies were not immediately available or adequate for the volume of their current patient census.

Based on observation, interview, and record review, the hospital failed to ensure that an adequate number of pharmacy personnel, independent of the University Medical Center's (Hospital B) pharmacy department and exclusive to the needs of the hospital's patients, were employed by the Children's Hospital. This failure to provide independent pharmacy service has the potential for medications to be dispensed and administered to patients that may not be accurate or timely. Medications that are not dispensed correctly or timely can lead to medication errors that can cause patient harm or death in a universe of 214 Patients.

Findings:

During an inspection of the 5th floor hospital pharmacy on September 8, 2015, at 9:40 AM, it was observed that there were 3 pharmacists and 3 pharmacy technicians working in the pharmacy.

During a concurrent interview with the Director of Pharmacy and Pharmacist 1, the Director of Pharmacy stated that the 5th floor pharmacy was responsible for providing pharmaceutical services to all hospital patients on the 2nd floor, 4th floor, and 5th floors located in the Children's Hospital (Hospital A).

Based on hospital bed licensing, the 5th floor pharmacy is responsible for a potential maximum of approximately 250 patients. Pharmacist 1 was asked how the 5th floor pharmacy provided medications to their patients. She stated that pharmacists in the 5th floor pharmacy dispensed the first dose of IV (intravenous - in the vein), solid oral (tablets and capsules) medications, and oral solution (liquid) medications. She also stated that they provided any immediate need medications that were not located in their Accudose machines (automated dispensing cabinets located on patient care units for storage and dispensing of immediate need medications), such as missing doses. She further stated that subsequent doses of routine IV, oral tablets/capsules, and oral solutions came from the University Medical Center (Hospital B), which has a license issued by the Board of Pharmacy, located on the 2nd floor, which Hospital A has a contract with.

During an inspection of the 3rd floor NICU (Neonatal Intensive Care Unit) pharmacy on September 8, 2015, at 2:00 PM, it was observed that there were 2 pharmacists and 1 technician working in the pharmacy.

During a concurrent interview with the Pharmacy Quality Management Coordinator (PQMC) and Pharmacist 2 on September 8, 2015, at 2:00 PM, the PQMC confirmed that the 3rd floor NICU (neonatal intensive care unit) pharmacy was responsible for NICU and Labor & Delivery patients located on the 3rd floor.

Based on hospital bed licensing, the 3rd floor pharmacy is responsible for a potential maximum of over 80 critically ill neonatal patients and Labor & Delivery unit patients. Pharmacist 2 was asked how the 3rd floor NICU pharmacy provided medications to their patients. He described a similar system of providing first doses of new orders but that subsequent doses of routine orders came from the 2nd floor University Medical Center (Hospital B), which has a license issued by the Board of Pharmacy.

During an interview with the Executive Director of Pharmacy Services and the Director of Pharmacy on September 16, 2015, at 9:00 AM, they were asked what the percentage of drug dispensed to the Children's Hospital (Hospital A) patients come from the University Medical Center (Hospital B) pharmacy. They stated that approximately 15% of drug purchased by the Medical Center (Hospital B) pharmacy is dispensed to the Children's Hospital (Hospital B) patients but that out of the total drug dispensed to Children's Hospital (Hospital A) patients, 75% of it was prepared using Medical Center (Hospital B) pharmacy staffing resources. This included the Medical Center (Hospital B) personnel staffing the Medical Center (Hospital B) IV room, Medical Center pharmacy oral solution preparation area, and the Medical Center pharmacy "Robot" (an automated packaging machine that prepares solid oral (tablets/capsules) medications in unit dose packaging for dispensing to patient care units).

During further interview, the Director of Pharmacy stated that all Children's Hospital (Hospital A) pharmacy staff are hired as Medical Center pharmacy personnel, but that the labor is transferred to the Children's Hospital (Hospital A) cost center.

During an interview with the Human Resources Coordinator on September 16, 2015, at 11:00 AM, she confirmed that Children's Hospital (Hospital A) pharmacy staff were hired as Medical Center (Hospital B) contracted employees, and that the employees (contracted) "clock-in" (log in for their scheduled shift) under the Children's Hospital (Hospital A) cost center. She further stated that Children's Hospital (Hospital A) pharmacy personnel files are "kept with the Pharmacy Department", and not necessarily under a separate Medical Center (Hospital B) or Children's Hospital (Hospital A) storage area.

