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Based on interview and document review, the facility did not have an effective governing body that carried out the functions required of a governing body by the following:

The Governing Body failed to ensure the Medical Staff operated under the Bylaws approved by the governing body and was responsible for the quality of care provided to patients. (A338, A385, A490, A618)

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

Based on document review and interview, the facility failed to ensure the contracted service that provided post pharmacy prospective review of medication orders, qualitatively evaluated their provision of pharmaceutical care..

Findings:

A Document titled, "Pharmacy PI Dashboard - Turn-Around Time for Medication Orders Processing," October 2010, page 1 of 1 reviewed in the pharmacy department on May 9, 2011, revealed the focus of the internal review was processing time. The review audited and measured medication order processing times such as, average time (min) from order written to scanned, reviewed, % of scans that met criteria. The review did not audit the quality of pharmacist review of orders by the vendor.

During the interview, at 11:12 a.m., the DOP was asked for a copy of the contract to determine the extent of services provided. The contract was not available, and was later obtained from administration.

A review of the contract presented on May 9, 2011, for review titled, "Amendment to Agreement between Valley Health System and Vendor", signed September 15, 2008, revealed in section 2.01- 2.02, Part II, Description of Services the vendor would not evaluate the quality of post-pharmaceutical services provided to the facility.

The daily pharmacy hours are 7 a.m. to 10:30 p.m. The vendor would process orders during the non-pharmacy hours i.e. 10:30 PM - 7 AM. The vendor prospectively reviewed new medication orders scanned, evaluated for appropriateness of dosing, allergies, therapeutic duplication, potential drug interactions, contraindications, entered the orders into the facility order entry system, which would release the medication for use by nursing. The exception would be in an emergent situation.

Pharmacist review of medication orders prior to administration is a key step in medication safety. The process should only be bypassed (overridden) when the clinical status of the patient would be significantly compromised by any delay that would result from the review process, or when an independent practitioner directly controlled the medication-use process. The override referred to the pharmacist review process, not the source of the medication. When the override process occurred, the caregiver was accountable to confirm the appropriateness of the drug, dose, route and frequency, as well as screen for allergies, potential drug interactions ..... and other contraindications for the drug being administered.

Based on interview, record review and observation, the facility failed to ensure patients were provided with written notice to disclose the facility was a physician-owned hospital, in a manner that was easily understood by all patients, at the time of the earliest contact from the hospital to the patient. This failed practiced resulted in the patient not receiving all the information necessary and compromised their opportunity to make an informed consent about their treatment at the physician-owned hospital.

Findings:

On May 10, 2011, at 9:30 a.m., record review and concurrent interview was conducted with the Clinical Nurse Manager. There was no record in the clinical records that written notice had been given to the patients to let them know the facility was a physician-owned hospital. The Clinical Nurse Manager reviewed the records and was not able to find the notification. The Clinical Nurse Manager stated she was not aware of the hospital's procedure for notifying the patients the facility was a physician-owned hospital.

During an interview with the CNO on On May 11, 2011, at 2 p.m., the CNO stated she did not know how or if they notified the patients about the facility being a physician-owned hospital.

During an interview with the Director of QA, on May 12, 2011, at 11 a.m., the Director of QA stated the facility had posted on the web the hospital was owned by physicians, but they were not providing their patients with written notification the facility was a physician-owned hospital. The Director of QA stated they were not aware they had to provide all patients with written notification about being a physician-owned hospital.

The facility failed to ensure patients were provided with written notice to disclose the facility was a physician-owned hospital, in a manner that was easily understood by all patients, at the time of the earliest contact from the hospital to the patient. This failed practice resulted in the patient not receiving all the information necessary and compromised their opportunity to make an informed consent about their treatment at the physician-owned hospital.

Based on observation, interview, and record review, the facility failed to maintain an effective, hospital-wide, quality assessment and performance improvement program. This was evident by the facility failing to do the following:

1. To ensure the Governing Body was responsible for the quality of care provided to patients (A338, A385, A490, A618);

2. To ensure the contracted service that provided post pharmacy review of medication orders, evaluated the provision of pharmaceutical care (A084);

3. To measure, analyze and track quality indicators and performance aspects that assess food safety to prevent cross contamination, food borne illness and maintain food quality (A267);

4. The Medical Staff failed to enforce bylaws when Physician A brought in adulterated drugs from an outside unknown source to use on patients (A338);

5. The Medical Staff failed to enforce bylaws to carry out responsibilities when Physician A brought in adulterated drugs from an outside unknown source to use on patients (A353);

6. To ensure the facility Infant Security Plan was implemented per the facility policy and procedure (A396);

7. To ensure appropriate levels of nursing care were provided (A385);

8. Pharmaceutical services were not provided according to accepted professional principles (A500);

9. The lack of an alert system in the ADC and pre-printed forms with a medication that did not contain warnings of high alert medications (A500);

10. Failure to have a contractual system to review medication orders for patient safety by providing reports for services (A0491);

11. Failure to have a controlled substance accountability system to readily identify loss or diversion in a timely manner (A0494);

12. Failure to ensure the Patient Own Medication policies and procedures be followed to prevent omission of medications (A0500);

13. The facility's intravenous preparation area did not comply with the United States Pharmacopeia (A501);

14. The daily management of dietary services provided patients with safe and high quality food (A620, A749);

15. To coordinate with Infection Control Practitioner to ensure had an effective system to identify, report, investigate and control unsanitary practices (A749);

16. To ensure a therapeutic diet and supplement was consistent with the physician's order (A629);

Based on observation, record reviews and staff interviews, the hospital failed to accurately measure, analyze and track quality indicators and aspects of performance that assess the processes involved with food safety to effectively prevent cross contamination, food borne illness and ensure food quality. This resulted in the potential for the deficient practices identified during the survey to continue in a hospital with a licensed bed capacity of 417.

Findings:

During a validation survey conducted May 8, through May 12, 2011, the following deficient practices were noted as they related to food safety, food quality (cross refer A 0620). The following was observed:

* Multiple opened food items were not dated with an open or use by/expiration date and some items in both dry and refrigerated storage were opened and not sealed. Liquid frozen egg products stored in the refrigerator were not dated with a use by date.

* Dishwashing staff were not using proper hand hygiene when switching between dirty and clean dishes. Clean and dirty dishes and utensils were not separated to prevent cross-contamination.

* Food service staff were unable to demonstrate how to properly determine the concentration of a sanitizer used to sanitize food contact surfaces

* Table mounted can openers had dried food residue on the blades. A ladder rack used to store food in the dairy refrigerator was noted to have a buildup of black crusty residue. There was dust accumulation on the fire suppression system over the stove.

* Expired products were stored in refrigerator and the dry storage.

* The First-In, First-Out method of food storage was not being used.

The hospital's Food and Nutrition Services Performance Improvement Plan for January 1 to December 31, 2011, dated March 28, 2011, was reviewed. The plan indicated the quality indicators that were being monitored were:

a. Nutrition trigger during the (nursing) initial (nutrition) screen were communicated to the dietician:
b. Patients identified as high or moderate nutrition risk per policies were evaluated and received a written (nutrition) assessment in the stated timeframes; and,
c. Entrees on trayline were held at 140 degrees F or higher.

During an interview with CNM on May 8, 2011, at 2:00 p.m., she stated these were the performance improvement projects FANS reported to the QMC for 2011. There was no documented monitoring of the deficient practices found during the survey.

During the exit conference on May 12, 2011, at 4:00 p.m., the CEO stated the FANS reported additional data to the QMC and information would be provided after the exit of the survey team.

A faxed report titled, "Hemet Valley Medical Center, Dashboard Report, Food and Nutrition Services," faxed May 16, 2011, was reviewed. The report indicated that FANS monitored a Food Safety (HACCP - Hazard Analysis Critical Control Points - Compliance) indicator derived from monthly Food Safety Audits. The target threshold for the indicator was listed as 95%. Actual performance for July 2010 - April 2011 ranged from 94 - 97%. All but one month during the reporting period met the threshold. No further evaluation of this score was provided. The Dashboard report provided was inconsistent with the deficient practices observed during the survey.

