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Based on record review, review of policy and procedure and interview, the hospital failed to assess a pressure ulcer on admission and notify the physician of the pressure ulcer for one (Patient #8) of one patient reviewed with pressure ulcers. The sample size was 41 patient records. The hospital's active census at the time of the survey was 401.
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Findings include:

The medical record of Patient #8 was reviewed on 11/06/13. Patient #8 was admitted on 11/03/13 with a primary diagnosis of dehydration. The admission assessment was completed on 11/03/13 at 7:32 PM. This assessment specified Patient #8 had three Stage III (full thickness skin loss) pressure ulcers located on the bilateral hips and buttocks. on admission. The record lacked evidence of wound measurements, physician notification or wound treatment orders.

Interview with Staff Y on 11/06/13 at 2:45 PM confirmed there was no measurement of the pressure ulcers and no documentation the physician was notified of the Stage III pressure ulcers on admission.

Further review of the adult assessment flowsheet indicated the first assessment of the pressure ulcers was on 11/05/13 at 8:00 AM, 36 hours after admission. This assessment revealed one pressure ulcer was on the gluteal/coccyx area and measured 2 centimeters (cm) by 2 cm by 0.5 cm. The stage of the pressure ulcer was not documented.


Hospital policies were reviewed for Wound Prevention Protocol and Wound Care Treatments. The Wound Prevention protocol specified the registered nurse (RN) was responsible for obtaining a physician's order for wound care. Review of the procedure for Wound Care Treatments indicated the responsibility of the RN was to assess all wounds for location, color, measurements and drainage. The Wound Prevention policy indicated all patients will have a skin assessment completed within 24 hours of admission.

Interview with Staff X on 11/07/13 at 8:05 AM revealed the Wound Care Clinician was notified on 11/06/13. Staff X indicated the Wound Care Clinician notified the physician on 11/06/13 at 4:07 PM for wound treatment orders three days after admission.

Based on observation and staff interview, the facility failed to protect medical records from potential water damage in the event the sprinkler system was engaged due to fire or smoke. This had the potential to affect all patients receiving outpatient services from the Orthopedic Clinic and the Psychiatric Intensive Outpatient Clinic at this facility. Six hundred ninety four patients were treated in the Orthopedic Clinic this year and 450 patients were treated in the Psychiatric Intensive Outpatient Clinic this year.

Findings include:

During tour of the Orthopedic Clinic on 11/05/13 from 3:40 PM until 4:00 PM, paper medical records were observed on open shelving units for storage. Staff F verified at 4:00 PM that the shelving units contained the patients' medical records for 2013 and were open with no mechanism for covering the medical records or closing up the shelves. Staff F also verified the entire room contained sprinklers that would be activated in the event of a fire.

During tour of the Psychiatric Intensive Outpatient Clinic on 11/06/13 from 3:00 PM until 3:30 PM, paper medical records were observed on open shelving units for storage in the secretarial office and active medical records were observed on open carts in a secured room in the clinic. Staff G verified at 3:25 PM, that the medical records on the open shelving in the secretarial office were the discharged records for this year and the medical records on the open carts were the current active medical records. Staff G stated the open carts of medical records were locked in the counselors offices after hours. In addition Staff G stated the secretarial office and the counselors offices contained sprinklers and the shelving and carts were open with no mechanism for covering the medical records or closing up the shelves.

Based on policy review, staff interview, review of temperature logs, and review of meeting minutes the facility failed to ensure medications were stored at a safe temperature (A491) and failed to ensure outdated medications were not available for patient use (A505). The cumulative effect of these systemic practices resulted in the facility's inability to ensure medications would be administered safely to patients.

Based on staff interview, documentation review and and meeting minutes review, the facility failed to ensure medications were stored and monitored at safe temperatures. This affected four out of nine medication refrigerators reviewed (7 West and 7 East location, Pharmacy at St Thomas) and and six of six patients reviewed at Summa Lake Medina Emergency Department) who received medications and has the potential to affect all patients at this facility. The facility's active census at the time of survey was 401.

