HospitalInspections.org

Based on observation, document review and interview the governing body failed to:
A. Protect patient rights by not providing a safe environment for patients to receive their medical care.
Refer to tag A0144
B. Provide quality oversight of three patient care related contracted services (Hospice, Dialysis, and Linen & Laundry).
Refer to tag A0308
C. Provide a safe, clean environment for patient to receive their medical treatments.
Refer to tags A0308 and A0749

Based on observation, interview, and record review the facility failed to:

(A) monitor and maintain a safe environment for the patients by allowing dummy drip chambers to be available for use in the clinical set up area.

(B) ensure that the Medical Director of Dialysis Unit reviewed the results of the water quality testing and directed corrective action, when indicated.

(C) ensure that appropriate action was taken when the difference in conductivity measures between the dialysis machine and the independent device was out of range.

(D) screen for hepatitis B surface antigen (HBsAg) and (HbAb) within 30 day prior to admission, at the time of admission or have a known HBsAg positive status prior to admission. In addition, the facility failed to ensure and provide evidence that the dialysis machines used by these patients with unknown hepatitis B status were given intermediate level disinfection prior to use by another patient.

(E) provide 4 (HD1, HD2, HD3 and HD4) out of 4 (HD1, HD2, HD3 and HD4) Hepatitis B Antibody negative patients literature describing the risk and benefits of the hepatitis B vaccination in order for the patients to make an informed decision of whether or not to take the vaccination.

(F) administer the hepatitis B vaccine, as indicated, for 4(HD1, HD2, HD3 and HD4) out of 4 patient (HD1, HD2, HD3 and HD4) records reviewed.

(G) check for bleach clearance after disinfection of 4 out of 4 machines listed on the log as 1, 2, 19, 25, and 27. In addition, the log indicated the RO 1-5 was also bleached and there was no documented clearance of the bleach from the RO.

(H) ensure the staff working on the Fresenius 2008K machines were qualified to complete repairs and certify the machines were safe for use on patients.

(I) secure dangerous items such as acid and other supplies.

These deficient practices had likelihood to cause harm to all patients receiving care at the facility.


Refer to tag 144

Based on observation, interview, and record review the facility failed to:

(A) monitor and maintain a safe environment for the patients by allowing dummy drip chambers to be available for use in the clinical set up area (See definition of dummy chambers in set up in the initial comments area). These findings were confirmed by observation and interview. In addition, these findings have the likelihood to create an unsafe dialysis treatment if staff use the dummy chamber for set up.

During a tour of the dialysis set up area on 10/27/2014 there was a dummy drip chamber on a dialysis machine in the clean storage area. The dialysis machine, with the dummy drip chamber attached, was accessible to the nursing staff.
During an interview with staff 2 # on 10/27/2014 at 1:30 p.m., she stated this machine was ready for patient use. The use of a dummy drip chamber has been contributed to the cause of patient deaths in dialysis.


(B) ensure that the Medical Director of Dialysis Unit reviewed the results of the water quality testing and directed corrective action, when indicated. In addition, there was no evidence the reports of equipment testing was trended and analyzed over time through the hospitals Quality Improvement meeting. This deficient practice created the likelihood to harm to all patients that were dialyzed in this dialysis facility. Citing 5 (June - October 27, 2014) out of 5 (June - October 27, 2014) months of equipment and machines laboratory report results reviewed.

Microbiological culture reports for the dialysis machines (serial # 2TOS-118044, 2TOS-117990, 2TOS-118084, 3KOS-H685, and 3KOS-G715) and ROs (serial #1318620, 1318625, 1318564, 1318955 and 1318565) were reviewed on 10/27/2014 at 2:30 p.m. There was no documentation that the Medical Director reviewed the results and/or advised corrective action, if one was required, for abnormal results. In addition, there were no trending logs for the water testing that recorded all test results, including repeat testing for out of range results over time.

Review of the Quality Improvement Committee minutes for the months of June, 17, 2014, August 19, 2014 and October 21, 2014, revealed that there was no evidence the machine cultures and endotoxin tests were reviewed over time and analyzed by the committee for the dialysis machine dialysis machines (serial # 2TOS-118044, 2TOS-117990, 2TOS-118084, 3KOS-H685, and 3KOS-G715) and ROs (serial # 1318620, 1318625, 1318564, 1318955 and 1318565). In addition, there was no evidence that the dialysis unit conducted monthly Quality Improvement meetings to review the operation of the unit.

Machine culture and endotoxin reports for June-October 2014 were reviewed. These reports did not identify each machine by its unique serial number. The reports identified the machines by a facility designated number that was affixed to each machine with removable adhesive. During the survey on 10/27/2014, it was discovered that the staff had removed the facility designated number on one machine and placed it on another machine. Without a unique identifying number on the lab reports, it was impossible to determine which cultures and endotoxin tests were taken from which machines.

An interview with Staff # 5 and # 6 on 10/27/2017 at 2:30 p.m. confirmed there was no evidence of the review by the Medical Director. In addition, staff # 5 and # 6 confirmed there was no evidence this information was presented to the Quality Improvement Committee. In addition, staff # 2 confirmed the Medical Director was not a member of the Quality Improvement Committee and there was not a Quality Improvement committee for the dialysis unit that included at least the Medical Director, Dialysis biomedical staff, and Dialysis Nurse Manager.


(C) ensure that appropriate action was taken when the difference in conductivity measures between the dialysis machine and the independent device was out of range. This deficient practice created the likelihood to harm to all patients that were dialyzed in this dialysis facility, by failure to ensure the correct conductivity was reached. Citing 3 patients (HD1, HD2, and HD4) out of 4 (HD1, HD2, HD3 and HD4) medical record reviewed.

Review of 3 (HD1, HD2, and HD4) out of 4 (HD1, HD2, HD3 and HD4) patient charts was conducted on 10/28/2014.

Review of HD1 dialysis treatment record for 10/06/2014 revealed the dialysis machine conductivity was 14.2. Conductivity tested with the independent device was 13.8. There was no evidence the conductivity variance of 0.4 was repeated or the machine conductivity settings validated by the biomedical staff.

Review of HD2 dialysis treatment record for 10/06/2014 revealed the dialysis machine conductivity was 13.6. Conductivity tested with the independent device was 14.2. There was no evidence the conductivity variance of 0.6 was repeated or the machine conductivity settings validated by the biomedical staff. In addition, on 09/30/2014 there was no recorded machine conductivity recorded to compare the reading of the independent device of 13.6.

Review of patient HD4 dialysis treatment record for 09/30/2014 revealed there was no evidence the conductivity was verified by an independent device.

