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Based on observation, interview and record review, the hospital failed to ensure that a State law was maintained, when the Child and Adolescent Psychiatric Services (CAPS) site did not have adequate food service equipment to provide patient food, in the event that the contracted outside food service was discontinued.

Findings:

On 5/25/11 at 11:10 A.M., at the CAPS location, Registered Dietician (RD) 53 stated that the 3-compartment sink and the stove range were removed because they were broken.

The hospital had contracted services from an outside food service to provide food to the patients at the CAPS site. The hospital had an approved program flexibility letter from the department, dated September 20, 1995, that indicated, "...your request for program flexibility to use an alternate method in dietetic service is approved on the following conditions: ...1. [name of contracted hospital] maintains compliance with all licensing requirements of the California Code of Regulations, Title 22, Governing Dietetic Service, including Sections 70271, 70273, 70275, 70277 and 70279., ...6. Kitchen facilities at the site are capable of becoming operative in accordance with the facility's policies within 48 hours in the event that the [contracted outside food service] becomes unable to provide this service."

The Food Service Director (FSD) acknowledged that there was not adequate equipment maintained in the kitchen at CAPS to implement the planned menu, in case services from the outside food service were no longer provided.

According to Title 22 70273 (a) (5), "When food is provided by an outside food service, all applicable requirements herein set forth shall be met. The hospital shall maintain adequate space, equipment and staple food supplies to provide patient food service in emergencies."

Based on interview and record review the hospital failed to have a mechanism in place to evaluate the competency (ability) of personnel involved in a contracted pharmacy compounding service (Pharmedium). Also, the hospital failed to include the contracted service in the hospital's quality assessment and performance improvement program (QAPI).

Findings:

On 5/23/11 at 10:50 A.M., an interview with Staff 81, the Pharmacist-in-Chief, indicated that the hospital's pharmacy had competency records for their own personnel that compound drugs in a sterile (clean) environment. He also stated they did not have competency records for the employees of the contracted pharmacy that provides similarly prepared drugs for use on the hospital's patients. Also, a review of hospital records failed to provide indication that the contract pharmacy's services were evaluated by the same hospital-wide QAPI evaluation as other services provided directly by the hospital.

Based on observation, interview and record review, the facility failed to ensure that a written physician's order for the use of a medical restraint, was completed within 12 hours after the initiation of restraints, for 1of 10 restrained patients (21).

Findings:

Patient 21 was observed on 5/24/11 at 2:10 P.M. being assisted to bed by two hospital staff. A review of Patient 21's medical record, conducted on 5/24/11 at 2:25 P.M., indicated that bilateral soft wrist restraints were applied to the patient on 4/20/11 at 3:00 P.M., due to the patient's pulling of intravenous lines.

However, a review of the physician's order indicated that a written physician's order for bilateral wrist restraints was not written until 4/21/11 at 9:22 A.M., 18 hours and 22 minutes after the bilateral wrist restraints were initially applied to Patient 21.

An interview with the 8th floor assistant manager was conducted on 5/24/11 at 2:50 P.M. The assistant manager stated that the written physician's order for Patient 21's bilateral wrist restraints should have been completed within 12 hours after the restraints were initially applied to the patient.

A review of the facility's policy and procedure titled "Restraints and Seclusion" indicated that, "For medical restraints: An order must be written and signed by a physician, nurse practitioner or physician assistant within 12 hours after the initiation of restraints."

Based on interviews and document reviews, the hospital failed to use data collected to identify opportunities to reduce or eliminate overrides and the resulting medication errors which endangered patient care.

Findings:

During a meeting on May 24, 2011 starting at 10:00 A.M., Staff 87, the Medication Safety Pharmacist, provided a report entitled Pyxis Overrides-Other (PORO) which identified the number of overrides which occurred in the Emergency Department (ED) from April 2010 through March 2011. During that period, according to Staff 87, the ED overrides remained consistent between 40% and 50% of the total number of medications accessed from the ED automated dispensing cabinets called Pyxis (ADC).

ADC's located in the ED allow quick access to medications by a nurse. When properly programmed, an ADC permits a nurse to remove a medication only after a pharmacist has reviewed the new physician's order, verified its appropriateness, and then enters the order into the pharmacy computer. This entry releases the medication, for that patient, and allows the dose to be accessed from the ADC by an authorized nurse. This access is permitted because the computer located in the pharmacy is electronically connected to the ADC.

If a nurse wishes to remove a medication before a pharmacist has reviewed and entered the order into the pharmacy computer, the nurse must use an overrride. An override usually occurs after hours when the pharmacy is closed and a pharmacist is not present in the hospital to review the order. The pharmacies in Hospital A and B provide services 24 hours each and every day, so a Pharmacist is always available to verify a new physician's order before a nurse attempts to access the medication from the ADC, thus avoiding an override.

During the meeting on May 24th, identified above, another report was provided by Staff 87. This report, entitled ED Med Errors (EME) dated April 2010 - March 2011, 12 months, the EME revealed that 713 medication errors were reported in the ED. This is the same time period that the overrides remained between 40% and 50% of the total number of medication doses removed from the ADC's as described in the PORO above.

The 713 medication errors identified in the EME report included:
Wrong dose; Override without a physician's order; Wrong patient; Wrong time; Wrong drug; Prescribing; Mislabeling; and Extra dose.

Of the 713 reported errors, 467 (65%) were due to no physician's order. That is, according to Staff 87, there was no evidence of a physician's order in the patient's record for the medication which was removed by a nurse from an ADC in the ED, via an override, in order to administer to the patient.

Although, according to Staff 87, Pharmacists are always available to review and verify the appropriateness of an order before the nurse attempts to access the medication from an ED ADC, nurses chose to use overrides (most without any evidence of a physician's order), which resulted in medication errors.

On May 26, 2011 starting at 8:00 A.M. the Safe Medication Practices Subcommittee (MERP) minutes for February 1, 2011 were reviewed. Staff 87 stated that MERP is a subcommittee of the Pharmacy & Therapeutics Committee (P&T) and reports its findings to the P&T. Under V. "ED Pharmacy Taskforce - Review of ED Override Plan," the minutes read: "Data analysis of ED and Urgent Care Pyxis overrides for December, 2010 shows an inappropriate override rate....Data analysis will be completed for several months before identifying a target...." Under action, the minutes read: "None."

During the above referenced date and time the P&T for March 26, 2011 was also reviewed. The minutes revealed, under C. "ED Med Review" read: "The rate of inappropriate overrides has stayed relatively constant over the past 3 months....We are approaching the one-year anniversary of Pharmacy review of ED medication orders so it may be time to re-evaluate the service." Under action, the minutes read: "Report accepted."

The MERP minutes of Feb 1, 2011 identify an inappropriate use of overrides in the ED. The P&T minutes of March 26, 2011 also identify an inappropriate use of overrides in the ED.
The consistent override rate of 40% to 50% in the ED was first identified in March 2010, and tracked from that date. However, there was no evidence that the hospital took measures to address the override issue and the resulting medication errors.

During a meeting with Staff 87 and Staff 81 starting at 10:00 a.m. on May 26, 2011, they both agreed that there was no action taken from April 2010 to the present, May 26, 2011.

Thus, although data had been collected for 14 months, there was no evidence that any action was taken by the hospital during the 14 months to identify opportunities to improve patient safety and the quality of patient care.

Based on interview and record review, the hospital failed to ensure that their auditing process pertaining to the discharge process of the emergency department (ED), identified all the patients that should have been reviewed in accordance with the hospital's recent plan of correction. In addition, the hospital failed to determine the causes of medication errors, and failed to implement corrective actions to reduce or prevent them from occurring in the future.

Findings:

1. On 3/8/11, a statement of deficient practice was issued to the hospital for Hospital A's failure to reassess the needs of a patient during the discharge process when the patient refused to leave.

A plan of correction was received from the hospital which documented that, "Security maintains a log when they are summoned to assist with a patient refusing to leave after being medically cleared and discharged. The log will be utilized by the Director of Risk Management and/or designee to audit 20 records per month for 4 months. Monitoring will also include a query of patient complaints, 'We Listen,' related to patients not feeling ready for discharge." Per the plan of correction, the auditing process was started on 4/1/11.

On 5/25/11 at 4:30 P.M., the "We Listen" report from 3/16/11 through 5/16/11, for both campuses were reviewed. Based on the review of the "We Listen" report, two patients were identified fitting the criteria of not feeling ready for discharge, Patient 24 and Patient 25. Per the same report, Patient 24 placed a call to "We Listen" on 4/16/11. The report indicated that the patient "expressed shock to be d/c (discharged) while her body was still spasming, with no relief." The report also indicated that Patient 25 placed a call to "We Listen" on 4/13/11. According to the report, the patient stated that "she had pneumonia, but the med (medical) team discharged her when she couldn't breathe or speak due to SOB (shortness of breath)."

The audits for March and April were requested. However, according to the Director of Regulatory Affairs, the April list to be reviewed by Risk Management was just finalized on 5/19/11, and was in the process of being reviewed.

An interview with the Director of Risk Management (DRM), Risk manager (RM), and the Director of Regulatory Affairs (DRA) was conducted on 5/31/11 at 9:35 A.M. The RM stated that the April audit had not been completed yet. The RM stated that the final list for the April audit was based on the security log given to Risk Management on 5/19/11. The RM stated that she also used the "We Listen" report to review the ED discharge process. However, the RM stated that the Director of Patient Experience/Guest Relations (DPEGR) did not provide Risk Management with patient names that needed to be reviewed for the month of April. After being read the "We Listen" report for Patient 24 and Patient 25, the DRM and RM acknowledged that both patient names should have been given to Risk Management for review.

An interview with the DPEGR was conducted on 5/31/11, at 10:20 A.M. The DPEGR stated that she thought that the discharge process audit applied only to patients in the in-patient areas. The DPEGR could not offer any explanation as to why she thought the discharge process audit applied only to in-patient units. The DPEGR acknowledged that Patient 24 and Patient 25 were not referred to Risk Management for the review of both patients' discharge process.

The audit process, per the hospital's plan of correction, failed to capture 2 patients that should have been reviewed by Risk Management for the appropriateness of the discharge process.


