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Based on observation, interview, and record review, the hospital failed to ensure Title 22 requirements for a pediatric play room. This had the potential to negatively impact the psychosocial well being of pediatric patients.

Findings:

During a concurrent interview and observation on 3/7/16, at 10:45 AM, with the Pediatric Registered Nurse (PRN) on the pediatric floor, a room with a couch, chairs and a small refrigerator was observed. The room was void of any decorations or toys. The PRN stated the room served as a play room and a break room for the staff. The PRN stated the hospital did not have a room that was designated solely as a play room for pediatric patients.

Title 22 70543(f) indicates a pediatric unit should have a play area of sufficient size.

Based on interview and document review, the hospital did not have an effective governing body that carried out the functions required of a governing body to provide a safe and secure environment for patients by the following:

The hospital did not ensure that its performance improvement activities included the evaluation and oversight of the hospital's fire alarm system. The Facilities management had been deactivating the hospital's audible and visual alarm system, dampers (devices that close air ducts to prevent smoke from traveling in the air conditioning system), and fire doors on a daily basis due to construction. The PBX (hospital phone operator) had been silencing the fire alarm panel and not notifying hospital management. In addition, the fire alarm system in the offsite wound care center was not functioning for several days and the oxygen shut off and master alarm panel for the hyperbaric oxygen chamber was not functioning for several days while patients were undergoing hyperbaric therapy. The Facilities management and hospital administration were not aware that there was no functioning fire alarm system on a daily basis to alert patients, or that the wound care center and oxygen shut off and alarm panel for the hyperbaric panel was not functioning. As a result there was a potential for harm for patients, hospital staff and visitors in the event of a fire. (See A-700)

There was no documented evidence of governing body oversight of the quality review of hospital contracts. (See A-0084)

The hospital did not ensure that it's Governing Body (GB) evaluated and had oversight of the Gastro-Intestinal (GI) department procedure rooms which are being performed in procedure rooms that are not adequate in size and do ensure that the procedures are performed in a safe setting. (See A-749, Item 9)

A review of the GB minutes dated July and November 2015 and concurrent interview with the Chief Operating Officer (COO) who is a representative of the GB was conducted on 3/9/16 at 9:25 A.M. There was no documentation in the GB minutes regarding the deactivation of the fire alarm system on a daily basis or the multiple perforations in the ceiling in the area adjacent to the sterile processing area and potential contamination of sterile instruments. The COO stated that the Governing Body was not informed that the fire alarm system was being deactivated on a daily basis. The COO also stated that the issue with the multiple perforations in the ceiling adjacent to the sterile processing area and potential for contamination of sterile instruments was not brought to the GB's attention. The COO acknowledged that the fire alarm system and sterile processing area issues should have been brought to the GB.

The cumulative effect of these systemic problems resulted in the hospital's failure to deliver care in compliance with the Condition of Participation for Governing Body and failure to provide a safe and secure environment for patients.

Based on interview and documents review, the hospital failed to ensure that the Governing Body (GB) 1) ensured that the hospital contracts were subject to Quality Assessment Performance Improvement (QAPI) evaluation, and 2) provide oversight to contracted services for sterile compounded medications. This failure had the potential for the hospital not being able to ascertain the services provided by the contractors were safe and effective.
Findings:

1) A review of the GB minutes dated July and November 2015 and concurrent interview with the Chief Operating Officer (COO) who is a representative of the GB was conducted on 3/9/16 at 9:25 AM. There was no documentation of quality review of the hospital contracts by the GB. The COO stated that hospital contracts are reviewed by the department heads of each department however, the COO acknowledged that other than the physician contract review; there was no documentation in the GB minutes of the GB's oversight of the quality review of all hospital contracts.



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2) During an interview on 3/7/16 at 11 AM, the Director of Pharmacy (DOP) stated three vendors were contracted to provide various sterile compounded medications.

During an interview and record review on 3/9/16 at 11 AM, the DOP stated the quality assurance data from the contracted services was available; however, the data was not reviewed by the governing body.

Based on interview and record review, the hospital failed to contact one of 29 sampled patient's (1) representative prior to performing an invasive procedure. This had the potential to cause patient representative/family to be uninformed of the risks and benefit of such procedure.

Findings:

During an interview with the Director of Med/Surg on 3/8/16, at 8:30 AM, she stated Patient 1 was unable to sign the consent for the insertion of a PICC line (peripherally inserted central catheter used for prolonged antibiotic use).

During a review of the clinical record for Patient 1,the consent for the PICC line dated 3/6/16, at 1:35 PM, was not signed by the patient or the patient's representative. The face sheet (form that gives demographic information about the patient) indicated Patient 1 had been admitted from a skilled nursing facility and did not list any contact family. Review of Nursing and Social Services notes did not indicate that staff had attempted to verify if Patient 1 had any family or representative.

During an interview with Social Services Staff (SS) 1 on 3/8/16 at 9 AM, she reviewed the clinical record of Patient 1 and was unable to find any documented evidence that staff had attempted to determine if Patient 1 had a representative who was able to consent to the treatment. SS 1 stated the usual practice is to call the facility the patient came from and inquire about family involvement.

Based on interview and record review, the hospital failed to ensure the Abuse Policy addressed the protection of patients during an abuse investigation. This had the potential to place patients at risk of continued abuse.

Findings:

The hospital policy titled Abuse/Neglect: Suspected Child, Adult, Spousal, Elder Dependent, Domestic, Fetal and Sexual Reviewed 1/2015, indicated the purpose of the policy was to provide guidelines for compliance with the Regulatory mandates that serve to identify and protect individuals who are suspect/actual victims of abuse/neglect.. The policy did not address how the hospital would ensure patient safety during an internal abuse investigation.

During an interview with the Director of Human Resources (DHR) on 3/9/16, at 9:05 AM, a request was made for evidence that the hospital policy addressed ensuring patient safety during an internal abuse investigation. During a subsequent interview with the DHR at 9:45 AM, he stated the hospital did not have any other abuse policies. No evidence was provided that the hospital's policy addressed the safety of the patient during an internal abuse investigation.

Based on interview and document review, the hospital failed to develop, implement and maintain an effective, ongoing, hospital wide, data driven quality assessment and performance improvement program as evidenced by the following:

The hospital did not ensure that its performance improvement activities included the evaluation and oversight of their fire alarm system. Facilities management had been deactivating the hospital's audible and visual alarm system, dampers (devices that close air ducts to prevent smoke from traveling in the air conditioning system), and fire doors on a daily basis due to construction. The PBX (hospital phone operator) had been silencing the fire alarm panel and not notifying hospital management. Facilities management and hospital administration were not aware that there was no functioning fire alarm system on a daily basis to alert patients, or that the wound care center and oxygen shut off and alarm panel for the hyperbaric panel was not functioning. As a result there was a potential for harm for patients, hospital staff and visitors in the event of a fire. (See A-700)

The hospital did not ensure that its performance improvement activities included oversight of the area adjacent to the sterile processing area that had multiple perforations in the ceiling due to water damage and unsanitary conditions. As a result there was a potential for contamination of sterile processing and storage of surgical instruments which are high risk problem prone areas. (See A-749, Item 2)

The hospital failed to ensure that a quality program evaluated the infection control which included: 1) the cleaning, sanitation, and maintenance of approximately 12 ice machines in the hospital, 2) Infection Control Committee or Infection Control Epidemiologist was involved in the oversight of the ice machines, or food safe practices in the production kitchen or cafeteria. (See A-749, Item 1 and 11)

The cumulative effect of the hospital's failure to have a quality assurance system in place to ensure oversight of the hospital wide fire alarm system and infection control program to include high risk problem prone areas such as sterile processing and storage of surgical instruments resulted in the hospital's failure to deliver care in compliance with the Condition of Participation for QAPI and failure to provide care to their patients in a safe environment.

Based on interview and record review, the hospital failed to ensure registered nurses were competent to perform Peritoneal Dialysis (CAPD) (Peritoneal dialysis-a procedure to remove waste products from your blood when your kidneys are not able to remove the waste). This had the potential to negatively impact the health of patients who require Peritoneal Dialysis.

Findings:

During an interview with the Director of Med/Surg (DMS) on 3/8/15, at 9:40 AM, she stated the hospital has at least one to two patients a month that require CAPD. New nurses were instructed in doing CAPD by their preceptors. She stated CAPD is not part of the nurses annual competencies.

During a review of the hospital's nursing competencies there was no listing of CAPD noted on the competencies.

Review of the American Nephrology Nurses' Association (ANNA) Nephrology (specialty of medicine that concerns itself with the study of the kidney) Nursing Scope and Standards of Practice 7th Edition indicates a competency is an expected level of performance that integrates knowledge, skills abilities, and judgement. Nephrology registered nurses must continually reassess their competencies and identify needs for additional knowledge, skills, personal growth, and integrative learning experiences.

Based on observation, staff interview, and document review, the hospital failed to ensure a registered nurse supervised the nursing care of each patient as evidenced by: patients receiving breakfast meal trays without a registered nurse verifying patients received diets as ordered by physician. This had the potential for patients to receive the wrong diet.

Findings:

During an observation on 3/8/16 at 7:45 AM, on Tower Medical Surgery Unit 5, Certified Nursing Assistant (CNA) 1 delivered three patient breakfast trays from the breakfast food cart. CNA 1 placed the breakfast trays on their overbed tables but did not verify their name on delivery. There was no licensed registered nurse verifying the diet orders after the food cart arrived and before being delivered to the patients.

During an interview with Registered Nurse (RN) 5 at 7:50 AM, RN 5 stated diets were computerized and sent from the kitchen. The CNA would be expected to set up the tray for the patient when the it was delivered. RN 5 was not able to verbalize how the CNA was to verify the patient identity before leaving the tray or how patient meal trays are checked to ensure accuracy of delivery to the correct patient.

The hospital policy titled "Patient Meal Service," dated 9/2013, indicated: "Trays are checked against diet list from the nursing station by the assigned nurse that verifies name, room number and diet order. When delivering the patient meal tray, the assigned nurse will knock on the patient's door and introduce him/her self. He/she will then call out the patient's name and ask the patient to show his/her identification band to verify the patient's name and birth date."

Based on observation, interview, and record review, the hospital failed to ensure:

1. Medication was administered according to the specifications;

2. Registered Nurses (RN) used the appropriate patient identifications immediately prior to the administration of medications;

3. Medication was not administered without a prescriber's order; and,

4. Medications were not administered as ordered.

As a result, there was a potential for medication errors to occur.

Findings:

1. During an observation of the medication administration on 3/8/16 at 8:40 AM., RN 1 administered Pantoprazole (acid-reducing medication) 40 mg injection to Patient 27 over 40 seconds.

RN 1 was interviewed immediately after, and stated Pantoprazole should be administered over 1.5 to 3 minutes.