During the interview with the Executive Director of Pharmacy Services and Director of Pharmacy on September 16, 2015, at 9:00 AM, they were asked if the Children's Hospital pharmacy would be able to provide accurate and timely pharmaceutical services to all Children's Hospital patients without the use of Medical Center staffing resources. They answered, "No, not immediately." They indicated that they could increase staffing to meet the needs of their patients within several hours.

Based on observation, interview, and document review, the facility failed to ensure that multiple expired and unusable medications, were not available for patient use, by removing them from the active and available medication storage area shelves. This failure had the potential to expose patients who may require antibiotics to treat infections, iron supplementation, hydration (need more fluid in their body), diuresis (reduction of fluid in the body), or nutrition and mineral replacement, to medications that may not have the same potency, integrity, or sterility intended by the manufacturer. Due to medications being used past their expiration date, they may not provide the desired effect, which can lead to patient harm in a universe of 214 patients.

Findings:

1. During a tour of the 5th floor Pharmacy on September 8, 2015, at 9:40 AM, the following medications were observed to be stored on shelves in the pharmacy medication storage area, immediately available for patient use:

a). One (1) bottle of ciprofloxacin (an antibiotic used to treat infections) 10% suspension, reconstituted (mixed with a liquid to make a suspension), and labeled with "Expires 9/6/15. Made 8/23/15". The bottle was stored in the liquid medication storage area bins immediately available for patient use.

b). One (1) box of Tobradex (a medication used to treat infections and inflammation) ophthalmic (eye) ointment. The box that contained the medication tube was stamped by the manufacturer with an expiration date of "2015 06", indicating that it expired June 2015. The box was stored in a drawer containing medications used for they eye and immediately available for patient use.

c). Five (5) boxes of neomycin/polymyxin B/bacitracin (a combination of 3 antibiotics used to treat infection) ophthalmic ointment. Four (4) of the boxes that contained the medication tube were stamped by the manufacturer with an expiration date of "8/15", indicating that they expired August 2015. One (1) box that contained a medication tube was stamped by the manufacturer with "6/15", indicating that it expired June 2015. The boxes were stored in a drawer containing medications used for they eye and immediately available for patient use.

d). Four (4) boxes of neomycin/polymyxin B/gramicidin (a combination of 3 antibiotics used to treat infection) ophthalmic solution. All four boxes that contained medication bottles were stamped by the manufacturer with an expiration date of "12/14", indicating that they expired December 2014. The boxes were stored in a drawer containing medications used for they eye and immediately available for patient use.

During a concurrent interview with the Director of Pharmacy, he confirmed the medications were expired and were stored with non-expired medications and available for patient use.

2. During a tour of the hospital's medication central storage area, labeled as "2800", on September 8, 2015, at 3:00 PM, the following medication was observed to be stored in the medication storage area, immediately available for patient use:

a). More than ten (10) Ferrous sulfate (a medication used to replenish iron levels in the blood) oral solution 5mL (milliliter) unit dose cups were stored in a bin area where other oral solution unit dose cups were stored. Stamped on the cups by the manufacturer was an expiration date of "7/15", indicating that the medication expired July 2015.

During a concurrent interview with the Pharmacy Quality Management Coordinator, she confirmed the medications were expired and were stored with non-expired medications and available for patient use.

3. During a tour of the 5200 patient care unit, on September 9, 2015, at 9:50 AM, the following medication was observed to be stored in the patient medication storage area, immediately available for patient use:

a). One (1) bag of TPN (total parenteral nutrition - a fluid composed of electrolytes, minerals, and other medication components that supply nutrition intravenously (through the vein) to patients that cannot or should not get it through eating or drinking) 1,514mL, labeled as bag number 38 for Patient 26, and dated as made on "9/7/2015", was found in a patient specific storage bin in a cabinet where active medications are stored for patient use. The medication label was printed with, "Keep refrigerated Do not use after: 9/9/15 3:53:24", indicating that the medication should be stored in the refrigerator and that it should not be used after 3:53 AM on September 9, 2015.

During a concurrent interview with the Manager of Acute Care Pediatrics and the Director of Acute Care Pediatrics, the Manager confirmed that the medication was not stored in the refrigerator and that it was still available in the active storage area despite the expiration date having already passed. The Director stated, "It should have been removed."

