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Based on observations, interview and facility policy review, the hospital failed to have an on-going hospital wide, data driven, quality assessment and performance improvement program by failing to make corrections subsequent to the validation survey completed on 4/23/10 regarding: 1. failing to ensure patient allergies were accurately documented in the Patient Data Profile for all patient records, 2. failing to review allergy quality review data by Pharmacy and Therapeutics Committee, 3. failing to ensure weekly spot checks of medication administration were performed, 4. failing to ensure pharmaceutical services monitored and managed a medication, clozapine, 5. failing to ensure controlled medications were accounted for, and, 6. failing to ensure the hospital had organized dietary services as evidenced by:


1. The hospital failed to make corrections subsequent to the validation survey completed on 4/23/10, by: failing to ensure that allergies would be accurately documented in the Patient Data Profile for all patient records, failed to ensure staff checked the allergy band against the medication administration record for all patients, and failed to implement the plan of correction with regard to flagging a bin of Augmentin (an antibiotic with an enzyme inhibitor as a second drug used to increase the antibacterial spectrum of the antibiotic). (Cross Reference A266)

2. The hospital failed to implement the plan of corrections from the 4/23/10 validation survey with regard to review of allergy quality review data by the Pharmacy and Therapeutics Committee and failed to follow the plan of correction to implement the plan of correction to have the pharmacy department track and analyze near miss medication error data. (Cross Reference A285)

3. The hospital failed to implement a plan of correction which included weekly spot checks of at least one scheduled episode of medication administration on one nursing unit followed by tracking and trending of the data generated by the process. (Cross Reference A404)

4. The hospital failed to ensure pharmaceutical services met the needs of the patients with respect to monitoring and management of clozapine when clozapine was not monitored according to mandated parameters documented in the product labeling, and failed to store medications properly. (Cross Reference A490)

5. The hospital failed to to clearly document what form of a controlled drug (immediate release morphine versus sustained release morphine) was actually being dispensed to patients as documented on the CSAR (Controlled Substance Administration Records). (Cross Reference 494)

6. The hospital failed to ensure that drugs were controlled and distributed according to standards of practice and state and federal regulations. (Cross Reference A500)

7. The hospital failed to ensure patients had organized dietary services that are directed and staffed by adequate qualified personnel. (Cross Reference A618, A620, A621, A628, A630)

8. The hospital failed to ensure food was prepared and served in a safe and sanitary manner as evidenced by a lack of cool-down monitoring, an ice machine that was not clean, a dish machine that was not functioning properly and food distribution activities that may promote cross contamination of food. (Cross Reference A749)

The cumulative effect of the systemic problems resulted in the hospitals' failure to meet statutorily mandated compliance with the Condition of Participation for Quality Assurance Performance Improvement.

Based on review of the plan of correction for this regulation provided by the hospital subsequent to a validation survey completed on 4/23/2010, clinical record review, document review and staff interview the hospital plan of correction failed to ensure that allergies would be accurately documented in the Patient Data Profile (PDP: a data file used by the electronic health records kept by the hospital) for one out of seven clinical record so reviewed (Patient 303), the hospital failed to implement the plan of correction to ensure that staff checked the allergy band against the medication administration record for one out of nine patients observed during a medication pass that covered three units (Patient 304), and the hospital failed to implement the plan of correction with regard to flagging a bin of Augmentin (an antibiotic with an enzyme inhibitor as a second drug used to increase the antibacterial spectrum of the antibiotic) in the night locker to ensure that staff knew it was a combination product and that two tablets of a lower strength may not be equivalent to one tablet with twice the antibiotic as both strengths had the same amount of an enzyme inhibitor. By doubling the dose of the lower strength a patient would receive twice the inhibitor normally ordered by a physician if the patient had received the higher strength tablet. This could increase the potential of patients to receive drugs to which they were allergic as well as expose them to possible adverse effects (nausea/vomiting) from excessive dose of an enzyme inhibitor found in Augmentin.

Findings:

1. During a validation survey completed 4/23/2010, the survey team found the hospital had not ensured that a patient (Patient 402) potentially would not receive a medication to which the patient had a listed allergy. As part of the plan of correction (POC) the hospital documented that allergies would be documented correctly in the PDP and that the hospital would monitor this on an on-going basis. This allergy sticker would be one of the safety measures to ensure that staff is aware of allergies that a patient may have.

On 11/8/2010 at 10:26 a.m. a review of Patient 303's clinical record indicated that Dilaudid (a narcotic used to relieve pain) appeared on an allergy sticker on the front of her clinical record as well as on the admission orders. However, it did not appear on the "Patient Census - Allergy & Reason for Visit" sheet provided by Administrative Staff Q on 11/8/2010. The patient had a face sheet from another hospital in her clinical record and this face sheet also documented that Patient 303 had an allergy to Dilaudid. A hand written note from the hospital Emergency Department documented that the reaction to Dilaudid was nausea and vomiting, which was not an allergy but which could be a reason to avoid this medication in this patient unless it was absolutely necessary to give it. A Post-It note in the chart documented that Patient 303 stated she was allergic to Dilaudid but it was not documented that she was allergic to it.

At 10:53 a.m. on 11/8/2010 a review of the electronic portion of the clinical record for Patient 303, with the help of Administrative Staff R, indicated that Dilaudid was not included in the allergy section. She stated, that as displayed, the record indicated that Dilaudid had never been entered into the electronic record by the hospital staff.

On 11/8/2010 at 11:29 a.m. after a review of the computerized pharmacy medication profile for this patient by Administrative Staff Q, he stated there was no clinical note indicating that this discrepancy had been investigated and clarified by the pharmacy department. At this time, Administrative Staff R stated that drugs that had resulted in an adverse effect on a patient would be documented in the allergy section even if the adverse reaction, such as nausea and vomiting, was not allergic in nature.

2. During a validation survey completed 4/23/2010, the survey team found the hospital failed to ensure that a patient potentially would not receive a medication to which the patient had a listed allergy. The plan of correction documented that staff would check the allergy band against the medication administration record (MAR: used by nurses to accurately medicate their patients and to document the date and time a dose of medication was administered) during medication administration.

On 11/5/2010 at 8:29 a.m. Licensed Staff W passed medications to Patient 304 on Unit 2. The medication administration record documented Patient 304 was allergic to erythromycin and to shellfish. Licensed Staff W did not check Patient 304' s allergy arm band and she did not compare it to the MAR. At 10:03 a.m. during an interview of Licensed Staff W, she stated she had not verified what was on the allergy band against the MAR.

3. During a validation survey completed 4/23/2010, the survey team found the one patient had received an incorrect dose of Augmentin (which is a combination of two drugs: amoxicillin which is an antibiotic and clavulanic acid which inhibits the ability of bacterial enzymes to inactivate the amoxicillin)) for two days and that the source of the Augmentin was the after-hours Night Locker accessed by nursing supervisors when the pharmacy was closed. The POC submitted by the hospital documented that "unusual" medications such as Augmentin would be "flagged in the night locker and additional information (will be) provided."

On 11/5/2010 at 3 p.m., an inspection of the Night Locker indicated that it contained one bin each of Augmentin 250 mg and Augmentin 500 mg. Neither bin was flagged in any special way nor was there any additional information provided in the Night Locker about these medications. During an interview of Administrative Staff Q at that time, he stated he was not aware of how the Augmentin supply was to be "flagged" in the Night Locker and he was not aware of what additional information needed to be provided.



16276

Based on review of the plan of correction for this regulation provided by the hospital subsequent to a validation survey completed on 4/23/2010, document review, and staff interview the hospital failed to implement the plan of correction with regard to review of allergy quality review data by the Pharmacy and Therapeutics Committee and failed to implement the plan of correction to have the pharmacy department track and analyze near miss medication error data.

Findings:

1. During a validation survey completed 4/23/2010, the survey team found the hospital had not ensured that a patient (Patient 402) potentially would not receive a medication to which the patient had a listed allergy. The plan of correction (POC) stipulated that the hospital staff would survey 100% of active charts each night and that a spread sheet had been developed to assist in the tracking and trending of the data. The results were to be analyzed and presented to the Pharmacy and Therapeutics (P&T) Committee (the committed with responsibility for developing policies and procedures ensuring safe and effective storage, distribution and use of drugs in the hospital) and the Performance Improvement (PI) Committee (a quality control committee). The hospital documented that this POC would be in place as of 7/2010.

On 11/9/2010 at 11:25 a.m., during an interview of Administrative Staff B she stated that she could not provide evidence that the data regarding allergy monitoring process was reviewed by the P&T Committee. She stated that it was on the agenda of the P&T Committee for the next day, 11/10/2010.

2. During a validation survey completed 4/23/2010, the survey team found the pharmacy department was not tracking near misses in their analysis of medication errors (errors that occurred in the pharmacy but did not reach the patient because the staff caught them). The findings of the survey team documented that analysis of such weaknesses was needed to identify potential weaknesses in the drug distribution system that could eventually result in an error that reached the patient.

The plan of correction for this deficient finding documented that "The pharmacist was educated by the Regional Director of Pharmacy about the importance of tracking errors related to near misses and the processing and filing of orders in the pharmacy". It documented that this had occurred 5/2010.

On 11/9/2010 at 11:25 a.m. during an interview of Administrative Staff RR, she stated that she had not seen any data regarding near misses from Administrative Staff Q. Administrative Staff Q stated that he thought he had a couple of examples of near misses since the 4/23/2010, validation survey but he said he had not seen the final data.

On 11/9/2010 review of the document entitled "Incident Notification Form: Falls, Medication Variances, Adverse Drug Events" indicating that under the section "Event Severity Rating" there was a check box for "Near miss: Risk of harm, incident, or error but none occurred" and a check box for "No harm: Incident/error did not reach or impact patient directly" . Therefore the hospital did have a mechanism to collect such data.