Based on interview and record review, the facility failed to ensure the Medical Staff operated under the Bylaws approved by the governing body, and was responsible for the quality of care provided to patients as evidenced by the following:

? The Medical Staff failed to enforce bylaws to carry out its responsibilities when Physician A brought in adulterated drugs from an outside unknown source to use on patients by his own admission. The Medical Staff having knowledge of Physician A's conduct did not act immediately to limit or restrict Physician A's clinical privileges as specified in the Medical Staff Bylaws to protect the life or well being of patients. (A 353)

On May 11, 2011, at 1 p.m., the CEO and CNO were notified an Immediate Jeopardy situation was identified, related to the facility's failure to protect the patient surgical population when it became known a physician brought adulterated drugs from an unknown source into the facility. There was a potential for use on surgical patients. On May 11, 2011, at 4:30 p.m., the CEO and CNO were informed the Immediate Jeopardy to resident safety was abated, after the plan of correction was submitted, accepted, implemented and verified.

The failure by the Medical Staff to take immediate action resulted in a failure to protect the life or well-being of patient(s) and to reduce a substantial and imminent likelihood of significant impairment of the life, health or safety of any patient or prospective patient. The cumulative effect of these systemic problems resulted in the facility's failure to deliver care in compliance with the Condition of Participation for Medical Staff, and failure to provide care to their patients in a safe environment.

Based on interview and document review, the Medical Staff failed to enforce bylaws to carry out its responsibilities when Physician A brought in adulterated drugs from an outside unknown source to use on patients by his own admission. An Immediate Jeopardy situation was identified as the Medical Staff had knowledge of Physician A's conduct, did not act immediately to limit or restrict Physician A's clinical privileges, as specified in the Medical Staff Bylaws. These bylaws protected the life or well being of patients and reduced a substantial and imminent likelihood of impairment of the life, health and safety of patients.

Findings:

During an interview with the CNO on May 9, 2011, at 1:35 p.m., she stated the cleaning person who cleaned the Anesthesiologist's sleep room on April 20, 2011, observed some drugs in an open drawer. She reported this to her supervisor, and during the hospital investigation, discovered 58 drugs in the anesthesia sleep room on April 20, 2011. The drugs included the following:

a. Fentanyl, assists with anesthetic effect;
b. Meperidine, pain relief;
c. Morphine, pain relief;
d. Ketamine, assists with anesthetic effect;
e. Dexamethasone, steroid;
f. Doxapram, respiratory stimulant;
g. Glyopyrrolate, assists with anesthetic effect;
h. Labetalol, used in emergency for high blood pressure;
i. Mivacron, neuromuscular block;
j. Naloxone, used for overdose of opioids;
k. Propofol, sedation;
l. Rocuronium, neuromuscular block;
m. Succinyl, neuromuscular block; and,
n. Ephedrine, low blood pressure, bronchospasm.

Some of the drugs included controlled substances, such as narcotics. The CNO also stated some of the drugs had been opened. The CNO stated the hospital discovered these drugs were not from the hospital's supply by checking the lot numbers and comparing to the hospital's drug supply. She stated more drugs were found in the anesthesia sleep room refrigerator during the week of May 2, 2011.

An interview was conducted on May 5, 2011, at 10:10 a.m., with the Chair of Anesthesia and COS. The COS stated the hospital started an investigation and had contacted legal counsel for guidance on how to proceed, because they had not experienced a staff member bringing in drugs to the hospital. He stated on May 5, 2011, after interviewing the staff anesthesiologists, Physician A admitted he brought the drugs into the hospital so he could have them on hand in case of an emergency surgical case. The COS stated all of the remaining anesthesiologists stated they obtained their medications from the Pyxis machine, including medications for emergent cases. The COS then stated a meeting was held on May 5, 2011, and it was decided to ask Physician A to voluntarily remove himself from the surgery schedule. This did not happen until May 11, 2011, (six days later). He stated Physician A was not suspended, only voluntarily removed from the schedule. When asked what the hospital would do if Physician A decided he wanted to participate in surgery, since the removal from the schedule was purely voluntary, the COS could not provide an answer that would clearly prohibit physician A from participating in surgical cases.

On May 10, 2011, the surgery schedule was reviewed. Physician A participated in an esophagastric surgery, a dilatation and curettage (scraping of the uterus), and a cholecystectomy (removal of gall bladder).

A review of the Pyxis records indicated Physician A was scheduled for surgery cases on May 9, 2011. Pysician A actively participated in surgical procedures, as evidenced by the removal of drugs from the Pyxis med station and surgery schedule on May 9, 2011.

A review of the Medical Staff Bylaws was conducted on May 10, 2011, Under section 6.2 Summary Restriction or Suspension, the Bylaws specified, "Whenever a member's conduct appears to require that immediate action be taken to protect the life or well-being of patient(s) or to reduce a substantial and imminent likelihood of significant impairment of the life, health or safety of any patient, prospective patient or other person, the chief of staff, the Medical Executive Committee, or the head of the department in which the member holds privileges may summarily restrict or suspend the medical staff membership or clinical privileges of such member."

On May 11, 2011, at 1 p.m., the CEO and CNO were notified an Immediate Jeopardy situation was identified, related to the facility's failure to protect the patient surgical population when it became known a physician brought adulterated drugs from an unknown source into the facility. There was a potential for use on surgical patients.

On May 11, 2011, at 4:30 p.m., the CEO and CNO were informed the Immediate Jeopardy to resident safety was abated, after an immediate plan of action was submitted, accepted, implemented and verified.

Based on interview and record review, the facility failed to ensure appropriate levels of nursing care were provided when a LVN was assigned to care for a critical patient on vasoactive IV medications (to support the blood pressure). This failed practice may have resulted in the death of Patient 101 (A397).

The cumulative effect of this failed practice resulted in the failure to provide safe and effective nursing care.

Based on interview and record review, the hospital failed to supervise and evaluate the nursing care for one of six medical records reviewed (Patient 703). For Patient 703 the hospital nursing staff failed to evaluate, in a timely manner, a lack of bowel movements for eight days. This failure had the potential to result in a decline in the medical status of the patient, due to patient care needs not being met.

Findings:

The medical record for Patient 703 was reviewed on May 12, 2011. The patient was admitted to the hospital on May 8, 2011, with diagnoses that included abdominal pain with a complaint of no bowel movements for four days.

A review of the nursing flowsheets revealed no documented evidence the patient had a BM from admission on May 8, 2011 to the date of the record review, on May 12, 2011. Further review revealed no documented evidence the physician was notified the patient had not had a bowel movement during this four day period.

During a concurrent interview with RN Y, she confirmed the patient did not have a BM since admission, and the record indicated the patient had complained of not having had a BM for four days before coming to the hospital. RN Y stated the physician had not been informed of the lack of BMs.

During a concurrent interview with Nurse Manager X, she stated it was a nursing "standard" to notify the physician when a patient had not had a bowel movement in three days. She further stated there was no documentation the physician was notified that Patient 703 had not had a bowel movement. She stated, "The physician should have been informed of the lack of BMs before today."

Based on observation, interview, and record review, the facility failed to ensure their Infant Security Plan was implemented per the hospital's policy and procedure. This failed practice placed the newborn at risk for abduction.

Findings:

A tour of the Nursery was conducted on May 9, 2011, starting at 10 a.m. The census was seven. A monitor was observed in the nurse work area. The monitor was blank.

An interview was conducted with the RN on duty, on May 9, 2011, at 10:15 a.m. The RN stated the monitor was for the TOTGuard security system. The RN further stated the monitor was turned off, because they ran out of the TOTGuard tags. The RN stated staff forgot to place the order for the TOTGuard equipment. The RN stated they had called the company last week and,"Were supposed to have received a shipment last Friday." The RN stated they had been out of the TOTGuard tags for about two weeks.

The hospital's policy and procedure titled, "Infant Security Plan," was reviewed on May 10, 2011. The policy had last been reviewed and approved on October 2010. The policy indicated the hospital was using the TOTGuard patient security devices. "The hospital installed security devices to help reduce the risk of an infant abduction. The following mechanism have been installed...A TOTGuard System tag will be applied to stable neonate immediately after birth. The tag will be removed at the time of discharge from hospital or upon transfer..."

The facility failed to order the infant security equipment timely and as a result was not able to implement their Infant Security Plan as indicated in their hospital policy and procedure.

Based on interview and record review, the facility failed to ensure appropriate levels of nursing care were provided to one of 50 sampled patients (Patient 101), when a LVN was assigned to care for a critical patient on vasoactive IV medications (to support the blood pressure). This failed practice may have resulted in the death of Patient 101.

