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Based on observation, interview and record review, the Governing Body of the hospital failed to ensure high-risk, high-volume and problem-prone areas of food service delivery was included into the QAPI program. A review of the cooling logs of the Food and Nutrition Department indicated that for 15 of 21 times in the last three months the cool down processes of potentially hazardous foods (PHF) were done incorrectly. This placed the medically fragile patients at risk for foodborne illnesses.

Findings:

From 1/9/12 to 1/12/12, during the course of the survey of the hospital's food service operations, it was identified that the system used for the cool down of potentially hazardous foods (PHF) had not been done safely for a period of at least three months. During interviews with dietary staff which included Chef 1, F/N Staff 4, F/N Staff 5 and the F/N Director 2, it was identified that dietary staff did not have a comprehensive understanding of the process of cooling down potentially hazardous foods to ensure safe food for patients and staff. Cross reference A-620.

Safe cooling requires removing heat from food quickly enough to prevent microbial growth. Excessive time for cooling of potentially hazardous foods (time/temperature control for safety foods) has been consistently identified as one of the leading contributing factors to foodborne illness. (FDA Food Code 2009).

On 1/12/12 at 0945 hours, a meeting with survey team and the hospital's designated QAPI staff was conducted. When asked, the hospital staff confirmed no mechanism was in place to monitor the high risk, high volume, and problem prone method of food handling practices by dietary staff. The unsafe practices used for the cool down of PHF observed by the survey team had not been previously reported to the hospital's designated quality assurance staff.

Based on observation, interviews and review of documents the hospital failed to ensure patient care was delivered in a safe setting as evidenced by:

* The hospital's policy on cooling down PHF (potentially hazardous food) was not followed by dietary staff which placed the medically fragile population at risk for foodborne illnesses.

* In five of five sub-sterile rooms in the Operating Room patient care items such as positioning devices used during surgeries, blankets in warmers, an ice machine, and autoclaves for sterilizing instruments, were placed next to sinks used to wash used instruments after surgeries. Biohazardous waste containers, and flush devices used to dispose of human waste, were also placed next to the sink for washing used surgical instruments. This had the potential for the transmission of bacteria into the sterile OR environment.

* There was no system in place to ensure sterile patient care items such as instruments used during a surgical procedure were labeled with lot control numbers to identifiy the sterilizer used, the cycle or load number, and the date of sterilization. This could result in the potential inability to track or retrieve items in the event of sterilizer failure or malfunction. Physician and patient notification of this risk of infection would not be possible.

* Autoclaves in the OR were not cleaned according to manufacturer's instructions.

*The infection control guidelines on caring for arterial catheters and enteral feeding set ups were not implemented for one of 49 sampled patients (Patient 82).

* A mattress pad on an OR table and a bed mattress in a patient room were observed with rips in the material which were made available for patients' use. Nonintact surfaces could potentially limit thorough cleaning and disinfection of mattresses to prevent transmission of germs.

* Used patient care items were not kept apart from clean linens. This could result in the linen being contaminated.

* EVS staff in the OR did not change gloves after cleaning a biohazardous waste container and a volunteer did not wash hands after removing gloves. These practices could result in the transmission of infection in the hospital.

Findings:

1. Review of the hospital's Policy #B017 on 1/9/12, entitled Food Handling Guidelines Hazard Analysis Critical Control Point (HACCP) Temperature Log, showed "Cooling...potentially hazardous food shall be cooled from 140 degrees F to 70 degrees F as measured at its center within two hours and from 70 degrees F to 41 degrees F within an additional four hours, for a total cooling time of six hours or less."

Safe cooling requires removing heat from food quickly enough to prevent microbial growth. Excessive time for cooling of potentially hazardous foods (time/temperature control for safety foods) has been consistently identified as one of the leading contributing factors to foodborne illness. The initial two hour cool time is a critical element of this cooling process. (FDA Food Code 2009).

Review of the previous three months of HACCP Temperature Logs indicated 21 times in which a PHF should have been cooled down. In 15 instances the process was done incorrectly. The incorrect cool down of PHF involved circumstances in which the two hour cool down did not meet the hospital's policy as well as times in which the six hour total cool down did not meet hospital's policy. Cross Reference A- 620.


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2. According to AORN 2011 edition, Recommended Practices for Sterilization in the Perioperative Practice Setting, the recommendation XVI d. indicated sterile processed items should be labeled with lot control numbers to identify the sterilizer used, the cycle or load number, and the date of sterilization. Lot control numbers allow items to be identified or retrieved in the event of a sterilizer failure or malfunction.

On 1/9/12 at 1336 hours, Central Processing was toured with the Director of Central Processing. The Director stated the hospital had a list of surgical instrument trays which included 10 laparoscopic trays, two trauma trays, two laparotomy trays, eight cataract trays, and 15 major trays.

During an interview on 1/9/12 at 1345 hours, the Central Processing Supervisor stated each different category of tray contained identical instruments. All of the instrument trays were sent back to the Operating Room for storage after the sterilization procedure. When asked the method used to identify the location of a tray if there was a failure in the sterile processing system, the Supervisor stated there was no method to do so. The Director of Surgical Services, present during the interview confirmed the Supervisor's response.

3. A tour of the OR was conducted on 1/11/12 at 0900 hours. Included in the tour were the sub-sterile rooms between OR 1 and 2, OR 3 and 4, OR 5 and 6, OR 7 and 8, and a sub-sterile room for OR 9, the cardiac surgery area. The following observations were noted:

a. A hopper device, a flush disposal unit used to dispose of human wastes and fluids, was observed in each of the five sub-sterile rooms. In the sub-sterile areas (except for the cardiac surgery area) blankets and devices used to position patients during surgery were stored next to the hoppers. In the sub-sterile room for the cardiac surgery area there was an ice machine. A concurrent interview with RN 53 revealed surgical staff used the hoppers to empty dirty bed pans and small amounts of blood from containers. The running water in the hopper was used to wash the bedpans.

b. Infectious waste containers (red biohazardous waste containers) were observed in each of the five sub-sterile rooms in the OR. In the sub-sterile room adjacent to OR 9, the cardiac surgery area, infectious waste containers were noted directly in front of the ice machine and the autoclave used during cardiac surgery procedures. A second infectious waste container was noted directly in front of the surgical scrub sinks. When interviewed concurrently during the tour, RN 53 and MD 21 seemed unaware these contaminated containers could contaminate the clean equipment and scrub sinks.

c. According to the AORN 2011 edition, Recommended Practices for Sterilization in the Perioperative Practice Setting, Recommendation XVI, preventive maintenance on sterilizers should be performed by qualified personnel as specified in the manufacturer's written instructions.

During the OR tour it was noted each of the sub-sterile areas contained an autoclave. During an interview, EVS 3 stated a pre-mixed disinfectant was used daily to clean the autoclaves. The disinfectant was observed to be of a specific brand and type. It was not a gel. It was not a cleaning; but, a disinfecting agent. Inspection of the five autoclaves showed each of the autoclaves had dark brown stained deposits present in the autoclave chamber.

Review of the manufacturer's written instructions for cleaning showed a liquid gel cleaner, not a disinfectant, was to be used weekly. MD 21, the Director of Infection Control, was interviewed on 1/12/12 at 1200 hours. MD 21 stated the hospital had a P&P instructing the cleaning staff to use a premixed disinfectant. MD 21 stated he was not aware there was a residue in the autoclave chambers. MD 21 stated he was unaware the disinfectant used by the hospital to clean the autoclaves was not a cleaning agent as recommended by the manufacturer for use in the autoclaves.

d. . According to AORN 2011 edition, Perioperative Standards and Recommended Practices, the Recommended Practices for a Safe Environment of Care, Recommendation II b., Mattress and padded positioning device surfaces (e.g., OR beds, arm boards, patient transport carts) should be moisture-resistant and intact.
On 1/9/12 at 1010 hours, OR 6 was inspected. A tear in the pad of the OR table was observed. This was replaced by staff.

4. On 1/9/12 at 1010 hours, EVS 5 was observed wiping a biohazardous waste container in OR 6 while wearing gloves. After completing this task, EVS 5 did not change gloves prior to cleaning and disinfecting the other surfaces in the OR. When interviewed, EVS 5 and RN 53 seemed unaware a change of gloves was required. When interviewed, EVS 5 stated she had not been instructed to do so.

5. According to General Principle of Infection Prevention and Control for Communicable Disease Investigation, revised on 2008, hand hygiene should be performed after the removal of gloves.

On 1/10/12 at 1320 hours, Volunteer 1 was observed in the lobby. The volunteer removed a glove from one hand and used the ungloved hand to push the elevator control bottom. The volunteer was not observed to perform hand hygiene after the removal of the glove. When interviewed Volunteer 1 stated he had taken a patient's blood sample to the lab wearing the gloves.


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6. The hospital failed to implement their P&P for Intravenous Therapy on one of 49 sampled patients (Patient 82) when the flush solution, stopcocks and tubing of an arterial line were not changed after 72-96 hours. In addition, the patient's feeding bag and tubing was found with no label to describe when it was hung and by whom. Cross Reference A-748 #7.

7. On 1/9/12 at 1001 hours, the 4 West Telemetry Unit's clean linen closet was found with a pair of used gloves rolled inside out and a 5-lb orthotic weight wrapped by a dusty pillow case together with the clean linens.