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Based on medical record review and dietary and nursing staff interview, the hospital failed to ensure comprehensive nutrition care planning for 3 of 3 patients with nutritional care issues (Patients 203,204, and 205). Failure to develop comprehensive care plans may result in patients ' nutritional needs not being met further compromising their medical status.

Findings:

Medical record review was conducted on 11/2 and 11/3/10. Patient 203 was admitted with diagnoses including lupus (an inflammatory disease caused by an autoimmune disease). Patient's admission diet order was a low fat diet. Patient's admission weight was 167% of her ideal body weight. A comprehensive nutrition assessment dated 10/25/10 noted that the patient had a variable appetite. The assessment also noted that the Current Diet order ...is appropriate ...and meets pt [patient] needs for wt [weight] loss." The assessment also documented that the plan was discussed and agreed upon with the patient; however there was no development of a nutritional care plan to address the weight loss plan.

Similarly Patient 204 was admitted with medical diagnoses including possible Bells Palsy (partial facial paralysis). A comprehensive nutrition assessment dated 10/29/10, noted that the patient was above her ideal body weight. The assessment also noted an average dietary intake of 75% that would " meet the needs for desired weight loss. Could not educate pt [patient], pt refused to talk. " There was no documentation that the patient agreed to a weight loss plan, nor was there any care plan developed to ensure the Patient 204's nutritional needs were met.

Additionally Patient 205 was admitted with medical diagnoses including obesity and high blood pressure. Admission diet order dated 10/29/10, was for a regular diet. A comprehensive nutrition assessment noted that the current diet was for a Regular diet. It was also noted that the current diet would meet the needs for a 4-5 pound weight loss/week. The assessment also noted that the weight loss plan was discussed and agreed upon with the patient; however there was no development of a nutritional care plan that provided measurable goals and objectives to ensure a safe and effective weight loss plan.

In an interview on 11/3/10 at 1 p.m., with Registered Dietitian P she stated that the dietitians did not develop care plans. She also stated that any care plans that were developed were completed by nursing staff. In a concurrent interview with Administrative Staff L she stated she was unaware that nutrition care plans were not developed. She further stated that nursing staff completed care plans related to medical or psychiatric issues. She also acknowledged nursing staff may not have the expertise to develop and evaluate an effective nutrition care plan.



21156

Based on review of the plan of correction for an incident in which a patient did not get a medication for 21 hours after a physician ordered it as found during a validation survey completed on 4/23/10 and interview of Administrative Staff B, the hospital failed to implement the plan of correction as written. The facility also failed to ensure that physician orders were being followed as evidenced by 3 out of 5 patients, with diabetes, (Patient 104,106, and 108) who had abnormal blood sugar readings and staff failed to contact the physician. This had the potential for patients to have hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar) which could result in neurological damage, coma and death. A similar deficiency was written for the validation survey which was completed on 4/23/10, and the plan of correction was not followed.

Findings:

1. During a validation survey completed on 4/23/2010 the survey team found that one patient did not get the antibiotic, Augmentin, until 21 hours after the physician ordered the drug. The hospital plan of correction (POC) included weekly spot checks of at least one scheduled episode of medication administration on one nursing unit followed by tracking and trending of the data generated by this process. The results were to be presented to the Pharmacy and Therapeutics (P&T) Committee (the committed with responsibility for developing policies and procedures ensuring safe and effective storage, distribution and use of drugs in the hospital) and the Performance Improvement (PI) Committee (a quality control committee).

On 11/9/2010 at 9:09 a.m. during an interview of Administrative Staff B she stated she had no data to show that the process described in the POC was, in fact, being done and therefore it was not possible to show that the data was also being tracked and trended and presented to the P&T Committee and the PI Committee. Administrative Staff B said she was not able to show that the data was being tracked and trended.



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2. On 11/2/10 at 3:25 p.m., a review of Patient 104's clinical record revealed that the patient was admitted to the facility in 10/10. The patient was treated for depression and also had a history of diabetes and was on a sliding scale regimen for insulin administration. Further review of the patient's record indicated a physicians order for blood sugars, dated 10/26/10, to be taken twice per day. The order also indicated that the physician was to be called if the patient's blood sugar level was less than 80 mg/dl (milligram per deciliter). Patient 104's history of blood sugar readings indicated that on 10/30/10, her blood sugar reading was 59.

On 11/3/10 at 12:00 noon, Licensed Staff D was interviewed. Upon inquiry regarding on what he would do if a patient blood sugar was below 80 mg/dl. He stated that most of the licensed staff would give the patient some food and then retake the blood sugar. He said he would notify the physician as per orders. Although Licensed Staff D did not take Patient 104's blood sugar reading on 10/30/10, he reviewed the patients nurse notes and stated that the physician was not notified of the 59 mg/dl blood sugar reading and could not answer why it was not done.

On 11/3/10 at approximately 1:00 p.m., Licensed Staff E was interviewed regarding Patient 104's blood sugar reading on 10/30/10. She acknowledged that the physician's order should have been followed and stated that she had told the charge nurse about the blood sugar of 59 mg/dl reading. " It was very busy at the time. I forgot to e-mail or call the physician."

3. On 11/3/10 at 2:00 p.m., a review of Patient 106's clinical record revealed that the patient was admitted to the facility on 6/10 due to psychosis and also had a history of diabetes. The clinical record included a physician order for blood sugar finger sticks dated 6/17/10. The order indicated that if the patient's blood sugar was less than 80 mg/dl or greater than 400 mg/dl, the physician should be notified. Review of the patient's blood sugars, for the period of hospitalization revealed that on 7/31/10, the patient's blood sugar level was 50 mg/dl. Administrative Staff C reviewed the nurse notes and found no documentation to support that the licensed staff had notified the physician of the patient's low blood sugar level. She stated "She didn't do what she was supposed to do."

4. On 11/3/10 at 3:55 p.m., Patient 108's clinical record was reviewed. The patient was admitted to the facility on 6/10 with a diagnosis of Diabetes Mellitus. A physician order dated 6/29/10 indicated fasting blood sugars to be done before meals and at bedtime and staff were to contact the physician if the patient's blood sugar readings were less than 80 mg/dl or greater than 400 mg/dl. On 7/14/10, the patient's blood sugar reading was 71 mg/dl. Administrative Staff C reviewed the clinical record notes and physician communication page and stated that the nurse did not notify the physician as ordered and should have.

Based on observation, document review, clinical record review and staff interview, the hospital failed to ensure that the pharmaceutical services met the needs of the resident with respect to monitoring and management of clozapine and tracking and documenting medication allergies, failed to ensure the pharmacy supervision of these process took place, failed to develop or implement policies to ensure that clozapine was monitored according to mandated parameters documented in the product labeling, failed to implement policies regarding documentation of allergies, and failed to store medications properly as evidenced by:

1. The failure of the hospital to ensure that the pharmacy department monitored patients taking clozapine according to the mandated parameters documented in the product labeling and the failure to use a clinical monitoring form for this purpose as documented in the plan of correction for validation surveys that were completed in 9/9/2009 and 4/23/2010 with the potential for increasing the risk for patients to receive clozapine when the product labeling guidelines indicated that the drug should be withheld or discontinued along with increased monitoring requirements of the patient's blood work (see A491 #1 and A500 #1).

2. The failure of the hospital pharmacy department to ensure that RID, an insecticide intended for use on furniture but not on humans, was stored separately in the medication night locker (an after hours supply of medications available to nursing staff when the pharmacy was closed) from medications intended for internal and external use in humans with the potential that this may be accidentally applied to humans with potential for and adverse effect (see A491, #2).

3. The failure of the hospital to develop a plan of correction addressing deficient practice found during a validation survey completed 4/23/2010 that would, in fact prevent a patient from receiving medications to which the patient had documented allergies, the failure of the hospital to ensure pharmacy staff investigated discrepancies in the allergy record to ensure that all allergies were properly documented in the patient's clinical record, and the failure of the hospital to ensure that all allergies were documented on the Allergy Alert Sticker placed on the covers of patients' clinical records to alert physicians and staff to patient allergies when prescribing, dispensing, and administering drugs, all with the potential for that patient to receive a medication to which he had an allergy or adverse reaction in the past (See A500 #2 through 4).

4. The failure of the hospital to ensure that the plan of correction regarding the monitoring of efficacy of pain medications for the deficient practice regarding monitoring of patients' pain noted during a Validation Survey completed on 4/23/2010 was in fact implemented during July 2010 and the failure of the hospital to implement the plan of correction as written (see A500 #5).

The cumulative effects of these systemic problems resulted in the hospital' s inability to ensure the provision for safe and effective use of drugs to meet the needs of the hospital patients and to minimize drug errors and adverse consequences.



16276

Based on inspection, document review, and staff interview the hospital failed to ensure that the Pharmacy Department was managed in accordance with accepted professional principals as evidenced by:

1. The failure of the hospital to ensure that the pharmacy department monitored patients taking clozapine according to the mandated parameters documented in the product labeling and the failure to use a clinical monitoring form for this purpose as documented in the plan of correction for validation surveys that were completed in 9/9/2009 and 4/23/2010, with the potential for increasing the risk for patients to receive clozapine when the product guidelines indicated that the drug should be withheld or discontinued along with increased monitoring requirements of the patient's blood work.

2. The failure of the hospital pharmacy department to ensure that RID, an insecticide intended for use on furniture but not on humans, was stored separately in the medication night locker (an after hours supply of medications available to nursing staff when the pharmacy was closed) from medications intended for internal and external use in humans with the potential that this may be accidentally applied to humans with the potential for an adverse effect.