During an observation of the medication administration on 3/8/16 at 9:25 AM, RN 2 administered Pantoprazole 40 mg injection to Patient 28 over 45 seconds.

RN 2 was interviewed immediately after, and stated, Pantoprazole should be administered over 1 minute.

Record review of the Medication Administration Record on 3/8/16 at 1:50 PM, with the Pharmacist indicated Pantoprazole 40 mg injection should be administered over 2 minutes (120 seconds).

2. During an observation of medication administration on 3/8/16 at 8:40 AM, RN 1 entered Patient 27's room, then proceeded to scan the armband on the patient's wrist. RN 1 then administered medications to Patient 27.

RN 1 was interviewed immediately after the administration, and stated she verified the patient's identifications "earlier."

According to the hospital's policy, "Administration of Medication," revised 1/2016, "Verification of Medication Administration a. For those areas using Bar Code Medication Verification (BMV) (1) Persons administering medications shall still complete the manual process of performing the "Eight Rights" (Right Patient, Right Medication ...)."

During an interview on 3/8/16 at 1:40 PM, the Assistant Director defined the "manual process" as asking the patient to identify himself or herself using the name and date of birth.

3. Following the observation of the medication administration on 3/8/16 at 9:25 AM, RN 2 identified NS (normal saline, salt solution) 500 mL was being used as "saline lock" for Patient 28. Saline lock is also known as hep-lock or TKO (to keep vein open by infusing a small volume each hour).

Patient 28's clinical record was reviewed with the Pharmacist on 3/8/16 at 1:50 PM. The Pharmacist stated Patient 28 did not have an order to receive saline lock.

According to the hospital's policy, "Intravenous (IV) Therapy," revised 10/2013, "Intravenous (IV) fluid administration at the "To Keep Open" rate (TKO) requires a Physician's Order."

4. Patient 27's clinical record was reviewed with the Pharmacist on 3/8/16 at 1:50 PM. The record indicated the prescribed was ordered Nitroglycerin (medication for chest pain) and Lidocaine (medication to control heart rates) infusions for Patient 27. Both medications were prescribed on 3/7/16 at 11:30 PM.

However, during the observation of medication administration on 3/8/16 at 8:40 AM, Patient 27 was not administered Nitroglycerin and Lidocaine.

Based on observation, interview, and record review, the hospital failed to ensure the safe delivery and storage of medications. The hospital failed to:

1. Ensure (1) the contents of the crash cart were consistent with the inventory list, and the crash cart was inspected every shift as specified by policy; (2) a process existed to manage discontinued medications; (3) medications were stored in approved devices; (4) policy and procedures existed for the management of infusion devices, and a process existed to ensure the devices were used safely; (5) staff who performed the repackaging of medications were competent; and (6) medications removed for administration without the pharmacist's review were appropriate to ensure patient safety. (See to A-0491)

2. Ensure a process existed for the accountability of all controlled drugs from the time they were ordered to final disposition. (See A-0494)

3. Ensure (1) medications were stored on well-lighted shelves, in clean storage bins; (2) medications for each patient were stored in separate bins, and appropriately labeled; and (3) the pharmacist had oversight of intravenous solutions containing potassium chloride, which were managed by the hospital's Central Supply. (See A-0500)

4. Ensure (1) staff who compounded intravenous (IV) medication was competent; (2) staff who performed the cleaning for the clean room (space designated for compounding of IV medications) was competent; and (3) the Quality Assurance plan for the clean room was followed, and the testing procedures validated the current compounding practices. (See A-0501)

5. Ensure only authorized staff had access to medications. (See A-0504)

6. Ensure (1) medications were stored according to manufacturer's specifications; and (2) vaccines were stored at the appropriate temperatures. (See A-0505)

7. Ensure appropriate instructions were available to nursing staff during medication administration. (See A-0510)

The cumulative effect of these systemic problems resulted in the failure of the hospital to deliver care in a safe manner.

Based on observation, interview, and record review, the hospital failed to ensure:

1. The contents of the crash carts were consistent with the inventory list, and the crash carts was inspected every shift as specified by policy;

2. A process existed to manage discontinued medications;

3. Medications were stored in approved devices;

4. Policy and procedures existed for the management of infusion devices, and a process existed to ensure the devices were used safely;

5. Staff who performed the repackaging of medications were competent; and,

6. Medications removed for administration without the pharmacist's review were appropriate to ensure patient safety.

As a result, patient safety was potentially compromised due to preventable medication errors.

Findings:

1. a. During an observation on 3/7/16, at 2:15 PM, of the of the Adult/Pediatric Crash Cart (a cart containing medications for a medical emergency) in the Emergency Department (ED) , with the Director of Pharmacy (DOP,) the medication box for Pediatric patients contained Naloxone (medication used to reverse the affects of narcotic medication) 2 mg per 2 ml syringe. The list of the medications indicating what medications were to be stored in the cart indicated the cart should contain Naloxone 1 mg per 1 ml syringe.

During an observation on 3/7/16, at 3:55 PM, of the Adult/Pediatric Crash Cart in the Direct Observation Unit on with the DOP, the medication box for Pediatric patients contained Naloxone 2 mg per 2 ml syringe. The list of the medications that were to be stored in the cart indicated the cart should contain Naloxone 1 mg per 1 ml syringe.

1. b. During an interview on 3/7/16, at 2:50 PM, Registered Nurse (RN) 7 stated the emergency medication carts (crash carts) should be checked at change of shift (twice daily).

Review of the Crash Cart Check Sheets with RN 7 in the ED indicated:

Crash Cart identified by hospital as 1-3 was not checked by the evening shift on 3/6/16;
Crash Cart identified by hospital as 4-7 was not checked by the evening shift on 3/6/16;
Crash Cart identified by hospital as 8-9 was not checked by the evening shifts on 3/5/16, and 3/6/16;
Crash Cart identified by hospital as 10-14 was not checked by the evening shifts on 3/5/16 and 3/6/16; and the Infant/Pediatric Trauma Cart was not checked by the evening shift on 3/6/16.

The hospital's policy titled "Maintenance and Review of Crash Carts," revised 5/2015, "Purpose ... To familiarize Hospital Staff with the contents, maintenance and review of emergency supplies.... When the Department or Unit is in operation, equipment and supplies on the top of the Crash Cart will be checked as follows: Emergency Care Center [an x was placed under "Every Shift," indicating it should be checked every shift]."

2. During a concurrent interview and observation on 3/8/16, at 10:04 AM, with the DOP and RN 5, on the 5th floor, the medication storage (cassette [storage system]) for Patient 29 was observed. In the cassette was the medication prochlorperazine (a medication for nausea). RN 5 verified the observation and stated the medication was discontinued on 3/2/16. RN 5 stated when medication is discontinued pharmacy staff was responsible for removing it from the storage bin.

During an interview on 3/9/16 at 11 AM, with the DOP and the Assistant Director (AD), they stated the hospital did not have a policy addressing the handling of medication storage in the cassette.

3. During a tour of the pharmacy with the DOP and the AD on 3/7/16 at 11:02 AM, Gabapentin (a medication for seizure) oral solution 250 mg per 5 ml was stored in 10 ml [brand] syringes, with the Best Use Date (BUD) of 6/20/16. Also observed was Simethicone (a medication for bloating) solution 40 mg per 0.6 ml was stored in [brand] syringes, with the BUD of 2/8/17.

According to the Food and Drug Administration (FDA), in a warning letter dated 8/8/15, and updated on 9/8/15, the "FDA has cleared these syringes as medical devices for general purpose fluid aspiration and injection only. These syringes were not cleared for use as a closed container storage system for drug products, and the suitability of these syringes for that purpose has not been established." The warning letter included [brand] syringes. The letter indicated, "... these syringes can cause some drugs stored in these syringes to lose potency if filled and not used immediately." The FDA recommended hospital pharmacies and staff should "[n]ot administer compounded or repackaged drugs that have been stored in any of these syringes unless there is no suitable alternative available."

During an interview with the DOP on 3/7/16, at 12:28 PM, he stated he had a discussion with the AD regarding the letter, and did not think there were other alternatives. However, they did not look into other available alternatives.

During an interview with the DOP on 3/9/16, at 10:10 AM, he stated he did not have any discussion regarding the continued use of these syringes with the medical staff or hospital leadership.

4. During an interview with the DOP on 3/7/16, at 11 AM, he stated the hospital was using [brand] infusion pumps for medication administration.

During an interview with the DOP, on 3/8/16, at 8:20 AM, he stated he was responsible for updating the pump when new medications became available. He added, the "basic mode" (safety features were bypassed) was used for infusion of cancer medications.

During an interview with the DOP on 3/9/16, at 10:10 AM, he stated the hospital did not have a policy regarding the use of the infusion pumps. In addition, the hospital did not review the quality assurance data. The quality assurance data contained data on the usage, including whether safety features were bypassed by the users. Review of such data would allow the hospital to evaluate the weaknesses in the system, and identify opportunities for improvement to ensure the infusion pumps would be used safely.

5. During a tour of the pharmacy on 3/7/16, 11:20 AM with the DOP and the AD, the AD stated the hospital used [brand] to manage medications in the crash carts. The system utilized the radio-frequency identification (RFID[system to track medications]) to correctly identify each medication, expiration date, and location.

During an interview with the DOP and the AD regarding the RFID system on 3/9/16, at 10:10 AM, they stated only one pharmacy technician was trained, and no other users (pharmacy technicians and pharmacists) were trained. They added, the users' competencies were not documented. In addition, the hospital did not have policy and procedures addressing the use of the RFID system.

6. During a concurrent interview and observation with the DOP, on 3/9/16 at 11:30 AM, the medications on override (can be removed and administered without the pharmacist's review and approval) for the patient care areas were reviewed. The DOP stated medications on override should be used to treat patients who would be in extreme pain, nausea, vomiting, or for other urgent treatments, and they should work quickly to relieve the symptoms.

The DOP agreed the following medications should not be on the override list because they would not work quickly to address the urgent needs of the patients: Dronabinol (medication for nausea), Morphine (medication given for pain) sustained-release 15 mg and 30 mg tablets, Oxycodone (medication given for pain) extended release 10 mg tablet.

The hospital's policy, "Medication: Automated Drug Distribution," revised 11/2014, "Overrides: Emergency: In some emergencies when time does not permit review by a Pharmacist. These include ... orders or those doses where the clinical status of the patient would be significantly compromised by the delay that would result from the Pharmacist review. NOTE: The Pharmacist's review is a key medication safety step. Bypassing this step through the use of the override function should only occur in the most serious of conditions."

Based on interview and record review, the hospital failed to ensure a process existed for the accountability of all controlled drugs from the time they were ordered to final disposition. As a result, there was the potential for diversion of controlled drugs.