Findings:

The record for Patient 101 was reviewed on May 10, 2011. Patient 101, a 35 year old male, was admitted to the facility on October 26, 2010, with diagnoses that included DM and meningoencephalitis (an inflammation of the brain, usually caused by a bacterial infection).

The Interdisciplinary Progress Notes, dated December 10, 2011, at 7:11 a.m., indicated the physician ordered the patient to be transferred to the ICU due to a low BP of 80/41 (normal 120/80).

According to the Critical Care Nurse's Notes, the patient was started on a Levophed drip (continuous infusion of medication to increase the BP) at 10:15 a.m., by the RN caring for the patient. The drip was started at 10 ml/hr (5 mcg/min), and titrated (increased or decreased) up periodically until 7 p.m. (to 21cc/hr [11.2 mcg/min]to keep the SBP (top blood pressure number) >80.

The Critical Care Nurse's Notes indicated the patient was assigned to LVN 1 for the next shift (starting at 7 p.m.). The notes written by LVN 1 indicated the following:

1. At 7 p.m., the BP was 91/39, and the levophed was increased to 24 ml/hr (13 mcg/min);

2. At 9:30 p.m., the BP was 106/49. There was no additional BP measurement until 10:15 p.m. (45 minutes later).

(According to the 2007 Lexi Comp's Drug Information Handbook for Nursing, the BP should be monitored every 5-15 minutes when levophed is being titrated. According to the facility document titled, "Preprinted Intravenous Medication Titration Orders," the levophed rate should be adjusted every 15 minutes to maintain the SBP >80) ;

3. At 10 p.m., the patient had, "severe agitation," and was medicated with Ativan 1 mg IM (an injection given to decrease anxiety);

4. At 10:15 p.m., the BP was 170/150 (a normal response to severe agitation), and levophed was decreased to 15 ml/hr (8 mcg/min);

5. At 10:30 p.m. (15 minutes later), the BP had dropped to 79/28. There was no evidence any changes were made in the levophed dose;

6. At 10:45 p.m., the BP was 67/28. There was no evidence any changes were made in the levophed dose;

7. At 11 p.m., the BP was 64/37. The levophed was increased to 24 ml/hr (13 mcg/min);

8. At 11:15 p.m., the BP was 58/18. There was no evidence any changes were made in the levophed dose;

9. At 11:30 p.m., the BP was 70/50. There was no evidence any changes were made in the levophed dose. There was no additional BP measurement until 12:15 a.m. (30 minutes later);

10. At 12:15 a.m., the BP was 64/28. The levophed was increased to 30 ml/hr (16 mcg/min);

11. At 12:30 a.m., the BP was 57/27. The levophed was increased to 50 ml/hr (26.7 mcg/min). The first call was made to a physician regarding the patient's BP, and the nurse was awaiting a return call;

12. At 12:45 a.m., the BP was 58/23. The levophed was increased to 75 ml/hr (40 mcg/min), and the BP increased to 83/20 at 1 a.m., and 91/63 at 1:15 a.m.

(According to the 2007 Lexi Comp's Drug Information Handbook for Nursing, the usual range of levophed is 8-30 mcg/min. According to the facility document titled, "Preprinted Intravenous Medication Titration Orders," the maximum dose of levophed was 30 mcg/min unless ordered differently by a physician. The record did not include an order to infuse greater than 30 mcg/min);

13. At 1:30 a.m., the BP was 59/22. There was no evidence any changes were made in the levophed dose, as the nurse indicated it was, "maxed" (as high as it could be infused);

14. At 1:45 a.m., the BP was 53/21. There was no evidence any changes were made in the levophed dose, as the nurse indicated it was, "maxed";

15. At 2 a.m., the BP was 42/37. There was no evidence any changes were made in the levophed dose, as the nurse indicated it was, "maxed";

16. At 2:30 a.m., the BP was 63/36. There was no evidence any changes were made in the levophed dose, as the nurse indicated it was, "maxed". There was no additional blood pressure measurement until 3:15 p.m.;

17. At 3 a.m., a second call was made to the physician regarding the patient's BP;

18. At 3:15 a.m., the BP was, "60 palp", (meaning only a systolic BP could be obtained). A third call was made to the physician regarding the patient's BP;

19. At 3:30 a.m., a fourth call was made to the physician regarding the patient's BP. There was no additional BP measurement until 3:45 a.m. (30 minutes later);

20. At 3:40 a.m., a fifth call was made to the physician regarding the patient's BP, documentation indicated a different number was used to call to the physician;

21. At 3:45 a.m., the BP remained, "60 palp,". There was no evidence any changes were made in the levophed dose, as the nurse indicated it was, "maxed". The LVN documented a verbal order on the Preprinted IV Medication Titration Order form for Nipride 50 mg in 250 ml of D5W (a glucose based IV solution) , start at 0.3 mck/kg/min, adjust rate every 3-5 minutes for a target goal SBP >90

(According to the 2007 Lexi Comp's Drug Information Book for Nursing, nipride is used for the management of hypertensive crises [extremely high BP] and adverse reactions include excessive hypotensive [low BP] response.

According to the ISMP, nipride is among the list of drugs which have a heightened risk of causing significant patient harm when used in error).

According to the notes, the nipride drip was started, but stopped 25 minutes later when they were unable to obtain a BP. A code blue was called at 4:54 a.m., and resuscitation efforts were unsuccessful. Patient 101 was pronounced dead on December 12, 2010, at 5:15 a.m.

The Code Blue Report, dictated by the ED physician on December 11, 2010, indicated when he arrived at the patient's bedside, the patient was hypotensive (low BP) and had a levophed drip and a nipride drip infusing. The physician indicated, "I stopped the nipride because of the hypotension with a blood pressure in the 60s, which quickly dissipated to no blood pressure."

During an interview with MD 1 on May 11, 2011, at 1:50 p.m., the MD stated when he spoke to LVN 1, he ordered neo-synephrine to be infused (a medication to increase the BP), not nipride.

A review of the Competency Assessment and Validation Form for LVN 1, dated March 16, 2010, indicated LVN 1 demonstrated competency in mixing and administering IV medications, including levophed. The competency did not include nipride or neo-synephrine.

The facility policy titled, "Medication Administration," was reviewed on May 11, 2011. The policy indicated the rights of the patient would always be practiced when administering medications, including the right drug, for the right reason.

The facility document titled, "Licensed Vocational Nurse Scope of Practice," was reviewed on May 11, 2011. The document indicated a LVN would not give IV medications.

Based on interview and document review, the facility failed to ensure the medical staff documented a complete anesthesia record and post operative evaluation note, for one out of six medical records reviewed, (Patient 202).

Findings:

On May 11, 2011, a review of patient 202's medical record that underwent a surgical procedure on April 27, 2011, included a form titled "Anesthesia Record." At the bottom of the form under the "fluid output summary", there was no documentation of fluid output. Under the PACU section, there was no documentation of patient blood pressure. On the back of the form, under postoperative evaluation, there was no documentation of level of consciousness, cardiopulmonary status, complication, follow-up care, and any anesthesiologist signature or time or date.

In an interview with the CNO on May 11, 2011, at 9:30 a.m., she acknowledged the anesthesiologist did not document the patient's blood pressure, hydration, output summary, or document, sign or date the postoperative evaluation note.

Based on observation, record review, interview, document review, and policy and procedure review, the hospital's pharmaceutical services did not meet the needs of all of the patients. This was evident in the following:

1. Pharmaceutical services were not provided according to accepted professional principles. The content of medication orders were not clearly communicated for Patient 507 to nursing staff. (Refer to A 500)

2. The lack of an alert system in the ADC and of pre-printed order forms with a medication that did not contain warnings of (a) high alert medications (haloperidol) with black box warnings. (Refer to A0500)

3. Failure to have a contractual system used to review medication orders to be done in a manner to promote patient safety by providing qualitative reports for services. (Refer to A0491)

4. Failure to have a controlled substance accountability system to be capable of readily identifying loss or diversion in a timely manner. (Refer to A0494)

5. Failure to ensure the Patient Own Medication policies and procedures to be followed in a manner to prevent omission of medications to Patients 501 and 502, during the medication pass observation, conducted on May 10, 2011. Facility to ensure that unit specific nursing staff administered medications to Patient 502. Patient 501 did not self-administer medication, unless it was verified and labeled by the pharmacy and approved by physician.
(Refer to 0500)

6. The facility's intravenous preparation area did not comply with the United States Pharmacopeia Chapter 797 Compounding-Sterile preparation, which set practice standards to ensure the safety and final quality of all products compounded under sterile conditions, and corrugated material was not present in the compounding (intravenous preparation) area. (Refer to A 501)

7. Failure to ensure contracted service provided post pharmacy prospective review of medication orders qualitatively evaluated their provision of pharmaceutical care. (A0084)

The cumulative effects of the systemic problems resulted in the hospital's inability to ensure the provision of pharmaceutical services in a safe environment.

