HospitalInspections.org

Based on interview, record and document review, the hospital failed to follow their policy and procedure for obtaining and documenting informed consent for Patient 43. Patient 43 signed an incomplete consent for blood transfusion form that lacked the surgeon's signature, the surgeon's documentation of a risks/benefit discussion with the patient, or a registered nurse's documented confirmation with the surgeon that the risks/benefit discussion occurred. This failure resulted in Patient 43 signing a consent without being fully informed.

Findings:

Record review on 3/6/12, showed Patient 43 had been admitted to the orthopedic nursing unit on 3/5/12 after a total knee replacement surgery performed that day. Review of the form, Verification of Consent For Blood Transfusion, indicated, "To be signed once per hospital inpatient admission or outpatient series event prior to first transfusion." Under the heading, Physician Certification, reflected, " I have discussed the administration of blood or blood products including the reason, risks, benefits and alternatives pertaining to blood transfusions with the patient or the person legally authorized to give consent on behalf of the patient. The patient has had the opportunity to ask questions and agrees to transfusion I have answered all questions."

The were two separate areas on the form; one for the RN to document the date and time, that the informed consent had been "Confirmed by telephone" and the other for the physician; to sign and date that an informed consent had been obtained. Review of Patient 43's form, Verification of Consent of Blood Transfusion, showed only the date, 2/23/12 with the time 0906, Patient 43's signature and RN 14's signature with the notation "Witness."

During an interview on 3/6/12 at 10:10 a.m., Patient 43 stated the surgeon had not discussed the risks and benefits of a blood transfusion with her prior to her signing the blood transfusion consent. Patient 43 stated she did not feel comfortable signing the consent and had spoken to the surgeon about it afterward.

On 3/8/12 at 1:20 p.m., RN 14, who had signed the Verification... form as the "Witness" stated she asked Patient 43 to sign the consent form ahead of time as part of her pre-operative paperwork, in the event she would require a blood transfusion either during surgery or afterward. RN 14 agreed it was her responsibility to confirm the surgeon had informed the patient of the risk and benefits of a blood transfusion either by the surgeon's signature on the consent or by her calling the surgeon to verify an informed discussion had occurred with the patient before asking a patient to sign the consent.

On 3/8/12 at 1:35 p.m., the Assistant Director of Peri-Anesthesia Services confirmed that if the surgeon had not signed the consent, the pre-operative nurse should have called the surgeon to verify the risks and benefits had been discussed with the patient prior to the patient signing a consent.

Review of the hospital's policy and procedure, titled, Informed Consent, last revised 7/11, indicated the role and responsibility of the hospital was to ensure hospital consents were complete. According to the policy, "Medical Center personnel involved in the consent process shall: Understand the rationale behind the consent forms; Recognize the circumstances which require the use of consent forms and Refrain from compelling patients to sign."

Based on observation, interview, and record review, the hospital failed to ensure all dialysis nursing and related personnel performing dialysis functions were screened for color blindness prior to performing a colorimetric (a device that measures the intensity of color by an individual's perception of the color) test on hemodialysis treatment water. The colorimetric test was required to be done to ensure treatment water was safe for patients undergoing hemodialysis treatments. The failure to screen personnel for color blindness to ensure they could differentiate shades of colors indicating the amount of chlorine/chloramines present in treatment water increased the risk that patients could be dialyzed with unsafe levels of chlorine/chloramines.

Findings:

Chlorine and/or chloramines are frequently added to municipal water supplies to reduce the amount of bacteria in the water; making water safe to drink. The presence of chloramines, and to a lesser degree, chlorine, is a significant concern for dialysis patients. Levels of chloramines exceeding 0.1 mg (milligrams) per liter of water, damages red blood cells in dialysis patients, increasing their anemia. Water is blended with a precise mix of chemicals to make dialysate, the solution used in the dialysis treatment.
(Hemodialysis; a procedure/treatment that uses an artificial kidney for patients with end stage renal failure to cleanse their blood of toxin and waste. During the procedure/treatment blood is removed from the body through a vascular access and filtered through a man-made membrane - a dialyzer, or artificial kidney, and then the filtered blood is returned to the body).

The hospital used the HACH company Free or Total Chlorine Test; utilizing a chlorine reagent powder and a color comparator (colorimeter). The steps involve the use of two test tubes; one tube filled with treatment water to a marked level and inserted into the left opening of the comparator to serve as the standard; the second tube filled to a marked level with treatment water and reagent powder (a chemical that reacts in a certain way to detect the presence of another substance) added, swirled, and inserted into the right opening of the comparator. The test/color is read within one minute, using a fluorescent light source directly behind the tubes. The presence of chlorine/chloramine in the water with reagent causes the water color to change to a shade of pink. The color disc on the comparator test unit is rotated until the colors in the front windows of the meter match and a reading is taken. Review of the comparator values reflected readings of 0 to .1 mg and up in increments of .1 mg. According to the comparator, the only reading that would be acceptable for chlorine/chloramine would be 0 since 0.1 mg represented an unsafe level.

During an interview on 3/7/12 at 8:15 a.m., registered nurse (RN) 1 stated she was not aware if hemodialysis staff had been tested for color blindness. At 1:20 p.m. RN 1 was asked for documentation/records that would show if any staff had been tested. RN 1 stated testing for color blindness was not done. The Renal Metabolic and Hemodialysis Manager, stated a screening test for color blindness was not required to work on the hemodialysis unit.

On 3/8/12 at 2:44 p.m., RN 1 stated during the interview, that the first chlorine/chloramine water test of the day was done by the engineering department staff. The remaining tests done throughout the day were done by the shift charge nurse. RN 1(charge nurse), who worked12 hour shifts/three days a week. RN 1 stated RN 3, RN 5, RN 6, and RN 7 were also utilized as charge nurses.

During an interview and employee health record review on 3/8/12 at 2:05 p.m., the Regional Director for employee health stated employees hired prior to 2000 had no documentation in their files of ever being tested for color blindness. The Director of Employee Health stated employees hired after 2000 had a color perception test. The employee health records showed only RN 3, hired in 2002, of the five registered nurses designated to do charge nurse duty, had a "color perception" test done. RNs 1, 5, 6, and 7 had been hired prior to 2000 and had no color blindness testing in their employee health file. Review of the engineering department employee health file showed the chief engineer, assistant chief engineer, and a third engineering staff member were hired prior to 2000 and had no documentation of being tested for color blindness.

During a telephone interview on 3/15 at 8:22 a.m., a technical representative of the manufacturer for the HACH company that produced the chloride test kit stated colorimetric testing required users of the test kit to be able to detect subtle color changes and having the test kit used by a person who had not been screened for color blindness was a "legitimate concern".

According to the authority for regulation, the Association for the Advancement of Medical Instrumentation's (AAMI) "American National Standard for Dialysate for Hemodialysis," 2004 (RD52:2004), the maximum concentration of chloramines in treated water used for dialysis should not exceed 0.10 mg per liter. According to the authority for regulation, the ability to discern colors is an essential job function for persons who have the responsibility to read colorimetric tests. They must have the capability to distinguish between different shades of pink and other colors.

Based on observation, interview, medical record and document review, the hospital failed to ensure nursing:

1. Provided comprehensive evaluations of three of five patients (Patient 65, Patient 66 and Patient 67) for nutrition care services as evidenced by 1) lack of referral to the Registered Dietitian for Patient 65 who had poor dietary intake; 2) lack of accurate nutrition screening at the time of admission for Patient 66 who had a 40 pound weight loss prior to admission; and 3) inconsistent evaluation for dietary intake for Patient 67 who had poor dietary intake. Failure to accurately and consistently evaluate patient nutritional risk could result in further compromising medical status.

2. Developed and implemented policies and procedures to ensure vascular access sites and bloodline connections were visible for four of four patients (Patient 37, Patient 45, Patient 46, and Patient 47) observed during the patients' dialysis treatment. The hospital's failure to have the patients' vascular access sites and bloodline connections exposed and visible, had the potential to cause patients' massive blood loss before detection if the needles dislodged from the access site or tubing connections came apart.

3. Implemented the hospital's policy for IV (intravenous) site rotation for Patient 41 whose IV was inserted longer than the 96 hour maximum, increasing the risk for an IV related infection.

4. Implemented the hospital's restraint policy and procedure by pre-charting assessments that included releasing the restraints for Patient 42 with bilateral wrist restraints. The failure to complete and document assessments and interventions in actual time increased the potential for an inaccurate clinical picture of Patient 42's physical and psychological status.

Findings:

1. Patient 65 was admitted with diagnoses that included high blood pressure and gall bladder inflammation. The Admission Nursing Nutrition screen dated 2/27/12 noted no nutritional risk factors; but did note the patient was admitted with abdominal pain. The nutrition screening also noted that the patient's diet preference was an Asian diet. Admission diet order dated 2/27/12 was NPO (nothing by mouth). Remaining diet orders were as follows: 2/28/12 - clear liquid; 3/2/12- low fat diet. A final diet order dated 3/2/12 was for low sodium, low protein diet.

Review of patients' dietary intake from 3/2-3/3/12 revealed that Patient 65 was consuming an average of 61%. Beginning on 3/4/12 there was no documentation of dietary intake. Additionally, there was no referral to the Registered Dietitian (RD), despite lack of dietary intake.

In an interview on 3/7/12 at 10 am, Patient 65's registered nurse (RN) 20 stated that she was aware that Patient 65 was not eating well. She also stated that the patient spoke no English and that the family was bringing cultural food from home because the patient did not like the foods that were offered. RN 20 also stated that while the hospital had access to translation services, to her knowledge these services were not utilized. She also acknowledged that she had not referred Patient 65 patient to the RD, despite recognizing that the hospital food did not meet Patient 65's food preferences.