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2. During a meeting conducted on May 24, 2011, at 10:00 A. M., with Staff 82, the Director of Inpatient Pharmacy, Staff 86, the Assistant Director of Inpatient Pharmacy, and Staff 87, the Medication Safety Pharmacist. A report was provided by Staff 87. The report, entitled ED Med Errors, was for April 2010-March 2011, for 12 months, and revealed that 713 medication errors were reported in the Emergency Department (ED).

Medication errors identified in the above report included:
Wrong dose; Override without a physician's order; Wrong patient; Wrong time; Wrong drug; Prescribing; Mislabeling; and Extra dose.

Of the 713 reported errors, 467 (65%) were due to no physician's order. That is, there was no physician's order found in the patient's record for the medication removed by a nurse from the Pyxis Cabinets or automated dispensing cabinets (ADC's) in the ED.

ADC's, which are similar to vending machines, contain medication doses stocked by the pharmacy. ADC's are located on the nursing units and in the ED and permit quick access to medications by a nurse. When properly programmed, an ADC permits a nurse to remove a medication only after a pharmacist has reviewed, verified, and then entered the new physician's order into the pharmacy computer. This entry allows the medication for that patient to be accessed by an authorized nurse. This release is permitted because the computer located in the pharmacy is electronically connected to the ADC.

If a nurse wishes to remove a medication before a pharmacist has reviewed and entered the order into the pharmacy computer, the nurse must use an overrride. An override usually occurs after hours when the pharmacy is closed and a pharmacist is not present in the hospital to review the order.

According to Staff 82, the hospital pharmacy is open 24 hours each day, every day. So, although Pharmacists are always available to enter new physician orders, nurses still chose to use overrides, most without a physician's order, which resulted in medication errors.

The Safe Medication Practices Subcommittee (MERP) minutes were reviewed on May 26, 2011 starting at 8:00 A.M. During a meeting with Staff 81 and Staff 82 starting at 10:00 a.m. on May 24, 2011, they stated that the MERP is a subcommittee of the Pharmacy & Therapeutics Committee (P&T). All reports prepared by the MERP are presented to the P&T.

The August 4, 2009 MERP minutes read: "SMP (Safe Medication Practices) Graphs: Error Rate by Process Node....The trends appear to be stable." A review of the appended SMP graph shows that while the trend for medication administration without overrides remained level, there was a three-fold increase in the administration errors with overrides from the 4th quarter of fiscal year 2007/2008, to the 3rd quarter of fiscal year 2008/2009. Under action, the minutes read "none."

The MERP minutes for Febrary 2, 2010 read: "Overall trends stable with decreasing trend in administration of medications without overrides." Under action the minutes read "." The appended graph shows at it lowest point in the 2nd quarter of fiscal year 2009/2010, administration errors with overrides were still more than twice the number without overrides.

The February 1, 2011 MERP minutes read: "Data analysis of ED and Urgent Care Pyxis overrides....shows an inappropriate override rate...."

Also on May 26, 2011 starting at 8:00 A.M., the P&T minutes from July 15, 2009 to April 20, 2011 were reviewed. There was no evidence of any analysis of overrides and the resulting medication errors in any of the minutes. There was no evidence of the determination of the cause of the overrides and medication errors in any of the minutes. There was no evidence of any actions taken to eliminate or reduce the overrides and errors.

For example, the March 16, 2011 minutes under 'standing reports' read: "Dr. (name of physician) presented extensive information about medication use in the ED. The rate of inappropriate overrides has stayed relatively constant over the past 3 months....We are approaching the one-year anniversary of Pharmacy review of ED medication orders so it may be time to re-evaluate the service."

Overrides were identified as problematic nearly 2 years ago. Data shows overrides result in medication errors particularly in the ED. Overrides in the ED continue to be inappropriate and there is no evidence to show that preventive action has been taken in the last year to reduce or eliminate them.

Thus the hospital failed to identify the cause of medication errors and failed to implement improvements to eliminate or reduce them from occuring in the future.

Based on interview and record review, the hospital failed to ensure that 2 patient audits (26,27) concerning the discharge process of emergency department (ED) patients, reflected an accurate review of the records.

Findings:

1. On 3/8/11, a statement of deficient practice was issued to the hospital for Hospital A's failure to reassess the needs of a patient during the discharge process when the patient refused to leave.

A plan of correction was received from the hospital which documented that, "Security maintains a log when they are summoned to assist with a patient refusing to leave after being medically cleared and discharged." The log will be utilized by the Director of Risk Management and/or designee to audit 20 records per month for 4 months. Monitoring will also include a query of patient complaints, 'We Listen,' related to patients not feeling ready for discharge. The audit will be performed using the 'Patients Refusing Discharge Monitoring Tool.' Records will be audited for appropriate documentation and compliance with the revision the hospital's policy and procedure section MCP 301.4 entitled, Patients Medically Cleared for Discharge Who Refuse to Leave the Hospital." Per the plan of correction, the auditing process was started on 4/1/11.

A review of the revised MCP 301.4 hospital's policy and procedure titled "Patient Admission and Discharge" indicated that, "Non Clinical Reason for Patient Refusal to Leave: 1. If the reason for refusal to leave is non-clinical and a resolution can be provided by the nurse (i.e., a bus pass, an umbrella, a meal ticket, etc.) the appropriate resolution should be provided. Any other department that can provide assistance with the resolution should be contacted. 2. If the patient still refuses to leave after the non-clinical reason(s) for refusal to leave have been addressed, the nurse may contact (facility name) Security as described in paragraph E below. 3. The nurse and any other staff involved in facilitating the patient's discharge will document the reason for refusal to leave, actions taken and any other pertinent information."

A review of the hospital's "Patient Refusing Discharge Record Audit" tool for March 2011, was reviewed on 5/26/11 at 9:00 A.M. According to the "Patients Refusing Discharge Monitoring Tool," dated 5/10/11, Patient 26's refusal to leave was due to a non-clinical reason, and that, the documentation supported the patient's discharge, reason for refusal to leave, and that actions were taken by nursing.

However, a review of Patient 26's nurse's notes indicated that on 3/11/11, at 6:30 A.M., Patient 26 became irate when he realized he lost his jacket and wallet. Per the nurse's notes, the patient was screaming at the nurses station. The nurse's notes indicated that the patient was informed that he arrived at the hospital with what he had on at that time and that he was brought in by ambulance. The nurse's notes then indicated that the patient was escorted out of the ED by staff and security. Contrary to the Risk Management's audit, there was no documented evidence that the nursing staff had taken action to assist with the patient's concern. There was no documented evidence that the staff attempted to contact any other department that could have provided some assistance to the patient.

An interview with the Risk Manager (RM) and the Director of Risk Management (DRM) was conducted on 5/31/11, at 10:30 A.M. The RM acknowledged that there was no documented evidence that the staff attempted to contact any other department that could have provided some assistance to the patient.

The hospital's own audit process per the hospital's plan of correction was inaccurate and failed to capture pertinent information to conduct a thorough review of the discharge process.

2. On 3/8/11, a statement of deficient practice was issued to the hospital for Hospital A's failure to reassess the needs of a patient during the discharge process when the patient refused to leave.

A plan of correction was received from the hospital which documented that, "Security maintains a log when they are summoned to assist with a patient refusing to leave after being medically cleared and discharged. The log will be utilized by the Director of Risk Management and/or designee to audit 20 records per month for 4 months. Monitoring will also include a query of patient complaints, 'We Listen,' related to patients not feeling ready for discharge. The audit will be performed using the Patients Refusing Discharge Monitoring Tool. Records will be audited for appropriate documentation and compliance with the revision to a section of the facility's policy and procedure MCP 301.4 entitled, "Patient Medically Cleared for Discharge Who Refuse to Leave the Hospital." Per the plan of correction, the auditing process was started on 4/1/11.

A review of the revised MCP 301.4 hospital's policy and procedure titled "Patient Admission and Discharge" indicated that, "Non Clinical Reason for Patient Refusal to Leave: 1. If the reason for refusal to leave is non-clinical and a resolution can be provided by the nurse (i.e., a bus pass, an umbrella, a meal ticket, etc.) the appropriate resolution should be provided. Any other department that can provide assistance with the resolution should be contacted. 2. If the patient still refuses to leave after the non-clinical reason(s) for refusal to leave have been addressed, the nurse may contact (facility name) Security as described on paragraph E below. 3. The nurse and any other staff involved in facilitating the patient's discharge will document the reason for refusal to leave, actions taken and any other pertinent information.

A review of the hospital's "Patient Refusing Discharge Record Audit" tool for March 2011 was reviewed on 5/26/11 at 9:00 A.M. According to the "Patients Refusing Discharge Monitoring Tool," dated 5/10/11, Patient 27's refusal to leave was due to a non-clinical reason and that the documentation supported the patient's discharge, reason for refusal to leave and that actions were taken by nursing.

However, a review of Patient 27's nurse's notes indicated that on 3/16/11, at 9:30 P.M., "attempted to D/C (discharge) pt (patient), pt became aggressive throwing BP (blood pressure) cuff and yelling." Per the nurse's notes, the patient refused to sign the discharge instructions and was refusing to leave. The nurse's notes then indicated that security was called for assistance. Contrary to the Risk Management's audit, there was no documented evidence that the reason for the patient's refusal to leave was assessed and documented.

An interview with the Risk Manager (RM) was conducted on 5/31/11, at 10:40 A.M. The RM acknowledged that there was no documented evidence that Patient 27's refusal to leave was assessed and documented.

The hospital's own audit process per the hospital's plan of correction was inaccurate and failed to capture pertinent information to conduct a thorough review of the discharge process.

Based on observation, interview and record review, the facility failed to show documented evidence that 2 of 26 sampled patients (22,23) pain status', was reassessed following the administration of pain medication, in an effort to ensure that the patients were relieved of pain.

Findings:

1. On 5/25/11 at 1:40 P.M., Patient 22 was observed awake in bed with family at the bedside. Patient 22's record was reviewed on 5/25/11. According to the record, Patient 22 was admitted to Hospital A on 5/22/11, per the facesheet. A review of Patient 22's physician's orders indicated that an order was written on 5/23/11, for fentanyl (pain medication) 25 mcg (micrograms) intravenous (IV), every 2 hours, as needed for moderate pain.

