HospitalInspections.org

17031

Based on observation, interview, and document review, the hospital's governing body failed to exercise responsibility for and control over the hospital's conduct in a manner that was sufficient to make sure that the hospital was in compliance with the Centers for Medicare and Medical conditions of participation as evidenced by:

1. The governing body failed to ensure that the facility provided a hospital wide infection control program to control and prevent foodborne illness when the dietary staff failed to handle and store food products in a safe manner (A 749). The dietary department failed to identify and implement quality measures for the contracted services by outside vendors for the dishmachine and pest control to prevent foodborne illness (A 264).

2. The governing body failed to ensure proper monitoring of the refrigerator temperature to ensure the integrity of the medications; failed to date medications in vials to ensure safety of the patients receiving the medications; failed to identify and properly label high risk medications for patient safety; failed to ensure that high risk medications were locked and made accessible to only authorized personnel; and failed to ensure that the medication carts had emergency drug supplies readily available (A490). The hospital also failed to administer medications in a timely manner as ordered by the Physician and in accordance to the Physician's order to ensure safety of the patients (A 490, A 500).

The cumulative effects of these systemic problems resulted in the inability of the hospital to ensure the provision of quality health care in a safe environment.

Based on observation, interview, and record review, the hospital failed to implement and maintain an effective, on-going hospital-wide Quality Assurance and Performance Improvement (QAPI) program which focused on indicators related to improved health outcomes and the prevention and reduction of medical errors.

Findings:

1. The QAPI program failed to to include a hospital-wide infection control program designed to control and monitor storage of food and safe handling of food by the dietary staff to prevent foodborne illness. (A 749).
2. The hospital's QAPI program failed to identify and implement quality measures for the dish washing machine and pest control vendors' contracted services to prevent foodborne illness. (A264).
3. The hospital's QAPI program failed to include monitoring of pharmaceutical services to ensure that medications are administered according to the Physician's orders; medications stored at the right temperature to maintain the integrity of the medications; medications dispensed by authorized personnel only, and medications locked for security. ( A 500, A 502, A 505).

The cumulative effect of these system failures resulted in the hospital's inability to implement and maintain an effective QAPI program which met the needs and safety of patients.


21155

Based on interview and document review the hospital failed to have an ongoing quality appraisal and performance improvement program that addressed the complexity and scope of Food and Dietetic Services and areas that would improve patient safety.

Findings:

The quality appraisal and performance improvement (QAPI) activities were reviewed on 1/27/11. It was noted that while the department submitted performance improvement information, the submitted report focused on the hospitals ' customer satisfaction indicators, efficiency of the blast chiller, and timeliness of nutrition assessment of patients. All selected activities in the acute care hospital were at the 99%-100% compliance level.
In an interview on 1/27/11 at 9:45 a.m. with Quality Assurance Officer F, which reported to the governing body, she was asked how the hospital ensured development of departmental improvement programs. She stated that that the committee did not make decisions on the types of activities, rather would rely on departmental leaders to choose the activities. There was no documentation provided to ensure the QAPI program was developed for the scope of the hospital food service that included food safety indicators.
Additionally, the hospital failed to identify quality measures for the contracted services provided by outside vendors for the dish washing machine and pest control and that might impact food safety and food borne illness.

Based on observation, record review and interview, the hospital failed to ensure that medications were administered in accordance with physicians ' orders and accepted standard of practice as evidenced by:

1. Patient 3 was not administered Metroniadazole (an antibiotic) for an infected hematoma until 7 hours after the physician ordered the medication.

2. Patient 6 was administered Ranitidine (a medication for treatment and prevention of ulcers or other digestive tract disorders) when there was no physician order for the medication.

3. Patient 2 ' s intravenous line was not flushed after the administration of hydromorphone (a narcotic medication for pain control).

4. RN 7 administered Arixtra (a blood thinner, a high risk medication) to Patient 4 without a second registered nurse performing an independent double check as required by hospital policy.

Findings:

1. A review of Patient 3 ' s clinical record on 1/25/11 showed that the patient was admitted to the hospital for infected hematoma (swelling with accumulation of blood) versus possible early abscess on 1/22/11. Metroniadazole 500mg (an antibiotic) intravenously every 8 hours was ordered by the physician at 10:40 a.m. on 1/23/11. Patient 3 ' s Medication Administration Record (MAR) showed that the first dose of Metroniadazole was administered at 5:51 p.m. on 1/23/11, 7 hours after the medication was ordered.