An interview with staff #7 on 10/28/2014 at 2:30 p.m. confirmed both the machine conductivity and the independent device records must be taken and variation of plus or minus 0.3 should be retaken or the machine setting evaluated by the biomedical staff for accuracy.

(D) screen for hepatitis B surface antigen (HBsAg) and (HbAb) within 30 day prior to admission, at the time of admission or have a known HBsAg positive status prior to admission, citing 4 (# HD1, HD2, HD3, and HD4) out of 4 patients (# HD1 HD2, HD3, HD) records reviewed. In addition, the facility failed to ensure and provide evidence that the dialysis machines used by these patients with unknown hepatitis B status were given intermediate level disinfection prior to use by another patient. These finding were confirmed on record review and interview.
These findings have the likelihood to cause harm to all non-immune patients being treated in the dialysis unit at the facility by exposing them to hepatitis B positive patients' equipment.

Review of HD1 medical record revealed the facility failed to draw a HBsAg level on admission. The last negative HBsAg status on this patient was collected on 02/02/2013. The HbAb status of this patient was negative on 02/02/2013. In addition, the facility failed to ensure and provide evidence that the dialysis machine used by this patient with unknown hepatitis B status was given intermediate level disinfection prior to use by another patient.

Review of HD2 medical record revealed the facility failed to draw a HBsAg level on admission on 09/20/2014. The negative HBsAg status on this patient was not collected until 10/06/2014. The HbAb status of this patient was negative on 10/06/2014. In addition, the facility failed to ensure and provide evidence that the dialysis machine used by this patient with unknown hepatitis B status was given intermediate level disinfection prior to its use by another patient.
Review of HD3 medical record revealed the facility failed to draw a HBsAg level on admission on 09/25/2014. The negative HbsAg was not drawn until 09/30/2014. The last negative HBsAg status on this patient was collected on 03/16/2011. The HbAb status of this patient was negative on 03/16/2011 and on 09/30/2014. In addition, the facility failed to ensure and provide evidence that the dialysis machine used by this patient with unknown hepatitis B status was given intermediate level disinfection prior to its use by another patient.

Review of HD4 medical record revealed the facility failed to draw a HBsAg level on admission. The last negative HBsAg status on this patient was collected on 12/27/2013. The HbAb status of this patient was negative on 12/27/2013. In addition, the facility failed to ensure and provide evidence that the dialysis machine used by this patient with unknown hepatitis B status was given intermediate level disinfection prior to its use by another patient.

An interview with staff #5 on 10/28/2014 at 2:30 p.m. confirmed the laboratory system only contained the above test results.

(E) provide 4 (HD1, HD2, HD3 and HD4) out of 4 (HD1, HD2, HD3 and HD4) Hepatitis B Antibody negative patients literature describing the risk and benefits of the hepatitis B vaccination in order for the patients to make an informed decision of whether or not to take the vaccination. These findings were based on record review and interview. In addition, these finding have the likelihood to cause harm to all high risk dialysis patients that are antibody negative by failure to give the hepatitis B vaccine information in order for them to make an informed decision.

Review of HD1, HD2, HD3 and HD4 medical record revealed no evidence the facility provided these Hepatitis Antibody negative patients literature describing the risk and benefits of the hepatitis B vaccination in order for the patients to make an informed decision of whether or not to take the vaccination.

An interview of staff 5 on 20/28/2014 at 3:30 p.m. confirmed there was no evidence documented in the medical record or any other record maintained by the hospital that these HBsAb negative patients were provided the hepatitis B literature.



(F) administer the hepatitis B vaccine, as indicated, for 4(HD1, HD2, HD3 and HD4) out of 4 patient (HD1, HD2, HD3 and HD4) records reviewed. These patients were hepatitis antibody negative (HBsAb). These finding were confirmed on record review and interview. In addition, these findings have the likelihood to cause harm to all patients receiving care in the dialysis unit that are not immune to hepatitis B.

Review of patient record for HD1, HD2, HD3 and HD4 revealed the facility failed to start the administration of the hepatitis B vaccine, as indicated. There was no evidence documented in the medical record that indicated the physician or patient was notified of the antibody status and was provided the immunization, as indicated.

An interview with staff #5 on 20/28/2014 at 3:30 p.m. confirmed there was no evidence documented in the medical record or any other record maintained by the hospital that these HBsAb negative patients were provided the immunization, as indicated.



(G) check for bleach clearance after disinfection of 5 out of 5 machines listed on the log as 1, 2, 19, 25, and 27. The serial numbers of the machines being cleaned was not listed. In addition, the log indicated the RO 1-5 was also bleached and there was no documented clearance of the bleach from the RO. These findings have the likelihood to cause harm to all patients receiving dialysis.

Review of a document labeled T Machine Maintenance log for machine #1 and RO #1 revealed, on September 1, 8, 14, 22, and 29, the machine and RO were bleached. There was no documentation of bleach clearance prior to use.

Review of a document labeled T Machine Maintenance log for machine #2 and RO #2 revealed, on September 1, 8, 15, 22, and 29, the machine and RO were bleached. There was no documentation of bleach clearance prior to use.

Review of a document labeled T Machine Maintenance log for machine #19 and RO #3 revealed, on September 1, 8, 15, 21, and 29, the machine and RO were bleached. There was no documentation of bleach clearance prior to use.

Review of a document labeled T Machine Maintenance log for machine #25 and RO #4 revealed, on September 1, 7, 15, 22, and 29, the machine and RO were bleached. There was no documentation of bleach clearance prior to use.

Review of a document labeled T Machine Maintenance log for machine #27 and RO #5 revealed, on September 2 and 7, the machine and RO were bleached. There was no documentation of bleach clearance prior to use. This machine was taken out of service from September 16th to September 29th.

There were no serial numbers listed on the "T Machine Maintenance Logs." In addition, 2 of the dialysis machines were not from the "T" series but were from the "K" series. In addition, the staff changed numbers from machine # 27 to another machine, so there is no indication which was bleached. This was identified by surveyor when verifying numbers. In an interview with staff # 2 on 10/27/2014 at 11:30 a.m., she confirmed she changed the number.



(H) ensure the staff working on the Fresenius 2008K machines were qualified to complete repairs and certify the machines were safe for use on patients. This finding has the likelihood to cause harm to patients treated on the machines.

The personnel record of staff #2 revealed no evidence of training for the 2008K Fresenius machines. Staff # 7 stated he thought, if the staff had training for the Fresenius "T" machine, that they could work on all models.

Contact with manufacture on 11/05/2014 confirmed the recommendation of the manufacture is for persons to have training on every model they are working on.



(I) secure dangerous items such as acid and other supplies. These findings have the likelihood to cause harm to all persons who may access the unsecured area.

