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Based on patient observation, nursing staff interview, medical record review and document review the hospital failed to ensure 1 patient (Patient 8) was free from unnecessary restraints.

Findings:

Patient 8 was admitted with diagnoses including pneumonia. Medical record review was conducted on 8/17/10 beginning at 11 am. A nurses' note dated 8/12/10 noted that the patients' physician was intubating the patient (the placement of a flexible plastic tube into the trachea to protect the patient's airway and provide a means of mechanical ventilation, Wikipedia, 2010). The physician also ordered a naso-gastric tube (tube placed through the nose into the stomach, Wikipedia, 2010) for feeding. Review of physicians' order history beginning on 8/14/10 noted that at 11:41 am, the physician ordered restraints. It was also noted that on 8/15/10 the physician ordered Midazolam, a medication utilized to sedate patients, 0.5 mg/hour as needed (Rxlist.com). Review of medication administration records (MAR's) noted that Patient 8 received the first dose of the medication on 8/15/10 at 1:10 pm. It was also noted that from 8/15-8/17/10 at 11 am, Patient 8 received a total of 43 doses of sedative.

In an interview on 8/17/10 at 11:30 am, with RN 1 the surveyor asked him to describe the situations in which restraints would be used. He stated that he would use them if a patient was hurting themselves or was pulling at their tubes.

An observation on 8/1710 at 12:15 pm, it was noted that Patient 8 was lying in bed. It was also noted that she continued to be on a mechanical ventilator with the naso-gastric feeding in place. RN 1 was asked to demonstrate the type of restraints being used. RN 1 proceeded to reposition the patients' arms at which time he was slightly shaking the patient. It was noted that Patient 8 had a soft wrist restraint on each wrist, which was tied underneath the bed. It was also noted that during the repositioning and slight shaking, Patient 8 continued to remain sedated.

Concurrent review of nurses notes beginning 8/12/10 (prior to intubation and sedation) nursing staff documented that Patient 8 was "emotional, crying. Stated I'm scared." Nurses' notes dated 8/12/10 at 2:30 pm, noted that the patient was anxious and agitated about a catheter insertion. There was no documentation that Patient 8 attempted to remove her catheter tubing. Additional nursing notes beginning on 8/13/10 (after the patient was intubated) failed to note any behaviors of self-injury or pulling at her tubes. Nurses note dated 8/13/10 at 2 am, noted the patient was sleeping and arouses to verbal stimuli. A follow up nurses note dated 8/12/10 at 8:10 pm, noted the patient was "lethargic, responds to verbal stimuli but falls back to sleep. Soft restraints in place." An additional note dated 8/14/10 at 9:35 am, noted that that "Pt [patient] lethargic open eyes then closed when stimulated." Nursing note dated 8/15/10 at 12:50 pm, "pt [patient] still sedated ...only occ [occasionally] moves both arms slowly, soft restraints on bilaterally to prevent pulling ET tube." There was no documentation that Patient 8 attempted to pull any tubing from 8/12-8/17/10.

Review of hospital document titled, "Default Flowsheet Data" from 8/14-8/17/10 revealed that while nursing staff documented that the clinical justification for the restraints was "pulling lines; pulling tubes" there was no documented evidence that the patient exhibited the behavior. There was also no documentation that nursing staff attempted a less restrictive alternative which failed.

Hospital policy titled, "Restraints" dated 3/3/10 guided nursing staff that "Restraint ...may only be used when less restrictive interventions have been determined to be ineffective." There was no documentation that hospital staff attempted to implement less restrictive methods prior to implementing bi-lateral soft wrist restraints.

Based on observation of three nurses passing medications to three patients on one shift on two nursing units the hospital failed to ensure that one of three patients (Patient 13) received one medication as ordered by the physician.

Findings:

On 8/17/2010 Staff C removed a 20 mg lisinopril tablet (used to treat high blood pressure) and placed it in a pill cutter to cut in half prior to administering it to Patient 13. When she cut the tablet, it broke into 3 pieces. The tablet was not scored (provided with an indented line on the tablet by the manufacturer to facilitate breaking of a tablet in half). She selected a piece that was approximately one-third the size of the original tablet and then administered it to Patient 13 at 9:25 a.m. The patient received an estimated dose of 7 mg.