Based on observation, interview, and document review, the facility failed to provide or have information available, to alert licensed staff or practitioners to serious risk, that may lead to death or serious injury.

Findings:

The facility provided a list of medications which did not require a pharmacist prospective (override, by-pass) review prior to removal by a nurse which included haloperidol (Haldol), a medication with a black box warning.

The Chemical Dependency Unit was toured May 11, 2011, at 2:34 p.m. The surveyor asked RN 503 to demonstrate a withdrawal of the injectable form of haloperidol which can be administered IM or IV from the Pyxis medstation, an ADC. When the ADC transaction occurred, the only alert to be seen by the RN 503 was, "See Black Box Warning". No other cautionary statement(s) were provided.

RN 503 was asked to provide the information as indicated by the "See Black Box Warning " ...RN 503 reported that she would find the information in a reference titled, 'Black Box Warnings'. She would find the drug name, and read the information prior to administering the drug. A concurrent review of the reference with RN503 revealed it was last updated October 26, 2006, and haloperidol was not listed.

Six minutes had elapsed. A pre-printed form titled, 'Informed Consent for Major Tranquilizers', was presented by RN 503 as a source of information for Black Box Warnings. Haloperidol was listed among the major tranquilizers, but the words, "Black Box Warnings," were not documented anywhere on the pre-printed form as an alert to the nurse. The use of black box warnings was not assessed at the time of dispensing.

Based on staff interview, and record review, the facility failed to ensure the method for accountability of the receipt and disposition of drugs subject to the Comprehensive Drug Abuse Prevention and Control Act of 1970, was capable of readily identifying loss or diversion of all controlled substances in Schedules 2 through 5, in such a manner as to minimize the time frame between the actual loss or diversion to the time of detection and determination of the extent of loss or diversion.

Findings:

1. A review of six sample documents on May 9, 2011 titled, "...Controlled Substance Mini-Investigation," revealed Event-Related Medication incidents related to ADC and investigated via the facility's current process showed a trend that continued despite nursing follow-up and pharmacy disposition of the incidents.

Investigations showed nursing removed the medication from the ADC and used the ADC transaction time as the actual administration time to the patient. In a concurrent interview with Tech 500, she reported this is the practice. There was a time-lag between the incident and initiation of the investigation process.

On January 17, 2011, RN 508 removed Percocet at 22:08 (10:08 p.m.). The investigation was initiated January 19, 2011, a copy of PRN MAR from nursing showed January 17, 2011 from 7a.m.-7p.m., no doses administered, on January 17, from 7p.m. to January 18, 2011, one dose administered at 10:08 p.m.

January 7, 2011 at 19:13 (7:13 p.m.) RN removed Dilaudid 1 mg/1ml tubex. Investigation initiated January 13, 2011 (six days later). MAR was not documented when medication was administered.

Morphine 10 mg /1ml vial removed March 4, 2011 at 4:12 p.m. from PACU. Investigation initiated March 25, 2011, (21 days later) 2 mg doses documented at 4 p.m., 4:15 p.m., 4:20 p.m., 4:30p.m., and a late entry on March 25, 2011.

2. A review of the facility's ADC summary of activity for User A on May 9, 2011, at 11 AM, as a result of an investigation, revealed irregular trends of withdrawal and waste by User A during transactions for December 1, 2010 through April 11, 2011. A discrepancy report for User A during the same time period could not be obtained to correlate with the irregularities. A discrepancy required specific resolution and explanation of cause, that is, why and how the discrepancy occurred and to trend patterns to minimize potential loss.

Further review of the summary report dated December 1, 2010 through April 11, 2011, showed irregular transactions, as evidenced by waste and restock activities on the following dates:

a. OR3 - Restocked Midazolam 2mg/2ml Vial December 4, 2010 10:21 a.m.;
b. OR6 - Restocked Heparin;
c. OR1 - Restocked Propofol 10 mg/ml/20ml vial, Fentanyl 100 mcg/2ml amp, Midazolam 2mg/2ml vial December 8, 2010;
Restock the ADC was an inventory function performed by pharmacy staff.
d. OR6 - Withdrawn Midazolam 2mg/2ml Vial 10:04 a.m., Restock 10:06, Withdrawn 10:21;
e. OR3 Withdrawn one Morphine PF 1mg/2ml Amp for DF, March 31, 2011, 10:11 a.m.;
f. OR3 Withdrawn one Morphine PF 5mg/10 ml Amp for DF, March 31, 2011, 10:12 a.m.;
g. OR3 Wasted Two (2) Morphine PF 5mg/10 ml Amp for DF March 31, 2011 10:46 a.m.;
h. OR3 Restock one Morphine PF 1mg/2ml Amp for DF March 31, 2011 10:46 a.m.;
i. OR3 Withdrawn one (1) Morphine PF 5mg/10 ml Amp for JS March 31, 2011 10:12 a.m.; and,
j. OR3 Wasted (2) Morphine PF 5mg/10 ml Amp for JS March 31, 2011 10:47 a.m.
Tracking and trending of controlled substance irregularities was expected of all users as part of the performance improvement measure and safe patient care.
Interview with Pharmacist 1 on May 10, 2011, at 10:10 a.m., revealed the facility's ability, but failure, to, investigate and resolve controlled substances discrepancies as evidenced by the time of the actual transaction and investigation contributed to the type of incidents and irregularities seen.

Based on observation, interview and record review, the facility failed to ensure:
1. Two patients did not self-administer medication, unless it was verified and labeled by the pharmacy and approved by the physician (Patients 501 and 502);
2. Two patients received medication on an empty stomach (Patients 501 and 502);
3. The content of medication orders were clearly communicated for Patient 507 to nursing staff;
4. Store pharmaceutical waste (for approximately 26 to 28 containers), as defined by the Medical Waste Management Act, in a safe manner, and confidential patient information on IV bags were protected from discovery during the storage on site, and at the destruction facility; and,
5. Ensure enough adenosine (medication used to treat SVT - a dangerously fast heart rate) was available in the adult crash carts to provide a full regimen to a patient suffering from SVT, resulting in the potential for harm or death in these patients.

Findings:

1. On May 10, 2011, at 9:11 a.m., during the morning medication pass, a bottle of TheraTears (eye drops) was observed on Patient 501's bedside table. A concurrent interview with the patient on May 10, 2011 revealed this medication was brought into the hospital, and the patient had self-administered this medication without the facility knowing of its existence.

An interview with Patient 501's medication nurse on May 10, 2011, at 9:13 a.m., revealed nursing staff were unaware this medication had come into the facility.

An examination of the TheraTears bottle and subsequent review of Patient 501's clinical MAR, revealed neither the patient's physician, nor the facility's pharmacy had inspected Patient 501's medications prior to Patient 501 self-administering this medication.

The facility had two P&Ps titled, "Patient's Own Medication, For Use in the Hospital" and Patient's Own Medication, Not For Use in the Hospital" created and reviewed/revised October 2010, Coded as PC.RX.108 and 109 respectively. A review of both P&Ps revealed medications brought into the facility were to be quarantined in the pharmacy. If the product is not included in facility's drug list, then the medication may be used providing it is verified, documented, and labeled by pharmacy. In addition, a physician's order is written to indicate the patient may use their own medication.

b. Patient 502 was admitted on May 8, 2011, with diagnoses that included right lower lobe pneumonia and electrolyte imbalance. On May 10, 2011, at 8:40 a.m., during the morning medication pass, Patient 502 did not receive three medications ordered on May 8, 2011, at 1:45 p.m., by the physician. The medications ordered were Namenda 5 mg PO BID, used for treatment of moderate to severe dementia of the Alzheimer's type, Aricept 10 mg PO q daily, used for treatment of mild, moderate or severe dementia of the Alzheimer's type, and Tricor 145 mg PO q am, used for treatment of elevations of serum triglyceride levels.