Findings:

During an interview with the Director of Pharmacy (DOP) on 3/9/16, at 8:30 AM, the hospital's medication records were reviewed. The DOP stated the hospital did not reconcile controlled drugs after they were removed from the Automated Dispensing Cabinet to ensure they were returned to the pharmacist. In addition, the hospital did not reconcile the controlled drugs in storage pending final disposition and the actual quantity received by the vendor for destruction to ensure drug diversion did not occur.

Based on observation, interview, and record review, the hospital failed to ensure:

1. Medications were stored on well-lighted shelves, in clean storage bins;

2. Medications for each patient were stored in separate bins, and appropriately labeled; and,

3. The pharmacist had oversight of intravenous solutions containing potassium chloride (electrolyte replacement), which were managed by the hospital's Central Supply.

As a result, there was a potential for preventable medication errors to occur.

Findings:

1. a. During an observation of the pharmacy on 3/7/16, at 11:02 AM, with the Director of Pharmacy (DOP) and Assistant Director (AD). Two randomly selected medication containers were inspected: Containers for Levobunolol and Loteprednol (eye drops) appeared dusty. The DOP agreed the storage containers were dusty.

1. b. During an observation of the pharmacy on 3/7/16, at 11:20 AM, with the DOP and the AD. One out of three lights was not working in the oral/liquid medication storage area. In the pharmacy storage area, two out of five lights were not working.

1. c. During an observation on 3/7/16 at 1:30 PM, of the medication storage area in the Emergency Department (ED), with the DOP and the AD. The storage bin contained six units of Vancomycin injection (antibiotic). The bin was observed to have a white substance inside.

2. During an observation on 3/8/16, at 9 AM, the medication storage bins for individual patients (cassette) on the 4th floor were inspected with the DOP and the AD. The bin designated for Room 425 contained medications for two different patients. In addition, the bin also contained one medication without any patient identifications. At that time the AD stated that each bin should only contain medications for one patient.

During an interview with the AD on 3/8/16, at 10:04 AM, she stated there was no cleaning schedule for the cassette bins, and the pharmacy technician should clean them when dirty.

During an interview on 3/9/16 at 11 AM, the DOP and the AD stated the hospital did not have a policy addressing the storage and maintenance of the cassettes.

3. During a concurrent interview and observation with the the DOP and the AD on 3/7/16, at 3:35 PM, in the Intensive Care Unit (ICU) medication storage area, various IV (intravenous) solutions (solutions given through a vein) containing potassium chloride (an electrolyte) were observed. The DOP stated IV solutions were stocked by Central Supply, and this had been the practice for approximately 15 years.

During a concurrent interview and observation with the the DOP and the AD on 3/7/16, at 3:55 PM, in the Direct Observation Unit's medication storage area, various IV solutions containing potassium chloride were observed. The DOP stated IV solutions were stocked by Central Supply.

During an interview with the Materials Coordinator (MC) on 3/9/16 at 9:25 AM, she stated her department orders IV solutions directly from the vendor, and stocked them in the medication storage areas. The MC did not indicate the pharmacist was involved in the process.

During an interview with the DOP on 3/9/16, at 11:30 AM, he stated the IV solutions containing potassium chloride should be in "red" bins [for patient safety], but were not.

According to the American Society of Health-System Pharmacists (ASHP), the minimum standard for pharmacies in the hospitals includes, "...storage, and preparation of medications under proper conditions of sanitation, temperature, light ... to ensure medication integrity ... throughout the hospital." In addition, "Storage conditions that would foster medication deterioration, storage arrangements that might contribute to medication errors, and other safety issues shall be assessed, documented, and corrected." http://www.ashp.org/DocLibrary/BestPractices/SettingsGdlMinHosp.aspx

According to the ASHP Statement on Pharmacist's Responsibility for Distribution and Control of Drug Products, "A fundamental purpose of pharmaceutical services in any setting is to ensure the safe and appropriate use of drug products.... Fulfillment of this responsibility is enhanced through the pharmacist's involvement in all aspects of the use of drugs.... This involvement should include decisions and actions with respect to the evaluation, procurement, storage, distribution, and administration of all drug products.... The pharmacist should be directly responsible for the control and distribution of all stocks of drugs." http://www.ashp.org/DocLibrary/BestPractices/DistribStRxResp.aspx

The hospital's policy, "Storage of Medications," revised 9/2015, indicated "Medications will be stored in a safe and orderly manner in well-lighted cabinets, shelves, drawers or carts...." In addition, "All medications ... must be labeled."

Based on observation, interview, and record review, the hospital failed to ensure:

1. Staff who compounded (ingredients are mixed together in exact strength and dosage for a patient) intravenous (IV) medication was competent;

2. Staff who performed the cleaning for the clean room (space designated for compounding of IV medications) was competent; and,

3. The Quality Assurance plan for the clean room was followed, and the testing procedures validated the current compounding practices.

As a result, compounded medications potentially were not performed under accepted standards for safe compounding, and therefore unsafe.

Findings:

During an interview with the Director of Pharmacy (DOP) on 3/7/16, at 11 AM, he stated the hospital follows USP <797> standards (United States Pharmacopoeia, establishes standards for safe compounding).

1. During a concurrent interview and observation with the DOP, and the Assistant Director (AD) in the pharmacy, on 3/7/16, 11:20 AM, the medication norepinephrine (Levophed, IV medication to treat low blood pressure) was observed as a "kit," (vials of medication packaged together with the IV solution). The AD stated the kit was prepared so the RN would "compound" when needed.

During an interview with Registered Nurse (RN) 3 on 3/8/16 at 10:35 AM, she stated she has worked in the Intensive Care Unit for four years, and frequently compounded norepinephrine for administration. RN 3 stated when compounded the medication it would be assigned a Beyond Use Date (BUD) of 24 hours at room temperature.

During an interview with the the DOP on 3/8/16, at 1:05 PM, he stated when an RN added norepinephrine to the IV solution, it would be considered "compounding."

According to USP <797>, norepinephrine compounded by a nurse would be considered an "immediate use" compounded sterile product (CSP), due to the increased likelihood of microbial contaminations. USP <797> further stated the duration of administration of this CSP "exceeding a few hours" would increase the potential for patient harm. The BUD, therefore, would be one hour.

During an interview with the AD, on 3/9/16, at 8:10 AM, she stated there was not an on-going process to ensure nurses were competent when compounding IV medications.

2. During an interview with the AD, on 3/8/16 at 3:15 PM, she stated daily and weekly cleaning of the clean room used for compounding medications was performed by Environmental Service Staff (EVS).

During an interview with the DOP and the AD on 3/9/16, at 11 AM, they stated the EVS trainer trained the EVS staff, but they were not sure who trained the EVS trainer. The EVS trainer was identified as the same individual who performed the cleaning of the clean room.

The hospital was unable to provide the training record for the EVS trainer, who also performed cleaning of the clean room.

3. During a concurrent interview and review of the hospital's policy, with the DOP, on 3/9/16, at 10 AM, the hospital policy titled "Quality Assurance Plan," revised 10/2015, was reviewed. The policy indicated End Product Testing and Quantitative Testing were to be conducted weekly. According to the policy, the hospital was to use "one returned IV product" for testing. The DOP stated these tests were currently conducted quarterly. The DOP provided records of the tests dated 1/28/16 for two IV medications, Ceftriaxone (antibiotic medication) 1 Gram in 67 ml and Cefazolin (antibiotic medication) 1 Gram in 67 Ml. The DOP stated these medications were prepared for purposes of testing, and were not normally compounded by pharmacy staff. During the same interview, the DOP also stated, the policy did not indicate the locations for the Environmental Testing.

Based on observation, interview, and record review, the hospital failed to ensure only authorized staff had access to medications. As a result, the respiratory therapists (RT) had access to medications they were not authorized to dispense or administer.

Findings:

During a concurrent interview and observation with the Director of Pharmacy (DOP) and Assistant Director (AD) in the Emergency Department (ED), on 3/7/16 at 1:30 PM, the DOP stated RTs only had access to respiratory medications. Inspection of the Automated Dispensing Cabinets in the ED with the DOP and the AD revealed that RTs had access to the following medications:

Magnesium ( a mineral found in the body) injection 2 Gram;
Ampicillin and Sulbactam (antibiotic) injection 3 Gram;
Ertapenem (antibiotic) injection 1 Gram;
Ceftaroline (antibiotic) injection 600 mg;
Levofloxacin (antibiotic) injection 500 mg;Cefepime (antibiotic) injection 1 Gram.

The hospital's policy titled "Storage of Medications," revised 9/2015, indicate Medications shall be secured and accessible only to authorized personnel as designated by the Hospital....

Based on observation, interview, and record review, the hospital failed to ensure:

1. Medications were stored according to manufacturer's specifications; and,

2. Vaccines were stored at the appropriate temperatures.

As a result, unusable medications were available for patient use.

Findings:

1. a. During a concurrent interview and observation on 3/7/16, at 11:02 AM, with the Director of Pharmacy (DOP) and the Assistant Director (AD), the following medications were observed stored unprotected from light:

Ofloxacin (antibiotic) eye drops;
Optiray (contrast solution);
Visipaque (contrast solution); and,
Conray (contrast solution).

The AD verified the above observations.

According to the manufacturers, the instructions for the storage of these medications included, "Protect from light."

1. b. During a concurrent interview and observation on 3/7/16, at 11:02 AM, with the DOP and the AD, the medication Budesonide (a respiratory medication given via inhalation) 0.5 mg in 2 ml was found out of the foil wrap, without the Beyond Use Date (BUD). The DOP stated he was not sure how long the medication was left unprotected, and would "throw away."

According to the manufacturer, the medication Budesonide should be stored in the aluminum foil envelope to protect from light, and would have a shelf life of two weeks when protected.

1. c. Also observed was the medication Levalbuterol (a respiratory medication given via inhalation) 0.31 mg per 3 ml. The medication was out of the foil wrap and did not have a BUD.

According to the manufacturer, this medication should be stored in the protective foil pouch, and once the foil pouch is opened, it should be used within two weeks. In addition, vials removed from the pouch should be protected from light and used within one week.

1. d. During an observation on 3/8/16, at 9 AM, on the 4th floor with the DOP, Darbepoetin was stored at room temperature with the expiration date of 10/17.

The storage instructions for the medication indicated it should be stored at 36º Fahrenheit to 46º Fahrenheit or refrigerated.

1. e. During an observation on 3/7/16, at 1:30 PM, with the DOP and the AD in the Emergency Department (ED), the medication Lorazepam (medication for seizures, anxiety) injection 2 mg per ml was observed stored at room temperature with the BUD of approximately 90 days.

During an observation with the DOP on 3/8/16 at 9:50 AM, of the 4th floor on, the medication Lorazepam injection 2 mg per ml was stored at room temperature with the BUD of approximately 90 days.

The manufacturer's recommendations for Lorazepam, indicated the medication should be stored in a refrigerator at 36° to 46°Fahrenheit.