3. The failure of the Pharmacy Department to detect staff modification of the Controlled Substance Administration Record with the potential to interfere with the ability of hospital pharmacy staff to track the flow of controlled substances (medications such as morphine with the potential to be abused) in the hospital.

4. The failure of the Pharmacy Department to stock the night locker with a medication that appeared on the hospital approved supply for the night locker or if the pharmacist felt the drug was not needed in the hospital, the failure to go through the committee approved process to remove the drug, Robitussin CF (a cough and cold preparation) from the night locker supply with the potential that this medication may not be available for patient use after hours when the pharmacy was closed.

Findings:

1. Clozapine is an atypical or second generation antipsychotic used to treat schizophrenia. It is atypical because it has lesser potential to cause movement disorders in patients who take the medication relative to the typical or first generation antipsychotics such as chlorpromazine (Thorazine) or haloperidol (Haldol).

Clozapine has a boxed warning (commonly known as a black box warning) which is the most serious warning that the FDA can require a manufacturer to print in the product labeling (also called the package insert) for a given medication. Boxed warnings document potential problems that can lead to serious injury or death. The FDA has required the various manufacturers of clozapine to include a boxed warning in the product labeling regarding agranulocytosis which is a potentially life-threatening decrease in the neutrophils (the neutrophils are a subcategory of white blood cells important to the maintenance of a person's immune function) that greatly increases an individual's risk of serious life-threatening infections. The FDA has a mandated schedule for monitoring the white blood cell (part of the immune system) count and the absolute neutrophil count in patients who take this medication which is published in the package insert in order to minimize the chance that patients taking clozapine will develop this potentially lethal side effect.

The following language appears in the Warnings Section of the clozapine package insert: "As described in Table 1, patients who are being treated with clozapine must have a baseline WBC (white blood cell) count and ANC (absolute neutrophil count) before initiation, and a WBC count and ANC every week for the first 6 months." All patients started on clozapine for the first time must have weekly WBC counts and ANCs but if certain conditions are met (neither the WBC count nor the ANC falls below critical predetermined levels documented in the package insert), the frequency of monitoring can be reduced to every two weeks after six months and every four weeks after one year of clozapine therapy. Table 1 in the package insert lists various parameters for the WBC count and ANC that mandate increased monitoring of the WBC count and ANC as well as conditions when the therapy must be temporarily interrupted and conditions when the therapy must be discontinued permanently (the patient can never receive clozapine again).

The following language appears in the boxed warning: "Clozapine is available only through a distribution system that ensures monitoring of WBC counts and ANC according to the schedule described below prior to delivery of the next supply of medications (see warnings)." This schedule is documented in Table 1 of the clozapine package insert. This "distribution system" includes a manufacturer specific monitoring system or registry with which the hospital pharmacy, prescribing physicians, and patients are to be registered to ensure the patients' blood work is monitored as required.

During a complaint validation survey completed 9/9/2009, the survey team found that one patient taking clozapine did not have the required blood work drawn within a seven day time frame as documented in the clozapine product labeling.

During a validation survey completed 4/23/2010, the survey team found the hospital had not ensured that pharmacy staff was not completing a pharmacy clozapine monitoring form as stipulated by hospital policy and procedure.

The plan of correction developed by the hospital stipulated that all patients taking clozapine would be monitored by the pharmacist and that the tracking would be done using a Clinical Pharmacy Monitoring form. It stipulated that the pharmacist was to contact the physician if concerns arose regarding timeliness (of required lab draws) or other clinical issues. This plan of correction was to have been in place as of May 2010.

On 11/3/2010 at 4:09 p.m. a review of Policy and Procedure PHM IV.B.2 entitled "Clozapine Dispensing and Reporting" (written 9/2009 and revised March 2010) indicated it stipulated: "The pharmacy will monitor the WBC/ANC for patients on Clozapine, maintain a Clinical Pharmacy Monitoring Form and ensure weekly, every two weeks, or monthly submission of the WBC/ANC reporting form to the manufacture (sic) as required." During an interview of Administrative Staff Q at that time he stated that there was no "Clinical Pharmacy Monitoring Form" and that he had never had such a form.

At this time Administrative Staff Q produced a copy of the clozapine product labeling and a review of Table 1 in that document indicated that a substantial drop of the WBC/ANC was defined as a single drop or a cumulative drop within three weeks of 3000 cell/cubic milliliter (mm?) or more in the WBC count or 1500 cells/ mm? in the ANC count. The product labeling indicated that the lab should be repeated and if the WBC fell between 3000 and 3500 cells/ mm? and the ANC was less than 2000 cell/ mm? the lab draws should be done twice weekly until the WBC was greater than 3500 cells/ mm? and the ANC was greater than 2000 cell/ mm?. At this time the surveyor asked Administrative Staff Q what he would do if a patients WBC count fell from 15,000 cells/ mm? to 11,900 cells/ mm? over a three week period (a fall greater than 3000 cells/ mm?) and he stated he would call the physician and recommend that the clozapine be discontinued. He did not mention twice weekly blood monitoring and then only if the lab was repeated and the result indicated that the WBC fell between 3000 and 3500 cells/ mm? and the ANC was less than 2000 cell/ mm?.

Administrative Staff Q stated he got an automatic printout each morning of patients of the lab work of patients who were on clozapine which indicated among other things when the last blood work had been done. Administrative Staff Q stated that all clozapine patients had weekly blood draws in the hospital and using the sheets allowed one to know when the next blood work was due based on the draw date of the last lab work.

A review of four lab reports dated 10/12/2010, 10/13/2010, 10/14/2010, and 10/15/2010 indicated they were entitled "Patients on Clozaril & Last WBC" and three patients appeared on the report. The following issues were noted:

Patient 300 had a WBC count done on 10/6/2010 and 10/14/2010 which was 8 days, not 7 days, as stipulated in the product labeling.

Patient 301 had a WBC count done on 10/7/2010, and it was not repeated on 10/14/2010. Patient 301 did not appear on the 10/15/2010, lab report and Administrative Staff R stated that Patient 301 had been discharged on 10/14/2010 at 11:35 a.m. Administrative Staff Q stated, after referring to the hospital computerized patient data base, that blood work was drawn between 5:30 and 9 a.m. so it would have been possible to get blood work on Patient 301 before he was discharged so that it could be reported to the pharmacy that would care for Patient 301 after discharge and enable that pharmacist to arrive at an informed decision regarding the dispensing requirements for clozapine.

No evidence was provided that the pharmacy or hospital made any attempt to determine if patients required less frequent monitoring based on parameters documented in the clozapine product labeling. No evidence was provided that the pharmacist had implemented the plan of correction and the hospital policy and procedure by monitoring patients using a monitoring form that could contain information to prompt the person monitoring the clozapine regimen. No evidence was provided that clozapine patients were monitored according to the guidelines stipulated in the product labeling. Finally lab draws were not done on time which had been an issue during the September 2009 validation survey.

2. On 11/4/2010 at 3:50 p.m. during an inspection of the night locker (a supply of drugs separate from the pharmacy available to staff via nursing supervisors after hours when the pharmacy is closed) indicated it contained five cans of RID Home Lice Control spray stored between five boxes of NIX (a product used to treat head lice) and two boxes of 25 gram tubes of 1% silver sulfadiazine cream (used on burns). A review of the label on one of the cans of RID documented it was for: "For Bedding and Furniture." Further on it documented: "Spray only those garments and parts of bedding including mattresses and furniture, that cannot be either laundered or dry-cleaned. Do not use on sheets or pillowcases." Under the "Precautionary Statement" it documented "Hazardous to Humans" and "Caution: Harmful if swallowed or absorbed through skin." At this time Administrative Staff Q stated that it would be possible for a nurse to confuse the NIX product and the RID product.

3. On 11/4/2010 at 5:06 p.m. a review of three Controlled Substance Administration Records (CSARs: used to track the use of controlled substance by medication name, amount dispensed, date and time dispensed, patient name, and person dispensing the medication to the patient) in the Nursing Unit 1 Medication Room indicated they were identified by sequential numbers found at the top of the CSAR sheet and had both printed names of medications as well as blank spaces in which staff could write the names of the medication. The sheets were used to track controlled drug (drugs that are likely to be abused) inventory on the unit. On CSAR form number 11063 (the current sheet) staff had altered the printed entry "15 mg (milligrams) Morphine Immediate Release" by crossing out the word "Immediate" and writing in "S". Administrative Staff Q stated that the "S" meant it was sustained release and, in fact, inspection of the controlled drug supply indicated it contained morphine 15 mg sustained release tablets. On sheet 11062 (covering the period 11/2, 8 p.m. to 11/3, 8 p.m.) the morphine entry had been altered as described above. However on CSAR sheet number 11061, the morphine entry had not been altered and therefore documented that the supply was immediate release and not sustained release.

At 5:18 p.m. in the pharmacy, inspection of Unit 1 CSAR sheet numbers 11058 (5:05 p.m., 10/31/2010 to 11:30 p.m., 10/31/2010), 11059 (11:30 p.m., 10/31/2010 to 2:30 p.m., 11/1/2010), and 11060 (3 p.m., 11/1/2010 to 8:15 a.m., 11/3/2010) indicated that the 15 mg Morphine Immediate Release printed entry had not been altered on sheet 11058, but on sheet 11059, "SR" and on sheet 11060, "S" had been written in while "Immediate" was crossed out.

Inspection of three more Unit 1 CSAR sheets, numbers 10994 (9 a.m., 8/30/2010 to 7:20 a.m., 8/31/2010), 10995 (8 a.m., 8/31/2010 to 9 p.m., 8/31/2010), and 10996 (9 p.m., 8/31/2010 to 12:30 p.m., 9/1/2010) indicated that "Immediate" was crossed off the printed morphine entry and "S" written in on sheet 10994 and sheet 10996 but the printed morphine entry was not altered on sheet 10995.