In an interview with dietary management staff (DMS) A at 10:10 a.m., she stated that the hospital had a mechanism to provide patients with culturally appropriate foods. The DMS also stated that it was the responsibility of the nutrition aides to obtain food preferences and acknowledged that if patients did not speak English they would likely not have obtained Patient 65's food preferences.

Patient 66 was admitted with a diagnosis that included end stage renal disease. Admission Nursing Nutrition screen dated 3/1/12, completed by the RN failed to note any nutritional risk triggers. Undated hospital document titled "DT Nutrition Information" completed by the diet assistant revealed that Patient 66 lost 40 pounds within the previous 4 months due to a poor appetite.

In an interview on 3/3/12 at 11 am, RN 21 was asked to describe the nutritional risk criteria for RD referral. She stated that she would refer patients to the RD based on the nutritional risk per the protocol. RN 21 was queried whether weight loss would be considered a nutritional risk to which she replied that it was. There was no indication that nursing staff accurately assessed Patient 66's nutritional risk at the time of admission which resulted in a delay in nutrition assessment.

Patient 67 was admitted with a diagnosis that included a stroke on the right side. Admission height dated 2/20/12 was documented as 5 feet 8 inches and weight was 169 pounds. Diet order on 3/5/11 was a cardiac diet. Review of dietary intake beginning 2/28-3/3/12 revealed that Patient 67's dietary intake varied from 25-100%.

Review of Patient 67's daily flow sheet revealed that RN's were inconsistent in evaluating the adequacy of the patient's dietary intake. On 2/28/12 nursing staff documented an intake of 25% for all three meals; however failed to note whether this intake was adequate or inadequate. On 3/5/12 it was noted that nursing staff failed to document any dietary intake; however documented that Patient 65's intake was adequate. Review of hospital document titled "RD Nutrition Care Plan" dated 3/2/12 noted that Patient 65's condition was guarded with an average dietary intake of 25%, episodes of vomiting and a recommendation to consider appetite stimulants of dietary intakes remain low.

In an interview on 3/3/12 at 2:30 p.m., RN 22 stated that to her knowledge, there was no specific criteria on what would constitute adequate versus inadequate intake. She also confirmed that it was the responsibility of nursing staff to complete an assessment of dietary intake as part of the Braden scale (an assessment tool to evaluate the risk for development of skin breakdown). RN 22 also acknowledged that nursing staff were inconsistent in the assessment of dietary intake. In an interview on 3/3/12 at 2:45 p.m., DMS A stated that an intake of 75% or greater of meals would be considered to be an adequate intake.



25714

2. On 3/7/12 at 9:04 a.m., observation in the hemodialysis unit showed Patient 45 was undergoing hemodialysis.
(Hemodialysis; a procedure/treatment that uses an artificial kidney for patients with end stage renal failure to clean their blood of toxin and waste. During the procedure/treatment blood is removed from the body through a vascular access and filtered through a man-made membrane [dialyzer, or artificial kidney], and then the filtered blood is returned to the body).

Patient 45's access site and blood tubing connections from the patient to the dialysis unit were not visible.

(During hemodialysis, a vascular access provides a way to remove and then return cleansed blood to the dialysis patient. There are three kinds of vascular access sites; a fistula, which is made when a artery and a vein are joined under the skin, a graft, where the artery and vein are joined by a plastic tube also under the skin, and a catheter, which is inserted into a vein in the neck or below the collarbone and intended for short term use).

The surveyor requested Licensed vocational nurse (LVN) 1 to show the location of Patient 45's access site. LVN 1 uncovered Patient 45's left upper arm whic revealed the access site and immediately re-covered the site location. Continued observations at 9:45 a.m., 10 a.m., and 10:50 a.m. noted Patient 45's access site remained covered. During an interview, on 3/7/12 at 9:25 a.m., the hemodialysis charge nurse (RN 1) stated access sites were to be exposed at all times.

At 9:40 a.m., the surveyor noted, Patient 46 had only her head exposed, the rest of her body was covered with blankets. At 10 :05 a.m. Patient 46's dialysis machine alarm went off and registered nurse (RN 2) responded, repositioned Patient 46 on her side and covered Patient 46 (up to her chin); the access site and blood tubing to the dialysis unit were also covered.

The surveyor noted at 1:40 p.m., LVN 1 covered Patient 47 with a blanket leaving only his face and head exposed. Patient 47's access site (located in the left internal jugular vein near upper chest/neck area) and blood tubings... were not exposed. At 1:55 p.m. Patient 47, using his bed control, raised the head of his bed up, causing the blanket to slip down exposing the left upper chest/neck access site and blood tubing.

At 2:25 p.m., the surveyor noted a blanket covered Patient 47, leaving only her face and head exposed. At this time RN 3, took over care for Patient 47 from RN 4 and uncovered Patient 47's left upper arm access site.

On 3/9/12 at 9:15 a.m., RN 3 stated she kept the access site and blood tubing connections exposed because she would be able to "eye ball" them for problems that may arise, such as blood tubing disconnecting, leaks, and hematoma formation from needles at the access site.

3. On 3/5/12 at 12:35 p.m., the surveyor noted Patient 41 receiving a continuous IV (intravenous) through a right lower forearm IV site. Noted on the IV site dressing, the date of insertion, 2/29/12; which indicated the IV had been in the same site for five days.

On 3/5/12 at 1:40 p.m., RN 12 double-checked Patient 41's IV site and confirmed the 2/29/12 insertion date. RN 12 was asked how long IV's are left in the same site before they have to be discontinued. RN 12 stated, " 96 hours." Record review on 3/5/12 showed Patient 41 had been admitted to the hospital's cancer unit on 2/29/12.

Review of the hospital's IV:General Policy and Procedure, dated 2/22/10, indicated a purpose of the policy was "To adhere to standards of infection control." The policy indicated, "IV catheter, site, dressings, needle-less injection cap, and tubings are changed every 96 hours for peripheral IV access."

4. Record review, on 3/5/12, showed Patient 42 had been admitted on 3/3/12 with a diagnosis of pneumonia. Patient 42 was not able to follow directions, was disoriented, and had been pulling her Bi-pap mask off her face (a special apparatus that assists patients with breathing, resulting in improved oxygenation).

On 3/5/12 at 3:14 p.m., record review of Patient 42's Restraint Flow Sheet For Non-Violent, Non-Self Destructive Behaviors, dated 3/5/12, showed page two of the flowsheet had a 4 p.m. restraint reassessment documented. The Special Care Unit & 5 West Telemetry Unit Manger, present during record review, confirmed the reassessment had been documented prior to 4 p.m., and lacked documentation which confirmed Patient 43's restraints had been released and range of motion performed on the upper extremities every two hours, as ordered.

During an interview on 3/9/12 at 11:08 a.m., RN 15 confirmed she had documented her reassessment ahead of time and did not intend to falsely document, but Patient 42 had been, "very challenging, very busy." RN 15 stated she had been releasing the restraints because she needed to provide personal care for Patient 42 and acknowledged that documentation of restraint release and range of motion needed to be done every two hours.

Review of the hospital policy and procedure, titled, Restraints, Assessment and Use of, last revised 2/10, instructed staff to:

1. Initiate Restraint Flow Monitoring form
2. Monitor patient at least every 2 hours, and
document on Restraint Flow Sheet
3. Release and reposition restraints,
4. Assist with ROM
5. Perform safety checks (i.e. restraints applied correctly, appropriate body alignment, check for injury.)
6. Check mental status
7. Response to restraints."

Based on interview and record review, the hospital failed to ensure all medications were administered as prescribed. Patient 47 did not receive Vancomycin, an antibiotic ordered by her physician for treatment of her leg infection. The failure to administer Vancomycin as directed increased the risk for delayed healing and bacterial resistance.

Finding:

On 3/6/12 record review indicated Patient 47 was admitted to the hospital on 3/2/12 for cellulitis (an acute infection of the skin and soft tissue) of the leg that would be debrided (surgical removal of infected tissue) and treated with intravenous (IV) antibiotics. Her medical history included end-stage renal disease (ESRD) for which she was dialyzed (a process utilizing an artificial kidney to cleanse the blood of patients whose kidneys have failed). Because of
Patient 47's end stage renal disease, her physician's order dated 3/2/12 at 3:45 p.m. for the antibiotic Vancomycin indicated "Vanco (Vancomycin) 1 gm IV- check Vanco levels after HD (hemodialysis) sessions, plus re-dose Vanco 1 gram IV if level (less than or equal to) 15 (mg/liter)."

Review of the Laboratory Report form indicated Patient 47's Vancomycin levels as follows:
1. On 3/3/12: 38.6 mg/L.
2. On 3/4/12: 27.0 mg/L,
3. On 3. 3/5/12 (at 11:20 a.m.).,: 14.5 mg/L

According to the physician order, Patient 47 should received a repeat dose of Vancomycin 1 gm. IV when her level dropped below 15 mg/L. Review of the Medication Administration Record (MAR) on 3/6/12 at 1:10 p.m. with the unit manager and the charge nurse (RN 9) failed to indicate repeat administration of Vancomycin on 3/5/12.

Review of the printout from the automated medication dispenser failed to reflect a withdrawal of a dose of Vancomycin 1 mg. for Patient 47 from 3/5/12 from 8:50 a.m. through 3/6/12 at 1:09 p.m. RN 9 confirmed the repeat dose of Vancomycin l mg. had not been administered as ordered.

According to the Centers for Disease Control (CDC), antibiotic use has been so widespread and for so long, " the infectious organisms the antibiotics are designed to kill have adapted to them, making the drugs less effective. People infected with antimicrobial-resistant organisms are more likely to have longer, more expensive hospital stays, and may be more likely to die as a result of the infection."