The hospital was unable to provide current information to support the practice of storing Lorazepam at room temperature for 90 days.

1. f. During an observation on 3/7/16, at 11:20 AM, in the pharmacy, with the DOP and the AD, a 2 Gram vial of Cefepime (antibiotic) was observed attached to a 100 ml bag of dextrose solution (D5W), stored at room temperature with a BUD of 28 days.

According to the letter dated 3/7/16 from the manufacturer of D5W, provided by the hospital, stability studies supported the storage for up to 15 days at room temperature.

The hospital was unable to provide documentation to support the BUD of Cefepime assembly beyond 15 days.

2. During a concurrent interview and observation on 3/8/16 at 11:20 AM of the Family Clinic with the AD and Medical Assistant (MA), the medication refrigerator was inspected. Three vaccines: Pneumovax, Tdap, and Influenza were stored in the refrigerator. The AD stated the temperatures were monitored twice daily and recorded manually on a temperature log.

According to the temperature logs, the daily min/max (low and high) temperatures were between 35° and 46°F between 3/1 and 3/8/16. However, the MA stated the range of 35° and 46°F were not the actual min/max reading from the thermometers, but were from a reference range.

As a result, the hospital was unable to demonstrate the vaccines were kept at the recommended temperature.

According to the record provided by the hospital, 10 patients received the vaccines in 2016 thus far, and 12 patients received the vaccines in 2015.

The hospital's policy, "Storage of Medications," revised 9/2015, indicated that the Director of Pharmacy was responsible to ensure that all drugs throughout the hospital are stored in accordance with ... the manufacturer's requirements and... in such a manner as to ensure their purity, potency and security.... Medications will be stored at appropriate temperatures ... between 36° to 46° Fahrenheit....

Based on observation, interview, and record review, the hospital failed to ensure appropriate instructions were available to nursing staff during medication administration. As a result, Registered Nurse (RN) 1 was unaware of how to correctly administration a medication to a patient. This had the potential to negatively impact patient health.

Findings:

During a concurrent interview and observation on 3/8/16, at 8:40 AM, RN 1 was observed administering Pantoprazole (Protonix, medication for stomach ulcer) injection, to Patient 27. RN 1 injected the medication through the patient's Intravenous (IV catheter placed into a vein to give medication through) line. The medication was injected in 40 seconds. RN 1 stated the medication should have been administered over 1.5 to 3 minutes.

During an interview with the Pharmacist on 3/9/16 at 11:25 AM, she reviewed the Medication Administration Record (MAR) for Patient 27, and stated the directions for Pantoprazole administration was not available on the MAR.

According to Lexicomp, a nationally recognized drug information for healthcare professional, Pantoprazole should be administered slowly over at least 2 minutes.

Based on observation, interview, and record review, the Food & Nutrition Director (FND) failed to ensure direct oversight of the daily operations of foodservice to ensure safe food handling practices, as evidenced by: 1) staff not followed safe cool down procedures, 2) potentially hazardous food was held above 41 degrees Fahrenheit (F) or below, 3) cafeteria handwashing sink was available to staff at all times, 4) staff with unsecured hair, and 5) staff not dating open products when stored in refrigerator.

The potential for not following safe food production practices can put patients at risk of receiving food borne illness.

Findings:

1. Improper cooling remains a major contributor to bacterial foodborne illness. Cooling temperatures and times needed to be maintained as prescribed in the Food and Drug (FDA) Food Code to limit the growth of pathogens that may be present in or on the food and may help prevent foodborne illness.

During an observation on 3/7/16 at 9:40 AM, one pan of frozen ground beef, dated 2/19, and one pan of beef picadillo, dated 2/14, were located in the six door freezer. Review of the HACCP (Hazard Analysis and Reheating Chart) dated for 2/2016, did not include the cooldown documentation for these two products.

During interview with the Executive Chef (EC) on 3/7/16 at 9:40 AM, he confirmed these products were not entered on the log and must have been missed. The EC confirmed all products must be cooled down safely and temperatures and times are to be entered on the log form before being stored for later use.

Review of the policy "Hazard Analysis Critical Control Point (HACCP)/Food Safety," last reviewed in 9/2013, indicated, "Proper cooling and holding procedures are followed."

2. a. During an observation on 3/7/16 at 9:45 AM, it was noted one large container of tuna salad, dated 3/5, (indicating preparation date), was 44 degrees F using the hospital digital thermometer. During an interview on 3/7/15 at 9:45 AM, the EC stated the tuna salad was prepared yesterday and there was no log to verify the product was cooled to 41 degrees F or below in four hours as required. The EC stated he was not aware that tuna salad was to be cooled to 41 degrees F or below within the four hours. Review of the policy "Patient Meal Service," revised 9/2013, indicated "Hold food below 40 degrees F and above 140 degrees F to prevent growth of microorganisms (pathogens that cause illness)."

Food and Drug Food Code (FDA) 2013, requires food prepared from ambient (room) temperature to be cooled to 41 degrees F or below in four hours.

During a review of policies and recipe 58022 review, it was noted there were no policies directing staff to the procedure for cooling foods prepared at room temperature that followed the FDA Food Code requirement.

2. b. During observation on 3/7/16 at 10 AM, approximately 8 to 10 turkey sandwiches were in a cafeteria self-serve open refrigerated display case. The turkey sandwiches temperature was measured by the hospital digital thermometer at 52 degrees F.

During an interview at 10:10 AM, the EC stated the sandwiches could have been put into the refrigerated case yesterday. The EC acknowledged there were no temperatures monitored for the potentially hazardous food like the turkey sandwiches and these sandwiches would be discarded because they could cause food borne illness if eaten.

The policy titled "Food Safety" dated 9/2013, indicated "All readily perishable foods or beverages capable of supporting rapid and progressive growth of microorganisms (causing illness) which can cause food infections or food intoxication shall be maintained at temperatures of 40 degrees F or below..."

3. The Center for Disease Control (CDC) estimates that Norovirus is the leading cause of food borne illness in the United States. Contaminated hands are a significant factor in the transmission of enteric viruses, including Norovirus and hepatitis A virus. And that proper handwashing will significantly reduce the chance of transmission of pathogenic viruses.

During observation on 3/7/16 at 10 AM, the handwashing sink in the cafeteria serving area was blocked by a tall cart.

During an interview at 10:15 AM, the EC acknowledged the cart should not be obstructing the hand washing sink.

4. During an observation on 3/8/16 at 7:15 AM, Food Service Worker (FSW) 1 did not have a hair net covering the hair over the bangs.

In an interview with the Food and Nutrition Manager (FNM) on 3/8/16 at 7:15 AM, the FNM stated FSW 1 was not wearing the hair net correctly. The FNM confirmed that the food service supervisor on duty that morning was to observe the FSWs and this had not been done.

The hospital policy titled "Food Safety," dated 9/2013, "Hair restraints (hairnets, hats or caps) must cover hair sufficiently to prevent hair from falling into food or food equipment and to minimize hand contact with hair."

5. During observation on 3/7/16 at 10:10 AM, there were six open frozen products (French fries, onion rings, and chicken nugget's) that were not dated when opened in Number 10 freezer.

During an interview with the EC on 3/7/16 at 10:10 AM, the EC stated the products should be dated when opened. The EC acknowledged he was responsible to oversee the cooks' practices and did not know why these products were not dated as required.

The hospital policy titled "Food Safety", dated 9/2013, indicated, "all food items are to be covered, labeled, and dated after opening/preparation."

Based on observation, record review, and interview, the hospital failed to maintain their fire and life safety systems to ensure a safe environment in accordance with the National Fire Protection Association (NFPA) 101 Life Safety Code (LSC) 2000 Edition, NFPA 72 National Fire Alarm Code 1999 Edition, NFPA 13 Standard for the Installation of Sprinkler Systems 1999 Edition, and NFPA 25 Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems 1998 Edition.

This was evidenced by the failure to:

1. Maintain a fully functional fire alarm system at the Main Hospital. (See LSC K51)
2. Conduct interim life safety measures (ILSM) in areas where the fire alarm system was disabled. (See LSC K155)
3. Maintain a fully functional fire alarm system at the hyperbaric facility. (See LSC K51)
4. Maintain a fully functional medical gas master alarm panel at the hyperbaric facility. (See LSC K142)
5. Visually inspect fire and life safety systems prior to pressurization of hyperbaric equipment. (See LSC K142)

The cumulative effect of these systemic problems, identified during the Life Safety Code (LSC) Survey, resulted in the failure to demonstrate the ability to ensure the provision of quality health care in a safe environment. This affected all patients at the Main Hospital and at the Wound Care Clinic (hyperbaric facility) and could result in injury due to the delay in notifying occupants of a fire, a failure of the fire alarm systems, a delay in evacuation in the event of a fire, and a delayed response from emergency forces. (Refer to the LSC Survey dated 3/10/16)

Findings:

During a facility tour with staff from 3/7/16 to 3/10/16, the fire alarm systems were observed, test and inspection records were reviewed, and staff was interviewed.

MAIN HOSPITAL:

1. At 11:10 AM, on 3/7/16, the fire alarm subpanel at the Central Plant exhibited over 30 trouble signals. The trouble signals indicated that fire dampers, smoke detectors, fire doors, and notification devices were "disabled."

During an interview at 11:15 AM, Plant Operations Engineer (FS) confirmed that all the devices were disabled and if the fire alarm were tested, no notification devices would activate. He stated that the fire alarm system was usually disabled Monday through Friday from approximately 5 AM, to 4:30 PM, because of construction going on in the building.

The Manager of Facilities Services (MPO) and the Project Manager for Construction (PM) stated that they were unaware that the fire alarm system was disabled and they thought the system was only being placed on test. They thought the fire alarm would activate but only the signal transmission to the monitoring company was disabled.

PM pointed out on the hospital floor plan that construction was conducted in five small areas of the first floor (approximately 5 percent of the total square footage), a small portion of the corridor in the basement, in both stairways of the Tower, and in two elevator lobbies in the Tower. She stated that the hospital was only conducting Fire Watch rounds in the two stairwells and in the basement flooring area.

The Plant Log, where Plant Operations Engineers log their activities, was reviewed. An entry at 5:15 AM, on 3/7/16, indicated "Posted fire system till 1630."

During an interview at 11:25 AM, Plant Operations Engineer 2 (POE 2) stated that "posted" means disabled. He confirmed that strobes, horns, fire dampers, and fire doors are bypassed during the weekdays when construction occurs at the hospital.

The Plant Logs dating back to the date of 2/9/16 indicated that the fire alarm system was "posted" on most weekdays from approximately 5 AM to 4:30 PM. Plant Logs before that date were not provided.

During an interview at 11:26 AM, FS and POE 2 stated that the fire alarm system has been disabled for construction for years. PM stated that this probably started when the VSI Project (seismic retrofit) began in 2014.