According to Patient 22's flowsheet, the patient was documented with a pain score of "7" on a pain scale of "1 to 10," with 10 being the most pain, on 5/25/11 at 1:54 A.M. and 1:56 A.M. Per the medication administration record, the patient was given fentanyl 25 mcg IV on 5/25/11, at 1:54 A.M. However, there was no documented evidence that the patient's pain status was reassessed following the administration of pain medication until 5:00 A.M., 3 hours later.

An interview with registered nurse (RN) 21 was conducted on 5/25/11, at 1:45 P.M. RN 21 stated that Patient 22's pain status should have been reassessed within an hour following the administration of the IV fentanyl.

A review of the hospital's policy and procedure titled "Pain Management" indicated that, "The patient's pain is reassessed by the medical/nursing staff to determine the effectiveness of the pain management strategies.......(ii) Within 1 hour following parenteral (a route of administration that involves piercing the skin or mucous membrane) administration of medication."

2. Patient 23's record was reviewed on 5/25/11. According to Patient 23's facesheet, Patient 23 was admitted to Hospital A on 5/23/11. A review of Patient 23's physician's orders indicated that an order was written on 5/23/11 for hydromorphone (pain medication) 1 mg (milligrams) intravenous (IV) every 3 hours as needed for severe pain.

A review of Patient 23's flowsheet indicated that on 5/25/11 at 3:08 A.M., the patient had a pain score of "8" out of 10 on a scale of 1 to 10 with 10 being the most pain. According to the medication administration record, the patient was given hydromorphone 1 mg IV on 5/25/11 at 3:08 A.M. However, there was no documented evidence that the patient's pain status was reassessed following the administration of the pain medication.

A joint record review and interview with the unit manager for 11 west was conducted on 5/25/11 at 3:25 P.M. The unit manager acknowledged that there was no documented evidence that Patient 23's pain status was reassessed following the administration of an IV pain medication.

A review of the hospital's policy and procedure titled "Pain Management" indicated that, "The patient's pain is reassessed by the medical/nursing staff to determine the effectiveness of the pain management strategies.......(ii) Within 1 hour following parenteral (a route of administration that involves piercing the skin or mucous membrane) administration of medication."

Based on observation, interview and record review, the hospital failed to ensure that the nutrition care plans for 2 patients (54,55) in regards to therapeutic diet and fluid restriction, were coordinated with the multidisciplinary team in accordance with the physician's order.

Findings:

On 5/24/11 at 8:05 A.M., breakfast tray assembly on 11 East floor was observed. Dietary Staff 56 cut a banana in half and placed it on Patient 54's breakfast tray, and provided sugar substitute for Patient 54's coffee. Dietary Staff 56 stated that Patient 54 was allowed to have only 5 carbohydrates per meal per the planned menu for Patient 54's diet order.

According to Patient 54's medical record the physician prescribed diet was "Diet Carb Limited," and the comments section of the diet order further specified "also cardiac diet" (low salt and low fat). Patient 54's medical record indicated that on 5/24/11 at 5:44A.M., his glucose was 269 (High), and he was given 3 units of insulin on 5/24/11 at 7:30A.M., in accordance with the physician's order for sliding scale insulin coverage.

On 5/24/11 at 8:09 A.M., Licensed Nurse (LN) 57 stood next to Patient 54 when Patient 54 stated, "Oh, I see I was given a half of a banana. Well, that is ok." LN 57 then proceeded to the breakfast cart that contained the various items available for breakfast, and took a whole banana and 4 packets of sugar from the cart. LN 57 gave the whole banana and sugar packets to Patient 54 and stated, "An extra banana in case you get hungry. Here is some sugar for your coffee."

On 5/24/11 at 8:12 A.M., LN 57 was asked by the evaluator if she knew Patient 54's diagnoses and diet order, and LN 57 stated, "I don't know his diagnosis or diet order but I know he came from the ER [emergency room] yesterday." LN 57 further added that she was on the floor to help out but that she was not Patient 54's assigned nurse.

On 5/24/11 at 8:15 A.M., LN 58 stated that he was Patient 54's assigned nurse. LN 58 stated that Patient 54 was on "a carb limited diet which means low sugar, low carbs [carbohydrates], diabetic diet." LN 58 stated that Patient 54 should not receive sugar, and stated that nurses should check a patient's diet order prior to providing any food or beverages. LN 58 was informed of the observation regarding the whole banana and packets of sugar and stated, "I know him."

On 5/24/11 at 8:30 A.M., Patient 55 was provided his breakfast meal tray by Dietary Staff 59. The breakfast tray contained the following fluids: an 8 oz can of a nutritional supplement, 4 oz of juice, and 4 oz of milk which totaled 16 oz of fluid.

On the outside of Patient 55's room was a sign that indicated "Fluid Restriciton - 1 Liter (approximately 32oz) per day." Dietary Staff 59 stated that a fluid restriction was not part of Patient 55's diet order, according to her diet census sheet that she obtained from the dietary department.

On 5/25/11 at 8:30 A.M., the Clinical Manager RD verified that the food and nutrition services department did not know that Patient 55 was on a fluid restriction of 1 liter per day. The Clinical Manager RD stated that the diet office was sending soup and sandwhich for snacks, in addition to multiple liquid nutritional supplements 4 or more times a day, in addition to the regular fluid that was placed on the meal trays.

According to Patient 55's medical record, Patient 55's diagnoses included end stage liver disease with ascities (excess fluid in the space between the tissues lining the abdomen and abdominal organs), for which a fluid restriction is ordered.

The Clinical Manager RD stated that after reviewing Patient 55's medical record, the problem was that the physician wrote the order for fluid restriction of 1 liter per day in "nursing orders," which the RD's "cannot read." The Clinical Manager RD stated that nursing should have documented under the comments section of the diet order that there was a physician's order for fluid restriction of 1 liter per day. The physician's order for the fluid restriction was in the nursing orders on 5/17/11.

On 5/25/11 at 9:26 A.M., LN 60 reviewed Patient 55's medical record and verified that the physician ordered fluid restriction of 1 liter per day electronically in "Notes to Nursing." LN 60 stated that a nurse should have entered the fluid restriction under the comments section of the diet order so that the food and nutrition services department would have known.

On 5/25/11 at 9:53 A.M., LN 50 reviewed Patient 55's medical record and stated, "The fluid restriction should have been entered as a physician's order and not just in "Notes to Nursing," so that all multidisciplinary team members would have known the complete diet order.

According to the hospital's Policy 14.8, entitled Diet Orders, "4. Comments Field; Special considerations are to be entered by nursing staff in the "comments" section...b. Fluid Restrictions: Enter total fluid restriction. If known, indicate the amount to be sent on trays. If not specified, half the volume will be delivered on meal trays."

The hospital's Policy 5.10 entitled, Communication with Nutrition Services by Medical Care Team indicated, "Policy: EPIC is the method for communication of Nutrition Care for food service to patients. Diet Order information entered into EPIC is passed thru the Order Entry Interface to the CBORD system," [used by the Food and Nutrition Services department], Purpose: To ensure proper communication of nutrition information for patients..."

Based on observations and interviews, the hospital failed to ensure that 3 of 6 sampled nurses (84,85.94) assigned to patient care areas, were competent to calculate or prepare medication doses for patients during simulated emergencies. Reference Title 22, 70214(a)(2)(A).

Findings:

Nursing unit 11 West was visited on May 23, 2011 at 1:25 P.M. Staff 84, a registered nurse (RN), was asked to calculate a medication dose for an adult patient in a simulated emergency. Staff 84 was given all the needed patient and dosage information. Staff 84 was unable to calculate the dose.

On the same day, the nursing unit on the 8th floor was visited at 2:10 P.M. Staff 85 an RN, was asked to calculate a medication dose for an adult patient in a simulated emergency. Staff 85 was given all the needed patient and dosage information. Staff 85 was unable to calculate the dose.

On the same day, the Emergency Department was visited at 3:05 P.M. Staff 94, an RN, was asked to calculate and draw up an intravenous medication dose (into a syringe) for a pediatric patient in a simulated emergency. Staff 94 was given the needed patient information and the name of the medication. Staff 94 was able to calculate the dose but then confused the dose with the volume of medication and was unable to draw up the correct needed dose.

Staff 83, a Nursing Director, and staff 95, the Director of Nursing Education, confirmed the nurses were unable to calculate or prepare the correct dose of medication during the simulated emergencies.

Based on record reviews and interviews, the hosptial failed to ensure that policy and procedures were followed for the administration of high risk medications, for 1 of 4 sampled patients (96). Reference Title 22, 70263(c)(1). The facility also failed to ensure that policies for the administration of high risk drugs implemented in Labor and Delivery, were approved by the Medical Staff or the Governing Body of the hospital.

Findings:

1. On May 25, 2011 starting at 2:30 P.M. 4 patient records were reviewed with staff 92, a pharmacist, and staff 93, the Nursing Director of Outpatient Services. The record for Patient 91 revealed that independent double check signatures as required for the administration of Warfarin (an anticoagulant) and Hydromorphone (a narcotic), were not documented.
Staff 92 and 93 confirmed there was no independent second signature on the medication administration record for patient 91, neither for Warfarin nor Hydromorphone.

On 5/25/11, policies and procedures were reviewed. The High Risk Medications policy and procedures (HRM) page 3 of the HRM reads: "B.1. Verify that a staff members follow procedures related to high risk medication by performing....an independent double-check." A review of the high risk medications list appended to the HRM policy and procedures identifies Warfarin and Hydromorphone as high risk medications.

Additionally, Page 3 of the Medication Preparation, Labeling and Administration (MPLA) policy F. reads: "The independent double-check is to be performed by two nurses or if a second nurse is not available another licensed personnel authorized to administer medication..."
F.3. of the same policy reads: "Independent Double-Checks serve two purposes:
a) to detect a serious error before it reaches a patient; and
b) to bring attention to the systems that allow the introduction of human error. Independent double-checks should be done on error-prone processes such as the use of high risk medications."

The hospital failed to ensure that the HRM and MPLA policies and procedures were followed for the administration of high-risk medications for Patient 96.


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2. On 5/24/11 at 2:35 P.M., an interview with Staff 96 was conducted and revealed that the nursing staff in Labor and Delivery, utilized policies and procedures (protocols) for the initiation and administration of 2 high-risk drugs: Oxytocin (causes contractions of the uterus to promote the start of labor) and Magnesium Sulfate (causes lowering of uterine contractions in the preterm patient).