According to a recent article in the Cleveland Clinic Journal of Medicine (July 2011 vol.78 7 465-471) citing recommendations for Vancomycin monitoring from the American Society of Health System Pharmacists, the IDSA, and the Society of Infectious Diseases Pharmacists, "The trough (representing the lowest level of a medication in the blood) Vancomycin serum level should be over 10 mg/L to prevent the development of resistance."

Based on interview and record review, the hospital failed to ensure all drugs and biologicals were administered within the scope of practice and according to hospital policy. A Licensed Vocational Nurse (LVN), acting outside the State's LVN's scope of practice and against hospital policy and procedure, administered intravenous (IV)medications. The hospital's failure to supervise the LVN, resulted in the LVN functioning outside her scope of practice and potentially putting patients at harm.

Definition(s):

Licensed Vocational Nurse (LVN); the Board of Vocational Nursing and Psychiatric Technicians describes LVN practice as rendering basic nursing care under the direction of a physician or a registered nurse.

The Vocational Nursing Practice Act defines the scope of practice and responsibilities of the Licensed Vocational Nurse.

Definitions as used in the Vocational Nursing Practice Act (LVN):

Intravenous fluids: fluid solutions of electrolytes, nutrients, vitamins, blood and blood products.

Superimposed; to connect a container of intravenous fluid to tubing through which another container of intravenous fluid has been administered.

Primary infusion line; the line which provides a direct infusion between the container and the peripheral vein.

Secondary infusion line; a line which provides infusion through a lateral access into a primary infusion line.

Findings:

Review of the hospital's LVN/LVN-IV Certified job description indicated an IV certified LVN, "Starts, superimposes, and maintains peripheral intravenous (IV) lines, excluding those that contain electrolytes and medications according to hospital policy."

Review of the hospital policy and procedure titled, IV: General Policy and Procedure, dated 2/22/10, indicated under Competency/Scope of Practice, that LVNs who had completed the 32 hour state approved course and the hospital's IV competency were deemed LVN-IV certified. The policy also indicated, " IV certified LVNs may not superimpose fluids into a central line, midline PIC [peripheral inserted IV catheter, that is threaded and terminates at a large vein in the chest near the heart], administer IV medications (continuous, intermittent, and push)."

Review of the Vocational Nursing Practice Act with Rules and Regulations, with amendments through 4/1/11, defined the LVN's scope of practice within the State of California as, "An LVN who had completed a Board approved intravenous therapy course and whose instructor had submitted their name for certification, and with Board approval, would be considered to be competent to start and superimpose intravenous fluids via primary or secondary infusion lines".

During an interview, on 3/7/12 at 8:15 a.m., the hemodialysis (a procedure/treatment that uses an artificial kidney for patients with end stage renal failure to cleanse their blood of toxin and waste) unit charge nurse (RN 1) identified licensed vocational nurse (LVN) 1 who worked in the hemodialysis unit as IV certified and could give all medications.

On 3/7/12 at 1:55 p.m., LVN 1 stated she could do more than the regular hemodialysis technician in a chronic hemodialysis clinic because she was "IV certified". LVN 1 stated she could and did give IV medications, including albumin (a preparation of albumin, a blood plasma protein, obtained from human donors used to treat low albumin levels).

Review on 3/7/12, of the Acute Hemodialysis Record showed Patient 66 received Dilaudid, a potent opioid pain medication, 1 mg (milligram) via IV push. Review of the medication administration record (MAR), dated 3/5/12-3/6/12, showed Dilaudid 1 mg. (a potent opioid pain medication), as administered IV on 3/5/12 at 10 a.m. by LVN 1.

On 3/7/12 at 2:30 p.m., RN 1 stated in interview that IV Certified meant LVN 1 could hang IV antibiotics, Albumin, blood and give medications such as Benadryl and Morphine IV. At 2:55 p.m., on 3/7/12, LVN 1 confirmed she had administered Patient 66's ordered Dilaudid by IV push, "under the supervision of an RN".

On 3/9/12, review of the hospital's pharmacy records for the past six months indicated LVN 1 had accessed the automated medication dispensing system and removed several medications ordered for IV administration. These ordered IV medications included: Morphine and Dilaudid (opioid pain medications), Zofran (anti-nausea), Benadryl (antihistamine), Albumin, Mannitol (used to support blood pressure) and Alteplase Recombinant (dissolves blood clots)

Review of LVN 1's employee file, on 3/8/12, noted LVN 1 on 2/3/06 and 8/29/11 had a Hemodialysis Unit evaluation that indicated "Pass" for the administration of medications and blood products which Included several IV medications, such as Albumin, Antibiotics, and TPN (total parenteral nutrition administered intravenously).

LVN 1's employee file also contained a competency evaluation titled, Aseptic Technique for Medication Admixtures RN/LVN, dated 10/1/04 and signed by RN 1. The competency evaluation indicated the evaluation reflected demonstrated " knowledge and skill necessary to apply and maintain aseptic technique in drawing up solution from a vial or ampoule and then injecting that solution via an injection port into an IV solution/bag." The competency evaluation form had checked boxes which indicated LVN 1 had passed those portions of the competency evaluation. In addition, on 9/29/11 LVN 1 had completed a facility online training for tube feedings and TPN.

During an interview with the hospital's Risk Management Director (RM) and Nurse Educator on 3/8/12 at 11:40 a.m. , RM stated "We did not know (an LVN had administered IV medications." Both staff confirmed it was not hospital policy to allow LVNs to administer IV medications.

Based on observation, interview and record review, the hospital failed to manage the storage of medications in accordance with standards of practice. The hospital failed to ensure that medications were stored within the manufactures recommended temperature range. Five medication refrigerators did not have a method to monitor temperatures should the temperatures fall below the manufacturers recommended storage range. This failure resulted in the potential for 361 patients, from 1/1/12 to 3/9/12, to be exposed to medications whose quality and effectiveness may have been altered due to storage temperature changes.


Findings:

During a concurrent tour and interview, in nuclear medicine, on 3/7/12 at 1:40 p.m., the surveyor noted a medication refrigerator in the hot lab. Inspection of the medication refrigerator showed a 3M Monitor Mark temperature indicator strip which Staff 1 indicated verified the medication refrigerator maintained the required temperature range. The surveyor asked Staff 1 to detail how the 3M Monitor Mark temperature indication strip verified maintenance of the low temperature limit (36 degrees Fahrenheit). Staff 1 failed to provide the requested information before the end of the survey.

During a concurrent tour and interview, on 3/7/12 at 2 pm, in the Cardiovascular Special Procedures (CVSP) department, Registered Nurse (RN 11) indicated the unit contained five medication refrigerators in which the department stored Methylergonovine injection (used in the treatment of postpartum and post abortion hemorrhage) which required refrigeration storage at temperature ranges of 36 degrees Fahrenheit (f) to 46 degrees F (LexiComp). RN 11 stated that the CVSP unit used the 3M Monitor Mark temperature indication strip to verify that the medication refrigerators maintained the required temperature range.

Record Review of the hospital's CVSP Labs indicated the following:

a. CVSP Lab 1-Merritt Pavilion: Refrigerator Temperature Log, for 1/12 and 2/12, the temperature indicator strip indicated the temperature remained in a range of 36 degrees F (Fahrenheit) to 46 degrees F" for 17 out of 60 days.

(CVSP Lab 2 - Merritt Pavilion is closed)

b. CVSP Lab 3-Merritt Pavilion, Refrigerator Temperature Log, for 1/12 and 2/12, the temperture indicator strip indicated the temperatrure remained in a range of 36 degrees F to 46 degrees F for 19 out of 60 days.

c. CVSP Lab 4-Merritt Pavilion, Refrigerator Temperature Log, for 1/12 and 2/12, the temperature indicator strip indicated the temperature remained in a range of 36 degrees F to 46 degrees F for 11 days out of 60 days.

d. CVSP Lab 5-Merritt Pavilion, Refrigerator Temperature Log, for 1/12 and 2/12, the temperature indicator strip indicated a range of 36 degrees F to 46 degrees F for 19 days out of 60 days.

During an interview, on 3/9/12 at 1:10 p.m., the Director of Risk Management stated that 361 patients were seen in the CVSP department since 1/1/12.

On 3/3/12, Record review, of the hospital's policy and procedure titled, 800.1 Drug Storage and Inspections (revision Date: 1/12) indicated:

"Medications shall be stored under appropriate conditions for product stability:

a) The refrigerator temperature shall be maintained between 36 F and 46 F...Refrigerators and freezers shall be monitored and recorded daily by the department personnel...

c) All medications in the out-of range refrigerators/freezers shall be returned to the Pharmacy..."

A product stored for stability at or near 15 C may have quite a different quality profile at its expiration date than a product stored at or near 30 C. [Reference: http://www.fda.gov/ICECI/Inspections/InspectionGuides/InspectionTechnicalGuides/ucm072919.htm]

Based on interview and record review, the hospital failed to keep accurate records of the disposition of scheduled (narcotic (morphine)) drugs. This failure had the potential for the hospital to be exposed to the loss or diversion of controlled (morphine) drugs.

Findings

During a concurrent interview and administrative record review, on 3/9/12 at 1:10 p.m., hospital's all station events report, for 13 licensed vocational nurses (LVN), were reviewed. Two LVNs removed intravenous (IV, directly into a vein) narcotics from an automated medication dispensing supply cabinet (Pyxis) that were administered by a different nurse.

Licensed Vocational Nurse (LVN 2), record record indicated she withdrew morphine 2 mg (milligram)/1 ml (milliliter) inj (injection) cartridge from the Pyxis on 2/26/12 for Patient 52. Review of Patient 52's stat and one time medications record (record of medication administration) indicated the withdrawn morphine as administered by a different nurse. The Chief Nursing Officer (CNO) acknowledged that the records did not show that LVN 2 administered the morphine to Patient 52.