The hospital policy and procedures titled "Medication Dosage Administration Time" indicated that medications ordered for every 8 hours should be administered at 8:00 a.m., 4:00 p.m. and at 12:00 midnight. The policy also indicated that if a medication is ordered at 10:00 a.m. to be administered every 8 hours, the first dose should be administered "now" and the following dose would be due at 4:00 p.m.

During an interview at approximately 10:25 a.m. on 1/28/11, Physician 1 stated that if she ordered Metroniadazole every 8 hours, she expected the first dose to be administered as soon as possible according to the hospital policy. Physician 1 also stated it would not be acceptable for an order for Metroniadazole to be administered 7 hours later.

2. During medication administration observation at approximately 8:30 a.m. on 1/27/11, RN 4 was observed administering Ranitidine 150mg (milligrams) one tablet to Patient 6.

A review of Patient 6 ' s clinical record with RN 5 at approximately 2:20 p.m. on 1/27/11 showed that Patient 6 did not have an active physician ' s order for Ranitidine. RN 5 acknowledged that the patient did not have a physician ' s order for Rantidine and should not have been administered the medication.

3. During medication administration observation at approximately 8:22 a.m. on 1/27/11, RN 4 was observed administering hydromorphone (a narcotic medication for pain control) 2 milligrams in 1 milliliter to Patient 2 by slow intravenous (IV) push. RN 4 did not flush Patient 2 ' s intravenous line (plastic tubing inserted through the skin and into a blood vessel) with saline solution after the administration of the medication.

During an interview at approximately 10:08 a.m. on 1/28/11, RN 5, a nursing manager, stated that the hospital did not have a written policy and procedure to address flushing of IV lines prior to and after medication to ensure proper administration. RN 5 further stated that it was her expectation that RN flushed Patient 2 ' s IV line after administration of the hydromorphone.

4. During medication administration observation at approximately 9:17 a.m. on 1/27/11, RN 7 was observed administering Arixtra (a blood thinning medication) 2.5mg (milligrams) by subcutaneous injection to Patient 4. RN 7 did not seek an independent double check by another registered nurse prior to the administration of the medication.

The hospital policy and procedure on high-risk medications anticoagulants (blood thinning medications) including Arixtra are considered high-risk medications. Administration of high-risk medication was required by the hospital to have another professional double-check prior to administration.

Based on observation, interviews and record reviews, the hospital failed to ensure the provision of pharmaceutical services and care that met the needs of the patients as evidenced by:

1. The hospital failed to ensure the proper monitoring of refrigerator temperature to ensure the integrity and effectiveness of medications. Three of 3 staff in Nursing Unit 2B demonstrated incorrect way of monitoring refrigerator temperatures. In addition, two bags of one-liter sterile water were found frozen in the medication storage refrigerator of the malignant hyperthermia supply cart. In the surgery department, the temperature log of the malignant hyperthermia supply refrigerator showed multiple out-of-range temperatures in the month of January 2011 but no action was taken to correct the out-of-range condition. In addition, pharmacy staff failed to identify and address out-of-range temperature during monthly medication storage inspection. (A500)

2. The hospital failed to consistently implement its policy and procedure on multi-dose medication vials (MDV) to ensure patient safety. Undated and inappropriately dated MDV were found in Nursing Unit 2B and Operating Room 3. (A505)

3. The hospital failed to ensure that outdated or otherwise unusable drugs were not available for patient use. Succinylcholine (a paralyzing agent to induce muscle relaxation for tracheal intubation) was stored at room temperature in the anesthesia cart of Operating Room 3 with no indication on the vials of the removal date from refrigeration or an updated expiration date. (A 505)

4. The hospital failed to consistently implement its policy and procedure on high risk medications. Hypertonic (3%) saline, a high risk medication, was stored in the night locker accessible to nursing staff when the pharmacy was closed. In addition, no warning labels were affixed to the bags of hypertonic saline to alert staff of the high risk status as required by the hospital policy. (A500)

5. The hospital failed to maintain records of medications removed from night locker as required by state regulation. (A500)

6. The hospital failed to ensure that drugs were kept in a secure area and locked when appropriate. The chemo cart containing normal saline for intravenous use was found unlocked in the second floor hallway accessible to unauthorized personnel. (A502)

7. The hospital failed to ensure that emergency drug supply was readily available. The malignant hyperthermia cart did not have sufficient sterile water for the reconstitution of dantrolene (a medication for the emergency management of malignant hyperthermia). (A500)

8. The hospital failed to ensure that medication orders were reviewed for appropriateness before the first dose was administered to patients in non-emergent situations. The procedures developed for the after review of physicians ' order by the hospital did not ensure the appropriate review of medication orders when the pharmacy was closed to ensure patient safety. (A 500)

The cumulative effects of these systemic problems resulted in the inability of the hospital to provide pharmaceutical services and care in a safe and effective manner in accordance with the statutorily-mandated Conditions of Participation for Pharmaceutical Services.