4. During a tour of station 2 in the 5700 patient care unit, on September 9, 2015, at 10:35 AM, the following medication was observed to be stored in the the malignant hyperthermia (a life-threatening condition that is usually triggered by exposure to certain drugs used for anesthesia (reduction/blocking of pain)) medication cart and available for immediate patient use:

a). Two (2) vials of furosemide (a medication used to reduce fluid in the body) 100mg (milligram)/10mL solution for injection. The vials were stored in a tray located in the cart with other non-expired medications and immediately available for patient use. On the vials, it was labeled by the manufacturer with an expiration date of "9/14", indicating that they expired September 2014.

During a concurrent interview with the Director of Pharmacy, he confirmed that the vials had expired and immediately removed them from the tray.

5. During a tour of station 1 in the 5800 patient care unit, on September 9, 2015, at 11 AM, the following medication was observed to be stored in the hospital's AccuDose machine (an automated dispensing cabinet - a medication storage machine used to dispense medication for immediate patient use):

a). One (1) bag of KCL (potassium chloride - a medication used to increase potassium levels in the blood) 40mEq (milliequivalents)/100mL for injection. The bag was labeled by the manufacturer with an expiration date of "9/1/15". It was found stored with other KCL bags that expired in 2016.

During a concurrent interview with the Manager of Cardiac/Intensive Care Unit Pediatrics, she confirmed that the bag had expired and was stored with other non-expired medications available for immediate patient use in the Accudose machine.

6. During a tour of the Outpatient Services at Pediatric Hematology/Oncology Clinic (PONC) on September 11, 2015, at 10:20 AM, the following medication was found stored in the clinic Accudose machine, immediately available for patient use:

a). One (1) bag of Normal Saline (a medication used to increase fluid in a patient) 500mL for injection was observed to be stored in the Accudose machine out of its manufacturer protective outerwrap. The bag was not labeled with any labeling or documentation by hospital staff when it was removed from its protective outerwrap.

A review of the manufacturer's (B. Braun Medical Inc.), package insert (a document provided by the manufacturer that provides detailed information about the medication), indicates the following:

"The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary."

"Do not remove overwrap until ready for use."

During a concurrent interview with the Supervisor Pharmacist PONC and the Director of Pharmacy, they confirmed the medication was removed from its overwrap and stored with active medications in the Accudose machine. They also confirmed it was not ordered to be used immediately. The Supervisor Pharmacist PONC stated, "That shouldn't be there." When asked if they had a policy on use of medication bags out of overwrap, the Director of Pharmacy stated, "We don't have one, but we use 24 hours." Both of them confirmed they did not know when the bag was removed from the outerwrap. When asked if they had documentation from the manufacturer regarding an expiration date after a medication bag is removed from its protective overwrap, they stated that they did not have anything.

A review of the hospital's Operating Policy titled "Storage and Beyond-Use Dating" and applicable to the Pharmacy Department, coded "CH (421) M-2" with an effective date of "11/2014", indicates the following:

"8. Pharmacy stock shall be inspected monthly and reviewed for any expired or soon-to-expire items."

"9. Expired items shall be disposed of properly, according to pharmacy or hospital policy."

A review of the hospital's Operating Policy, titled "Medication Storage in Patient Care Areas", coded "CH-R-23" with an effective date of 11/2014, indicates the following:

"Medications that are outdated.......shall be placed in separate, designated storage area for return to Pharmacy...."

Based on observation, interview, and record review, the facility failed to ensure that pharmaceuticals in the radiology department were stored at temperatures recommended by the product manufacturer. This failure had the potential to adversely affect the products and affect the overall health and safety of the patients receiving radiological services in a universe of 214 patients.

Findings:

On September 8, 2015 at 4:20 PM, an inspection of the pharmaceutical "supply closet" in the radiology department with the Radiology Manager, the Facility Director and the Chief Nursing Officer (CNO), was conducted. A "warmer" (a unit) used to warm the contrast solution (a solution used to enhance the structures of fluids inside the body during a radiological procedure), was located on top of a shelf inside the "supply closet." Pharmaceuticals stored immediately on either side of the warmer unit, were noted to be warm to touch.

A concurrent temperature measurement (using a temperature humidity meter instrument) of the pharmaceuticals that were stored on either side of the warmer unit, was conducted by the Facility Manager.