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8. EVS 4 was observed during the cleaning of a patient room following the discharge of a patient on the 6 W unit on 1/10/12 at 1410 hours, with the EVS Supervisor in attendance. Observation of the underside and sides of the bed mattress during cleaning showed approximately six to seven tears in the fabric, two to four inches in size. The foam padding of the mattress was exposed. After wiping down the mattress with a bleach solution, EVS 4 made the bed with fresh linens and placed a sign on top of the bed which indicated the bed was ready for a new patient.

Based on observation, interview and record review, the hospital failed to include the high-risk, high-volume and problem-prone area of food service delivery into the QAPI program. A review of the Food and Nutrition Department log books indicated that 15 of 21 times in the past three months, cool down processes of potentially hazardous foods (PHF) were done incorrectly. This placed the medically fragile patients at risk of foodborne illnesses.

Findings:

During the course of the survey of the hospital's foodservice operations it was identified that the system used for the cool down of potentially hazardous foods (PHF) had not been done safely for a period of at least three months. During interviews with dietary staff which included Chef 1, F/N Staff 4, F/N Staff 5 and the F/N Director 2, it was identified that dietary staff did not have a comprehensive understanding of the need/process for cooling down potentially hazardous foods to ensure safe food. Cross Reference A-620.

Safe cooling required removing heat from food quickly enough to prevent microbial growth. Excessive time for cooling of potentially hazardous foods (time/temperature control for safety foods) had been consistently identified as one of the leading contributing factors to foodborne illnesses. (FDA Food Code 2009).

On 1/12/12 at 0945 hours, a meeting with survey team and the hospital's designated QAPI staff was conducted. When asked, the hospital staff confirmed no mechanism was in place to monitor the high risk, high volume, and problem prone method of food handling practices by dietary staff. The unsafe practices used for the cool down of PHF observed by the survey team had not been previously reported to the hospital's designated quality assurance staff.

Based on observation, interview and review of medical records, the Registered Nurses failed to document the implementation of a physician's order to increase fluid intake for one of 49 sampled patients (Patient 75). Patient 75 refused to take medication while in the psychiatric ward. The absence or inaccuracy of fluid intake documentation could potentiate a patients' low blood pressure, a side effect of anti-psychotic medications the dose of which was increased by the physician. In addition, two of 49 sampled patients' (Patients 63 and 91) health status and their response to interventions were not assessed by the Registered Nurse as ordered by the physician with a potential for delay of treatment.

Findings:

1. During a tour of the psychiatric unit on 1/11/12 at 1005 hours, a grease board in the nurses' station showed a listing of patients on the unit. Written next to some of the patients' names were instructions to record the patient's intake and output and/or to increase their fluid intake. Documentation on the grease board for Patient 75 showed the patient was to have her fluid intake monitored.

The medical record for Patient 75 was reviewed with RN 60 and MD X on 1/11/12 at 1100 hours. The patient had been admitted to the hospital on 12/29/11, on a 14-day psychiatric hold, with a history of refusal to take medication and a decreased intake of food and fluids.

Review of the Inpatient Progress Notes dated 1/8/12 at 0812 hours, showed physician documentation Patient 75's blood pressure was decreased. The physician documented this could be secondary to Zyprexa medication (an anti-psychotic) as the patient's oral intake was acceptable. The physician planned to monitor the patient's fluid intake closely and to push fluids. Review of the Physician's Orders for Patient 75 showed an order dated 1/8/12 at 0820 hours to push fluids to 1000 ml per shift.

MD X stated the hydration order for Patient 75 was written due to the need to increase the patient's Zyprexa medication. MD X stated the patient's blood pressure had been low. The MD stated if the patient was not well hydrated, as the Zyprexa dose was increased, the blood pressure might decrease further.

When asked how nursing documentation would show implementation of the physician's order to increase fluids for Patient 75, RN 60 stated the patient was on intake and output monitoring so the nurse could document the intervention in the Inpatient Progress Notes.

The Inpatient Progress Notes for Patient 75 dated 1/8/12 through 1/11/12, were reviewed. On 1/8/12 at 1300 hours, documentation showed the patient was encouraged to take fluids of 1000 ml per shift and the patient was documented as "hydrated well." For the night shifts of 1/8/12 and 1/9/12, documentation showed fluids were encouraged; however, the patient's response to the intervention was not documented. Review of documentation for the remaining six shifts did not show documentation the physician's order to push fluids was implemented.


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2. Patient 63 required insulin medication after a surgical procedure. However, Patient 63's blood sugar (BS) was not measured hourly as ordered. Not following a physician's order could result in delayed treatment of high or low blood sugar.

Furthermore, the initial order for intravenous insulin, written by MD T00441 read "Start at 1 unit/ml." This medication order referred to the concentration of insulin per volume but did not identify the dose to be administered. Per RN 54 and Pharm 4 on 1/10/12 at 1400 hours, this order was interpreted as 1 unit/hour. There was no documentation an RN clarified the order to confirm it was 1 unit per hour prior to administration of the insulin. Cross Reference A-405 #1.

3. Patient 91's BS level required insulin medication given intravenously to maintain his BS within acceptable ranges. There were five times when Registered Nurses did not document the hourly BS levels as ordered by the physician. Cross Reference A-405 #2.

Based on observation, interview and review of the medical record, the nursing staff failed to ensure the plan of care for one of 49 sampled patients was updated to reflect physicians' orders to increase fluid intake to lessen the potential side effects of a medication (Patient 75).

Findings:

During a tour of the psychiatric unit on 1/11/12 at 1005 hours, a grease board in the nurses' station showed a listing of patients on the unit. Written next to some of the patient's names were instructions to record the patient's intake and output and to increase their fluid intake. Documentation for Patient 75 showed the patient was to have her fluid intake monitored.

The medical record for Patient 75 was reviewed with RN 60 and MD X on 1/11/12 at 1100 hours. The patient had been admitted to the hospital on 12/29/11, on a 14-day psychiatric hold with a history of refusal to take medication and a decreased intake of food and fluids. Review of a physician's order for Patient 60 showed an order dated, 1/3/11, for fluids of 750 ml per shift.

Review of the Inpatient Progress Notes dated 1/8/12 at 0812 hours, showed physician documentation Patient 75's blood pressure was decreased. The physician planned to monitor the patient's fluid intake closely and to push fluids. Review of the Physician's Orders for Patient 75 showed an order dated 1/8/12 at 0820 hours to push fluids to 1000 cc per shift.

MD X stated the hydration order for Patient 75 was written due to the need to increase the patient's Zyprexa medication. MD X stated the patient's blood pressure had been low. The MD stated if the patient was not well hydrated, as the Zyprexa dose was increased, the blood pressure could decrease further.

Review of the plan of care for Patient 75 with RN 60 and MD X showed the plan was initiated on 12/29/11. There was no update on the plan of care to reflect the physician's order for 1000 cc of fluid per shift. RN 60 stated care plans for patients were updated at weekly interdisciplinary meetings by the physicians. The RN stated if there were changes prior to the meeting they would be written on the board in the nurses' station. MD X stated the care plans for patients on the psychiatric unit could also be updated by the resident physicians during their daily rounds four days a week. When asked, MD X and RN 60 were unable to state why the care plan for Patient 75 had not been updated.

Based on observation and interviews the hospital failed to ensure that 2 sampled nurses (RNs) assigned to patient care areas were competent to calculate and prepare a dose for an adult patient in an emergent situation.

Findings:

1. During a visit to 3 West on 1/11/12 at 0830 hours, RN 62 was asked to calculate and prepare a dose of medication X in mg. per kg. for an adult patient. RN 62 was given all the information necessary such as the doctor's order and the patient's weight. RN 62 was unable to calculate the dose.

2. During a visit to the adult Emergency Department (AED) on 1/11/12 at 1515 hours, RN 59 was asked to calculate and prepare a dose of medication X in mg. per kg. for a patient. RN 59 was given all the information necessary such as the physician's order and the patient's weight. RN 59 was unable to calculate the dose.

Based on interviews and record reviews, the hospital failed to ensure physicians' orders for two of three sampled patients on IV insulin were followed (Patients 63 and 91). The hospital failed to ensure that:
* For Patient 63:
a) The blood sugar (BS) levels were measured as ordered.
b) The initial order of insulin was clarified with the physician.
*For Patient 91:
a) The BS levels were measured as ordered.
b) The finger stick BS measuring as "critical high" was verified by a laboratory value in order to provide treatment per the adult medical admission orders (AMAO).
c) Insulin was administered as ordered in a timely manner.

Findings:

a. Patient 63's medical record was reviewed with RN 54 and Pharm 4 on 1/10/12 at 1400 hours. Patient 63 was admitted to the Emergency Department (ED) on 1/2/12 at 0120 hours with a diagnosis of chest pain radiating to the left arm. Patient 63 was placed on an insulin IV drip at 0500 hours on 1/4/12, to decrease the patient's blood sugar. The insulin drip dosage was controlled by the Adult Critical Care Insulin Infusion Orders (ACCIO) which was signed by Physician T00441. However, the initial insulin order was written to start at 1 unit per ml. The order referred to the concentration of insulin, not the dosage to be administered. RN 54 indicated the order was interpreted as 1 unit of IV insulin per hour. There was no evidence the order was clarified by nursing or pharmacy to confirm the interpetation was correct.

