HospitalInspections.org

Based on observation, document review, manufacturer's manual review and interview, the facility failed to ensure that defibrillators were discharged as the manufacturer requires in 3 areas toured (ED [emergency department], Med/surg, and ICCU [intensive/coronary care unit]).

Findings:
1. at 4:45 PM on 11/30/10, review of the Philips HeartStart XL instruction manual (copyright 2006), indicated:
a. in section 11. "Maintaining the HeartStart XL, it reads in section 11-2 under "Operations Checks": "...Every Shift: Perform a 'Shift/System Check' every shift to verify that the HeartStart XL is functioning properly and to ensure..."

2. at 2:30 PM on 11/29/10, while on tour of the ED in the company of staff members NB and NF, it was observed that the "Cash Cart Inspection" form (which includes a defibrillator check), was lacking a check by either shift on 11/1/10 and was lacking a day shift (12 hour shifts) check on 11/7/10; 11/9/10; 11/16/10 through 11/20/10, 11/22/10 and 11/23/10

3. at 2:30 PM on 11/30/10, while on tour of the Med/surg nursing unit in the company of staff members NB and NJ, it was observed that the "Cash Cart Inspection" form was lacking a check by any shift on: 11/7/10, 11/11/10, 11/14/10, 11/19/10 and 11/24/10 and lacking a check by two shifts on 22 days in the month of November and lacking one shift check on one day

4. at 3:00 PM on 11/30/10, while on tour of the intensive care unit, in the company of staff members NB and NJ, it was observed that the "Cash Cart Inspection" form was lacking a check by any shift on: 11/1/10, 11/4/10, 11/7/10, 11/10/10, 11/11/10, 11/19/10, 11/21/10, 11/23/10, 11/24/10 and 11/26/10 and was lacking two shift checks on 17 days and one shift check for 2 days in the month of November

5. interview with staff member NB at 8:50 AM on 12/1/10 indicated:
a. med/surg staff work 8 hour shifts
b. ED staff mostly work 12 hour shifts with some 8 hour shift personnel, as well
c. the crash cart checklist is printed for 3 shift checking
d. it was unknown that the manual for the Philips HeartStart XL required an every shift check of the defibrillator
e. it was thought that some of the days that are blank for the ICCU were days they were closed, but staff should have indicated the unit was closed and not left the area blank

Based on observation, review of preventative maintenance documentation, preventative maintenance schedules, policies and procedures, patient records and staff interview, the hospital failed to ensure patient care and laboratory equipment were maintained in accordance with policies and procedures for 18 of 18 pieces of equipment

Findings:

1. During tour of the laboratory and respiratory departments on 11-29-10 between 1:45 PM and 3:00 PM, the following was observed:
a. A Healthdyne Quantum 7700 Positive Pressure Portable Vent, asset tag number 2174; a Healthdyne Pressure Support Ventilator, model number 7700, asset tag number 2013; a Viasys VMax 777494 pulmonary function test machine, asset tag number 2007; a MaQuet Servo Ventilator, model number 6640440, asset tag number 2236; and a Quinton Q Stress Treadmill, asset tag number 1962 located in the respiratory department, available for use.
b. A cryostat located in the surgery department frozen section room, available for use.

2. Review of preventative maintenance documentation for the respiratory equipment on 11-3-10 between 2:00 PM and 2:30 PM indicated the respiratory equipment had preventative maintenance last performed on "12/5/09" and indicated the next preventative maintenance was due "6/10".

3. Review of the preventative maintenance schedule provided by the biomedical department on 12-1-10 between 2:00 PM and 3:25 PM indicated preventative maintenance on the respiratory equipment was scheduled every 6 months, June and December.

4. Policies and procedures for the preventative maintenance of respiratory equipment were requested on 12-1-10 between 11:15 AM and 11:38 AM and were not provided during survey.