All these sheets had blank spaces on which staff could have written in morphine 15 mg sustained release tablets.

During an interview of Administrative Staff Q at that time, he stated that the variance in the labeling could cause confusion in the future when it was no longer clear what had actually been stored on the unit. He stated that comparing the August 2010 sheets to the more recent ones indicated that this had been a problem for at least the past two months. He stated he was not aware that the sheets had been altered.

4. On 11/4/2010 at 3:50 p.m. during an inspection of the night locker medication supply (an after hours drug supply accessible to nursing supervisors after hours when the pharmacy was closed), one shelf had an area labeled to contain Robitussin CF (a cough syrup) and this product also was listed on the "Hospital Drug Formulary" with night locker symbols next to the name indicating it could be found in the night locker. There was no Robitussin CF in the night locker medication supply. Administrative Staff Q stated he had never seen this product in the night locker and that inclusion of the product as part of the night locker supply on the formulary was an "oversight".

Based on inspection of nine Nursing Unit 1 Controlled Substance Administration Records (CSARs: used to track the use of controlled substance by medication name, amount dispensed, date and time dispensed, patient name, and person dispensing the medication to the patient) covering a two month period the hospital pharmacy and nursing departments failed to clearly document what form of a controlled drug (immediate release morphine versus sustained release morphine) was actually being dispensed to patients as documented on the CSAR. Three of the nine sheets documented Unit 1 stored morphine 15 mg immediate release tablets while six of the CSARs documented Unit 1 stored morphine 15 mg sustained release tablets which meant that not all the records accurately recorded what morphine product was actually stored and dispensed on Nursing Unit 1. This could make it more difficult to track controlled drugs and at face value, three of the six records were not accurate (the ones that documented Unit 1 stored immediate release morphine tablets).

Findings:

1. On 11/4/2010 at 5:06 p.m. a review of three Controlled Substance Administration Records (CSARs) in the Nursing Unit 1 Medication Room indicated they were identified by sequential numbers found at the top of the CSAR sheet and had both printed names of medications as well as blank spaces in which staff could write the names of the medication. The sheets were used to track controlled drug (drugs that are likely to be abused) inventory on the unit. On CSAR form number 11063 (the current sheet) staff had altered the printed entry "15 mg (milligrams) Morphine Immediate Release" (morphine is a drug with a high potential for abuse and which is used to relieve pain) by crossing out the word "Immediate" and writing in "S". Administrative Staff Q stated that the "S" meant it was sustained release and, in fact, inspection of the controlled drug supply indicated it contained morphine 15 mg sustained release tablets. On sheet 11062 (covering the period 11/2/2010, 8 p.m. to 11/3/2010, 8 p.m.) the morphine entry had been altered as described above. However on CSAR sheet number 11061, the morphine entry had not been altered and therefore documented that the supply was immediate release and not sustained release.

At 5:18 p.m. in the pharmacy, inspection of Unit 1 CSAR sheet numbers 11058 (5:05 p.m., 10/31/2010 to 11:30 p.m. 10/31/2010), 11059 (11:30 p.m., 10/31/2010 to 2:30 p.m. 11/1/2010), and 11060 (3 p.m., 11/1/2010 to 8:15 a.m., 11/3/2010) indicated that the 15 mg Morphine Immediate Release printed entry had not been altered on sheet 11058, but on sheet 11059 "SR" and on sheet 11060 "S" had been written in while "Immediate" was crossed out.

Inspection of three more Unit 1 CSAR sheets, numbers 10994 (9 a.m., 8/30/2010 to 7:20 a.m., 8/31/2010), 10995 (8 a.m., 8/31/2010 to 9 p.m., 8/31/2010), and 10996 (9 p.m., 8/31/2010 to 12:30 p.m., 9/1/2010) indicated that "Immediate" was crossed off the printed morphine entry and "S" written in on sheet 10994 and sheet 10996 but the printed morphine entry was not altered on sheet 10995.

All these sheets had blank spaces on which staff could have written in morphine 15 mg sustained release tablets.

During an interview of Administrative Staff Q at that time, he stated that the variance in the labeling could cause confusion in the future when it was no longer clear what had actually been stored on the unit. He stated that comparing the August 2010 sheets to the more recent ones indicated that this had been a problem for at least the past two months.

Based on observation, clinical record review, document review and staff interview the hospital failed to ensure that drugs were controlled and distributed according to standards of practice and state and federal regulation as evidence by:

1.The failure of the hospital to ensure that blood work for monitoring the WBC and ANC counts of patients taking clozapine was done according to product requirements (which had been an issue during the Sept 2009 validation survey) and the failure to develop and use a monitoring form as stipulated in the plan of correction for a validation survey completed 4/23/2010 as well as documented in the hospital clozapine policy to ensure patients taking clozapine were monitored according to product guidelines with the potential that a patient may receive clozapine when his or her blood work indicated that the dose should be held or the drug discontinued.

2.The failure of the hospital plan of correction, written subsequent to a survey completed 4/23/2010, to prevent patients with listed drug allergies from receiving those medications in one patient (Patient 305) and the failure of staff to clarify orders for medications to which the patient had listed allergies with the physician as required by policy and procedure. The patient received three medications, between 10/20/2010 and 10/22/2010 to which he had listed allergies (Geodon, Ativan, and Benadryl), and one medication to which he was potentially allergic due to cross-allergenicity (Restoril). No evidence was presented that a pharmacist, nurse, or psychiatric technician called the doctor about the Restoril allergy. The policy would not have prevented the Restoril from reaching the patient because it was a floor stock item and staff could access it without having to go through the pharmacy.

3. The failure of the hospital to ensure that discrepancies in the allergy information in a patient's clinical record (Patient 303) was questioned by the pharmacy services with the potential that Patient 303 might have received Dilaudid, a medication which had caused nausea and vomiting in Patient 303 in the past.

4.The failure of the hospital to ensure that all documented allergies for Patient 306 (one out of seven such clinical records reviewed) were written onto an Allergy Alert Sticker placed on the front of the clinical record, in accordance with a plan of correction written for deficient findings on a previous survey completed 4/23/2010 and in accordance with hospital policy with the potential that physician and staff may not be alerted to allergies when prescribing, dispensing, and carrying out medication orders for medications to which the patient may be allergic.

5.The failure of the hospital to ensure that the plan of correction regarding the monitoring of efficacy of pain medications for the deficient practice noted during a Validation Survey completed on 4/23/2010 was in fact implemented during July 2010 as documented on the 2567 (a Centers for Medicaid and Medicare Services document listing deficient practices found by surveyors and with plans of correction documented by the facility so surveyed) and the failure of the hospital to implement the plan of correction as written.

6. The failure of the hospital to develop procedures directing staff how to fill out the Controlled Substance Administration Records so a clear historical record was kept of the disposition of controlled drugs (drugs subject to abuse) that would allow staff to accurately track these drugs in their transit through the hospital.

7. The failure of the hospital to implement the policy regarding authentication of telephone orders from prescribing physicians by that physician (or a covering physician) within 48 hours (the physician would countersign the order). Patient 305 had three telephone orders that were authenticated 15 to 18 days after they were taken by licensed staff.

8. Patients 107,108, and 109 also had telephone/verbal orders that were not authenticated within 48 hours as per hospital policy.


Findings:

1. Clozapine is an atypical or second generation antipsychotic used to treat schizophrenia. It is atypical because it has lesser potential to cause movement disorders in patients who take the medication relative to the typical or first generation antipsychotics such as chlorpromazine (Thorazine) or haloperidol (Haldol).

Clozapine has a boxed warning (commonly known as a black box warning) which is the most serious warning that the FDA can require a manufacturer to print in the product labeling (also called the package insert) for a given medication. Boxed warnings document potential problems that can lead to serious injury or death. The FDA has required the various manufacturers of clozapine to include a boxed warning in the product labeling regarding agranulocytosis (defined in the product labeling as an ANC less than or equal to 500 cells/cubic millimeter (mm?) which is an extreme decrease in the neutrophil count (the neutrophils are a subcategory of white blood cells important to the maintenance of a person's immune function) that places the individual at extreme risk of a serious life-threatening infection. The FDA has a mandated schedule for monitoring the white blood cell (part of the immune system) count and the absolute neutrophil count in patients who take this medication which is published in the package insert in order to minimize the chance that patients taking clozapine will develop this potentially lethal side effect.

The following language appears in the boxed warning: "Clozapine is available only through a distribution system that ensures monitoring of WBC counts and ANC according to the schedule described below prior to delivery of the next supply of medications (see warnings)." This schedule is documented in Table 1 of the clozapine package insert. This "distribution system" includes a manufacturer specific monitoring system or registry with which the hospital pharmacy, prescribing physicians, and patients are to be registered to ensure the patients' blood work is monitored as required.

The following language appears in the Warnings Section of the clozapine package insert: "As described in Table 1, patients who are being treated with clozapine must have a baseline WBC (white blood cell) count and ANC (absolute neutrophil count) before initiation, and a WBC count and ANC every week for the first 6 months." All patients started on clozapine for the first time must have weekly WBC counts and ANCs but if certain conditions are met (neither the WBC count nor the ANC falls below critical predetermined levels documented in the package insert), the frequency of monitoring can be reduced to every two weeks after six months and every four weeks after one year of clozapine therapy. Table 1 in the package insert lists various parameters for the WBC count and ANC that mandate increased monitoring of the WBC count and ANC as well as conditions when the therapy must be temporarily interrupted along with increased monitoring requirements and conditions when the therapy must be discontinued permanently (the patient can never receive clozapine again) along with increased monitoring requirements to ensure the patient does not develop agranulocytosis. The product labeling provides guidance for those patients who may be rechallenged with clozapine after a brief interruption secondary to moderate leukopenia (defined as 3000 cell/ mm? > WBC ? 2000 cells/ mm?) and/or moderate granulocytopenia (defined as 1500 cell/ mm? > WBC ? 1000 cells/ mm?) as well as increased risks for agranulocytosis in this population. It also provides guidance in Table 2 for reinitiating clozapine therapy after an interruption in therapy with comitant WBC/ANC monitoring requirements.