The ACCIO also indicated BS levels were to be checked every hour until the level reached between 70-130. Review of Patient 63's medical record dated 0600 hours on 1/4/12, showed his BS was 189. The next documentation at 0800 hours, showed the BS was 180. There was no documented BS at 0700 hours as required by the ACCIO or as ordered by the physician. RN 54 and Pharm 4 confirmed there was no documented BS at 0700 hours and no evidence the incorrect 1 unit per ml order was clarified by nursing to confirm 1 unit dose of insulin per hour.

b. Patient 91's medical record was reviewed on 1/12/12 starting at 0845 hours, with RN 54 and Pharm 4. MD 24 joined the interview at 1000 hours. Patient 91 was admitted to the ED on 1/6/12 at 1604 hours as the patient's PICC (peripherally inserted central catheter) line was accidentally pulled out. It was during the physical examination and blood work the patient was identified to have high BS.
a) At 1900 hours on 1/6/12, the initial laboratory studies were drawn.
b) At 2130 hours, 2.5 hours later, the initial laboratory results showed a BS of 834 (a dangerously high value). IV fluids and a BS measurement every hour was ordered by MD 24.
c) At 2207 hours, his BS was 675.
d) At 2230 hours, his BS was measured via a finger stick (a drop of blood taken from the tip of a finger) as"critically high." There was no laboratory value documented. It was not known if a specific value was reported at 2230 hours, or if the insulin dose would have been increased to match the guidelines as reflected on the insulin standing orders. An intravenous insulin drip at 8 units per hour was ordered by MD 24.
e) At 2325 hours, a BS laboratory value of 582 was documented. Eight units of insulin per hour was continued.
f) At 0115 hours on 1/7/12, a finger stick BS value was documented as "critically high." There was no laboratory value documented. Eight units per hour of IV insulin was continued. There was no documentation to show the nurse requested a physician's order for a BS laboratory value in order to determine if 8 units per hour of IV insulin was an appropriate dosage.
g) At 0200 hours, MD 24 documented MD H0056 requested him to discontinue the IV insulin, order IV fluids, and measure the BS every hour.
h) At 0345 hours, Patient 91's BS was documented as 309. There was no BS measurement or insulin administered for 2 hours. This was confirmed by MD 24.
i) At 0424 hours, 2.5 hours later, subcutaneous insulin was ordered.
j) There was no documented BS measurement at 0700, 0900 or 1000 hours, as ordered. This was confirmed by RN 54 and Pharm 4.
k) At 1330 hours, MD K00715 changed the BS measurement to before meals and at bedtime, with insulin to be administered per the AMAO. The AMAO described the different doses of insulin to be administered based on the patient's BS level.
l) At 1641 hours on 1/712, Patient 91 was transferred to another unit.
m) Patient 91's BS continued to be documented at levels between 340 and 441 for the remainder of 1/7 to 1/8/12.
n) On 1/8/12 between 1730 and 2200 hours, Patient 91's BS was 302 and 346 respectively. Per the AMAO guideline, 8 units of insulin should be administered when the BS was between 301 and 350. There was no insulin documented as administered and there was no reason documented on the flow sheet as to why the insulin was not administered.

During a meeting with MD 22 on 1/12/12 at 1100 hours, he confirmed the above findings for Patient 91. MD 22 stated the record revealed the physicians determined Patient 91's BS was not under control and referred him to a specialist.

Based on interview and record review, the hospital failed to document a patient's arrival time in the medical record for one of five ED patient records reviewed (Patient 96). This could potentially result in miscommunication among care givers.

Findings:

On 1/11/12 at 1110 hours, a review of Patient 96's medical record showed there was no documentation of the patient's arrival time to the ED. The area for documentation of the patient's arrival time was left blank. The ED RN assisting with the medical record review for Patient 96 was unable to locate the patient's arrival time to the ED anywhere else in the patient's medical record.

Based on observation, interview and record review, the pharmaceutical service failed to establish and be aware of guidelines for maintaining the pressure differential of the IV preparation areas according to USP <797> standards which was a stated goal of the pharmacy. The area where chemotherapeutic medications were compounded was not maintined at a pressure differential stipulated by USP <797> guidelines at the time of the survey with the potential result that the anteroom adjacent to the area where staff prepared hazardous IV chemotherapeutic medications (chemo) and ultimately the main pharmacy work area could potentially become contaminated.

Findings:

The USPs revised general chapter <797> entitled PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS documents in the Introduction that "The objective of this chapter is to describe conditions and practices to prevent harm, including death to patients that could result from ... unintended chemical and physical contaminants ...". Under "Hazadous Drugs as CSPs" it documents: "Hazardous drugs shall be prepared for administration only under conditions that protect the healthcare workers and other personnel in the preparation and storage areas."

On 1/9/12 at 1013 hours, the DOP and Pharm 2 showed the surveyor two IV rooms in the pharmacy. The DOP said the room on the left was used to compound IV solutions and the room on the right was used to compound chemo IV solutions. The surveyor saw an anteroom between the two IV rooms. The anteroom opened into the main pharmacy and staff had to use the anteroom to gain entrance to the IV room on the left and the chemo room on the right. Hospital staff had placed three dials above the door to the anteroom and a sign beneath each dial. The sign beneath the left dial read "Room Differential Pressure anteroom to IV." The sign beneath the middle dial read "Room Differential Pressure anteroom to Work Area." The sign beneath the right dial read "Room Differential Pressure Chemo to anteroom." During an interview at that time the DOP could not state what the numbers on the dial meant nor could he state what an adequate reading of the dials was supposed to be. He stated the rooms had specifications to match USP <797>. He stated the goal of the hospital was to keep the chemo room with a negative airflow with respect to the pharmacy work area. The negative pressure differential was meant to prevent flow of potentially contaminated air from the chemo IV room into the anteroom and then into the main pharmacy work area. During a later interview on 1/9/12 at 1307 hours the DOP stated that the intent of his pharmacy department was to follow USP <797> standards.

During a telephone interivew of Service Techician 1, he stated that the anteroom needed to be at a positive 0.02 to 0.05 inches of water differential with respect to the main pharmacy work area. He stated that the chemo room needed to be at least at a negative 0.01 inches of water differential with respect to the anteroom.

On 1/9/12 at 1013 hours, the surveyor noted that the dials above the room had "Inches of Water" printed below the dial calibration numbers and hash marks. The middle dial (anteroom to main pharmacy) read 0.0075 inches of water and the right dial (chemo room to anteroom) read 0.0025 inches of water. During a telephone interview with Service Teachnician 1 about the dial readings, the technician stated representatives from his company checked the pressure differentials between these rooms and sometimes calibrated the dials. He stated that the anteroom needed to be at a 0.02 to 0.05 inches of water differential with respect to the main pharmacy work area (those dials read 0.0025). He stated that the chemo room needed to be at least at a 0.01 inches of water differential with respect to the ante rooom. The chemo room dials read 0.0025. Thus, the proper pressure differential was not maintained.

During an interview of Pharm 2 on 1/12/12 at 0854 hours, she stated that there were no policies and procedures that addressed monitoring the pressure differentials between the IV rooms and that there was no process in place to monitor the pressure readings on the dials above the anteroom.

Based on observation, interview and review of medical records, the hospital failed to ensure:

* Development and implementation of a process to ensure fentanyl patches
were placed only on opioid tolerant patients per the guidelines on a
pre-printed order set. This resulted in one of two patients reviewed (Patient 95)
to have a patch placed on them when they did not meet the criteria
of opioid tolerance, which exposed them to the risk of significant respiratory
depression.

* The pharmacy IV rooms were maintained to the recognized USP standards
adopted by the hospital to maintain the pressure differential of the IV
preparation areas. This resulted in the potential for contamination in the areas
of the pharmacy adjacent to the area where staff prepared hazardous IV
chemotherapeutic medications (used to treat cancer).

* The MH supply was stocked according to standards adopted by the hospital for the amount of furosemide available and the hospital's P&P reflected the MHAUS guidelines for the pediatric dose of dextrose and the storage of sterile water used to reconstitute dantrolene.

* Solutions were stored according to hospital policy in one of four warmers in the
Surgical Department to ensure solutions were not stored outside of temperatures established by P&P and the manufacturer's recommendations for storing these solutions.

* Nursing staff prepared an IV solution of vancomycin according to manufacturer's recommendation resulting in an unknown amount of IV antibiotic not administered to Patient 72.

* Physicians' orders for two of three sampled patients on IV insulin were
followed (Patients 63 and 91). The hospital failed to ensure:
For Patient 63:
a) The blood sugar (BS) levels were measured as ordered.
b) The initial order of insulin was clarified with the physician.
For Patient 91:
a) The BS levels were measured as ordered.
b) The finger stick BS measuring as "critical high" was not verified by a laboratory value in order to provide treatment per the adult medical
admission orders (AMAO).
c) Insulin was administered as ordered in a timely manner.

Findings:

1. The fentanyl transdermal system, also called a fentanyl patch, contains fentanyl, a potent synthetic opiod medication used to treat pain. This medication has a black boxed warning from the manufacturer that documents the fentanyl patch has an associated risk of fatal overdose due to respiratory depression. The use of the patch to treat patients who are not opioid-tolerant is contraindicated because serious or life-threatening respiratory depression can occur. Opioid-tolerant is defined in the boxed warning as those patients who have taken oral opioid medications (used to treat pain) daily for a week or longer or an equivalent dose of another opioid medication.