5. Review of policies and procedures for the preventative maintenance of the cryostat on 11-29-10 between 3:00 PM and 5:00 PM indicated the following:
a. A policy/procedure titled: "Frozen Section Protocol", effective date unknown, last reviewed "10/10", read: "The Cryostat will be cleaned after each use..." and "The Cryostat...will be cleaned according to the Frozen Section Room and Cryostat Cleaning Procedure provided by South Bend Medical Foundation (SBMF)." and "Cleaning will be documented on the appropriate checklist provided by SBMF." and "The cryostat will be shut down for defrosting every 3-4 weeks..."
b. A policy/procedure titled: "Frozen Section Room and Cryostat Cleaning", effective and last review date unknown, read: "Daily Cleaning Tasks (or when used)...Wipe the exterior of the cryostat with hypochlorite...Internal cleaning and decontamination of the cryostat will be done weekly or as needed." and "Record the temperature each day of use..."
c. A document titled: "Cameron Hospital Frozen Section Room Check Sheet", read: "Document each day of use...Clean working surface of cryostat...Record temperature of cryostat..." and "Vacuum cryostat (to be done twice monthly)..." and "Disinfect cryostat (monthly)."

6. Review of the "Frozen Section Room Cleaning" log for the months of August through date of survey, on 11-29-10 between 11:45 AM and 2:30 PM and review of patient records on 12-1-10 between 12:00 PM and 12:20 PM indicated the following:
a. The cryostat monthly decontamination was performed on the following dates: 9-20-10 and 11-11-10.
b. The cryostat weekly vacuuming was performed on the following dates: 9-14-10, 11-11-10 and 11-23-10.
c. The following patients had frozen sections performed, as indicated, when the daily cleaning and/or cryostat temperature had not been documented:

Patient Date Cleaning Temp.
______________________________________
L32 10-15-10 N Y
L33 10-15-10 N Y
L34 10-6-10 N Y
L37 9-1-10 N Y
L38 8-30-10 N N

Temp. - Temperature; N - "no", task was not performed on that date; Y - "yes", task was performed on that date

7. In interview on 11-30-10 between 11:20 AM and 12:00 PM, Staff Member #L33 acknowledged respiratory equipment preventative maintenance was last performed on 12-5-09 and conveyed the above mentioned equipment should have preventative maintenance performed every 6 months.

8. In interview on 11-29-10 between 1:45 PM and 3:00 PM, Staff Member #L3 acknowledged the cryostat maintenance had not been documented in accordance with policies/procedures.

9. On 11-29-10 employee #A8 was requested to provide documentation of preventive maintenance on a newborn bed, overhead adjustable surgery lights, parallel bars and stair step located in Physical Therapy and a C-arm located in surgery. No documentation was provided prior to exit.

10. At 2:00 PM on 11/29/10, while on tour of the ED (Cardiac room #1) in the company of staff members NB and NF, it was observed that:
a. one I/V (intravenous) pump with asset tag number A 2154 last had preventive maintenance performed on 12/5/09 and was due for the next preventive maintenance on 6/10
b. one overhead pull down/surgical type light with asset tag number A 1704 was due for preventive maintenance 6/10
c. one Philips HeartStart XL defibrillator had a tag indicating the last PM (preventive maintenance) was done 12/5/09 with the next date due of 6/10

11. At 1:40 PM on 11/30/10, while on tour of the OB unit in the company of staff members NB and NI, it was observed in LDR (Labor/Delivery Room) A and the Medication room that:
a. the overhead pull down/surgical type light last had PM done 3/10 and was due for PM on 8/10
b. a new "Panda" baby warmer was attached to the wall above the infant crib unit and was lacking any indication of preventive maintenance check
c. I/V pump, with asset tag number A 1927, last had PM checks done 2/1/10 and were due for PM on 8/10

12. Interview with staff member NI at 1:45 PM on 11/30/10 indicated:
a. the "Panda" warmer unit was "just hung about 2 weeks ago"

13. At 2:00 PM on 11/30/10, while on tour of the newborn nursery in the company of staff members NB and NI, it was observed that:
a. the "Panda" warmer last had PM checks done 2/10 and were due for the next PM on 8/10

14. Interview with staff member NK at 8:30 AM on 12/1/10 indicated:
a. there is no policy and procedure related to various pieces of equipment and their preventive maintenance needs/schedules
b. the facility has scheduled times for PM on its equipment which is every 6 months for every piece of equipment, but no policy as such

15. Review of the "Bio-Medical Checklist" for June and December at 11:05 AM on 12/1/10 indicated:
a. RT (respiratory therapy), PT(physical therapy)...and Cardiac Rehab departments are done these months

