HospitalInspections.org

Based on staff interview, record review, and document review, the hospital failed to ensure that an effective governing body (GB) is responsible for overseeing the conduct of the hospital in the provision of patient care as evidenced by deficiencies cited throughout the survey as follows:

Findings:

1. The GB failed to develop, implement, and maintain an effective, ongoing, hospital-wide data-driven quality assessment and performance improvement (QAPI) program (See A263,).

2. The GB failed to develop, implement, and maintain an effective, ongoing, hospital wide-data driven infection control program to provide a sanitary environment and to avoid transmission of infections and communicable diseases (See A747, A748, A749, and A264).

3. The GB failed to ensure that the availability of organized dietetic services are directed and staffed by adequately qualified personnel and The GB failed to ensure that there was no unsafe food handling practices and lack of effective monitoring of potentially hazardous and provide effective sanitation of food production surfaces (See A619, A620, A622, and A749).

4. The GB failed to ensure that the nutritional needs of patients are met (See A628 and A629).

The cumulative effect of these systemic failures resulted in the failure of the hospital to deliver statutorily mandated compliance with the Condition of Participation for Governing Body.

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Based on observation, staff interview, and record review, the hospital failed to implement and maintain an effective , hospital-wide, data-driven quality assessment and performance improvement (QAPI) program that identified and addressed systemic problems in dietary and infection control program as follows:

Findings:

1. The hospital failed to ensure:

a. That the dietetic services were directed and staffed by qualified personnel.

b. That handling of potentially hazardous food was effectively monitored.

c. That kitchen equipment and food storage areas were clean.

d. That stationary food contact surfaces were effectively sanitized.

e. That the nutritional needs of patients were met.

f. That there was accurate distribution of physician ordered therapeutic diets to ensure staff competency for duties associated with food production activities.

(See A618)

2. The hospital failed to ensure implementation of a comprehensive nutritional services performance improvement program that included improvement indicators relative to the current scope of service as evidenced by:

a. Performance improvement activities with no identified problem and b. Lack of performance improvement activities surrounding identified food service issues (See A264).

3. The hospital failed to ensure delivery of enteral feeding in a manner that met the nutritional needs of patients, ensure implementation of effective systems of for food safety of previously cooked foods and stored foods (See A747).

5. The hospital failed to develop hospital-wide measures governing identification, investigation, reporting, prevention, and control of infections and communicable diseases that were specific to each department that included laboratory services, radiology services, and physical therapy services to prevent the transmission of communicable diseases (See A264).

6. The hospital failed to conduct random audits of their glucometers to ensure compliance and to prevent the transmission of communicable diseases (See A264).

The cumulative effect of these systemic problems resulted in the hospital's Quality Assessment Performance Improvement program's inability to ensure the provision of quality care and meet mandated compliance with the Condition of participation for Quality Assessment Performance Improvement. The Condition of QAPI was not met.

Based on quality staff interview, and document review, the hospital failed to ensure:

1. That a comprehensive dietary department performance improvement program that included indicators relative to the current scope of service as evidenced by:

a. Performance improvement activities with no identified problems.

b. Lack of performance improvement activities surrounding identified food service issues.

2. Develop hospital wide measures governing identification, investigation, reporting, prevention and control of infections and communicable diseases that were specific to each department that included laboratory services, radiology services, and physical therapy services to prevent the transmission of communicable diseases.

3. Conduct random audits of their glucometers to ensure compliance and to prevent the transmission of communicable diseases.

Findings:

Food and Nutrition Services

1. On 2/11/10 at 10:15 a.m., dietary department performance improvement activities were reviewed in conjunction with quality staff that included all administrative staff. In a concurrent interview hospital administrative staff was asked how performance improvement activities were determined. They stated that within the dietary department there were per-selected indicators for areas of improvement. Upon inquiry regarding how the quality process was done, the staff stated that the hospital utilized what was referred to as the "dashboard" which was consistent with accreditation performance activities. The staff also stated that individual departments would submit performance improvement activities and the quality committee would decide which of those elements would be forwarded to medical staff and governing body. The committee additionally stated that departments could develop their own indicators that were reflective of the scope of the individual departments.

Concurrent review of the document titled "2008 Department Performance Improvement Indicators Summary," revealed that for nutritional services the selected indicators were quality and temperature of the food as well as courtesy of the person serving the food. Review of this performance measure revealed that the department did not meet the target goal of 60% compliance, rather noted a 56% compliance rate. It was also noted that the plan was to continue to monitor the elements with the same action plan and "...implement our new 90 day plan." There was no documentation of any nutrition care performance improvement activities.

Review of the document titled "2009 Department Performance Improvement Indicators Summary," for January-August 2009, revealed that the nutritional services report consisted of completion of nutritional risk triggers. It was also noted that the targeted rate of compliance was 100%. The resulting compliance was noted to be an average of 82%. It was also noted that the committee commented that there was a new nutrition screening checklist was being used; however there was no documentation as to how the hospital would meet the desired compliance rate. It was also noted that despite an unacceptable target rate, per hospital criteria, for nutritional services in 2008, there was no documentation that the hospital continued to collect data or evaluated the effectiveness of interventions. Similarly, for 2009, the hospital documented that there was updated nursing admission assessments being used on some of the units, there was no documented intervention to ensure the assessments were completed thoroughly and accurately. It was also noted that there were no performance improvement activities related to safe food handling practices or nutrition support.

The Food and Nutrition Services staff submitted additional quality indicators for 2009. It was noted that the indicators being monitored were food safety temperature logs and nutritional assessment for high risk patients. It was also noted that during 2008 and 2009 all of the reviewed elements resulted in a 97-100% compliance rate. The exceptions were the nursing admission assessment nutrition trigger and completion of nursing orders for a nutrition consult. However, despite identification of these areas of concern, there was no documented comprehensive plan to implement corrective actions or to evaluate the effectiveness of any actions. While the hospital completed performance improvement activities they did not fully reflect the depth and extent of departmental functions.






17151

Infection Control

2. During an interview on 2/8/10 at 1:30 p.m., Radiology Staff CC was asked how does the hospital monitor infection control practices in radiology, Radiology Staff CC stated that if there is a problem they notify the Infection Control Practitioner. Radiology Staff CC could not explain what the department specific practices were for monitoring and evaluating infection control practices.

During another interview on 2/8/10 at 2:35 p.m., Laboratory Staff DD was asked how the hospital monitors infection control practices in the laboratory, Laboratory Staff DD could not explain how explain how infection control practices are monitored in the laboratory. Laboratory Staff DD stated that they have safety checks but she could not state what department specific evaluations were conducted that were related to department specific infection control practices on the (Environmental of Care (EOC) rounds.

During an interview on 2/8/10 at 2:55 p.m., with Radiology Staff EE who is working on the Magnetic Resonance Imaging (MRI-Use to visualize detailed internal structure and limited function of the body) mobile unit, which is adjacent to the hospital, indicated that she has not seen the Infection Control Practitioner since she left in August 2009, and could not say when the Infection Control Practitioner was last out in the trailer or what she was monitoring. Radiology Staff EE stated that Human Resources conducts the infection control checks.

During an interview on 2/9/10 at 3 p.m., Physical Therapy Staff AAA was ask how the hospital monitors infection control practices of the physical therapy staff. Physical Therapy Staff AAA stated that the EOC rounds are conducted monthly. Physical Therapy Staff AAA could not state what department specific evaluations were conducted that were related to infection control practices on the EOC rounds.

Review of the EOC rounds did not include a department specific infection control component to address who, when, and what the hospital was evaluating that related to infection control practices in the above mentioned departments.

During an interview on 2/11/10 at 10:30 a.m., Administrative Nursing Staff E was asked how the hospital evaluates and monitors infection control practices for radiology, laboratory, and physical therapy. Administrative Staff E stated that they did not have what was requested. The hospital did not have a hospital wide infection control program to provide oversite of the infection control practices in laboratory, radiology, and physical therapy to prevent and control hospital infections.

The policy and procedure titled "Infection Control Program," revised 12/09, indicated that all departments, services, and staff are part of the Infection Control Program. and this includes the management of critical data and information, including surveillance of Hospital Acquired Infections (HAI). To recommend and establish policies and procedures. To maintain an effective, hospital-wide system for surveillance, prevention and control of infections at this hospital.

3. During an interview on 2/11/10 at 10:30 a.m., Administrative Nursing Staff E was asked how it was determined that licensed nursing staff were 100% compliant with the manufactures's guidelines for cleaning the glucometers, Administrative Nursing Staff E stated that the nursing managers of each nursing department are responsible for in-servicing licensed nursing staff regarding the correct procedures for cleaning glucometers. Administrative Nursing Staff E stated that the nurse managers documented it on an audit record and sign their names.

Interviews on 2/8/10 with licensed nurses did not indicated that the licensed nurses were following the facility's policy and procedure and the manufacturers recommendations when cleaning the glucometers.

There was no documented evidence that the Nursing Administration conducted random audits to ensure compliance with their policy and procedure.

Based on staff interview, record review, and document review, the hospital failed to ensure orders for Parenteral Nutrition (PN) for Patient 303 were dated, timed, and authenticated promptly by the ordering physician over a period of six days. This failure had the potential to cause delays in Patient 303's therapy, which may have prolonged his malnutrition and contributed to delays in the management of his electrolyte and fluid imbalance.

Findings:

Review of Patient 303's record on 2/10/10, with Staff L revealed that Patient 303 was admitted on 2/2/10 to the Intensive Care Unit (ICU) with diagnoses of hypertension (high blood pressure), pneumonia (infection of the lungs), stroke (is the rapidly developing loss of brain function (s) due to disturbance in the blood supply to the brain), congestive heart failure (Heart failure), hypernatremia (electrolyte disturbrance that is defined by an elevated sodium level in the blood), malnutrition, and pressure ulcers on both feet. Review of the physician's written and verbal orders for Total Parenteral Nutrition (TPN) revealed the following:

1. A verbal order on a pre-printed physician's order dated 2/4/10 at 9:00 a.m. indicated TPN was to be administered at a rate of 75 milliliters (ml) per hour. The physician signed the order but did not date or time his signature.

2. The pre-printed physician's order "Parenteral Nutrition TPN/PPN," dated 2/5/10 at 11:20 a.m., indicated that TPN was to be administered at the rate of 75 ml per hour. The order was signed by the pharmacist and cosigned by the physician. The physician did not date or time his signature.

3. A physician order dated 2/7/10 at 10:00 a.m., indicated to administer parenteral nutrition at the rate of 75 ml per hour. The order was signed by the pharmacist and cosigned by the physician. The physician did not date or time his signature.

4. Physicians Orders dated 2/8/10 at 1:00 p.m. for central parenteral nutrition indicated to administer the TPN at the rate of 50 ml per hour. The order was signed by the pharmacist and cosigned by the physician. The physician did not date or time his signature.

5. A handwritten entry dated 2/9/10 at 7:55 a.m., in the Physician's Order section indicated that the Nutrition Recommends decrease PN to 50 ml per hour (Amino Acid 4.25 percent [%] solution [a protein source]; Dextrose 20% in water solution [a carbohydrate source], and lipid 20% solution [a fat source]). Below the entry was a handwritten checkbox "yes" and "no". Below the check yes or no boxes, there was an "X" with a line beside it that indicated "MD signature". The order was signed by the physician but not dated or timed.

6. Physicians Orders dated 2/9/10 at 12:00 p.m. for parenteral nutrition indicated to administer at the rate of 50 ml per hour. The order was signed by the pharmacist and cosigned by the physician. The physician did not date or time his signature.

During an interview on 2/11/10 at 10:00 a.m., Staff L stated that the pharmacists' orders had to be cosigned by a physician and signed and dated by the physician.

Based on document review and staff interview, the facility failed to ensure that 94 or 94 physicians completed their medical records within 14 days of patient discharge, per "Medical Staff Bylaws, Rules and Regulations." This failure had the potential to result in records that lack vital patient health care data.

Findings:

On 2/10/2010 at 1:30 p.m., a review of the "Medical Staff Bylaws," pages 37 and 38, #6.3-5 indicated that the "...Medical Records-For failure to complete medical records in timely fashion, a practitioner's clinical privileges (except with respect to patients already in the hospital), his rights to admit or treat patients and to consult with respect to patients, and his voting and office-holding prerogatives shall, after written warning of delinquency, be automatically administratively suspended and shall remain suspended until medical records are completed (see medical staff rules and regulations for procedure)..."

On 2/10/2010 at 2:35 p.m., a review of the "Medical Staff General and Departmental Rules and Regulations, " page 8, #1.6-10 revealed the following: "...The medical record shall be complete within 14 days following discharge, including progress notes, final diagnosis, dictated resume and signatures. ...........Charts will be considered delinquent on the fourteenth day after discharge. Practitioners whose charts are delinquent at that time will be subject to temporary suspension of admitting privileges. The suspension will remain in effect until all delinquent charts are completed..."

On 2/10/2010 at 3: 30 p.m., a review of the "Medical Record Suspension List," revealed that there were no physicians on suspension. Staff Member YYY stated during a concurrent interview that physicians are notified on a weekly basis of delinquent records.

On 2/11/2010 at 10:30 a.m., an audit of the "MIRA-Chart Analysis-Incomplete Deficiencies by Physician," printed on 2/9/2010, revealed that there were 94 physicians with 345 delinquent records. The oldest record dated back to 3/24/09.

Based on observation, policy and procedure review, document review and staff interview, the hospital failed to ensure: 1. That the medication's were stored in refrigerators and warmers in accordance with the manufacturer's recommendations and their policies and procedures. This failure to store medications within the required temperature ranges in 1 of 3 refrigerators in the central pharmacy had the potential to result in deteriorated and ineffective medications and 2. That the past use date system was implemented for irrigation solutions stored in warmers in the Operating Room. This failure had the potential to expose surgical patients to more concentrated saline solutions than ordered by the physician.