On 7/15/05 the FDA published a warning letter entitled SAFETY WARNINGS REGARDING USE OF FENTANYL TRANSDERMAL (SKIN) PATCHES. The FDA documented: "The directions for using the fentanyl skin patch must be followed exactly to prevent death or other serious side effects from overdosing with fentanyl. These directions are provided in the product label and patient package insert."

On 1/12/12, a review of Patient 95's medical record indicated he was admitted to the ED on 1/7/12 at 1845 hours and was subsequently admitted to the hospital. On 1/8/12, MD 17 utilized a printed order set entitled "Fentanyl Patch Orders" to order a 25 mcg/hr fentanyl patch for Patient 95. Printed on the order set was "Inclusion Criteria: Must meet one of the following criteria," followed by doses of morphine, oxycodone, and hydromorphone for one week that met the fentanyl patch black boxed warning criteria. The criteria were followed by "Yes" and "No" boxes to be checked by a prescriber to document opioid tolerance. MD 17 documented Patient 95 had been taking 30 mg of oxycodone daily for a week or longer by checking a "yes" box after a printed statement to that effect on the printed order form. MD 17 also checked a box documenting this was a "New Order" as opposed to a "Continued Order of the same dose."

The "Home Medication List" in Patient 95's chart showed "...a list of medications the patient is currently taking at home ..." It did not list oxycodone as a medication Patient 95 took at home but it did show Patient 95 took Vicodin (hdrocodone, an opiod) at home. MD 17's Progress Note written on 1/7/12 at 2157 hours, showed Patient 95 took two tablets of Vicodin every six hours at home.

During an interview of MD 17 on 1/12/12 at 1154 hours, the physician stated Patient 95 had told her he was taking Vicodin around the clock when he was not sleeping. She stated she felt he took six to eight tablets a day at home. When asked if the patient took Vicodin for a week prior to admission, MD 17 stated she did not know exactly when Patient 95 started taking the Vicodin.

A further review of Patient 95's clinical record showed Patient 95 took a total of 10 mg of hydrocodone and 40 mg of morphine sulfate in the hospital from the time of admission on 1/7/12, until the 25 mcg/hr fentanyl patch was placed on Patient 95 on 1/8/12 at 1600 hours.

During an interview with RPh Staff 1 on 1/12/12 at 1330 hours, he produced a chart to show equivalent doses of various opioid pain relieving medications he said was used by the hospital. A review of this document showed 30 mg of oral hydrocodone was equivalent to 30 mg of oral morphine.

During an interview with Pharm 2 on 1/12/12 at 1228 hours, she stated the pre-printed order set for fentanyl patches was how the hospital regulated the prescribing of the fentanyl patch. Pharm 2 stated there was not a formal policy and procedure in the hospital that addressed the fentanyl patch. Pharm 2 stated the word "must" in the order set language "Inclusion Criteria: Must meet one of the following criteria" were guidelines to show the criteria had to be met before a patch could be dispensed. Pharm 2 stated even if the "Yes" box was checked, she would expect the dispensing pharmacist to verify the patient met the boxed warning criteria for opiod-tolerance prior to dispensing the patch. Pharm 2 stated the pharmacist could accomplish this by checking a computerized record of outpatient prescriptions for the patient dispensed by outpatient pharmacies associated with the hospital. Pharm 2 stated the pharmacist could also check the Hospital Information System (HIS). Pharm 2 checked a computer data base she stated was maintained in the HIS in which all pharmacists could document their clinical interventions for individual patients. Pharm 2, when asked, stated she found no interventions documented for Patient 95.

During an interview with RPh 1 on 1/12/12 at 1333 hours, he stated when a dispensing pharmacist received a fentanyl patch order the pharmacist should go back and review the patient's past use of opioid medications to ensure the patient was opioid-tolerant before dispensing the patch.

2. On 1/9/12 at 1013 hours, two IV rooms in the pharmacy were inspected with the DOP and Pharm 2. The DOP stated the room on the left was used to compound IV solutions and the room on the right was used to compound chemotherapeutic (chemo) IV solutions. An anteroom was located between the two IV rooms. The anteroom opened into the main pharmacy. To gain entrance to the IV room on the left and the chemo room on the right staff, had to pass through the anteroom. There was no system in place to ensure the negative pressure of the chemotherapy room was maintained according to USP in the revised general chapter <797> entitled PHARMACEUTICAL COMPOUNDING-STERILE PREPARATIONS, which states in the Introduction the objective of this chapter is to describe conditions and practices to prevent harm including ... unintended chemical and physical contaminants ..." (Cross Reference A-491)

3. MHAUS recommended institutions using medications that are MH triggers (volatile anesthetic gases and succinylcholine) maintain an MH Cart containing MHAUS recommended medications and equipment. The cart should contain four 40 mg vials of furosemide among other medications.

On 1/9/12 at 1314 hours, an inspection of the single MH Cart located in the Surgery Department indicated it contained four 20 mg vials of furosemide. At that time the DOP stated the hospital followed MHAUS guidelines. The DOP was unable to state why the hospital did not stock the MH Cart according to the MHAUS guidelines the hospital had decided to follow.

4. On 1/10/12, a review of Policy and Procedure 10037 entitled MANAGEMENT OF PATIENT WITH MALIGNANT HYPERTHERMIA (sic) Revised 3/1/08, Reviewed 11/1/11, showed the pediatric dose of glucose to be used in conjunction with insulin (to lower high blood levels of potassium) was 1 ml. In addition, the sterile water needed to reconstitute the dantrolene kept in the MH Cart would be stored in the refrigerator.

On 1/9/12 at 1314 hours, an inspection of the single MH Cart located in the Surgery Department showed it contained two one liter bags of sterile water for reconstitution. They were not stored in the refrigerator.

During an interview of Pharm 2 on 1/10/12 at 1027 hours, she stated the MHAUS guidelines documented the dose of dextrose (a molecular chain of glucose molecules) for a pediatric patient was 1 ml/kg.

During an interview with the DOP on 1/10/12 at 1027 hours, he stated the policy should have read "dextrose" instead of "glucose." In addition, the DOP stated the intent of the hospital was to store the sterile water for injection in the MH Cart where it would be available to reconstitute the dantrolene.

5. On 1/10/12 at 1408 hours, an inspection of the warmer in the sub-sterile room between ORs Room 5 and 6 showed the temperature reading on the digital indicator located on the front of the cabinet was 117 degrees F the section of the warmer containing irrigation solutions. A sign on the warmer showed: "Maximum Temperature of 110 degrees F." During an interview with RN 52, she stated it was the policy of the hospital not to store irrigation solutions above 110 degrees F. The section of the warmer used to store irrigation solutions showed it contained 1000 ml plastic pour bottles of sterile normal saline and sterile water for irrigation.

The manufacturer's information for the irrigation solutions, showed irrigation solutions in plastic pour bottles can be warmed to a temperature not to exceed 150 deg F for a period no longer than 72 hours and to a temperature not to exceed 104 deg F for a period no longer than 30 days. This medical information also stipulated: "For those products, which have two temperature guidelines, warming to temperature between the two guidelines would result in having to follow the upper temperature time guidelines (i.e. for pour bottles, if the the desired warming temperature is above 104 F, the guidelines for warming at 150 F must be followed (i.e. warm at 110 F only for 72 hours maximum)."

On 1/10/12 at 1427 hours, a review of the hospital's P&P entitled WARMING CABINET FOR SOLUTION/BLANKETS indicated that these irrigation solutions could be stored at a maximum temperature of 110 deg F. If the temperature was found to be above this temperature the solutions would not be used for patient care. During a concurrent interview with RN 52, she stated the solutions should be removed from the warmer but she did not know if this was in the written policy.

6. On 1/11/12 at 0953 hours, the surveyor observed a nurse passing medications to Patient 72. The surveyor observed an empty 250 ml IV piggyback bag with an attached vial of vancomycin attached to it. The vancomycin vial was about 1/7 full of fluid.

During an interview with Pharm 2 at 1107 hours on 1/11/12, she stated a collapsible vial system was used to attach the vancomycin vial to the IV piggyback bag. A review of the MAR for Patient 72 indicated nursing staff had hung this IV piggyback bag to infuse at 0200 hours on 1/11/12.

During an interview of the DOP and Pharm 2 in the pharmacy on 1/11/12 at 1111 hours, it was stated nursing staff activated the vial system by squeezing the collapsible vial device allowing IV fluid to run into the vial of vancomycin vial reconstituting the powdered vancomycin in the vial. Then, by holding the vial assembly above the bag and squeezing the bag, nursing staff drained the dissolved vial contents into the IV piggyback bag to hang the solution for administration to the patient. The DOP stated if the nurse squeezed the bag while hanging the solution (the vial would be hanging upside down at that point), some of the solution would be squeezed back into the vial. Pharm 2 stated the proper way to use the system was to drain the vial completely.

A review of the manufacturer's instructions for the proper use of the collapsible vial system showed documentation to: "Hang container on IV pole and prime set per directions. Ensure that vial is empty of drug and solution, Repeat step 8 if drug and solution remains in vial".