During a concurrent interview and the concurrent inspection of the pharmaceuticals, the Radiology Manager, the Facility Manager, and the CNO confirmed the following:

a). Thirteen vials of 0.9% Sodium Chloride solution (a sterile solution of salt in water) - Temperature was 88.2 F (degrees Fahrenheit - a unit of temperature measurement). The vials were warm to touch.

b). Seventeen vials of "ISOVUE-300" injection (used during radiological procedures) - Temperature was 84.2 F. The vials were warm to touch.

c). Eleven vials of "Omnipaque 300" injection (used during radiological procedures) - Temperature was 80.4 F. The vials were warm to touch.

d). Twenty bags of 0.9% Sodium Chloride 50 ml bags - Temperature was 86 F. The bags were warm to touch and moisture was noted inside the bags.

e). Two bags of 0.9% Sodium Chloride 250 ml bags - Temperature was 86 F. The bags were warm to touch and moisture was noted inside the bags.

During a concurrent interview with the CNO, she stated these pharmaceuticals should have been removed out of this "supply closet."

An interview with the Radiology Manager and a concurrent review of the procedure schedule list was conducted on September 9, 2015 at 2:45 PM. The Radiology Manager confirmed the pharmaceuticals were used on 18 patients during "INPATIENT" radiological procedures on September 1, 2015 to September 8, 2015, and on 14 patients during "OUTPATIENT" radiological procedures on September 1, 2015 to September 4, 2015. The Radiology Manager stated these pharmaceuticals stored in the "supply closet" were "restocked" on September 4, 2015 (9 days ago).

A review of the 0.9% Sodium Chloride manufacturer's recommendation revealed, "It is recommended that the product be stored at room temperature (25 degrees centigrade); however brief exposure up to 40 (degrees centigrade) does not adversely affect the product."

A review of the "ISOVUE-300" injection manufacturer's recommendation revealed, "Storage: Store at 20-25 (degrees centigrade) (68-77 degrees Fahrenheit)..."

A review of the "Omnipaque 300" injection manufacturer's recommendation revealed, " ...should be stored at controlled room temperature, 20-25 (degrees centigrade) (68-77 degrees Fahrenheit)..."

A review of the facility's policy and procedure titled "MEDICATION STORAGE IN PATIENT CARE AREAS," EFFECTIVE 11/2014, revealed, "1.1 Storage space in patient care areas shall be adequate for storage and preparation of medication..."

Based on observations, interviews and record reviews the facility failed to develop a system to identify, prevent and control infections when:
1.) The ice machine was not maintained in a sanitary condition.
2.) The air gap (a sewage water backflow preventer) was not maintained between the pipe from the ice machine storage bin to the floor drain.
3.) Eleven cases of expired tube feeding formula were stored in Central Supply, and
4.) There was a significant accumulation of garbage outside and around a trash compactor located on a loading dock outside of the kitchen.
5.) The facility failed to ensure standard isolation precautions were observed for 2 of 32 sampled patients (Patient 24 and 26).

These failures had the potential to result in food borne illness in a highly susceptible patient population of 214 patients.

Findings:

During a tour of the kitchen, on September 8, 2015 at 2 PM, the ice maker section of the ice machine used for patient food service was observed. A clean paper towel swipe of the interior of the ice maker produced a black, brown residue. There was also a fair amount of a white mineral build up and a black dust inside the ice maker. The ice maker was not clean.

During a concurrent interview with Engineering Staff 1 (ES 1), he stated that the residual, mineral build up and the black dust were not good. He stated that the parts of the ice maker should be scrubbed to remove the mineral deposits. He further stated that the hospital had a contracted service that cleaned the ice machine on a routine basis. ES 1 stated that the hospital staff did not verify the cleanliness of the ice maker after the contracted service cleaned it. They also did not monitor the cleanliness of the ice maker between cleanings by the contracted service.

During a concurrent interview with the Contracted Technician, he stated that he was responsible for cleaning the ice machine. He stated that he cleaned the ice machine quarterly. He thought that the last time it was cleaned was August 12, 2015, less than one month before. He stated that he usually saw a significant amount of residual build up when he cleaned the machine every three months. He stated that he informed his supervisor (with the contracted service) that the ice machine may need cleaning more frequently, but he did not tell the hospital staff. He did not follow up with his supervisor to ensure the facility was informed of this.

A review of the Preventive Maintenance (PM) invoice from the contracted service, dated July 28, 2015, indicated that the last time the ice machine was cleaned by the contracted service was on that date, six weeks before the observation. The next scheduled cleaning would have been three months later, or the end of October, 2015.