The Oxytocin policy was reviewed on 5/24/11. The Oxytocin policy was initiated in 1989, and the Magnesium Sulfate policy was initiated in 1983. Both policies were noted to have been updated every 2 to 3 years since inception, and provided direction to nurses as to how and when to initiate or adjust the dose of these drugs.

During the above interview, Staff 96 indicated that these polices had been developed and approved internally by the Labor and Delivery department. There was no indication or evidence that these policies or protocols had ever been approved by the appropriate medical staff committees or the facility's governing body.

Based on interviews and document review, the hospital failed to ensure that medications taken by nurses for patients in the Emergency Department (ED), from Pyxis/ADCs (automated dispensing cabinets, ADC's), via an override, were ordered by a physician. Reference Title 22, 70263(g).
ADC's in the ED permit quick access to medications by a nurse. When properly programmed an ADC allows a nurse to remove a medication only after a pharmacist has reviewed the new physician's order, verified its appropriateness, and then enters the order into the pharmacy computer. This entry releases the medication for that patient and allows the dose to be accessed from the ADC by an authorized nurse. This access is permitted because the computer located in the pharmacy is electronically connected to the ADC. If a nurse wishes to remove a medication before a pharmacist has reviewed, verified, and entered the order into the pharmacy computer, the nurse must use an overrride.

Findings:

During a meeting on May 24, 2011 starting at 10:00 A.M. with Staff 87, the Medication Safety Pharmacist, a report entitled ED Med Errors for April 2010 through March 2011, 12 months, was provided. The report revealed that 713 medication errors were reported in the ED. Of the 713 reported errors, 467 (65%) were due to no physician's order. That is, according to Staff 87, there was no evidence of a physician's order in the patient's record for the medications removed from the ADC in the ED, in order to administer to patients.

Based on interviews and document reviews, pharmacists failed to provide supervision of medication distribution and use. Pharmacists failed to ensure that medications removed from the Pyxis/ADC's (automated dispensing cabinets) as overrides, were accurate and appropriate as ordered by a physician. Pharmacists failed to control the use of overrides, and the medication errors which resulted from the use of overrides. Reference Title 22, 70265. The Director of Pharmacy also failed to ensure the approval of policies and procedures for the administration of 2 high risk drugs used in Labor and Delivery, Oxytocin and Magnesium Sulfate.

In addition, Hospital B failed to ensure that their High Risk Medications policy and procedure was implemented, for 2 of 33 sampled patients (11, 12). There was no documented evidence that independent double checks of high risk medications during handoffs were performed.

Findings:

1. ADC's are located on all nursing units and in the ED (emergency department) and permit quick access to medications by a nurse. When properly programmed an ADC permits a nurse to remove a medication only after a pharmacist has reviewed the new physician's order, verified its appropriateness and then enters the order into the pharmacy computer. This entry releases the medication and allows the dose for that patient to be removed by an authorized nurse. This release is permitted because the computer located in the pharmacy is electronically connected to the ADC.
If a nurse wishes to remove a medication before a pharmacist has reviewed and entered the order into the pharmacy computer, the nurse must use an overrride. An override usually occurs after hours when the pharmacy is closed and a pharmacist is not present in the hospital to review the order before the nurse removes it from the ADC. Use of an override generates a medication order override report which includes:
1. The name of the patient.
2. The name and dosage of the medication.
3. The number of doses removed.
4. The reason the dose(s) were removed.
5. The nurse who removed the dose.

According to Staff 82, the pharmacies in the hospitals provide services 24 hours each and every day. Thus, a Pharmacist is always available to review and verify the appropriateness of a medication before a nurse removes the dose from the ADC in order to avoid the use of an override.

Hospital policies and procedures were reviewed. Page 5 of the hospital policy and procedure entitled "Medication Preparation, Labeling and Administration" (MPLA policy) reads:
"E.2. The prescriber's medication orders will be reviewed and verified by a pharmacist prior to administration, except:
a) Cases where the prescriber controls the ordering, dispensing and administration of the drug, i.e. operating rooms and procedural areas.
b) Emergency situations or time-critical "STAT" orders when time does not permit such review...."

The American Society of Health-Systems Pharmacists, (the internationally recognized organization which establishes standards for pharmacists in hospitals), under Standard III, Medication Orders, reads: "All prescribers' medication orders (except in emergency situations) must be reviewed for appropriateness by a pharmacist before the first dose is dispensed."

A report, provided by Staff 87, entitled "(Hospital A) Pyxis Overrides (HPO)" for 4/24/11-5/22/11, was reviewed on May 24, 2011 starting at 11:15 A.M., with Staffs 81, 82, 86, and 87. The report identified that 2,813 overrides occurred at Hospital A during that 1 month period. A sample of 204 overrides revealed:
1. Eight were for Bacitracin-Polymyxin a topical antibiotic ointment. The reasons given were: 4 for protocol and 3 to avoid suffering or harm. One override reason given for removing a topical ointment was for a code blue (an emergency).
2. Sixty-five were for Acetaminophen also known as Tylenol. Six had no reason indicated for its removal. Nineteen reasons indicated they were for physician directed care. The remaining 40 reasons were to avoid suffering or harm.
3. Twenty-nine were for aspirin. Two reasons indicated were for physician directed care. Three reasons indicated were to verify patient drug allergies. The remaining 24 reasons indicated were to avoid suffering or harm.

Of the 204 sampled overrides, 107 were for topical and oral medications not known for their use in emergencies. Sixty-four reasons indicated were to avoid suffering or harm, 21 reasons were physician directed care and none, except for 1 topical antibiotic, indicated the reason for its removal was for an emergency.

There was no evidence that the 106 oral and topical medications removed from the ADC, were for emergencies or were ordered by a physician who controlled the ordering, dispensing and administration of the drug, as in the operating rooms and procedural areas as required by hospital policy.

During a meeting with Staffs 87, 86 and 82 on May 24, 2011 starting at 10:00 A.M., a report, entitled ED Med Errors (EME), for April 2010 - March 2011, 12 months, was reviewed. The EME revealed that 713 medication errors were reported in the ED as a result of nurses accessing an ED ADC and using overrides. According to Staff 87, this is the same period that the high rate of overrides in the ED remained between 40% and 50% of the total number of medications accessed from the ADC's.

Medication errors identified in the EME report included:
Wrong dose; Override without a physician's order; Wrong patient; Wrong time; Wrong drug; Prescribing; Mislabeling; and Extra dose.
Of the 713 reported errors, 467 (65%) were due to no physician's order. That is, according to Staff 87, there was no evidence of a physician's order in the patient's record for the medications removed by nurses from an ADC in the ED via an override in order to administer to patients.

During the meeting with Staffs 81, 82, 86, and 87on May 24, 2011, they all agreed that the overrides identified in the HPO report and the EME report were inappropriate.

During this same meeting, Pyxis Override Graphs for Obstetrics (OB), from June 2009 through March 21, 2011, and the ED, from April 2010 through March 2011, were reviewed. New physician order sets were implemented in OB during September 2009. This resulted in a decline in overrides. In September 2010, computerized physician orders were initiated. From October 2010 through March 2011 there was an increase in the number of overrides in OB. Staffs 81, 82, 86, and 87 agreed that there was no action taken to reverse that trend.

Overrides in the ED between April 2010 and March 2011 remained between 40% and 50% of the total number of medication doses removed from an ADC. Staffs 81, 82, 86, and 87 indicated that overrides were problematic for OB, but particularly problematic in the ED because of the high rate of overrides, and the large numbers of errors which resulted from use of the ED ACD. They also indicated that nothing had been done to reduce the number or percentage of errors.

The purpose of the "prior review" by Pharmacists, per the hospital's policy, was to ensure the accuracy and appropriateness of medication orders. The override serves as a "red flag" which advises a pharmacist that the medication removed from the ADC was done so without the pharmacist's prior review. Since a pharmacist is available in the hospital 24 hours each and every day, overrides should only be used in emergencies or in procedure areas as identified by hospital policy. Evidence shown in the HPO report was contrary to hospital policy.

The Pyxis override graphs show that overrides were tracked since April 2010. Nevertheless, overrides in OB spiked upward and the high rate of overrides continued in ED. The EME report showed that use of the ED ADC, and overrides in particular, from April 2010 through March 2011 resulted in 713 medication errors. However, Staffs 81, 82, 86, and 87 confirmed that nothing was done about this situation.

In summary:
1. The HPO Report identified that overrides were not used in compliance with hospital policy.
2. The Pyxis Override Graphs identified that there was an upward spike in overrides used in OB starting in October 2010.
3. The Pyxis Override Graphs identified that a high rate of overrides were used in the ED from April 2010 to March 2011.
4. The EME report identified that from April 2010 to March 2011, 713 errors occurred in the ED with the use of the ADC. Further, that at least 467 of those errors were a direct result of the use of overrides.
5. Pharmacy staff confirmed that no action was taken to reverse these problems.

As a result of the inactions:
1. Pharmacists failed to enforce hospital policy and procedures to control the use overrides.
2. Pharmacists failed to follow professional standards of practice regarding the use of overrides by nurses.
3. Pharmacists failed to reduce the number of overrides and thus failed to reduce the resulting medication errors.
These failures resulted in the Pharmacists failure to ensure patient safety.


25051

2. On 5/24/11 at 2:35 P.M., an interview with Staff 96 indicated that the nursing staff in Labor and Delivery utilized policies and procedures (protocols) for the initiation and administration of 2 high-risk drugs: Oxytocin (causes contractions of the uterus to promote the start of labor) and Magnesium Sulfate (causes lowering of uterine contractions in the preterm patient). The Oxytocin policy was initiated in 1989 and the Magnesium Sulfate policy had been initiated in 1983. Both policies were noted to have been updated every 2 to 3 years since inception and provided direction to nurses as to how and when to initiate or adjust the dose of these drugs.

An interview with Staff 96 elicited the information that these polices had been developed and approved internally by the Labor and Delivery department. There was no indication or evidence that these 2 policies had ever been approved by the appropriate medical staff committees or by the facility's governing body.