Based on observation, interview, document review and record review, the hospital failed to ensure that drugs were controlled and distributed in accordance with applicable standards of practice and consistent with Federal and State law to ensure patient safety as evidenced by:

1. The hospital failed to ensure the proper monitoring of refrigerator temperature to ensure the integrity and effectiveness of medications. Three of 3 staff in Nursing Unit 2B demonstrated incorrect way of monitoring refrigerator temperatures. In addition, two bags of one-liter sterile water were found frozen in the medication storage refrigerator of the malignant hyperthermia supply cart. In the surgery department, the temperature log of the malignant hyperthermia supply refrigerator showed multiple out-of-range temperatures in the month of January 2011 but no action was taken to correct the out-of-range condition. In addition, pharmacy staff failed to identify and address out-of-range temperature during monthly medication storage inspection.

2. The hospital failed to ensure that emergency drug supply was readily available for the management of malignant hyperthermia (MH). There was not sufficient sterile water in the MH cart for the reconstitution of dantrolene (a medication for the management of malignant hyperthermia).

3. The hospital failed to consistently implement its policy and procedures on the high risk medications. Hypertonic saline (sodium chloride 3%), a high risk medication, was stored in the night locker accessible to nursing managers when the pharmacy was closed. In addition, no warning labels were affixed to the bags of hypertonic solution to alert staff of the high risk status as required by the hospital policy.

4. The hospital failed to ensure that medication orders were reviewed for appropriateness before the first dose was administered in non-emergent situations. The procedures developed for the after hour review of physicians ' orders did not ensurethe appropriate review of medication orders when the pharmacy was closed to ensure patient safety.

5. The hospital failed to maintain records of medications removed from the night locker as required by state regulations.

Findings:

1a. During an inspection of the medication storage room in Nursing Unit 2B with Administrative Staff 1 at approximately 10:45 a.m. on 1/25/11, a thermometer that measures temperatures in Fahrenheit (?F) was found inside the medication storage refrigerator. A temperature log sheet for Jan 2011which recorded temperatures in Celsius (a scale of temperature measuring; a different scale from Fahrenheit) was posted on the bulletin board. The temperature log showed that the refrigerator temperature was 4.5 degree (?C) and 4.4 ?C in the mornings of 1/24/11 and 1/25/11 respectively.

During an interview at the time of the inspection, RN1, the nursing unit manager, was presented with the thermometer which read 45?F and was asked how she would record the temperature on the log. RN 1 responded that she would record 4.5?C on the log sheet. By appropriate conversion, 45?F is equal to 7.78?C. After the surveyor pointed out that the thermometer and the log sheet were of different temperature scale, RN acknowledged that she was not aware of the different scales.

During an interview at approximately 10:50 a.m. on 1/25/11, RN 2 stated that she recorded the temperature of 4.5?C on the log sheet on 1/25/11 that morning. When being presented the refrigerator thermometer reading at 50?F (10.5?C), RN 2 stated that she would record the temperature as 5.0?C. RN 2 failed to appropriately interpret thermometer temperature.

During an interview at approximately 11:01 a.m. on 1/25/11, RN 3 stated that he recorded the temperature of 4.4?C on the log sheet on 1/24/11 in the morning. When being asked how he interpreted the temperature on the thermometer, RN 3 stated that he did not know how to read the temperature on the thermometer and therefore he had been copying temperatures from the previous days on the log sheet when he was responsible for temperature monitoring.

The plan of correction submitted by the hospital to the Department of Public Health in December 2010 indicated that in-service education was provided to nursing staff in December 2010 to ensure competency in medication temperature monitoring.

During an interview at approximately 10:50 a.m. on 1/26/11, the hospital Director of Pharmacy (DOP) stated that the hospital had not provided in-service to nursing staff on medication temperature monitoring as stated on the plan of correction.

1b. During a tour of the surgery department stock room with Operating Room (OR) Administrative Staff 3 at approximately 10:30 a.m. on 1/27/11, two 1-liter bags of sterile water were found frozen in the malignant hyperthermia refrigerator adjacent to 0.9 % sodium chloride intravenous solution. OR Administrative Staff 3 stated that the sterile water was not intended to be frozen but was unable to tell what the sterile water was intended for.

Sterile water is identified by ISMP (The Institute for Safe Medication Practices) as a high alert medication. Inadvertent intravenous administration of sterile water has resulted in serious patient harm, including death. The storage of sterile water with sodium chloride 0.9% intravenous solution posed a risk to patient safety.