Licensed Vocational Nurse (LVN 3), record record showed that she withdrew morphine 2 mg/1 ml inj cartridge on 2/14/12 from Pyxis for Patient 53. Review of Patient 53's medication administration record showed that the morphine as administered by a different nurse. The CNO acknowledged that the records did not show that LVN 3 administered the morphine to Patient 53.

During an interview, on 3/9/12 at 1:55 p.m., Pharmacist 3 stated the hospital's expectation is for the nurse that withdraws a narcotic, from an automated dispensing cabinet, as the same nurse to administer the narcotic.

Based on observation, interview and record review, the hospital pharmacy failed to ensure:

1. The development and implementation of a policy and procedure for the use of Fentanyl patches (topical opioid for pain control). Patient 51's received a Fentanyl patch without a qualifying evaluation. This failure to evaluate Patient 51's tolerance had the potential to result in respiratory (breathing) depression after administration.

2. Medications removed from the automatic medication dispensing supply cabinet (Pyxis) were administrated by the same person that withdrew the medication. This failure had the potential for drug diversion and medication errors.

3. The development and implementation of a policy and procedure for the documentation of the tuberculosis status for patients receiving Remicaide (drug used for treatment of chronic diseases also known as infliximab). This failure resulted in the potential for 26 patients, over the past three months, being exposed to tuberculosis infections.

4. Ensure the analysis of automated medication dispensing supply cabinet (Pyxis) override (removal without pharmacist review) data supported the conclusion. This failure resulted in the potential for 184 a day patients to be exposed to avoidable medication errors.

5. The pharmacy failed to ensure the development and implementation of a policy and procedure for the monitoring of dispensing of Duramorph (Morphine, narcotic pain reliever) from the operating room (OR) automated medication dispensing supply cabinet( Pyxis). This failure had the potential for the hospital to be exposed to the loss or diversion of controlled drugs.

Findings:

1. Two medical records reviewed for patients receiving Fentanyl patches failed to reflect evaluation of tolerance for the opiod medication. During a clinical record review, on 3/6/12 at 9:50 a.m., Patient 51's clinical records showed admission to the hospital on 2/21/12 and a physician order, dated 2/21/12 at 11:32 p.m., for a Fentanyl patch 12 microgram every 72 hours. Review of Patient 51's medication administration record (MAR) showed the hospital administered the Fentanyl patch on 2/22/12 at 0500. Continued review of Patient 51's clinical records failed to reflect documentation of an evaluation for opoid tolerance prior to administration of the patch on 2/12/12.

Review on 3/6/12, of the pharmacy's policy and procedure titled, ABSMC- Fentanyl Patch Guidelines for Use, Screen Procedure for Pharmacy (Fentanyl Patch Pharmacy Screen..."Fentanyl patches should ONLY be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to fentanyl 25 mcg/hr. Patients who are considered opioid-tolerant are those who have be taking, for a week or longer, at least 60 mg of morphine daily...or an equianalgesic dose of another opioid."

(The U.S. Food and Drug Administration (FDA) issued a boxed warning (the strongest label warning) on Fentanyl regarding the "...potentially life-threatening [risk] of hypoventilation [too shallow or too slow breathing], respiratory depression [a condition of having a breathing rate that becomes too low to ventilate the lung], and/or death...Duragesic®...should only be prescribed for opioid-tolerant patients...Patients are considered opioid-tolerant if they have been receiving...oral morphine 60 mg per day, or...equianalgesic (same level of pain control) dose of another opioid...for at least one week..."

2. The hospital's all station events for 13 nurses were reviewed on 3/19/12 and four licensed vocational nurses (LVN 2, LVN 3, LVN 4 and LVN 5) documented removal of a controlled intravenous (IV, directly into a vein) medications from the automated medication dispensing supply cabinets (Pyxis) which were documented as administered by different nurses.

During a concurrent interview and record review, on 3/9/12 at 1:10 p.m., the dispensing log indicated Licensed Vocational Nurse (LVN 2) withdrew Morphine 2 mg (milligram)/1ml (milliliter) inj (injection) cartridge from the Pyxis 2/26/12 for Patient 52. Review of Patient 52's stat and medication administration record (MAR) showed that the morphine was administered by a different nurse.

On 3/9/12 at 1:10 p.m., record review indicated Licensed Vocational Nurse (LVN 3), withdrew Morphine 2mg/1ml inj cartridge on 2/14/12 for Patient 53. Review of Patient 53's MAR showed that the Morphine was administered by a different nurse.

During record review, on 3/9/12 at 1:10 p.m., showed LVN 3, withdrew Haloperidol (antipsychotic) 5mg (milligram)/1ml injection on 2/2/12 for Patient 54. Review of Patient 54's MAR showed that the Haloperidol was administered by a different nurse.

On 3/9/12 at 1:10 p.m., record review showed Licensed Vocational Nurse (LVN 4), withdrew Furosemide (diuretic) 20mg/2ml inj on 2/10/12 for Patient 55. Review of Patient 55's MAR showed the Furosemide was administered by a different nurse.

During record review, on 3/9/12 at 1:10 p.m., showed Licensed Vocational Nurse (LVN 5), withdrew Diphenhydramine (antihistamine) 50mg/1ml inj on 2/21/12 for Patient 56. Review of Patient 56's MAR showed that the diphenhydramine was administered by a different nurse.

On 3/9/12 at 1:40 p.m., Pharmacist 3 informed the surveyor that it was the hospital's expectation that the nurse who withdrew a medication from a Pyris as the nurse who to document and administer the medication.

Review of the policy and procedure titled, Medication Use and Administrationm dated 05/11, Practice, Administering Medications:
1. Review the MAR
2. Compare and verify each medication...
3. Transport Medication...to patient
4. Identify the patient
5. Check allergy bracelet
6. Recheck medication with MAR
7. Complete any necessary assessments...
8. Administer medications

3. Two charts were reviewed on 3/9/12 of Oncology and Infusion Center patients who had received Remicade (disease modifying medication used in the treatment of chronic disease such as rhuematoid arthritis and ulcerative colitis).

(The U.S. Food and Drug Administration (FDA) issued a black boxed warning (the strongest label warning) on Remicade® regarding the "...increased risk for developing serious infections that may lead to hospitalization and/or fatality...Evaluate patients for tuberculosis risk factors and latent tuberculosis infection [with a tuberculin skin test] prior to and during therapy. Treatment for latent infection should be initiated before use Patients with initial negative tuberculin skin tests should receive continued monitoring for tuberculosis throughout treatment... "). Review of the hospitals Top Black Box Warning List dated 7/18/11, failed to list Remacide (infliximab).

During a concurrent interview and clinical record review, on 3/9/12 at 9:20 a.m., of Patient 57's clinical records showed admission to the Oncology (cancer) and Infusion center on 3/2/11 for a dose of Remicade. Further review of Patient 57's clinical record failed to reflect documentation of his tuberculosis status prior to his first dose of Remicade. The Oncology and Infusion Center Manager and Registered Nurse 8 acknowledged that the clinical records failed to documentation of Patient 57's tuberculosis status prior to the start of his Remicade dose.

4. During an interview, on 3/9/12 at 12:20 p.m., with Pharmacist (Pharm) 3, she stated that the Pyxis override study was presented to the pharmacy and therapeutics Committee (P&T) on 1/12/12. Pharm 3 further stated that P&T did not get the detailed information contained in the Pharmacy Monitoring of Pyxis Override Function, Month: August (December 14, 2011), that supported the information presented to P&T.

The pharmacy analysis of Pyxis override data did not include the total number of overrides during 8/11, the confidence level (how sure the hospital was of the results, an example being 95%) and the confidence interval (margin of error, an example being plus/minus 5%).

During an administrative record review on 3/9/12, of the Medication Use: Non-clinical Quality Assurance / Performance Improvement, Pyxis Override, presented at the 1/12/12 P&T meeting, showed "Ensure 100% accurate use of Pyxis Override Function." Further review of the document showed the Pyxis override function was used accurately 100% and the P&T action was to continue to monitor.

Record review, of Pharmacy Monitoring of Pyxis Override Function, Month: August (December 14, 2011) showed the sample size was 30 overrides. The audit did not document the total number of overrides during 8/11, the confidence level and the confidence interval. Continue review of the audit showed Conclusion: "The Override Function was appropriately used during the month of August, based on a 1 day spot audit. All overrides were done within current policy and procedure."

5. During an interview, on 3/5/12 at 9:55 a.m., Pharmacist (Pharm) 2 the surveyor requested the location (s) in the hospital where medications can be removed from the automated medication dispensing supply cabinet (Pyxis) without prior order review by a pharmacist. Pharm 2 stated the Pyxis in the operating room (OR) did not require prior order review by a pharmacist.

During a tour, on 3/8/12 at 12:05 p.m., in the OR, the surveyor noted the Pyxis contained Morphine injection which lacked an audit and monitoring process for documentation of the narcotic Morpine administration and if need wastage of the unused Morphine.

On 3/9/12 at 2 p.m., during concurrent interview and record review of the hospital's Medication Use: Non-clinical Quality Assurance / Performance Improvement report indicated narcotic audits "Ensure 100% Compliance with Documentation of Narcotic Administration and Wastage by Nursing." Further review of the document indicated the hospital at 96% compliance with documentation of narcotic administration and wastage by nursing.

Review of the hospital's Narcotic Waste Review Summary 2011, on 3/9/12 showed the data to support the study above, however, failed to reflect an audit of the Pyxis in the OR. Pharma 3 acknowledged audit did not reflect use and wastage of the Morphine removed from the Pyxis in the OR.