16. Review of the "Bio-Medical Checklist" for February and August at 11:05 AM on 12/1/10 indicated:
a. surgery department equipment is done during these months

17. Interview at 11:10 AM on 12/1/10 with staff members NK and NL indicated:
a. all equipment has PM done every 6 months at this facility
b. staff is behind in accomplishing PM duties due to extra time needed in preparing for future building plans





19814




20625

Based on observation, review of the Indiana Sanitary Standards for the Operation of Retail Food Establishments, patient care refrigerator temperature documentation, pantry logs, policies and procedures, and staff interview, the hospital failed to ensure temperature control for food storage in patient care refrigerators for two of three patient care areas of the hospital where food items were stored and the pharmacy failed to ensure the appropriate storage of drugs and immunizations in the off site urgent care center.

Findings included:

1. During tour of the patient care areas on 11-30-10 between 3:30 PM and 4:30 PM and on 12-1-10 between 11:38 AM and 12:00 PM, the following were observed:
a. In the obstetrics unit patient care refrigerator, the alcohol thermometer used to record the refrigerator temperature contained a bubble in the alcohol, resulting in inaccurate temperature readings.
b. The temperature reading on the thermometer in the medical/surgical unit patient care refrigerator was 44 degrees Fahrenheit. Temperatures were obtained for the following potentially hazardous food items (as defined by 410 IAC 7-24, Indiana Sanitary Standards for the Operation of Retail Food Establishments) observed in the medical/surgical unit patient care refrigerator: Milk, 46 degrees Fahrenheit; and Cream Cheese, 44 degrees Fahrenheit. Additionally, the following potentially hazardous foods were observed in the medical/surgical unit patient care refrigerator: 2 turkey sandwiches; yogurt, and cottage cheese.

2. Review of the Indiana Sanitary Standards for the Operation of Retail Food Establishments (410 IAC 7-24) during survey read: "...potentially hazardous food shall be maintained as follows...at forty-one (41) degrees Fahrenheit or less..."

3. Review of food pantry logs on 12-1-10 between 8:30 AM and 10:00 AM indicated the following:
a. The obstetrics unit routinely stored the following potentially hazardous foods in the patient care refrigerator: 6 single serving margarine packets; two half-pint containers of chocolate milk; four half-pint containers of whole milk; and two half-pint containers of skim milk.
b. The medical/surgical unit routinely stored the following potentially hazardous foods in the patient care refrigerator; 6 single serving margarine packets; 6 single serving butter packets; one half-pint container of chocolate milk; six half-pint containers of 2% milk; one half-pint container of skim milk; two turkey sandwiches; 2 slices of yellow cheese; and 2 single serving packages of string cheese.

4. Review of policies and procedures on 11-30-10 between 3:20 PM and 4:30 PM indicated a policy/procedure titled: "Refrigerator / Freezer Temperature Monitoring", last revised "1/10", which read: "Refrigerator/freezers utilized for food (patient and staff) outside of the Food Services Department..Monitor temperatures on a monthly basis in both the refrigerator and freezer compartments...Maintain refrigerator temperature below 45 degrees F and freezer below 5 degrees F."

5. Review of patient care refrigerator/freezer temperature documentation on 11-30-10 between 3:20 PM and 4:30 PM indicated temperatures were observed and documented monthly and:
a. Refrigerator temperatures were above 41 degrees Fahrenheit, as required by 410 IAC 7-24, as indicated:

Date Temp. OB Med./Surg.
________________________________
5-6-10 46 X
6-2-10 44 X
7-5-10 48 X
8-4-10 42 X
8-4-10 50 X
9-2-10 45 X

b. Freezer temperatures were above 5 degrees Fahrenheit, as required by approved policy / procedure, as indicated:

Date Temp. OB Med./Surg.
_________________________________
5-6-10 15 X
6-2-10 10 X
7-5-10 10 X
8-4-10 10 X
9-2-10 11 X
10-1-10 16 X
11-3-10 16 X

6. In interview on 11-30-10 between 3:30 PM and 4:30 PM, Staff Member #L34 acknowledged the above findings.

7. At 3:35 PM on 11/30/10, review of the policy and procedure "Refrigerator/Freezer Temperature Monitoring" with a last date reviewed of 1/12/10 indicated:
a. under "Policy", in section "2.", it read: "Refrigerator/freezers utilized for medications outside of the pharmacy: ...f. Maintain refrigerator temperatures between 36 and 46 degrees F (2-8 degrees C)..."