On May 10, 2011, the MAR for Patient 502 was reviewed. The MAR indicated for May 8, through May 9, 2011, and May 9 through May 10, 2011, the orders were transcribed unto the MAR to be administered at 9 a.m. daily as POM. The three medications (Namenda, Aricept, Tricor) were not listed on the physician's orders as Patient Own Medications.

Patient 502 stated he could not afford the Namenda co-pay, so he has not taken that medication before he came into the hospital. On the MAR, Namenda was documented as POM. Documented on the May 8, through May 9, 2011 MAR of Patient 502 was the notation, "Pt Own," with a circle around the "21(9PM)" dose indicating Namenda was not given. Documented on the May 9, 2011 through May 10, 2011 MAR of Patient 502, were the notations n.a at 0900 (9a.m.) and 1700 (5 p.m.) and circled indicating that Namenda was not given.

Patient 502 also stated, "My wife gave me meds last night." When asked which medications, he stated, "She told the nurse." Patient 502's charge nurse, who was present during the interview, on May 10, 2011, at 11:45 a.m., was asked to locate the medications in the medication room. Patient 502's cassette was observed in the medication room, but could not find the medications.

Further review of the MAR dated May 9 through May 10, 2011, for scheduled medications from 7a.m. - 7 p.m., on May 10, 2011, revealed Tricor and Aricept administration times were documented as n.a at 9 a.m., and circled. There were notations, "Spouse will bring". "Spouse gave 16 (4 PM)". The 16 was lined through and initialed which indicated the medication was administered.

The facility was not aware of the following:

a. Medications (Tricor, Aricept) were not processed as POM but were administered to Patient 502 by the patient's wife, who is an employee of the facility; who has possession of the medications as evidenced by the documentation in the clinical record by the facility's nurse:
b. A medication (Namenda) documented on the MAR as POM was not available for use by Patient 502 before it was processed (verified, documented, and labeled by pharmacy) and sent to the unit; and,
c. Specific physician's orders were not written to indicate the patient may use his/her own medication. POM was part of the order to indicate that it had been vetted via the facility's medication use processes and available for use.

The facility had two P&Ps titled: "Patient's Own Medication, For Use in the Hospital," and Patient's Own Medication, Not For Use in the Hospital," created and reviewed/revised October 2010, Coded as PC.RX.108 and 109 respectively. A review of both P&Ps revealed medications brought into the facility shall be quarantined in the pharmacy. If the product is not included in the facility's drug list, then the medication may be used providing it was verified, documented, and labeled by pharmacy. In addition, a specific physician's order was written to indicate the patient may use his/her own medication. POM was part of the order to indicate it had been vetted via the facility's medication use processes and available for use. The nurse administered the medication, and each administration was documented on the MAR. The medication was kept in the medication room.

2. On May 10, 2011, at 8:40 a.m., during the morning medication pass, the following was observed:

a. Patient 502 received Levothyroxine 100 mcg tablet. This medication was administered after breakfast. According to LexiComp Online edition, the medication is to be taken on an empty stomach at least 30 minutes before food.

A review of Patient 502's clinical MAR on May 10, 2011, revealed the order was transcribed to the MAR to be administered at 9 a.m. daily, without dietary considerations.

In a concurrent interview with pharmacy management, he acknowledged the medication should be timed to be taken before breakfast.

b. Patient 501 received a Levothyroxine 50 mcg tablet. This medication was administered after breakfast. According to LexiComp Online edition, the medication is taken on an empty stomach at least 30 minutes before food.

A review of the patient's clinical MAR on May 10, 2011, revealed the order was transcribed to the MAR to be administered at 9 a.m. daily, without dietary considerations.

In a concurrent interview with pharmacy management, he acknowledged the medication should be timed to be taken before breakfast.

3. Medication orders processed by the post-pharmacy provider were reviewed on May 10, 2011. Patient 507's post-operative medication orders were reviewed. Patient 507's medication orders were faxed to the tele-pharmacy vendor by nursing on May 5, 2011, for prospective review prior to administration. The faxed orders included the following orders:

a. Dilaudid 1 mg (milligram) I (one) PO q4h PRN. The order lacked the indication (purpose) and intensity of the pain being treated.
b. Demerol 50 mg IM q4h PRN for pain. The order lacked the intensity of the pain being treated.

The content of the medication orders (a) and (b) that were sent for a pharmacist prospective review did not describe the quality or character of the pain being treated according to the pain scale adopted by the facility. The medication orders should have included intensity ratings of the pain, such as, mild, moderate, or severe; and indication for use respectively. In addition, PRN orders were not clearly communicated to licensed staff, therefore subject to variability in interpretation as to when Dilaudid or Demerol would be selected.

The physician had essentially relinquished his/her authority as a prescriber of medication to a nurse, who may then determine when it is appropriate to select one of the two scheduled II drugs, determine the route which may increase the drug twofold, and document that decision in the medical record. Interview with the pharmacy staff on May 10, 2011, at 2:55 p.m, the pharmacist acknowledged the medication orders were not clarified for nursing to ensure they were complete and not subject to interpretation prior to administration.

4. On May 12, 2011, at 1:05 p.m., a tour was conducted of the medical waste storage area, where pharmaceutical waste was kept prior to transport for destruction. There were approximately 26 to 28 containers observed. The containers provided by PharmaSafety were easily opened to reveal approximately 50 or more used IV bags, tubing, and IV sets. These containers were not rendered tamper resistant.

There were clearly identifiable labels with confidential patient information that were affixed to the used IV bags.When the containers would be opened at the receiving facility, the information would be readily compromised. They were not rendered unrecognizable before they were disposed of in the nursing units. The information on the labels contained the following:

a. Name of patient;
b. Medical record number;
c. Name of the medication and rate; and,
d. The name of the MD.

On May 12, 2011, the contract titled, "Service Agreement for Pharm Away," signed on February 1, 2011, was reviewed. The contract was between the Waste company and the GACH. The language of the contract did not specify or imply the GACH information remain confidential, such as patient names.

On May 12, 2011, at 1:25 p.m., the EVS area director was interviewed. The EVS area director acknowledged the containers were easily opened and the procedure to completely render them tamper resistant, by removing the seal strip located on each side of the container. The instructions had not been followed to seal the containers.

5. During a tour of the ED on May 9, 2011, at 11:25 a.m., the contents of the adult crash cart was observed. The medication tray included three vials of adenosine, 6 mg in 2 ml.

According to the 2007 Lexi-Comp's Drug Information Handbook for Nursing, adenosine is indicated for SVT as follows:

a. Administer 6 mg rapid IV push (over 1 - 2 seconds);

b. If ineffective, repeat in 1 - 2 minutes with 12 mg rapid IV push;

c. If ineffective, repeat in 1 - 2 minutes with an additional 12 mg rapid IV push.

The facility document titled, "Adult Crash Cart Medications," was reviewed on April 20, 2011. The document included a list of the medications stored in the adult crash cart. The list included three vials of adenosine, 6 mg in 2 ml.

To administer 6mg, followed by 12 mg, followed by 12 mg as indicated in the Drug Information Handbook, five vials of adenosine would be needed. The crash cart did not include enough adenosine to provide a complete regimen to a patient suffering from SVT.

During an interview with the ED Director on May 9, 2011, at 11:25 a.m., the director stated the crash cart did not include enough adenosine to fully treat a patient suffering from SVT.

Based on observation, document review, and interview, the facility failed to ensure:
1. The facility's intravenous preparation area complied with the USP, Chapter 797 Compounding-Sterile preparation, which set practice standards to ensure the safety and final quality of all products compounded under sterile conditions;
2. Corrugated material was not present in the compounding (intravenous preparation) area; and,
3. IV medications were labeled when prepared by the nurses.

Findings:

1. During an inspection of the pharmacy on May 10, 2011, at 3:46 p.m., it was observed the IV preparation area was not separated into a clean and non-clean (buffer, ante) area. USP 797 addressed facilities in which sterile products were prepared according to the manufacturers' labeling, and where manipulations were performed during the compounding of sterile products which increased the potential for microbial contamination of the prepared products. It delineated what training was needed, how the preparation area should be designed, equipment type, and quality control program formalized in writing.

2. Two corrugated boxes were observed in the refrigerator located in the compounding area on May 11, 2011, at 3:49 p.m. Corrugated material is prohibited from being stored in this area to prevent particles that may contaminate the IV products prepared in this environment.