Based on observation, interview and record review, the hospital failed to develop and implementation a policy and procedure to ensure the intravenous (IV, directly into a vein) compounding (mixing) rooms were free of dust and debris. This failure had the potential to expose patients to infectious material found in dust and particulate matter.

Findings:

During a concurrent tour and interview, on 3/5/12 at 11 a.m., in the 4 th floor Pharmacy, of the segregated IV compounding area the surveyor noted a IV mixing hood (used to for overhead coverage of an area where sterile [germ free] infusions are mixed) covered with a moderate amount of dust. Pharmacist (Pharm) 1 confirmed and acknowledged dust covered mixing hood.

On 3/9/12 at 10:15 a.m., during a tour of the sterile IV compounding suite, the surveyor noted the suite consisted of an ante-room, a hazardous (chemotherapy) medication compounding room, and a non-hazardous medication compounding room. Inspection of the ante-room sink showed stains and dried residue, on a panel, directly under the sink.
A printer located on the counter top in the ante room, when lifted, the surveyor and the Director of Pharmacy noted a light layer of dust and paper particles, on the counter where the printer had been located.

Continuing the inspection, in the hazardous compounding area, showed it contained a black chair with debris stuck to the surfaces of the chair. The surveyor removed several pieces of debris stuck to the chair.

In the hazardous compounding area, in a medication refrigerator, the surveyor noted a clear plastic tube which contained a brown and green material which could not be identified. The surveyor requested the hospital to provide information of the maintenance log for the refrigerator. The requested information had not been provided by end of the survey.

During an interview, on 3/9/12 at 12:15 p.m., a request for the hospital's policy and procedure for Cleaning of the Pharmacy Sterile compounding areas had been made but not provided by the end of the survey. Review on 3/9/12 of the Pharmacy Department Personnel, Clean Room/Ante Room Quality Control Record, of the Main Pharmacy, for March 2012, failed to indicate documentation of Environmental Service (EVS) service for 3 days out of 8 days. The Pharmacy Department Personnel, Clean Room/Ante Room Quality Control Record, for the 4 th floor Pharmacy, March 2012 failed to show documentation of EVS service for 6 days out of 7 days.

During record review, of the hospital's Pharmacy Department Personnel, Clean Room/Ante Room Quality Control Record, (sterile IV compounding suite) Pharmacy, for February 2012 and March 2012, failed to indicated documentation of EVS service for 9 out of 33 days.

Review of the policy and procedure titled, 200.6 b Sterile Compounding: IV's Prepared in Pharmacy IV Preparation Areas indicated, Buffer Area and Ante Area, 9, indicated, "Clean all buffer area work surfaces, carts, chairs, stools with Sani-Cloth HB or other cleaning agent at a minimum weekly, and more often according to the Compounding Room Cleaning Log frequency. The Buffer area and Ante area shall be cleaned daily by the Environmental Services Department, as per EVS Department P&P "Cleaning Services - Pharmacy Sterile compounding Areas."

(Review of the United States Pharmacopeia 797 (USP <797>), a nationally recognized compounding information source, Guidebook to Pharmaceutical Compounding-Sterile Preparation (2008, pg. 48) showed "Work surfaces in the ISO Class 7 buffer areas and ISO Class 8 ante-areas as well as segregated compounding areas shall be cleaned and disinfected at least daily, and dust and debris shall be removed when necessary from storage sites for compounding ingredients and supplies...Floors in the buffer or clean area, ante-area, and segregated compounding area are cleaned by mopping with a cleaning and disinfecting agent once daily at a time when no aseptic operations are in progress. Mopping shall be performed by trained personnel using approved agents and procedures described in the written SOPs. It is incumbent on compounding personnel to ensure that such cleaning is performed properly. In the buffer or clean area, ante-area, and segregated compounding area, walls, ceilings, and shelving shall be cleaned and disinfected monthly").

Based on observation, interview and record review, the hospital failed to develop and implement a policy and procedure to ensure that only authorized staff had access to drugs in drug storage areas. This failure resulted in the potential for unauthorized persons having access to medications.

Findings:

During a concurrent tour and interview, on 3/7/12 at 8:50 a.m., in the Intensive Care Unit (ICU), the surveyor and Pharmacist (Pharm 2) observed the medication storage room door held open by a cleaning cart and an Environmental Services Aide (EVA) 1 inside the medication room. On 3/9/12 at 12 p.m., Pharm 2 and Pharmacist 3 informed the surveyor EVS staff should not have been in the medication room unless supervised by a licensed staff.

On 3/7/12 at 11:15 a.m., during a concurrent tour and interview of the a procedure suite (GI lab) the surveyor and the Director of Nursing Education noted an open door to the procedure suite. On the counter of of the procedure room lay two intravenous solutions. The Director of Nursing Education confirmed the open door to the suite; the suite unstaffed staffed, and the IV fluids unsecured.

Review of the hospital's policy and procedure titled, 800.1 Drug Storage and Inspections (revision date: 1/12) showed Procedure: 2. "Only authorized persons in accordance with job description, the hospital policy and law or regulation, can have access to medications and medication storage areas."

Based on record review and staff interviews, the hospital failed to provide a patient with the diet ordered by the physician. Patient 61, a cardiac patient, received a carbohydrate controlled diet instead of the ordered carbohydrate cardiac controlled diet. This failure had to potential to further compromise Patient 61's medical status by providing a diet with inappropriate nutrient composition.

Findings:

A review of the medical record for Patient 61, on 3/6/12, indicated that the patient was admitted to the hospital on 2/27/12 with diagnoses that included morbid obesity, diabetes, aortic stenosis (when the heart valve does not fully open) and hypertension (high blood pressure). Patient 61 had a physician order dated 3/1/12 for a carbohydrate controlled cardiac diet.

A review of the hospital's document titled, Diet Worksheet, dated 3/5/12, noted the diet order entered in the computer system for Patient 61 as a carbohydrate controlled diet. The cardiac element of the diet had been left off. A review of Patient 61's menu for 3/6/12 showed that Patient 61 received a carbohydrate controlled diet.

A review of the hospital's Diet Manual, dated 2011, for the carbohydrate controlled diet, indicated only foods that provide carbohydrates are limited. The cardiac diet provides low cholesterol, low saturated fats and no added salt which the carbohydrate controlled diet does not specifically limit these components.

Further review of the medical record showed that Diet Technician 1 (DT 1) made an entry in the Progress Notes on 3/4/12 in which she stated that she reviewed the chart and the diet was carbohydrate controlled. She did not note the cardiac element of the diet as ordered by the physician on 3/1/12. There was no registered dietitian entry in the medical record which indicated review of the diet order.

During an interview with (dietary management staff member (DMS) G on 3/6/12 at approximately 10:00 am, she stated that the order had been entered in the computer incorrectly and Patient 61 was receiving the wrong diet.

Based on record review and staff interviews, the hospital failed to meet the nutritional needs of 4 of 10 patients (Patient 2, Patient 10, Patient 65 and Patient 61) reviewed for nutrition care when:

1. The registered dietitian's (RD) review and recommendations were not communicated to physicians for 2 of 10 patients (Patients 62 and Patient 68) in a timely manner which resulted in Patient 62 receiving inadequate nutrition for 10 days and Patient 68 receiving inadequate nutrition for 3 days.

2. Patient 65's failed to received a physician-ordered diet and failed to have a diet which had been developed by a dietary staff person reviewed by the RD for nutritional adequacy prior to implementation.

3. For one patient (Patient 61) identified with inadequate intake and poorly controlled blood sugars, the RD failed to assess the diet for possible nutritional interventions.

4. The hospitals' menus failed to meet the Recommended Dietary Intake/Dietary Reference Index as established by the National Institutes of Medicine and/or the hospitals' diet manual. Specifically, the fiber content of diets failed to meet the national standard of practice and the hospitals' renal diet failed to meet the hospital's developed standards.

These failures had the potential to further compromise the nutritional status of these patients and result in a general decline in their overall medical condition.

Findings:


1. A review of the medical record for Patient 62, on 3/6/12, showed the facility admitted Patient 62 on 2/23/12 with diagnoses that included abdominal pain, inflammatory colitis (inflammation of the colon or lower bowel) and cervical cancer. On admission Patient 62 also complained of no appetite for several weeks, weight loss and nausea.

A review of the Nutrition Assessment dated 2/24/12 revealed Patient 62's estimated nutritional needs as 1650 calories and 70 grams of protein. A diet order dated 2/14/12 ordered NPO (nothing by mouth) and a clear liquid diet after completion of a scheduled test on 2/24/12. The nutritional assessment indicated the Patient 62's nutrition risk level as 1-2 (high to moderate) and that a follow-up assessment would occur within 5 days.

A review of the Nutrition Follow-up note dated 2/29/12 revealed Patient 62 continued on a clear liquid diet with poor meal intake and had been started on TPN (total parenteral nutrition, nutrition that goes directly into the blood) which provided 1027 calories and 65 grams of protein (62% of calorie needs and 93% of protein needs). The Nutrition follow-up note further indicated that Patient 62 met the criteria for severe protein calorie malnutrition. The RD's note included a recommendation to increase the TPN to help provide more nutritional support.

A review of a second Nutrition Follow-up note dated 3/2/12 revealed that Patient 62's TPN still had not been increased as recommended by the RD on 2/29/12. and that Patient 62 continued not to eat anything. Once again the RD recommended to increase the TPN to meet the Patient 62's nutritional needs. The RD recommendations for an increase in the TPN did not occur until 3/4/12; 10 days after the patient was admitted.

During an interview with Registered Dietitian 1 (RD 1) on 3/6/12 at approximately 10:00 am, she stated that the system for communicating the RD recommendations to the physician required the physician to read the RD's notes. RD 1 stated she did not contact the physician with the recommendations. Review of Patient 62 clinical record failed to indicate a documented response of acknowledgment by the physician regarding the RD recommendations.