The construction permit for the VSI Project HL111174-0 was approved by the Office of Statewide Health Planning and Development (OSHPD) on 10/25/13.

At 11:30 AM, the main fire alarm control panel (FACP) on the first floor exhibited the same troubles as the subpanel in Central Plant. The smoke detector outside the FACP Room was sprayed with aerosol smoke three times by FS. The smoke detector failed to activate any fire alarm devices or a signal at the FACP. The smoke detector was not located in close proximity to any construction areas. The smoke detector was in a hallway near the main lobby and in a central hallway close to patient care areas.

At 11:32 AM, the pull station in the hallway outside the FACP Room was tested by FS. A local signal at the FACP was heard. All notification devices in the hospital failed to activate and all the fire doors failed to close.

During an interview at 11:33 AM, MPO stated that when Public Board Exchange (PBX) operators hear the local signal at their fire alarm subpanel, they dispatch facility staff and plant operations engineers.

No fire alarm dispatch could be heard from FS, POE 2, and MPO's radios. During an interview at 11:38 AM, after MPO came back from the PBX Office, he stated that the operators heard the signal but failed to dispatch facilities and plant operations engineers.

During an interview at 11:40 AM, PBX Operator 1 and PBX Operator 2 both stated that the fire alarm panel exhibited an audible signal. They stated that they were not informed that the fire alarm system was being tested and they did not know if the signal was from an actual fire incident. PBX Operator 2 stated that he silenced the fire panel after the signal was received because they were busy with calls.

During an interview at 2:45 PM, on 3/7/16, the Operating Room Director (DPS) stated that she was not told the fire alarm system was regularly disabled.

The facility disabled the fire alarm system in the entire hospital regularly without implementing a fire watch in accordance with their Interim Life Safety Measures (ILSM) policy.

An Immediate Jeopardy (IJ) was called at 12:45 PM, in the presence of PM, the Chief Operating Officer (COO), and the Chief Executive Officer (CEO).

The IJ was removed at 6:04 PM, in the presence of the COO and CEO, after the fire alarm devices were enabled and an acceptable Plan of Correction (POC) was received. (See LSC K51)

2. a. At 10:30 AM, on 3/8/16, the smoke detector outside the fourth floor elevator lobby, and the two smoke detectors inside the lobby, were entirely covered with tape.

During an interview at 10:31 AM, the Construction Contractor (CC) 1 stated that they have been working on replacing the floor in the elevator lobby since 6:30 AM.

During an interview at 10:32 AM, MPO stated that PM told him over the telephone that fire watch was only being conducted at the stairwells and not at the elevator lobby renovation locations. She stated fire watch was not required at the other construction sites.

The hospital was issued Building Permit S152541-19-00 by the Office of Statewide Health Planning and Development (OSHPD) on 12/11/15 for cosmetic upgrades on multiple floors. The Interim Life Safety Measure (ILSM) plan connected to this permit was signed by the OSHPD Fire Life Safety Officer (FLSO) on 1/6/16. The ILSM plan stated that "dedicated individual to be posted at working phase to provide fire watch for that specific area."

The hospital's Life Safety Management policy, last revised 10/27/15, listed ILSM measures during construction or fire alarm system failures as one of the objectives required to meet the hospitals "fire safety and prevention needs." (See LSC K155)

2. b. At 3 PM, on 3/8/16, a first floor door labeled "Room 8" in the Radiology Department was closed off for construction. There were four smoke detectors entirely covered with tape. The area was non-sprinklered, unsupervised, and housed some construction material. There were no records of conducting a fire watch at this construction area with the covered smoke detectors. (See LSC K155)

2. c. At 3:24 PM, on 3/8/16, the construction area near the first floor Radiology Department, called by MPO as the "old corridor leading to Radiology," was observed. The smoke detector in that area was completely covered with tape. The area was non-sprinklered, unsupervised, and housed some construction material. There were no records of conducting a fire watch at this construction area with the covered smoke detectors.

During a telephone interview at 8:18 a.m., on 3/9/16, the OSHPD FLSO stated that fire watch is needed in areas where fire alarm devices are disabled. He stated that the facility should follow the ILSM procedures. (See LSC K155)

WOUND CARE CLINIC (HYPERBARIC CENTER):

3. At 10:39 AM, on 3/9/16, the main FACP was in the lobby directly outside the hyperbaric holding area. There were no indicators lit on the panel and the screen on the panel was not functioning. When the panel box was open, there were scorch marks on the power board.

During a telephone interview at 10:40 AM, a representative from the remote monitoring station stated that the last signal received from the facility's panel was a trouble signal on 3/6/15 at 11:29 AM. He stated that the monitoring station conducted daily tests to ensure communication with the facility's panel.

At 10:45 AM, the pull station near the FACP was tested by FS while the monitoring station representative was on the telephone. No alarms were activated in the facility and the monitoring station representative did not receive any signal from the facility after more than two minutes.

At 3:06 PM, the Detailed Activity Report from the monitoring company indicated that the monitoring station conducted a daily "Periodic test with system trouble" at 11:29 AM to establish a connection with the facility's panel. The report showed that on 3/7/16 at 12:41 PM, and on 3/8/16 at 1:53 PM, a test signal was not received and a notification email was sent to a representative from the fire alarm vendor.

During an interview at 3:41 PM, MPO stated that he spoke to the fire alarm vendor representative who was emailed about the test signal not being received. MPO was told that the incident happened midnight on Sunday (3/6/16) and the representative was planning to call the facility yesterday (3/8/16).

There were nine patients in the facility at the time, one of them in a hyperbaric chamber when the fire alarm panel failure was discovered.

4. At 10:45 AM, on 3/9/16, there was one patient in a hyperbaric chamber, and one patient in the hyperbaric holding area, during the time the failed medical gas alarm panel and fire alarm panel were observed. Facility staff failed to inspect the fire alarm system before administering treatment to a patient in the hyperbaric chamber, as required by NFPA 99.

An IJ was called at 12:21 PM, in the presence of the COO and Chief Nursing Officer (CNO).

The IJ was removed at 5:55 PM, in the presence of the COO, after the facility ended procedures, evacuated the building, initiated repairs to the fire alarm and medical gas alarm panels, and after an acceptable POC was received. (See LSC K142)

During a telephone interview at 2:01 PM, on 3/15/16, the city's Fire Marshal, who is the local authority having jurisdiction (AHJ), stated no patients should be treated in the hyperbaric chambers when the fire alarm system and the oxygen alarm system are not working. (See LSC K142)

5. At 10:48 AM, on 3/9/16, the facility was equipped with a piped-in oxygen system feeding the two hyperbaric chambers. The medical gas master alarm, located in the hyperbaric holding area, exhibited a "Low" oxygen pressure trouble light.

During an interview at 10:49 AM, the Director of Wound Care (WCD) stated that the panel has been that way since he started working at the facility two weeks ago. He stated that staff are manually checking the pressure once a day. The Director of Facilities Services (DFS) 1 stated that the parts to repair the panel were on order. He stated that the panel's audible alarm was silenced.

During an interview at 11:07 AM, the hyperbaric technician overseeing the patient in the chamber stated that he did not know that the master alarm panel for the piped-in oxygen system was broken and the pressure reading on the panel was not accurate. The hyperbaric technician stated that he checks the oxygen master alarm panel, the dials on the hyperbaric chamber, and the readings on the cryogenic cylinders before he starts any treatment in the hyperbaric chamber, but did not realize the master panel was not working.

At 1:55 PM, results from the survey by the accreditation organization, conducted from 2/2/16 to 2/4/16, were reviewed. Finding 2 on Page 35 stated that the medical gas alarm panel in the Wound Care Offsite Location was faulty and that staff at the Wound Center were unaware that the panel was in alarm. The surveyor noted that staff continued to use the system even though it was in alarm.

An estimate for the cost of the repair from the medical gas vendor was dated 2/3/16. The vendor indicated that outstanding bills must be paid before an order for the panel parts can be placed. A purchase requisition from hospital staff for the panel repair, requested 2/5/16, also indicated that past due bills to the medical gas vendor be paid. Records showed that the vendor was paid on 2/25/16 and he made a service call to repair the panel on 3/2/16. In his field report, he stated the "back circuit board" was defective and a custom manufactured part will need to be ordered. He estimated the part would arrive within four to six weeks.

During an interview at 2 PM, DFS 1 confirmed that the panel repairs were delayed due to outstanding bills owed to the vendor. (See LSC K142)

Based on observation, interview, and record review, the hospital failed to ensure:

1. Storage rooms for soiled utility and EVS were locked when not in use. As a result, potential hazardous chemicals were accessible to unauthorized individuals and patients.

2. Equipment was not blocking egress. As a result, the evacuation route for patients and staff would be obstructed during an emergency.

Findings:

1. During an observation on 3/7/16, at 3:35 PM, in the Intensive Care Unit (ICU) with the Director of Pharmacy (DOP) the room labeled as "Soiled Utility" was unlocked. The sign on the door indicated, "Caution Biohazardous Waste Storage Area."

2. During a concurrent interview and observation on 3/8/16 at 9 AM, with the DOP on the 4th floor, a patient bed and wheelchair were observed in the hallway. The DOP estimated the presence of the bed in the hallway would leave about 4 to 5 feet for egress.

The bed and wheelchair were observed in the same location again at 9:57 AM. At that time, Registered Nurse (RN) 4, a charge nurse (a nurse who is in charge of the area), was interviewed. RN 4 stated the bed was in the hallway since 7 AM. RN 4 also stated this was the only emergency exit route.

Policies for the soiled utility and storage of equipment, were requested, but were not provided at the conclusion of the survey.

Based on observation, staff interview, and document review, the hospital failed to ensure they maintained the specified 240 five gallon bottled water supply designated for consumption and essential care activities during a disaster. This had the potential for the hospital not meeting minimal water requirements during disastrous situation.

Findings:

During an observation of emergency/disaster water on 3/8/16 at 9:30 AM, central supply had 160 five gallon bottles of water as part of the disaster water supply.

During an interview with the Materials Coordinator (MC) on 3/8/16 at 9:30 AM, the MC stated the five-gallon bottles were delivered every two weeks and the disaster water supply goes down until the next delivery. The MC confirmed there was no system for a par level (the minimum quantity of an item stocked, which will be automatically reordered, should the level fall below a preset level) to ensure there stock met the required quantity.

The hospital policy titled "Emergency Operation Plan," page 43, dated 10/2015, and indicated water supply on site was to be 240 five-gallon bottles.

Based on observation and staff interview, the hospital failed to ensure 1) the walk-in freezer was maintained in an acceptable level of safety, when ice accumulated on the freezer floor under the condenser. This can cause accumulation of soil or mold. 2) Two housekeeping rooms were left unlocked. 3)The medication refrigerator in the pharmacy was maintained according to the maintenance schedule. These failures had the potential to put patients health and safety medication at risk.