Findings:

1. During a medication storage inspection of the inpatient pharmacy on 2/8/10 at 10:35 a.m. Staff L acknowledged that the hospital's policy mirrored the state requirements for medication refrigeration 36 degrees (?) Fahrenheit (F) - 46 ?F. The Health Logistics monitor readings showed temperatures for Refrigerator 1; had been out of range (too cold - less then 36 ?F) for 8 days between 2/1/10 and 2/8/10. A review of the temperature record on 2/8/10 indicated the following range of temperatures for Refrigerator 1:

2/1 32 ?F to 42 ?F
2/2 32 ?F to 43 ?F
2/3 35 ?F to 43 ?F
2/4 35 ?F to 43 ?F
2/5 33 ?F to 44 ?F
2/6 33 ?F to 43 ?F
2/7 33 ?F to 44 ?F
2/8 33 ?F to 44 ?F

During an interview on 2/8/10 at 10:40 a.m., Staff L stated that Refrigerator 1 had readings too cold since the beginning of the month. Staff L stated that the minimum/maxim (min-max) mode reflected the range of temperatures recorded since the last reading. He stated that an alarm sounds when low and high settings are exceeded. An observation of the "Hi-Lo" setting showed the monitor was set to alarm when temperatures exceeded 70 ?F - 87 ?F. Staff L was unable to explain why the monitor's "Hi-Lo" settings were observed at 70 ?F - 87 ?F, instead of 36 ?F - 46 ?F. Staff L stated that the settings should be set at 36 ?F - 46 ?F.

During an interview on 2/8/10 at 10:45 a.m., Staff M was shown the refrigeration logs for February 2010. Staff M was unable to identify from the documents that temperatures had been out of range according to hospital policy, "...I don't see anything out of range..." Staff M acknowledged that she was unfamiliar with the technology of the monitor, "...I don't know what "Hi-Lo" means. I can't even speculate..."

According to the manufacturer's guidelines the min-max range refers to the actual range of temperatures recorded during continuous monitoring since the machine was last cleared. The "Hi-Lo" range refers to the alarm settings (The usual standard of temperatures is between 36 ?F - 46 ?F for medication refrigeration). The standards do not vary.

During an interview on 2/8/10 at 10:50 a.m., Staff L stated that it is the expectation that when a technician is recording the refrigerator temperatures and finds the temperatures out of the acceptable range, that they would notify the pharmacist. Staff L acknowledged that temperature fluctuations had the potential to compromise the integrity of some of the medications, particularly vaccines.

On 2/10/10, a review of the inventory list for of the contents of Refrigerator 1 taken on 2/8/10, showed vaccines for pneumonia (abnormal inflammatory condition of the lung), influenza (infectious and contagious viral respiratory illness usually occurring in the winter), and tetanus (also called lockjaw, is a medical condition characterized by a prolonged contraction of skeletal muscle fibers).
During an interview on 2/10/10 at 2:30 p.m., Staff L acknowledged that vaccines were susceptible to deterioration when stored under fluctuating temperatures. Staff L stated that the policies needed to be developed further to ensure patients are not affected by improperly stored medicines in the future.

Review of the policy and procedure titled "Refrigerator Temperature Policy and Procedure," revised 7/2009, on 2/10/10, indicated that "...all drug storage refrigerators will be checked by pharmacy personnel for proper temperature..." It also indicated that "...Refrigerators that are not within the prescribed temperature limits, shall be reported to the unit coordinator responsible for that refrigerator..." "...if at any time a refrigerator is found to be out of the acceptable range (36 ?F - 46 ?F) and does not return to the appropriate range within 1 hour, Engineering and Pharmacy must be notified..."

2. During a tour of the Operating Room (OR) medication storage area with Staff LLL on 2/8/10 at 11:35 a.m., Staff L, and Staff MMMM, revealed that five (5) one (1) liter bottles of a Sterile Solution used for irrigation were observed in the warmer with green stickers affixed. Four (4) bottles of Sterile Water for Irrigation were dated 2/22/10. One (1) bottle of Normal Saline for Irrigation was dated 2/24/10. Staff LLL stated that the green stickers were expiration dates that OR staff affixed to sterile solutions in the warmer to make sure that none of the solutions stayed in the warmers for a period greater than 14 days. Staff L stated that storing these solutions greater than 14 days had the potential to unsafely concentrate them through evaporation. Staff LLL stated "...for those with an ambiguous date they cannot use..." Staff LLL stated "...I think our expiration sticker labeling machine might have been off..." Staff L verifies that this area has been checked at least monthly on unit inspections, but he had never received a report of expired medications in the warmers, nor had he ever noticed it himself.

Review of the policy and procedure titled, "Warming IV and Irrigation Solutions," revised 7/2009, indicated under subsection; Solution for Irrigation: that the solutions are not to be stored in a warmer no longer than 14 days. Instructions for dating irrigation solutions; "...Aqualite semi-rigid pour bottles will be dated with the EXPIRATION DATE (14 days past the date of placing the bag in the warmer) before being placed in the warmer. Once they have exceeded their assigned expiration date, they will be removed from the warmer."

Based on staff interview, policy and procedure review, document review, and record review, the hospital failed to ensure: 1. That there was supervision of the pharmacist staff assigned to order parenteral nutrition for Patient 303. This failure to prevent Patient 303 from receiving excess calories for 5 days placed Patient 303 at risk for metabolic complications from overfeeding, 2. The hydromorphone, a potent opiate, for Patient 300 was reviewed for appropriateness by a pharmacist. This failure placed Patient 300 at risk for oversedation and respiratory depression, and 3. That there was no oversight of the drug supply by implementing unit (floor) inspections by pharmacists, which placed all patients at risk for harm from deteriorated medications.

Findings:

1. Review of Patient 303's record on 2/10/10, revealed that the patient was admitted 2/2/10 to the Intensive Care Unit (ICU), with diagnoses of hypertension (high blood pressure), pneumonia (infection of the lungs), stroke (is the rapidly developing loss of brain function (s) due to disturbance in the blood supply to the brain), congestive heart failure (Heart failure), hypernatremia (electrolyte disturbrance that is defined by an elevated sodium level in the blood), malnutrition, and pressure ulcers on both feet.
Parenteral Nutrition (PN- Parenteral Nutrition is a means of feeding a patient intravenously [Though a vein] to ensure they get all their nutritional requirements when they cannot eat themselves) was started 2/3/10. Overfeeding is a complication of PN, which can lead to electrolyte disturbances. It is listed by the Institute of Safe Medicine Practices as a high alert medication, which has been associated with reports of potentially serious medication errors. (www.ismp.org/Tools/highalertmedications ).

Review of the physician's order dated 2/3/10 at 3 p.m. on 2/4/10, revealed an order for TPN (Total Parenteral Nutrition - An intravenous (IV) infusion of nutrients through a catheter placed in a large vein) per pharmacy protocol.

Review of the physician's order dated 2/4/10 at 9 a.m., on 2/4/10, revealed a telephone order for TPN to be administered at a rate of 75 milliliters (ml) per hour (hr). A TPN rate of 75 ml/hr theoretically delivers 1800 ml (1.82 liters) per 24 hours.

Review of the physician's order dated 2/4/10 at 1:10 p.m., on 2/4/10, revealed a clarification order with instructions to decrease the TPN to 50 ml/hr when it started at 9 p.m. that night.

Review of the physician's order dated 2/5/10 at 11:20 a.m., on 2/4/10, revealed an order for Central PN and to administer at a rate of 75 ml/hr.

An infusion rate of 50 ml/hr delivers 1200 ml per 24 hours. An infusion rate of 74 ml delivers 1800 ml per 24 hours (a fifty percent increase).

Review of the physician's order dated 2/9/10 at 7:55 a.m., on 2/4/10, revealed a Nutrition Recommendation to decrease PN to 50 ml/hr; AA 4.25%; D20%, 250 ml 20% lipids (Is an individual macronutrient medication sources and their concentrations in the potential nutrition order (Amino Acid 4.25 percent [%] solution [a protein source]; Dextrose 20% in water solution [a carbohydrate source], and lipid 20% solution [a fat source]).
Review of the physician's order dated 2/9/10 at 12 p.m., on 2/4/10, indicated that Central PN to be administer at a rate of 50 ml/hr. The were signed by the pharmacist. The order was signed by the physician but not dated or timed.
Review of the dietitian's interdisciplinary progress notes dated 2/3/10 at 11:00 a.m., on 2/10/10, revealed a recommendation that "TPN at 75 ml/hr...provides 2030 kilocalorie (kcal - a unit of energy), 76 grams protein. TPN would recommend goal rate 50 ml/hr ...called a pharmacist to recommend (rec'd) decreasing TPN to 50 ml/hr, which would provide 1520 kcal, 51 grams (gm) protein.

Review of the dietitian's interdisciplinary progress notes dated 2/9/10 at 12 midnight, on 2/10/10,indicated that the nutrition reassessment: TPN 75 ml/hr. Provide 2030 kcal, 76 gm protein. Rec'd 1. Decrease TPN to 50 ml/hr (1520 kcal, 51 gm protein) called the pharmacist and asked them again to decrease TPN.

Review of the dietitian's interdisciplinary progress notes dated 2/10/10 at 11:50 a.m., on 2/10/10, reflected the nutritional findings: TPN running at 50 ml/hr: 1520 kcal, 51 gm protein/day. Nutrition needs 1200-1450 kcal 50-60 gm pro /day. The record lacked documented evidence regarding a response to the dietitian's recommendations by either the pharmacist or the physician.

Review of the policy and procedure titled "PARENTERAL NUTRITION POLICY AND PROCEDURE," revised 3/2007, on 2/10/1, indicated that if there are recommendations, if appropriate, are made to the physician in the progress notes. Monitoring and reassessment is made per chart note documented in the progress notes of the medical record.

During an interview on 2/10/10 at 2 p.m. Staff L stated that the hospital's PN policy, directs dietitians to make recommendations in the progress notes of the clinical record. Staff L stated that in his experience, the dietitians routinely make appropriate recommendations.

During an interview on 2/11/10 at 1 p.m., Staff O stated that he writes TPN orders all the time but, "...I never write in the progress notes..." and "...We are not supposed to adjust the rate..." During a concurrent interview, Staff M stated "...Sometimes we don't look in the hard copy (chart), we just get information from the electronic record (computer)..." Staff M and Staff O were unable to explain how an effective reassessment of the PN therapy was carried out without looking at parts of the medical record, which include information essential to a reassessment (i.e. intake and output, patient weights, progress notes, capillary blood glucose measurements).

2. Review of the Patient 300 record on 2/10/10, revealed that Patient 300 was admitted 2/4/10 to the hospital with diagnosis of excessive vaginal bleeding for which she would receive a surgical treatment (hysterectomy) and a history of bleeding for 2-3 months. The physician's order dated 2/5/10 at 6 p.m. indicated an order for Dilaudid (hydromorphone - a potent pain medication ) 4 milligrams (mg) intramuscularly (IM) now, and every 4 hours as needed for severe pain.

Review of the Medication Administration Record (MAR) on 2/10/10 indicated that Patient 300 received one (1) dose on 2/5/10 at 6:55 p.m., and another dose on 2/7/10 (time not provided).

According to the manufacturer's guideline, indicated that Hydromorphone is a semi synthetic derivative of morphine and it resembles morphine pharmacologically. Results of controlled studies comparing the two analgesics have demonstrated that hydromorphone is approximately 8 times more potent on a milligram basis in producing analgesia [pain relief] as well as respiratory depression. The manufacturer's label reflects that the usual adult dose is 1 milligram (mg) to 2 mg subcutaneously (SQ) or intramuscularly (IM) every four to six hours as necessary. The dose may be increased to 4 mg. The manufacturer's guideline cautions, IM administration can result in variable or delayed absorption.

During an interview on 2/10/10, Staff L was unable to explain, from available documentation, how the pharmacist assessed the patient for the appropriateness of the medication (the pharmacist who verified the order was unavailable for interview). Staff L stated that there was no current process to ensure that patients' receiving Dilaudid were screened for appropriateness of drug administration.

Review of the pharmacy computer order entry records on 2/10/10, revealed Staff KK verified the Dilaudid (hydromorphone) for Patient 300. Hospital staff said Staff KK was unavailable for interview during the survey.

During an interview on 2/11/10 at 11:55 a.m., Staff L stated that the policy and procedure titled "New Medication Orders," revised 4/2007, did not completely address how pharmacists are expected to evaluate initial orders for pain medications to ensure patients received an appropriate starting dose. Review of the policy and procedure titled "New Medication Orders," revised 4/2007, on 2/11/10, indicated that the pharmacist shall check and verify the medication order for appropriateness based on the information contained in the patient medical and the pharmacy profile and the order screening should include but not be limited to; Appropriate drug, dose, route, and time."

3. Review of the checklist for Radiology dated 1/20/10, on 2/8/10, revealed that expired medications were noted identified and pulled. Documentation by Staff MM indicated "...No weekly narc (narcotics) audits for past month..." The following three (3) questions listed on the checklist lacked documented evidence regarding choices: YES, N/A, and NO: 1. Temperature logs are complete and up to date, 2. Only appropriate drugs for warmer are present and dated correctly, and 3. Warmers have been checked for expired solutions. The checklist contained a signature line for the pharmacist, however, it was blank.