On 8/17/2010 at 10:19 a.m. a review of Patient 13's clinical record indicated that the physician had ordered that Patient 13 receive 10 mg of lisinopril daily. Patient 13 received about 30% less than ordered by the physician.

Based on inspection of one out of six warmers in the Modesto hospital campus Surgery Department, inspection of temperature logs, hospital policies, and staff interview, the hospital failed to develop a policy that would consistently direct staff when to call the Engineering Department to adjust fluid warmer temperatures that the hospital had defined as being out of range, failed to ensure that the policy provided for the disposal of IV solutions when temperatures in the fluid warmer were above those specified by the manufacturer for these IV solutions, and failed to implement the procedure to re-date solutions that could be re-dated when found to be in a fluid warmer that was out of range.

Findings:

1. On 8/18/2010 a review of policy and procedure PC.PCS. 134 entitled Blanket, IV Fluid and Irrigation Solution Warming indicated it documented the following:

a. The safe temperature range for warming fluids was up to 104 degrees Fahrenheit.

b. The temperature was to be documented daily on the temperature log.

c. If the temperature were found to be outside the "safe" range staff was to:

i. Open the doors with constant observation and/or other actions as applicable.

ii. If these actions failed to control the temperature within guidelines, staff would contact the Engineering Department.

iii. Staff would document all actions taken and rechecked temperatures on the temperature log.

On 8/17/2010 a review of the temperature log for August 2010 for the OR #1 Fluid Warmer indicated the following:

a. 8/12/2010: temperature was 109.4 degrees Fahrenheit (deg F), opened door with supervision, rechecked temperature was 101.9 deg F.

b. 8/13/2010: temperature was 110 deg F, opened door with supervision, called engineer, rechecked temperature was 103.5 deg F.

c. 8/14/2010: temperature was 112.9 deg F, opened door with supervision, rechecked temperature was 103.9 deg F.

c. 8/15/2010: temperature was 110 deg F, opened door with supervision, rechecked temperature was 102.4 deg F.

e. 8/16/2010: temperature was 109.6 deg F, opened door with supervision, called engineer, rechecked temperature was 102.4 deg F.

On 8/18/2010 at 9:06 a.m. during an interview of Staff B, he stated that there was no record that staff had called the Engineering Department about the elevated Fluid Warmer Temperatures in OR #1 on 8/12, 8/14, or 8/15/2010. He stated that opening the door and rechecking the temperature was not an adequate solution to the problem of temperatures that were out of range. He stated that he felt that nursing staff should not intervene to fix the warmer temperatures, that they should contact the Engineering Department when they found an out of range temperature. He stated that the Engineering Department provided coverage for the hospital 24 hours a day, seven days a week.

In all cases, after closing the door the temperature returned to a level above that defined as "safe" in the hospital policy by the next day. The engineer was called on two out of five days. There was no standard provided to staff in the policy that indicated when staff could know when their actions had failed so that they could consistently call the engineering department.


2. On 8/17/2010 at 1:46 p.m. an inspection of the OR #1 Warmer indicated that the top compartment contained nine1000 ml plastic pour bottles (PPBs) of NS for irrigation, eight PPBs of sterile water for irrigation, and three 1000 ml IV bags of lactated ringers. On the label of the plastic pour bottles (PPB) staff had written the date the solution was put into the warmer and the date it would expire (14 days later). Staff had put similar dated labels on the overwrap bag in which the manufacturer put the 1000 ml IV bags. All the solutions were manufactured by Baxter Healthcare Corporation.