Findings:

1. During an observation on 3/7/16, at 9:45 AM, there was ice accumulated on the floor of the walk-in freezer and under the condenser unit. The ice measured approximately 20 to 25 inches long, 4 inches wide and 3-4 inches in height.

During an interview with the Food and Nutrition Director (FND) on 3/7/16, at 9:45 AM, she stated she thought this was addressed with Facilities management three months ago and would see if there were work orders. The FND stated the condenser was turned off when staff stocked the walk in freezer and this was the cause of the ice on the floor.

During an interview on 3/9/16 at 11 AM, the Facilities Supervisor (FS) stated ice formed when defrost cycle was turned on, but there had been no documented maintenance on the ice forming on the freezer floor.



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2. During a concurrent observation and interview with the Director of Cardiology (DOC) and Quality & Risk Management Coordinator (QRC), on 3/7/16, at 2:34 PM, in Tower 4, the housekeeping room, which contained cleaning supplies including chemicals, was unlocked. The DOC and QRC verified the finding. The DOC stated the housekeeper had just been in there.

During an observation on 3/7/16, at 2:56 PM, in Tower 5, with the DOC and QRC, the housekeeping closet door was again observed to be unlocked. The DOC and QRC verified the finding.

During a subsequent interview with Housekeeper 1, on 3/7/16, at 2:58 PM, in Tower 5, she stated the housekeeping closet should be kept locked for patient safety.



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3. During an observation on 3/8/16 at 2:45 PM, in the pharmacy, stickers were observed posted on the medication refrigerator. The stickers indicated the refrigerator was last serviced on 4/2015.

During an interview with the Director of Pharmacy and the Assistant Director, on 3/9/16 at 10:10 AM, both stated the next service date was scheduled for 10/2015 as indicated on the sticker.

The hospital provided the service record for the refrigerator performed on 4/2015, but was unable to provide the record for 10/2015.

Policy and procedures for the maintenance of equipment was requested, but was not provided at the conclusion of the survey.

Based on observation, interview, and document review, the hospital failed to implement an effective, active, and a systematic surveillance program to provide a sanitary environment and minimize the sources of infections. The Infection Prevention program did not ensure the safety of 105 in-patients and the clinic patients in the outpatient areas during the survey. The hospital failed to:

1. Ensure proper cleaning, sanitation, and maintenance of its 12 ice machines in the hospital. (See A-0749, Item 1)

2. Repair and seal a room with water leakage and mold-like material on the ceiling inside the Sterile Supply Processing area. (See A-749, Item 2)

3. Develop a policy and procedure in consistent with Center for Disease Control's (CDC) recommendations to disinfect a patient care item, Glucose meter (a device used to check blood sugar level), after each use. (See A-749, Item 3)

4. Ensure the sink in the clean supply room of the Emergency Care Center was not used for dirty procedures. (See A-749, Item 4)

5. Ensure Tuberculosis (TB) Screening results and Influenza vaccination information were obtained for 10 out of 10 physician credential files. (See A-749, Item 5)

6. Ensure three hospital staff were knowledgeable in the proper use of disinfectants on surfaces in between patients per manufacturer's guidelines. (See A-749, Item 6)

7. Ensure visitors complied with directions required to avoid transmission of infectious diseases. (See A-749, Item 7)

8. Ensure a dialysis (a blood-cleansing procedure, used to treat kidney failure) registered nurse used personal protective equipment when disconnect a patient from dialysis machine. (See A-749, Item 8)

9. Provide sufficient space to safely perform procedures in two endoscopy (procedures done by looking inside the body through a hollow tube with a camera) rooms. (See A-749, Item 9)

10. Provide and monitor effective ventilation in two endoscopy rooms. (See A-749, Item 10)

11. Have a handwashing sink in the cafeteria available to staff at all times. (See A-620, Item 3)

12. Assure sterile supplies were not stored next to a hand-washing sink. (See A-749, Item 12)

13. Ensure the faucets in several areas of the hospital were free of white, greenish calcium build up around it. (See A-749, Item 13)

14. Repair cracked flooring in two operating rooms, 1 and 3, and torn mattress in Operating Room 3 and Radiology Room 1. (See A-749, Item 14)

15. Ensure patient use equipment was maintained in sanitary conditions. (See A-749, Item 15)

16. Maintain two nourishment rooms in sanitary condition. (See A-749, Item 16)

17. Replace a Pharmaceutical waste container in Tower Room 4 and a red sharp container in the triage room in the Emergency Care Center. (See A-749, Item 17)

18. Ensure clean and dirty supplies were stored separately. (See A-749, Item 18)

19. Ensure expired patient care items were not available for patient use. (See A-749, Item 19)

20. Ensure Registered Nurses (RN) performed hand hygiene before preparing an intravenous (IV) medication.

Findings:


The cumulative effect of these system problems resulted in the hospital's inability to provide a sanitary environment which had placed all patients, staff, and visitors at risk of contracting infectious and communicable diseases.

Based on observation, interview, and review of the hospital's policies and procedures, the hospital's Infection Control Officer [an Epidemiologist (EPI)] failed to identify violations of infection prevention practices in the hospital to prevent infections and communicable diseases as evidenced by the following activities:

1. Twelve ice machines in the hospital were not cleaned, sanitized, and maintained. The Infection control committee or Infection Control Epidemiologist did not provide oversight of the ice machines.

2. Obsolete equipment was removed and area sealed from Sterile Supply Processing area.

3. The policy and procedure on disinfection of glucose meter (a device used to check blood sugar level) was in accordance with Center for Disease Control's (CDC, is the leading national public health institute of the United States) recommendations.

4. The sink in the clean supply room in the Emergency Care Center (ECC) was not used for dirty procedures.

5. Ten out of ten physician did not obtain Tuberculosis (TB) Screening results and Influenza vaccination information in their credential files.

6. Three hospital staff were not knowledgeable in the proper use of disinfectants on surfaces in between patients per manufacturer's guidelines. One staff in the therapy room was unaware of not to use disinfectant wipes for "non-porous surface."

7. Visitors were allowed to enter an isolation room without wearing an isolation gown.

8. A dialysis registered nurse (Dialysis RN 2) did wear face shield when disconnecting a patient from the dialysis machine.

9. Insufficient space to safely perform procedures in two endoscopy (procedures done by looking inside the body through a hollow tube with a camera) rooms.

10. Monitor effective ventilation in two endoscopy rooms.

11. A Hand-washing sink was available to staff at all times. (See A-620, Item 2)

12. Sterile supplies were stored next to the hand-washing sink.

13. The faucets of sinks in several areas of the hospital had white, greenish calcium build up around them.

14. Cracked flooring in Operating Room 1 and 3, and a torn mattress in Operating Room 3 and Radiology Room 1 were observed.

15. Patient-use equipment was not maintained in sanitary conditions.

16. Two nourishment rooms were not kept in sanitary condition.

17. An overflow of a Pharmaceutical waste container in Tower Room 4 and a red sharp container in the emergency triage room were observed.

18. Clean and dirty supplies were stored together.

19. Expired patient care items were available for patient use.

20. A Registered Nurses (RN 2) did not performed hand hygiene before preparing an intravenous (IV) medication. This had the potential for the patient to develop healthcare associated (acquired) infection (HAI).

Findings:

These failures had the potential for the hospital's inability to provide a sanitary environment which had placed all patients, staff, and visitors at risk of contracting infectious and communicable diseases.

Findings:

1. Not maintaining ice machines per manufacturers' directions had the potential for all patients who consumed contaminated ice from the machine were at increased risk for foodborne illness from any chemical, physical or biological contamination of the ice. Infection control oversight is to be hospital wide and include food production practices and safe holding of potentially hazardous food.

Microorganisms may be present in ice, ice-storage chests and ice-making machines. The two sources of microorganisms in ice are the potable water from which it is made and a transferal of organisms from hands. Therefore, protecting immunosuppressed and otherwise medically at-risk patients from exposure to ice potentially contaminated with opportunistic pathogens is prudent. Recommendations of the CDC, and the Healthcare Infection Practices Advisory Committee (HICPAC) Dated 10/17/2011.

During an observation on 3/7/16, at 1:45 PM, it was noted the ice machine shoot in the pediatric unit pantry had white substance on the interior of the clear plastic shoot.

During an interview on 3/8/16, at 2:30 PM, with the Director of Epidemiology (EPI) and Infection Control Coordinator, the EPI stated they both have not had any involvement in the ice machine cleaning process implemented by a contracted service through facilities and housekeeping. The EPI and the Infection Control Coordinator stated they were not involved in food service operations oversight beyond occasional environmental rounds which did not include extensive review of all food safe practices.

During an interview on 3/8/16 at 1:30 PM, with the Director of Environmental Services (EVS), he stated the environmental services staff wiped down the exterior of the ice machines including cleaning the interior of the shoot with a product named Oxycide. Written document on Oxycide indicated it was a daily disinfectant cleaner. There was no documentation that this product was food safe for use on food equipment.

During a review of documents provided by the hospital on 3/8/16 at 11:30 AM, the documents indicated an outside company performed preventative maintenance on the 12 hospital ice machines. The company invoices dated between 11/6/15 to 11/27/15, did not specify how the ice machines were cleaned and sanitized. There was no description of the chemicals used or how the work performed met the manufacturers' directions for multiple brands of ice machines.

2. During an observation and concurrent interviews with the Director of Nursing (DON), Director of Perioperative Services (DPS), Sterile Processing Supervisor (SPS), and Manager of Plant Operations (MPO), on 3/8/16, at 8:48 AM, the hospital failed to provide a sterile (free of bacteria, mold or other organisms capable of spreading disease) environment in the Central Sterile Processing area (area where medical or surgical supplies and equipment are cleaned, prepared, processed, stored, and issued for patient care) when a sterilizer (a machine used to ensure medical items are sterile) was removed from service and that area not properly decontaminated or contained. While touring the Central Sterile Processing area, a louvered door (a door with angled horizontal slats) behind several clean isolation carts was noted. The SPS stated this is the "old sterile processing area." The door had brownish stains running down the length of the door and in the lower louvers, some gray and black stringy, clumpy dust was noted. Upon opening the door, it was observed a dripping pipe with reddish brown water running across the floor to a floor drain was noted. The SPS stated that this was not normal; water should not be dripping from that pipe. The ceiling was noted to have two gray access doors, which were open to the buildings framework and pipes. Next to one of the access panels were three adjoining rectangular areas cut from the ceiling. The total area of the rectangular cutouts visually estimated to be between five and six square feet. In the center of the ceiling was a hole, large enough for a fist to pass through, with water dripping down from a pipe onto the obsolete sterilizer. The hole was circulated by blackish substance and then surrounded by a larger circle of a reddish brown stain. Open areas between the wall and the sterilizer were also observed. The DON, DPS and SPS all confirmed the above observations. The SPS stated she did not know when the ceiling was cut, but perhaps after the flood that occurred on 9/15/15. The SPS also stated the ceiling was intact before the flood and may be a project in progress. The DON stated the flood was a big event and an internal emergency had been declared to deal with the effects of the flood. The DON and the DPS denied having been in the room prior to this and were not aware of the situation. The MPO stated he was not aware of the date the leak started. This damage was caused by a pipe leak and not related to the flood; however, the cutouts may have occurred at the time of the flood.