Review of the checklist for Labor and Delivery (L&D) dated 1/20/10, on 2/8/10, revealed documentation by Staff MM that 14 of 31 stocked medications in the automated dispensing cabinet for the following departments: Obstetrics (OB), OB-Anesthesia (ANES), and X-RAY machine, were were outdated: Dextrose 5% Water 50 ml (a hydrating fluid), naloxone PFS 2 mg/2 ml (an opiate reversal agent), doxycycline 100 mg tablets (an antibiotic), lamivudine 150 mg tablet (an antiretroviral agent), lidocaine jelly 2% 5 ml (a local anesthetic), ceftriaxone 1 gm vial (an antibiotic), ascorbic acid 500 mg tablets (a vitamin), hydroxyzine pamoate 25 mg capsule (an antihistamine), erythromycin base 250 mg tablet (an antibiotic), pregabalin 75 mg capsule (a pain reliever and anticonvulsant), alprazolam unit dose 0.5 mg tablet (an anti-anxiety medication), furosemide 40 mg tablet (a diuretic), diaper rash 30 gm ointment, and guiafenesin DM (an expectorant) unit dose 10 ml syrup. Comments on the floor check document by the pharmacy technician indicated "...some IV fluids in bottom drawer had exp (expired) on 5/10, opened not dated NS (Normal Saline) 50..." Weekly narcotic inventories were noted as not done, with a notation, "...Spoke with (pharmacist's name withheld)."

Review of the policy titled "Floor Survey Checklist," updated 4/2007, on 2/8/10, indicated that ALL DRUGS SHOULD HAVE 3 MONTHS BEFORE EXPIRATION. According to staff, the expectation is that drugs found in the units will be removed during unit inspections whenever they have an expiration date less than three months remaining.

During an interview on 2/8/10 at 2 p.m., Staff L stated that technicians' do the floor checks but they are verified at least monthly by a pharmacist. Staff L was unable to show where a pharmacist conducted or verified floor checks for radiology and L&D within 30 days. Staff L stated "...the pharmacist didn't sign it..." Staff L stated that the pharmacist who was responsible for the radiology and L&D, had not brought up any issues with pharmacy management staff regarding the results of the technician's findings. Staff L was unable to comment on the pharmacist's response, and indicated that he had not been made aware of any issues on the units. Staff L stated that there was no routine audit process or system to ensure pharmacists were accomplishing their floor check responsibilities, or that medication safety items identified received timely follow-up in order to reduce potential for medication errors.

Based on observation, staff interview, record review, and document, the hospital failed to ensure drugs were controlled and distributed in accordance with applicable standards of practice, consistent with federal and state law. Specifically, the hospital failed to:

1. Ensure pharmacists are supervised with regard to implementation of, and maintenance of, repackaging logs. The hospital's failure to ensure expiration dates had the potential to cause patient harm from delays in medication retrieval in the event of a medication recall.

2. Ensure policies are developed which provide guidance to nursing staff with regard to procedures for discontinued medications. The hospital's failure had the potential to result in deteriorated nitroglycerine (a medication used to treat heart conditions) to be administered to Patient 301 in the Intensive Care Unit.

3. Ensure activities regarding Look-Alike-Sound-Alike (LASA) medications and High Alert Medications are coordinated within the hospital. The hospital's failure to ensure Staff MMM (a Cancer Center oncology registered nurse), Staff OO (a respiratory therapist) and Staff KKK (a respiratory therapist) were familiar with the underlying concepts of these policies, and were able to identify the associated medications within their respective areas, had the potential to expose all patients to harm from medication errors.

Findings:

1. During an interview on 2/9/10 at 11:20 a.m., Staff L provided pharmacy repackaging logs for the inclusive dates 12/30/09 - 2/9/10). Staff L acknowledged that there were entries missing. "...It is my expectation that the staff write the manufacturer's expiration date..." and "...It's important for recalls..." Staff L further explained that staff had just received an in-service on repackaging in December and provided the minutes, which were reviewed in the same interview.

According to the American Society Hospital Pharmacists' (ASHP) Drug Distribution and Control: Distribution-Technical Assistance Bulletin,"...ASHP Technical Assistance Bulletin on Repackaging Oral Solids and Liquids in Single Unit and Unit Dose Packages...," Subsection 10: "...Control records of all packaging runs must be kept..." These records should include the following information:

a..Complete description of the product, i.e., name, strength, dosage form, route of administration, etc.

b. The product's manufacturer or supplier.

c. The control number.

d. The pharmacy's control number if different from the manufacturer's.

e. The expiration dates of the original container and the repackaged product.

f. The number of units packaged and the date(s) they were packaged.

g. The initials of the operator and checker (if any).

h. A sample of the label and, if feasible, a sample of the finished package, which should not be discarded until after the expiration date and which should be examined periodically for signs of deterioration.

i. The description (including lot number) of the packaging materials and equipment used.

Subsection 11: Indicates that it is the responsibility of the pharmacist to determine the expiration date to be placed on the package, taking into account the nature of the drug repackaged, the characteristics of the package, and the storage conditions to which the drug may be subjected.

During an interview on 2/9/10 at 11:25 a.m., Staff M was asked if she ever received an in-service on repackaging. She said, "...I have not signed a document that I've been trained on it. I have not had any formal training, but I have received informal training..." Staff M was shown staff meeting minutes dated 12/09 which included repackaging" as an agenda item. Staff M confirmed her signature on the attendance records, explaining,"..I forgot..." She was unable to recall any details about the training provided and was unable to explain what was expected of staff with regard to maintaining the repackaging logs.

During an interview on 2/9/10 at 11:38 a.m., Staff N was shown pharmacy repackaging logs for the dates 12/30/09 - 2/9/10. She indicated she had received an in-service on repackaging and reviewed 14 of 19 entries with the surveyor. She stated "...Ten of fourteen is complete...," and then elaborated that the manufacturer's expiration dates are missing. On the Xopenex (A medication used to ease lung spasms and the work of breathing), dated 12/31/09, the manufacturer's expiration date, quantity repackaged, the repacked expiration date, and the repacked by entries are missing. When asked why it mattered whether logs were kept, Staff N stated that among other things, the detailed records were necessary to expedite medication retrieval in the event of a recall and "...we do it because it's our policy..."

2. Review of Patient 301 record on 2/9/10, revealed that Patient 301 presented to the Emergency Department (ED) with a complaint of burning chest pain. The patient's had a prior history of Gastroesophageal reflux disease (GERD) and hypertension (high blood pressure). An electrocardiogram (Examination of the heart's electrical activity captured through electrodes placed on the skin) was ordered, a nitroglycerine patch (A medicine that dilates arteries causing decrease in workload on the heart) was applied for chest pain, and the patient received Maalox (A medication for heartburn). A cardiologist (who was unavailable for interview) was consulted. The patient was stabilized and was transported to the Intensive Care Unit (ICU).

During the tour of the ICU on 2/9/10 at 3:05 p.m., observation revealed that Staff NNN was observed caring for Patient 301 in his room in the ICU. As she explained her process for administering medications, Staff NNN pointed to a nitroglycerine bottle and explained that the drip was ordered for chest pain and said, "...I think it was either discontinued either this morning or before I got here..." Concurrent review of Patient 301's record indicated that the nitroglycerine infusion was discontinued 2/8/10 at 7:55 p.m. Staff NNN explained why the medication was still hanging at the bedside 19 hours later. She also acknowledged that there was no current order for the nitroglycerine and that nitroglycerine has known stability issues, which require it to be dispensed in glass. She stated "...it is good for 24 hours, if I need it for emergencies. I would be inclined to keep it for the patient..." She stated that she had been a nurse for 32 years, and "...it was not her usual practice to discard medications, before the end of my shift..." Staff NNN acknowledged that unopened nitroglycerine infusions and administration sets were stocked and available in the unit. The manufacturer's guarantees the stability of nitroglycerine for 24 hours after opening (www.lexicomp.com).

During an observation on 2/9/10 at 3:15 p.m., of the automated dispensing cabinet in ICU unit, revealed an inventory of 3 bottles of nitroglycerine.

During a concurrent interview on 2/9/10 at 3:18 p.m., Staff OOO was asked to explain her usual process when she received a physician's order to discontinue a medication. She said, "...If I get a discontinue order for an intravenous medication I verify the order, I go to the patient and check the identification, communicate with the patient and empty it..." When asked what does empty it means, she said, "...to throw away and I throw it away right away..."

During a concurrent interview on 2/9/10 at 3:20 p.m., Staff NNNN was asked to explain what was expected of the nurses with regard to processing discontinued medications. She said, "...I don't know. I haven't been here very long..." When asked if she could find a policy which addressed discontinued medications, she said, "...I haven't had a chance to read all the policies yet, I have only been here a short time, since January..." She said, "...I think when they give report they are supposed to check the medications. That's how we did it at my last hospital..." Staff NNNN stated that the nurses' worked 12 hour shifts and that the last shift change was at 7 a.m. that morning. Staff NNNN was prompted by the surveyor to look for a policy regarding hand off communications but was unable to retrieve it at the nurses' station. The interview was deferred until the following day to allow Staff NNNN to locate any related policies.

During an interview on 2/11/10 at 10 a.m., Administrative Nursing Staff K, stated that the hospital identified that there was no policy specifically addressing the expectations for staff with regard to disposition of discontinued medications. He stated that out of safety concerns, a memo had been distributed to all nursing managers and staff which stated in part,

Review of the memo revealed the following: "...Effective immediately, any and all discontinued intravenous fluid medications must be DISCARDED within one hour following the discontinuance order..." "...Policy concerning this important safety concern is currently being drafted and will be forthcoming."

Review of the policy and procedure titled "Triage Standardized Procedures, implementation of By Registered Nursed," on 2/10/10, revised 6/08, indicated that the staff are to review current medications to include discontinued medications as well as a scan of the patient's room for discontinued intravenous medications.

3. During an tour of the Cancer Center on 2/9/10 at 2:21 p.m., Staff MMM was interviewed and asked to identify what Look-Alike Sound-Alike (LASA) medications were in her area. She referenced a list posted above the automated dispensing cabinet dated 2008, Attachment A: Look-Alike/Sound-Alike Drug list. She was unable to access a current version, and was unable to say for sure if the medications in her area had changed, explaining, "I was unable to find the Look-Alike Sound-Alike policy."

Review of the policy and procedure titled "Look Alike/Sound Alike Medication policy," revised 1/2007, indicated that the medications identified as "Sound Alike/Look Alike" medications will have special labeling stickers to draw attention to the medication name. In addition, there is a electronic reminder including but not limited to "Tallman" lettering (Tallman lettering involves highlighting the dissimilar letters in two names to aid in distinguishing between the two, have shown that highlighting sections of drug names using Tallman (mixed case) letters can help distinguish similar drug names, making them less prone to mix-ups) will be used in patient care systems whenever possible to alert clinical staff to the potential for error.
During the tour Pulmonary Function Laboratory on 2/9/10 at 2:52 p.m., with Staff L, Staff OO and Staff KKK were interviewed and asked to identify what Look-Alike/Sound-Alike medications were in their area. Staff OO said, "...I don't know what you mean by Look -Alike/Sound-Alike..." Staff OO further explained, "...I've never heard this maybe because we don't have any..." During a concurrent interview Staff KKK said, "...I've never heard of "Tallman" lettering." Staff L confirmed that Mucomyst (Medication used to treat thick secretions associated with lung diseases) was available for use by the respiratory therapists in the Pulmonary Function Laboratory and that is was on the hospital's 2010 LASA list. Staff L was unable to explain why the current list of LASA drugs was not available in the laboratory or why staff was unaware of their designation and use in the hospital.

Based on observation and staff interview, the hospital failed to ensure that only authorized personnel have access to the locked medication storage area in the nuclear medicine hot lab. The hospital's failure had the potential to cause a loss of control of medications.

Findings:

During the tour of the Nuclear Medicine Hot lab on 2/9/10 at 2:20 p.m., with Staff L and Staff NN, the drug storage areas were inspected. Staff NN showed where cold kits, saline, and heparin (all prescription drugs used in the preparation of radiopharmaceuticals) were stored. Staff NN stated that radiopharmaceuticals were delivered early each morning by the vendors and they were permitted entrance into the hot lab by a security guard.

During an interview on 2/9/10 at 2:25 p.m., Staff L stated that the hot lab was a locked medication storage area and that security guards had not been authorized access.

Based on observation, staff interview, and record review, unusable and expired drugs must not be available for patient use. The hospital's failure to ensure unusable saline in the Operating Room (OR) was available and placed patients at risk for harm from deteriorated drugs.

Findings:

During the tour of the Operating Room medication storage area on 2/8/10 at 11:35 a.m., with Staff LLL, Staff L, and Staff MMMM, revealed five (5) 1 liter bottles of sterile solutions for irrigation were observed in the warmer with green stickers affixed. Four (4) bottles of Sterile Water for Irrigation were dated 2/22/10. One bottle of Normal Saline for Irrigation was dated 2/24/10. Staff LLL stated that these green stickers were expiration dates that the OR staff affixed to sterile solutions in the warmer to make sure none stayed in the warmers for a period greater than 14 days. Staff L stated that storing these solutions greater than 14 days had the potential to unsafely concentrate them through evaporation. Staff LLL stated "...For those with an ambiguous date they cannot use..."

Review of the policy and procedure titled "Warming IV and Irrigation Solutions," revised 7/2009 on 2/8/10, indicated that solution for irrigation can be store in warmer no longer than 14 days. The policy showed instructions for dating irrigation solutions, " ...Aqualite semi-rigid pour bottles will be dated with the EXPIRATION DATE (14 days past the date of placing the bag in the warmer) before being placed in the warmer. Once the solutions had exceeded the assigned expiration date, the solutions will be removed from the warmer.

Based on food service observations, dietary and administrative staff interview and dietary and administrative document review the hospital failed to:

1. Ensure the availability of organized dietetic services that are directed and staffed by adequately qualified personnel (See A619, A620, A622, and A749).

2. Provide organized dietetic services as evidenced by findings of unsafe food handling practices and lack of effective monitoring of potentially hazardous (See A 620 and A749).

3. Provide effective sanitation of food production surfaces (See A749).

4. Ensure the nutritional needs of patients are met (See A628 and A629).

The cumulative effects 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 organized dietetic services and to ensure the nutritional needs of patients were being met in accordance with acceptable standards of practice. The Condition for Food and Dietetic Services was not met.