22930


3. A review of Patient 11's medical record with Registered Nurse (RN 12) was conducted on 5/25/11 at 9:20 A.M. Patient 11 was admitted to the hospital on 5/11/11 per the facesheet. The Physician's Orders indicated that Patient 11 was receiving a continuous intravenous infusion of Diprivan (propofol- a short acting, intravenously administered hypnotic agent used for induction/maintenance of general anesthesia, sedation for mechanically ventilated adults and procedural sedation) 10 mg/ml (milligrams per milliliters), continuous rate of 2.6 - 31.5 ml/hr (milliliters per hour) for an ordered dose of 5-60 mcg/kg/min (micrograms per kilogram per minute) times 87.5 kg. In addition, Patient 11 was receiving a continuous intravenous infusion of Levophed (norepinephrine- a medication to raise the blood pressure) 8 mg in sodium chloride 0.9% 250 ml, with an ordered rate of 0.9-56.3 ml/hr.

According to the medication administration record (MAR) dated 5/24/11, Patient 11 had received a continuous intravenous infusion of propofol 10 mg/ml at a rate of 45 mcg/kg/min at 6:59 A.M. There was only the initials of one staff noted, beside the documented infusion rate on the MAR, during handoff (change of shift).

Patient 11 had received a continuous intravenous infusion of norepinephrine 8 mg in sodium chloride 0.9% 250 ml that was titrated down to 6 mcg/min at 5:52 A.M. The norepinephrine infusion rate remained at 6 mcg/min at 6:59 A.M. There was only one staff person's initials noted, beside the documented infusion rate on the MAR, during handoff.

An interview with RN 12 was conducted on 5/24/11 at 9:59 A.M. RN 12 stated that high risk medications were double checked with a second registered nurse, however, she did not know that the independent double checks that occurred during handoffs at each shift needed to be documented in the medical record. She acknowledged that there was no documented evidence that independent double checks for high risk medications were performed during handoff at change of shift, on 5/24/11 at 7:00 A.M.

A review of the hospital's policy and procedure entitled "High Risk Medications" effective date of 2/17/11, was conducted on 5/24/11. The policy indicated that independent double checks served 2 purposes:
to detect a serious error before it reaches a patient; and to bring attention to the systems that allow the introduction of human error.
The policy defined independent double checks to mean 2 nurses or if a second nurse was not available another licensed personnel authorized to administer medications may perform the double check. Per the policy, there were attachments that included instructions to licensed staff when administering high risk medications. The following high risk medications required documentation of independent double checks upon initiation and handoff: propofol (Diprivan), phenylephrine (Neo-Synephrine) and norepinephrine (Levophed).

An interview with the intensive care unit manager (ICM) was conducted on 5/24/11 at 11:12 A.M. The ICM acknowledged that the independent double checks during handoffs for high risk medications, should have been documented in Patient 11's medical record, in accordance with the hospital's policy and procedure.

4. A review of Patient 12's medical record with Registered Nurse (RN 13) was conducted on 5/24/11 at 10:56 A.M. Patient 12 was admitted to the hospital on 5/22/11, per the facesheet. The Physician's Orders indicated that Patient 12 was to receive a continuous intravenous infusion of Diprivan (propofol- a short acting, intravenously administered hypnotic agent used for induction/maintenance of general anesthesia, sedation for mechanically ventilated adults and procedural sedation) 10 mg/ml (milligrams per milliliters), continuous rate of 2.5 - 29.7 ml/hr (milliliters per hour) for an ordered dose of 5-60 mcg/kg/min (micrograms per kilogram per minute) times 82.6 kg. In addition, Patient 12 was to receive a continuous intravenous infusion of Neo-Synephrine (phenylephrine- a medication used primarily as a decongestant, an agent to dilate the pupil or used to increase blood pressure) 80 mg in sodium chloride 0.9% (percent) 250 mL infusion, ordered dose of 10-200 mcg/min and frequency of continuous at 1.9 - 37.5 ml/hr.

According to the medication administration record (MAR) dated 5/23/11, Patient 12 had received a continuous intravenous infusion of propofol 10 mg/ml at a rate of 25 mcg/kg/min at 7:00 P.M. There was only one staff person's initials noted beside the documented infusion rate on the MAR, during the handoff.
Patient 12 had also received a continuous intravenous infusion of phenylephrine 80 mg in sodium chloride 0.9% 250 ml at a rate of 10 mcg/min at 7:00 P.M. There was only one staff persons initials noted beside the documented infusion rate on the MAR during the handoff.

An interview with RN 13 was conducted on 5/24/11 at 11:00 A.M. RN 13 stated that the hospital had a list attached to the high risk medications policy and procedure that listed all the high risk medications. She stated that the policy instructed licensed staff to perform independent double checks upon initiation of the medication, handoff and rate change. She stated that the documentation required 2 initials of registered nurses or other licensed staff usually found in the MAR. She acknowledged that Patient 12's propofol infusion on 5/23/11 at 7:00 P.M. and phenylephrine infusion on 5/23/11 at 7:00 P.M. did not have evidence that the independent double checks were performed.

A review of the hospital's policy and procedure entitled "High Risk Medications" effective date of 2/17/11, was conducted on 5/24/11. The policy indicated that independent double checks served 2 purposes: to detect a serious error before it reaches a patient; and to bring attention to the systems that allow the introduction of human error.
The policy defined independent double checks to mean 2 nurses or if a second nurse was not available, another licensed personnel authorized to administer medications may perform the double check. Per the the policy, there were attachments that included instructions to licensed staff when administering high risk medications. The following high risk medications required documentation of independent double checks upon initiation and handoff: propofol (Diprivan), phenylephrine (Neo-Synephrine) and norepinephrine (Levophed).

An interview with the intensive care unit manager (ICM) was conducted on 5/24/11 at 11:12 A.M. The ICM acknowledged that the independent double checks for high risk medications should have been documented in Patient 12's medical record in accordance with the hospital's policy and procedure.

Based on observation, interview and record review, the hospital failed to ensure safe food handling practices as evidenced by: Hospital A:

1. Poultry was not cooked to a safe internal temperature
2. There was potential for cross-contamination when a food preparation area was not protected from splash from hand washing
3. Dry food items were opened, but not dated
4. Meat that was thawing in a box was not dated
5. There were expired food items available in the walk-in refrigerator, on tray line, and in a pantry near a nursing unit
6. There was no comprehensive system in place to ensure effective sanitation concentration for food surface contact areas
7. There was a lack of comprehensive disaster meal planning to meet the needs of patients, staff and visitors in the event of a disaster.

Findings:

1. On 5/23/11 at 3:10 P.M., at Hospital A, in the presence of the FSD (Food Service Director), Cook 51 stated that he cooked chicken breasts to an internal temperature of 160 degrees Fahrenheit (F). Cook 51 stated that he would report the internal temperatures of cooked food to another food service worker who was responsible for cooling down of the food. Cook 51 reviewed the log that was used by the food service worker and acknowledged that the internal temperatures of cooked food were not accurately reflected on the log.

The FSD stated that chicken breasts should be cooked to 165 degrees F. The FSD acknowledged that there was not a log that would reflect the internal temperatures to ensure food safety.

According to the Food and Nutrition Services Policy 9.11, entitled The HACCP (Hazard Analysis Critical Control Point) System, "...Identify potentially hazardous foods and monitoring control of these foods to avoid contamination..."

The Food and Nutrition Services Policy 9.12 indicated, "Have a record-keeping system with logs to monitor HACCP-related temperatures, ...Critical Control Points: Raw food is cooked to correct minimum internal temperature, ...Poultry 165 degrees F..."

2. On 5/23/11 at 11:24 A.M., at Hospital A, there was a hand washing sink in very close proximity to a container of cooked bacon that was loosely covered. The FSD acknowledged that there was a potential for cross contamination from the splash of hand washing at the hand washing sink, which did not contain a barrier, when exposed food was placed on the edge of the counter next to the sink.

According to the hospital's Food and Nutrition Services Policy 7.1, entitled Overview of Sanitation, "Protect the food against contamination - sanitation standards have been developed to reduce to a minimum the opportunity for micro-organism to gain entrance and multiply in food. Those organisms that may cause communicable illness merit primary consideration."

3. On 5/23/11 at 11:27 A.M., at Hospital A in the dry food storage room, there was a large bag of tightly wrapped granola that was opened, and not dated. There was an opened package of brown sugar, an opened 4 lb box of mashed potatoes, two packages of opened pasta and an opened bag of rice, all without a date as to when they were opened. At the time of the observation of the opened and undated products, the FSD stated that dietary staff were trained to date food items when opened.

The hospital's Food and Nutrition Services Policy 9.10, entitled HACCP Compliance indicated, "Food inventory will be rotated, and utilized within designated time. Food not used within the designated time period will be discarded."

4. On 5/23/11 at 11:50 A.M., at Hospital A in the walk-in refrigerator, there was 25 pounds of top round beef that was in a box, thawing, and not dated. The FSD acknowledged that there was no date to indicate when the meat had started thawing and stated that it "Should have a thaw date."

The hospital's Food and Nutrition Services Policy 3.10, entitled Labeling of Food Deliveries indicated, "PROCEDURE: Labels are to be placed on all products with date of preparation, date received, and/or date defrosted."

The hospital's Food and Nutrition Services Policy 4.9, entitled Storage and Defrosting of Meats, Fish and Poultry indicated, "Purpose: To allow frozen meat, fish and poultry to defrost with minimized risk of bacteria contamination..., All meat products will be placed on sheet pans to prevent blood drippings from coming in contact with other products."

5. On 5/23/11 at 11:47 A.M., at Hospital A in the walk-in thaw box was a carton of thawed egg whites with a sticker label of "5/22/11." The FSD stated that the 5/22/11 date was an expiration date and "should have been discarded."

At Hospital A observation in the walk-in thaw box noted 3 boxes of raw chicken breasts with a sticker label that indicated, "Use by 5/22/11," and the FSD stated that those boxes should have been discarded.

The Purchase Coordinator viewed the boxes of chicken dated, "Use by 5/22/11," and stated that staff were trained to date products when received to be placed in the freezer, and then to date the items when the items were taken out of freezer to the thaw box, and date the items 4 days out from that date with a "use by" date. The Purchase Coordinator further stated that dietary staff had mislabeled the boxes of chicken, and that they should have indicated a use by date of 5/24/11 instead of 5/22/11.