A tour of the facility revealed a dialysis storage room located in a hall with public access. The door to the storage room had no lock and was accessible to the public. Also, the dialysis treatment area was unsecured. The storage room and the treatment area contained dangerous items, such as acid and other medical supplies.



It was determined these deficient practices created an Immediate Jeopardy situation and placed patients at risk of potential harm, serious injury, and subsequent death. These failed practices had the likelihood to affect all patients receiving dialysis in the facility.

Based on record review and interview, the facility failed to monitor the quality provided by 3 of its patient care related contracted services (Hospice, Dialysis, and Linen & Laundry).

Refer to tag A0308

Based on record review and interview, the facility failed to monitor the quality provided by 3 of its patient care related contracted services (Hospice, Dialysis, and Linen & Laundry).


Findings include:

Review of the facility's Performance Improvement/Patient Safety Committee Minutes from August 2013 to October 2014 revealed no evidence the contracted hospice service nor the contracted linen and laundry service had been reviewed for quality. The facility's contracted dialysis service had an evaluation form; however, there was no data included in the evaluation.

During an interview on 10/29/2014 at 11:45am, staff #5 reported the following:
-there was no evidence in the Performance Improvement/Patient Safety Committee Minutes from August 2013 to October 2014 that the hospice and linen and laundry services had been evaluated for quality;
-there was no data included to evaluate the dialysis service;
-these services were also not evaluated by the Governing Body.


22676

Review of the QAPI meeting minutes for year 2014 revealed no documentation of quality indicators relating to Dialysis care. There was no evidence of any tracking or trending of health associated infections, water quality(chemical, bacteriological analysis, and other indicators specific to the facility's water treatment system), dialysis equipment preventative maintenance, or adverse events. There was no dialysis related infection control date (staff and patient screening, sepsis episodes, and patient infections) or staffing data (training, certification of water policies, and non-adherence to policies and procedures by facility staff). Also, there was no documentation of a clinical record review to include dialysis treatment errors and medication errors.

Based on policy and procedures, record review and interview the facility failed to ensure nursing followed physician recommendations for care/treatment plan interventions in 2 (#6 and #22) of 15 Gero-Psychiatric patients identified.

On 10/28/2014 in the conference room of the Gero-psychiatric treatment unit the medical record for Patient (pt) #22 revealed the following: a physician's progress note dictated 10/25/2014 documented "The patient overall appears to be improved today from a cognitive standpoint. We did note a pattern yesterday as she had asked for a PRN (as needed) pain medicine. It appeared as though she calmed down significantly and interactions improved significantly as well. She does continue to voice lower back pain and we will start her on a set does of Norco, which does appear to help. I suspect some of this irritability may be driven by pain ..."

Further review of the medical record, revealed upon admission, Pt #22 was admitted with a history of lower back and neck pain. Review of the treatment plan/care plan did not identify pain as a potential factor for behavioral outburst and was not identified for treatment inventions from the date of admission on 10/6/2014 through the day of review 10/28/2014.

On 10/28/2014 in the conference room of the Gero-psychiatric unit staff #11 confirmed the care plan did not address pain.


32143

Review of the nursing progress notes revealed patient #6 was sent to the Emergency Room on 10-25-14 at 9:15 PM due to a fall. Review of the Nursing notes on 10-25-14 at 12:25 AM stated, "Patient back on unit from ER. Patient has concussion and bandage above right eye. "Review of the treatment care plan reveals no mention or problem developed to address the concussion.
An interview with staff #10 and #11 on 10-28-14 at 11:15 AM performed. Staff #10 reported that the Treatment Care Plans were progressing and education on care plans were still in progress. Staff #10 agreed with the above findings.

Based on observation, interview and document review the facility failed to insure intramuscular and intravenous medications were stored in refrigerators that maintained temperatures between 35 degrees Fahrenheit and 49 degrees Fahrenheit in 9 of 9
refrigerators monitored.

On 10/28/2014 during a walking tour of the third floor East wing (3E), the refrigerator used to store pharmaceutical drugs for patient use was visually checked to see if the temperature logs were current and the temperature maintained within recommended parameters.

The documented that was being used to record the refrigerator/freezer temperatures on 3E was titled: "Temperature Log for Refrigerator and Freezer-Fahrenheit". The instructions found on the form reflected the following: Check the temperatures in both the freezer and the refrigerator compartments of your vaccine storage units at least twice each working day. Place a "X" in the box that corresponds with the temperature and record the ambient (room) temperature, the time of the temperature readings, and your initials.
If the recorded temperature is in the shaded zone: This represents an unacceptable temperature range. Follow these steps as quickly as possible. (unacceptable range, above 46 degrees or below 35 degrees)
1. Store the vaccine under prosper conditions as quickly as possible.
2. Temporarily mark exposed vaccine "Do not use" until you have verified whether of not the vaccine may be used.
3. Call the immunization program at your state or local health department and/or call the vaccine manufacturer to determine whether the vaccine is still usable. ( a space on the form was given for a phone number to be placed. No phone number was written in the space)
4. Document the action taken on the reverse side of this log.

Observation revealed the 27 days recorded for the month of October five (4) days were documented with temperatures above 49 degrees. (the highest temperature the form permitted) October 18, 2014 both morning (AM) and evening (PM) temperatures were documented as 56 degrees. October 19, 2014 the recorded AM temperature was 56 and the PM temperature was recorded as 54. October 24, 2014 the AM temperature was recorded as 48 degrees and on October 27 both AM and PM temperatures were recorded as 49 degrees. All of these temperatures were documented within the shaded zone above a bold printed statement that read "Take immediate corrective action if temperature is in the shaded section". Review of the findings were confirmed by RN staff # 12. Further scrutiny of the temperature log revealed no corrective action was documented. There was no indication the content of the refrigerator was removed to proper temperature storage and no indication the safety of the drugs contained within this refrigeration unit were check for safety with the manufacturer or any health department.

On October 29, 2014 at 2:30 PM, a tour of the hospitals pharmacy department request to review all refrigerator/freezer logs.

Third Floor East wing refrigerator revealed:
July 2014 documented 1 of 31 days with a temperature out of range. On July 27, 2014 a recorded temperature of 52 degrees was identified with a notation "door open". There was no PM temperature documented and no further follow up to insure the proper temperature was regained or maintained.
August 2014, 21 of 31 days documented 1 or both daily temperatures were out of range. All temperatures that were out of range were between 50-57 degrees.
September 2014, 29 of 30 days documented 1 or both daily temperatures were out of range. All out of range temperatures were documented between 48-56 degrees.