Based on food storage observations, dietary staff interview and dietary document review, the hospital failed to ensure storage of foods in a manner consistent with food safety standards (Food Code, 2009). Poor storage practices may result in cross contamination, food borne illness and/or the use expired food items. Poor food handling practices may result in food borne illness which in turn may be associated with nausea, vomiting, and gastrointestinal distress and in severe instances may result in death.

Findings:

During initial tour on 2/8/10 at 9:45 a.m., the following was noted:

1. In freezer #5 there was a flat of muffins that were unsealed and undated. In a concurrent interview with Dietary Staff A she stated that the departmental policy was to seal and date all opened items.

2. In refrigerator #7 there were two 5-pounds of thawing cooked turkey no date;10 pounds of thawing raw beef, undated; marinating raw teriyaki chicken, no thaw date and 2 bags of raw chicken breast, no thaw date. It was also noted that the cooked turkey was thawing below raw beef.

During a concurrent interview with Dietary Staff A, she was asked to describe when each of the items were thawed, to which she replied that depending on the item it would have been pulled 2-3 days prior to the use date. Upon inquiry regarding how she ensured that the items were not pulled more than 3 days in advance, she stated that she could not ensure that items were not pulled more than 3 days in advance.

Review of policy and procedure titled "Covering, Dating and Labeling," dated 6/07, guided staff that "All products my have "USE BY DATE" after the opened or in thaw stage." There was no evidence of a system to indicate when frozen food was pulled from the freezer.

3. In the spice storage area there was curry powder, onion powder, nutmeg, tarragon leaves, basil and Cajun seasoning all of which were opened and undated. It was also noted that the Cajun seasoning was a faded dull red color. It was also noted that there was nutmeg, opened and undated with a receipt date of 7/07. During a concurrent interview with Dietary Staff A corroborated
that the above items should have been dated when opened.

Review of policy and procedure titled "Covering, Dating and Labeling of Foods," dated 6/07, noted that "all foods are dated with "RECEIVE DATE" and "All products must have a 'USE BY DATE" after ...opened ..." The policy also noted that there was no guidance for the length of storage for spices.

4. During an inspection of refrigerator #8, revealed that there was a box of mushrooms that appeared partially dried with significantly browned edges.
During a concurrent interview with Dietary Staff A, she stated that the items were received the week prior.

Review of policy and procedure titled "Covering, Dating and Labeling of Foods," dated 6/07, guided staff that fresh produce had a shelf life of 7-10 days; however there was no guidance to staff for actions if the items no longer appeared fresh.

5. During an inspection of refrigerator #9, revealed that there was mustard with a use by date of 2/1/10 and the sour cream with an expiration date of 1/31/10. It was also noted that staff placed sticker with a "use by" date of 2/16/10, which was past the manufacturer's expiration date. It was additionally noted there were 2 packages of ham with no thaw date.

Review of policy and procedure titled "Covering, Dating and Labeling of Foods," dated 6/07, guided staff that all " Yogurt ....with a manufacture's date must be used by the "expire date" on package."

6. During an inspection of freezer #9, revealed that there were chicken strips, chicken fritters, fish squares, egg plant, chicken breasts and vegetables rolls all of which were opened and undated.

7. In the under counter freezer there was a package of waffle fries, undated and unsealed.

Review of policy and procedure titled "Covering, Dating and Labeling of Foods," dated 6/07, revealed that "all foods are dated with "RECEIVE DATE" and "All products must have a 'USE BY DATE" after ...opened ..."

Based on food service observations, dietary staff interview and dietary document review the food service director failed to ensure: 1. The comprehensive oversight in food production activities, 2. That staff were sufficiently trained to follow established policies and procedures as evidenced by; 1. The lack of a system to ensure patient foods were handled in a safe manner, 2. The ineffective sanitation of food production surfaces, 3. The issues surrounding cleanliness of equipment, 4. The storage of undated and/or expired potentially hazardous food items, and 5. The lack of comprehensive disaster meal planning. These failures to ensure effective food production systems that include comprehensive evaluation of the processes and equipment being used as well as ensuring the quality of foods may put patients at risk for food borne illness. Food borne illness may result in gastrointestinal distress, nausea, vomiting, may further compromise the medical/nutritional status of patients and in severe instances may cause death.

Findings:

1. During the initial tour of the dietary department on 2/8/10 at 10 a.m., an inspection of the cooks refrigerator; refrigerator # 6, revealed that there were 2 pieces meat, one of which was approximately 3 pounds and the second was approximately 0.5 pounds. It was also noted that the meat was stored in a plastic container with 3 inches of beef broth.

During a concurrent interview with Dietary Management Staff F, she stated that the items was cooked on 2/7/10 and would be used over the course of the next 3 days. The internal probed temperature of the item was noted to be 47 degrees (?) Fahrenheit (F). Leftover meats are considered to be a potentially hazardous food (PHF) (Cross Reference 749). PHF's are those foods that are capable of supporting bacterial growth associated with foodborne illness. The standard of practice for leftover PHF's would be to cool them from 140 to 70 ?F within 2 hours and to 41 ?F within an additional 4 hours. It would also be the standard of practice to maintain all PHF's at 41 ?F or below (Food Code, 2009).

During an interview on 2/8/10 at 10:15 a.m., with Dietary Staff G he was asked to describe the use of the leftover foods to which he replied that both of the items would be used over the next several days for patients as a substitute. In an interview on 2/8/10 at 2 p.m., with Dietary Staff H he was asked to describe how he handled leftover foods. He stated that after the food was taken out of service he would put it in a shallow pan, cover it, label and date it after which he would place it in the refrigerator. The surveyor asked if there were any other actions he would take in handling leftover foods, to which he replied that if the food was very hot he would leave it on the counter for a period of time to cool off prior to placing it in the refrigerator.

In a follow up observation on 2/8/10 at 2:15 p.m., it was noted that both pieces of pot roast were still in the refrigerator. Follow up internal temperatures were taken and were noted as 47 ?F for both cuts of meat.

In an interview on 2/8/10 at 4 p.m., with Dietary Staff I he was asked to describe how he handled leftover foods. He demonstrated by using a pan of leftover taco meat that was in the hot holding over. He stated that he would remove the item from hot holding, cover it with plastic wrap and place it on the counter for a period of time to cool it down. He stated that "after a while" he would place the item in the refrigerator. The surveyor asked how he ensured that the food was safe to use at a later date. Dietary Staff I stated that he would check the date to be sure that it wasn't any older than 3 days, he also stated he would visually inspect the item and smell it as well. If it didn't look or smell acceptable he would toss the item.

A final temperature of the pot roast was taken on 2/8/10 at 4:20 p.m. The internal probed temperature was 46 ?F.

In an interview on 2/8/10 at 5 p.m., with Dietary Management Staff F the surveyor asked her to describe how she ensured that leftover, cooked, foods were safe to be used on multiple days. DMS F stated that she ensured that staff followed HACCP (Hazard Analysis Critical Control Points) procedures by reheating the food to 165 ?F. She also stated that she would expect that staff would put the item to be stored in an ice bath on the counter or in the refrigerator. She further stated that the item would need to reach an internal temperature of 70 ?F within 2 hours. The surveyor asked DMS F how she ensured that staff was following a HACCP plan. She replied that she reviewed refrigerator temperatures on a weekly basis and observed the cooks performing tasks. The surveyor asked if she probed temperatures of leftover foods, to which she replied that she did; however the results were not documented. She further stated that she has never monitored the cool down temperatures of foods.

Review on 2/8/09 at 4:50 p.m., of hospital document titled "HACCP Critical Control Points" for 1/31/-2/6/10, revealed that the system was limited to monitoring of minimum internal temperature requirements for cooking raw food and recommended serving temperatures. While there was a space on the log to monitor the cooling temperatures of foods, these were blank on all of the forms.

Review on 2/10/10 of policy titled "Cooling and Reheating of Foods" and dated 6/07 guided staff that leftover food must be " ...cooled quickly and safety to 70 ?F within 2 hours and then to 40 ?F within an additional 4 hours... " It was also noted that the "Internal product temperatures must be taken ...recorded on the cooling log and kept on file for one (1) year."

Review on 2/10/10 of the undated dietary department organizational structure revealed that the Food Service Manager had overall responsibility for the functioning of the department.

Review on 2/10/10 at 9 a.m., of the position description titled "Food Service Manger," (FSM) provides overall management and operational direction..." The position description also noted that the FSM is the person responsible for demonstrating "a clean understanding of, and consistently adheres to department facility policies and procedures."

2. During review of food storage practices on 2/10/10 beginning at 11:30 a.m., it was noted that dietary staff was storing sandwich prep items in a deli-type refrigeration unit adjacent to the steam tables. In a concurrent interview with Dietary Staff GGG she stated that the deli area was set up daily at 11 a.m.. She also stated that the items would be stored in the unit for the duration of the day and would be discarded at approximately 8 p.m. each evening.

During an observation of the internal probed temperature of a container of sliced ham that was taken on 2/10/10 at 2:45 p.m., and was noted to be 43 ?F. A follow-up temperature was taken on 2/10/10 at 4:45 p.m., and was noted to be 42 ?F. In a concurrent interview with RD J she was asked to describe how the hospital monitored the temperature of foods. She replied that the refrigeration units were monitored; however food temperatures were not taken. It was also noted that in addition to meat, dietary staff were also storing sliced tomatoes in the unit. The meat and tomatoes are considered to be potentially hazardous foods that require time/temperature control to prevent the bacterial growth associated with food borne illness (Food Code 2009). The standard of practice would be to ensure that PHF's are not stored in the food danger zone, defined as 41 ?F -135 ?F for greater than 4 hours (Food Code, 2009).

During an interview on 2/10/10 at 2:15 p.m., with Dietary Staff I the surveyor asked him to describe how he cleaned his work surfaces. He stated that once surfaces were soiled he would wipe the counter with a sanitizer and afterwards he spray them down and polish them with an orange solution. Review of the Material Safety Data Sheet for the product called Oasis 137 revealed that under the"hazards identification" section guided staff to "wash thoroughly after handling." The Material Safety Data Sheet (MSDS) also guided staff to "use chemical resistant impervious gloves" when handling the solution. There was no documentation that this product was acceptable to use on food contact surfaces as a final step prior to continuing food production activities.

3. During general kitchen observation on 2/10/10 beginning at 11:40 a.m., it was noted that there were several kitchen areas that were not clean (Cross reference A749).

During an interview on 2/10/10 at 9:30 a.m., with DMS F and RS GG, the surveyor asked how kitchen cleanliness was ensured. They stated that there was no formal cleaning schedule and that cleaning duties were incorporated into each dietary staff members' position description.

Review of the policy and procedure titled "Sanitation Program," (not dated) on 2/11/10, revealed that it was the responsibility of the Food Service Manager to monitor sanitizing schedules and procedures. It was also noted that items such as refrigerators, can openers and ovens were designated to be cleaned both daily and weekly. There was no documentation that the DMS F monitored the cleanliness of kitchen areas and that the sanitation program was being followed.

Based on food production observations, Registered Dietitian (RD) and dietary staff interview and dietary document review the hospital failed to ensure that patient menus were reviewed and approved by the RD.

Findings:

Review of the tray line on 2/8/10 at 11:40 am, the following was noted: In place of the hamburger entree, patients were able to select breaded chicken strips. It was noted that patients with regular and consistent carbohydrate diets got 1 piece of breaded chicken. Concurrent review of the therapeutic spreadsheet noted that patients should have received 3 pieces. It was also noted that the spreadsheet had a signature line for RD approval; however that line was blank.

During a concurrent interview with RD J she was asked to describe her oversight in food production oversight. RD J stated that on occasion she did tray line accuracy audits however had not identified any significant issues. It was also noted that in comparison patients who chose the chicken teriyaki entree received a 4 ounce portion. RD J was also asked if she had approved the menu. She stated that she used it as a basis for tray line accuracy audits; however had not reviewed or approved the document.

During an interview on 2/10/10 at 3 pm, with Dietary Management Staff (DMS) F she stated she had been in the position since 9/09 and maintained purchasing systems that were in place. DMS F was also asked who approved the patient menus. DMS F stated she was unsure as the menu was a hospital system-wide menu.

Review of a document titled "Product Detail Print," on 2/10/10, for the breaded chicken tenderloin revealed that the total amount of protein in the item equated to 2.5 ounces of protein, rather than a 4 ounce portion as specified on the therapeutic spreadsheet. It was also noted that the hospital had been purchasing this product on a weekly basis. There was no documentation that the product had been reviewed to ensure the protein specifications met the requirements of the therapeutic spreadsheet.

Review of the policy and procedure titled "Food, Supplies and Equipment Procurement," dated 6/07 on 2/11/10, revealed that while the hospital had a policy to ensure "accurate" purchases there were no guidelines to ensure that purchased products met menu specifications.

Review of the policy and procedure titled "Patient Menus," dated 6/07, on 2/11/10, indicated that the menus will be reviewed annually, or as needed, for changes. There was no documented evidence that the menu was reviewed by the RD to accommodate a possible change in the products ordered.

Review of the policy and procedure titled "Purchasing Guidelines," on 2/11/10, outlined purchasing procedures based on competitive systems and to base all purchases on quality, service or price. There was no documented evidence that the purchasing guidelines would be based on menu specifications.

Based on food service observations, staff interview (Dietary Staff I, G, and FF) and dietary document review the hospital failed to ensure staff competency as evidenced by: 1. Lack of effective competency evaluation to ensure implementation of an effective cool down system for potentially hazardous foods and 2. Lack of comprehensive training in the use of the dishwasher. Lack of staff competency in dietetic services may result in food practices that promote food borne illness and cross contamination. Both may result in nausea, vomiting, gastrointestinal distress, further compromising the health status of acute patients. In severe instances food borne illness may result in death.