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7. The American Society of Health-Systems Pharmacists (ASHP) is an internationally recognized organization which establishes standards for professional practice in hospitals. ASHP's statement on Pharmacist's responsibility for distribution and control of drug products read: "A fundamental purpose of pharmaceutical services in any setting is to ensure the safe and appropriate use of drug products and drug-related devices. Fulfillment of this responsibility is enhanced though the pharmacist's involvement in all aspects of the use of drugs." In ASHP's practice setting guidelines, page 439 reads: "Medication Orders - All....medication orders....must be reviewed by a pharmacist before the first dose is dispensed. Any question regarding the order must be resolved with the prescriber....a writing notation of these discussions must be made in the patient's medical record...." "Medication-therapy monitoring includes an assessment of a) The appropriateness of the route and method of administration. d) The degree of patient compliance.... f) Clinical and pharmacokinetic laboratory data to evaluate the efficacy of medication therapy and to anticipate toxicity and adverse effects."

a. Patient 63's medical record was reviewed with RN 54 and Pharm 4 on 1/10/12 at 1400 hours. Patient 63 was admitted to the Emergency Department (ED) on 1/2/12 at 0120 hours with a diagnosis of chest pain radiating to the left arm. Patient 63 was placed on an insulin IV drip at 0500 hours on 1/4/12, to decrease the patient's blood sugar. The insulin drip dosage was controlled by the Adult Critical Care Insulin Infusion Orders (ACCIO) which was signed by Physician T00441. However, the initial insulin order was written to start at 1 unit per ml. The order referred to the concentration of insulin not the dosage to be administered. RN 54 indicated the order was interpreted as 1 unit of IV insulin per hour. There was no evidence the order was clarified by a pharmacist to confirm the interpetation was correct.

The ACCIO also indicated BS levels were to be checked every hour until the level reached between 70-130. Review of Patient 63's medical record dated 0600 hours on 1/4/12, showed his BS was 189. The next documentation at 0800 hours, showed the BS was 180. There was no documented BS at 0700 hours as required by the ACCIO or as ordered by the physician. There was no evidence a pharmacist was aware of the missing blood sugar.

b. Patient 91's medical record was reviewed on 1/12/12 starting at 0845 hours, with RN 54 and Pharm 4. Patient 91 was admitted to the ED on 1/6/12 at 1604 hours. During the physical examination and blood work the patient was identified to have high BS. Testing of his blood sugar and administration of intravenous insulin failed to follow physicians' orders. There was no evidence a pharmacist was monitoring the medication administration of Patient 91. (Cross reference A-405 #2).

Based on inspection of two of two RSI (rapid sequence intubation) Kits in the Surgery Department, inspection of nine medications in an "Antiarrhythmic Kit" found in one crash cart on the 4 West Medical Surgical Unit and inspection of anesthesia carts in the Surgery Department:

a. Pharmaceutical services failed to ensure that a used container of topical lidocaine in one out of the two RSI kits was discarded after use per hospital P&P (and would be considered unusable for further use on patients). This exposed patients to the risk of infection.

b. Pharmaceutical services failed to ensure that staff had accurately posted seven of nine expiration dates on the "Antiarrhythmic Kit" in the 4 West Crash Cart (used for emergency treatment of patients). These dates were used by staff to determine the date of the first drug to expire within the crash cart which would then be posted outside the cart so that staff would know when to remove and replace the effected medication. The expiration dates are part of the product label and thus these medications were mislabeled. As a result, the crash cart could have had expired drugs when the staff needed to use them for a patient.

Findings:

1. During an inspection of two RSI Kits in the Surgery Department on 1/9/12 at 1357 hours, the surveyor found the following:

Both RSI Kits contained two PFS (prefilled syringes) of atropine for injection each. Both syringes in one kit had been labeled by the packager as having expired 11/12/11 (about two months prior to the survey). The two atropine PFS in the second RSI Kit expired on 11/12/11 and 11/22/11 respectively.

Both kits contained one 50 ml bottle of lidocaine 4% topical solution each. One kit contained a bottle with a seal. The second kit contained a bottle without a seal and which contained less solution than the sealed bottle. At that time MD 15 stated that the Surgery Department procedure was to use this medication once and then discard it (not leave it in the RSI Kit).

2. An inspection of an "Antiarrhythmic Kit" (AK) contained within the 4 West Crash Cart on 1/11/12 at 1424 indicated it contained nine different types of medications and these medications and their respective expiration dates were listed on a label attached to the outside of the plastic bag sealing this supply. A second "Expiration Date" label with a single expiration date was placed below this content list. The expiration dates were in the "month/year" format. During an interview of Pharm 2 at that time, she stated that if just the month and year was listed, the hospital policy considered the medication was good to the end of that month. During an interview of RN 54 on 1/11/12 at 1540 hours he stated that nursing staff reviewed the single expiration date on the "Expiration Date" label during their inspections of the crash cart. He stated that the nurses would utilize this date and other such expiration dates listed on other medications and kits contained in the crash cart to determine the earliest expiration date to post outside the cart so that staff would know to remove and replace that medication.

The surveyor noted the following error in the posted expiration dates on the AK:

a. The AK contained two vials of phenylephrine for injection: one with a manufacturer expiration date of 3/13 and one with a manufacturer date of 5/13. The posted expiration date on the AK content list was 5/13 (two months later than the first of these expiration dates).

b. The AK contained three vials of NS for injection all with manufacturer expiration dates of 6/1/12. The posted expiration date on the AK content list was 6/12
(29 days later). Also, this was the date on the separate "Expiration Date" label found below the content list on the AK.

c. The AK contained two vials of sterile water for injection both with manufacturer expiration dates of 8/1/12. The posted expiration date on the AK content list was 8/12
(30 days later).

d. The AK contained two vials of dobutamine, both with an expiration date of 1/1/13. The posted expiration date on the AK content list was 1/13 (30 days later).

e. The AK contained three ampules of metoprolol with manufacturer expiration dates of 3/1/13. The posted expiration date on the AK content list was 1/13 (30 days later).

f. The AK contained two ampules of Levophed with manufacturer expiration dates of 10/1/12. The posted expiration date on the AK content list was 10/12 (30 days later).

g. The AK contained two vials of procainamide with manufacturer expiration dates of 11/1/12. The posted date on the AK content list was 11/12 (29 days later).


On 1/12/12 a review of the policy and procedure entitled CARDIAC ARREST CARTS, MAINTENANCE OF (Effective 7/28/11, Supercedes 3/15/11) indicated that policy F stipulated that staff would inspect crash carts on the 15th and 30th of the month. Policy F(3) stipulated that staff were to replace items that would outdate before the next routine check (which per policy was every 15 to 16 days).


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3. On 1/9/12 at 0950 hours, the OR was toured with MD 15. During inspection of one of the two back-up anesthesia carts, a liter bag of an IV solution was observed with the label showing the solution expired on 1/5/12. The IV bag had been removed from its outer cover and a tubing was attached and primed with the solution. The IV bag was prepared for emergency use. MD 15 stated the Anesthesia technicians were responsible for checking the cart daily; however, MD 15 stated he was not aware of how the expired IV bag remained in the patient care area.

Based on observation, record review and staff interview, the hospital failed to ensure a Radiology Technician enforced proper radiation safety precautions before the operation of x-ray equipment under the staff's control. A nurse holding an infant for a procedure did not wear any protective apparel during the three x-rays taken (Patient 76). In addition, the x-ray room was not cleared of all nonessential personnel before the x-rays were taken. This resulted in the nurse being exposed to unnecessary radiation and potentially placed the other staff at risk for radiation exposure.

Findings:

On 1/10/12, review of the hospital's "Radiation Safety Instructions" showed the registrant and supervisor/operator were responsible for radiation safety. Responsibilities included: assuring only competent persons with proper certification operate x-ray equipment; must provide safety rules to each individual operation of x-ray equipment under his/her control; and no supervisor/operator should permit operation of x-ray equipment unless the equipment met the State and Federal equipment regulation.
Some of the items pertinent to radiation safety included: 1) x-ray technical personnel should not hold patients and no person should regularly or repeatedly be used to hold patients; 2) the x-ray room should be cleared of all nonessential persons before x-ray technicians take x-rays; and 3) individuals who hold patients should use appropriate protective apparel such as a leaded apron, a thyroid shield and lead gloves.

Patient 76 was observed in the Radiology Department on 1/10/12 at 1330 hours, while under going an Upper GI Study (study of the upper gastrointestinal system by tracking injected dye).

Observation during the third x-ray taken during the procedure by Rad Tech 3 showed RN 41 was holding Patient 76. RN 41 was not wearing a protective lead apron, a thyroid shield or lead gloves. RN 41 was standing on the patient's left side holding a pacifier for Patient 76. Three other staff were also in the room. The main physician was on the patient's right side injecting dye during the procedure, a resident physician observing the procedure stood behind the main physician, and another nurse, also observing the procedure, stood behind RN 41.

On 1/10/12 at 1345 hours, RN 41 and Rad Tech 3 were interviewed. When asked why she did not wear protective apparel during the x-ray procedure, RN 41 stated she was not aware of the need for protective equipment. Rad Tech 3 stated RN 41 was reminded twice that she was not wearing any protective apparel. RN 41 stated she did not hear the technician's reminders. The technician continued to take x-rays without insisting RN 41 use protective apparel. Rad Tech 3 also did not instruct the other people in the room to clear the x-ray field or put on protective apparel.