Third floor West wing refrigerator revealed:
July 2014 documented 3 of 31 days documented 1 or both daily temperatures out of range. The out of range temperatures were between 47-48 degrees.
August 2014 documented 3 of 31 days with temperatures out of range. September 3,4,5 of 2014 recorded temperature below freezing.
September 2014 documented 2 of 30 days each documented 1 daily temperature at 47 degrees.

Fourth floor East wing refrigerator revealed:
August 2014 documented 4 of 31 days with 1 or both daily temperatures between 47-49 degrees.

Fourth floor West wing refrigerator revealed:
July 2014 documented 8 of 31 days with one or both daily temperatures recorded 32-34 degrees.
August 2014 documented 20 of 31 days with 1 or both daily temperatures recorded between 29-34 degrees.
September 2014 the refrigerator documented 15/31 days with 1 or both daily temperatures 23-34 degrees and 13 of 31 days recorded 1 or both daily temperatures between 52-58 degrees.

Fifth flour West wing refrigerator documented
July 2014 documented 15 of 31 days with 1 or both daily temperatures between 49-63 degrees.
August 2014 documented 16 of 31 days with 1 or both daily temperatures between 47-52 degrees.
September 2014 documented 14 of 31 days documented 1 or both daily temperatures between 47-51 degrees. The refrigerator identified as the "IV" (intravenous fluids) refrigerator revealed 4 of 30 days with no recorded temperature. September 6,7,8 documented "no thermometer?"September the 21 documented no temperature and "Wire cut in 2 (sic) no reading".

CICU (Coronary Intensive Care Unit)
August 2014 documented 1 of 31 days with a temperature recorded at 34 degrees.
September 2014 documented 2 of 30 days with temperatures recorded at 34 degrees and 60 degrees.

ICU (Intensive Care Unit)
July 2014 the IV storage refrigerator documented 7/31 days with temperatures below 35 degrees. 4 of those were below freezing.
August 2014 the vaccine refrigerator documented 2 of 31 where 1 of both daily temperatures were between 47-48 degrees.

Emergency Room (ER)
July 2014 documented 3 of 31 days with 1 of both daily temperatures between 47-56 degrees.
August documented of 31 days with 1 or both daily temperatures between 47-54 degrees.

The refrigerator in the house supervisors office (used to store medications)
August 201426 of 31 days the daily temperature was recorded between 48-50 degrees.
September 2014 documentation revealed 8 of 31 days with recorded temperatures between 48-50 degrees.

All nine (9) refrigerators were found to have failed to maintain the internal temperature within safe parameters between 35 degrees and 46 degrees. This was confirmed by consulting pharmacist #39. Further review of the documentation revealed no corrective action was indicated. The medication was not removed to a working refrigeration unit, the medication was not checked for safe usage with the manufacturer or local health department and no request for service of any unit which did not maintain desired temperature was identified. This was also confirmed by consultant Pharmacist #39.

Based on document review and interview the facility failed to insure the pharmacy staff had specific job duties listed in job description . The pharmacist failed to monitor pharmacy staff for job duties.

On 10/28/2014 during a walking tour of the third floor East wing (3E), the refrigerator used to store pharmaceutical drugs for patient use was visually checked to see if the temperature logs were current and the temperature maintained within recommended parameters.

The documented that was being used to record the refrigerator/freezer temperatures on 3E was titled: "Temperature Log for Refrigerator and Freezer-Fahrenheit". The instructions found on the form reflected the following: Check the temperatures in both the freezer and the refrigerator compartments of your vaccine storage units at least twice each working day. Place a "X" in the box that corresponds with the temperature and record the ambient (room) temperature, the time of the temperature readings, and your initials.
If the recorded temperature is in the shaded zone: This represents an unacceptable temperature range. Follow these steps as quickly as possible. (unacceptable range, above 46 degrees or below 35 degrees)
1. Store the vaccine under prosper conditions as quickly as possible.
2. Temporarily mark exposed vaccine "Do not use" until you have verified whether of not the vaccine may be used.
3. Call the immunization program at your state or local health department and/or call the vaccine manufacturer to determine whether the vaccine is still usable. ( a space on the form was given for a phone number to be placed. No phone number was written in the space)
4. Document the action taken on the reverse side of this log.

Observation revealed the 27 days recorded for the month of October five (4) days were documented with temperatures above 49 degrees. (the highest temperature the form permitted) October 18, 2014 both morning (AM) and evening (PM) temperatures were documented as 56 degrees. October 19, 2014 the recorded AM temperature was 56 and the PM temperature was recorded as 54. October 24, 2014 the AM temperature was recorded as 48 degrees and on October 27 both AM and PM temperatures were recorded as 49 degrees. All of these temperatures were documented within the shaded zone above a bold printed statement that read "Take immediate corrective action if temperature is in the shaded section". Review of the findings were confirmed by RN staff # 12. Further scrutiny of the temperature log revealed no corrective action was documented. There was no indication the content of the refrigerator was removed to proper temperature storage and no indication the safety of the drugs contained within this refrigeration unit were check for safety with the manufacturer or any health department.

On October 29, 2014 at 2:30 PM, a tour of the hospitals pharmacy department request to review all refrigerator/freezer logs.

Third Floor East wing refrigerator revealed:
July 2014 documented 1 of 31 days with a temperature out of range. On July 27, 2014 a recorded temperature of 52 degrees was identified with a notation "door open". There was no PM temperature documented and no further follow up to insure the proper temperature was regained or maintained.
August 2014, 21 of 31 days documented 1 or both daily temperatures were out of range. All temperatures that were out of range were between 50-57 degrees.
September 2014, 29 of 30 days documented 1 or both daily temperatures were out of range. All out of range temperatures were documented between 48-56 degrees.

Third floor West wing refrigerator revealed:
July 2014 documented 3 of 31 days documented 1 or both daily temperatures out of range. The out of range temperatures were between 47-48 degrees.
August 2014 documented 3 of 31 days with temperatures out of range. September 3,4,5 of 2014 recorded temperature below freezing.
September 2014 documented 2 of 30 days each documented 1 daily temperature at 47 degrees.

Fourth floor East wing refrigerator revealed:
August 2014 documented 4 of 31 days with 1 or both daily temperatures between 47-49 degrees.

Fourth floor West wing refrigerator revealed:
July 2014 documented 8 of 31 days with one or both daily temperatures recorded 32-34 degrees.
August 2014 documented 20 of 31 days with 1 or both daily temperatures recorded between 29-34 degrees.
September 2014 the refrigerator documented 15/31 days with 1 or both daily temperatures 23-34 degrees and 13 of 31 days recorded 1 or both daily temperatures between 52-58 degrees.