8. At 9:45 AM on 11/30/10, while on tour of the urgent care center in the company of staff members NB and NG, it was observed that:
a. the medication "Temperature Monitoring Log" for November 2010 had a temperature below the 36 degree policy limit for a low temperature with both checks on 19 of 30 days checked and for one of the two temperature checks/day on 6 of 30 days checked in November

9. Interview with staff member NG at 9:50 AM on 11/30/10 indicated:
a. staff is checking the temperature twice a day as required since vaccines/immunizations are stored in the medication refrigerator
b. the Temperature Log does not indicate/list high and low refrigerator temperature limits, or what to do if the temperature is not within the appropriate range
c. staff did not contact anyone when checking temps and finding they were not within the range required by policy for medications and immunizations
d. it cannot be determined that medications and vaccines are safe and not compromised since the medication refrigerator is not maintained at the temperature range required by policy



20625

Based on review of policies and procedures, patient records and staff interview, the Critical Access Hospital failed to ensure: A) Blood transfusions were administered in accordance with written policies and procedures and B) Blood transfusion reactions were identified and appropriate action was taken in accordance with written policies and procedures for 7 of 10 patient records reviewed.

Findings included:

1. Review of blood transfusion policies and procedures on 11-29-10 between 3:00 PM and 5:00 PM revealed the following:
a. A policy / procedure titled: "Blood Transfusion, Outpatient", last revised "06/09", which read: "Check vital signs and observe patient for adverse reaction at...15 minute intervals after transfusion started." and "Check vital signs and observe patient for reaction one hour after transfusion completed." and "If reaction occurs...stop blood immediately...take vital signs...notify lab immediately. Lab will follow "Transfusion Reaction Investigation" Policy...notify physician of clinical data and lab's conclusion regarding reaction investigation..."
b. A policy / procedure titled: "Blood Transfusion, InPatient / 23 hour Observation", last revised "06/09", which read: "Check vital signs and observe patient for adverse reaction...15 minute intervals after transfusion started." and "Check vital signs and observe patient for reaction one hour after transfusion completed." and "Observe for signs / symptoms of transfusion reaction as listed below...blood pressure changes, usually acute, either hypertension or hypotension..." and "If reaction occurs...stop blood immediately...notify lab immediately. Lab will follow "Transfusion Reaction Investigation" policy...notify physician of clinical data and lab's conclusion regarding reaction investigation..."
c. A policy / procedure titled: "Blood Transfusion Reaction", last revised "11/05" which read: "If reaction occurs..stop blood immediately...notify lab immediately. Lab will follow "Transfusion Reaction Investigation" policy...notify physician of clinical data and lab's conclusion regarding reaction investigation..."