A review of the January 2011 temperature log of the malignant hyperthermia refrigerator showed out-of range temperatures (desired range 2?C to 8?C) in 7 of 27 days and . In addition, temperature was not recorded in 10 of 27 days. Under the column of " Comments-Actions taken if temp. out of range " , there was no documentation for the days when out of range temperatures were recorded. OR Administrative Staff stated that engineering department should be notified when the refrigerator temperature was noted to be out of range.

The plan of correction submitted by the hospital to the Department in December 2010 stated that temperature in refrigerators used to store medications should be monitored daily.

A review of the pharmacy monthly medication storage area inspection report dated 1/13/11 showed that the pharmacist did not identify and address the out-of-range temperatures recorded on the temperature log sheet.

2. During an inspection of the MH cart with OR Administrative Staff 3 at approximately 10:30 a.m. on 1/27/11, 36 vials of dantrolene and 10 60-ml (milliliters) of sterile water were found in the medication drawer of the cart.

According to Lexi-Comp, a drug information provider for health care professionals, each vial of dantrolene is to be reconstituted with 60 ml of sterile water. By calculation, 2160 ml of sterile water is needed to reconstitute 36 vials of dantrolene.

A review of the hospital MH cart supply list showed that only 4 vials of 100-ml sterile water were to be stored in the cart.

During an interview at the time of inspection, OR Administrative Staff 3 acknowledged that the 10 vials of 60-ml of sterile were not enough for the management of malignant hyperthermia.

3. During an inspection of the pharmacy night locker with Administrative Staff 1 and the hospital Director of Pharmacy (DOP) at approximately 10:30 a.m. on 1/26/11, two 500-ml (milliliters) bags of hypertonic (3%) saline ( a concentrated electrolyte for the treatment of severe low blood sodium; a high risk medication) were found in Drawer C of the night locker. There was no additional labeling on the outer packaging of the solution to denote its high risk status. The DOP stated that nursing managers had access to hypertonic saline when the pharmacy was closed.

The Institute for Safe Medication Practices (ISMP) has identified hypertonic saline (sodium chloride > 0.9%) as a high alert medication since 2005. High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients.

The hospital High Risk Medications policy and procedure last revised and approved in September 2010 was reviewed on 1/26/11. The policy indicated that high risk / high alert medications were medications that were known to be error-prone or which posed a significant hazard to the patient if not properly handled. Hypertonic (3%) saline was listed as one of the high risk/high alert medication identified by the hospital Pharmacy and Therapeutics (P&T) Committee. The policy also stated that " high risk medications would be stored with additional labeling to make them more obvious to personnel. " Concentrated sodium chloride including hypertonic saline (sodium chloride 3%) should be stored in the pharmacy and with warning" intended for patients with severe hyponatremia, NOT for hydration " .

4. During an interview at approximately 3:15 p.m. on 1/25/11, RN 8 stated that he was in charge of training nursing staff on the new procedures for physicians ' medication orders review when the pharmacy was closed. RN 8 stated that he was given a hand-out as an educational material by the hospital director of pharmacy (DOP) which provided guidance on when pharmacist should be contacted after hour to review and approve medication orders. RN 8 added that majority of the after hour physicians' orders did not warrant the contact of the on-call pharmacist for after-hour review according to the hand-out. RN 8 gave an example that if a patient was on Metformin (a medication for diabetes control) prior to admission to the hospital, a new physician order for Metformin upon admission would not be considered a new orders and therefore, the medication could be administered without a pharmacist's review and approval.

Metformin is a medication for the management of diabetes. A boxed warning was issued by the FDA (Food and Drug Administration) associated with the use of Metformin and lactic acidosis, a life-threatening condition. Lactic acidosis is a condition caused by too much lactate in the blood and high acidity of the blood. Discontinuation of metformin therapy is warranted in clinical situations predisposing patients to hypoxemia (low blood oxygen), including conditions such as cardiovascular collapse, respiratory failure, acute myocardial infarction (heart attack), acute congestive heart failure, and septicemia (blood infection). The risk of accumulation of lactate and lactic acidosis increases with reduced renal (kidney) function. Hence, continuation of metformin therapy upon hospital admission should be carefully evaluated due to the acute changes of the patients' health conditions, which may increase the risk of lactic acidosis.