Fifth flour West wing refrigerator documented
July 2014 documented 15 of 31 days with 1 or both daily temperatures between 49-63 degrees.
August 2014 documented 16 of 31 days with 1 or both daily temperatures between 47-52 degrees.
September 2014 documented 14 of 31 days documented 1 or both daily temperatures between 47-51 degrees. The refrigerator identified as the "IV" (intravenous fluids) refrigerator revealed 4 of 30 days with no recorded temperature. September 6,7,8 documented "no thermometer?"September the 21 documented no temperature and "Wire cut in 2 (sic) no reading".

CICU (Coronary Intensive Care Unit)
August 2014 documented 1 of 31 days with a temperature recorded at 34 degrees.
September 2014 documented 2 of 30 days with temperatures recorded at 34 degrees and 60 degrees.

ICU (Intensive Care Unit)
July 2014 the IV storage refrigerator documented 7/31 days with temperatures below 35 degrees. 4 of those were below freezing.
August 2014 the vaccine refrigerator documented 2 of 31 where 1 of both daily temperatures were between 47-48 degrees.

Emergency Room (ER)
July 2014 documented 3 of 31 days with 1 of both daily temperatures between 47-56 degrees.
August documented of 31 days with 1 or both daily temperatures between 47-54 degrees.

The refrigerator in the house supervisors office (used to store medications)
August 201426 of 31 days the daily temperature was recorded between 48-50 degrees.
September 2014 documentation revealed 8 of 31 days with recorded temperatures between 48-50 degrees.

All nine (9) refrigerators were found to have failed to maintain the internal temperature within safe parameters between 35 degrees and 46 degrees. This was confirmed by consulting pharmacist #39. Further review of the documentation revealed no corrective action was indicated. The medication was not removed to a working refrigeration unit, the medication was not checked for safe usage with the manufacturer or local health department and no request for service of any unit which did not maintain desired temperature was identified. This was also confirmed by consultant Pharmacist #39.

The above lack of documentation was discussed at length with the pharmacist and it was discovered that the job description for the pharmacy tech did not include checking the accuracy of the refrigerator and the pharmacist job description did not include oversight of the safe functioning of the refrigeration units or the pharmacy tech who was recording the data. It was also confirmed no pharmacist was reviewing the data for the refrigeration units.

Based on observation and interview, the facility failed to ensure equipment had electrical safety checks completed in the appropriate time frames. Two fans in the offsite cardiac rehabilitation area had past-due electrical safety checks. One fan in the offsite cardiac rehabilitation area had not been checked for electrical safety.

Findings include:

During a tour of the offsite cardiac rehabilitation area on 10/28/14 at 10:50am, the following was observed:
-a fan had a biomedical electrical safety check sticker dated 8/31/12 (due for re-checks in August 2013 and 2014);
-a fan had a biomedical electrical safety check sticker dated 12/07/09 (due for re-checks in December 2010, 2011, 2012, and 2013);
-a fan had no biomedical electrical safety check sticker, indicating it had not been checked for electrical safety.

During the tour, staff #16 confirmed this observation and reported the checks should occur annually.

Based on observation, document review and interview the facility failed to

A. monitor the quality care provided by 3 of its patient care related contracted services (Hospice, Dialysis, and Linen & Laundry).

Refer to A0308


B. separate clean supplies from soiled items in the dialysis storage area and in the dialysis treatment area. These finding have the likelihood to cause cross contamination of clean equipment and supplies which could increase the risk of infection to the patient by allowing clean equipment to come in contact with dirty equipment and supplies.

Refer to A0749

Based on observation and interview, the facility failed to separate clean supplies from soiled items in the dialysis storage area and in the dialysis treatment area. These finding have the likelihood to cause cross contamination of clean equipment and supplies which could increase the risk of infection to the patient by allowing clean equipment to come in contact with dirty equipment and supplies.

Findings:

Observation in the dialysis storage area and set up area on 10/272014 revealed clean and sterile supplies mixed with dirty items such as shipping cartons, a bottle of pink liquid, and unlabeled bottles containing a yellow liquid. There were two dialysis machines sitting side by side. One was ready for use and one was in the area for repair. The floor behind the machines was unsealed porous concrete. There were cases of supplies sitting directly on the floor. In the corner were boxes of open "clean" dialyzers with boxes of contaminated items, such as PVC cement, hoses, and other unclean items.

In the dialysis unit, there was a container of expired bicarb sitting on a dialysis machine in the small dialysis treatment room. In the larger room, there were unsecured medications and supplies.

An interview with staff # 2 on 10/27/2014 at approximately 1:30 p.m. confirmed the equipment repair is done in the same area as the clean equipment and supplies. In addition, staff #2 confirmed the condition of the storage area and the dialysis treatment area.

Based on observation, document review and interview the governing body failed to:
A. Protect patient rights by not providing a safe environment for patients to receive their medical care.
Refer to tag A0144
B. Provide quality oversight of three patient care related contracted services (Hospice, Dialysis, and Linen & Laundry).
Refer to tag A0308
C. Provide a safe, clean environment for patient to receive their medical treatments.
Refer to tags A0308 and A0749

Based on observation, interview, and record review the facility failed to:

(A) monitor and maintain a safe environment for the patients by allowing dummy drip chambers to be available for use in the clinical set up area.

(B) ensure that the Medical Director of Dialysis Unit reviewed the results of the water quality testing and directed corrective action, when indicated.

(C) ensure that appropriate action was taken when the difference in conductivity measures between the dialysis machine and the independent device was out of range.

(D) screen for hepatitis B surface antigen (HBsAg) and (HbAb) within 30 day prior to admission, at the time of admission or have a known HBsAg positive status prior to admission. In addition, the facility failed to ensure and provide evidence that the dialysis machines used by these patients with unknown hepatitis B status were given intermediate level disinfection prior to use by another patient.

(E) provide 4 (HD1, HD2, HD3 and HD4) out of 4 (HD1, HD2, HD3 and HD4) Hepatitis B Antibody negative patients literature describing the risk and benefits of the hepatitis B vaccination in order for the patients to make an informed decision of whether or not to take the vaccination.

(F) administer the hepatitis B vaccine, as indicated, for 4(HD1, HD2, HD3 and HD4) out of 4 patient (HD1, HD2, HD3 and HD4) records reviewed.

(G) check for bleach clearance after disinfection of 4 out of 4 machines listed on the log as 1, 2, 19, 25, and 27. In addition, the log indicated the RO 1-5 was also bleached and there was no documented clearance of the bleach from the RO.

(H) ensure the staff working on the Fresenius 2008K machines were qualified to complete repairs and certify the machines were safe for use on patients.

(I) secure dangerous items such as acid and other supplies.