The dates on the NS PPBs were:

8/12 (date in) and 8/26 (exp date): one bottle
8/13 (date in) and 8/27 (exp date): three bottles
8/16 (date in) and 8/30 (exp date): five bottles

The dates on the sterile water PPBs were:

8/12 (date in) and 8/26 (exp date): two bottles
8/13 (date in) and 8/27 (exp date): four bottles
8/16 (date in) and 8/30 (exp date): two bottles

The dates on the lactated ringers IV bags were:

8/12 (date in) and 8/26 (exp date): one bag
8/13 (date in) and 8/27 (exp date): one bag
8/16 (date in) and 8/30 (exp date): two bags

A review of the August temperature logs (one for the period 8/1 through 8/9/2010 and one for the period 8/10 through 8/17/2010) indicated the following temperatures on the following dates:

8/12: 109.4 degrees Fahrenheit
8/13: 110 degrees Fahrenheit
8/14: 112.9 degrees Fahrenheit
8/15: 110 degrees Fahrenheit
8/16: 109.6 degrees Fahrenheit

On 8/18/2010 a review of a letter from Baxter (dated 9/23/2008) to the hospital indicated it documented the following:

a. Irrigation solutions in plastic pour bottles can be warmed to 104 degrees Fahrenheit for 30 days and to 150 degrees Fahrenheit for 72 hours.

b. Large volume IV solutions can be warmed to 104 degrees Fahrenheit for 14 days.

On 8/18/2010 a review of policy and procedure PC.PCS. 134 entitled Blanket, IV Fluid and Irrigation Solution Warming indicated it documented all solutions were to be re-dated to expire within 48 hours if the warmer temperature fell between 104 and 150 degrees Fahrenheit.

None of the solutions had been re-dated as stipulated in the policy. Baxter made no provision for storage of it's IV solutions above 104 degrees and therefore, these would have needed to be discarded, not re-dated.

Based on inspection two out of seven warmers in the Modesto Campus Surgery Department the hospital failed to ensure that IVs were stored according to the manufacturer's specifications and irrigation solutions were removed when expired in one warmer (Operating Room #1 Warmer) which rendered them unusable for patient use.

Findings:

On 8/17/2010 at 1:46 p.m. an inspection of the OR #1 Warmer indicated that the top compartment contained nine1000 ml plastic pour bottles (PPBs) of NS for irrigation, eight PPBs of sterile water for irrigation, and three 1000 ml IV bags of lactated ringers. On the label of the plastic pour bottles (PPB) staff had written the date the solution was put into the warmer and the date it would expire (14 days later). Staff had put similar dated labels on the overwrap bag in which the manufacturer put the 1000 ml IV bags. All the solutions were manufactured by Baxter Healthcare Corporation.

The dates on the NS PPBs were:

8/12 (date in) and 8/26 (exp date): one bottle
8/13 (date in) and 8/27 (exp date): three bottles
8/16 (date in) and 8/30 (exp date): five bottles

The dates on the sterile water PPBs were:

8/12 (date in) and 8/26 (exp date): two bottles
8/13 (date in) and 8/27 (exp date): four bottles
8/16 (date in) and 8/30 (exp date): two bottles

The dates on the lactated ringers IV bags were:

8/12 (date in) and 8/26 (exp date): one bag
8/13 (date in) and 8/27 (exp date): one bag
8/16 (date in) and 8/30 (exp date): two bags

A review of the August temperature logs (one for the period 8/1 through 8/9/2010 and one for the period 8/10 through 8/17/2010) indicated the following temperatures on the following dates:

8/12: 109.4 degrees Fahrenheit
8/13: 110 degrees Fahrenheit
8/14: 112.9 degrees Fahrenheit
8/15: 110 degrees Fahrenheit
8/16: 109.6 degrees Fahrenheit

On 8/18/2010 a review of a letter from Baxter (dated 9/23/2008) to the hospital indicated it documented the following:

a. Irrigation solutions in plastic pour bottles can be warmed to 104 degrees Fahrenheit for 30 days and to 150 degrees Fahrenheit for 72 hours.

b. Large volume IV solutions can be warmed to 104 degrees Fahrenheit for 14 days.