Findings include:

1. An off-site visit was made to Summa Health Care Systems Lake Medina Emergency Department on 11/08/13 at 8:45 AM. A review of the electronic medication dispensing machine revealed the medication temperatures are monitored by an internal electronic temperature monitoring system.

Review of the medication temperature log revealed from 10/30/13 to 11/02/13 the average temperatures were noted to be below the alert limit of 35 degrees F. On 10/30/13 the temperature log average in the morning was 31.9 F below freezing. There was no evidence to support action taken for the reading below the alert range. Interview on 11/08/13 at 10:55 AM with Staff C confirmed this finding. Interview of Staff B on 11/08/13 at 3:15 PM revealed that medications were not cold enough to freeze therefore no action was needed.

On 11/12/13 a list of medications removed from the electronic dispensing machine during 10/30/13 to 11/02/13 when temperatures were below the alert limit was reviewed. The medications were identified as Insulin, Lorazepam injection, Famotidine injection, Influenza vaccine and Penicillin G benzathine. Patients A, D, E, F, G and H were identified as receiving medications during this time frame.

Staff C confirmed on 11/08/13 at 10:50 AM no alerts were issued from 10/30/13 thru 11/02/13 for continuous temperatures below 35 degrees Fahrenheit and was unaware of these low temperatures. Further review of a historical alert report revealed the last alert from the Medina medication temperature alarm system was on 01/15/2013. Staff W was interviewed on 11/12/13 at 10:25 AM and stated the alarm on 01/15/13 was acknowledged by staff but not cleared until 11/06/13 therefore no alarms were triggered for this 10 month period.


Pharmacists (Staff A and Staff B) were interviewed on 11/08/13 at 1:30 PM. Both Staff A and B revealed the action to be taken if an alarm was received for possible frozen medications was to assume the medications were frozen, research each medication for stability and safety from the manufacturer then discard if needed.

A review of the Refrigerator Monitoring policy Staff C presented on 11/08/13 at 9:30 AM as the policy used for the internal electronic temperature monitoring system revealed all drug refrigerators will be maintained at 36 degrees to 46 degrees Fahrenheit to maintain the strength and potency and avoid contaminants. If the temperature is not within these parameters, it should be rechecked in one hour. The new temperature should be recorded on the chart indicating second reading. The Facilities Engineering Department will be notified immediately whenever the temperature is not within these parameters on the second measure.



The Unit Director of the Emergency Department (Staff D) was interviewed per phone on 11/08/13 at 9:15 AM and stated the internal electronic temperature monitoring system has been in use since 2011. Staff D stated the temperatures are not checked by the facility's staff, only by the Temp Trak system.


Staff E was interviewed on 11/04/13 at 4:30 PM and stated Project Management is working on the internal electronic temperature monitoring system project. Staff E also confirmed current oversights of the temperatures have not been done.

A review of the Pharmacy Temperature Monitoring policy, also used for theinternal electronic temperature monitoring system per Staff C revealed refrigerators not monitored by the electronic system will be monitored manually by staff daily.


2. A tour of 7 West, the pulmonary unit at Akron City Hospital (ACH), on 11/04/13 at 2:25 PM revealed the medication refrigerator temperature log from 10/19/13 to 10/23/13(five days) had a constant temperature of 50 degrees Fahrenheit with no documentation the out of range temperatures were rechecked or maintenance or pharmacy notified. This was confirmed by Staff V on 11/04/13 at 2:30 PM. The log revealed the acceptable range was 36 to 46 degrees F.

3. A tour of the pharmacy department at St Thomas Hospital on 11/05/13 at 1:20 PM included a review of the medication refrigerator temperature log dated 01/01/13 to 11/05/13. Review of this log revealed many blanks with an average of seven missed daily temperatures per month with no documented temperatures available from 01/01/13 to 01/13/13. This was confirmed by the assistant director of pharmacy (Staff U) on 11/05/13 at 1:55 PM. The log revealed the acceptable range was 36 to 46 degrees F.