These deficient practices had likelihood to cause harm to all patients receiving care at the facility.


Refer to tag 144

Based on observation, interview, and record review the facility failed to:

(A) monitor and maintain a safe environment for the patients by allowing dummy drip chambers to be available for use in the clinical set up area (See definition of dummy chambers in set up in the initial comments area). These findings were confirmed by observation and interview. In addition, these findings have the likelihood to create an unsafe dialysis treatment if staff use the dummy chamber for set up.

During a tour of the dialysis set up area on 10/27/2014 there was a dummy drip chamber on a dialysis machine in the clean storage area. The dialysis machine, with the dummy drip chamber attached, was accessible to the nursing staff.
During an interview with staff 2 # on 10/27/2014 at 1:30 p.m., she stated this machine was ready for patient use. The use of a dummy drip chamber has been contributed to the cause of patient deaths in dialysis.


(B) ensure that the Medical Director of Dialysis Unit reviewed the results of the water quality testing and directed corrective action, when indicated. In addition, there was no evidence the reports of equipment testing was trended and analyzed over time through the hospitals Quality Improvement meeting. This deficient practice created the likelihood to harm to all patients that were dialyzed in this dialysis facility. Citing 5 (June - October 27, 2014) out of 5 (June - October 27, 2014) months of equipment and machines laboratory report results reviewed.

Microbiological culture reports for the dialysis machines (serial # 2TOS-118044, 2TOS-117990, 2TOS-118084, 3KOS-H685, and 3KOS-G715) and ROs (serial #1318620, 1318625, 1318564, 1318955 and 1318565) were reviewed on 10/27/2014 at 2:30 p.m. There was no documentation that the Medical Director reviewed the results and/or advised corrective action, if one was required, for abnormal results. In addition, there were no trending logs for the water testing that recorded all test results, including repeat testing for out of range results over time.

Review of the Quality Improvement Committee minutes for the months of June, 17, 2014, August 19, 2014 and October 21, 2014, revealed that there was no evidence the machine cultures and endotoxin tests were reviewed over time and analyzed by the committee for the dialysis machine dialysis machines (serial # 2TOS-118044, 2TOS-117990, 2TOS-118084, 3KOS-H685, and 3KOS-G715) and ROs (serial # 1318620, 1318625, 1318564, 1318955 and 1318565). In addition, there was no evidence that the dialysis unit conducted monthly Quality Improvement meetings to review the operation of the unit.

Machine culture and endotoxin reports for June-October 2014 were reviewed. These reports did not identify each machine by its unique serial number. The reports identified the machines by a facility designated number that was affixed to each machine with removable adhesive. During the survey on 10/27/2014, it was discovered that the staff had removed the facility designated number on one machine and placed it on another machine. Without a unique identifying number on the lab reports, it was impossible to determine which cultures and endotoxin tests were taken from which machines.

An interview with Staff # 5 and # 6 on 10/27/2017 at 2:30 p.m. confirmed there was no evidence of the review by the Medical Director. In addition, staff # 5 and # 6 confirmed there was no evidence this information was presented to the Quality Improvement Committee. In addition, staff # 2 confirmed the Medical Director was not a member of the Quality Improvement Committee and there was not a Quality Improvement committee for the dialysis unit that included at least the Medical Director, Dialysis biomedical staff, and Dialysis Nurse Manager.


(C) ensure that appropriate action was taken when the difference in conductivity measures between the dialysis machine and the independent device was out of range. This deficient practice created the likelihood to harm to all patients that were dialyzed in this dialysis facility, by failure to ensure the correct conductivity was reached. Citing 3 patients (HD1, HD2, and HD4) out of 4 (HD1, HD2, HD3 and HD4) medical record reviewed.

Review of 3 (HD1, HD2, and HD4) out of 4 (HD1, HD2, HD3 and HD4) patient charts was conducted on 10/28/2014.

Review of HD1 dialysis treatment record for 10/06/2014 revealed the dialysis machine conductivity was 14.2. Conductivity tested with the independent device was 13.8. There was no evidence the conductivity variance of 0.4 was repeated or the machine conductivity settings validated by the biomedical staff.

Review of HD2 dialysis treatment record for 10/06/2014 revealed the dialysis machine conductivity was 13.6. Conductivity tested with the independent device was 14.2. There was no evidence the conductivity variance of 0.6 was repeated or the machine conductivity settings validated by the biomedical staff. In addition, on 09/30/2014 there was no recorded machine conductivity recorded to compare the reading of the independent device of 13.6.

Review of patient HD4 dialysis treatment record for 09/30/2014 revealed there was no evidence the conductivity was verified by an independent device.

An interview with staff #7 on 10/28/2014 at 2:30 p.m. confirmed both the machine conductivity and the independent device records must be taken and variation of plus or minus 0.3 should be retaken or the machine setting evaluated by the biomedical staff for accuracy.

(D) screen for hepatitis B surface antigen (HBsAg) and (HbAb) within 30 day prior to admission, at the time of admission or have a known HBsAg positive status prior to admission, citing 4 (# HD1, HD2, HD3, and HD4) out of 4 patients (# HD1 HD2, HD3, HD) records reviewed. In addition, the facility failed to ensure and provide evidence that the dialysis machines used by these patients with unknown hepatitis B status were given intermediate level disinfection prior to use by another patient. These finding were confirmed on record review and interview.
These findings have the likelihood to cause harm to all non-immune patients being treated in the dialysis unit at the facility by exposing them to hepatitis B positive patients' equipment.

Review of HD1 medical record revealed the facility failed to draw a HBsAg level on admission. The last negative HBsAg status on this patient was collected on 02/02/2013. The HbAb status of this patient was negative on 02/02/2013. In addition, the facility failed to ensure and provide evidence that the dialysis machine used by this patient with unknown hepatitis B status was given intermediate level disinfection prior to use by another patient.

Review of HD2 medical record revealed the facility failed to draw a HBsAg level on admission on 09/20/2014. The negative HBsAg status on this patient was not collected until 10/06/2014. The HbAb status of this patient was negative on 10/06/2014. In addition, the facility failed to ensure and provide evidence that the dialysis machine used by this patient with unknown hepatitis B status was given intermediate level disinfection prior to its use by another patient.
Review of HD3 medical record revealed the facility failed to draw a HBsAg level on admission on 09/25/2014. The negative HbsAg was not drawn until 09/30/2014. The last negative HBsAg status on this patient was collected on 03/16/2011. The HbAb status of this patient was negative on 03/16/2011 and on 09/30/2014. In addition, the facility failed to ensure and provide evidence that the dialysis machine used by this patient with unknown hepatitis B status was given intermediate level disinfection prior to its use by another patient.