A review of the hospital's policy titled, Clinical Nutrition Services - Interdisciplinary Patient Care, Hospital Wide, dated 10/11 revealed that nutrition needs are communicated to other disciplines via the medical record, in patient care rounds and via person-to-person communication. It further stated that upon follow-up by the dietitian, if the physician has not addressed the suggested plan of care, the dietitian will attempt to contact the physician.

A review of the medical record for Patient 68 on 3/7/12, showed the patient was admitted with diagnosis including respiratory failure. Admission diet order dated 3/2/12 was for a tube feeding at a goal rate of 50 cc's/hour. A comprehensive nutrition assessment dated 3/4/12 noted an admission weight of 138 pounds and a height of 5 feet 7 inches. The RD also noted that the enteral feeding provided 1200 calories and 75 grams of protein.

Patient 68's estimated nutritional requirements were 1260-1575 calories and greater than 75 grams of protein in order to meet 100% of the patients recommended dietary intake. The current tube feeding order would provide 260-575 fewer calories/day than the patients' estimated nutritional needs. The RD recommended an increase of the tube feeding to 60 cc's/hour to better meet the nutritional needs. There was no indication that the physician reviewed and/or acknowledged the RD's recommendations.

In an interview on 3/7/12 at 11 a.m., RN 23 was asked to describe how RD recommendations were forwarded to the physician. She stated that nursing staff would usually advise physicians of recommendations; however there was no formal mechanism in place to ensure that physicians' were advised of the recommendations. RN 23 also stated that in the intensive care unit (ICU) an interdisciplinary team reviewed all patients on a daily basis and as topics were discussed they would be coded on the documentation tool. Review of hospital document titled Patient Education Interdisciplinary documentation Tool noted that there were daily rounds but failed to demonstrate mention of Patient 69's nutritional status or the recommendation to increase tube feeding.

In an interview Dietary Management Staff (DMS) A stated that the RD's would evaluate whether or not nutritional interventions were implemented until the follow up assessment. Review of the hospital Progress Note dated 3/4/12, completed by the RD revealed that the follow up would occur within 3 days.

2. Medical record review on 3/6/12 revealed Patient 65 was admitted with diagnosis including high blood pressure and inflammation of the gall bladder and an admission weight of 64.8 kilograms. The admission nursing nutrition screen dated 2/27/12 noted no nutritional risk factors; however noted that Patient 65 had been admitted for abdominal pain. An admission diet order dated 2/29/12 ordered NPO (nothing by mouth). A diet order dated 3/2/12 ordered a low sodium, low protein diet, specifically 0.8 grams of protein per kilogram of body weight. This diet order equated to 52 grams of protein.

In an interview on 3/6/12 at 11:30 a.m., the dietary staff (DS) E described how she would ensure that the patient selected foods met the physician ordered diet. She stated that the hospital had standard meal patterns for a 40 gram protein, 2 gram sodium and 3 gram potassium diet. DS E stated that she would utilize this meal pattern and would add additional items. Concurrent review of the meal ticket for 3/3/12 revealed that the patient selected items would have contained 48 grams of protein. DS E also stated that the menu had not been reviewed by the RD prior to releasing the tray ticket for Patient 65 to the kitchen staff.

In an interview on 3/3/12 at 12 p.m., DMS A stated that it would be the department policy for the RD to review any patient meal tickets if the diet order was outside one of the pre-approved meal patterns. She also acknowledged that Patient 65's meal ticket should have been reviewed and signed by a RD prior to being released to the kitchen staff.

3. On 3/6/12, review of the medical record indicated Patient 61 had been admitted to the hospital on 2/27/12 with diagnoses that included morbid obesity, diabetes and aortic stenosis (when the heart valve does not fully open) and had been scheduled for an aortic valve (heart valve) replacement. A review of the Blood Glucose/Insulin Record showed that 4 of the 27 entries for blood sugars results were less than 200. Six entries were greater than 300 and one greater than 400, indicating poorly controlled diabetes. A physician order dated 3/1/12 ordered a Carbohydrate Controlled Cardiac Diet.

A review of the progress notes dated 3/4/12 revealed a note from the diet technician that stated Patient 61 had a fair appetite, taking 58 - 60% of his meals. The note did not discuss the patient's blood sugars, and it did not indicate that the diet technician would refer the patient to the RD for follow-up. There was no documentation in the medical record from the RD.

During an interview with RD 2 on 3/6/12 at 1:45 p.m., she stated that for the patients on that unit, she usually only provides diet education. She stated that she had not assessed the nutrition needs for Patient 61 and therefore did not know if his diet intake was meeting his needs and failed to know that Patient 61 continued to consume 60% or less of his meals with uncontrolled blood sugars results.

A review of the hospital's Diet Manual dated 2011 revealed that a Carbohydrate Controlled Diet provides 1800 calories. Sixty percent of this would be less than 1100 calories intake a day.

During an interview with DMS G on 3/6/12 at 2:00 p.m., she confirmed that 60% meal intake for patient 61 was inadequate and should have been referred to the RD for assessment and follow-up. DMS G was unable to explain why the diet technician was allowed to assess the adequacy of the Patient 61's intake and not refer the diet plan to the RD for review and evaluation.


4. On 3/7/12 beginning at 2 p.m., the hospital's menus were reviewed for nutritional adequacy in accordance with Recommended Dietary Intakes and Dietary Reference Index standards set forth by the Institute of Medicine, National Academy of Sciences as well as hospital specified parameters as defined in the hospitals' 2011 diet manual. Diets were randomly reviewed on 3/7/12 beginning at 9 a.m., and the following was noted. Per the hospitals' diet manual the purpose of a renal diet was to normalize a patients' blood chemistries and was defined as an 80 gram protein diet/day.

Review of the nutritional analysis revealed that the protein content ranked from a low of 68 grams to a high of 105 grams of protein/day. It was also noted that the renal diet did not meet specified parameters 7 of 7 days and that the fiber content of the renal diet ranged between 16 and 17 grams of fiber.

The Dietary Reference Index (DRI) for fiber is age and gender dependent and ranges between 19 grams of fiber for children 1-3 years of age and 38 grams of fiber for men ages of 14-50. Similarly the average fiber content of the regular diet was 25 grams of fiber and the pureed diet was 18 grams, both of which were significantly below the DRI. In a concurrent interview with DMS A she acknowledged that the reviewed diets did not meet the national standards of practice for menu planning.

.

Based on food production observations, dietary management staff interview and dietary document review, the hospital failed to ensure that all prepared diets were part of the hospitals' diet manual. Lack of the development of a diet manual that was inclusive of all routinely prepared diets had the potential to result in a lack of adequate guidance for dietary staff preparing meals.

Findings:

During trayline observation on 3/5/12 beginning at 11:45 am, it was noted that the hospital was preparing meals for a non-affiliated, contracted pediatric hospital. In a concurrent interview with DMS A she stated that the contracted hospital provided a listing of the food items for dietary staff to prepare. The surveyor queried whether or not the physician ordered diets were part of the hospitals' diet manual. She stated that they were not.

Review of a sampling of tray cards revealed that they had a wide variety of diets such as a pre-school diet and toddler diets. DMS A also acknowledged that while the contracted hospital provided individual tray tickets for each patient at each meal, without a description of the diets the dietary staff would not have the guidance for preparing the patient diets. Review on 3/7/12 of the hospitals' diet manual dated 2011 confirmed that the meals prepared for the contracted service were not present.

Based on observation, interview, and record review, the hospital failed to ensure equipment was maintained in good working order. Repair of an identified leak in the water line system of the water treatment equipment in the dialysis unit had the potential for the leak to progress and interfere with the function of the water used during hemodialysis treatments.

Definitions:
Hemodialysis; a procedure/treatment that uses an artificial kidney for patients with end stage renal failure to clean their blood of toxin and waste. During the procedure/treatment blood is removed from the body through a vascular access and filtered through a man-made membrane - a dialyzer, or artificial kidney, and then the filtered blood is returned to the body.
In hemodialysis blood flows through the inside of hollow fibers in the dialyzer. Dialysate, which is a mixture of water and a precise mix of chemicals bathes the outside of the fibers. The fibers let small wastes/toxins pass out of the blood into the dialysate. Drinking water contains small amounts bacteria, mineral, and chemicals that can build up and make dialysis patients ill. Treating the water used for hemodialysis eliminates this.
Reverse Osmosis (RO) is a sophisticated filter system that uses pressure and reverse osmosis to produce purified water. In RO water is pushed under pressure against the concentration gradient; pure water is pushed across a membrane to the side with fewer particles.

Findings:

During an observation, on 3/7/12 at 8:29 a.m., in the hemodialysis unit water treatment room, the surveyor noted a clear plastic round, approximate quart size container on the floor adjacent to the RO equipment which contained one to two inches of clear fluid. On further observation the surveyor noted the water leaked from a water line connection located above the container.

The Engineering Assistant Chief (EAC), present during the water treatment unit observation at 8:5 a.m. stated the water leak was from the valve regulator on the water line that fed the reverse osmosis (RO)unit section of the water treatment system. The EAC stated the maintenance on the RO unit had been done by an outside contractor. Review of the maintenance binder for the RO unit indicated the contractor's last system checked had been done on 2/28/12.

Review, on 3/7/12, of the Engineering department Work Order-Non-Scheduled Maintenance for 2/12 of the dialysis RO system daily checks showed the water leak had been first observed on 2/23/12 and document the location of the water leak to be in the "regulator bonnet". At 9:25 a.m. the Chief Engineer failed to locate documentation that a work order for repair of the leak had been forwarded to the contractor.