During a complaint validation survey completed 9/9/2009, the survey team found that one patient taking clozapine did not have the required blood work drawn within a seven day time frame as documented in the clozapine product labeling.

During a validation survey completed 4/23/2010, the survey team found the hospital had not ensured that pharmacy staff was not completing a pharmacy clozapine monitoring form as stipulated by hospital policy and procedure.

The plan of correction developed by the hospital stipulated that the all patients taking clozapine would be monitored by the pharmacist and that the tracking would be done using a Clinical Pharmacy Monitoring form. It stipulated that the pharmacist was to contact the physician if concerns arose regarding timeliness (of required lab draws) or other clinical issues. This plan of correction was to have been in place as of May 2010.

On 11/3/2010 at 4:09 p.m. a review of Policy and Procedure PHM IV.B.2 entitled "Clozapine Dispensing and Reporting" (written 9/2009 and revised March 2010) indicated it stipulated: "The pharmacy will monitor the WBC/ANC for patients on Clozapine, maintain a Clinical Pharmacy Monitoring Form and ensure weekly, every two weeks, or monthly submission of the WBC/ANC reporting form to the manufacture (sic) as required." During an interview of Administrative Staff Q at that time he stated that there was no "Clinical Pharmacy Monitoring Form" and that he had never had such a form.

At this time Administrative Staff Q produced a copy of the clozapine product labeling and a review of Table 1 in that document indicated that a substantial drop of the WBC/ANC was defined as a single drop or a cumulative drop within three weeks of 3000 cells/mm? or more in the WBC count or 1500 cells/ mm? in the ANC count. The product labeling indicated that the lab should be repeated and if the WBC fell between 3000 and 3500 cells/ mm? and the ANC was less than 2000 cell/ mm? the lab draws should be done twice weekly until the WBC was greater than 3500 cells/ mm? and the ANC was greater than 2000 cell/ mm?. At this time the surveyor asked Administrative Staff Q what he would do if a patients WBC count fell from 15,000 cells/ mm? to 11,900 cells/ mm? over a three week period (a fall greater than 3000 cells/ mm?) and he stated he would call the physician and recommend that the clozapine be discontinued. He did not mention twice weekly blood monitoring and then only if the lab was repeated and the result indicated that the WBC fell between 3000 and 3500 cells/ mm? and the ANC was less than 2000 cell/ mm? nor did he indicate that the product labeling would not require an interruption of therapy under this situation.

Administrative Staff Q stated he got an automatic printout each morning of patients of the lab work of patients who were on clozapine which indicted among other things when the last blood work had been done. Administrative Staff Q stated that all clozapine patients had weekly blood draws in the hospital and using the sheets allowed one to know when the next blood was due based on the draw date of the last lab work.

A review of four lab reports dated 10/12/2010, 10/13/2010, 10/14/2010, and 10/15/2010 indicated they were entitled "Patients on Clozaril & Last WBC" and three patients appeared on the report. The following issues were noted:

Patient 300 had a WBC count done on 10/6/2010 and 10/14/2010 which was 8 days, not 7 days, as stipulated in the product labeling.

Patient 301 had a WBC count done on 10/7/2010 and it was not repeated on 10/14/2010. Patient 301 did not appear on the 10/15/2010 lab report and Administrative Staff R stated that Patient 301 had been discharged on 10/14/2010 at 11:35 a.m. Administrative Staff Q stated, after referring to the hospital computerized patient data base, that blood work was drawn between 5:30 and 9 a.m. so it would have been possible to get blood work on Patient 301 before he was discharged so that it could be reported to the pharmacy that would care for Patient 301 after discharge and enable that pharmacist to arrive at an informed decision regarding the dispensing requirements for clozapine.

No evidence was provided that the pharmacy or hospital made any attempt to determine of patients required less frequent monitoring based on parameters documented in the clozapine product labeling. No evidence was provided that the pharmacist had implemented the plan of correction (following the April 2010 survey) and the hospital policy and procedure by monitoring patients using a monitoring form that could contain information to prompt the person monitoring the clozapine regimen. No evidence was provided that clozapine patients were monitored according to the guidelines stipulated in the product labeling. Finally lab draws were not done on time which had been an issue during the September 2009 validation survey.

2. During a validation survey completed 4/23/2010, the survey team found the hospital had failed to ensure that a patient (Patient 402) had not received a medication, acetaminophen, to which he had a listed allergy. The hospital wrote a plan of correction after the survey to ensure this did not happen again.

On 11/5/2010 a review of Patient 305's clinical record indicated that Geodon (an antipsychotic), Ativan (used to treat agitation and anxiety), and Benadryl (an antihistamine with significant sedative side effects) were listed as allergies by the physician on the admission order set dated 10/16/2010.

On 10/18/2010 at 2:40 a.m., Licensed Staff X took a telephone order from a physician for Restoril (a sleeping medication in the same class of drugs as Ativan and to which one could be considered potentially cross-allergic if one had an allergy to Ativan) 30 mg orally each night at bedtime if needed for sleep; may repeat once in one hour as needed. Ativan was listed as a medication to which the patient was allergic on the top of the "Physician's Orders" sheet on which this telephone order was taken. A review of the medication administration record (MAR: used by nurses to accurately medicate their patients and to document the date and time a dose of medication was administered) indicated that Patient 305 received Restoril 30 mg at 1:05 a.m. on 10/20/2010. The MAR listed Ativan as a medication to which Patient 305 was allergic.

On 10/21/2010 at 7:50 p.m., Licensed Staff S took a telephone order from a physician for Haldol (an antipsychotic) intramuscularly (IM), Ativan 2 mg IM, and Benadryl 50 mg IM for extreme anxiety and agitation. A review of the MAR indicated these medications were injected into the right buttock on this date (no time indicated). Ativan and Benadryl were listed as medications to which Patient 305 was allergic on this MAR. A nursing note on this date and timed at 8 p.m. indicated these medications were given secondary to Patient 305's severe agitation at that time.

On 10/22/2010 at 10:15 a.m., Licensed Staff W took a telephone order from a physician for Geodon (an antipsychotic) 20 mg IM now for agitation. A review of the MAR indicated that the Geodon was given to Patient 305 on this date at 10:35 a.m. On 11/5/10 at 11:38 a.m. during an interview of Licensed Staff W she stated she took this telephone order for Geodon and she had not noted at that time that Geodon was listed on the MAR as a medication to which Patient 305 had an allergy.

There was no evidence that Patient 305 had any adverse effects to these medications and at 5:15 p.m. on 10/22/2010, a physician ordered that Geodon, Ativan, and Benadryl be removed from the clinical record as medications to which Patient 305 was allergic.

On 11/5/2010 a review of Policy and Procedure PCM I.14 entitled "Allergy Screening" (written 12/1991, revised 1/2007) indicated staff was to obtain information regarding allergies at admission of a patient to the hospital, to document them in the clinical record and to notify the pharmacy of these allergies by fax.

On 11/5/2010 a review of Policy and Procedure PHM IV.B.5 entitled "Allergy Wristbands" (written 9/2003, revised 11/2004) indicated that it stipulated that "The Pharmacy shall note allergies on the patient's profile for reference when filling medication orders" and "Any order that the Pharmacy receives for drugs that appear on the list of allergies, or drugs that may have cross-allergenicity, shall be reported to the nursing staff, The order shall not be filled until the doctor has been notified of the allergy, and has changed the order or given clearance to proceed as written. If clearance is given, the pharmacist will so document in the patient's profile".

On 11/5/2010 a review of Policy and Procedure PCM VI.A.5 entitled "Medication Orders" indicated it stipulated: "Hospital nursing and pharmacy staff will clarify any unclear orders at the time they are received ..."

On 11/5/2010 at 1:42 p.m. during an interview of Administrative Staff Q, he stated that if a patient had an allergy for Ativan entered into the patient computerized medication profile and an order for Restoril was entered by a pharmacist, the computer program would alert the pharmacist of the potential cross-allergenicity of the two drugs. He stated the computerized profile had a space that the pharmacist could use to document he had called the doctor about any clinical concerns such as an allergy to a prescribed medication as documented in Policy and Procedure PCM I.14. He checked Patient 305's profile and found a note dated 10/18/2010 regarding the potential cross-allergenicity of Restoril in a patient who was allergic to Ativan. The note documented the pharmacist had asked for clarification. Administrative Staff Q stated this meant he had called a psychiatric technician and asked them to clarify this issue with the physician. Administrative Staff Q stated that the Policy and Procedure PCM VI.A.5 stipulation regarding clarification of orders would apply to clarifying an order for a drug to which the patient may be allergic due to cross-allergenicity to a drug to which the patient was allergic. Administrative Staff Q stated the routine in this hospital was to notify the nursing staff or the psychiatric technicians regarding such concerns who would then inform the doctor. He stated when he first started to work at the hospital, the physicians told him he preferred to have the nurses or the psychiatric technicians call them with concerns regarding medication therapy. He did not recall if he discussed this issue with his superiors.

3. On 11/8/2010 a review of a document entitled "Patient Census - Allergy & Reasons for Visit" provided by Administrative Staff R indicated that it contained allergy information for the patients listed on that document. Patient 303's name appeared on this document and "penicillin" and "tramadol" (a pain relieving medication). During an interview of Administrative Staff R at that time, she stated the source of the allergies on this document was the computerized Patient Data Profile (PDP) used by the hospital and that this allergy information was also printed on the MARs.