Review of HD4 medical record revealed the facility failed to draw a HBsAg level on admission. The last negative HBsAg status on this patient was collected on 12/27/2013. The HbAb status of this patient was negative on 12/27/2013. In addition, the facility failed to ensure and provide evidence that the dialysis machine used by this patient with unknown hepatitis B status was given intermediate level disinfection prior to its use by another patient.

An interview with staff #5 on 10/28/201

Based on record review and interview, the facility failed to monitor the quality provided by 3 of its patient care related contracted services (Hospice, Dialysis, and Linen & Laundry).

Refer to tag A0308

Based on record review and interview, the facility failed to monitor the quality provided by 3 of its patient care related contracted services (Hospice, Dialysis, and Linen & Laundry).


Findings include:

Review of the facility's Performance Improvement/Patient Safety Committee Minutes from August 2013 to October 2014 revealed no evidence the contracted hospice service nor the contracted linen and laundry service had been reviewed for quality. The facility's contracted dialysis service had an evaluation form; however, there was no data included in the evaluation.

During an interview on 10/29/2014 at 11:45am, staff #5 reported the following:
-there was no evidence in the Performance Improvement/Patient Safety Committee Minutes from August 2013 to October 2014 that the hospice and linen and laundry services had been evaluated for quality;
-there was no data included to evaluate the dialysis service;
-these services were also not evaluated by the Governing Body.


22676

Review of the QAPI meeting minutes for year 2014 revealed no documentation of quality indicators relating to Dialysis care. There was no evidence of any tracking or trending of health associated infections, water quality(chemical, bacteriological analysis, and other indicators specific to the facility's water treatment system), dialysis equipment preventative maintenance, or adverse events. There was no dialysis related infection control date (staff and patient screening, sepsis episodes, and patient infections) or staffing data (training, certification of water policies, and non-adherence to policies and procedures by facility staff). Also, there was no documentation of a clinical record review to include dialysis treatment errors and medication errors.

Based on policy and procedures, record review and interview the facility failed to ensure nursing followed physician recommendations for care/treatment plan interventions in 2 (#6 and #22) of 15 Gero-Psychiatric patients identified.

On 10/28/2014 in the conference room of the Gero-psychiatric treatment unit the medical record for Patient (pt) #22 revealed the following: a physician's progress note dictated 10/25/2014 documented "The patient overall appears to be improved today from a cognitive standpoint. We did note a pattern yesterday as she had asked for a PRN (as needed) pain medicine. It appeared as though she calmed down significantly and interactions improved significantly as well. She does continue to voice lower back pain and we will start her on a set does of Norco, which does appear to help. I suspect some of this irritability may be driven by pain ..."

Further review of the medical record, revealed upon admission, Pt #22 was admitted with a history of lower back and neck pain. Review of the treatment plan/care plan did not identify pain as a potential factor for behavioral outburst and was not identified for treatment inventions from the date of admission on 10/6/2014 through the day of review 10/28/2014.

On 10/28/2014 in the conference room of the Gero-psychiatric unit staff #11 confirmed the care plan did not address pain.


32143

Review of the nursing progress notes revealed patient #6 was sent to the Emergency Room on 10-25-14 at 9:15 PM due to a fall. Review of the Nursing notes on 10-25-14 at 12:25 AM stated, "Patient back on unit from ER. Patient has concussion and bandage above right eye. "Review of the treatment care plan reveals no mention or problem developed to address the concussion.
An interview with staff #10 and #11 on 10-28-14 at 11:15 AM performed. Staff #10 reported that the Treatment Care Plans were progressing and education on care plans were still in progress. Staff #10 agreed with the above findings.

Based on observation, interview and document review the facility failed to insure intramuscular and intravenous medications were stored in refrigerators that maintained temperatures between 35 degrees Fahrenheit and 49 degrees Fahrenheit in 9 of 9
refrigerators monitored.

On 10/28/2014 during a walking tour of the third floor East wing (3E), the refrigerator used to store pharmaceutical drugs for patient use was visually checked to see if the temperature logs were current and the temperature maintained within recommended parameters.

The documented that was being used to record the refrigerator/freezer temperatures on 3E was titled: "Temperature Log for Refrigerator and Freezer-Fahrenheit". The instructions found on the form reflected the following: Check the temperatures in both the freezer and the refrigerator compartments of your vaccine storage units at least twice each working day. Place a "X" in the box that corresponds with the temperature and record the ambient (room) temperature, the time of the temperature readings, and your initials.
If the recorded temperature is in the shaded zone: This represents an unacceptable temperature range. Follow these steps as quickly as possible. (unacceptable range, above 46 degrees or below 35 degrees)
1. Store the vaccine under prosper conditions as quickly as possible.
2. Temporarily mark exposed vaccine "Do not use" until you have verified whether of not the vaccine may be used.
3. Call the immunization program at your state or local health department and/or call the vaccine manufacturer to determine whether the vaccine is still usable. ( a space on the form was given for a phone number to be placed. No phone number was written in the space)
4. Document the action taken on the reverse side of this log.

Observation revealed the 27 days recorded for the month of October five (4) days were documented with temperatures above 49 degrees. (the highest temperature the form permitted) October 18, 2014 both morning (AM) and evening (PM) temperatures were documented as 56 degrees. October 19, 2014 the recorded AM temperature was 56 and the PM temperature was recorded as 54. October 24, 2014 the AM temperature was recorded as 48 degrees and on October 27 both AM and PM temperatures were recorded as 49 degrees. All of these temperatures were documented within the shaded zone above a bold printed statement that read "Take immediate corrective action if temperature is in the shaded section". Review of the findings were confirmed by RN staff # 12. Further scrutiny of the temperature log revealed no corrective action was documented. There was no indication the content of the refrigerator was removed to proper temperature storage and no indication the safety of the drugs contained within this refrigeration unit were check for safety with the manufacturer or any health department.

On October 29, 2014 at 2:30 PM, a tour of the hospitals pharmacy department request to review all refrigerator/freezer logs.

Third Floor East wing refrigerator revealed:
July 2014 documented 1 of 31 days with a temperature out of range. On July 27, 2014 a recorded temperature of 52 degrees was identified with a notation "door open". There was no PM temperature documented and no further follow up to insure the proper temperature was regained or maintained.
August 2014, 21 of 31 days documented 1 or both daily temperatures were out of range. All temperatures that were out of range were between 50-57 degrees.
September 2014, 29 of 30 days documented 1 or both daily temperatures were out of range. All out of range temperatures were documented between 48-56 degrees.