The ASHP (American Society of Health-System Pharmacists) published guidelines on minimum standard for pharmacies in hospitals indicated that all prescribers ' medication orders (except in emergency situations) must be reviewed for appropriateness by a pharmacist before the first dose is dispensed. Any questions regarding the order must be resolved with the prescriber at this time, and a written notation of these discussions must be made in the patient ' s medical record or pharmacy copy of the prescriber ' s order. Information concerning changes must be communicated to the appropriate health professional.

In additional, the educational material provided by RN 8 showed the following example:

"New medication order for Protonix - this can wait until pharmacy opens in am - no need to contact pharmacist after hour."

During an interview at approximately 10:28 a.m on 1/28/11, Physician 1 stated that if she prescribed Protonix for a patient who was admitted in the evening for stomach bleeding, she would expect the medication to be administered as soon as possible. According to the educational material provided by the hospital, Protonix would not be administered until after the pharmacist reviewed the order the next morning, contrary to Physician 1's expectation of prompt initiation of therapy. Physician 1 also stated that waiting for the pharmacy to reopen to administer the first dose of protonix in such case would not be acceptable.

The hospital's new procedures on after-hour medication order review by pharmacists failed to ensure the appropriate review of physicians' orders prior to administration.

5. During an inspection of the medication night locker with Administrative Staff 1 and DOP at approximately 10:30 a.m. on 1/26/11, the DOP stated that the pharmacy did not maintain record of medications removed from the night locker. The DOP stated that the nursing manager would leave a copy of the physician ' s order in the night locker when removing medications from the night locker and such orders would be reviewed by the pharmacist the following morning ad then the order would be filed away.

California Code of Regulations, Title 22, 70263 (n) stipulates that records of drugs taken from the night locker shall be maintained. The record shall include the name and strength of the drug, the amount taken, the date and time, the name of the patient to whom the drug was administered and the signature of the registered nurse.

Based on observation, interview and document review, the hospital failed to ensure that drugs and biologicals were kept in a secure area. A chemo supply cart containing medications was unlocked and left unattended in the hospital hallway.

Findings:

During a tour of the nursing units on the second floor with RN 5 at approximately 9:38 a.m. on 1/27/11, a chemo supply cart was found unlocked and unattended in the hallway between Nursing Unit 2A and 2B. Upon inspection of the chemo supply cart, saline flush syringes and 2 bags of 250-ml normal saline for intravenous infusion were found in the drawers. RN 5 acknowledged that the cart should be locked to prevent unauthorized access to the drug and supply stored in the cart to ensure patient safety.

Based on observation and interview, the hospital failed to ensure that outdated or otherwise unusable drugs were not available for patient use as evidenced by:

1. Mulitidose medication vials were not dated after initial opening in the medication room of Nursing Unit 2B.

2. Expired drugs were found in the anesthesia cart available for patient use.

3. Succinylcholine (a paralyzing agent to induce muscle relaxation for tracheal intubation) was stored at room temperature in the anesthesia cart in Operating Room 3 with no indication of removal date from refrigeration or revised expiration date.

Findings:

1. During a tour of the medication storage room of Nursing Unit 2B with Administrative Staff 1 at approximately 11:05 a.m. on 1/25/11, one opened vial of 20-ml (milliliters) lidocaine (a local anesthetic) 1 % was found in Patient 1 ' s medication drawer with no indication of opening date or revised expiration date.

A review of the hospital multidose medication vials policy and procedures on 1/26/11 showed that the individual who first punctured the vial must label the vial with the new expiration date 28 days after the initial opening date.

2. During an inspection of the anesthesia cart in Operating Room 3 at approximately 10:00 a.m. on 1/27/11, one 20-ml vial of lidocaine 1 % with an expiration date of 1/11/11 and one vial of flumazenil (a reversing agent for sedative overdose) 5mg/0.5 ml with an expiration date of 1/24/11 were found in the anesthesia cart available for patient use. Operating Room Administrative Staff 3 stated that the expired drugs should have been removed from the cart.

3. During an inspection of the anesthesia cart in Operating Room 3 at approximately 10:00 a.m. on 1/27/11, two 10-ml vials of succinylcholine 20mg/ml were found in the medication drawer of the cart at room temperature. There was no revised expiration date or any indication on the vials of the date when the medications were removed from refrigeration. Operating Room Administrative Staff 3 stated that the identified succinylcholine were not suitable for patient use.

According to Lexi-Comp, a drug information provider for health care professionals, succinylcholine is recommended by the manufacturer to be stored under refrigeration at 2?C to 8?C (36?F to 46?F) and may be stored at room temperature for 14 days.

Drugs and biologicals should be stored according to the predetermined conditions as supported by stability data. The failure of the hospital to store drugs at their recommended storage condition had the potential of impacting the safety and effectiveness of the drug products.