On 11/5/2010 at 1:42 p.m. during an interview of Administrative Staff Q, he stated that allergies were entered by nursing staff into the hospital patient information system (PDP) and that the pharmacy computerized patient medication profiles were part of this system. He said that the allergies entered by the nursing staff were viewable by the pharmacy staff in the pharmacy computerized patient medication profiles. He said that the MARs were printed from the pharmacy computerized patient medication profiles and the allergies also printed out on the MARS.

On 11/8/2010 a review of Patient 303's clinical record indicated that it contained a face sheet (contained patient demographic and abbreviated clinical information) from another local hospital and that face sheet documented that Patient 303 had an allergy to Dilaudid (a narcotic pain reliever) as well as to tramadol and penicillin. A handwritten note from the other local hospital Emergency Department documented that penicillin use resulted in a rash, tramadol use resulted in throat swelling, and Dilaudid use resulted in nausea and vomiting. Nausea and vomiting is not an allergic reaction but it is an adverse reaction to this drug. The Admitting Orders listed Dilaudid, penicillin, and tramadol as medications to which Patient 303 was allergic but the admitting physician note indicated that Patient 303 was only allergic to penicillin and tramadol.

On 11/8/2010 during a review of the Power Chart (an electronic medical record) conducted with the help of Administrative Staff R indicated it only listed penicillin and tramadol, not Dilaudid. The "All" choice was highlighted on the "Display" section of the allergy field. At that time, Administrative Staff R stated that the "All" choice would list allergies that had originally been entered by the nursing staff and subsequently deleted. She stated that as Dilaudid did not appear in the allergy field with the "All" choice highlighted meant that staff had not entered Dilaudid into the allergy field. She stated that the PDP was part of the Power Chart.

On 11/5/2010 a review of Policy and Procedure PCM I.14 entitled "Allergy Screening" (written 12/1991, revised 1/2007) indicated staff would "Notify ...physician of any allergy not mentioned in the H&P (History & Physical)". The H&P is an admitting assessment of a patient. It would not necessarily be equivalent to an admitting note but the hospital had documented that staff should alert physicians to discrepancies regarding allergies found in the clinical record.

On 11/8/2010 at 11:29 a.m. during an interview of Administrative Staff Q, he stated there were no clinical notes in Patient 303's pharmacy computerized medication profile regarding the fact that there was a discrepancy between the allergy information found in the Power Chart and that found on Patient 303's admitting orders. He could not say where non-allergic adverse reactions to medications (such as nausea and vomiting) would be documented in the Patient Data Profile. At this time Administrative Staff R stated such information would be entered into the allergy field so that hospital staff would be alerted (to the potential for a given drug to cause an adverse reaction).

4. During a validation survey completed 4/23/2010, the survey team found the hospital had failed to ensure that a patient (Patient 402) had not received a medication, acetaminophen, to which he had a listed allergy. The hospital wrote a plan of correction after the survey to ensure this did not happen again. Part of the plan stipulated that allergies would be placed on an Allergy Alert Sticker found on the front cover of any given patient's clinical record.

On 11/5/2010 at 1:12 p.m. a review of Policy and Procedure PCM I.14 indicated that if a patient had documented allergies to "...drugs, food, tape, etc ..." they were to be written on an "Allergy Alert Sticker" which would then be placed on the outside cover of the chart. This sticker was one of the first places that would alert staff and physicians to patient allergies when prescribing, noting, or carrying out medication orders. The "Intent" of the policy was documented to be: "To outline the process for identifying and reporting patient allergies."

On 11/8/2010 a review of a document entitled "Patient Census - Allergy & Reasons for Visit" indicated that Patient 306 was allergic to amoxicillin (an antibiotic), codeine (a narcotic pain reliever), phenothiazine (a drug class of antipsychotics), ampicillin (an antibiotic), penicillin, and sulfadiazine (an antibiotic).

On 11/8/2010 a review of Patient 306's clinical record indicated that amoxicillin and phenothiazine did not appear on the Allergy Alert Sticker that was placed on the cover of Patient 306's clinical record.

5. During a validation survey completed 4/23/2010, the survey team found the hospital had failed to ensure that methadone use had been assessed with regard to efficacy of pain relief as required by the facility policy and procedure entitled "Pain Management" (revised 6/08) in one patient (Patient 200). The Plan of correction submitted by the hospital documented that "At least twice a week nursing supervisors conduct spot checks of at least one (1) open chart for nursing documentation of pain assessments for patients receiving narcotic pain medication", and that the plan would be implemented by July 2010.

On 11/9/2010 at 9:09 a.m. during an interview of Administrative Staff B she provided a copy of a document entitled "Weekly Pain Assessment Audit Tool (Supervisor Only)". It consisted of three pages dated as 10/11/2010, 10/18/2010 and 10/31/2010. The 10/11/2010 sheet contained data colleted between 10/8 and 10/10/2010. The 10/18/2010 sheet contained data collected between 10/15 and 10/17/2010. The 10/31/2010 sheet contained data collected between 10/29 and 10/31/2010. There was a gap in the data from 10/17 to 10/29/2010. Nothing on the form indicated when a week started and ended which could then be used to monitor if the nursing supervisors were in fact monitoring patients at least twice a week. There was no way to tell if the gap in monitoring was due to the fact that there were no patients on narcotic pain medications during this period or because staff failed to carry out the monitoring as stipulated in the hospital policy and procedure.

At this time, Administrative Staff B stated that this corresponded to the hospital Plan of correction for the cited deficient practice found during the last survey. She stated that the weekly assessment was started during the first week of October 2010 (not July 2010). She stated there was no defined "week" in which data were collected.

6. On 11/4/2010 at 5:06 p.m. a review of three Controlled Substance Administration Records (CSARs: used to track the use of controlled substance by medication name, amount dispensed, date and time dispensed, patient name, and person dispensing the medication to the patient) in the Nursing Unit 1 Medication Room indicated they were identified by sequential numbers found at the top of the CSAR sheet and had both printed names of medications as well as blank spaces in which staff could write the names of the medication. The sheets were used to track controlled drug (drugs that are likely to be abused) inventory on the unit. On CSAR form number 11063 (the current sheet) staff had altered the printed entry "15 mg (milligrams) Morphine Immediate Release" by crossing out the word "Immediate" and writing in "S". Administrative Staff Q stated that the "S" meant it was sustained release and, in fact, inspection of the controlled drug supply indicated it contained morphine 15 mg sustained release tablets. On sheet 11062 (covering the period 11/2/2010, 8 p.m. to 11/3/2010, 8 p.m.) the morphine entry had been altered as described above. However on CSAR sheet number 11061, the morphine entry had not been altered and therefore documented that the supply was immediate release and not sustained release.

At 5:18 p.m. in the pharmacy, inspection of Unit 1 CSAR sheet numbers 11058 (5:05 p.m., 10/31/2010 to 11:30 p.m., 10/31/2010), 11059 (11:30 p.m., 10/31/2010 to 2:30 p.m., 11/1/2010), and 11060 (3 p.m., 11/1/2010 to 8:15 a.m., 11/3/2010) indicated that the 15 mg Morphine Immediate Release printed entry had not been altered on sheet 11058, but on sheet 11059 "SR" and on sheet 11060 "S" had been written in while "Immediate" was crossed out.

Inspection of three more Unit 1 CSAR sheets, numbers 10994 (9 a.m., 8/30/2010 to 7:20 a.m., 8/31/2010), 10995 (8 a.m., 8/31/2010 to 9 p.m., 8/31/2010), and 10996 (9 p.m., 8/31/2010 to 12:30 p.m., 9/1/2010) indicated that "Immediate" was crossed off the printed morphine entry and "S" written in on sheet 10994 and sheet 10996 but the printed morphine entry was not altered on sheet 10995.

All these sheets had blank spaces on which staff could have written in morphine 15 mg sustained release tablets.

During an interview of Administrative Staff Q at that time, he stated that the variance in the labeling could cause confusion in the future when it was no longer clear what had actually been stored on the unit. He stated that comparing the August 2010 sheets to the more recent ones indicated that this had been a problem for at least the past two months. He stated that the procedure was for staff to handwrite in the name of a controlled medication into a blank space if it was not one of the printed entries on the top of the CSAR.

On 11/8/2010 a review of Policy and Procedure PCM VI.B.4 (written 12/2006, revised 12/2009) entitled "Controlled Substances" indicated there was no description of the CSAR sheet with respect to the printed names versus the blank areas and there was no direction to staff to write in names of medications rather than altering printed names.

On 11/8/2010 a review of Policy and Procedure PHM IV.E.2 (Written 9/2003, revised 2/2004) entitled "Controlled Substances, Distribution" indicating it did not provide direction to staff as to how to fill out the CSAR sheet.

On 11/8/2010 at 3 p.m. during an interview of Administrative Staff Q he stated he not found a nursing policy and procedure directing staff how to full out the CSAR sheet.

7. On 11/5/2010 a review of Policy and Procedure PCM VI.A.6 entitled "Verbal and Telephone Orders" indicated it stipulated that verbal orders (V.O.s) and telephone orders (T.O.s) were to be signed, dated and timed by the ordering physician within 48 hours (2 days). It also indicated that a covering physician could authenticate such orders on an "infrequent" basis.

On 11/5/2010 a review of Patient 305's clinical record indicated the following:

On 10/16/2010 at 1:30 p.m. Licensed Staff Y took a T.O. for Benadryl (an antihistamine) from Physician Z. It was countersigned by Physician QQ on 11/3/2010 at 11:45 a.m. (18 days later).