During an observation on 3/8/12 at 2:30 p.m., in the hemodialysis water treatment room the surveyor noted a second water leak further up the same line from the first leak . This water leak occurred at the connection between a hose and the bottom of the "T" on the water line system.

The Director of Support Services (DSS), which included the engineering department, on 3/8/12 at 2:50 p.m., identified the contractor as responsible for the RO unit maintenance and repairs. At 3:25 p.m. the DSS stated the contractor did a systems service check every two weeks, with the last check done on 2/28/12. The Director stated there had been a "disconnect" in communication between the contractor, the engineering department and the hemodialysis charge nurse during the contractor's onsite visit on 2/28/12 when neither the engineering department or the hemodialysis nurse failed to inform the contractor of the leak that had been discovered in the system on 2/23/12.

Review of the service agreement between the hospital and contractor showed, "Customer and Facilities shall retain all professional and administrative responsibility for the Services rendered under this Agreement..."

During a telephone interview, on 3/12/12 at 10 a.m., the contractor's manager stated the hospital had not contacted them to report a problem/leak in the RO unit or RO water lines until 3/8/12. Review record of the engineering department communications noted the first call to the contractor regarding the leak in the water treatment line as 3/8/12.

Based on observation, interview, and document review the hospital failed to:

1. Develop and implement policies and procedures that would ensure hemodialysis staff wore face shields and gowns along with gloves (personal protective equipment - PPE) when initiating or terminating dialysis treatments.
This failure had the potential for staff exposure and contamination by blood and blood products.

2. Ensure hemodialysis staff members performed hand hygiene; washing hands with soap and water or using an alcohol base hand sanitizer after removal of gloves, and failed to ensure staff removed contaminated gloves between tasks. This failure had the potential for the of risk of cross contamination and transmission of infectious agents by staff to patients, patient care equipment and the environment

3. Develop and implement policies and procedures that would ensure prompt identification of dialysis patients testing positive for Hepatitis B and following Centers for Disease Control guidelines to prevent transmission of Hepatitis B infections to patients not immune to the Hepatitis B virus.

4. Develop and implement policies and procedures to ensure monitoring and testing of of dialysate used in dialysis for bacterial content and the presence of harmful bacteria. The failure to monitor the dialysate increased the potential for infection of dialysis patients.

5. Develop and implement policies and procedures to ensure safe food handling practices and maintenance of equipment. These failures put patients at risk for the potential for foodborne illness further compromising their medical status

Findings:

1. During an observation, on 3/7/12 at 1:30 p.m., the surveyor noted RN 1, with only a mask over her nose and mouth, access Patient 37's left internal jugular vein access site. RN 1 wear a mask a face shield or ac cover gown for protection against possible blood spurting or splatter.

(Vascular access; in hemodialysis, a vascular access provides a way to remove and then return blood from and to the body.
There are three kinds of vascular access sites; a fistula, which is made when a artery and a vein are joined under the skin, a graft, where the artery and vein are joined by a plastic tube also under the skin, and a catheter, which is inserted into a vein in the neck or below the collarbone and which is meant for short term use).

On 3/9/12 from 8:35 a.m. to 9:15 a.m., the surveyor observed RN 3 access Patient 48's right anterior thigh access graft site wearing gloves on but not a face mask with a shield or a cover gown. RN 3 stated it was not the unit practice to wear PPE when needles were inserted into the access site or when connecting dialysis machine blood line tubing to the needle tubing extensions. RN 3 also stated that the staff did not wear PPE when central line/catheters were directly connected to the dialysis machine blood tubing.
(Hemodialysis; a procedure/treatment that uses an artificial kidney for patients with end stage renal failure to cleanse their blood of toxin and waste. During the procedure/treatment blood is removed from the body through a vascular access and filtered through a man-made membrane - a dialyzer, or artificial kidney, and then the filtered blood is returned to the body.)

RN 3 stated the only time any type of PPE would be worn is when a central/intravascular catheter (a intravenous catheter that terminates in a large vein in the chest that is near the heart) site was accessed. (The purpose of the mask is to protect the patient from pathogens present in the nurses' airway. Patients with catheters are at higher risk for bacterial growth in the blood stream.).

During an interview on 3/7/12 at 8:15 a.m., the Renal Metabolic & Hemodialysis Unit Manager stated hemodialysis staff did not need to wear protective gowns during the course of caring for patients undergoing hemodialysis treatments. The Renal Metabolic & Hemodialysis Unit Manager stated the only exception was hemodialysis patients who were undergoing treatment and had infections that required isolation.

On 3/7/12 at 3:10 p.m., the Infection Control Manager (ICM) stated hemodialysis staff were to wear gowns when ever there was an opportunity for blood exposure. There was no policy and procedure that address personal protective equipment
(PPE) use in the hemodialysis unit.

On 3/8/12 received from the Infection Control Nurse written "Clarifications" on concerns that were brought up on 3/7/12. The use of PPE by hemodialysis staff was addressed, "Hooking patients to machine, nurse wears mask, gloves." There was no mention of face shields or gowns.

2. On 3/7/12 At 10:30 a.m., the surveyor observed licensed vocational nurse 1 (LVN 1) had a glove on the left hand, none on the right hand. LVN 1 handled Patient 45's bloodline/tubing, then went directly to the door of the technician's room and with gloved hand pressed the key pad to gain access to the room. LVN 1 exited the technician's room, the left hand glove still on, removed the glove and did not perform hand hygiene. LVN 1 again put a glove on the left hand only, made direct contact with Patient 45's bedside, and then went to the nurses' station and entered data via keyboard.

At 1:40 p.m. the surveyor observed LVN 1 with gloves on, charting on Patient 37's paper record, and touching the dialysis machine screen. LVN 1 removed her gloves and did not perform hand hygiene and proceeded to open and reach into the top drawer of a bedside supply cabinet which contained several tape rolls and dressing supplies.

LVN 1 then proceeded to touch the dialysis machine screen in response to an alarm, adjusted Patient 37 and his bedding and then went directly to the clean utility room, turned the door knob to gain access, and removed a blanket from the blanket warmer for the patient. Hand hygiene had not been implemented by LVN 1 any point as she touched patient equipment, provided patient care and touch unit equipment.

During an interview with LVN 1, on 3/7/12 at 2:20 p.m., she stated she had washed her hands while in the clean utility room. LVN 1 had been followed into the utility room by the surveyor who did not witness LVN 1 performance hand hygiene while in the utility room.

At 1:50 p.m. the surveyor noted registered nurse 4 (RN 4), while wearing gloves gathered dirty bed linen from hemodialysis station 4, placed the linen in the linen hamper, and pressed the keypad lock to gain access to the technician room and returned with a disinfectant in hand, and poured the disinfectant solution onto a cloth. RN 4 then returned the disinfectant solution to the technician room.

RN 4 returned from the technician room and wiped down the dialysis machine with the cloth and then wiped the top of the bedside table. RN 4 removed his gloves and went directly to the supply dispensing machine, and using his ungloved hand, punched the keypad on the supply cabinet. RN 4 then went directly from the supply dispensing machine to the hand sink, washed his hands and went back to the supply dispensing machine keypad. During an interview on 3/7/12 at 2:15 p.m. RN 4 acknowledged he should have removed his gloves and washed his hands before he proceeded on the next task.

The Infection Control Nurse, on 3/7/12 at 3:10 p.m., stated gloves were to be worn for only one procedure/task, then removed and hand hygiene performed.

Review of the hospital policy and procedure titled, "Hand Hygiene Policy, revised 1/2012, indicated, "Wearing gloves does not replace the need for hand hygiene. Hand hygiene was to be done after removing gloves, after contact ...with a patient's intact skin (e.g., when taking a pulse or blood pressure, and lifting a patient) dirty linen, and medical equipment in the patient's immediate vicinity."



21174

3. On 3/7/12 at 3:10 p.m., the infection control manager (ICM) stated the dialysis unit followed Centers for Disease Control (CDC) guidelines and Association for the Advancement of Medical Instrumentation (AAMI) standards for infection control issues. Asked to describe what infection control practices for Hepatitis B (Hep B) were followed by dialysis staff, ICM stated "Our nurses follow standard precautions to deal with blood-borne infections." Standard precautions were described as wearing gloves "for opportunity for blood exposure", removing gloves and washing hands. ICM stated the dialysis unit did not have a policy in place regarding dialyzing Hep B positive patients but "they (dialysis staff nurses) follow CDC parameters for dialysis." When asked how the dialysis staff identified Hep B positive patients, the ICM responded "I believe it's their protocol to know the patients' status."

(Hepatitis B is a very contagious virus infection carried in the bloodstream or body fluids of an infected individual. Hepatitis B virus [HBV] can be transmitted to non-immune, or susceptible persons by direct contact with an infected person's blood or body fluids or indirectly by cross-contamination [by personnel contacting the environment of an infected individual and subsequently contacting the susceptible patient or susceptible patient's environment].

According to the CDC "chronic hemodialysis patients are at high risk for infection because the process of hemodialysis requires vascular access [exposure of the vascular access connections] for prolonged periods. In an environment where multiple patients receive dialysis concurrently, repeated opportunities exist for person-to-person transmission of infectious agents, directly or indirectly via contaminated devices, equipment and supplies, environmental surfaces, or hands of personnel.

Furthermore, hemodialysis patients are immunosuppressed [poor resistance to disease], which increases their susceptibility to infection. HBV infection among chronic hemodialysis patients also has been associated with hemodialysis provided in the acute-care (hospital) setting. Transmission appeared to stem from chronically infected HBV patients who shared staff members...with susceptible patients ").