Findings:

1. During the initial tour on 2/8/10 at 10 a.m., and subsequent observations on 2/8/10 at 2:15 p.m., and 2/18/10 at 4:20 p.m., it was noted that there were issues surrounding the storage protein based PHF's (Cross Reference 749). Protein based PHF's are considered to be a potentially hazardous food (PHF). PHF's are foods that are capable of supporting bacterial growth associated with foodborne illness (Food Code, 2009).

During an interview on 2/8/10 at 10:15 a.m., with Dietary Staff G, he was asked to describe the use of the leftover foods to which he replied leftovers would be used over the next several days for patients as a substitute. In a follow up interview on 2/8/10 at 2 pm, with Dietary Staff G he was asked to describe how he handled leftover foods. He stated that after the food was taken out of service he would put it in a shallow pan, cover it, label and date it after which he would place it in the refrigerator. The surveyor asked if there were any other actions he would take in handling leftover foods, to which he replied that if the food was very hot he would leave it on the counter for a period of time to cool off prior to placing it in the refrigerator.

During an interview on 2/8/10 at 4 pm, with Dietary Staff I, he was asked to describe how he handled leftover foods. He demonstrated by using a pan of leftover taco meat that was in the hot holding over. He stated that he would remove the item from hot holding, cover it with plastic wrap and place it on the counter for a period of time to cool it down. He stated that "after a while" he would place the item in the refrigerator. The surveyor asked how he ensured that the food was safe to use at a later date. Dietary Staff I stated that he would check the date to be sure that it wasn't any older than 3 days. He also stated he would visually inspect the item and smell it as well. If it didn't look or smell acceptable he would toss the item. The surveyor also asked what he would look for in a visual inspection. Dietary Staff I replied that if it appeared to have a slimy film on it he would discard the item.

Review of the dietary department training records on 2/11/10 at 8 a.m., revealed that there was no documented in-service provided to staff on properly cooling leftover PHF's. Review on 2/11/10 at 8 a.m., of the performance evaluation for Dietary Staff I, dated 1/20/10 revealed that one of the principal accountabilities for the cooks' position was to "maintain department food safety and sanitation standards." The evaluation also noted that Dietary Staff I ranked 2 out of 3 for following the proper technique in handling leftover and follows standards and records information on required forms. It was also noted that the hospital submitted an orientation for Dietary Staff I, dated and signed on 1/13/09; however with the exception of the signature the orientation document was blank. There was no documentation that staff was effectively trained or evaluated to ensure competency in position accountabilities.

During an interview and concurrent document review on 2/11/10 at 8 a.m., with DMFS AF, she stated that Dietary Staff G was recently hired and had not yet had a formal performance evaluation. Hospital document titled "Departmental Orientation Checklist-Nutritional Services" revealed a hire date of 6/3/09. It was also noted that the orientation consisted of 48 items, all of which were reviewed with the employee in the matter of a 10 day timeframe. It was also noted that while the hospital provided orientation to food production practices, there was no evaluation of Dietary Staff G's competency related to the functions.

2. During an interview on 2/8/10 at 5 pm, with Dietary Management Staff F, the surveyor asked her to describe how, as the department manager, she ensured that leftover, cooked, foods were safe to be used on multiple days. Dietary Staff F stated that she ensured that staff followed HACCP (Hazard Analysis Critical Control Points-a comprehensive program ensuring food safety, Food Code, 2009) procedures by reheating the food to 165 degrees (?) Farenheit (F). She stated that she would expect that staff would put the item to be stored in an ice bath on the counter or in the refrigerator. She further stated that the item would need to reach an internal temperature of 70 ?F within 2 hours. The surveyor asked Dietary Staff F how she ensured that staff was following a HACCP plan. She replied that she reviewed refrigerator temperatures on a weekly basis and observed the cooks performing tasks. The surveyor asked if she probed temperatures of leftover foods, to which she replied that she did; however the results were not documented. She further stated that she has never monitored the cool down temperatures of foods.

Review of a document titled "Exempt Introductory Review," dated 11/17/09, on 2/11/10, that was completed by Regional Director GG, revealed that the evaluation focused primarily on working relationships, financial benchmarks, patient satisfaction surveys and community coordination. The evaluation also revealed that Dietary Management Staff F "...implemented quality controls through the use of temperature tracking..." Similarly a follow up evaluation dated 2/2/10 revealed that while the employee exceeded expectations in business elements such as patient satisfaction, financial benchmarks, team development and work load there was no evidence the hospital fully evaluated the competency of Dietary Management Staff F's ability in ensuring safe food handling practices. It was also noted there was no documentation that Dietary Management Staff F received any specialized training in safe food handling practices.

Review of a document titled "Management Sanitation Certification," (not dated) on 2/10/11, revealed that it was the policy that "...all management associates become certified by the Education Foundation of the National Restaurant Association in Applied Food Service Sanitation." There was no documentation that Dietary Management Staff F possessed this certification.

3. During review of dish washing process on 2/10/10 at 2 p.m., Dietary Staff FF was asked to describe the process of ensuring that the dish machine was functioning properly. It was noted that the hospital utilized a machine that sanitized dishes using hot water at greater than 180 ?F rather than chemicals. Dietary Staff FF stated that the machine was installed over the past several years. She described that she would monitor the dials that displayed the temperature of the wash and rinse cycles. She also stated that in addition to monitoring temperatures she would utilize a chemical reagent strip. Dietary Staff FF demonstrated the use of the strip by dipping into the water residue on 1 plate daily. It was noted that there was no reaction as evidenced by no change in color of the strip. Dietary Staff FF stated that this was the expected and that no reaction was acceptable. The surveyor asked the frequency of testing the machine using the reagent strips. Dietary Staff FF replied that it was done daily. She was also asked if the information was recorded anywhere, to which she replied that only the temperatures were recorded on the dish machine log.

During an interview on 2/12/10 at 9 a.m., with Dietary Staff F, the surveyor asked her to provide departmental in-service training records. She stated that the only records that were retained in the department began in 9/09.

Document review occurred from 2/9-2/11/10. Review of hospital training records beginning in September 2009 revealed that dietary staff had not been trained on monitoring the functionality of the dish machine.

Review of the employee evaluation for Dietary Staff FF dated 6/29/09 revealed that she "know the dish room inside and out ...is very proficient in all of her duties ..." There was no documentation that hospital staff observed or interviewed Dietary Staff FF on how she monitored the equipment.

Review of the policy and procedure titled "Assessment of Competency," (not dated) indicated that the competence of all employees will be assessed annually. While the hospital completed annual evaluations, they did not effectively assess the competency of staff as evidenced by deficient practices (Cross Reference A Tag 619, 628, 629 and 749).

4. Review of the ice machine cleaning process on 2/10/10 at 2:35 p.m., and a concurrent interview with Maintenance Staff FF, the surveyor asked that he describe maintenance of the ice machine. Maintenance Staff FFF further described the cleaning process. He stated that he would use a mineral descaling product after which he would sanitize the machine using household grade bleach. It was noted that the bleach being used was not food grade bleach. It was also noted that the bleach being used was a 6.15% hyper chlorite solution. Concurrent review of manufacturers' guidance revealed that the recommended strength for the bleach was 5.25%. Maintenance Staff FFF stated he believed that any type of bleach solution would be acceptable.

Review of the document titled "Sanitation Program," dated 6/07, on 2/11/10, indicated that it was the responsibility of the Food Service Manger to monitor sanitizing procedures. There was no documentation that the FSM evaluated the effectiveness of the ice machine sanitation process.

5. During a review of tray line on 2/8/10 at 11:40 a.m., observation revealed that there were issues surrounding protein portions of the breaded chicken strips and turkey sandwiches (Cross Reference 628) as follows:

a. In place of the hamburger entree, patients were able to select breaded chicken strips. It was noted that patients with regular and consistent carbohydrate diets got 1 piece of breaded chicken. Concurrent review of the therapeutic spreadsheet noted that patients should have received 3 pieces.

During an interview on 2/10/10 at 3 pm, Dietary Management Staff F stated that she had been in the position since 9/09 and maintained purchasing systems that were in place.

Review of a document titled "Product Detail Print" on 2/10/10, for the breaded chicken tenderloin revealed that the total amount of protein in the item equated to 2.5 ounces of protein, rather than a 4 ounce portion as specified on the therapeutic spreadsheet. There was no documentation that the product had been reviewed to ensure the protein specifications met the requirements of the therapeutic spreadsheet.

b. In place of the hamburger entree, patients were able to choose a turkey sandwich as a substitute. During observation of the preparation of several sandwiches it was noted that Dietary Staff III was placing several unmeasured slices of meat on the sandwich. The surveyor asked Dietary Staff III if this was the usual process for making sandwiches. She replied that it was.

A sandwich was requested for the purpose of weighing the meat. It was noted that the weight of the resulting protein portion was 3.5 ounces, rather than the 4 ounces as specified on the therapeutic spreadsheet.

6. Observation of the tray line on 2/10/10 at 11:40 a.m., the following was noted (Cross Reference Tag A 629):

a. Patient 200's physician ordered diet was noted to be an ADA (American Diabetes Association) soft diet. Dietary staff placed a full hamburger on the patients' plate.

In an interview on 2/10/10 at 12:15 p.m., with RD J she was asked to describe the hospital policy for a soft diet. RD J presented the surveyor with 3 separate documents, with vast differences, that described varying degrees of soft diets.

Review of the following documents titled "Interpretation of Diet Orders," dated 7/07 and "Patient Menus," dated 6/07 on 2/10/10, revealed that while there was a listing for a "soft" diet the diet manual did not fully or comprehensively describe the elements of the diet.

Review of the organizational chart for Food and Nutrition services (not dated) on 2/10/10, revealed that DMS F was the person that was responsible for all processes within the department which included ensuring the accuracy of patient therapeutic diets.

b. Review of Patients 201's physician order diet, indicated that it was a cardiac diet. It was noted that dietary staff placed a turkey sandwich with French fries on the plate. Review of the therapeutic spreadsheet revealed that there were no fried foods allowed on the cardiac diet.

Review of policy and procedure titled "Meal Accuracy," dated 6/03, on 2/11/10, guided staff that all completed meal orders will be checked for accuracy by a food service designee. In addition, the patient trays would be checked for diet order restrictions. There was no observed mechanism to ensure that meals were checked prior to nursing unit delivery.

Based on tray line observations, dietary staff interview and dietary document review the hospital failed to ensure regular and therapeutic diets were followed as evidenced by the lack of consistency in the protein portions for all diets.

Findings:

During review of tray line on 2/8/10 at 11:40 a.m., the following was observed:

1. In place of the hamburger entree, patients were able to select breaded chicken strips. It was noted that patients with regular and consistent carbohydrate diets got 1 piece of breaded chicken. Concurrent review of the therapeutic spreadsheet noted that patients should have received 3 pieces.

During a concurrent interview with RD J she was asked to describe her oversight in food production oversight. RD J stated that on occasion she did tray line accuracy audits however had not identified any significant issues. It was also noted that in comparison patients who chose the chicken teriyaki entree received a 4 ounce portion.

During an interview on 2/10/10 at 3 p.m., with Dietary Management Staff F she stated she had been in the position since 9/09 and maintained purchasing systems that were in place.

Review of the document titled "Product Detail Print," on 2/10/10, for the breaded chicken tenderloin revealed that the total amount of protein in the item equated to 2.5 ounces of protein, rather than a 4 ounce portion as specified on the therapeutic spreadsheet. It was also noted that the hospital had been purchasing this product on a weekly basis. There was no documentation that the product had been reviewed to ensure the protein specifications met the requirements of the therapeutic spreadsheet.

Review of the policy and procedure titled "Food, Supplies and Equipment Procurement," dated 6/07, on 2/11/10, revealed that while the hospital had a policy to ensure "accurate" purchases there were no guidelines to ensure that purchased products met menu specifications.

Review of the policy and procedure titled "Patient Menus,"dated 6/07, on 2/11/10, indicated that the menus will be reviewed annually, or as needed, for changes. There was no documented evidence that the menu was reviewed to accommodate a possible change in the products ordered.

Review of the policy and procedure titled "Purchasing Guidelines," on 2/11/10, outlined purchasing procedures based on competitive systems and to base all purchases on quality, service or price. There was no documentation that purchasing guidelines would be based on menu specifications.

2. In place of the hamburger entree, patients were able to choose a turkey sandwich as a substitute. During observation of the preparation of several sandwiches it was noted that Dietary Staff III was placing several unmeasured slices of meat on the sandwich. The surveyor asked Dietary Staff III if this was the usual process for making sandwiches. She replied that it was.

During an interview with RD J on 2/10/10 at 12 p.m., the surveyor asked how the hospital ensured that the designated protein portions were being served. She stated that she was unsure. The surveyor requested a sandwich for the purpose of weighing the meat. RD J stated she was unsure if the dietary department had a scale. It was noted that the weight of the resulting protein portion was 3.5 ounces, rather than the 4 ounces as specified on the therapeutic spreadsheet.

The surveyor asked RD J where the second scale came from. She replied that it was in a storage area across the hall. The surveyor asked the likelihood that dietary staff were utilizing any type of measuring equipment for items such as sandwiches, to which RD J replied they were likely not weighing any items for accuracy of portions prior to meal service.

Review of hospital policy and procedure titled "Meal Accuracy," dated 6/03, on 2/11/10, guided staff that all completed meal orders will be checked for accuracy by a food service designee. In addition, it was noted that patient trays would be checked for "diet order restrictions." There was no observed mechanism to ensure that meals were checked prior to nursing unit delivery.

Based on tray line observations, dietary staff interview and dietary document review, the hospital failed to ensure the physician ordered therapeutic diets were followed as evidenced by errors on tray line for 2 of 6 random patients. Patient 200 received a regular textured meal rather than the physician ordered soft diet and Patient 201 received french fries on a cardiac diet. These failures to offer the correct texture of the physician ordered diet may result in the risk of choking, aspiration food into the lungs, and in severe instances may result in death, and to offer the correct therapeutic diet may further compromise patients' medical status.