On 10/16/2010 at 6 p.m. Licensed Staff RR took a T.O. to discontinue the order for Benadryl from Physician Z. It was countersigned by Physician QQ on 11/3/2010 at 11:45 a.m. (18 days later).

On 10/18/2010 Licensed Staff X took a T.O. for Restoril (a sleeping medication) from Physician Z. It was countersigned by Physician V on 11/2/2010 at 5:50 p.m. (15 days later).



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21156

8. On 11/3/10 at 3:00 p.m., Patient's 107, 108, and 109 clinical records were reviewed. Patient 107's "Physician Admission Orders and Initial Treatment Plan," which included the names of the attending physicians, patient's diagnoses, medications, labs, and non medications orders prescribed, and patient's legal status , was ordered by telephone on 6/11/10 at 4:30 p.m., The physician did not authenticate (to validate) the admission orders until 3 days later, on 6/14/10 at 11:40 a.m. Patient 108's clinical record revealed that her "Physician Admission Orders and Initial Treatment Plan" was ordered by telephone on 6/28/10 at 1:55 p.m. and was not authenticated until 7/8/10 at 5:20 p.m., 10 days later and Patient 109's clinical record revealed that the patient's "Physician Admission Orders and Initial Treatment Plan" was ordered by telephone on 10/29/10 at 12:40 p.m. and was not authenticated until 11/1/10 at 6:00 p.m., 3 days later.

On 11/3/10 at 4:30 p.m., Administrative Staff C acknowledged that the orders for the patient's initial treatment plan was not authenticated within the 48 hours time limit consistent with the facility's policy. There was no explanation given.

On 11/3/10, the facility's policy titled "Orders" dated January 16, 2008, indicated "The responsible practitioner who gave the verbal or telephone order shall, within 48 hours, sign, date and time the order.

17065


Based on observation, interview and document review, the hospital failed to ensure that dietary services met the needs of all patients as evidenced by:

1. Provide organized dietetic services as evidenced by findings of unsafe food handling practices and supervision of Dietary Department (Cross Reference A620).
2. Ensure effective food production systems that were delivered per the physicians orders and met the nutritional needs of the patient population (Cross Reference A630).
3. Ensure standardization of regular and therapeutic diets (Cross Reference A631).
4. Ensure the therapeutic diet manual was approved by the dietitian and medical staff prior to implementation.
5. Ensure safe and effective food production practices (Cross Reference A749).

The cumulative effect of these systemic problems resulted in the hospitals' inability to ensure that the nutritional needs of the patients are met in accordance with the Conditions Of Participation for Food and Dietetic Services.

17065

Based on food service observations, dietary staff interview and dietary document review the hospital failed to ensure the dietary department was effectively managed as evidenced by: 1. inability of dietary staff to honor patient food preferences; 2. maintaining hot food in the oven for excessive time with the potential of loss/compromise of nutrient content; 3. kitchen areas that were not clean; 4. storage of expired items. Failure to ensure effective dietetic systems may result in unsafe food handling systems that do not meet the nutritional needs of patients.

Findings:

1. On 11/3/10 beginning at 11:30 a.m., food distribution to patients was observed. It was noted that dietary staff failed to honor the patient preference for Patient 201. Patient 201 was observed receiving his meal at the cafeteria tray line. He stated to Dietary Staff J that he would like to have the alternate entree of manicotti in place of his previous selection of ham. Dietary Staff J replied that he could not have the alternate entree because he had already chosen the ham. After Patient 201 received the ham, he was observed to hesitate for several minutes at the tray line after which he left.

In a follow up interview on 11/3/10, with Dietary Management Staff I she acknowledged that she had not witnessed the events; however stated that it would be the expectation that patients would be allow to change their entree selection and it would be the expectation that dietary staff honor patient preferences.

2. During food production observations on 11/3/10 beginning at 11 a.m., it was noted that Dietary Staff K was completing the final items for the noon meal, which included green beans. In a concurrent interview the surveyor asked him to describe the process for preparing the beans. He stated that he mixed the ingredients following the recipe at approximately 9:15 a.m., at which time he placed it in the oven at a temperature of 350?F. He further stated that the item would be removed from the oven at approximately 11:30 a.m., and placed on the steam table. He also stated that at that time a pan of the green beans would be taken to the cafeteria for patient meal service which started at 12 p.m., and ended 30-40 minutes later. The surveyor also asked Dietary Staff K if this was his usual process for preparing the vegetables. He replied that it was.

In an observation on 11/3/10 at 12 p.m., it was noted that the green beans were blacked, appearing burned around the edge of the pan. In a concurrent interview with Dietary Management Staff I she acknowledged that holding vegetables for extended periods of time for 2-3 hours would compromise the nutrition content especially the heat labile vitamins.

The standardized recipe for the green beans guided staff to bake at a temperature of 325?F for 45 minutes. Hospital policy titled "Quality Standards-Prepared Foods " dated 5/09 guided staff that "All menu items are to be prepared in accordance with standardized recipes ..."

3. During initial tour on 11/2/10 beginning at 10:20 a.m., in refrigerator #3 it was noted that there was a case of thawed, liquid eggs. It was noted that the box had a facility label with an expiration date of 1/21/11. It was additionally noted that the manufacturers' expiration date, stamped on the produce, was 12/30/10. There was also cheese with an open date of 11/10 and labeled with an expiration of 4/11 and chicken base that was opened and undated. Additional observation in the secondary dry storage area revealed that there were various boxes of cookies and graham crackers with a facility expiration dates of 2/11, 4/11 and 5/11 respectively.

In a concurrent interview with Dietary Management Staff I she was asked to describe the facility policy for determining the hold time of foods. She stated that the practice was to hold shelf stable foods for 1 year whether they were opened or sealed unless there was a manufacturers' date that was different. She also stated that she was unsure how the hospital determined the guidance and acknowledged it was not likely based on any particular reference or manufacturers' guidance.

Hospital policy titled "Dating Refrigerated/Frozen Foods" revised 6/03 revealed that while the policy included eggs, dairy, meats, produce and leftovers the section of the policy titled " Nonhazardous Foods " included only items such as jams, vinegar, gelatin and bottled sauces the policy did not reflect all the food products purchased by the hospital.

4. During general kitchen observation on 11/2/10 beginning at 11:10 a.m., it was noted that there were several areas of the kitchen that were not clean. In the cabinet to the left of the oven there was a build up of food particles on the shelves. It was also noted that there were dried food particles on the food processor and blender as well as a build up of a grey slimy substance on the "o" ring of the blender. It was also noted that cleaned and sanitized knives were stored touching the counter that was observed to have a build up of food particles.

In a concurrent in interview with Dietary Management Staff I she acknowledged these areas were not clean. She also stated it was the responsibility of the p.m. cook to clean the cabinet areas and the responsibility of the individuals using the equipment to effectively clean them after each use. She also stated that while the hospital had a general cleaning schedule; there was no detailed schedule for all kitchen areas. She also stated that cleaning duties were incorporated into the cooks and dietary aid position descriptions.

Based on food distribution observations, dietary management staff interview and dietary document review, the hospital failed to ensure menus for pediatric patients met the nutritional needs of the patient population. Failure to ensure nutritional needs are met may compromise the medical and nutritional status of patients.

Findings:

During initial tour on 11/2/10 beginning at 10 a.m., in an interview with Administrative Staff L she was asked to describe the demographics of patients that would be accepted. She stated that they accept children as young as 4 years of age through adulthood.

During cafeteria tray line observations on 11/3/10 beginning at 12 p.m., it was noted that greater than 50% of the patients utilizing cafeteria services were in the adolescent age groups. It was also noted that Patients 200 and 201, who were adolescents, did not receive the foods that were ordered by their physician or patient preference. (Cross Reference A620 and A630).

In an interview on 11/3/10 beginning at 12:30 p.m., with Dietary Management Staff I she was asked to describe how the hospital ensured the nutritional needs of the adolescent population were met. She stated that they were given the regular menu. In a follow up interview on 11/3/10 at 1 p.m., the RD presented a nutritional analysis of the menu that revealed the average caloric intake for the menu cycle was 2100 calories. Dietary Management Staff I also stated that there were no modifications to the menu to address the specialized nutritional needs of the adolescent nor was there a therapeutic spreadsheet to guide staff on the preparation of meals for the pediatric population. She also acknowledged that without the benefit of therapeutic spreadsheets for the non-adult patient population the individiual nutritional needs of all patients may not be met.

Review on 11/3/10 at 12:30 p.m., of the American Dietetic Association Pediatric Manual of Clinical Dietetics dated 2003 and approved on 9/7/10 by the medical staff and the Registered Dietitian revealed that the recommended energy intakes, in particular for male adolescents, range from 2500-3000 calories. Concurrent review of the hospitals ' patient census dated 11/2/10 revealed that there were 18 patients that were classified as adolescents.

Based on food production observations, dietary staff interview and dietary document review the hospital failed to ensure food production activities met the nutritional needs of patients as evidenced by 1. the lack of standardized recipes for alternate menu items; 2. utilization of substitutes that were not of equal nutritive value; 3. inability of staff to follow the physician ordered diet and 4. lack of physician orders for therapeutic nutritional interventions.

Findings:

1. During food production observations on 11/2/10 beginning at 11:20 a.m., Dietary Staff M was observed making turkey sandwiches. In a concurrent interview she stated the sandwiches would be used as a substitute entrees and snacks. She also stated that in addition to turkey sandwiches she routinely prepared egg and tuna sandwiches. The surveyor asked her to describe how she determined the portion of each sandwich. She replied that she didn't use any measuring device, rather "just spread it on the bread - maybe ? cup." She also stated that she did not prepare the egg or tuna salad; rather it was prepared by the cooks.