On 5/24/11 at 8:35 A.M., observation at Hospital A in the nourishment room of 11 East, was conducted with the FSD. In the nourishment room were noted 2 cans of nutrition supplement that indicated "Enteral Nutrition for Hepatic [liver] Patients." They were dated 3/7/2011, and were observed to be dented along the seams. At the same location, inside the reach-in refrigerator was also observed an individual sized carton of milk dated, "May 23."

The FSD stated that the date on the nutrition supplements and on the carton of milk were expiration dates, and that, the dented cans should also be discarded.

On 5/25/11 at 9:26 A.M., patient meal trays were observed being assembled in preparation to load onto the re-thermalization units for patient's lunches that day. On the lower shelf of the tray line unit were noted 6 cans of a nutrition supplement specific for the pediatric population, that were dated "March 2, 2011." The Retail Manager observed the date on the nutrition supplements and stated, "It's an expiration date."

According to the hospital's Food and Nutrition Services Policy 9.11, entitled The HACCP System, "Identify potentially hazardous foods and monitoring control of these foods to avoid contamination and control use of product..., Food Safety...Products are stored correctly,...products are thawed correctly.

The hospital's Food and Nutrition Services Policy 9.10, entitled HACCP Compliance indicated, "Food inventory will be rotated, and utilized within designated time. Food not used within the designated time period will be discarded."

The hospital's Food and Nutrition Services Policy 4.5 indicated, "All foods that have passed the expiration date should be disposed."

The hospital's Food and Nutrition Services Policy 10.1 indicated, "Cans that display visible swelling, leakage, bulges, or seam line dents are not used..."

The hospital's Food and Nutrition Services Policy 6.6 indicated, "Maintain sanitation of pantry refrigerator."

The hospital's Food and Nutrition Services Policy 5.18, entitled Floor Pantry Maintenance indicated, "Cart Man...Discard all out-date items."

6. On 5/23/11 at 2:30 P.M., at Hospital A in the kitchen, observation noted 2 buckets, a green bucket and a red bucket, near the cooks workstation. When asked about the different color buckets, Cook 52 stated that there was no difference between the green bucket or the red bucket, and that both contained a sanitizer. When asked how Cook 52 ensures the sanitizer in the bucket was at an effective concentration, he stated, "I don't know." Cook 52 stated that he filled his own bucket with sanitizer one time during his scheduled shift. Cook 52 stated he had been employed at the hospital for 32 years. When chemistry test strips were requested to check the concentration of the sanitation, the FSD and the Clinical Manager RD were unable to locate any test strips in the main kitchen. The FSD asked a dietary staff to obtain the sanitizer chemistry strips from a "coffee cart" location.

The FSD stated that the green buckets are designated for detergent, and the red buckets are designated for the sanitizing solution. The FSD acknowledged that there was not a comprehensive sanitation system in place, as staff were unsure of who was responsible to fill the buckets, test the solution, and how often to change the detergent and sanitizer.

According to the hospital's Food and Nutrition Services Policy 7.4, entitled "Cleaning and Sanitizing General Equipment and Utensils," the policy indicated: "Regular, effective cleaning and sanitizing of equipment, utensils and work or dining surfaces minimize the probability of contaminating food during preparation, storage, service and the transmission of disease organisms to consumers and employees."

The hospital's Food and Nutrition Services Policy 9.13, entitled "Environment of Care Rounds," indicated: "Sanitizing agents are present at workstations, are stored correctly in clearly labeled containers away from foods and have been tested for correct concentration."

7. On 5/23/11 at 3:22 P.M., the FSD stated that he was unsure of the number of people for which the hospital planned to provide food for on a daily basis, in the event of a disaster. The FSD acknowledged that the food supply to be used in the event of a disaster could not be inventoried and ensured to be at a par level, if the par level was undetermined.

On 5/24/11 at 12:14 P.M., the FSD stated that he was unable to verify the number of people that the hospital planned to provide food for on a daily basis in the event of a disaster at Hospital A. The FSD stated that for Hospital B, the plan was to have enough disaster food supply to feed 714 persons per day for three days.

The emergency menu that was located in the Emergency Operations Plan indicated, "For Liquid diets: Milk, juice, and broth packets prepared with water, and liquid supplements are available... For Renal (kidney) diets: Limit milk to 4 oz/day. Limit peanut butter to 1 Tbsp/day. Limit beans to ? cup/day."
The FSD acknowledged that the directions provided to hospital staff on what to provide to "liquid diets" did not discern between a full liquid and a clear liquid diet. In addition, the FSD acknowledged that the direction on the emergency menu for a renal diet was not clear to hospital staff on what beverage to provide or what liquid supplement to provide, in a time during which dialysis may be delayed.

On 5/25/11 at 2:00 P.M., at the Child and Adolescent Psychiatric Services (CAPS) site, the three day emergency menu and emergency food inventory was reviewed with the FSD and RD 53. RD 53 stated that the plan was to have enough emergency food supply on site to feed 70 people a day, for three days. RD 53 reviewed the Three Day Emergency Menu and determined that there should be 700 slices of bread at the CAPS site in order to implement the Emergency Menu as written. RD 53 stated that there were only 480 slices of bread at the CAPS site. RD 53 also acknowledged that the par level inventory sheet did not reflect the par level as planned, in the event of a disaster.

According to the hospital's Emergency Operations Plan, "The department of Food and Nutrition Services has the responsibility for: our staff, ongoing care of our patients, and the families of the patients."

Based on observation, interview and record review, the hospital failed to ensure that dietary staff served diets in accordance with the planned menu, to ensure that the nutritional needs of the patients were met.

Findings:

On 5/24/11 at 10:00 A.M., patient meal assembly was observed for the lunch tray line. According to the menu that was approved by a Registered Dietitian, a # 8 scoop size (1/2 cup) should have been used for the vegetable blend, carrots, macaroni and cheese, and rice. However, dietary staff were using a slotted spoon which would not produce a standardized portion size in accordance with the nutritionally analyzed menu that indicated to use a #8 scoop size. The production sheet for the menu specified that dietary staff use a # 8 scoop for the macaroni and cheese and rice. However, dietary staff used a # 12 scoop which provided less than a 1/2 cup portion, for the macaroni and cheese, and rice.

The Retail Manager was observing the tray line and providing oversight. The Retail Manager verified that the incorrect scoop sizes and incorrect utensils were being used and stated, "Staff need an in-service on proper portion sizes."

According to the hospital's Food and Nutrition Services Policy 6.5, "10. Use of suitable serving utensils for each meal service. In order to ensure portion control, suitable utensils will be used during meal service."

The hospital's Food and Nutrition Services Policy 4.3 entitled "Food Production" policy indicated, "Policy: To meet dietary requirements through proper food production. Purpose: To insure proper menu planning that will achieve the nutrition and cultural needs of the patients. All foods are to be properly handled, prepared and served to maintain the highest quality possible...6. Serve foods with appropriate utensils in proper quantity, temperature and attractive manner."

According to the job description entitled, "Nutrition Services, Retail Food Service Manager," the Retail Food Service Manager, "Develops portion control procedure for area, trains staff and ensures compliance."

Based on observation, document review and interview, the facility failed to maintain their fire alarm system in accordance with NFPA 72 (National Fire Protection Amendments), to ensure prompt notification of patients, staff and visitors during a fire. This was evidenced by: staff members did not have keys to activate locked fire alarm pull stations; chimes and audible devices that failed to operate; fire alarms not heard in the room housing the hyperbaric chamber; the fire alarm annunciator panel was not zoned correctly; and there were no records of sensitivity tests performed on smoke detectors. The above failures had a potential to affect 14 patients in the CAPS (Child and Adolescent Psychiatric Services) unit, staff and visitors in the CAPS unit, and patients in the Hyperbaric and Wound Care Center, which could result in delayed evacuation and potential injury from smoke inhalation and burns during a fire.

The cumulative effect of these systemic problems identified during the Life Safety Code (LSC) portion of the survey, resulted in the facility's inability to ensure the provision of a safe environment. The results of the survey are cross referenced to the CMS 2567 representing the K tags for the Life Safety Code. Refer to K51 and K54 of the LSC survey.

Based on observation, interview and record review, the hospital failed to: 1. Maintain a sufficient emergency water supply in the event of a disaster, for the Child and Adolescent Psychiatric Services (CAPS) location; and, 2. Sanitize an ice machine located at Hospital B in the kitchen, in accordance with manufacturer's guidelines.

Findings:

1. On 5/25/11 at 2:00 P.M., the FSD (food service director) and RD (registered dietician) 53 stated that, the hospital had planned to have enough water at the CAPS site in the event of a disaster, to provide water for 3 days, at a gallon of water per person per day, for a total of 70 people per day. RD 53 and the FSD quantified the water supply that was on site at the CAPS facility and determined that, the hospital only had 70 gallons of water, and needed to have 140 gallons more of water, to meet the determined needs as identified by the hospital, in the event of an outside disaster.

RD 53 verified with the staff at CAPS that there was no other source of potable water, other than the 70 gallons of bottled water. RD 53 stated, "We need to get more water here."

According to the hospital's Emergency Operations Plan, "The department of Food and Nutrition Services has the responsibility for: our staff, ongoing care of our patients, and the families of the patients."

2. On 5/24/11 at 2:20 P.M., located in the kitchen of Hospital B, the external air filter on the ice machine was observed to be covered with a furry grey substance. This observation was verified by the Food Service Manager for Hospital B. The Food Service Manager stated that the facility was responsible for maintenance of the ice machine.

On 5/25/11 at 2:25 P.M., the facility's Systems Operator stated that he was responsible for cleaning and sanitizing the ice machine in the kitchen. The Systems Operator stated that the ice machine was cleaned on a quarterly basis, and that he used a metal safe ice machine cleaner, followed by a sanitizing with a quaternary ammonium chloride sanitizer.

According to the manufacturer's guidelines for the ice machine in the kitchen of Hospital B, "SANITIZING PROCEDURE - Following Cleaning Procedure; 1. Dilute IMS-II Sanitizer or a 5.25% Sodium Hypochlorite solution with water (Add 2.5 oz. of sanitizer to 5 gal. of water)." The manufacturer's guidelines were posted on the inside panel of the ice making apparatus. The standard of practice in the food service industry is to follow the manufacturer's guidelines.