According to the 2013 Food and Drug Administration (FDA) Food Code, in equipment such as ice bins and enclosed components of equipment such as ice maker, surfaces of equipment shall be cleaned at a frequency necessary to preclude accumulation of soil or mold.

2. During an observation in the kitchen, on September 8, 2015, at 4:30 PM, a pipe, coming from the ice machine's ice storage bin, was positioned so that the end of the pipe was in the floor sink drain, not maintaining an air gap (an unobstructed vertical space between the water outlet and the flood level of the floor sink drain to prevent any contaminants in the sink from flowing into the ice storage bin during a negative water pressure condition, a form of backflow prevention ).

During a concurrent interview with the Director of Nutrition Services (DNS), she stated that she did not know that the air gap was not maintained and she would call Engineering to fix it.

During a follow up interview with the DNS on September 10, 2015 at 9:20 am, she stated that the Engineering staff told her that the pipe was not bolted down as it should be to maintain the air gap.

According to the 2013 FDA Food Code, if a connection exists between the system and a source of contaminated water during times of negative pressure, contaminated water may be drawn into and foul the entire system. Standing water in sinks, dipper wells, steam kettles, and other equipment may become contaminated with cleaning chemicals or food residue. To prevent the introduction of this liquid into the water supply through back siphonage (siphon off), various means may be used. The water outlet of a drinking water system must not be installed so that it contacts water in sinks, equipment, or other fixtures that use water. Providing an air gap between the water supply outlet and the flood level rim of a plumbing fixture or equipment prevents contamination that may be caused by backflow.

3. During an observation in the central supply room, on September 10, 2015 at 9:40 am, 11 cases of pediatric enteral formula (tube feeding formula for feeding by a tube placed into the patient's stomach or intestines) that had past their expiration dates. Eight cases of six one liter containers had an expiration date of August 25, 2015. Three cases of six one liter containers had an expiration date of September 3, 2015.

During a concurrent interview with the Manager of Central Supply, he stated that the enteral formulas were rotated and checked monthly for outdated or expired product. He was unable to explain why the expired formula had not been discarded.

4. During an observation of the trash compactor on the loading dock just outside the kitchen, on September 10, 2015, at 9:30 am, a significant accumulation of garbage was noted outside and around the trash compactor. The garbage consisted of more than ten cardboard boxes, and at least three plastic bags of trash. One of the plastic bags was ripped so that the garbage inside was exposed.

During an interview with the Director of Environmental Services (DES), the same day, at 10:00 am, he stated that he was surprised to see the garbage accumulation outside the trash compactor. He stated that the compactor was not used for cardboard. The same day, at 11:40 am, the DES stated the compactor had been placed out of service and needed to be replaced. He could not explain why the trash had been placed there. He agreed that the accumulation of trash was an attraction for pests.

According to the 2013 FDA Food Code, proper storage and disposal of garbage and refuse are necessary to minimize the development of odors, prevent such waste from becoming an attractant and harborage or breeding place for insects and rodents, and prevent the soiling of food preparation and food service areas. Improperly handled garbage creates nuisance conditions, makes housekeeping difficult, and may be a possible source of contamination of food, equipment, and utensils.



32496

5). On September 9, 2015 at 8:45 AM, a sign posted outside Patient 24's door indicated that contact precaution (infection transmissible by direct or indirect contact) and droplet precautions (infection transmissible by droplets of mucus and saliva) were to be observed.

During a concurrent observation with Executive Director, the Acute Care Pediatric Patient Care Manager, and the Regulatory Specialist 1, Respiratory Therapist (RT 1), who had a mask and a personal protective gown on, was observed providing respiratory breathing treatment to Patient 24. RT 1 was later observed coming out of Patient 24's room still wearing a mask, walking to the nurses station across Patient 24's room, and disposing the mask at the nurses station's regular trash container.

During an interview with RT 1 on September 9, 2015 at 8:50 AM, when asked how he would ensure that personal protective equipment (PPE) such as the mask, was disposed of properly according to the isolation precautions, RT 1 stated before leaving the patient's room, he would take off the mask and dispose it in a designated trash container located by the door inside the room. He stated he should have done so and confirmed he disposed the mask at the nurses station instead.