The PPB solutions that had been put into the warmer on 8/12 and 8/13/2010 would have expired by 8/15 and 8/16/2010 respectively. The IV solutions were stored outside of the manufacturer's recommendations and should have been removed from active stock on the first day, 8/12/2010, that the temperature was elevated.

Based on observation, interview and document review the hospital failed to:
1. Correctly implement the physician's fluid restriction order for patient 5
2. Clarify Resident 8's tube feeding order to include a total volume rate and did not follow the physicians's present order as written.
3. Clarify Resident 11's tube feeding for the rate and/or frequency of advancement of the feeding.

Findings:

Patient 5 was admitted with diagnoses including congestive heart failure and had physician's diet order including 1200 ml fluid restriction. On 8/17/10 at 1:00 p.m. during observations of lunch tray delivery, it was observed Patient 5 had spaghetti noodles with meat sauce, diet pudding, an 8 ounce can of diet cola, and a sealed clear plastic cup of canned mandarin oranges in liquid.
Concurrent observation of the meal tray card revealed the order for the 1200 ml total daily total fluid restriction and information that the current tray provided 8 ounces of liquid. When asked by the surveyor about the fluid in the mandarin oranges, Dietary Supervisor Staff D stated the tray came up right and no fluid would ever be drained "on the floors."

At 1:10 p.m. during an interview in the diet office, Dietary Staff E provided the 9/10/02 hospital "Fluid Restriction Procedure." The procedure did not identify canned fruits in liquid as a source of fluids. Additionally, DS E stated "We only count fluids when the patient asks for them. That patient didn't select them meal. The "system" (menu system) knows how much the patient gets." At 1:15 p.m. DSS D drained the fluid from a plastic cup of mandarin oranges identical to the one the patient received and determined that there was approximately two ounces of fluid provided.

At 1:20 p.m. during an interview, Registered Dietitian F observed the liquid drained from the mandarin oranges and stated "that could really add up." Upon review of the Fluid Restriction Procedure, RD 4 stated the lunch tray should have provided only 240 mls and that for the entire day dietary was allowed 720 mls total from all meals and nursing was allowed the remaining fluids to give to the patient so that the entire day was only 1200 mls. At 1:30 p.m. HDMS C acknowledged the fluid restriction procedure had failed to ensure the physician's fluid restriction orders would be complied with by the dietary department.

2. Patient 8 was admitted with diagnoses that included pneumonia. Medical record review was conducted on 8/17/10 beginning at 11:40 am. A physicians' order dated 8/16/10 noted an order for Crucial (a nutritional supplement) via tube feeding at a rate of 10 cc's/hour; increase by 10 cc's every 6 hours if tolerated. There was no final goal rate established. It was also noted that nursing staff failed to clarify the order.

Observation of Patient 8 on 8/17/10 at 12:15 pm, revealed that the patients' pump was set at a rate of 40 cc's/hour. Concurrent review of the daily flow sheet dated 8/17/10 revealed that on 8/17/10 at midnight nursing staff initiated the tube feeding at 20 cc's hour. The feeding was advanced to 30 cc's/hour on 8/17 at 4 am and to 40 cc's/hour at 8 am. In addition to the lack of final goal rate it was also noted that nursing staff advanced the feeding every 4 hours rather than following the physicians' orders of advancing every 6 hours.

In a concurrent interview with RN 2 the surveyor asked her to describe how nursing staff would ensure that physicians' orders were both complete and were followed. She stated that it was the responsibility of the nurse ending her shift to report to the nurse assuming the care of the patient to review all physicians' orders.

Hospital policy titled Enteral Feeding Management, dated 8/28/08 guided nursing staff to "verify physicians' orders for formula, rate, route and frequency."

3. Patient 11 was admitted with acute respiratory failure and severe hypoxia due to pneumonia. The physician diet order dated 8/15/10 revealed an order for tube feeding of Peptamin starting at 15 cc's/hour with a final rate of 90 cc's/hour. There was no guidance for nursing staff for the rate and/or frequency of advancement of the feeding.