Based on observation, interview and document review the hospital failed to ensure that dietary services met the needs of all patients by handling food safely to prevent foodborne illness; follow and implement food safety indicators; availability of a diet manual as reference for ordered therapeutic diets.
Findings:
1. The hospital failed to provide organized dietetic services as evidenced by findings of unsafe food handling practices and supervision of the dietary department (Cross Reference A620).
2. Develop performance improvement activities that reflected the scope and nature of the services and that would include food safety indicators (Cross Reference A264).
3. Ensure a diet manual for medical nutrition therapy that provides guidance on the therapeutic diets provided by the hospital and specific to the patient population and has been approved by the medical staff and the registered dietitian and has been revised within the past five years(Cross Reference 631).
4. Ensure the development of comprehensive policies and procedures that reflected the scope and nature of services (Cross Reference A 619, A620, A749)

The cumulative effect of these systemic problems resulted in the inability of the hospitals ' food and nutrition services to direct and staff in such a manner to ensure that the nutritional needs of the patients ' were met in accordance with practitioners ' orders and acceptable standards of practice.

20245

Based on dietetic services observations, dietary management staff interview and dietary document review the hospital failed to ensure the department was organized in a manner to ensure safe food handling practices, and to provide therapeutic diets as ordered by the physician. Failure to implement safe food handling practices may result in food borne illness, further compromising patient medical status. Failure to provide the therapeutic diet may result in the patient receiving foods that would further compromise their frail medical condition.

Findings:

During comprehensive review of the hospitals ' food service systems it was noted that dietary management staff failed to ensure an organized food and nutrition department that included safe food handling practices as evidenced by, lack of procedures to ensure safe storage of refrigerated foods over time, use of conflicting temperature taking equipment, lack of food service staff with recent training in food safety lack of policies and procedures for safe cool down (Cross Reference 749) and lack of a diet manual approved by the registered dietitian and the medical staff and revised at least every five years (Cross Reference 631).

1. On 1/27/11 the hospital provided a document Food Storage dated 3/10/2010 that specified all food items would be labeled with four pieces of information in the following manner: name of item, when prepared or removed from the freezer, by whom, use by date. During refrigerated food storage observations on 1/25/11 between 10:40 a.m.-11:45 a.m., foods were noted to be labeled with a single piece of information: the use-by date. The Food Storage policy also specified cooked foods are stored for 72 hours and then discarded. Based on observations and concurrent interview with (Dietary Management Staff) DMS A on 1/25/11 between 10:40 a.m. - 11:45 a.m., the hospital practice was to retain and serve patients cooked potentially hazardous foods for up to 10 days after preparation (Cross reference 749).

2. During kitchen observations at 10:45 a.m.-11:45 a.m. on 1/25/11, the walk-in refrigerator #77 temperatures were observed to be 39?-40?F based on an internal portable thermometer and a second electronic probe. Additionally a Temperature Log completed by dietary staff in the a.m. and p.m. on a daily basis indicated the temperature to be 36?-40? F for the month of January, 2011. DMS A obtained the temperature of refrigerated foods (cooked chicken thighs and legs) using an infrared thermometer and recording the surface food temperature through plastic wrap and stated the temperature was actually 32? F. Concurrently, the surveyor obtained temperature of the same cooked chicken with a calibrated, digital thermometer and determined the temperature to be 39?F. During the duration of the survey 1/25/11-1/28/11, DMS A continuously expressed the infrared thermometer was accurate, rather than the other thermometers. He stated he always relied on the infrared thermometer reading and the county used one and it was accurate. When asked by the surveyor how the infrared thermometer accuracy was determined, DMS A revealed the hospital did not have procedures for determining thermometer accuracy.

3. On 1/27/11 at 11:15 a.m. during an interview regarding cool down, DMS A stated the hospital did not have any procedures to ensure safe cool down of potentially hazardous foods (Cross reference 749).

4. On 1/27/11 at 1:30 p.m. DMS A acknowledged no food service staff had recent training in food safety. He stated (Dietary Staff) DS C, a registered dietitian had recent training in food safety. However, during an interview on 1/25/11 at 2:30 p.m., DS C had stated her position was strictly clinical, and she did not provide food safety consultation in the kitchen.

5. On 1/26/11 during medical record review of a patient with a diet order for a renal diet, DS B stated she was unable to say what the patient would receive on the tray because the hospital no longer had a diet manual, although there had been one several years ago. DS B stated they would have to print out a tray card to see what any patient diet would receive. Additionally, DS B stated the diets were "old fashioned" and not up to date, for example the diabetic diets were not based on carbohydrate counting."