Findings:

1. During tray line observations on 2/10/10 beginning at 11:40 a.m., the following was noted:

a. Patient 200's diet was noted to be an ADA (American Diabetes Association) soft diet. Dietary staff placed a full hamburger on the patients' plate.

During an interview on 2/10/10 at 12:15 p.m., with RD J she was asked to describe the hospital policy for a soft diet. RD J presented the surveyor with 3 separate documents, with vast differences, that described varying degrees of soft diets. The first was a patient education tool explaining a "Soft-Bland-Low Residue Diet," which guided staff to provide foods low in dietary fiber. While Patient 200's diet was a "soft" diet the physician did not order a bland or low residue diet. It was also noted that this document described a mechanical soft diet which guided staff to modify the texture of foods to chopped, ground mashed or pureed.

The additional 2 documents that were presented were print from the hospitals' Nutrition Care Manual. It also noted that the mechanically altered diet guided staff to provide moist-ground or minced tender cooked meat, no larger than ?" pieces. Similarly the third document titled "National Dysphagia Level 2 Mechanically Altered Nutrition Therapy," printed by the American Dietetic Association guided staff to provide meats that were mechanically altered to no larger than ?" in size.

During a concurrent interview with RD J, she stated that it would be difficult to determine the intentions of the physician with the inconsistency of interpretation by the dietary department. It was also noted that the therapeutic spreadsheet that was in use by tray line staff failed to provide staff any guidance for mechanically altered diets, rather was limited to diets that altered only the nutritional composition of the diets.

Review of the documents titled "Interpretation of Diet Orders,"dated 7/07 and "Patient Menus,"dated 6/0, on 2/10/10, revealed that while there was a listing for a "soft" diet the diet manual did not fully or comprehensively describe the elements of the diet.

b. Patients 201's physician ordered diet was noted to be a cardiac diet. It was noted that dietary staff placed a turkey sandwich with French fries on the plate. Review of the therapeutic spreadsheet revealed that there were no fried foods allowed on the cardiac diet.

During an interview on 2/8/10 at 11:50 am, with RD J, she was asked if French fries were part of a cardiac diet, to which she stated they were not. She also stated she had noted the error. It was also noted that while RD J noted the error there were no interventions to offer the correct diet prior to the patient receiving the meal.

Review of policy and procedure titled "Meal Accuracy," dated 6/03, on 2/8/10, guided staff that all completed meal orders will be checked for accuracy by a food service designee. In addition, it was also noted that patient trays would be checked for diet order restrictions. There was no observed mechanism to ensure that meals were checked prior to nursing unit delivery.

Based on patient observations, nursing staff interview and medical record review, the hospital failed to ensure the nutritional needs of patients were met as evidenced by the failure of the staff to follow the physician orders for nutrition support, daily weights and lack of interventions for a severely depleted albumin for 1 of 3 sampled patients (Patient 304). Failure to ensure the nutritional needs of patients are met may result in weight loss, compromised nutritional status and may further compromise the medical status of patients.

Findings:

Observation on 2/10/10 beginning at 3 p.m., revealed an elderly male patient who appeared thin and frail lying in bed. It was also noted that the patient was receiving parenteral nutrition (feeding through a catheter in the arm) at a rate of 45 cc's/hour. The feeding was hung on 2/9/10 at 10:38 p.m.. In addition, it was observed that there was 450 cc's of feeding left in the bag. During a concurrent interview with Licensed Nurse (LN JJJ), she was asked how the hospital ensured the feeding was being delivered per the physician's order. The surveyor also requested for the nursing staff to display the amount of feeding that was delivered on the pump. It was noted that the pump indicated that a total of 802 cubic centimeter (cc) were delivered. It was also noted that LN JJJ began to determine the amount of feeding that was delivered by calculating the rate of the feeding by using the time it was hung as a reference. She also stated that it was likely that the pump was not cleared when the feeding was hung. The surveyor also asked how the nursing staff could ensure the feeding was delivered per the physicians' order if it was calculated based on the amount of time the formula was hanging, rather than an actual delivery from the pump. LN JJJ acknowledged that assessing the amount of feeding delivered by using a calculator may not accurately reflect the amount of feeding the patient received.

Review of Patient 304's record review on 2/9/10, revealed that the patient was admitted to the hospital with diagnosis sepsis (an infection in the bloodstream). Review of the comprehensive nursing assessment dated 2/1/10, revealed an admission weight of 5 feet 5 inches and a weight of 90 pounds. The assessment also noted that the RN was "unable to determine" whether or not Patient 304 was at nutritional risk despite an admission weight indicating he was at least 20 pounds underweight for his height (American Dietetic Association, 2009).

Review of the physician order dated 2/2/10, revealed an order diet to start parenteral nutrition per pharmacy protocol. The pharmacy protocol dated 2/2/10 initiated a standardized feeding at a rate of 75 cc /hour as well as daily weights and strict intake and output monitoring. On 2/5/10, the enteral feeding was changed to a rate of 45 cc/hour, which would equate to 1080 cc/day, where it remained. It was also noted that the physician's order included daily weights and strict intake/output.

A comprehensive nutrition assessment completed by the RD dated 2/3/10, indicated that the patient's estimated nutritional needs were 1225-1430 calories, 50-60 grams of protein and greater than 1400 cc of fluid. The assessment also noted that the current recommended feeding rate should meet the patient's nutritional needs. The assessment also indicated that the patient had inadequate energy intake, had increased nutrient needs and was underweight.

Lab work dated 2/7/10 noted an albumin (a measure of protein stores) of 1.2 grams (gm)/deciliter (dl) (normal 3.2-4.7), indicating a severe depletion (American Dietetic Association, 2007). A nutrition re-assessment dated 2/10/10 failed to document any issues with the patient's protein stores. There were no recommended interventions for replenishment of protein stores, despite the severely depleted albumin stores.

It was also noted there were no additional weights, despite physician's orders for daily weights. On 2/9/10 at 3:30 p.m., the surveyor requested nursing staff to weigh the patient. It was noted that the bed scale recorded a weight of 83 pounds, a loss of 7 pounds since admission.

Review of intake/output records indicated that the following amount of feeding was delivered: 1. On 2/6/10 the patient received 675 cc. On 2/7/10 the patient received 360 cc. On 2/8/10 and 2/9/10 nursing staff recorded exactly 360 cc of feeding for each shift.

Based on observation of breast milk storage practices, staff interview, and document review, the hospital failed to ensure proper maintenance of equipment as evidenced by: 1. A food storage refrigerator that did not maintain food temperatures within acceptable parameters, 2. A broken refrigerator thermometer. These failure to ensure temperature monitoring devices are functioning properly may result in foods/breast milk being stored at unacceptable temperatures result in food borne illness of patients. Food borne illness in infants may result in decreased nutritional intake compromising patient health status, and 3. A broken kitchen scale. This failure to maintain kitchen scales may result in patients receiving incorrect portion sizes affecting nutritional intake. Decreased nutritional intake may result in weight loss, further compromising medical/nutritional status, 4. Failed to have a comprehensive meal planning in the event of a disaster. This failure to fully a disaster feeding plan that meets the nutritional needs of hospitalized status may further compromise the medical status of patients.

Findings:

Temperature of Thermometer

1. Inspection of the breast milk storage practices on 2/10/10 at 3 p.m., revealed that the thermometer in the refrigerator did not have a solid red line, rather it had several broken lines. It was also noted that there currently was no stored breast milk. In a concurrent interview with Licensed Nurse (LN HHH), was asked to read the thermometer. She stated that the thermometer appeared to indicate a temperature of 52 degree (?) Farenheit (F). In a concurrent interview with Registered Dietician (RD J) she stated that it appeared the thermometer was broken.

Concurrent interview with LN HHH and review of the document titled "Family Birth Center QC Log," dated February 2010, revealed that nursing staff were consistently documenting a temperature of 36 ?F. Upon inquiry regarding how staff arrived at the temperature of 36 ?F in light of a broken thermometer, LN HHH stated that she was unable to explain it. It was also noted that the log guided staff to "Write actual temp here" and to notify the charge nurse if any equipment did not pass the quality control check for reporting to the appropriate unit. There was no documentation that staff members recognized that the thermometer was broken.

The standard of practice would be to store breast milk taking into account time/temperature controls to maintain breast milk safety and integrity (Medscape, 2009). It was also noted that the guidelines for breast milk storage temperatures was 36 ?F - 46 ?F, the range for medication storage. The standard of practice for storage of breast milk would be at temperatures less than 41 ?F (Centers for Disease Control, 2010).

Review on 2/10/10 at 3:15 p.m., revealed that it was the responsibility of the OB Tech on the night shift to record the refrigerator temperatures.

Broken Scale

2. In place of the hamburger entree, patients were able to choose a turkey sandwich as a substitute. During observation of the preparation of several sandwiches it was noted that Dietary Staff III was placing several unmeasured slices of meat on the sandwich. The surveyor asked Dietary Staff III if this was the usual process for making sandwiches. She replied that it was.

In an interview with RD J on 2/10/10 at 12 p.m., the surveyor asked how the hospital ensured that the designated protein portions were being served. She stated that she was unsure. The surveyor requested a sandwich and a scale for the purpose of weighing the meat. After several minutes a dietary staff member obtained a scale that was not functional. The surveyor asked the likelihood that dietary staff were utilizing any type of measuring equipment in light of the fact that the scale was broken, to which RD J replied they were likely not weighing any items for accuracy of portions prior to meal service.

3. During general kitchen observation on 2/8/10 at 9:45 a.m., it was noted that there were 2 pieces of roast been in the refrigerator #6. The internal probed temperature of the item was 47 ?F. It was also noted that the temperature indicator on the exterior of the unit was 42 ?F. The separate internal thermometer registered a temperature of 50 ?F.

In a follow-up observation on 2/8/10 at 2:15 p.m., observation revealed that both pieces of pot roast were still in the refrigerator. Follow up internal temperatures were taken and were noted as 47 ?F for both cuts of meat. The separate internal thermometer registered at 48 ?F. A final temperature of the pot roast was taken on 2/8/10 at 4:20 p.m. The internal probed temperature was 46 ?F. At that time the surveyor placed the thermometer used to probe food temperatures in the refrigerator for several minutes. The thermometer registered 47 ?F. On 2/8/10 at 4:40 p.m., in the presence of RD J, the surveyor's thermometer was calibrated and determined to be accurate.

In an interview on 2/8/9/10 at 8:30 a.m., with Dietary Staff FF, she stated she was responsible for taking temperatures of all of the refrigerator units. She stated that she utilized the internal thermometer. She also stated that the temperatures were usually taken between 6 a.m. and 7:30 a.m. She further stated that there were no other temperatures taken throughout the day. There was no documentation that hospital staff recognized that Refrigerator #6 was not maintaining food temperatures.

Review of the document titled "Temperature Log," for January 2010 and February 2010, revealed that the temperatures for Refrigerator #6 were recorded as 38 ?F.
Disaster Meals
4. Disaster meal planning was reviewed on 2/11/10 at 10 a.m. During an interview, Dietary Management Staff F and Regional Staff GG were asked to describe disaster meal planning. RS GG stated that he had developed a disaster meal plan utilizing ready to eat type meals. Review of the product revealed that it was a foil wrapped ready to eat packet that contained 9-lemon flavored square bricks that were intended to be reconstituted with water. He further stated that this was the intended meal plan for both patients and employees during a disaster regardless of physician ordered therapeutic diet. He additionally stated there was storage of 5,000, 6-ounce water packets (totaling 238 gallons) that were intended to be used for reconstitution of the lemon bar. Upon inquiry regarding how the hospital planned to ensure that specialized therapeutic diets such as renal, cardiac or diabetic diets would be met. RS GG acknowledged that while this plan may provide nutrition to employees and less acute patients, it may not meet the nutritional needs of patients that required specialized therapeutic diets in an effort to maintain medical status. He also acknowledged that 238 gallons of readily potable water would likely not be adequate to meet the hydration and menu needs of patients and staff.
Review of the ingredient label of the product revealed that the first ingredient was enriched flour with added vitamins and minerals. It was also noted that the next several ingredients were several different oils such as shortening, soybean oil, corn starch and corn syrup as well artificial color and flavorings.
Review of policy and procedure titled "Disaster/Emergency Feeding," dated 6/07, revealed that the hospital approved menu consisted of canned entrees such as beef stew and ravioli, dried cereal, vegetables, juices and milk. It was also noted that the hospital was planning on 536 employees, staff and visitors.

Based on observation, staff interview, record review, and document review, the facility failed to provide a sanitary environment to avoid sources and transmission of infections and communicable disease as evidenced by:

1. Failed to implement their policy and procedure to clean glucometers between patient use to prevent the transmission of infectious organisms and Failed to implement their policy and procedure to demonstrate knowledge that the three different hepa filters devices that were utilized by nursing staff, were functioning properly to prevent the transmission of airborne organisms (See A748).

2. Failure to provide safe/effective dietetic services as evidenced by findings of unsafe food handling practices and lack of effective monitoring of potentially hazardous foods that resulted in immediate jeopardy to the health and safety of the patients (A620 and A749).

3. Failure to implement infection control policy and procedures when disposing of blood which could have resulted in the transmission of blood born diseases (See A749).

4. Failure to provide a hospital-wide infection control program to conduct surveillance and prevent the transmission of infections in the laboratory, radiology, and physical therapy services (See A749).

The cumulative effect of these systemic problems resulted in the inability of the hospital's infection control program and food and nutrition services ensure that the patients' food was handled safely and potentially hazardous foods were monitored in accordance with acceptable standards of practice.