Medical record review was conducted on 8/17/10 beginning at 2 pm. Review of nursing flow sheet noted that the feeding was implemented on 8/15/10 at 12 pm at a rate of 15 cc's. The feeding was advanced to 30 cc's at 6 pm; to 45 cc's at 11 pm; to 55 cc's on 8/16/10 at 2 am; to 70 cc's at 4 am and to 75 cc's at 5:15 am. There was no documentation that nursing staff clarified the diet order.

Hospital policy titled Enteral Feeding Management, dated 8/28/08 guided nursing staff to "verify physicians' orders for formula, rate, route and frequency."

Based on observation, interview and document review, the hospital failed to:
1. Store cold foods following scientific safe food handling guidelines from their reference the 2009 Federal Food Code.
2. Utilize the appropriate cleaning solution for the ice machines.
3. Develop a preventative maintenance program to ensure that the floor drains were kept clean.

Findings:


On 8/16/10 during cafeteria observations between 12:15 p.m. and 1:15 p.m. the following was observed in the walk-in refrigerator:

1. A plastic container one-half full of canned sliced peaches dated 8/10 and 8/18. During a concurrent interview, Dietary Management Staff A stated the first date was when the peaches were transferred from an open can, and the last date was the expiration date. On 8/18/10, the hospital provided the undated "Refrigerated Storage Life of Food" that revealed maximum storage of opened canned fruits is five days.
2. A 20 pound box of opened raw hamburger slabs dated 8/13 and 8/19. Hospital Refrigerated Storage Life list revealed maximum storage of five days.
3. Approximately 30 undated thawed chicken breasts that had been taken out of the original package and put in zip lock bags, and in a 12 inch deep steam table pan. Maximum refrigerated storage was 3 days.
4. Feta cheese out of the original package and in a plastic covered container dated 8/10 and 10/10. Maximum storage per Hospital Refrigerated Storage Life once opened was one week.

On 8/18/10 at 10:00 a.m. during an interview, Hospital Dietary Management Staff C acknowledged cafeteria staff had not followed safe food handling procedures per their own policy.

On 8/16/10 at 2:00 p.m. Cafeteria Staff B was observed cutting melons and during a concurrent interview stated part of the duties for her position that day was to set up the salad bar items and then to regularly check them during the service hours and replenish as needed. CS B stated she used her personal judgment in preparing foods for the salad bar, and that she regularly added vegetables to containers of vegetables already in service, but would always throw away the prepared salads such as tuna salad, eggs, and use fresh prepared if more were needed during the meal service hours. Review of the undated hospital-provided policy Food Handling Guidelines (HACCP= Hazard Analysis Critical Control Point) for Cold Holding directed "Do not combine freshly prepared food with foods being held for service." Additional interview revealed CS B took food temperatures at the start of service and then at the end of service, approximately four hours later. This was confirmed during review at 2:15 p.m. of the "Salad Bar/Deli Holding Log dated 8-16-10 that revealed temperatures of the foods had been taken at "Beginning Service" but no temperatures had been taken since that time. CS B stated she would take temperatures about "2:30 or 3:00." Review of the Cold Holding policy revealed staff should "Record internal temperatures every two hours."

Further review of the The Salad Bar/Deli Holding Log directed that food below 55 degrees at the end of service could be frozen or refrigerated in shallow plans and then re-used. According to the Federal Food Code 2009, cold food must be kept at 41 degrees or below. During a concurrent interview, DMS A stated that was the policy of the cafeteria management. At 2: 20 p.m., Hospital Dietary Management Staff C acknowledged the Federal Food Code did not have a reference for the cafeteria action to freeze or refrigerate foods held at 55 degrees.

2. On 8/16/10 at 11:40 am, in an interview Engineering Staff (ES) 1 the procedures for ice machine maintenance were reviewed. The surveyor asked that he describe the cleaning process. He stated that on a monthly basis he utilized an ice machine cleaner after which he utilized a sanitizing solution. He stated that both of these chemicals were flushed through the system as well as the ice holding bin.