Based on observation, interview and review of documents the hospital failed to ensure the P&P for safe handling of PHF were implemented by the F/N Director and F/N staff were trained to cool down PHF safely. Safe cooling requires removing heat from food quickly enough to prevent microbial growth. Excessive time for cooling of PHF (time/temperature control for safe foods) has been consistently identified as one of the leading contributing factors to foodborne illnesses. In addition, the hospital failed to ensure expired food products were discarded and were not available for patients' use.

Findings:

1. On 1/9/12, review of the hospital's Policy #B017 on 1/9/12, entitled Food Handling Guidelines Hazard Analysis Critical Control Point (HACCP) Temperature Log, showed "Cooling...potentially hazardous food shall be cooled from 140 degrees F to 70 degrees F as measured at its center within two hours and from 70 degrees F to 41 degrees F within an additional four hours, for a total cooling time of six hours or less."

According to the job description, the Chef's duties included training kitchen staff in food preparation, safe handling, operation of equipment, food safety and sanitation based on policy and regulatory standards.

According to the job description for the F/N Director, the duties included directing the operation of Food & Nutrition Services and evaluation of the production, safe handling and quality of all food prepared and distributed to ensure that it was consistent with policy and procedures for quality food service.

On 1/9/12 at 0955 hours, a pan of cooked chicken was observed inside the walk-in refrigerator with a sticker label indicating it was cooked on 1/8/12, and was to be used by 1/12/12. F/N Director 2 verified the chicken was cooked on site. The Director stated the chicken was intended for the "doctors' dining room."

On 1/9/12 at 1000 hours, in another walk-in refrigerator (Box 7), a four-inch deep pan containing cooked chicken was observed with a label that indicated the chicken was cooked on 1/8/12, to be used by 1/12/12. In addition, there was a tray of cooked roast pork with a label that indicated it was cooked on 1/8/12, and was to be used by 1/11/12. F/N Director 2 stated the cooked chicken and the cooked roast pork were intended for use by patients.

On 1/9/12 at 1100 hours, the cool down log for the cooked chicken and the cooked roast pork was requested. Review of the HACCP Temperature Log did not show a cool down process was used for the chicken cooked on 1/8/12.

On 1/9/12 at 1100 hours, Chef 1 viewed the HACCP Temperature Log. Chef 1 stated, "Retail should log their own." Chef 1 looked for another cool down log on the retail side of the kitchen and stated, "maybe the cook took it with him."

When asked, F/N Director 2 stated, "If things don't meet temperature they have to be discarded. There was only one log as far as I know."

Chef 1 and F/N Director 2 viewed the HACCP Temperature Log for the roast pork. Both staff confirmed the directions on the log were not followed to ensure food safety. F/N Director 2 instructed the dietary staff to discard the roast pork.

At that time, Chef 1 was asked to view the logged entry of a roast turkey dated 1/6/12, and reflected a two-hour cool down temperature of 82 degrees F. When Chef 1 was asked what he would have expected staff to do at that point, he stated, "It needed to be continued to be cooled down."

According to standards of practice in the food service industry, (FDA Food Code 2009) the PHF should have been re-heated, or discarded, but not allowed to continue to cool.

On 1/9/12 at 1325 hours, F/N Director 2 stated she decided to throw away the cooked chicken intended for patients as there was no documented evidence to show it was cooled down safely.

On 1/9/12 at 1331 hours, F/N Staff 4 was asked how PHF should be cooled down if they were cooked previous to the day they were to be served. The HACCP Temperature Log with the pre-printed directions on the log was available to F/N Staff 4 for review. F/N Staff 4 stated, "I check the temperature two-three hours later" after the initial cool-down period. F/N Director 2 stated she was satisfied with F/N Staff 4's response, even though F/N Staff 4 stated she may check the temperature three hours after the initial cool.

According to the FDA Food Code 2009, the initial two hour cool is a critical element of this cooling process. Checking the 2 hour temperature of the cooling process, three hours later is not an acceptable safe food handling practice.

On 1/10/12 at 0928 hours, observation inside the walk-in refrigerator showed multiple trays of round eye meat labeled as cooked on 1/9/12. When asked, F/N Staff 5 took the temperature of the round eye meat. The temperature was 41.7 degrees F.

Review of the HACCP Temperature Log showed on 1/9/12, the round eye cool down time was started at 1100 hours, at a temperature of 163 degrees F. The temperature was checked again at 1200 hours and it was 109 degrees F. According to the log directions the temperature was to have been checked again at the end of the total six hour cooling time; however, the log was left blank.

On 1/10/12 at 0928 hours, F/N Staff 5 stated he was responsible for the cooling down of the round eye meat cooked on 1/9/12. F/N Staff 5 stated he entered the information on the log for the round eye. F/N Staff 5 stated after two hours of cooling the meat in the freezer it was 109 degrees F. F/N Staff 5 stated he knew the meat needed to continue to cool, so he moved the meat to the walk-in freezer so he would not forget about it later, as he was going home at 1500 hours. F/N Staff 5 stated he did not inform anyone the meat was in the cooling down period prior to leaving for the day. F/N Director 2 informed F/N Staff 5 that the potentially hazardous food had not been cooled down safely and needed to be discarded. F/N Director 2 informed HA 2, who was present during the interview that the meat had to be discarded because it was not less than 41 degrees F.

On 1/10/12 at 1100 hours, F/N Director 2 stated, "the more important temperature to me was the final six hour temperature to be less than 41 degrees F." F/N Director 2 stated she was unaware the two hour cooling time/temperature was an important step to promote food safety for PHF in the cool down process.

The previous three months of HACCP Temperature Logs were requested. Review of the logs indicated 15 of 21 times in which a PHF should have been cooled down, the process was done incorrectly. The incorrect cool down of PHF involved circumstances in which the two hour cool down as well as the times of the six hour total cool down did not meet hospital's policy.

2. According to the hospital's Policy #B006 entitled Food and Supply Storage Procedures, "Policies: All food, non-food items, and supplies used in food preparation shall be stored in such a manner as to maintain the safety and wholesomeness of the food for human consumption..., The "use-by" date is the last date that a food can be consumed...,Foods past the "use-by" date should be discarded."

A "Best if Used By" date is recommended for best flavor or quality per the USDA (US Department of Agriculture) Food Safety and Inspection Service.

Observation of the dry food storage room on 1/9/12 at 0940 hours, showed there were 11 unopened pre-thickened juice products with a manufacturer's date that indicated, "Use By Oct 17, 2011."

On 1/9/12 at 0943 hours, in a reach-in refrigerator for patient use located at trayline, five pre-thickened juice products were observed with a manufacturer's date that indicated, "Best by 12/11." F/N Staff 2 stated she was a supervisor for the trayline area. When asked, F/N stated she only checked the dates on the milk.

Based on observation, interview and review of documents the hospital failed to ensure the Food Service Director was competent in implementing the hospital's P&P for the safe cooling of PHF (foods capable of supporting microbial growth), and to ensure the PHF was safely cooled down by the dietary staff responsible for that function. This placed medically fragile patients at risk of foodborne illnesses.

Findings:

On 1/9/12, review of the hospital's Policy #B017 entitled, Food Handling Guidelines Hazard Analysis Critical Control Point (HACCP) Temperature Log, showed "Cooling...potentially hazardous food shall be cooled from 140 degrees F to 70 degrees F as measured at its center within two hours and from 70 degrees F to 41 degrees F within an additional four hours, for a total cooling time of six hours or less."

Safe cooling required removing heat from food quickly enough to prevent microbial growth. Excessive time for cooling of potentially hazardous foods (time/temperature control for safety foods) had been consistently identified as one of the leading contributing factors to foodborne illnesses. The initial two-hour cool was a critical element of this cooling process. (FDA Food Code 2009).

Review of the F/N Director's job description showed the Director would "Direct the operation of Food & Nutrition Services...Evaluate the production, safe handling and quality of all food prepared and distributed to ensure that it was consistent with the policy and procedure for quality food service."

On 1/9/12 at 0955 hours, a pan of cooked chicken was observed inside the walk-in refrigerator with a sticker label indicating it was cooked on 1/8/12, and was to be used by 1/12/12. F/N Director 2 verified the chicken was cooked on site. The Director stated the chicken was intended for the "doctors' dining room."

On 1/9/12 at 1000 hours, in another walk-in refrigerator (Box 7), a four-inch deep pan containing cooked chicken was observed with a label indicating the chicken was cooked on 1/8/12, and to be used by 1/12/12. In addition, there was a tray of cooked roast pork with a label indicating it was cooked on 1/8/12, and was to be used by 1/11/12. F/N Director 2 stated the cooked chicken and the cooked roast pork were intended for use by patients.

On 1/9/12 at 1100 hours, the cool down log for the cooked chicken and the cooked roast pork was requested. Review of the HACCP Temperature Log did not show a cool down process was used for the chicken cooked on 1/8/12.

On 1/9/12 at 1100 hours, Chef 1 viewed the HACCP Temperature Log. Chef 1 stated, "Retail should log their own." Chef 1 looked for another cool down log on the retail side of the kitchen and stated, "maybe the cook took it with him."

When asked, F/N Director 2 stated, "If things don't meet temperature they have to be discarded. There is only one log as far as I know."

Chef 1 and F/N Director 2 viewed the HACCP Temperature Log for the roast pork. Both staff confirmed the directions on the log were not followed to ensure food safety. F/N Director 2 instructed the dietary staff to discard the roast pork.