On 3/8/12 at 10:55 a.m., RN 1 stated the dialysis unit kept no central log of Hep B positive patients to alert staff "but before they (dialysis patients) dialyze, we look in the cardex (a working nursing document for the individual patient that is not part of the patient's medical record)." Random review of one cardex showed the Hep B status for the random patient as "negative", meaning on the documented date the patient did not have Hep B. RN 1 stated she thought "once or twice a month we get a Hep B positive patient" and that a nurse taking care of a Hep B positive patient could take care of another patient in isolation not Hep B positive.

On 3/8/12 at 12:30 p.m., the ICM stated "They (Hep B positive patients) will dialyze in isolation if they're (dialysis staff) aware of it."

The ICM acknowledged that dialysis patient's Hep B status is determined on admission and their Hep B status is not updated when these patients are readmitted for care and subsequent dialysis treatments. The ICM confirmed staff caring for a Hep B positive patient could also care for a patient not Hep B positive by following standard precautions.

On 3/9/12 at 9:35 a.m., review of the cardex files of 13 patients dialyzing in the dialysis unit during the day on 3/8/12 showed three patients (Patient 27, Patient 28, and Patient 29) lacked documented evidence of their Hep B status.

Record review showed Patient 27 had undergone more than 140 dialysis treatments during multiple admissions from 2009 to 2012 without staff knowing if he were Hep B or susceptible to the virus.

Patient 28, first admitted to the hospital in 2008 and readmitted yearly, had undergone 130 dialysis treatments without the staff knowing if he were with Hep B positive or susceptible to the virus.

Patient 29 was newly admitted and had undergone three dialysis treatments without his Hep B status being known. RN 6 confirmed the dialysis unit failed to ascertain the Hep B status for the three patients and confirmed the dialysis unit failed to document if the three patients (Patient 27, 28 and 29) were immune or susceptible to Hep B.

(According to the CDC guidelines from the Mortality and Morbidity Report (MMR) Vol. 50 / No. RR-5 "Hemodialysis in Acute-Care Settings" "For patients with acute renal failure who receive hemodialysis in acute-care settings, Standard Precautions as applied in all healthcare settings are sufficient to prevent transmission of bloodborne viruses. However, when chronic hemodialysis patients receive maintenance dialysis while hospitalized, infection control pre- cautions specially designed for chronic hemodialysis units should be applied to these patients.

If both acute and chronic renal failure patients receive hemodialysis in the same unit, these infection control precautions should be applied to all patients. Regardless of where in the acute-care setting chronic hemodialysis patients receive dialysis, the HBsAg (HBV positive) status of all such patients should be ascertained at the time of admission to the hospital, by either a written report from the referring center (including the most recent date testing was performed) or by a serologic test. The HBV serologic status should be prominently placed in patients' hospital records, and all health-care personnel assigned to these patients, as well as the infection control practitioner, should be aware of the patients' serologic status.

While hospitalized, HBsAg-positive chronic hemodialysis patients should undergo dialysis in a separate room and use separate machines, equipment, instruments, supplies, and medications designated only for HBsAg-positive patients. While HBsAg-positive are receiving dialysis, staff members who are caring for them should not care for susceptible patients").

According to the hospital's Infection Prevention and Control Program the purpose of the program indicated, "The goal of the program is to ensure that the medical center patients, health care personnel and visitors will be protected form hospital acquired infections and the transmission of communicable diseases within the hospital environment...Department Managers/Nursing Directors works with Infection Prevention and Control Department to develop department-specific infection control policies and procedures where appropriate."

4. During the tour of the dialysis unit on 3/7/12 at 8:15 a.m., registered nurse (RN) 1 stated "The RNs do all the water cultures" both for the reverse osmosis water purification system and the dialysis machines. RN 1 was asked if the dialysate (the mixture of the RO-purified water, acid concentrate, and bicarbonate that run through the dialyzer to cleanse a patient's blood) run through the dialysis machines had been cultured (tested for the bacterial level and presence of harmful bacteria) as well. RN 1 stated "We don't culture dialysate."
On 3/8/12 at 12:55 p.m., RN 6 stated she would obtain a water sample from the dialysis machine after disinfecting the water with bleach and during the rinse. RN 6 demonstrated she obtained at the sample from the inlet port prior to dialyzing a patient. RN 6 stated the sample "still reflects what's been in the system (internal pathways of the dialysis machine)." The Dialysis Unit Manager present during the demonstration confirmed the dialysate was not tested because "it's a unit dose", meaning that the acid concentrate and the bicarbonate used came in manufactured pre-filled jugs, not derived from bulk containers.

On 3/9/12 at 11:25 a.m., the Dialysis Unit manager stated "All our (dialysis) machines are cultured monthly." According to the manager, APIC (Association for Professionals in Infection Control and Epidemiology) drives all infection control.

Review of the hospital-provided (APIC) guide 2010 entitled "Guide to the Elimination of Infections in Hemodialysis" indicated that monitoring of dialysis machine disinfection entailed monthly testing of dialysis machine dialysate and RO water for bacteria and endotoxin (a harmful bacteria). According to the guide "This should involve testing of at least two HD (hemodialysis) machines each month. The sampled machines must be rotated so that each machine in the facility is tested at least annually. Testing of dialysate should be performed at the end of the treatment day."





17065

5a. During initial tour on 3/5/12 beginning at 9 a.m., the surveyor observed on a shelf in the walk in refrigerator a stainless steel pan labeled "pork loin" with a preparation date of 3/2/12. In the refrigerator located adjacent to the stove the surveyor noted portions of cooked meat loaf and prepared tuna salad.

(Meats are potentially hazardous foods (PHF's) which are capable of supporting bacterial growth associated with foodborne illness. PHF's which are cooked and stored for later use must be monitored for time/temperature control during the cool down process. The standard of practice would be to ensure that PHF's cool to 70°F within 2 hours and to 41°F or below within an additional 4 hours, for a total of 6 hours. Foods prepared from ingredients at room temperature must reach 41°F within 4 hours of preparation).

In an interview on 3/5/12 at 2 p.m., with Dietary Management Staff (DMS) A, the surveyor queried how she provided oversight of cooked and stored foods. DMS A stated that she reviewed the logs and that the DMS B had the responsibility to provide oversight of day to day food production observations.

During an interview on 3/5/12 at 2:30 p.m., Dietary Staff (DS) C , the surveyor asked Dietary Staff (DS) C to describe the cooking process for the observed meats. He stated that several times each week items such as roast and pork were cooked and would be used as patient entrees for the next several days. DS C stated that after the items were cooked they were placed in the blast chiller (a unit that circulates cold air to facilitate cooling). Once the items were cooled they were wrapped, labeled, dated and placed in the refrigerator.

DS C stated that sometimes he checked the temperature of the food item before placing the item in the refrigerator but did not record the temperature in the facility cool down log. The surveyor also queried the process of preparing the tuna salad. DC C stated he retrieved the ingredients from the dry storage area, mixed together the ingredients that were at ambient room temperature after which he placed it in the refrigerator. DS C also confirmed items such as meat loaf, pot roast and pork loin which are on the menu regularly as routinely cooked the day prior to service.

Review of facility policy titled Food Cooling Log from 2/20-3/14/12, that while the facility had a system to monitor the time/temperature control of potentially hazardous foods, the observed items were not monitored and/or entered on the cool down log. The Food Cooling Log policy indicated " ...items must be logged: proteins including eggs, sauces, soups ..." In an interview on 3/5/12 at 2:45 p.m., with DMS B he acknowledged time/temperature control for the observed items as not documented.

At 10:00 a.m., the surveyor noted a stainless steel pan of cooked bacon labeled 3/5/12 in the cold prep refrigerator. During an interview with DS F on 3/5/12 at 10:00 am, he stated that the bacon had been cooked at 7:00 am and held for service at lunch. DS F stated that he did not monitor the temperature of the bacon during the cool down process. During a concurrent interview with DMS B, he stated that the temperature of the bacon should have been taken at 9:00 am and recorded on the Food Cooling Log. Review of the Food Cooling Log dated 3/5/12 failed to indicate an entry for the bacon.

5b. On 3/5/12 at 10:30 a.m., the surveyor asked DS C to describe the cleaning process for the steam kettles. DS C stated that he would remove all remaining foodstuffs, fill the kettle with water, scrub as necessary and sanitize the interior.

In a follow up interview on 3/5/12 at 2:45 p.m., the surveyor asked DS D to describe the cleaning process for the steam kettle and DS D reported an identical process identical to the process described by DS C.

It would be the standard of practice to ensure that cleaning in-place equipment such as steam kettles would be washed utilizing a detergent, rinsed and sanitized (Food Code, 2009). Review of hospital policy #F 013 dated 10/11 guided staff that "surfaces of equipment shall be washed, rinsed and sanitized ..."

5c. During the initial tour of the kitchen on 3/5/12, beginning at 9:00 am, the surveyor noted three cases of sausage links, one case of sausage patties, one case of veggie patties, one case of tilapia (fish), one case of ground beef, and two cases of four ounce containers of grape juice all labeled "keep frozen." The label on the containers of grape juice indicated to "use within 14 days of thawing". None of the food items had a label which indicated a a thaw or use by date. The surveyor also noted a stainless steel pan which contained cooked, cut up turkey meat with no label or date.

During an interview with DMS B on 3/5/12 at 9:45 am, could not detail how the staff determined a use by date without having in place a system for dating the food placed in the refrigerator to thaw. DMS B stated that the food items should be labeled with a date when they are pulled from the freezer to thaw in the refrigerator and the turkey meat should have been labeled and dated with a use by date.

A review of the hospital's policy titled, Food and Supply Storage Procedures dated 10/11, revealed that for refrigerated storage, items must be dated. A review of the hospital's policy titled, "Dating of Food" dated 10/11, revealed that all foods will be dated to preserve wholesomeness and freshness