A review of the facility's policy and procedure titled, "STANDARD AND TRANSMISSION-BASED PRECAUTIONS," effective 11/2014, revealed, "Definitions: Standard Precautions: ...Equipment or items in the patient environment likely to have been contaminated with infectious fluids must be handled in a manner to prevent transmission of infectious agents ...1. Standard Precautions shall be used when caring for all patients receiving care regardless of their diagnoses or presumed infections status..."

During an observation with the Executive Director, the Acute Care Pediatric Patient Care Manager, and the Regulatory Specialist 1, on September 9, 2015 at 8:45 AM, Respiratory Therapist (RT 1) was observed talking and providing care to Patient 24. RT 1 had a personal protective gown on that was untied at the back and did not fully cover RT 1's clothing. A sign posted outside Patient 24's door indicated that contact precaution (infection transmissible by direct or indirect contact) and droplet precautions (infection transmissible by droplets of mucus and saliva) were to be observed.

During an interview with RT 1 on September 9, 2015 at 8:50 AM, when asked how he would ensure isolation precautions were followed when using the personal protective gown, RT 1 stated the personal protective gown should have been tied "in a knot" at the back.

During an observation with the Executive Director, the Acute Care Pediatric Patient Care Manager, and the Regulatory Specialist 1, on September 9, 2015 at 9 AM, Registered Nurse (RN 1) was observed talking and providing care to Patient 26. RN 1 had a personal protective gown on that was untied at the back and did not fully cover RN 1's clothing. A sign posted outside Patient 26's door indicated that contact precautions were to be observed.

During an interview with RN 1 on September 9, 2015 at 9:10 AM, when asked how she would ensure isolation precautions were followed when using the personal protective gown, RN 1 stated she did not feel the gown was loose until she came out of Patient 26's room.

A review of the facility's policy and procedure titled, "STANDARD AND TRANSMISSION-BASED PRECAUTIONS," effective 11/2014, revealed, "...Gowns, aprons, or other approved protective clothing ...Appropriate protective clothing must prevent contamination of an employees' skin or clothing by blood or other potentially infectious materials..."

Based on observation, interview, and record review, the hospital failed to have an independent Surgical Service that was exclusive to the needs of the Children's Hospital's (Hospital A) patients that was independent from the University Medical Center (Hospital B) Surgical Services Department by failing to:

1. Ensure that Children's Hospital (hospital A) had a separate location of surgical suites, independent from the University Medical Center (Hospital B). The two hospitals have the same physical space for operating room (OR) services, some of the nursing staff are contracted, including the sterile processing services. This resulted in the inability of the hospital to ensure that it had the capability to provide surgical services to all Pediatric Patients and having a separate space and separate and distinct staffing resources independent from the University Medical Center (Hospital B). (See A 0941)

The cumulative effect of these systemic problems resulted in the hospital's failure to deliver safe care to all patients requiring surgical services and not to be in compliance with the Condition of Participation for Surgical Services.

Based on observation, interview, and record review, the organization failed to ensure that Children's Hospital (Hospital A) had a separate surgery service independent from the University Medical Center (Hospital B). The two hospitals have the same physical space for operating room (OR) services as well as having some contracted nursing staff including the sterile processing services. This resulted in the inability of the hospital to ensure that it had the capability to provide surgical services to patients and to provide space and staffing in a universe of 214 patients.



Findings:



The Executive Director of Perioperative Services for both Hospitals A and B was interviewed on 9/8/15 at 9:50 AM. It was described that the outpatient surgical center (OSC) was leased to the Hospital A, but used also by Hospital B. The space was used by each particular hospital on scheduled days. A policy entitled " Operating Policy " for the Hospital A, subtitled General Management, Scheduling, Utilization and Allocation of Block Time was reviewed. It stated " Operations shall be scheduled ...at the Outpatient Surgery Center on Tuesday, Thursday and Friday. " The outpatient surgical center is under the license of both Hospital A and Hospital B. It is also under the CCN of Hospital A and Hospital B.

The facility clarified that the schedule for Hospital A (Children ' s) are every Tuesday (0700 hours- 1700 hours); Fridays (0715 hours - 1700 hours) and every other Thursday (0715 hours - 1700 hours). Hospital B (Medical Center) are every Monday (0715 hours - 1700 hours); Wednesdays( 0900 hours - 1700 hours); and every other Thursday (0715 hours - 1700 hours). This is how the facility charges for reimbursement.