2. Review of patient records on 11-30-10 between 4:30 PM and 5:00 PM and on 12-1-10 between 10:00 AM and 11:15 AM revealed the following:
a. Patient #L16 was an inpatient admitted on 8-2-10. On, 8-7-10, a blood transfusion was initiated at "1815". At "1830", the nurse documented: "Blood stopped due to bp - 193/119. Dr...called and informed. Order received to give Lasix...and slow rate of infusion..." Physician orders at "1842" note: "Give...Lasix IV now for BP. Slow rate of blood transfusion..." There was no indication in the patient's record that the nurse had notified the laboratory of a possible transfusion reaction prior to notification of the patient's physician, nor was there documentation a transfusion reaction investigation had been performed, as required by written policies and procedures.
b. Patient #L17 was an outpatient. On 8-29-10 at "1552", a blood transfusion was initiated. The patient's pre-transfusion blood pressure was "165/72". At "1810", the blood pressure was "208/79" and under "observations", the nurse noted "0 s/s of reaction". A second transfusion was initiated on the same date at "1954". Fifteen minute vital signs were taken at "2015", 21 minutes after the transfusion was initiated. At "2115", the patient's blood pressure was "212/88"and under "observations", the nurse noted "0 s/s of reaction". At "2215", the patient's blood pressure was "203/79", and under "observations" the nurse noted "no [change]". At "2245", the patient's blood pressure was "239/143", and under "observations", the nurse noted "0 s/s of reaction". The nurse did not recognize the change in blood pressure as a possible transfusion reaction, as required by written policies and procedures and the patient was discharged at "0001" on 8-30-10. Subsequently, on 8-30-10 at "0200", the patient presented in the emergency room with a blood pressure of "246/99" and a diagnosis of "transfusion reaction." A transfusion reaction investigation was initiated at that time.
c. Patient #L18 was an inpatient. On 7-4-10, the patient received 2 units of blood. The second transfusion was completed at "0602". At "2345", the nurse noted the patient's temperature was "100.2". The nurse contacted the physician, who ordered Tylenol. The patient was given the Tylenol at "0005" on 7-5-10. At "0105", the nurse noted the patient's temperature was "99.7" and the patient received more Tylenol at "0400". At "0405", the nurse noted "Started blood transfusion rxn paperwork d/t temp above baseline et headache et pain in infusion site." The laboratory was notified at "0430" to initiate a transfusion reaction investigation, and not immediately when the increase in temperature was identified at "2345", as required by written policies and procedures.
d. Patient #L21 was an outpatient. On 7-29-10, the patient received 2 units of blood. The first transfusion was initiated a "0922", and 15 minute vital signs were taken at "0942", 20 minutes after the transfusion was initiated. The transfusion was completed at "1132" and vital signs taken one hour after transfusion was discontinued, as required by written policies and procedures, were not documented.
e. Patient #L22 was an outpatient. On 7-24-10, the patient received a unit of emergency release, uncrossmatched blood. The infusion began at "1131" and fifteen minute vital signs were taken at "1152", 22 minutes after the transfusion was initiated. At "1220", the patient's temperature was documented as "98%" and at "1250", the patient's temperature was documented at "100%" It was unable to be determined if the patient had a two degree increase in temperature during the transfusion, due to the manner in which the patient's temperature was documented. The transfusion was discontinued at "1233" and vital signs taken one hour after transfusion was discontinued, as required by written policies and procedures, were not documented.
f. Patient #L23 was an outpatient. The patient received 2 units of blood on 8-7-10. The first unit was initiated at "1045", and fifteen minute vital signs were taken at "1055", 10 minutes after the transfusion was initiated.
g. Patient #L25 was an outpatient. The patient received 2 units of blood on 7-12-10. The first unit was initiated at "1945". Fifteen minute vital signs were taken at "2005", 20 minutes after the transfusion was initiated. The transfusion was completed at "2245" and the one hour post-transfusion vital signs were taken at "2335", 50 minutes after the transfusion was completed. The second transfusion was initiated at "2340" and fifteen minute vital signs were taken at "0001", 21 minutes after the transfusion was initiated.

3. In interview on 12-1-10 between 12:20 PM and 12:36 PM, Staff Member #L31 acknowledged the above findings.

Based on personnel file review, policy and procedure review, interview and observation, the facility failed to ensure the communicable disease history, related to Varicella, in 10 of 12 employee files reviewed (P1 through P4, P6, P7, P8, P10, P11 and P12), related to Rubeola for two agency staff (P1 and P2) and TB (tuberculosis) testing for two agency staff (P1 and P2) and created 1 condition which failed to provide a healthful environment that minimized infection exposure and risk to patients, employees and visitors.

Findings:

1. At 1:00 PM on 11/29/10, review of the policy and procedure "Measles (Rubeola), Mumps, Rubella and Varicella (Chickenpox) Immunity in New Employees, Contracted Employees, Students, and Volunteers.", with a start date of 4/06 and a revised date of 1/10, indicated:
a. in item 1. "Documented evidence of Measles (Rubeola) immunity will be required for all staff members as follows: a. Record of two live virus vaccines...Laboratory evidence of Measles immunity (i.e. titer),...MMR [measles, mumps, rubella] Immunity:...If laboratory screening demonstrates lack of full immunity, a MMR vaccine will be administered..."
b. in item 4. "Documented evidence of Varicella (Chickenpox) immunity will be required for all staff members as follows: a. Record of 2 doses of live Varicella vaccine 4 - 8 weeks apart, b. Laboratory evidence of immunity (titer), or c. Reliable verbal report of a history of Varicella (Chickenpox or Shingles). Varicella Immunity: Employee Health will ask each staff member if they have a reliable history of Varicella (Chickenpox). If the staff member does not have a reliable history, laboratory screening for immunity will be obtained. If not immune, 2 doses of Varicella vaccine given 4 - 8 weeks apart will be administered..."