In an interview on 11/2/10 at 2:30 p.m., with Dietary Staff N she stated that she usually prepared both the egg and tuna salads. She further stated that she usually used three-60 ounce cans of tuna without draining the liquid mixed with 1 gallon of mayonnaise. She further stated that she had a similar process for mixing the egg salad sandwiches, using pre-packaged hard boiled eggs, each bag containing 20-25 eggs.

In an interview on 11/2/10 at 2:35 p.m., with Dietary Management Staff I she stated that to her knowledge there were no standardized recipes for any of the sandwiches that would be used as a replacement for the protein-based entree. She also acknowledged that without standardized recipes there were no assurances that when sandwiches were used as a substitute for an entree they were of equal nutritive value.

Review on 11/3/10 at 10 a.m., of the recipe book for week 4 revealed that a standardized recipe did exist for an egg salad sandwich; however was not being utilized.

2. During general food production observations on 11/2/10 beginning at 12 p.m., Dietary Staff N was observed preparing grilled cheese sandwiches for the noon meal by placing 2 slices of cheese in between 2 slices of bread. In a concurrent interview with Dietary Staff N she stated the sandwiches would be used as a substitute for the entree.

On 11/3/10 at 10 a.m., Dietary Management Staff I was asked to weigh 2 slices of cheese which equaled 1.5 ounces of cheese for the 2 slices. Dietary Management Staff I acknowledged that the current method of preparation for the cheese sandwiches was not of equal nutritive value when used as replacement for a protein based entree.

3. On 11/3/10 beginning at 11:30 a.m., food distribution to patients was observed. It was noted that dietary staff failed to honor Patient 200 ' s physician ordered lactose free diet. It was also noted that the patients' tray card requested soy milk as a substitute. After Patient 200 received her tray she told Dietary Staff J that her tray should include soy milk. Dietary Staff J told her that they did not have any soy milk. Patient 200 was observed to hesitate for several minutes at the tray line after which she left.

In a follow up interview on 11/3/10 with Dietary Management Staff I she acknowledged that she had not witnessed the event; however stated that it would be the expectation that patients receive meals according to their physicians' diet order. Dietary Management Staff I also confirmed that the facility did have soy milk in stock.

4. Medical record review was conducted on 11/2 and 11/3/10 intermittently between the hours of 12 p.m. and 3 p.m. Patient 202 was admitted with diagnoses including bipolar disorder. Admission physician diet order dated 10/28/10 was for a regular diet. A comprehensive nutrition assessment dated 10/29/10 and completed by the Registered Dietitian noted that the patient had inadequate oral intake, an average of 33% for the meals consumed. The assessment also noted that the patient was 89% of his ideal body weight. The assessment additionally documented that the diet that currently being offered was 2100 to 2500 and noted that the patients' caloric needs ranged from 1800-2200 calories/day. As a result of the assessment the RD implemented a fortified diet as well as nutritional supplements 3 times/day. There was no physicians' order for either of the nutritional interventions. It was also noted that there was no description or guidance for dietary staff on the implementation of a fortified diet as part of the diet manual.

In an interview on 11/3/10 at 1 p.m., with Licensed Staff D he was asked to describe the process once the Registered Dietitian made recommendations for nutrition interventions. He stated that once the recommendations were made he would enter them into the electronic medical record.

In an interview on 11/3/10 at 9 a.m., with Dietary Management Staff I she acknowledged that there was no physician order for Patient 202's therapeutic diet interventions.

17065

Based on dietary document review and dietary staff interview, the hospital failed to ensure the diet manual was approved prior to implementation. Failure to obtain approval from physicians' may result in misunderstandings of the nutritional content of diets, further compromising nutritional and medical status.

Findings:

During tray line observation on 11/2/10 beginning at 12 p.m., it was noted that there were several therapeutic diets including 2 gram sodium, carbohydrate controlled diets with three different calorie ranges and a 2 gram sodium restricted diet that was defined as a low sodium diet.

In a concurrent interview with Dietary Management Staff I she stated that they recently purchased a new menu and therapeutic diet manual from separate vendors. She also acknowledged that since the diet manual, menus and patient ordering system were independent systems the diet manual did not match the terminology utilized on the therapeutic spreadsheets or the available selections for diet orders in the electronic medical record. She also acknowledged that the recently implemented diet manual was not reviewed by the medical staff.

Review on 11/3/10 at 12 p.m., of hospital document titled "Medical Executive Committee" dated 11/20/09 noted that the previous diet manual, dated 2008 was reviewed. There was no documentation that the new diet manual was reviewed and approved by the Registered Dietitian or medical staff prior to implementation.

17065

Based on food production observations, dietary staff interview and dietary document review, the hospital failed to ensure that food was prepared and served in a safe and sanitary manner as evidenced by: 1) lack of cooldown monitoring of foods prepared at room temperature; 2) an ice machine that was not clean; 3) a dish machine that was not functioning properly and 4) food distribution activities that may promote cross contamination of food. Failure to ensure food service systems are effectively implemented may result in practices associated with foodborne illness and contamination of patient food. Foodborne illness may result in gastrointestinal distress, compromise of medical condition and in severe instances may result in death.

Findings:

1. During initial tour on 11/2/10 beginning at 10:20 a.m., it was noted that in refrigerator #3 there were plastic containers that contained tuna salad and egg salad each of which were dated 10/31/10. The internal temperature of the products was noted to be 41?F. In an interview on 11/2/10 beginning at 3 p.m., with Dietary Staff N she stated that she was the person responsible for preparing items such as egg and tuna salad for sandwiches. The surveyor asked her to describe how she prepared the items as well as ensured that foods prepared several days in advance were safe for continual usage. She stated that items such as tuna sandwiches were prepared from ingredients that were at ambient room temperature, with the exception of the hard boiled eggs that were refrigerated. She further stated once the item was prepared she would label, date and place the item in the refrigerator for no longer than 3 days. She also stated that there was no cooldown temperature monitoring of the items once they were prepared.

Review of hospital document titled " HACCP Daily Temperature Logs " dated 10/31/10 revealed that while the hospital had a system to monitor time/temperature control of hot foods, the system did not include any cold food items.

Hospital policy titled "Food:Safe Cooling" dated 4/10 revealed that while there was guidance for properly cooling foods that were hot there was no guidance for monitoring time/temperature control of potentially hazardous foods (PHF's) prepared at room temperature. PHF's are defined as foods capable of supporting growth associated with foodborne illness. PHF's require time/temperature control during preparation and storage to inhibit the growth of bacteria (Food code, 2009).

In a follow up interview on 11/3/10 at 2:30 p.m., with Dietary Management Staff I she acknowledged that she was unaware of the need to monitor PHF's prepared at room temperature and that staff was not following safe food handling practices with respect to these foods.

The standard of practice to ensure time/temperature control of potentially hazardous foods (PHF's) would be to monitor the cooldown of both hot foods as well as cold foods prepared from ingredients at room temperature (Food Code, 2009).

2. Review of ice machine sanitation procedures was completed on 11/3/10 at 9 a.m., in conjunction with the semi-annual equipment maintenance. In a concurrent interview with the contracted vendor the surveyor asked him to open the ice machine. Upon opening the front panel of the machine it was noted there was a build up of a white calcified substances as well as a pink slimy substance. The surveyor asked Vendor O to identify the substance and describe the process for cleaning the machine. He replied that it was probably mold. He also described that on a semi-annual basis he descaled and sanitized the machine. He further demonstrated that the chemical used to sanitize the machine was household bleach that was a 6% chlorine solution.

Concurrent review of the manufacturers' label on the bleach revealed the product could be used for clothing, floors, toilets and bathrooms. There was no indication the item could be used for food contact surfaces such as those found in an ice machine. It was also noted that the manufacturers' guidance for sanitation of the ice machine was a 5.25% chlorine solution, not a 6% solution.

In a concurrent interview with Dietary Management Staff I she also acknowledged that while the frequency of the ice machine cleaning was completed according to manufacturers' guidance the current frequency may not be adequate to ensure that ice was produced in a sanitary manner.

3. During general observation on 11/2/10 beginning at 11:45 a.m., it was noted that dietary staff was washing food production utensils and then returning to food production activities. The observed wash and rinse temperatures were 150?F. It was also noted that the manufacturers' guidance printed on the machine guided that the wash cycle of the machine should be 150?F and rinse cycle should be 180?F.

In a follow up observation on 11/2/10 at 2:45 p.m., it was noted that that dietary staff was continuing to use the machine. It was noted that the wash and rinse water temperatures were 150?F and 160?F respectively. In a concurrent interview with Dietary Staff N the surveyor asked her to describe how she ensured the machine was working properly. She demonstrated that she would check the wash and rinse temperatures and record them on the dish machine temperature log. Concurrent review of the hospital document titled "Dish machine Temperature Log" dated 11/10, revealed that the temperature recorded for the noon meal was 189?F. The surveyor also asked whether or not the observed temperatures were acceptable. She replied that they were.

In a follow up interview on 11/3/10 at 11 a.m., with Dietary Management Staff I she stated that a dish machine repair man was called the previous evening. She also stated that dietary staff was not turning on the hot water booster. She also acknowledged that the recorded temperatures of the dish machine likely did not accurately reflect the actual temperatures since the equipment was not be used properly.

4. During food distribution observation on 11/3/10 beginning at 12 p.m., in the cafeteria service it was noted that Dietary Staff J was chewing gum. In a follow up interview on 11/3/10 at 12:30 p.m., with Dietary Management Staff I she acknowledged that the staff member was chewing gum and acknowledged the risk of potential cross contamination of patient food with this practice.

Review on 11/3/10 at 1 p.m., of hospital policy titled " Food Contamination, Avoiding " dated 11/04, noted that " Eating ...in food ...serving areas is not allowed. "