On 1/27/11 at 10:30 a.m. DMS A provided a document "Menu Support Diet Manual" printed from the tray card system. The document had not been revised in the past five years, and had not been approved by the registered dietitian and medical staff for use with the patient population in the hospital.

20245

Based on food production observations, dietary staff interview and dietary document review the hospital failed to ensure dietary management staff provided effective oversight into food services as evidenced by 1) the lack of a qualified food and nutrition director, 2) lack of an effective system to ensure time/temperature control for potentially hazardous foods in refrigeration; and 3)lack of a diet manual to provide guidance to medical staff when ordering therapeutic diets for patients with nutritional diagnoses.

Findings:

1. On 1/25/11 during interview and personnel document review with Dietary Management Staff A, it was revealed he had not completed requirements for his position as required by California state law. DMS A acknowledged he had failed to complete all requirements.

2. On 1/25/11 during food service observations between 10:40 a.m. and 11:45 a.m. it was revealed the hospital had a blast chiller, cold food trayline, and re-therm food carts to heat and transport meals to the patients. During concurrent interview, DMS A stated the hospital had a "Cook-Chill system" of food service. However during refrigerated food storage observations, it was revealed the hospital did not have all the components to chill and store prepared hot foods that would allow for extended refrigerated food storage times. The hospital did not have the bags where hot foods would be transferred to and sealed from all air contact, and then cooled quickly and refrigerated between 28?-32? F as recommended in the "Memorandum to Cook-Chill Prospects" that the hospital provided as the policy and procedure for food storage. This resulted in the hospital retaining potentially hazardous foods for longer than safe (Cross reference 749).

3. On 1/26/11 at 2:30 p.m. it was revealed the hospital did not have a diet manual approved by the registered dietitian and the medical staff. DMS A stated the hospital had purchased a "system about three years ago" that had everything, but they did not know where all the parts were such as the diet manual.

Based on observation, interview and medical record review the hospital failed to ensure that 1 patient (Patient 20) in a sample of 2 patients reviewed for nutrition care received their physician ordered nutritional intervention because the facility did not have a diet manual that was approved by the dietitian and the medical staff. Failure to provide for identified nutritional needs may result in further compromise of medical status.

Findings:

Patient 20's medical record was reviewed on 1/26/11 at 11:45 AM. Patient 20 had a diagnosis of end stage renal disease and had a Physician's order for renal diet. During a concurrent interview with the surveyor regarding what foods would be allowed on a renal diet, Dietary Staff B stated her expectation would be 60 grams of protein, low potassium and low phosphorus. "However" she stated, "I'm not sure exactly what the computer would say, because there was no diet manual. We would have to print out a tray card and then see what it says." DS B stated there was a diet manual several years earlier but it was no longer there. DS B said the computer program is being used to print tray cards.

At 2:45 p.m. on 1/26/11 DMS A acknowledged the lack of a hospital diet manual that had been approved by the registered dietitian and the medical staff and revised every five years at a minimum and provide guidance to dietary staff on the foods to be provided to patients with medical diagnoses to complement the medical condition. During a concurrent interview, DS B stated the foods served to patients were not correct, particularly for diabetic and renal patients.

Based on observation, interview and document review the facility failed to develop and implement safe food storage and food preparation systems to avoid sources and transmission of infections as evidenced by:

1. Failure to provide safe/effective dietetic services as evidenced by findings of unsafe food storage and handling practices (Cross Reference A620 and A749).

2. Failure to provide a hospital wide infection control program to conduct effective surveillance that would prevent the transmission of food borne infections in the dietary department (Cross Reference A 749)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

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21155




20245

Based on refrigerated food storage observations of food storage cooked meats, cereals, and vegetables, dietary staff interview, and dietary document review, and infection control document review, the hospital failed to ensure comprehensive systems to minimize the risk of food borne illness as evidenced by: lack of an effective system to store refrigerated foods prepared in the hospital, and failed to incorporate food safety practices in the hospital wide infection control program.