Concurrent review of the ice machine cleaner revealed that it was an ice machine de-scaling product. The surveyor also asked ES 1 to demonstrate the sanitizing solution that was used. He stated that the solution was obtained from housekeeping; however there currently was no supply within the hospital. The surveyor requested a product specification for the chemical.

On 8/18/10 at 10 am, the hospital presented a Material Safety Data Sheet for "Pure Bright Bleach." While the hospital submitted an MSDS for the product Engineering Staff was unable to demonstrate the product was safe for food contact surfaces. Review of the product specification obtained by the surveyor, via the intranet (hospaa.org, 2010), revealed that the product was a detergent free cleaner/bleach intended to be used for cleaning environmental surfaces in patient rooms. There was no documentation that this product would be appropriate for use on food contact surfaces.

3. On 8/16/10 at 11:40 am, during review of ice machine maintenance, in the 3rd floor pantry, the surveyor asked ES 1 to remove the plate covering the plumbing. Once the plate was removed it was noted that the drain hose from the ice machine was resting directly on the grate of the floor sink. It was also noted that there was a black-grey slimy as well as a black dirt-like substance on the grate and in the floor sink. In a concurrent interview with ES 1 he was asked how long ago the floor sink was cleaned, to which he replied "3 months ago." He also stated that the cleaning of the floor sink was part of the regular preventive maintenance of the ice machines.

Review of undated hospital document titled "Detailed Data Manager Listing for Tasks" which described maintenance steps for the ice machine revealed there were annual and quarterly tasks to be complete; however the cleaning of the floor sinks was not listed on either the quarterly or annual maintenance instructions.







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Based on interviews and review of the facility P&P and POC, the ED failed to follow their P&P, or develop a process that would ensure that the splints applied to in-house patients by non-licensed ED staff were monitored with the same parameters as an ED patient.Findings:On 8/17/10 at 9:40 a.m., an interview was conducted with one of the non-licensed staff (ED tech) in the ED. The ED tech stated that all non-licensed staff at both hospitals had been in-serviced about the new splinting process. The ED tech stated that now there had to be a physician's order entry before he could apply any splint. The ED tech went on to say that he enters the type of splint that he applied in the, "notes" section of the medical record. The ED tech stated that he also ensures that the ordering ED physician reassesses the splint and documents that reassessment in the medical record. The ED tech stated that all of these steps were part of the department's new P&P. During the interview, the ED tech stated that he has, on occasion, been sent to the in-patient area to apply a splint on an admitted patient. The ED tech stated that there is no orthopedic coverage after 5:00 p.m. and that he has gone up and applied a splint if there was an order. The ED tech was asked if that was part of the new ED process and he stated, "No." The ED tech stated that if the ordering physician is on the unit, he will ask him to check the splint, otherwise, the nurse can contact the hospitalist to check the splint. The ED tech was asked if the physician's document the reassessment in the chart and stated that he was not sure and that he (ED tech) did not enter the type of applied splint into an admitted patient's medical record. An interview was conducted with the ED manager (EDHN) at 10:05 a.m. The EDHN was asked if the ED tech's applied splints to in-house patients and she stated, "No." The EDHN was told that the ED tech stated he had applied splints to in-house patients and she stated that she was unaware that this was occurring. A follow-up interview was conducted with the on-duty assistant department manager, (ADM) at 10:10 a.m. with the EDHN. The ADM was asked if the ED techs were putting splints on in-house patients and she stated, "It has happened, but I have not personally sent anyone up." The ADM stated that there was no formal monitoring process like the ED's and that it would be the responsibility of the admitted patient's primary nurse to get a physician to reassess the splint. The ADM did not know if the in-house staff were aware that they needed to do this. The EDHN was asked in the presence of the QIMD and CNO if the hospital could produce the charts of the splinted in-house patients to see if those patients had been reassessed after the splint placement and the QIMD stated that they could not produce the charts. A review of the P&P titled, "Splinting of Extremities in the Emergency Department", (effective date 6/30/10) indicated that there must be documentation of the type of splint that was applied and a documented pre and post assessment of the splinted extremity by a physician.