In an interview with the Director of Pharmacy on May 10, 2011, at 3:50 p.m., he reported the corrugated boxes were stored inappropriately, and the facility's intravenous preparation area did not comply with the United States Pharmacopeia 797 (USP) standards for Pharmaceutical Compounding-Sterile Preparations, and plans were progressing to be in compliance;

3. During a tour of the ICU on May 11, 2011, at 1:25 p.m., with a Clinical Nurse Manager, the following was observed:

a. An IV medication Dopamine 400 mcg in dextrose 5 percent 250 milliliters was found hanging for Patient 504. The medication was prepared by RN 504 on the unit. When asked why the medication was not labeled, RN 504 reported it was hung in an emergency, and she did not label it when the emergency ended.
b. Cardizem 125 mg/100 milliliters of 0.9% sodium chloride was not labeled when prepared for Patient 505; and,
c. A 10 milliliter syringe containing 0.9% sodium chloride, Nystatin topical powder, and Chlorhexidine 0.12% oral rinse were found on the bedside table in Rm 163 at 1:25 p.m., on May 11, 2011 unattended.

During an interview with RN 506 on May 11, 2011, at 1:35 p.m., she reported the nurses on the unit frequently mixed IVs, because medications were not consistently delivered in a timely manner, and Stat, (immediately) or Now, have different time-frame interpretations.

Based on interview and record review, the facility failed to ensure a physician, or RN was physically present, when radiology technologists administered a contrast IV for MRI testing. This failed practice could interfere with immediate medical intervention in the event of an adverse reaction from the contrast.

Findings:

On May 9, 2011, at 2:35 p.m., a tour was conducted of the MRI suite. The MRI suite was located out of the facility between the lobby and the ED. In a concurrent interview with Radiologist Technician 1, he stated the technician is the only one with the patient in the suite. Radiologist Technician 1 stated the MD is available by phone if there were an adverse reaction from the contrast. Radiologist Technician 1 would have to leave the patient to go to an outer room to initiate a code blue, and would have to transfer the patient by himself on a guerney to remove the patient away from the sensitive equipment in the MRI suite.

On May 10, 2011, the facility policy and procedure titled, "Radiology," was reviewed. The policy indicated, "Purpose To ensure the safety of our patients from preventable allergic reactions to contrast media."

Based on observation, interview and record review, the hospital condition of participation was not met as evidenced by:

1. GMFS failed to ensure the daily management of the dietary services to provide patients with safe and high quality food due to a lack of monitoring of food storage and sanitation practices (Cross refer A-620 and A-749)

2. The GMFS failed to coordinate with the Infection Control Practitioner to ensure the dietary services department had an effective system to identify, report, investigate and control unsafe and unsanitary practices, which created the potential to result in cross contamination and food borne illness. (Cross refer A-749)

3. GMFS and CNM, failed to ensure a therapeutic diet and nutritional supplement served was consistent with the physician's order. (Cross refer A-629)

4. The GMFS failed to accurately measure, analyze and track quality indicators and aspects of performance that assess the processes involved with food safety to effectively prevent cross contamination, food borne illness and ensure food quality (Cross refer A-267)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure safe food handling to prevent the potential of food borne illness, to ensure physician ordered diets were accurately served to the patients, and to prevent deficient practices identified during the survey to continue in a hospital with a licensed bed capacity of 417.

Based on observation, document review and staff interview, the hospital General Manager of Food Service failed to ensure the daily management of the dietary services for food safety and quality as specified by the department policies for food storage and sanitation when:

1. Multiple opened food items were not dated with an open or use by/expiration dates and some items in both dry and refrigerated storage were open and not sealed. Liquid frozen egg product stored in the refrigerator was not dated with a use by date.

2. Dishwashing staff was not using proper hand hygiene when switching between dirty and clean dishes. Clean and dirty dishes and utensils were not separated to prevent cross-contamination.

3. Food service staff were unable to demonstrate how to properly determine the concentration of a sanitizer used to sanitize food contact surfaces

4. Table mounted can openers had dried food residue on the blades. A ladder rack used to store food in the dairy refrigerator was noted to have a buildup of black crusty residue. There was dust accumulation on the fire suppression system over the stove.

5. Expired product was stored in refrigerator and the dry storage.

6. The First-In, First-Out method of food storage was not being used.

These failures in the daily management of the dietary services had the potential to result in food-borne illness and a failure to ensure high quality food service for patients, staff and visitors.

Findings:


1. During a tour of the main kitchen on May 11, 2011, at 9 a.m., multiple food items were observed opened and were not dated. In the walk-in refrigerators: a box of sausage was opened and not dated; a box of bacon was opened and not dated; a box of sliced pepperoni was opened, not sealed and was not dated; a half gallon size container of liquid frozen egg product was opened, not sealed and not dated. In the walk-in freezer: a six pound pan of lasagna had been removed from the original box and was not dated; and a container of sweet pepper soup was removed from the original box and was not dated. In the dry storage room: a package of biscuit mix was opened and not dated; a package of corn muffin mix was opened and not dated; a package of honey bran muffin mix was opened and not dated; a package of chocolate cake mix was opened, not sealed and not dated; and packages of crushed chocolate candies, sweetener mix, pecans and a dry scallop potato mix were all opened and not dated. GMFS confirmed the findings.

During a tour of the satellite kitchen on May 11, 2011, at 2:05 p.m., multiple food items were observed opened and were not dated. In the walk-in refrigerator: a package of flour tortillas was opened, not sealed and not dated; a box of sausage was opened and not dated; a box of bacon was opened and not dated; a jar of chopped garlic packed in oil was opened and not dated. In the walk-in freezer: a plastic bag containing 6 veggie burgers was removed from the original packaging and not dated; a black bean burger was opened and not dated; a box of ground beef was opened, not sealed and not dated; and a bag of quesadillas was opened and not dated. In the dry storage room: two packages of gelatin mix were opened and not dated; and a package of vanilla muffin mix was opened, not sealed and not dated. The GMFS confirmed the findings.

Also observed in both kitchens was a liquid frozen egg product which the label stated, "Keep frozen until needed. Thaw in the refrigerator 2-3 days. After thawing, use within 3 days." The product was not dated in order to ensure it was used within the timeframe instructed by the manufacturer. The Chef confirmed the findings.

A review of the hospital's policy titled, "Food Storage," revised January 2010, indicated, "It is the policy of the Food and Nutrition Services Department to develop a mechanism to ensure the safe and accurate storage of food and non-food products. Food storage methods are strictly defined." The purpose of the policy was, "To prevent contamination by or transmission of disease-causing bacteria." The procedures stated, "Rotate stock so that the older items are used first. Date products to ensure the use of ' First-In, First-Out ' procedures. Date open products when opened."

During concurrent interviews with GMFS, and the Chef, GMFS was unable to state why the food items were not dated and why the items were not properly sealed. She stated it was the standard of practice in the hospital that all opened foods would be sealed and dated with an open date. She further stated it was the responsibility of the hourly dietary staff, the chef and ultimately, her responsibility to ensure the policy was followed. The Chef was unable to state how the staff was able to determine how long the liquid egg product was stored in the refrigerator without dating the product when it was removed from the freezer.


2. During a tour of the main kitchen dishwashing room on May 11, 2011, at 10:10 a.m., FSW 1 was observed removing clean dishes from the dishwashing machine. During a concurrent interview she stated she also loaded the dirty dishes into the dishwashing machine. She stated she washed her hands in the three compartment sink when she changed from dirty dishes to clean dishes. She confirmed she washed her hands in the same sink that is used for washing pots and pans.

During a concurrent interview with GMFS, she stated when a FSW changed from dirty to clean dish handling, the proper method for hand washing was in the hand washing sink. She was unable to explain why FSW 1 used the three compartment pot washing sinks to wash her hands.
According to the 2009 United States Department of Agriculture Food Code, FOOD EMPLOYEES shall clean their hands in a HAND WASHING SINK or APPROVED automatic hand washing facility and may not clean their hands in a sink used for FOOD preparation or WARE WASHING, or in a service sink or a curbed cleaning facility used for the disposal of mop water and similar liquid waste.
Also during a concurrent observation in the dishwashing room, clean patient trays were stacked adjacent to racks of dirty dishes. There was no noted separation between the clean and the dirty items.
During a concurrent interview with the GMFS, she confirmed the observation. She further stated the clean and the dirty dishes should be separated to prevent cross contamination. She was unable to state why the clean dishes were stored adjacent to the dirty dishes.