Additionally the hospital failed to identify safe refrigerated storage times for prepared frozen food items once they were taken out of the freezer and put in refrigerated storage

Findings:

On 1/25/11 between 10:40 a.m.-11:55 a.m. during the initial kitchen tour the following was observed:

1. In the produce refrigerator:

a. A box of sliced mushrooms dated 1/20 that were brownish in color and open to the air. Dietary Management Staff (DMS) A stated the mushrooms were still good to use. Review of the packing box holding the mushrooms revealed the mushrooms were good for 4 days when held at 40?F. Review of the temperature of the refrigerator log revealed the refrigerator temperature was 38-40?F for the month of January.
b. Minced beef salad and minced tuna salad, dated 1/30. During a concurrent interview, DMS A stated "Those are made without mayonnaise, so they are good for five days. On 1/

2. In walk-in refrigerator D there were three two-inch deep pans of cooked breakfast cereal labeled "Use by 1/30".

3. In walk-in refrigerator 77 there were:
a. Five pans of cooked chicken legs and thighs covered with thin, clear plastic wrap, all dated 1/30.
b. Three pans of cooked puree bread covered with thin, clear plastic wrap, dated 1/30, and
c. Four pans of cooked mashed potatoes covered with thin, clear plastic wrap, dated 1/30.

During a concurrent interview, DMS A stated he the hospital policy was to date foods with the use-by date which was 10 days after it was prepared. He further stated he could keep the food for 45 days because the hospital had a blast chiller to quickly chill foods. But, he stated, he had decided to just keep it for 10 days instead of 45 days allowed. On 1/25/11 DMS A provided the undated document "Memorandum- To Cook-Chill Prospects" that he stated was the policy that allowed the hospital to keep prepared foods for 45 days. The document introductory paragraph read as follows "The purpose of this document is to provide prospects with a better understanding of the process of packing kettle pump casings. We are not certified food technicians and cannot make recommendations regarding food handling or storage." Further information provided in the document revealed the storage/shelf life of food prepared in casings and refrigerated from 28?-32? may range from 30-45 days depending on the menu item and how quickly chilling occurs. During an interview on1/26/11 at 3:00 p.m. DMS A acknowledged the hospital did not use casings as described in the memorandum and did not have refrigeration that maintained 28?-32?F. He acknowledged the hospital did not use any of the methods for chilling as described in the memo.
According to the 2009 Federal Food Code the refrigerated shelf life of prepared foods is 3 to 5 days depending on the food. Additionally on 1/29/11 the hospital provided a Food Storage policy that specified prepared foods would be discarded after 72 hours

4. In walk-in refrigerator A&B there were two 12-pound boxes of thawed New England clam chowder dated 1/10/11 and boxes with manufacturer's stamp "Keep Frozen."

In walk-in refrigerator A there were two partially used cases (originally containing 75 shakes each) of a thawed prepared strawberry and chocolate shakes, both dated 1/7, and boxes with manufacturer's stamp "Keep Frozen".

During concurrent interview, DMS A stated he did not know how long the products were safe to use when removed from the freezer. DMS A stated the hospital had no food policy for safe food storage times for foods when thawed. The shake manufacturer revealed the shakes have a 14 day shelf life once thawed. DMS A did not provide safe shelf life information from the clam chowder manufacturer prior to the survey exit on 1/27/11.

5. Two whole cooked turkeys in two separate original 6-inch deep cooking pans surrounded by solidified opaque substance approximately two inches up the sides of the turkey. DMS A stated "those were cooked yesterday." When asked by the surveyor to show how the turkeys had been cooled down, DMS A stated the cook should have written the food temperatures on the cooling log. Upon review of the temperatures on the cooling log located adjacent to the blast chiller, it was observed there were no temperatures for the turkey. DMS A stated the staff who had cooked the turkey was here today. During an interview, Dietary Staff D stated he had taken the turkeys directly out of the oven and put them in the blast chiller to chill in the cooking pans, hot liquids and all. The industry standard for cooling cooked meats is to remove them from the original roasting pan without the juices, and cut them into smaller pieces to ensure quick cooling.
He stated he had the temperature information somewhere else. On 1/25/11 at DS D provided a separate log to indicate the cooling temperatures of the turkey. DMS A state "I don't know why he wrote on that paper."

On 1/27/11 at 3:30 p.m. DMS A revealed the hospital did not have a policy or procedures for safely cooling foods.

6. One pan of thawed raw hamburger patties over ready to eat hamburger buns and cheese. During a concurrent interview, DMS A stated "The raw meat should probably be under the buns and the cheese."

On 1/27/11 beginning at 10:20 a.m. the (ICP) Infection Control Preventionist E was interviewed regarding how food and nutrition services were monitored as part of the hospital wide infection control program. ICP E stated "That's not part of the infection control area. We just do the new hire orientation. DMS A is responsible for ensuring prevention of food borne illness. We haven't had any problems."

Additionally ICP E stated the infection control committee did not have Environment of Care Rounds to oversee infection control practices throughout the hospital, but that she herself did rounds every day. She stated "I check the refrigerator temperature logs in the kitchen." She acknowledged the hospital infection control program did not encompass food safety systems in the food and nutrition services department.