During an interview with the Project Manager for Construction (PM), on 3/8/16, at 3:15 PM, she stated she had not provide any monitoring of the area after the flood.

3. During an observation, on 3/8/16, at 11:51 AM, Licensed Vocational Nurse (LVN) 1 was noted to be performing blood glucose tests (a test to measure the amount of sugar in the blood) in the medical surgical (med-surg) area. LVN 1 was observed to place the glucose meter on the cart after testing a patient's blood glucose. Without cleaning the machine, she then placed a new test strip into the glucometer and entered the next patient's room. No cleaning items were noted on the cart at this time. LVN 1 was observed to repeat the process for the next patient, again without cleaning the glucose meter before or after each patient use.

During an observation on 3/8/16, at 12:03 PM, RN 4 got a carton of sanitizing wipes and asked another staff at the nurses' station to take the carton of sanitizing wipes to LVN 1.

During an interview with LVN 1, on 3/8/16, at 12:14 PM, she stated the glucose meter should be cleaned after isolation patients and when she was done with all the blood glucose tests on the unit. When asked to clarify, she stated she does "not (clean) after every patient."

The hospital policy and procedure titled "Blood Glucose Testing", dated 2/25/14, read: "...2. The meter is cleaned with a damp cloth as needed. 3. The meter and strip holder are wiped with a bleach (1:10 dilution) moistened towelette if they have been used for a patient in contact isolation... The bleach residue is removed from the meter by wiping with a damp cloth."

During a review of the CDC document titled "Infection Prevention during Blood Glucose Monitoring and Insulin Administration," dated 5/2/12, "Whenever possible, blood glucose meters should not be shared. If they must be shared, the device should be cleaned and disinfected after every use, per manufacturer's instructions. If the manufacturer does not specify how the device should be cleaned and disinfected then it should not be shared."

The hospital failed to develop a policy and procedure, in accordance with nationally recognized standards, to ensure the glucometer was cleaned after each patient use to reduce the risk of cross-contamination and transmission of blood-borne (a disease transmitted by contaminated blood) pathogens [an infectious agent found in the blood such as hepatitis (inflammatory liver disease caused by viral infection)].

4. During an observation and concurrent interview with the Director Emergency Services (DES) and DON, on 3/7/16, at 10:24 AM, the sink in the clean storage room of the ECC was noted to have white splatter in the sink, on the counter, down the side of the sink cabinet, on the sterile supply cart next to the sink. The DES stated it appears to have been used for casting. Neither DES nor DON could state the last time this sink was used for casting. The DES stated she checked it daily (Monday through Friday) and it was not like that last Friday. Exposed wood was also noted on the sink countertop. The DES and DON agreed with observation. Director of Environmental Services (DEVS) stated sink should be cleaned daily. She [unit housekeeping] is on rounds now.

5. On 3/9/16 at 8:30 AM, ten physician credential files were reviewed. The files did not contain TB screening results or Influenza Vaccination information for the physicians on staff at the hospital.

On 3/9/16 at 10:10 A.M. the Policy and Procedure for employee health services was reviewed. The policy indicated that all employees will be required to have an annual health review by completing an annual health questionnaire and Tuberculosis Skin test screening. The policy did not indicate that physicians are included with employees in the TB testing.

On 3/9/16 at 11 AM, the Policy and Procedure entitled "Influenza Flu vaccine Program" was reviewed. The policy did not specify that physicians would be included in the Influenza vaccination program.

An interview with the Medical Staff Coordinator (MSC) was conducted on 3/9/16 at 8:40 A.M. The MSC acknowledged that the TB screening results or influenza vaccination information has not been obtained for the physicians on staff at the hospital.

6. a. An observation of the ultrasound room and concurrent interview with Ultrasound Technician (US) 1 was conducted on 3/7/16 at 9:50 A.M. US 1 stated that if a patient with Clostridium Difficile (C. Diff. a bacterial infection that can live for long periods on surfaces) is seen in the examination room, she would use the bleach wipe for surfaces such as the examination table and leave wet for 1 minute.

An observation of the bleach wipes container specified that for disinfection for C. diff. that the bleach must be left wet on the surface for three minutes.

A repeat interview with US 1 was conducted on 3/7/16 at 9:52 AM, US 1 acknowledged that she was not aware that the bleach wipe was to be left wet on the surface for three minutes to ensure the disinfection for C. Diff.

An observation of the MRI room (magnetic resonance imaging- a device used for scanning the body) and concurrent interview with Radiology Technician (RT) 2 was conducted on 3/7/16 at 10 AM. RT 2 stated that he used the bleach wipes for disinfection of surfaces in between patients wiping the surfaces and then wiping off the excess. RT 2 did not specify a time that the bleach was left wet on the surface. RT 2 acknowledged that he was not aware that a specific time was required for the surfaces to remain wet to ensure disinfection.

An observation of the Women's Care Center and concurrent interview with Medical Assistant (MA) 1 was conducted on 3/8/16 at 9:20 AM. MA 1 stated that she used a sanitizing wipe on surfaces in between patients and that she let the disinfectant "air dry" which took about 30 seconds. An observation of the sanitizing wipe container specified that the disinfectant must be left wet on the surface for two minutes. MA 1 acknowledged that she was not aware of the 2-minute time to ensure disinfection.

A review of the hospital's policy entitled "Infection Prevention/Environmental Cleaning" was conducted on 3/7/16 at 2:40 PM. The policy specified, "Disinfectants are used to eliminate or greatly reduce these live pathogens and help prevent the transmission of disease. You should routinely disinfect high tough surfaces." The policy did not specify that the disinfectant's manufacturer's guidelines for the time that the disinfectant is to remain wet were to be followed.

A review of the Hospital's policy entitled "Clostridium Difficile (is a bacterium that can cause symptoms ranging from diarrhea to life-threatening inflammation of the colon) Infection Control Precautions" and concurrent interview with the Director Infection Control (DIC) and Infection Control Coordinator (ICC) was conducted on 3/8/16 at 2 PM. The policy indicated: "all Clostridium Difficile rooms shall be cleaned daily with a hospital grade disinfectant (Sodium Hypochlorite 0.52%). Use bleach for frequently touched surfaces and those items within reach of the patient ..." The DIC and ICC both acknowledged that the hospital staff should be knowledgeable regarding disinfectant time requirements per manufacturer's recommendation to ensure effective disinfection. Both the DIC and ICC also acknowledged that the hospital policies do not specify to adhere to the disinfectant manufacturer's recommendations for the time to leave wet on surfaces.

6. b. During a review of the Super Sani-Cloth Germicidal Wipes (a brand name of a disinfectant wipes) label, it indicated two minutes wet time for non-porous surface.

During a review of the Safety Data Sheet for the Super Sani-Cloth Germicidal Wipes, dated 3/27/16, it indicated, "For use on non-porous surfaces only."

7. On 3/8/16, at 11:15 AM, during a tour of the Intensive Care Unit (ICU), it was noted Room 7 had isolation set-up on the door alerting the staff and visitors gowns, masks, and gloves were required before entering the room. There were two visitors visiting the patient (Patient 9) at this time. Both visitors had gloves and masks on but did not wear isolation gowns. RN 10 was present in the room providing care to the patient. RN 10 had all required protective equipment on.

Patient 9's electronic health record was reviewed. Patient 9 was put on contact isolation for C. Diff infection. The warning sign outside the door indicated gowns, gloves, and face masks are required to enter the room.

Currently both visitors were interviewed. One of them was Patient 9's son (Family 1) and the other one, Patient 9's wife (Family 2). Both Family 1 and 2 stated they were aware of wearing mask, gloves, and isolation gowns while visiting. Family 2 stated they had been at Patient 9's bedside since 9 AM this morning. At 11:20 AM, the hospital's EPI was interviewed in regards to what appropriate personal protective equipment for visitors visiting patients with C-Diff. The EPI stated: "It is not required for visitors to wear if they are not touching patients."

The hospital's policy and procedure on "Clostridium Difficile (C-Difficile) Infection Control Precautions," last revised on 11/2015, read: "Wear gloves and gown when entering the patient's room and when providing direct patient care." And "D. Visitors shall follow the same guidelines as healthcare providers. They are to wash their hands with soap and water and wear gowns and gloves when entering the patient's room. They shall remove protective barriers and wash their hands when leaving the patient's room."

At 11:22 AM, during an interview, RN 10 stated the family members had been told to wear masks, gloves, and gowns when entering the room. No explanations given at this time when both family members did not wear isolation gowns especially since they had been visiting the patient for over two hours.

8. On 3/8/16, at 1:15 PM, a dialysis registered nurse (Dialysis RN 2) was observed in a patient's room in the process of disconnecting the patient from the dialysis machine. The patient had a dialysis access to his forearm. Dialysis RN 2 had a pair of gloves and a yellow gown on. He was not wearing a face shield. Concurrently, Dialysis RN 2 was interviewed. He replied, "I am not using the shield (face shield) because this is a shunt, not a catheter (venous catheter)."

A shunt is a man-made connection between an artery and a vein for dialysis, usually in the forearm or upper arm. It is a preferred access for long-term dialysis. A venous catheter is a tube inserted into a vein in the neck, chest, or leg near the groin, usually only for short-term hemodialysis.

On 3/9/16, at 3:52 PM, during an interview with Dialysis RN 1, she stated she always wore a mask for protection when initiating or disconnecting dialysis. She could not articulate policy but later provided one titled "HEMODIALYSIS INFECTION CONTROL GUIDELINES," UNDATED. The policy read: "When doing dialysis, the nurses shall wear protective gowns, goggles, mask and gloves."

CDC "Guidelines and Recommendations in Dialysis Resources" recommended the following: "staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Such protective clothing or gear should be changed if it becomes soiled with blood, body fluids, secretions, or excretions ..." During a review of the hospital's policy and procedure on "HEMODIALYSIS INFECTION CONTROL GUIDELINES," undated, it read: "When doing dialysis, the nurse shall wears protective gowns, goggles, mask and gloves. They are removed after leaving the room."

9. During an observation and concurrent interviews with RN 6 and DPS, on 3/8/16, at 9:34 AM, of the endoscopy procedure rooms it was noted the space around the procedure gurney was approximately three feet wide. Room A included the endoscopy tower, a desk, a supply cart and the gurney. Room B included the same furniture with the addition of a medication dispenser on a wheeled table. An accordion-type door separated the two rooms. When asked how does the nurse in Room A get additional medication for the patient if Room B is also performing a procedure, RN 6 stated, that the Room A nurse would request the medication from either the nurse in Room B or from another nurse not involved in the procedure. When asked about the size of the rooms, the DPS stated a long time ago they were converted from patient care rooms. During an interview with the DPS, on 3/9/16, at 10:47 AM, she stated ...could not add any more [equipment].