4. A review of the October temperature log for the medication refrigerator, located on the Main 7 E unit at St. Thomas Hospital, revealed on 10/11/13 the temperature was out of range at 31 degrees Fahrenheit . No documentation was found to support the temperature was rechecked or action taken. This was confirmed by the Unit Director (Staff Q) on 11/06/13 at 3:40 PM. The log revealed the acceptable range was 36 to 46 degrees F.

Based on observation, interview and policy review, the facility failed to ensure outdated insulin medications were not available for patient use on one (Second Floor Intensive Care Unit) of three intensive care units surveyed. This had the potential to affect all patients who receive insulin.

Findings include:

A tour of the second floor intensive care unit was completed on 11/04/13 at 5:05 PM. A unopened box that contained a multi dose vial of Humalog Mix 75/25 ( a medication to lower blood sugar) lot # A907649A with an expiration date of 07/2013 and an unopened box that contained a multi dose vial of Humulin (a medication to lower blood sugar)70/30 lot # A833664C with an expiration date of 12/2012 were observed in a medication refrigerator in Medication Room B.

The findings were shared with Staff Z on 11/04/13 at 5:05 PM and confirmed.

On 11/5/13 at 12:58 PM, the facility's Pharmacy Areas - Medication Expiration Check policy was reviewed. The policy stated all medications will be inspected regularly to ensure expired medications are quarantined from usable stock. The policy stated all medications with less than three months until expiration will be quarantined in the expired medication cabinet to be picked up by a reverse drug distributor.

On 11/05/13 at 12:58 PM, the facility's Nursing Units Inspection policy was reviewed. The policy stated pharmacy staff will examine the nursing units on a regular basis for outdated medications and will remove any outdated medications.

Based on interview, record review, and observation, it was determined the facility's physical environment for buildings 9 of 9 was not maintained in a manner to ensure the safety of patients. The facility failed to maintain a two hour fire wall between buildings, failed to ensure exit signs were intact, failed to maintain smoke barriers from penetrations, failed to ensure areas enclosed with a one hour fire-rated barrier were free from penetrations, failed to ensure fire rated door labels were present and legible, failed to ensure exit access was arranged so exits were accessible, failed to ensure smoke detectors were at least 36 inches from sources of air ventilation, failed to ensure sprinkler heads were maintained, failed to ensure medical gas storage door was self closing, failed to maintain smoke detector sensitivity reports, failed to ensure quarterly testing of the sprinkler system, failed to ensure transfilling of oxygen was done in a fire protected area, failed to ensure mobile trash receptacles were located in a protected room, failed to perform battery back up lighting testing, and failed to ensure fire rated doors closed and were free from gaps in excess of 1/8 inch. The cumulative effect of these systemic practices resulted in the facility's inability to ensure the safety of all patients in the facility.

Findings include:

Refer to A 710 for findings during the survey visit of 11/04/13 through 11/14/13.

Based on interview, record review, and observations, the facility was not maintained in a manner safe from fire for buildings 9 of 9. This has the potential to affect all patients in the facility.

Findings include:

During the life safety code survey with facility staff on 11/04/13 through 11/14/13 the following findings were noted:

Please refer to life safety code findings at:

Kll Failed to maintain a two hour fire wall between buildings
K22 Failed to ensure exit signs were intact
K25 Failed to maintain smoke barriers from penetrations
K29 Failed to ensure areas enclosed with a one hour fire-rated barrier were free from penetrations
K33 Failed to ensure fire rated door labels were present and legible
K38 Failed to ensure exit access was arranged so exits were accessible
K52 Failed to ensure smoke detectors were at least 36 inches from sources of air ventilation
K62 Failed to ensure sprinkler heads were maintained
K76 Failed to ensure medical gas storage door was self closing
K130 Failed to maintain smoke detector sensitivity reports, failed to ensure quarterly testing of the sprinkler system, failed to ensure transfilling of oxygen was done in a fire protected area, failed to ensure mobile trash receptacles were located in a protected room, failed to perform battery back up lighting testing, and failed to ensure fire rated doors closed and were free from gaps in excess of 1/8 inch.