On 1/9/12 at 1325 hours, F/N Director 2 stated she decided to throw away the cooked chicken intended for patients as there was no documented evidence to show it was cooled down safely.

On 1/9/12 at 1331 hours, F/N Staff 4 was asked how PHF should be cooled down if they were cooked previous to the day they were to be served. The HACCP Temperature Log with the pre-printed directions on the log was available to F/N Staff 4 for review. F/N Staff 4 stated, "I check the temperature two-three hours later" after the initial cool-down period. F/N Director 2 stated she was satisfied with F/N Staff 4's response, even though F/N Staff 4 stated she may check the temperature three hours after the initial cool.

On 1/10/12 at 0928 hours, observation inside the walk-in refrigerator showed multiple trays of round eye meat labeled as cooked on 1/9/12. When asked, F/N Staff 5 took the temperature of the round eye meat. The temperature was 41.7 degrees F.

Review of the HACCP Temperature Log showed on 1/9/12, the round eye cool down time was started at 1100 hours, at a temperature of 163 degrees F. The temperature was checked again at 1200 hours and it was 109 degrees F. According to the log directions the temperature was to have been checked again at the end of the total six hour cooling time; however, the log was left blank.

On 1/10/12 at 0928 hours, F/N Staff 5 stated he was responsible for the cooling down of the round eye meat cooked on 1/9/12. F/N Staff 5 stated he entered the information on the log for the round eye. F/N Staff 5 stated after two hours of cooling the meat in the freezer it was 109 degrees F. F/N Staff 5 stated he knew the meat needed to continue to cool, so he moved the meat to the walk-in freezer so he would not forget about it later, as he was going home at 1500 hours. F/N Staff 5 stated he did not inform anyone the meat was in the cooling down period prior to leaving for the day. F/N Director 2 informed F/N Staff 5 that the potentially hazardous food had not been cooled down safely and needed to be discarded. F/N Director 2 informed HA 2, who was present during the interview, that the meat had to be discarded because it was not less than 41 degrees F.

On 1/10/12 at 1100 hours, F/N Director 2 stated, "the more important temperature to me was the final six hour temperature to be less than 41 degrees F." F/N Director 2 stated she was unaware the two hour cooling time/temperature was an important step to promote food safety for PHF in the cool down process.

The previous three months of HACCP Temperature Logs were requested. Review of the logs indicated of the 21 times in which a PHF should have been cooled down, in 15 instances the process was done incorrectly. The incorrect cool down of PHF involved circumstances in which the two hour cool down as well as times of the six hour total cool down did not meet hospital's policy.

Based on observation, interviews and record review, the hospital failed to ensure the hospital was maintained in an acceptable level of safety and quality. The hospital failed to ensure:

In the OR (Operating Rooms):

* The potential for contamination of equipment from human waste was not present in the sub-sterile areas.

* Five of five autoclaves in the sub-sterile areas were cleaned according to manufacturer's guidelines to prevent corrosion.

* The OR table mattress was intact for one of 10 ORs (OR 6) to allow for adequate disinfection between patients.

In the Laboratory:

* Multiple areas of the laboratory were cleaned and/or maintained in good repair to eliminate the potential for spread of infection.

* Policies and procedures for refrigerator temperature checks were followed in the cytology laboratory area for four of four refrigerators not on an automatic temperature monitoring system. This could potentially affect the quality of testing reagents.

* Manufacturer's instructions for humidification for four of four incubators were followed. This could potentially result in malfunction of the equipment.

On the Medical/Surgical Unit:

* A ripped mattress was not in service for patients. Non-intact surfaces could potentially prohibit thorough cleaning/disinfection of mattresses.

Findings:

1. In the ORs:
a. A tour of the OR areas was conducted on 1/11/12 at 0900 hours. Included in the tour were the sub-sterile rooms between ORs 1 and 2, ORs 3 and 4 ORs 5 and 6, ORs 7 and 8 and a sub-sterile room for OR 9, the cardiac surgery area. The tour revealed a hopper device, a flush disposal unit used to dispose of human wastes and fluids in all the sub-sterile rooms. In the sub-sterile areas (except for the cardiac surgery area) were blankets and devices used to position patients during surgery. In the sub-sterile room for the cardiac surgery area there was an ice machine. A concurrent interview with RN 53 revealed the surgical staff used the hopper to clean and empty dirty bed pans and blood containers.

b. Red biohazardous (infectious) waste containers were found in each of the sub-sterile rooms between ORs. In the sub-sterile room adjacent to OR 9, the cardiac surgery area, infectious waste containers were noted directly in front of the ice machine and the autoclave used during cardiac surgery procedures. A second infectious waste container was noted directly in front of the surgical scrub sinks. When interviewed concurrently during the tour, RN 53 and MD 21 seemed unaware these contaminated containers could constitute contamination of the restricted area.

c. On 1/11/12, during the OR tour, it was noted each of the sub-sterile areas contained an autoclave. During an interview, EVS 3 stated a pre-mixed disinfectant was used to clean autoclaves daily. Inspection of the autoclaves showed presence of dark brown stained deposits in the autoclave chamber. A review of the manufacturer's written instruction for cleaning showed a liquid gel cleaning agent, not a disinfectant, was to be used weekly.

During interview with MD 21 on 1/12/12 at 1200 hours, MD 21 stated the hospital had a P&P instructing the cleaning staff to use a premixed disinfectant. MD 21 was not aware of the residue in the autoclave chambers or that the disinfectant was not recommended by the manufacturer.

d. According to AORN's edition 2012, Perioperative Standards and Recommended Practices, the Recommended Practices for a Safe Environment of Care, Recommendation II b. Mattresses and padded positioning devices (e.g., OR beds, arm boards, patient transport carts) should be moisture-resistant and intact. On 1/9/12 at 1010 hours, OR 6 was inspected. A tear of the pad on the operating room table was found.


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2. In the Laboratory beginning on 1/10/11 at 1330 hours:
a. In the Blood Bank, two portable air conditioning units had cardboard taped to outflow hoses. Laboratory Staff 1 stated engineering had placed the cardboard to help direct airflow to keep the area cool.

b. In Room 2S8 there was a 4 inch X 2 inch gouge in the back splash, plus a two-foot opening along the back splash attachment to the counter area above the sink.

c. In Microbiology, an MDF (medium density fiberboard) pallet was on the floor. Styrofoam was also on the floor and bare wood was nailed to the floor. These porous surfaces could not be adequately cleaned/disinfected.

d. In the Urology section a cupboard door had a large (greater than 12 inch x 12 inch) area that was rusted.

e. In Cytology, four of four refrigerators did not have temperature checks done on Saturdays and Sundays from January 2010 to January 2011. Testing reagents were stored in the refrigerators. According to Laboratory Staff 2, the Department was closed on weekends and the refrigerators were kept locked for safekeeping of reagents. The other refrigerator temperatures in the laboratory were continuously monitored on a central system. The hospital's P&P, Quality Control of Equipment 2004, showed manual refrigerator temperature checks were to be done daily.

f. In Room 2S38, two incubators were observed. The incubators were large stainless steel machines slightly larger than and of the same shape as a large residential single-door refrigerator. There was rust along the bottom of both machines and the floor tiles between the machines was discolored. The incubator on the left had a loose strip of metal along the bottom of the front of the machine. Opening the door revealed multiple metal shelves with specimens. At the bottom of each incubator was a pan of water. Around the pans of water, on the bottom shelf of both refrigerators was white and brown particulate matter/debris. When asked why there were pans of water in the machines, Laboratory Staff 3 stated they were required to maintain humidity in the machines. When asked what type of water was in the pan, Laboratory Staff 3 stated it was tap water and the pan was filled when empty. When asked if tap water was appropriate, the response was that the machines were old and tap water was what had been used for many years. Additionally, according to Laboratory Staff, there was no policy and procedure for cleaning the machine.

On 1/11/12 at 1410 hours, the above incubators were observed to be fixed and cleaned. However, the two remaining incubators were inspected and found to have white and brown debris on the bottom of the machine and tap water in pans at the bottom of the machines. The water in one of the pans had a film of growth in it.


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3. EVS 4 was observed, with the EVS Supervisor in attendance, cleaning a patient room following the discharge of a patient on the 6 W Unit on 1/10/12 at 1410 hours. Observation of the underside and sides of the bed mattress during cleaning showed approximately six to seven tears in the fabric, two to four inches in size. The foam padding of the mattress was exposed. After wiping down the mattress with a bleach solution, EVS 4 made the bed with fresh linens and placed a sign the bed was ready for a new patient.

Based on observation, interviews and review of documents the hospital's infection control committee failed to ensure:

* The hospital's policy on cooling down potentially hazardous food was followed by dietary staff which placed the medically fragile population at risk for foodborne illnesses.

* The potential for contamination of equipment used in surgery by human waste material was not present in the sub-sterile areas.

* Contaminated biohazardous waste containers were kept away from the sub-sterile areas.

* There was a system in place to ensure sterile processed items such as instruments used during a surgical procedure were labeled with lot control numbers to identify the sterilizer used, the cycle or load number, and the date of sterilization. This could result to potential inability to track or retrieve sterile items in the event of sterilizer failure or malfunction.

*The implementation of infection control guidelines on caring for arterial catheters and enteral feeding set ups for one of 49 sampled patients (Patient 82).