According to the hospital's Food and Nutrition Services Policy 10.1, entitled "Infection Control Manual," indicated the following: "Ice Maker Cleaning and Sanitizing performed every six (6) months according to manufacturer's instructions. In the event there are no cleaning instructions, follow this list..."

Based on observation, interview and record review, Hospital A failed to implement their policy and procedure related to, "Dust Control and Containment During Construction, Renovation, Remodel, Maintenance and Water Remediation," for 2 patient rooms. Carpet was installed in medical-surgical licensed inpatient rooms, without documented evidence of approval from the hospital's Facilities Engineering Department, in accordance with the hospital policy.

Findings:

On 5/31/11 beginning at 1:10 P.M., a tour of the hospital's clinical research (9 East) was conducted with the Director of Medical-Surgical Services (DMS).

An interview and joint observation of room 915 was conducted with the clinical research nurse manager (NM 11). NM 11 stated rooms 915 and 916 were identical. Blackout curtains and carpet were observed installed in rooms 916 and 916. NM 11 stated that the rooms were single occupancy, had blackout curtains and were carpeted for the sleep or nap study that were conducted in those rooms.

A review of the hospital's Client Accommodations Analysis (CAA) was conducted on 5/31/11. The CAA indicated that room 915 and 916 were licensed as medical-surgical inpatient beds, single occupancy.

An interview with a lead custodian (LC 11) was conducted on 6/1/11 at 11:50 A.M. LC 11 stated that the carpets in room 915 and 916 had been there since he started working day shifts which was 15 years ago. He stated that the carpets in both rooms were replaced 2 years ago. He explained that he had been responsible for cleaning the carpets.

A review of the hospital's policy entitled "Dust Control and Containment During Construction, Renovation, Remodel, Maintenance and Water Remediation," effective date of 12/20/10, was conducted on 6/1/11. The policy's abstract indicated that the identification of potential problems associated with new construction, renovation and maintenance in hospitals can greatly alleviate the chances of infection or other dangers being transmitted to patients or staff.

An interview with the Director of Regulatory Affairs (DRA) was conducted on 6/1/11 at 12:00 P.M. The DRA stated that there was no documented evidence of when the carpets were installed or any approvals that may have been obtained during the planning or installation process. The DRA stated that the Senior Management Lead of Facilities, informed him that the carpet installation would not have been approved by the Facilities Department. He further stated that, the proper channels may not have been followed in accordance with the facility's policies and procedures, when the carpets were installed in rooms 915 and 916.

Based on observations, interviews and document reviews, Hospital B failed to ensure that, 2 of 5 warming cabinets containing patient care items, such as blankets and gowns, did not exceed a temperature of 110 degrees Fahrenheit, in an effort to ensure patient comfort and safety. In addition, Hospital B failed to store 2% Chlorhexidine Gluconate Cloths (CHG is a common skin antiseptic used to reduce infections), in warmers in accordance with the manufacturer's guidelines, for 1 of 5 warming cabinets observed.

Findings:

1. On 5/25/11 at 9:35 A.M., a general tour of the hospital's cardiac catherization laboratory with the Nursing Director of Professional Services, (NDP) was conducted. The temperature of the blanket warmer read 142 degrees Fahrenheit. The blanket warmer contained patient blankets. There was no evidence of a log for the warming cabinet temperature readings, or that the warming cabinet temperatures were recorded.

An interview with the NDP was conducted on 5/25/11 at 9:40 A.M. The NDP stated that the hospital's practice was to set the blanket warmers to 110 degrees Fahrenheit. She stated that logs were not kept for the warming cabinet temperatures per the hospital's practice.

2. On 5/25/11 at 1:10 P.M., a general tour of the hospital's interventional radiology (IR) department with the Nursing Director of Professional Services (NDP) was conducted. A blanket warmer containing patient gowns and blankets was observed.

A review of the IR's warming cabinet temperature log dated 5/2011, was conducted on 5/25/11. The log listed the following dates, temperatures and notes: on 5/16/11, the temperature read 118 degrees Fahrenheit; on 5/17/11, the temperature read 118 degrees Fahrenheit; on 5/18/11, the temperature read 121 degrees Fahrenheit and a handwritten note read "adjusted," on 5/19/11, the temperature read 115 degrees Fahrenheit; and on 5/20/11, the temperature read 114 degrees Fahrenheit.

An interview with the licensed vocational nurse (LVN 11) was conducted on 5/25/11 at 1:20 P.M. The LVN stated that the acceptable temperature parameters for the warming cabinets were from 110 degrees to 120 degrees Fahrenheit. She stated that if the temperature reading was above 120 degrees, the temperature knob was adjusted. She stated that she was not aware that the warming cabinets that contained patient gowns and blankets was not to exceed a temperature of 110 degrees Fahrenheit.

An interview with the NDP was conducted on 5/25/11 at 1:25 P.M. The NDP stated that the hospital's practice was to ensure that the warming cabinets that contained patient gowns and blankets did not exceed 110 degrees Fahrenheit.

3. On 5/25/11 at 10:30 A.M., a general tour of the post anesthesia care unit (PACU) with the Director of Nursing (DON) was conducted. Nine packages of 2% CHG Cloths were found stored in a warming cabinet that also contained patient gowns and blankets. The temperature of the warming cabinet read 110 degrees Fahrenheit.

An interview with the DON was conducted on 5/25/11 at 10:40 A.M. The DON stated that the 2% CHG Cloths should not have been stored in the warming cabinet with patient gowns and blankets. She stated the cloths should be stored in a warmer that was designed to hold the cloths, which was in accordance with the manufacturer's guidelines.

A review of a letter from the manufacturers of the 2% CHG Cloths was conducted on 5/25/11. The letter indicated that, "Product testing has been completed on the (brand) 2% CHG Cloths to show stability up to 84 hours when warmed in a Comfort Warmer at 125 degrees Fahrenheit plus or minus 5 degrees...." In addition, the letter instructed that after 84 hours, the CHG cloths should be discarded.

An interview and joint observation with the intensive care unit manager (ICM) was conducted on 5/25/11 at 10:45 A.M. The ICM stated that the 2% CHG cloths were used on patients in the intensive care unit to reduce their chances of developing an infection. He stated that studies have shown that using these wash cloths have reduced nosocomial (facility acquired) infections. However, he acknowledged that based on the manufacturers letter, if the 2% CHG cloths are not stored or discarded properly they may not serve their purpose in reducing infections.

Based on observation, interview and document review, the facility failed to provide a sanitary environment to avoid sources and transmission of infections and communicable diseases, at both hospital campuses.

Findings:

1. Single use suction canisters were being used for multiple patients in the Gastrointestinal (relating to the stomach or intestine) (GI) Endoscopy (visual examination of a hollow organ) unit of both hospital campuses.
A Tag 749 (#1)

2. Two staff members at Hospital A were unable to verbalize the disinfectant that was effective in destroying Clostridium Difficile (a bacteria that causes diarrhea and other intestinal diseases (C.Diff).
A Tag 749 (#3) (#4)

3. One staff member at Hospital A and one staff member at Hospital B were unable to verbalize the contact time required by the manufacturer, for the effectiveness of the disinfectant the staff used on patient gurneys and treatment tables.
A Tag 749 (#2) (#5)

4. A Medical Surgical Unit at Hospital A did not complete an Infection Control Risk Assessment, prior to the installation of carpets in two patient rooms, in accordance with hospital policy and procedure.
A Tag 749 (#6)

The cumulative effect of these systemic practices and issues, resulted in the failure of the hospital to deliver statutorily mandated compliance with the Condition of Infection Control.

Based on observation, interview and document review, the facility failed to ensure that single use suction canisters were not used for multiple patients, in the Gastrointestinal (GI: relating to the stomach or intestine) Endoscopy (visual examination of a hollow organ) Unit, of both hospital campuses. There were inconsistent practices throughout the facility at both campuses, pertaining to the re-use of single use suction canisters.
In addition, 2 staff members at Hospital A, were unable to verbalize the disinfectant that was effective in destroying Clostridium Difficile (C. Diff : a bacteria that causes diarrhea and other intestinal diseases).
And, 1 staff member at Hospital A, and 1 staff member at Hospital B, were unable to verbalize the contact time required by the manufacturer, to ensure the effectiveness of the disinfectant, staff used on patient gurneys and treatment tables. Additionally, Hospital A failed to ensure that an Infection Control Risk Assessment (ICRA- a tool to identify areas requiring special precautions prior to the start of any construction, alterations, remodeling or physical repairs), was completed prior to the installation of carpets in 2 inpatient rooms (915,916), in accordance with the hospital's policy and procedure.

Findings:

1. A general observation tour of the GI Endoscopy Unit at Hospital A was conducted with the Director of Regulatory Affairs for Ambulatory Care, on 5/25/11, at 10:20 A.M. During the observation tour, a suction canister was observed in an endoscopic procedure room. The suction canister was covered with an 8 1/2" by 11" blue piece of paper that was taped onto the suction canister. A GI endoscopy RN removed the paper cover from the suction canister which revealed a clear plastic 2000 ml (milliliter) suction canister with a blue plastic top. A circle with the number 2 in the middle and a slash through the circle, was noted on the suction canister along with the statement, "For Single Use Only." The suction canister was three quarters full of brown watery fluid.

An interview was conducted with a GI endoscopy RN on 5/25/11, at 10:35 A.M. The GI endoscopy RN stated that the suction canister contained GI secretions from 3 previous patients. The GI endoscopy RN further stated that the suction canisters were re-used until the canisters were full and then they were replaced.

A telephone interview was conducted with the Territory Sales Consultant (TSC) of the manufacturer of the suction canisters, on 5/26/11 at 11:20 A.M. The TSC stated that, "blue top hard clear suction canisters are only to be used once."

Additonally, the TSC emailed the evaluator an email he received from the Perioperative Education Specialist, for the Association of PeriOperative Registered Nurses (AORN) which read: "The contents of the suction canister are considered a biohazard (hazardous biological materials that present a risk or potential risk to the health of humans, animals or the environment.)"

On 5/27/11 at 5:05 P.M., a review of the suction canisters manufacturer's recommendations for use was conducted. It was noted in the manufacturer's recommendation document that, "Canisters are disposable and should not be re-used." It was further noted in the document that a symbol of a circle with the number 2 in the middle and a slash through the circle, indicated "For Single Use Only."