16501

Based on observation, staff interview, record review, and document review, the infection control officer failed to: 1. Implement policies and procedures for the control of infections and communicable diseases by not cleaning glucometers (A medical device used to test the approximate concentration of sugar in the blood) between patient use to prevent the transmission of infections and communicable diseases on 4 of 6 nursing departments and 2. Implement their policy and procedure to demonstrate knowledge that the three different HEPA filters (High Efficiency Particulate Air filters that traps large amount of very small particles not allowing the small particles to recirculating back into the air) machines that were utilized by licensed nurses were functioning properly to prevent the transmission of airborne organisms on 3 of 6 nursing departments staff.

Findings:

Cleaning of the glucometers

1. Review of Patient 100's record on 2/8/10 at 10:15 a.m., revealed that the patient was admitted on 2/6/10 with diagnoses of diabetic ketoacidosis (a life threatening condition in which blood sugar levels are high) and altered mental status. During an observation on 2/8/10 at 10:30 a.m., in the Intensive Coronary Care Unit (ICCU) revealed that Licensed Nurse A (LN A) wiped the outside of the glucometer (She used to test the blood sugar of a patient) with a towelette that contained a disinfectant (10% bleach solution).

During an interview on 2/8/10 at 10:31 a.m., LN A stated that the licensed nurses are to wipe the outside of the glucometer with a disinfectant prior to taking the patients' blood sugars, it is a part of the hospital's quality control (QC) check. LN A stated that they are to document the QC in the computer with a check mark.

During an interview on 2/8/10 at 11:00 a.m., in the Operating Room (OR) and in the Post Anesthesia Care Unit (PACU), Licensed Nurse (LN B) stated that she only wipes the outside of the glucometer with the disinfectant towelette.

During an interview on 2/8/10 at 11:10 a.m., in the Obstetrics and Nursery, Licensed Nurse C (LN C) stated that she wiped down the outside of the glucometer with the disinfectant towelettes, popped out the cartridge (test strip holder), and wipes the glucometer cartridge on the outside.

During an interview on 2/8/10 at 11:30 a.m., in the Emergency Department (ED), Licensed Nurse D (LN D) stated that she did not know the procedure for cleaning the glucometer, "...I would have to look it up..." Upon inquiry regarding how often she cleans the glucometer, LN D stated, "...I don't know how often."

Review of the policy and procedure titled,"Blood Glucose Point of Care Testing and Quality Control," (not dated) under the section Cleaning for Outside the Meter; gives the directions for the staff to use in Cleaning the Test Strip Holder. Staff are to remove the test strip holder by pressing down on the left side and sliding to the right. Then staff are to wipe the test strip holder cover and base with hypochlorite wipes (10% bleach solution) and to wipe off the outside of the meter using a dampened cloth with water to remove residual bleach. Staff are to thoroughly dry the test strip holder with a soft cloth or lint-free tissue. Staff are to wipe the lens area and contact points with hypochlorite wipes (10% bleach solution). Follow with dampened cloth with water to remove residual bleach. Staff are to dry the lens area with a clean, soft cloth or lint free tissue. Staff are to replace the closed test strip holder by sliding it into the meter. Push the test strip holder until it clicks into place. Staff are to clean meters after each patient use.

Review of the manufacturer's recommendations for cleaning the glucometer confirmed the above mentioned instructions.

HEPA filters

2. During an interview on 2/8/10, Administrative Nursing Staff E stated that there were no patients currently on airborne precautions.

Review of the policy and procedure titled "Beat the Bugs," dated 10/8/09, indicated it is the responsibility of the day shift (7 a.m. to 3 p.m.) nurses caring for an patient in isolation with a HEPA filter to check for the proper function of the filter.

Review of the policy and procedure for monitoring the proper operation of the hospital's HEPA filters for airborne precautions included three different HEPA filters: NQ 500, HC 600 UV, and 800 F.

a. HEPA filter unit NQ 500: Staff are to observe that the 4 green lights are lit. They may flicker as the bulbs warm up.
Staff are to observe the "DP Gauge" on the front of the panel. It should not go < 0.3 or > 0.7 inches of water. If DP is out of this range, filters need to be replaced.

b. HEPA filter unit HC 600 UV: Staff are to observe filter "alarm" lights are off and UV lamp indicator is on. If unit is not operating properly, request a replacement from Central Services and send a work order to Engineering.

c. HEPA filter 800 F: Staff are to observe filter "light" off. If filter light is on, filter needs to be changed soon and if the unit is not operating properly, request a replacement from Central Services, & send a work order to Engineering.

During an interview on 2/8/10 at 10:00 a.m., in the ICCU, LN A stated, "...We monitor the gauge on the side of the machine (HEPA filter- NQ 500)." LN A could not explain the monitoring procedures for the other two HEPA filters (600 UV and 800 F).

During an interview on 2/8/10 at 11:00 a.m., on the Medical/Surgical Unit, Licensed Nurse (LN AA) stated that she would monitor the gauges (NQ 500), but she could not explain the monitoring procedures for the other two HEPA filters (600 UV and 800 F).

During an interview on 2/8/10 at 11:50 p.m., Licensed Nurse (LN BB) stated that the HEPA filters had alarms (only the HC 600 UV had an alarm). "...if we are not there, there are alarms on it..." LN BB could not explain the monitoring procedures for the other two HEPA filters (600 UV and 800 F).





16501

Based on food service observations, dietary and corporate staff interview, infection control and administrative document review, the hospital failed to ensure: 1. Food safety as evidenced by the lack of a comprehensive system to monitor time/temperature control of potentially hazardous foods (PHF's). PHF's have the capability of supporting bacterial growth associated with foodborne illness. Foodborne illness may result in nausea, vomiting, and gastrointestinal distress further compromising the medical status of hospitalized patients. In severe instances foodborne illness may result in death. Additional failures not related to the IJ situation included, 2. That the storage of personal clothing/items in the dry storage area, 3. That there was an effective sanitation of work surfaces, 4. That there was a clean and sanitary work surfaces, 5. That there was overall kitchen cleanliness, 6. That the cleaning of hospital ice machines did not meet manufacturer's specifications.These failure may result in food borne illness and/or cross contamination of patient meals, 7. That the staff implemented the infection control policy and procedures when disposing of blood was, which could have resulted in the transmission of blood borne disease; 8. That the hospital-wide infection control program included surveillance to prevent the transmission of infections, 9. That the staff implemented the policy and procedures for disposing of blood. This failure had the potential for the transmission of blood born diseases, and 10. That there is a hospital-wide infection control program to conduct surveillance in the laboratory, radiology, and physical therapy services.

Findings:

Provide safe/effective dietetic services as evidenced by findings of unsafe food handling practices and lack of effective monitoring of potentially hazardous foods that resulted in immediate jeopardy to the health and safety of the patients (Cross reference: See A620, and A749).

This resulted in the notification of administrative staff of an Immediate Jeopardy (IJ) situation on 2/9/10 at 10:20 a.m.. Administrative staff were notified that the IJ was abated on 2/11/10 at 10:20 a.m., after the hosptial removed all previously cooked PHF's from service; began monitoring time/temperature control of PHF's; trained all dietary staff on properly handling PHF's; implemented and completed competency evaluation of all dietary staff handling PHF's.

1. During initial tour on 2/8/10 at 10 a.m., observation revealed that in the cook's refrigerator (Refrigerator # 6) there were 2 pieces meat, one of which was approximately 3 pounds and the second was approximately 0.5 pounds. It was also observed that the meat was stored in a plastic container with 3 inches of beef broth.

During a concurrent interview, Dietary Management Staff F stated that the items were cooked on 2/7/10 and would be used over the course of the next 3 days. The internal probed temperature of the item was noted to be 47 ?F. It was also noted that there was spaghetti with a discard date of 2/9/10. Leftover meats are considered to be a potentially hazardous food (PHF). PHF's are those foods that are capable of supporting bacterial growth associated with foodborne illness. The standard of practice for leftover PHF's would be to cool them from 140 ?F to 70 ?F within 2 hours and to 41 ?F within an additional 4 hours. It would also be the standard of practice to maintain all PHF's at 41 ?F or below (Food Code, 2009).

During an interview on 2/8/10 at 10:15 a.m., Dietary Staff G was asked to describe the use of the leftover foods, to which he replied, that both of the items would be used over the next several days for patients as a substitute. During an interview on 2/8/10 at 2 p.m., Dietary Staff H was asked to describe how he handled leftover foods. He stated that after the food was taken out of service he would put it in a shallow pan, cover it, label and date it after which he would place it in the refrigerator. The surveyor asked if there were any other actions he would take in handling leftover foods, to which he replied that if the food was very hot he would leave it on the counter for a period of time to cool off prior to placing it in the refrigerator.

During a follow-up observation on 2/8/10 at 2:15 p.m., it was observed that both pieces of pot roast were still in the refrigerator. Follow-up internal temperatures were taken and were noted as 47 ?F for both cuts of meat. In a concurrent interview, Registered Dietitian (RD J) was asked to describe her function as the RD within the hospital to which she replied that she was the Chief Clinical RD. Upon inquiry on food service oversight, RD J stated her responsibility in food service oversight was that she performed duties such as tray line audits. Upon inquiry of the oversight of the food production activities, RD J stated that she did not have oversight of the food production activities.

During an interview on 2/8/10 at 4 p.m., Dietary Staff I was asked to describe how he handled leftover foods. He demonstrated by using a pan of leftover taco meat that was in the hot holding over. He stated that he would remove the item from hot holding, cover it with plastic wrap and place it on the counter for a period of time to cool it down. He stated that "after a while" he would place the item in the refrigerator. The surveyor asked how he ensured that the food was safe to use at a later date. Dietary Staff I stated that he would check the date to be sure that it wasn't any older than 3 days, he also stated he would visually inspect the item and smell it as well. If it didn't look or smell acceptable he would toss the item. The surveyor also asked what he would look for in a visual inspection. Dietary Staff I replied that if it appeared to have a slimy film on it he would discard the item. Dietary Staff I also stated that leftover foods would be reheated to 165 ?F.

A final temperature of the pot roast was taken on 2/8/10 at 4:20 p.m.. The internal probed temperature was 46 ?F. It was also observed that there were several slices missing from the smaller piece of pot roast. During a concurrent interview with Dietary Staff I he stated he was using it as an alternate for patients. Concurrent review of the production sheet for dinner revealed that 5 patients had requested the pot roast for the evening meal.

On 2/8/10 at 4:40 p.m., in the presence of RD J, the surveyor's thermometer was calibrated and determined to be accurate.

During an interview on 2/8/10 at 5 p.m., Dietary Management Staff (DMS F) was asked to describe how she ensured that leftover, cooked, foods were safe to be used on multiple days. DMS F stated that she ensured that staff followed Hazard Analysis Critical Control Points (HACCP) procedures by reheating the food to 165 ?F. She stated that she would expect that staff would put the item to be stored in an ice bath on the counter or in the refrigerator. She further stated that the item would need to reach an internal temperature of 70 ?F within 2 hours. The surveyor asked DMS F how she ensured that staff was following a HACCP plan. She replied that she reviewed refrigerator temperatures on a weekly basis and observed the cooks performing tasks. The surveyor asked if she probed temperatures of leftover foods, to which she replied that she did; however the results were not documented. She further stated that she has never monitored the cool down temperatures of foods.

During an interview on 2/8/10 at 5:15 p.m., Regional Director GG, whose responsibility was to provide oversight to the department was asked how he ensured that the hospital was implementing safe food handling procedures. He replied that he performed this function by applying tools that were developed within the corporation. He also stated that food handling process was recently evaluated by a regional team. He also stated that he visited the hospital on a weekly basis. The surveyor asked if he had identified that the hospital did not have an effective program to ensure time/temperature control of PHF's, he replied he had not.

During an interview on 2/9/10 at 8:30 a.m., Infection Control Staff (ICS HH) was asked to describe the role of the infection control practitioner in food service. She stated that while she had not evaluated the department she was familiar with critical areas in food service such as food receiving, storage and potential hazards in food service. She also stated that Environment of Care (EOC) rounds of the dietary department would happen yearly; however it would be likely that the staff completing the EOC rounds would rely on the expertise of dietary staff to guide them through identified issues.

During an interview on 2/9/10 at 9 a.m., RD II participated in the regional evaluation on 1/29/10. The surveyor asked her to describe how the service was evaluated. RD II stated that she acted as the recorder and documented the findings of the remaining team. She also stated that the team evaluated an isolated point in time and did not perform a system evaluation. She also stated that the evaluation was done late in the afternoon and the kitchen was basically empty. She further stated that the regional team usually asked dietary staff questions and depending on the answer may or may not review system documentation. She acknowledged that the regional team did not identify the lack of monitoring for time/temperature controls of PHF's.

Review of the document titled "HACCP Critical Control Points," for 1/31/-2/6/10, on 2/8/09 at 4:50 p.m., revealed that the system was limited to monitoring of minimum internal temperature requirements for cooking raw food and recommended serving temperatures. While there was a space on the log to monitor the cooling temperatures of foods, these were blank on all of the forms.

Review of the policy and procedure titled "Cooling and Reheating of Foods," dated 6/07, on 2/10/10, guided staff that leftover food must be "...cooled quickly and safety to 70 ?F within 2 hours and then to 40 ?F within an additional 4 hours..." It was also noted that the "Internal product temperatures must be taken ...recorded on the cooling log and kept on file for one (1) year."

Review of hospital Environment Of Care (EOC) rounds, dated 4/4/09, on 2/9/10, related to the dietary department revealed there was no assessment of safe food handling procedures related to food production activities, rather was limited to environmental factors such as life safety, building maintenance, storage of chemicals, area cleanliness and hand washing.

2. During review of food storage practices on 2/10/10 at 11:30 a.m., observation revealed that dietary staff was storing sandwich prep items in a deli-type refrigeration unit adjacent to the steam tables. In a concurrent interview with Dietary Staff GGG she stated that the deli area was set up daily at 11 a.m. She also stated that the items would be stored in the unit for the duration of the day and would be discarded at approximately 8 p.m. each evening.

