HospitalInspections.org

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 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.