* A mattress pad on an OR table and a bed mattress in a patient room was intact with no rips in the material. Non intact surfaces could potentially prohibit thorough cleaning and disinfection of mattresses to prevent transmission of germs.

* Dirty items were kept apart from clean linens. These could result in the transmission of bacteria.

* EVS staff in the OR changed gloves after cleaning a biohazardous waste container and then cleaning other surfaces in the OR.

This could result in the transmission of infection in the hospital.

Findings:

1. Review of the hospital's Policy #B017 on 1/9/12, entitled Food Handling Guidelines Hazard Analysis Critical Control Point (HACCP) Temperature Log, showed "Cooling...potentially hazardous food shall be cooled from 140 degrees F to 70 degrees F as measured at its center within two hours and from 70 degrees F to 41 degrees F within an additional four hours, for a total cooling time of six hours or less."

Safe cooling requires removing heat from food quickly enough to prevent microbial growth. Excessive time for cooling of potentially hazardous foods (time/temperature control for safe foods) has been consistently identified as one of the leading contributing factors to foodborne illness. The initial two hour cool is a critical element of this cooling process. (FDA Food Code 2009).

Review of the previous three months of HACCP Temperature Logs indicated of the 21 times in which a PHF should have been cooled down, in 15 instances the process was done incorrectly. The incorrect cool down of PHF involved circumstances in which the two hour cool down did not meet the hospital's policy as well as times in which the six hour total cool down did not meet hospital's policy.

In a meeting with the survey team and the hospital's designated Infection Control Committee on 1/11/12 at 1320 hours, the committee was asked if a system was in place to identify issues in the food service area. Staff stated regular rounds were conducted by the committee in dietary; however, RN 61 stated foodborne issues were quality control issues within the dietary department. Dietary was responsible for their QA program and RN 61 stated the Infection Control staff were here to support them. RN 61 stated, in the future Dietary will be asked to report to the Infection Control Committee. Cross Reference A-620.



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2. According to AORN edition 2011, Recommended Practices for Sterilization in the Perioperative Practice Setting, the recommendation XVI d. indicated processed items should be labeled with lot control numbers to identify the sterilizer used, the cycle or load number, and the date of sterilization. Lot control numbers allow items to be identified or retrieved in the event 0f a sterilizer failure or malfunction.
On 1/9/12 at 1336 hours, Central Processing was toured with the Director of Central Processing. The Director stated the hospital had a list of surgical instrument trays which included 10 laparoscopic trays, two trauma trays, two laparotomy trays, eight cataract trays, and 15 major surgery trays.

During an interview on 1/9/12 at 1345 hours, the Central Processing Supervisor stated each of the different category of trays contained identical instruments. All of the instrument trays were sent back to the Operating Room for storage after the sterilization procedure. When asked the method used to identify the location of a tray if there was a failure in the sterilization process, the Supervisor stated there was no method to do so. The Director of Surgical Services, present during the interview, confirmed the Supervisor's response.

3. A tour of the OR areas was conducted on 1/11/12 at 0900 hours. Included in the tour were the sub-sterile rooms between Surgical Suites 1 and 2, Surgical Suites 3 and 4 Surgical Suites 5 and 6, Surgical Suites 7 and 8 and a sub-sterile room for OR 9, the cardiac surgery area. The tour revealed a hopper device, a flush disposal unit used to dispose of human wastes and fluids in all the sub-steriles room. In the sub-sterile areas (except for the cardiac surgery area) were were blankets and devices used to position patients during surgery. In the sub-sterile room for the cardiac surgery area there was an ice machine. A concurrent interview with RN 53 revealed the surgical staff used the hopper to clean and empty dirty bed pans and small amount of blood containers.

Red biohazardous (infectious) waste containers were found in each of the sub-sterile rooms between ORs. In the sub-sterile room adjacent to OR 9, the cardiac surgery area, infectious waste containers were noted directly in front of the ice machine and the autoclave used during cardiac surgery procedures. A second infectious waste container was noted directly in front of the surgical scrub sinks. When interviewed concurrently during the tour, RN 53 and MD 21 seemed unaware these contaminated containers could constitute contamination of the restricted area.

4. According to AORN edition 2012, Perioperative Standards and Recommended Practices, the Recommended Practices for a Safe Environment of Care, Recommendation II b. Mattress and padded positioning device surfaces (e.g., OR beds, arm boards, patient transport carts) should be moisture-resistant and intact.
On 1/9/12 at 1010 hours, OR 6 was inspected. A tear in the pad of the operating room table was found. This was replaced by staff.

5. On 1/9/12 at 1010 hours, EVS 5 was observed wiping the biohazard waste container with gloves in OR 6. After completing this task, EVS 5 did not change gloves prior to cleaning and disinfecting the other surfaces in the operating room. When interviewed, EVS 5 and RN 53 seemed unaware that a change of gloves was required. When interviewed, EVS 5 stated she had not been instructed to change gloves between cleaning/disinfecting the waste container and other surfaces in the room.


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6. On 1/10/12, review of the hospital's policy and procedure manual for Intravenous Therapy showed Swan-Ganz catheters and peripheral arterial lines (lines used for pulmonary and blood pressure monitoring) flush solution, stopcocks and tubing should be changed every 72-96 hours (3- 4 days), with the exception of the PICU and NICU. The dressing must be changed every seven days unless the catheter was discontinued, changed, or the dressing became damp, soiled or loose.

On 1/10/12 at 0900 hours, the 3 West ICU unit was toured with RN 33. Observation of Patient 82 showed an arterial line in the right wrist. A label on the arterial line dressing and on the tubing were both dated 1/3/12, seven days from the last day the dressing and tubing were changed.

Further inspection of Patient 82 showed the patient's enteral feeding bag and the connected tubing did not have labels attached to describe when the feeding was initiated.

On 1/10/12 at 0920 hours, during an interview with RN 57, she stated the enteral feeding bag and tube should be labeled when these items were hung. The RN stated she was not aware the arterial line dressing and tubing were due for change.

7. On 1/9/12 at 1001 hours, during tour of the 4 West Telemetry Unit accompanied by RN 33, the clean linen closet was inspected. A pair of used gloves rolled inside out and a five-pound orthotic weight wrapped in a dusty pillow case were observed stored with the clean linens.

RN 33 was observed to discard the used gloves in the trash can and the dusty pillow case in the soiled linen container.


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9. EVS 4 was observed during the cleaning of a patient room following the discharge of a patient on the 6 W unit on 1/10/12 at 1410 hours, with the EVS Supervisor in attendance. Observation of the underside and sides of the bed mattress during cleaning showed approximately six to seven tears in the fabric, two to four inches in size. The foam padding of the mattress was exposed. After wiping down the mattress with a bleach solution, EVS 4 made the bed with fresh linens and placed a sign on top of the bed which indicated the bed was ready for a new patient.

Based on a review of the hospital policy for procedural sedation and the minutes of the Governing Body for 2011-2012, the hospital failed to ensure the provision of an appropriate procedural sedation policy in keeping with the recommendations of nationally recognized organizations. This could lead to adverse patient outcomes during procedural sedation.

Findings:

The P&P for Procedural Sedation, last reviewed on 8/09, showed on page 1: procedural sedation required at least two staff, an authorized operator who was to perform the procedure and a staff who was responsible for monitoring the patient's condition and assisting in any supportive or resuscitative measures that might be required. The monitoring staff could be a physician, nurse practitioner, physician's assistant, RN or CRNA; however when the intent was to induce deep sedation (a drug induced depression of consciousness during which patients could not be easily aroused and breathing might be depressed) or when ketamine (a rapid-acting general anesthetic) was administered, either the operator or the monitor must have competency to independently perform endotracheal intubation

The American Society of Anesthesiology (ASA) website for 2012 and CMS recommends the individual monitoring the patient's condition be a licensed anesthesia provider or a physician with credentials and documented airway training, in the event intubation was required. Deep sedation might facilitate transition to general anesthesia, or be complicated by significant airway complications during ketamine induced dissociative anesthesia (a state induced by certain medications that distorts patient awareness and may be used for induction of anesthesia).

Interviews with the CNO, MD 19 and MD 18 were conducted on 1/12/12 at 1030 hours. The recommendation of the ASA and the hospital's P&P regarding the qualifications of the staff monitoring patients during deep sedation was discussed. The hospital's P&P did not indicate the staff monitoring patients during deep sedation would always be a staff member with competency to independently perform endotracheal intubation. The staff acknowledged they were not familiar with the ASA recommendations for airway management during dissociative anesthesia or deep sedation.

Based on interviews, a review of selected policies and procedures, and a review of medical records, the hospital failed to ensure a pre-anesthetic assessment for one of three patients reviewed (Patient 71).

Findings:

A review of the hospital's P&P, last revised on 12/1/11, Assessment Prior to Induction of Anesthesia/Sedation, showed the attending anesthesiologist would review the preoperative evaluation of the patient with the anesthesia provider and approve the anesthetic plan prior to the provision of services.

The medical record for Patient 71 was reviewed on 1/9/12. Patient 71 underwent a six-hour surgery with general anesthesia performed by a CRNA. Review of the Anesthesia Notes did not show documentation the pre-anesthetic evaluation of the patient was reviewed by MD 15, the attending anesthesiologist assigned to approve CRNA 1's plan prior to induction of anesthesia.