3. During a tour of the satellite kitchen on May 11, 2011, at 2:45 p.m., FSW 2 was asked to demonstrate how he tested the concentration of the sanitizer in the red buckets used to sanitize food contact surfaces. FSW 2 used chlorine based test strips to check the concentration of the sanitizer. The strip did not change color to indicate the concentration was adequate. FSW 2 stated the concentration of the sanitizer in the red buckets was checked every hour. FSW 2 was unable to explain why the test strip did not change color to indicate the sanitizer concentration was adequate.

During a concurrent interview with the GMFS, she stated the sanitizer in the red buckets was a quaternary solution and not a chlorine solution. The procedure for testing the sanitizer in the red buckets was to use the quaternary test strips. The GMFS was unable to explain why FSW 2 did not use the proper test strips to test the concentration.

4. During a tour of the main kitchen on May 11, 20/11 at 9:30 a.m., the table mounted can opener was noted to have a sticky substance on the blade. During a concurrent interview with Cook 1, he stated the can opener was cleaned every day. He confirmed the can opener was used to open more than one can each day. He further confirmed the sticky residue on the blade could potentially cross contaminate the next can that was opened before it was cleaned for the day.

Additionally during the tour of the main kitchen at 10 a.m., a ladder rack storing trays of food was noted to be crusted with a black and gray residue in the walk-in refrigerator. During a concurrent interview with the Chef, he stated the cart was dirty and it needed to be cleaned. He was unable to state why the cart had not been cleaned before placing food trays on it, creating the potential for contamination of the food.

During the tour of the main kitchen, at 11:30 AM, the pipes for the fire suppression system over the stove and grill areas had a buildup of dust. During a concurrent interview with the GMFS, she confirmed the presence of the dust. She also confirmed the potential for the dust to contaminate food cooking on the stove and grill areas. She stated the pipes were cleaned weekly. She was unable to state why there was a buildup of dust.

During a tour of the satellite kitchen on May 11, 2011 at 2:15 p.m., the table mounted can opener was observed to have a dry crusty residue on the blade. During a concurrent interview with the GMFS, she confirmed the potential for cross-contamination of canned foods if the can opener blade was not cleaned and sanitized after each use.

According to the 2009 United States Department of Agriculture Food Code,
EQUIPMENT FOOD-CONTACT SURFACES and UTENSILS shall be clean to sight and touch. AND UTENSILS shall be cleaned throughout the day at least every 4 hours.

5. During a tour of the main kitchen on May 11, 2011, at 9 a.m., a large metal bowl containing salsa was observed labeled with a date of May 10, 2011. Further observation revealed an opened package of sliced, cooked roast beef labeled with a date of May 3, 2011. In the dry storage room, a gallon sized open container of fruit punch concentrate was observed dated September 3, 2010, and an open jar of capers was observed dated March 29, and the label stated, "Refrigerate after opening."

A review of the hospitals policy titled, "Label, Wrapping and Dating," undated, showed , "Any food item past the 'use by date', is to be discarded and not be used under any circumstance."

During a concurrent interview with GMFS, she stated the dates on the products were the "use by" or expiration dates. She stated the products should have been discarded at the end of the dates indicated. She was unable to state why the items had not been discarded. She further stated it was the responsibility of the hourly dietary staff, the chef, and ultimately, her responsibility to ensure the policy was followed.

Foods used past their use by dates have the potential to cause food borne illness and/or to deteriorate in quality.

6. During a tour of the main kitchen on May 11, 2011 at 9 a.m., multiple gallon sized containers of mayonnaise and salad dressings were noted in the walk-in refrigerator. Some of the containers were dated March 25, 2011 and April 12, 2011. Eighteen of the containers were not dated. Three of the containers that did not have dates had been opened.

A review of the hospital's policy titled, "Food Storage," revised January 2010, indicated, "It is the policy of the Food and Nutrition Services Department to develop a mechanism to ensure the safe and accurate storage of food and non-food products. Food storage methods are strictly defined." The purpose of the policy was, "To prevent contamination by or transmission of disease-causing bacteria." The procedures indicated, "Rotate stock so that the older items are used first. Date products to ensure the use of 'First-In, First-Out ' procedures. Date open products when opened."

During a concurrent interview with the GMFS, she stated the containers were not dated were received the previous day, May 10, 2011. She was unable to explain why product that was received on May 10, 2011 was used prior to the same product that was labeled as received on March 25, 2011 and April 12, 2011. She further stated it was the responsibility of the hourly dietary staff, the chef, and ultimately, her responsibility to ensure the policy was followed.

Based on observation, record review and interview, the hospital failed to ensure the therapeutic diet and nutritional supplement served to one of six sampled patients (Patient 704) was consistent with the physician's order.

Findings:

The medical record for Patient 704 was reviewed on May 12, 2011. The patient was admitted to the hospital on May 6, 2011 with diagnoses that included renal insufficiency (a medical condition in which the kidneys fail to adequately filter toxins), and morbid obesity.

On May 8, 2011 the physician ordered a 2 gram sodium, medium consistent carbohydrate (diabetic) renal (referring to the kidneys) soft diet. The order also included Boost Renal (a liquid nutritional supplement for patients with impaired kidney function) 8 ounces twice a day.

During an observation and interview with the patient and RN X on May 12, 2011 at 12 p.m., an 8 ounce carton of milk and an 8 ounce carton of Boost Glucose Control (a liquid nutritional supplement for patients with diabetes) were observed on the patient's bedside table. The patient stated the Boost and milk were both served on her breakfast tray. RN X confirmed both items were delivered to the patient on her breakfast tray.

Review of the Initial Nutrition Assessment showed RD 1 had completed the assessment on May 9, 2011 and listed the diet order as CCD (consistent carbohydrate diet) medium and 2 gram sodium. The nutritional supplement, "renal" and "soft" parts of the diet order were not listed on the assessment. There was no evaluation of the accuracy of the diet order that was in the computer versus the actual written physician order.

During a concurrent interview with the CNM, she stated patients on a renal diet should only receive 4 ounces of milk a day. She also stated the patient should have received a renal nutritional supplement, not the Boost Glucose Control supplement. She stated the diet order had been entered in the computer (the hospital's system for communicating physician's written diet orders to the kitchen) to indicate an order for the Boost Renal and the Boost Diabetic. She also stated the "renal" portion of the diet order had been left off. The patient diet order was incorrect in the computer (as CCD medium, 2 gram sodium, soft diet with Boost Glucose Control) since May 8, 2011. She further confirmed the accuracy of the order was not evaluated by RD 1 when she assessed the patient.

2. On May 10, 2011, starting at 9:30 a.m., a tour of the third floor-medical surgical floor was conducted with the Clinical Nurse Director.

a. An interview was conducted with the charge nurse on May 10, 2011, at 9:35 a.m. The CN stated the census was 32 and four patients were on Isolation. Three patients were in contact isolation for C-diff. and two for MRSA.

Inspection of the isolation equipment and storage room revealed there were no Clorox Germicidial Bleach wipes on the unit. The clorox bleach was currently the only product to obtain federal and state EPA registration for killing the C-Diff. spores on hard, nonporous surfaces when used as directed by the manufacturer.

b. Ten of eleven staff interviewed on the unit did not know how to properly use the disinfectants and did not know about the contact time for the disinfectant products used on the unit.

Nurse A did not know the contact time for the PDI SuperSanicloths. Nurse A was caring for a patient with diagnosis of C-diff. Nurse A stated she used the SuperSanicloths to disinfect any patient equipment. Nurse A did not have any Clorox Germicidial Bleach wipes as part of her isolation equipment. The Clorox Germicidial Bleach wipes were not readily available on the unit.

Nurse B stated she would use the clorox bleach wipes for MRSA and the PDI SuperSanicloths for C-diff. Nurse B did not know the contact time for any of the products. "I wipe and let it dry."

Nurse C did not know the contact time for the PDI SuperSanicloths. Nurse C was caring for a patient with diagnosis of C-diff. Nurse C stated she would use the bleach wipes for C-diff, but did not have any Clorox Germicidial Bleach wipes as part of her isolation equipment. The Clorox Germicidial Bleach wipes were not readily available on the unit. Nurse C did not know the contact time for the Clorox Germicidial Bleach wipes.