2. Review of personnel files P1 and P2 (agency RNs) at 11:15 AM on 11/30/10 indicated:
a. P1 had a negative Rubeola titer in the employee file with no indication of a MMR vaccination being given
b. P2 was lacking any information related to Rubeola in the employee file
c. there is no documentation of TB testing/results in either employee file

3. Review of personnel files through out the survey process of 11/29/10 to 12/1/10 indicated:
a. staff members (and agency nurses) P1, P2, P3, P4, P6, P7, P8, P10, P11 and P12 had only verbal/self reported immunity to Varicella in their employee files

4. Interview with staff member NE at 2:20 PM on 12/1/10 indicated:
a. it is difficult to get the staffing agency to send appropriate information for files at the facility
b. per facility policy, P1 and P2 should have current TB testing on file
c. verbal reporting of Varicella history is no longer accepted at the facility as evidenced by the revised infection control policy related to immunization status
d. with the implementation of the newly revised infection control policy in 1/10, it was thought that current employees would begin to have Varicella titers done on their "check day" (annual inservicing day)
e. it is unclear why there has been a delay in getting Varicella titers on current employees since 1/10 as all of the files reviewed have already participated in check day at the facility
f. it is unclear what "reliable history" of having had Varicella as a child entails, but should be a physician's documentation of such having happened

5. On 11-29-10 at 1:25 pm in the presence of employee #A8, it was observed in a housekeeping closet on the second floor adjacent to the ambulatory care area, there was stored on open shelves, 44 rolls of toilet paper and 29 packages of handtowels. The rolls and packages were not in any shipping case and had ends that were open and not wrapped. Also observed in the closet was a housekeeping cart containing cleaning solutions, mops and rags, creating a potential for contamination of the clean patient care items.








19814

Based on review of policies and procedures, patient records and staff interview, the Critical Access Hospital failed to ensure it maintained a patient record that included evidence of informed consent for blood transfusions for 1 of 10 patient records reviewed.

Findings included:

1. Review of policies and procedures on 11-29-10 between 3:00 PM and 5:00 PM revealed a policy / procedure titled: "Blood Transfusion, Outpatient", last revised "06/09" which read: "Obtain written consent from patient or authorized guardian for administration of blood on "Agreement for Blood Transfusion" form."

2. Review of blood transfusion records on 12-1-10 between 10:00 AM and 11:15 AM revealed Patient #L21 was an outpatient who received 2 blood transfusions on 7-29-10. Documentation of consent for a blood transfusion was absent from the patient's medical record.

3. Upon request for documentation of consent for a blood transfusion for Patient #L21 on 12-1-10 between 11:30 AM and 11:36 AM, Staff Member #L31 confirmed there was no consent for the blood transfusion in the patient's medical record.

Based on review of documents, the hospital failed to ensure inclusion of 3 services provided by a contractor as part of its comprehensive quality assessment and improvement (QA&I) program and failed to report through its quality assurance, 3 contracted monitors activities.

Findings:

1. Review of the facility's QA&I program indicated it did not include the contracted services of pharmacy, electroencephalography and bone densitometry.

2. On 11-29-10 at 11:55 am, employee #A4 was requested to provide the above documentation and none was provided prior to exit.

3. Review of the facility's QA&I program indicated it included monitoring of contracted biohazardous waste, response to patient emergencies and reportable events. There was no documentation these activities were reported through the hospital's quality assurance mechanism.

4. On 11-29-10 at 11:55 am, employee #A4 was requested to provide documentation of reporting the 3 activities through the hospital's quality assurance mechanism and none was provided prior to exit.

Based on document review, the facility failed to ensure evaluations by a member of the CAH staff who is a doctor of medicine or osteopathy or by another doctor of medicine or osteopathy under contract with the CAH for 2 of 4 (AH#3 and AH#4) allied health practitioners.

Findings:

1. Review of 4 allied health practitioner credential files indicated files AH#3 and AH#4 did not contain any documentation of current performance evaluations.

2. On 11-20-10 at 11:55 am, employee #A4 was requested to provide the above documentation and none was provided prior to exit.