The internal probed temperature of a container of sliced ham was taken on 2/10/10 at 2:45 p.m., and was noted to be 43 ?F. A follow-up temperature was taken on 2/10/10 at 4:45 p.m., and was noted to be 42 ?F. During a concurrent interview, RD J was asked to describe how the hospital monitored the temperature of foods. She replied that the refrigeration units were monitored; however food temperatures were not taken. It was also noted that in addition to meat, dietary staff were also storing sliced tomatoes in the unit. The meat and tomatoes are considered to be potentially hazardous foods that require time/temperature control to prevent the bacterial growth associated with food borne illness (Food Code 2009). The standard of practice would be to ensure that PHF's are not stored in the food danger zone, defined as 41 ?F through 135 ?F for greater than 4 hours (Food Code, 2009).

During a concurrent interview, RD J was asked whether or not dietary staff monitored temperatures of the deli unit throughout the day. She replied they did not.

Review of a document titled "Daily Temperature Log," on 2/10/10, revealed that the form guided staff to monitor the temperatures of both hot and cold items; however it was noted there was no mechanism to monitor food temperatures of the deli unit.

Storage of personal clothing/items in the dry storage area;

3. During initial tour on 2/8/10 at 10 a.m., the following was observed: a. That in the dry storage area there was a coat and umbrella hanging from a shelf that contained patient food. In a concurrent interview with DMS F she stated that employees always stored the freezer coat in the dry storage area. b.That there was a bank of employee lockers in the food production area. During a concurrent interview DMS F stated that to her knowledge these lockers had always been in the food production area.

During an interview with ICS Staff HH on 2/9/10 at 8:30 a.m., she was asked to describe the involvement of the infection control preventionist in ensuring safe food storage. ICS HH stated that the dietary department underwent yearly environment of care rounds that would include reviewing basic storage practices.

Review of a document titled "EOC rounds," dated 4/4/09, revealed that while there was an evaluation of environmental factors such as, building maintenance, storage of chemicals, area cleanliness the EOC round did not identify issues surrounding storage of personal items or the presence of the employee lockers.

Lack of effective sanitation of work surfaces;

4. During general kitchen observation on 2/10/10 at 11:40 a.m., it was observed that there were several kitchen areas that were not clean. Observation revealed that all of the refrigerator doors had a clear grease-like substance on the doors and the refrigerator handles left a sticky/greasy residue after being touched. Observation revealed that there were several racks that held dome covers for patient meals. These racks were covered with grey fuzzy material resembling dust. There was also a stuffed plush toy hanging over the utensil rack in the food production area. Inspection of the knife holder, the ovens, as well as the can opener, revealed that the equipment was covered with a grease-like substance, unidentified food particles and grey dust-like matter.

During an interview with DMS F and RS GG on 2/10/10 at 9:30 a.m., they were asked how kitchen cleanliness was ensured. They stated that there was no formal cleaning schedule and that cleaning duties were incorporated into each dietary staff members' position description.

Review of the policy and procedure titled "Sanitation Program," (not dated) on 2/11/10, revealed that it was the responsibility of the Food Service Manager to monitor sanitizing schedules and procedures. It was also noted that items such as refrigerators, can openers and ovens were designated to be cleaned both daily and weekly. There was no documentation that the DMS F monitored the cleanliness of kitchen areas and that the sanitation program was being followed.

Lack of clean and sanitary work surfaces and lack of overall kitchen cleanliness;

5. During an interview with Dietary Staff I on 2/10/10 at 2:15 p.m., he was asked to describe how he cleaned his work surfaces. He stated that once surfaces were soiled he would wipe the counter with a sanitizer and afterwards he spray them down and polish them with an orange solution.

Review of the Material Safety Data Sheet for the product called Oasis 137 revealed that under the "hazards identification" section guided staff to "wash thoroughly after handling." The MSDS also guided staff to use chemical resistant impervious gloves when handling the solution. There was no documentation that the orange solution was acceptable to use on food contact surfaces as a final step prior to continuing food production activities.

Review of a document titled "Sanitation Program," dated 6/07 on 2/11/10, revealed that it was the responsibility of the Food Service Manger to monitor sanitizing procedures; however it was noted that the policy failed to provide any guidance on cleaning food contact surfaces.

Lack of overall kitchen cleanliness and cleaning of hospital ice machines that did not meet manufacturers' specifications.

6. The ice machine cleaning process was reviewed on 2/10/10 at 2:35 p.m.. During a concurrent interview with Maintenance Staff FFF, he was asked to describe the maintenance of the ice machine. He stated that on a semi-annual basis he cleaned and sanitized the machine. Observation of the ice machine revealed a build up of grey dust-like material on the water tubes and surfaces in the ice production area of the machine.

Maintenance Staff FFF further described the cleaning process. He stated that he would use a mineral descaling product after which he would sanitize the machine using household grade bleach. Observation revealed that the bleach being used was not a food grade bleach. The bleach being used was a 6.15% hyper chlorite solution. Concurrent review of manufacturers' guidance revealed that the recommended strength for the bleach was 5.25 percent (%). Maintenance Staff FFF stated he believed that any type of bleach solution would be acceptable.

Review of a document titled "Sanitation Program," dated 6/07 on 2/11/10, revealed that it was the responsibility of the Food Service Manger to monitor sanitizing procedures. There was no documentation that any dietary management staff evaluated the effectiveness of the ice machine sanitation process.



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25447

Transmission of blood born diseases

7. Review of Patient 302 record on 2/10/10, revealed that the patient presented to the Emergency Department (ED) on 2/7/10 with a chief complaint of weakness and not being able to use restroom. Patient 302 was diagnosed with failure to thrive, pneumonia, acute respiratory distress, and septic shock (It is the uncontrolled production of bacterial overload in the blood stream), severe dehydration, hypotension and malnutrition, and anemia (It is a deficiency of hemoglobin [red blood cells]. The hemoglobin is responsible for carrying the oxygen that we breath from the lungs to the body tissues). Review of the physician's orders dated 2/10/10 at 9:00 a.m., revealed a order to transfuse 2 Packed Red Blood Cells (PRBC) today.
On 2/10/10 at 2:17 p.m., Staff KKKK and Staff LLLL, in the Intensive Care Unit (ICU), escorted surveyors to the bedside of Patient 302 for the purpose of observing a blood transfusion. Staff KKKK was observed priming the tubing of the blood administration set (When blood is run through the line to displace all air in the intravenous tubing so as to avoid introducing an air bubble into the vein). Fluid blood was observed flowing from the bag , through the tubing, then dripping (three drops) from the terminal end of the intravenous (IV) administration set into a paper box. Staff KKKK placed a bloody cap from the set and two used alcohol prep pads into the same box, smearing the blood so that it was visible amongst the used supplies. While still in the room, Staff KKKK picked up the box with the bloodied trash and disposed of it in an empty white (regular) plastic-lined garbage container in the patient's room. She discarded her gloves into the sharps container and washed her hands. The administration pump alarmed. Staff KKKK donned gloves, addressed the alarm, and then disposed of her gloves in the same white (regular) plastic lined garbage container. Upon inquiry regarding the disposal of the bloodied items in the white trash container, Staff KKKK said, No, she had not disposed bloodie items in the white trash container. After looking at the box in the trash can again, Staff KKKK acknowledged, that's blood in the box. Staff KKKK then transferred the bloodied items in the box and the plastic liner into a red biohazardous waste container.

Review of the policy and procedure titled "Medical Waste," dated 4/09, on 2/10/10, defines biohazard as Blood or Body Fluids Waste, which at the point of transport from the generator's site, at the point of disposal, or thereafter, contains recognizable fluid blood, fluid blood products, containers or equipment containing blood that is fluid. Under the subsection of the same policy, "Waste Segregation, Labeling and Collection/Transport" indicted that all medical waste shall be segregated from other waste at the point of origin and all biohazardous waste, except sharps, will be placed into disposable red impervious bags conspicuously labeled with the words "Biohazardous Waste" or with the international biohazard symbol and the word BIOHAZARD.

Review of the policy and procedure titled "STANDARD AND TRANSMISSION BASED PRECAUTIONS GUIDELINES," dated 8/09, on 2/10/10, indicated that Standard Precautions (work practices which require everyone to assume responsibility) are designed to reduce the risk of transmission of microorganisms from both recognized and unrecognized sources of infection in hospitals. Standard Precautions provide a consistent approach to managing body substances from ALL patients and are essential to prevent transmission of potentially infectious agents. They apply to all patients with regard to: blood. Under the subsection of the same policy, "Trash/Infectious Waste & Needle Disposal," indicated that all trash generated from individual patient rooms and ICUs with the exception of items listed in # 6 below can be disposed of in regular trash bags as per usual practice. Under # 6, the policy listed, "BIOHAZARDOUS WASTE," as waste that has been classified as infectious and red bagged will be handled as described in, "Infectious Waste Management" policy in Housekeeping manuals, WR060. Infectious waste will be stored in rigid, leak proof container. The policy further indicated that implementing the Standard Precautions system should be followed by ALL personnel at all times and, Department Directors/Managers are responsible for assuring that employees are following Standard Precautions guidelines and using protective barriers, that employees who do not follow the policy will be counseled, and that "Safety inspections will include adherence to standards.

During an interview on 2/11/10 at 2:00 p.m., Staff K explained that the hospital does not require nurses to dispose of administration sets with "flash blood" in the biohazardous waste container. Flash back blood may refer to the small amount of blood that returns into a catheter during veinipuncture (blood-drawing procedures unrelated to priming tubing).

According to a phebotomists' guidelines, "flash back blood" is defined as, "The appearance of a small amount of blood in the neck of a syringe or tubing. This is a sign that the vein has been properly accessed (reference www.phlebotomypages.com). The hospital did not provide their definition or a policy describing flash blood, or explain the relevance of "flash blood" to the observation of the fluid blood.

In the same interview, staff was unable to explain why nurses needed to prime a line with blood into a paper box. A review of the hospital policy "Blood Transfusion/Blood Transfusion Reaction policy (revised 9/09) requires nurses to use the following equipment for blood transfusions, "Blood tubing, surgical Y-Type". This type of specialized administration set allows blood to be infused into a line already primed with normal saline all the way from the bag to the chamber to the terminal end. As the saline infuses into the patient through one arm of the "Y" , the chamber never completely empties, and by unclamping the blood bag, gravity pulls blood in from the other arm of the "Y" in a closed system. Thus, the need to prime the line with blood to the terminal end (with the attendant potential for contamination) is avoided.
FLASH-BACK
Relative to venipuncture, the appearance of a small amount of blood in the neck of a syringe or the tubing of a butterfly. This is a sign that the vein has been properly accessed.
FLASH-BACK
Relative to venipuncture, the appearance of a small amount of blood in the neck of a syringe or the tubing of a butterfly. This is a sign that the vein has been properly accessed.

8. During an interview on 2/8/10 at 1:30 p.m., Radiology Staff CC was asked how does the hospital monitor infection control practices in radiology. Radiology Staff CC stated that if there is a problem they notify the Infection Control Practitioner. Radiology Staff CC could not explain what the department specific infection practices were implemented and monitored in Radiology.

During another interview on 2/8/10 at 2:35 p.m., Laboratory Staff DD was asked how the hospital monitors infection control practices in the laboratory, Laboratory Staff DD could not explain how explain how infection control practices were monitored in the laboratory. Laboratory Staff DD stated that they have safety checks but she could not state what department specific infection control practices that were implemented and monitored on the Environment of Care (EOC) rounds.

During an interview on 2/8/10 at 2:55 p.m., Radiology Staff EE (MRI trailer located adjcent to the hospital) stated that she has not seen the Infection Control Practitioner since she left in Aug 2009, and could not say when the Infection Control Practitioner was last out in the trailer or what she was monitoring. Radiology Staff EE stated that Human Resources conducts the infection control checks.

During an interview on 2/9/10 at 3:00 p.m., Physical Therapy Staff AAA was ask how the hospital monitors infection control practices of the physical therapy staff, Physical Therapy Staff AAA stated that the Environmental of Care (EOC) rounds are conducted monthly. Physical Therpay Staff AAA could not state what department specific evaluations were conducted that were related to infection control practices on the EOC rounds.

Review of the EOC rounds did not include a department specifiic infection control component to address who, when, and what the hospital was evaluating related to infection control practices in the above mentioned departments.

During an interview on 2/11/10 at 10:30 a.m., Administrative Nursing Staff E was asked how the hospital evaluates and monitors infection control practices for outpatient cancer center, radiology, laboratory, and physial therapy. Administrative Staff E stated that they did not have what was requested. The hospital did not have a system developed for evaluating infection control practices in laboratory, radiology, physical therapy and the outpatient cancer center.

Review of the policy and procedure titled "Infection Control Program," dated 12/09, indicated that all departments, services, and staff are part of the Infection Control Program: To manage critical data and informtion, including surveillance of Hospital Acquired Infections (HAI) To recommend and establish policies and procedures, and to maintain an effective, hospital wide system for sureveillance, prevention and control of infections at this hospital.

Based on staff interview, medical record review, and document review, the hospital failed to ensure that a medical history and physical examination was completed and documented no more than 30 days prior to admission in one case.

Findings:

Review of Patient 402's record on 2/10/10, revealed that the patient was admitted for surgery and the record lacked documented evidence that a medical history and physical examination had been performed no more than 30 days prior to admission.

During an interview on 2/10/12, Administrative Staff P stated that for the type of procedure performed (yag laser capsulotomy, which is eye surgery involving laser vaporization of a film over the outside of the eyeball that occurs after many cases of cataract surgery), there is no requirement for a preoperative history and physical examination documented in the record prior to surgery.

On 2/10/10, review of the hospital's medical staff rules and regulations, approved 11/08, revealed that the requirement that a complete history and physical examination shall be done no more than 30 days prior to surgery and must be present in the patient's medical record prior to the start of inpatient or outpatient surgery. The hospital staff could not locate a document that excused yag laser capsulotomy from the requirement.