CNA 1 stated she did not know what disinfectant product to use when cleaning equipment for patients with C-diff.

LN 1 stated she would use the PDI SuperSanicloths to disinfect for MRSA and C-diff. LN 1 stated contact time was 30 minutes to an hour.

The RT stated she would use the PDI SuperSanicloths to disinfect for MRSA and C-diff. The RT stated she would wipe and let the product dry. The RT stated there was no minimum contact time.

Nurse D stated that to disinfect for C-diff, she would use soap and water and follow up with some alcohol. Nurse D further stated she used the PDI SuperSanicloths to disinfect for MRSA and contact time was ten minutes.

Nurse E stated she would use the clorox wipes for C-diff and the contact time was about 30 seconds or until it dries. Nurse E stated she did not know the contact time for the "DPI" sanicloths.

3. On May 10, 2011, starting at 11:30 a.m., a tour of the sixth floor was conducted with the Clinical Nurse Director. Nurse F stated the census was 20 and four patients were in isolation for either MRSA or C-diff. Nurse F stated the contact time for the PDI SuperSanicloths, "until it dries." Nurse F stated she was not sure what the contact time was for the clorox bleach wipes.

Inspection of the isolation room and equipment for a patient with diagnosis of C-diff. and MRSA was conducted. There were no Clorox Germicidial Bleach wipes as part of the isolation equipment. The nurse stated she did not have the clorox bleach wipes, but she have the PDI SuperSanicloths available to disinfect equipment. The nurse further stated that the PDI SuperSanicloths would not kill the C-diff. spores. The nurse stated bleach was the only product that would kill the C-diff. spores. The nurse acknowledged the clorox wipes should have been readily available and kept with the isolation equipment, instead of the PDI SuperSanicloths.

An interview was conducted with the Director of EVS, on May 12, 2011, at 10 a.m. He stated Bleach at a 1:10 dilution was the only product that would kill the C-diff. spores. The Director of EVS stated contact time for the bleach solution was 10 minutes and for the clorox wipes was two minutes.

The manufacturer indicated their recommended contact time to kill C-diff. spores was five minutes for their Clorox bleach and Dispatch disinfectant wipes with bleach. The manufacturer's literature further indicated Clorox bleach was currently the only product to obtain federal and state EPA registration for killing the C-Diff. spores on hard, nonporous surfaces when used as directed by the manufacturer.

The label on the container of PDI SuperSanicloths was reviewed on May 12, 2011. The directions indicated two minute contact time.
The surface contact time is the length of the time the product must remain wet on a surface to effectively kill germs.
The facility failed to have a system in place to ensure all healthcare workers were knowledgable about the disinfectant products used at the hospital for MRSA and C-diff. The facility failed to ensure all staff used disinfectant products per manufacturer's recommendations to properly disinfect patient areas and equipment.

4. On May 10, 2011, at 11 a.m., a tour was conducted of the outpatient rehabilitation area. In a concurrent interview with the PT Assistant, he stated he cleaned the mats in the department with a disinfectant cleaner (HB Quat or 456). The PT Assistant stated he allowed the cleaner to stay on the mats for about 10 to 15 seconds, and then wiped it off.

5. On May 10, 2011, at 12:20 p.m., Housekeeper 1 was interviewed. Housekeeper 1 stated she did not remember how long to keep the cleaner (456 or HB Quat ) on the surface of objects that she cleaned.

On May 10, 2011, at 4:50 p.m., the Director of EVS and the Supervisor were interviewed. The Director of EVS and the Supervisor stated it was recommended to leave the 456 (or HB Quat) disinfectant cleaner on the surface of the item to be cleaned for 10 minutes.

On May 10, 2011, the facility policy and procedure titled, "Patient Room Cleaning-Isolation Discharge," was reviewed. The policy indicated, "...456 germicidal solution dwell time is 10 minutes."



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Based on observation, staff interviews and document reviews, the hospital failed to ensure it had a system in place for identifying, reporting, investigating and controlling unsafe and unsanitary practices in the dietary services department. This failure had the potential to result in cross contamination and food borne illness in a hospital with a licensed bed capacity of 417. (cross refer A620). The facility further failed to ensure staff were knowledgeable in the contact time for disinfecting surfaces.

Findings:

1. An inspection of the main kitchen and the satellite kitchen on May 11, 2011 at 8:30 a.m., revealed unsanitary, cross contamination conditions and practices. The following was observed:

a. Dishwashing staff were not using proper hand hygiene when switching between dirty and clean dishes;
b. Clean and dirty dishes and utensils were not separated to prevent cross-contamination in the dishmachine room;
c. Multiple opened food items were not dated with an open or use by/expiration dates and some items in both dry and refrigerated storage were opened and not sealed;
d. Food service staff were unable to demonstrate how to properly determine the concentration of a sanitizer used to sanitize food contact surfaces;
e. Table mounted can openers had dried food residue on the blades;
f. A ladder rack used to store food in the dairy refrigerator was noted to have a buildup of black crusty residue;
g. There was dust accumulation on the fire suppression system over the stove and grill areas; and,
h. Expired products were stored in refrigerator and the dry storage.

During concurrent interviews, the GMFS and the Chef confirmed the findings. They also confirmed the dietetic staff needed to use clean and sanitary equipment, and needed to have knowledge regarding the proper testing of the potency of the sanitation solution used for the sanitation of food contact surfaces.

A review of the hospital's policy titled, "Surveillance, Prevention, and Control of Infection - Nutrition Services," revealed the policy of the Food and Nutrition Services Department were to maintain a sanitation program. Purpose was to maintain a clean, safe and effective environment of care, and to prevent the transmission of disease-carrying organisms. The policy indicated GMFS monitored sanitizing schedules and procedures.

During an interview with the ICP on May 12, 2011, at 9:50 a.m., she stated she was not aware of the findings in the dietary services department. She further stated she and the GMFS had made rounds one time in the kitchen during the approximately one year that she had held the position of ICP.

On May 12, 2011, at 1 p.m., they stated they attended the Infection Control Committee quarterly meetings when they were invited. They had not attended a meeting recently. They stated hand hygiene was an emphasis of the infection control program in the dietary services department. The GMFS was unable to explain why the FSW did not use proper hand hygiene when moving from dirty to clean dish handling. They also stated the monthly food sanitation reports completed by the department were forwarded to the Director of Engineering quarterly, but they had no knowledge if those reports were also forwarded to the infection control committee.

The hospital did not have an effective system to identify, report, investigate and control unsafe and unsanitary practices in the dietary services department which created the potential to result in cross contamination and food borne illness.

Based on interview, medical record and document review, the facility failed to ensure physicians documented a complete recovery from general anesthesia evaluation note for patients that had surgery with general anesthesia prior to discharge, for six of six medical records reviewed (Patients 202, 203, 204, 205, 403, and 404). Furthermore, the facility's Anesthesia Department Rules and Regulations did not specify what the Anesthesiologist's duties and responsibilities were for the post surgery patient assessment.


Findings:

On May 11, 2011, at 9 a.m., six medical records of patients that underwent surgery with general anesthesia were reviewed. A review of these six Patient charts 202, 203, 204, 205, 403 and 404 contained documents titled, " Anesthesia Record " . On the back of the form under postoperative evaluation note there was no documentation in the six post anesthesia notes of the patient's pain or nausea and vomiting.

A review of the facility's Anesthesia Department Rules and Regulations was conducted on May 12, 2011, under the duties of the anesthesiologist, the document did not specify what the post surgery anesthesiologist's duties or responsibilities were regarding patient assessment after a surgical procedure, with general anesthesia.

The CNO was interviewed on May 11, 2011, at 9:30 a.m. She stated the anesthesiologists were assessing the patients for recovery from anesthesia and documenting the patient was stable and ready for discharge. She acknowledged the anesthesiologists were not documenting the patient's pain, or nausea and vomiting.

An interview with the Director of Quality was conducted on May 12, 2011, at 2 pm. She acknowledged the Anesthesia Department Rules and Regulations did not address what the post surgery patient anesthesia assessment duties and responsibilities were for patients undergoing surgical procedures with general anesthesia. She stated the Anesthesia Department was currently updating the Rules and Regulations to include what the Anesthesiologist's duties and responsibilities were for these patients.