Based on policy review, staff interview, review of temperature logs and project management meeting minutes the facility failed to ensure patient food temperatures were maintained safely. This affected six out of twelve patient food refrigerators observed and had the potential to affect all patients receiving food from these refrigerators. (7 West, two on Center 5, Main 7 East and Dietary refrigerators #4 and D at St Thomas Hospital. The facility active census at the time of survey was 401.

Findings include:

1. Tour of 7 West, the pulmonary unit at Akron City Hospital, on 11/04/13 at 2:25 PM revealed the patient food refrigerator temperature was observed to be below range at 30 degrees F and confirmed by Staff V. Review of the temperature log revealed the acceptable food temperature range was pre-printed on form as 34 to 38 degrees F. The refrigerator contained juice, jello and pudding products.

Interview of the Unit Director (Staff V) at 2:27 PM on 11/04/13 revealed the temperatures are recorded in the morning.

A review of the October temperature log for this refrigerator revealed nine temperatures below 34 degrees F (28 to 32 degrees F) without documentation of any recheck of temperatures or notification to the facilities engineering department. This was confirmed by Staff V on 11/04/13 at 2:45 PM.

2. A review of the October temperature log for the patient food refrigerator, located on the Main 7 E unit at St. Thomas Hospital, revealed on 10/10/13 the temperature was out of range at 40 degrees F with the acceptable range listed as 34 to 38 Degrees F. No documentation was found to indicate the temperature was rechecked or action taken. This was confirmed by the Unit Director (Staff Q) on 11/06/13 at 3:45 PM.

3. A review of the temperature log for the patient food (refrigerator #4), located in the Dietary Department at St. Thomas Hospital, revealed five temperatures above 40 degrees F from 11/01/13 to 11/05/13 and 22 temperatures above 40 degrees F from 10/01/13 to 10/31/13. No documentation was found of action taken. Staff S confirmed this finding on 11/06/13 at 11:15 AM.

On 11/06/13 at 11:30 AM refrigerator D had a sign "called for service." The temperature log for 11/06/13 did not have a temperature recorded. This refrigerator was observed to be in use at this time. No documentation was found to explain the need for service.

On 11/06/13 at 11:40 AM Staff E and Staff R both confirmed no oversight, monitoring or auditing had been done with the temperatures.

4. A review of the October and November temperature logs for the patient food refrigerator, located on the Center 5 Unit at St. Thomas Hospital, revealed five temperatures out of range (10/08/13, 10/15/13, 10/22/13, 11/01/13 and 11/03/13) with no documentation of temperature recheck as required per policy. This was confirmed by Staff J on 11/06/13 at 5:30 PM.

A review of the October temperature log for a second refrigerator (Stabilization Food Refrigerator) revealed eight temperatures below the range 34 to 38 degrees F with no documentation of recheck. Documentation revealed maintenance was notified 13 times at the bottom of the log. The unit manager (Staff H) and Staff I were interviewed on 11/07/13 at 11:15 AM and both confirmed there was no documentation maintenance responded. Staff H was unaware if any maintenance visits were made. Staff E confirmed on 11/07/13 at 11:20 AM there are no maintenance logs of visits to the units.

A review of the Refrigerator Monitoring policy revised 11/11/2011 revealed patient food refrigerators will be maintained at 36 to 41 degrees F. If the temperature is not within these parameters, it should be rechecked in one hour. The new temperature should be recorded on the chart indicating second reading. The Facilities Engineering Department (maintenance) will be notified immediately whenever the temperature is not within these parameters on the second measure.