A general observation tour of the GI Endoscopy Unit at Hospital B was conducted on 5/31/11 at 8:35 A.M. An interview was conducted with a GI Endoscopy Technician who stated that the suction canisters were not changed between GI procedures. The suction canisters were only changed when they were full or at the end of the day.

A supply of suction canisters were observed stored on a shelf in a supply room. The suction canisters were clear plastic with a blue plastic top. On the side of the clear plastic suction canister was a circle with the number 2 in the middle and a slash through the circle. Next to this symbol was written "For Single Use Only."

On 5/31/11 at 9:55 A.M. an empty clear plastic suction canister was observed in the GI Endoscopy Unit of Hospital A. On the side of the clear plastic suction canister was a circle with the number 2 in the middle and a slash through the circle. Next to this symbol was written "For Single Use Only."

An interview was conducted with the Director of Regulatory Affairs (DRA) on 5/31/11, at 11:05 A.M. The DRA stated that it was the policy of the hospital to follow manufacturer's recommendations when using patient supplies and equipment.

On 5/31/11 at 11:45 A.M., an interview was conducted with the Infection Control Administrative Director (ICAD). The ICAD stated that she had been in her position for six years. The ICAD further stated that the practice of re-using the suction canisters in the GI Endoscopy Units had been in place prior to her starting in her position. The ICAD was unable to produce anything in writing from any nationally recognized organization, such as, permission from the Food and Drug Administration, that would support the re-use of disposable suction canisters that were specifically labeled for single use only.

On 5/31/11, the following patient care areas were visited: Telemetry, Surgical Intensive Care Unit, and the Operating Room. In all three patient care areas when suction was used for a patient the suction canister was discarded between patient use. Suction canisters were never re-used for another patient in these three areas.

A review of the number of GI endoscopy procedures performed in the past ten months at both hospital campuses, was conducted on 6/1/11, at 7:20 A.M. An average of 319 GI endoscopy procedures were performed per month at Hospital A; and an average of 352 GI endoscopy procedures were performed per month at Hospital B.

The Post Anesthesia Care Unit was visited on 6/1/11 at 10:55 A.M. and an interview was conducted with a Post Anesthesia Care Unit RN (PACU RN.) The PACU RN stated that, suction canisters are always replaced after patient use "because they are considered dirty."

The above practices demonstrated the inconsistencies in practice and the inconsistent management and oversight of Infection Control at both hospital campuses.

2. A general observation tour of the Post Anesthesia Care Unit (PACU) was conducted on 5/25/11 at 9:50 A.M. During the tour an interview was conducted with a PACU Nursing Aide. The Nursing Aide stated that between patient use she sprayed an Asept-HB Virucidal Disinfectant on the mattress of the gurney. The Nursing Aide further explained that she left the disinfectant on the mattress of the gurney for one minute.

A review of the label on the spray bottle of disinfectant revealed that, the manufacturer's recommendation for the contact time for ensuring effectiveness of the disinfectant, was 10 minutes. The Nursing Aide acknowledged that she was not aware that she had to allow the disinfectant to stay in contact with the surface of the gurney mattress for 10 minutes for the disinfectant to be effective.



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3. A tour of the 6 west unit was conducted on 5/27/11 at 9:25 A.M. An interview with registered nurse (RN) 22 was conducted on 5/27/11 at 9:40 A.M. When asked what she would use to disinfect movable equipment that was used on a patient with C.diff (Clostridium difficile - a bacteria that causes severe diarrhea), RN 22 stated that she would use "Sani-wipes." However, the unit's assistant manager was present during the interview and stated that the disinfectant to be used against C.diff was not the "Sani-wipes," but the disinfectant "Dispatch," due to its bleach content.

The manufacturer's label for Sani-wipes (Sani-Cloth Plus Germicidal Disposable Wipes) did not indicate that the product was effective in destroying C.diff vegetative cells (vegetative cells of C.diff are easily killed by heat, drying and many disinfectants due to their inability to tolerate oxygen; they can live for only a few hours on surfaces) and spores (a spore form of C.diff represents a dormant, highly protected stated and is extremely resistant to heat, drying and numerous chemical agents, including a variety of disinfectants; germicidal bleach is the first product to obtain federal EPA (Environmental Protective Agency) and state registration for killing C.diff spores on hard, nonporous surfaces when used as directed).

According to the Center for Disease Control (CDC), a 1:10 dilution of 5.25% sodium hydrochlorite (household bleach) and water freshly mixed daily should be used to clean the rooms of those patients with symptomatic C.difficile (e.g. diarrhea) infection.


22930

4. On 5/27/11 at 2:08 P.M., a tour of the progressive care unit (PCU- 7 th Floor) with the Director of Medical-Surgical Services (DMS) was conducted.

An interview with a clinical care partner (CCP 11) was conducted on 5/27/11 at 2:15 P.M. CCP 11 was asked, what disinfectant would he use to destroy Clostridium difficile spores (a bacteria that causes diarrhea and other intestinal disease when competing bacteria are wiped out by antibiotics, also known as C-diff), he stated that he would use the Sani-Cloths to disinfect equipment or surfaces that had come in contact with C-diff spores. He was not able to verbalize the hospital's disinfectant to destroy C-diff.

The manufacturer's label for Sani-Cloth Plus Germicidal Disposable Wipes did not indicate that the product was effective in destroying Clostridium difficile vegetative cells (vegetative cells of C-diff are easily killed by heat, drying and many disinfectants due to their inability to tolerate oxygen; they can live for only a few hours on surfaces) and spores (a spore form of C-diff represents a dormant, highly protected stated and is extremely resistant to heat, drying and numerous chemical agents, including a variety of disinfectants; germicidal bleach is the first product to obtain federal EPA (Environmental Protective Agency) and state registration for killing C-diff spores on hard, nonporous surfaces when used as directed).

According to the Center for Disease Control (CDC), a 1:10 dilution of 5.25% sodium hydrochlorite (household bleach) and water freshly mixed daily should be used to clean the rooms of those patients with symptomatic Clostridium-difficile (e.g. diarrhea) infection.

An interview with the charge registered nurse (RN 11) was conducted on 5/27/11 at 2:20 P.M. RN 11 stated that the hospital's disinfectants used to destroy Clostridium difficile spores were disinfectants that had bleach like the product Dispatch. She acknowledged that the Sani-Cloth Germicidal Wipes was not the correct disinfectant to use against Clostridium difficile.

5. On 5/25/11 at 1:30 P.M., a tour of the physical therapy, occupational therapy and speech therapy departments with the Nursing Director of Professional Services (NDP) was conducted.

On 5/25/11 at 1:45 P.M., during general observations, physical therapist (PT 11) sprayed disinfectant on a treatment table after a patient had left. PT11 left the disinfectant on the table for about a minute and proceeded to wipe the surface down with a towel.

An interview and joint manufacturer's guideline review with PT 11 was conducted on 5/25/11 at 1:50 P.M. PT 11 stated that staff were responsible to clean the treatment tables inbetween patients. She stated that she used ASEPT-HB Virucidal Disinfectant Spray, sprayed the surface of the treatment table, lightly wiped down the area to spread the disinfectant, allowed the disinfectant to sit for a few seconds, "maybe a minute or two" and then proceed to dry the area. She stated that she was not aware of the manufacturer's instructions located on the bottle of the disinfectant, which read that a contact time of 10 minutes was required for the disinfectant to be effective.

An interview with the manager of physical and occupational therapy (MPT) was conducted on 5/25/11 at 2:00 P.M. She stated that the physical therapy staff used two types of disinfectant to clean treatment tables and equipment used in the department. She stated that a disinfectant spray called ASEPT-HB with a contact time of 10 minutes and the other was the SaniCloths with a contact time of 5 minutes. She stated that the staff will use the appropriate contact times to ensure the effectiveness of the disinfectants in accordance with the manufacturer's guidelines.

6. On 5/31/11 beginning at 1:10 P.M., a tour of the hospital's clinical research (9 East) was conducted with the Director of Medical-Surgical Services (DMS).

An interview and joint observation of room 915 was conducted with the clinical research nurse manager (NM 11). NM 11 stated rooms 915 and 916 were identical. He stated that the rooms were single occupancy, had blackout curtains and were carpeted for the sleep or nap study that was conducted in those rooms. The blackout curtains and carpet were observed and present in rooms 915 and 916.

A review of the hospital's Client Accommodations Analysis (CAA) was conducted on 5/31/11. The CAA indicated that rooms 915 and 916 were licensed as medical-surgical inpatient beds, single occupancy.

An interview with the Infection Control Administrative Director (ICAD) was conducted on 6/1/11 at 8:36 A.M. The ICAD stated that she was not aware that carpets were installed in patient rooms 915 and 916. She stated that all hospital projects like carpet or flooring installations required the completion of an Infection Control Risk Assessment (ICRA) prior to installation. She stated that Infection Prevention and Clinical Epidemiology (IPCE) would not have approved the installation of carpet in patient rooms because of an infection control issue. She further explained that it was difficult to clean blood and body fluids from soiled carpets especially from an infection control perspective.

An interview with the Licensing Consultant was conducted on 6/1/11 at 1:00 P.M. The Licensing Consultant acknowledged that the IPCE would not have approved the installation of carpet for patient rooms, 915 and 916. She stated that there was no evidence that an Infection Control Risk Assessment was completed or obtained prior to the installations of the carpet, in accordance with the hospital's policy.

A review of the hospital's policy entitled, "Dust Control and Containment During Construction, Renovation, Remodel, Maintenance and Water Remediation," with an effective date of 12/20/10, was conducted on 6/1/11. The policy's abstract indicated that the identification of potential problems associated with new construction, renovation and maintenance in hospitals can greatly alleviate the chances of infection or other dangers being transmitted to patients or staff. The policy further explained under procedures and responsibilities, the hospital representatives needed to ensure that the information on the Infection Control Risk Assessment (ICRA) was complete and accurate. In addition, the policy stipulated that an ICRA was approved and posted prior to the commencing of work. Per the policy under Infection Prevention and Clinical Epidemiology (IPCE), IPCE practitioners will be members of the project planning group and they will conduct periodic rounds on all Class 3 and 4 projects to ensure compliance with infection control standards. All approved ICRAs for a period of 3 years from approval date will be kept and maintain copies of all daily checks.