During an interview with the EPI on 3/7/16 at 10:42 AM, he stated [hospital follows] CDC guidelines and Title XXII for infection control.

A review of an untitled document on 3/8/16 by Facilities management indicated Room A was 148.73 square feet and Room B was 152.39 square feet. A review of Title XXII Section 70229 (a)(1) indicated operating rooms should not contain less than 324 square feet of floor area. The square footage of both rooms is less than half of Title XXII requirements.

10. During a review of the hospital documents of Air Exchange Rates (AER) (the number of interior volume air changes that occur per hour), no documentation for the AER of the endoscopy procedure rooms was noted. During concurrent interviews with the MPO and the PM, on 3/9/16, at 4:46, the MPO stated he did not believe there were any. The PM reviewed the logs and agreed the endoscopy areas did not have an AER. The "Guidelines for Design & Construction of Hospital and Health Care Facilities" indicated the minimum ventilation for endoscopy is six total air changes per hour and air should flow into the endoscopy procedure rooms.

11. Please see A-620, Item 2.

12. During an observation and concurrent interview with the DES and DON, on 3/7/16, at 10:24 AM, the sink in the clean storage room of the ECC was noted to have white splatter in the sink, on the counter, down the side of the sink cabinet, on the sterile supply cart next to the sink, and on sterile items on the cart. The DES stated it appears to have been used for casting. Neither the DES nor the DON can state the last time this sink was used for casting.

Contaminated sterile items on the sterile supply cart included: a Central line (a catheter placed into a large vein) dressing kit, a Foley catheter (a sterile, flexible tube used to drain urine), one incision and drainage kit, five items used for peritoneal dialysis (a procedure to cleanse the blood of waste and toxins) procedures, a surgical gown, some respiratory supplies, a hemorrhage (bleeding) tray, a burn pack, a suture (stitches) tray, a thoracotomy (chest) pack, two defibrillator paddles (used to shock the heart), and some electrodes (to shock the heart) and two 250 milliliter (ml) bags of 10% dextrose (sugar) solution.

12. b. The burn kit was packaged inside a clear plastic bag knotted closed. Inside the bag it contained a sterile wrapped basin wrapped in another clear plastic bag that was also knotted closed. On top of the basin was a bottle of sterile fluid and a package of sterile gauze.

During an interview with the EPI on 3/7/16 at 10:42 AM, he stated, "does not see a problem with fluids on top of the sterile package." He also stated the hospital follows CDC guidelines and Title XXII (a set of State regulations) for infection control.

12. c. During an observation on 3/7/16, at 10:30 AM, items on the sterile supply cart, in the clean room of the ECC, was noted to be stacked on top of one another. Some lighter weight objects were placed underneath heavier objects.

During an observation and concurrent interview with the DES, on 3/7/16, at 11:45 AM, multiple items in the sterile supply were noted to be standing on the edge, or lying on the side, or hanging over containers. The DES stated the hospital used event related sterility. The DES also stated that how the items were stored was not as important as how they were handled.

The CDC guidelines indicated sterile supplies should be stored in a manner which prevents contamination, there should be a clear separation of sterile items and dirty items, and there must be separate clean/dirty rooms or the designated utility room must flow from clean to dirty. A review of Association for Professionals in Infection Control and Epidemiology (APIC, is a leading professional association for infection preventionists) document "Sterile Processing", dated 11/13/15, recommended: "items should arranged to prevent crushing, bending or compression...avoid dragging, sliding, crushing, bending, compressing or puncturing the packaging or otherwise compromising the sterility of the contents."

12. d. During an observation and concurrent interview with the Materials Coordinator (MC), PM, on 3/8/16, at 9:50 AM, in the clean storage area, a large plastic sheet in the shape of a funnel was noted hanging from water, sprinkler, steam pipes, and the air conditioning ducts. The plastic funnel came down from these popes and covered a clean supply cart containing some sterile chest packs. The end of the funnel lead to a trash can to collect floodwater. The MC stated it was hung after the September flood, and remained hanging as a precaution. The PM stated, "The roof repair for this area was completed in November and the contractors had said it was all right to remove the plastic." The PM could not provide a reason the plastic remained hanging. The PM further stated the plastic was not hanging in this manner when the project was started.

12. e. During an observation and concurrent interview with the DPS, on 3/7/16, at 11:28 AM, a vacuum cleaner was noted in the sterile supply room of Operating Room 9. Observation was confirmed by the DPS who also stated she did not know why it was there.

13. a. During the initial tour of the hospital, on 3/7/16, at 9:50 AM, multiple handwashing sinks were observed in need of cleaning. The handwashing sink in the ECC by the trauma area eight of nine handwashing sinks had white and greenish buildup at the end of the faucet. The sink in the ECC clean supply room had whitish splatter in and around the sink, paper and a black plastic item were seen on the bottom of the sink. In the Sterile Supply Processing area, the sink and the surrounding counter and wall had been splattered with a white powdery material and the faucet had white and greenish buildup.

During an observation, on 3/8/16, at 1:28 PM, the handwashing sink in the dialysis machine storage room was noted to have brownish stains on it. It was also observed with some green and white buildup on the faucet. Splatter was also observed on the soap dispenser. The Director of Telemetry (DT) agreed the sink and storage room needed cleaning, but was not sure who was responsible.

During an interview with the Dialysis RN 1, she stated, "The Intensive Care Unit (ICU) housekeeper used to clean the [dialysis storage] room. But they don't have a key and have to call her. It is difficult to get housekeeping to clean the area because she has erratic hours."

During an interview with the DEVS, on 3/7/15, at 10:42 AM, he stated housekeeping should clean sinks daily.

14. a. During an observation, on 3/7/16, at 3:05 PM, non-intact flooring was noted in surgical rooms one and three. The DPS stated these rooms get a lot of use. The flooring needs to be replaced.

14. b. During an observation, on 3/7/16, at 3:05 PM, a non-intact mattress was noted on the surgical table in surgical room three. The DPS stated a new mattress is on order.

14. c. An observation of Radiology Room 1 and concurrent interview with RT 1 was conducted on 3/7/16 at 9:15 AM. A mattress with approximately 27 inches of gray tape along one side of the mattress was observed on the radiology examination table. The RT 1 stated that the tape was used to cover a tear in the mattress. The RT 1 acknowledged that disinfection of the mattress between patients could not be ensured if the tape became soiled with body fluids.

An interview with the Director of Radiology (DR) was conducted on 3/7/16 at 9:17 A.M. The DR stated that the torn mattress with tape should not be used in the patient care areas and acknowledged that disinfection of the mattress could not be ensured.

15. a. During an observation and concurrent interview with the EPI, on 3/7/15, at 10:42 AM, a grimy gurney was noted in the hallway with brownish water-type stain on the shelf below the mattress. The EPI was unable to clean with paper towel and water.

15. b. During an observation and concurrent interview with the DON, on 3/7/15, at 10:47 AM, several untagged, and uncovered IV poles and vital sign machines were noted in the hallway. The DON stated they were clean and should be clean at all times.

15. c. During a concurrent observation and interview with Materials Management Assistant (MM), on 3/7/16, at 9:44 AM, in Tower 4, he transported the clean linens without a cover. He stated he just finished filling up one clean linen cart and did not cover the linens.

The hospital policy and procedure titled "Linen", revised 1/2014, indicated "Cart covers are used when linen is in transit or in storage."

15. d. During a concurrent observation and interview with RN 7, on 3/7/16, at 9:53 AM, in Tower 4, five pillows were stored uncovered on top of the clean linen cart, two of which had pillowcases. RN 7 verified the findings and stated they should not have been there.

The hospital policy and procedure titled "Linen Delivery and Storage" revised 1/2014, indicated "Each linen item is to be stored on the shelf area marked for that item."

15. e. During a concurrent observation and interview with the Director of Med/Surg (DMS) and Pediatric Registered Nurse (PRN), on 3/7/16, at 10:35 AM in the Pediatric shower room four pillows were observed on the floor, and one pillow was resting on top of a trash can that contained trash. The observation was verified by the PRN who stated the pillows should not be stored in the shower room.

15. f. During a concurrent observation and interview with the DMS on 3/7/16, at 2 PM, in the room of Patient 1, a used suction catheter was observed stored uncovered in a metal basket that was attached to the wall. The catheter was touching the metal basket and the wall. The DMS verified the observation, and stated the catheter should be covered when not in use.

15. g. During a concurrent observation and interview with the DMS on 3/8/16 at 2:10 PM, in Room 173. The Respiratory Therapist (RT) was observed using a hand held machine to check a patient's oxygen level. After using the machine he placed it on the patient's over bed table. He then placed the machine in his coat pocket and exited the room. At that time, the DMS verified the observation and stated the RT was called to labor and delivery.

During an interview with the RT on 3/9/16, at 9:20 AM, he verified he did not clean the machine after use. He stated the machine should have been cleaned using Sani Wipes (disposable disinfectant wipes) and the dry time (time the cleaner should remain wet on surface to ensure area is disinfectant) for the cleaner was "instantaneous."

Review of the instructions on the container of Sani Wipes indicates the surface is to remain wet for two minutes.

16. a. During a concurrent observation and interview with RN 8, on 3/7/16, at 1:52 PM, in Tower 3 Nourishment Room, the patient refrigerator glass bottom had white stains and the right bottom drawer had brown stains and white debris. RN 8 verified the findings and stated the Dietary Department was responsible for the refrigerator.

The hospital policy and procedure titled "Patient Refrigerator" revised 1/2009, indicated "Interior of the refrigerator is clean and free of outdated foods and debris."

16. b. During a concurrent observation and interview with the Director of Cardiology (DOC), on 3/7/16, at 2:28 PM, in Tower 4 Nourishment Room, the floor on the right side of the refrigerator had brown stains. The DOC verified the findings and stated the housekeeper was in charge of cleaning the nourishment room.

The hospital policy and procedure titled "7-Step Cleaning Process" revised 1/2009, indicated "F. Damp Mop... 2. Start with the corner fart

Based on interview and record review, the hospital failed to ensure the Physical Therapy Department was under the direction of a qualified director. This had the potential to cause un-met patient care needs.

Findings:

During an interview with the Director of Cardiology/Physical Therapy Department on 3/9/16, at 1:10 PM, he stated he was the Director of the Physical Therapy Department. He also stated he was a Respiratory Therapist and did not have any physical therapy training.

Review of the hospital Position Description for the Director of Rehabilitation Services department, effective date 6/4/2002, indicated the director is required to have a current California Physical Therapy License.