Third floor West wing refrigerator revealed:
July 2014 documented 3 of 31 days documented 1 or both daily temperatures out of range. The out of range temperatures were between 47-48 degrees.
August 2014 documented 3 of 31 days with temperatures out of range. September 3,4,5 of 2014 recorded temperature below freezing.
September 2014 documented 2 of 30 days each documented 1 daily temperature at 47 degrees.

Fourth floor East wing refrigerator revealed:
August 2014 documented 4 of 31 days with 1 or both daily temperatures between 47-49 degrees.

Fourth floor West wing refrigerator revealed:
July 2014 documented 8 of 31 days with one or both daily temperatures recorded 32-34 degrees.
August 2014 documented 20 of 31 days with 1 or both daily temperatures recorded between 29-34 degrees.
September 2014 the refrigerator documented 15/31 days with 1 or both daily temperatures 23-34 degrees and 13 of 31 days recorded 1 or both daily temperatures between 52-58 degrees.

Fifth flour West wing refrigerator documented
July 2014 documented 15 of 31 days with 1 or both daily temperatures between 49-63 degrees.
August 2014 documented 16 of 31 days with 1 or both daily temperatures between 47-52 degrees.
September 2014 documented 14 of 31 days documented 1 or both daily temperatures between 47-51 degrees. The refrigerator identified as the "IV" (intravenous fluids) refrigerator revealed 4 of 30 days with no recorded temperature. September 6,7,8 documented "no thermometer?"September the 21 documented no temperature and "Wire cut in 2 (sic) no reading".

CICU (Coronary Intensive Care Unit)
August 2014 documented 1 of 31 days with a temperature recorded at 34 degrees.
September 2014 documented 2 of 30 days with temperatures recorded at 34 degrees and 60 degrees.

ICU (Intensive Care Unit)
July 2014 the IV storage refrigerator documented 7/31 days with temperatures below 35 degrees. 4 of those were below freezing.
August 2014 the vaccine refrigerator documented 2 of 31 where 1 of both daily temperatures were between 47-48 degrees.

Emergency Room (ER)
July 2014 documented 3 of 31 days with 1 of both daily temperatures between 47-56 degrees.
August documented of 31 days with 1 or both daily temperatures between 47-54 degrees.

The refrigerator in the house supervisors office (used to store medications)
August 201426 of 31 days the daily temperature was recorded between 48-50 degrees.
September 2014 documentation revealed 8 of 31 days with recorded temperatures between 48-50 degrees.

All nine (9) refrigerators were found to have failed to maintain the internal temperature within safe parameters between 35 degrees and 46 degrees. This was confirmed by consulting pharmacist #39. Further review of the documentation revealed no corrective action was indicated. The medication was not removed to a working refrigeration unit, the medication was not checked for safe usage with the manufacturer or local health department and no request for service of any unit which did not maintain desired temperature was identified. This was also confirmed by consultant Pharmacist #39.

Based on document review and interview the facility failed to insure the pharmacy staff had specific job duties listed in job description . The pharmacist failed to monitor pharmacy staff for job duties.

On 10/28/2014 during a walking tour of the third floor East wing (3E), the refrigerator used to store pharmaceutical drugs for patient use was visually checked to see if the temperature logs were current and the temperature maintained within recommended parameters.

The documented that was being used to record the refrigerator/freezer temperatures on 3E was titled: "Temperature Log for Refrigerator and Freezer-Fahrenheit". The instructions found on the form reflected the following: Check the temperatures in both the freezer and the refrigerator compartments of your vaccine storage units at least twice each working day. Place a "X" in the box that corresponds with the temperature and record the ambient (room) temperature, the time of the temperature readings, and your initials.
If the recorded temperature is in the shaded zone: This represents an unacceptable temperature range. Follow these steps as quickly as possible. (unacceptable range, above 46 degrees or below 35 degrees)
1. Store the vaccine under prosper conditions as quickly as possible.
2. Temporarily mark exposed vaccine "Do not use" until you have verified whether of not the vaccine may be used.
3. Call the immunization program at your state or local health department and/or call the vaccine manufacturer to determine whether the vaccine is still usable. ( a space on the form was given for a phone number to be placed. No phone number was written in the space)
4. Document the action taken on the reverse side of this log.

Observation revealed the 27 days recorded for the month of October five (4) days were documented with temperatures above 49 degrees. (the highest temperature the form permitted) October 18, 2014 both morning (AM) and evening (PM) temperatures were documented as 56 degrees. October 19, 2014 the recorded AM temperature was 56 and the PM temperature was recorded as 54. October 24, 2014 the AM temperature was recorded as 48 degrees and on October 27 both AM and PM temperatures were recorded as 49 degrees. All of these temperatures were documented within the shaded zone above a bold printed statement that read "Take immediate corrective action if temperature is in the shaded section". Review of the findings were confirmed by RN staff # 12. Further scrutiny of the temperature log revealed no corrective action was documented. There was no indication the content of the refrigerator was removed to proper temperature storage and no indication the safety of the drugs contained within this refrigeration unit were check for safety with the manufacturer or any health department.

On October 29, 2014 at 2:30 PM, a tour of the hospitals pharmacy department request to review all refrigerator/freezer logs.

Third Floor East wing refrigerator revealed:
July 2014 documented 1 of 31 days with a temperature out of range. On July 27, 2014 a recorded temperature of 52 degrees was identified with a notation "door open". There was no PM temperature documented and no further follow up to insure the proper temperature was regained or maintained.
August 2014, 21 of 31 days documented 1 or both daily temperatures were out of range. All temperatures that were out of range were between 50-57 degrees.
September 2014, 29 of 30 days documented 1 or both daily temperatures were out of range. All out of range temperatures were documented between 48-56 degrees.

Third floor West wing refrigerator revealed:
July 2014 documented 3 of 31 days documented 1 or both daily temperatures out of range. The out of range temperatures were between 47-48 degrees.
August 2014 documented 3 of 31 days with temperatures out of range. September 3,4,5 of 2014 recorded temperature below freezing.
September 2014 documented 2 of 30 days each documented 1 daily temperature at 47 degrees.

Fourth floor East wing refrigerator revealed:
August 2014 documented 4 of 31 days with 1 or both daily temperatures between 47-49 degrees.

Fourth floor West wing refrigerator revealed:
July 2014 documented 8 of 31 days with one or both daily temperatures recorded 32-34 degrees.
August 2014 documented 20 of 31 days with 1 or both daily temperatures recorded between 29-34 degrees.
September 2014 the refrigerator documented 15/31 days with 1 or both daily temperatures 23-34 degrees and 13 of 31 days recorded 1 or both daily temperatures between 52-58 degrees.

Fifth flour West wing refrigerator documented
July 2014 documented 15 of 31 days with 1 or both daily temperatures between 49-63 degrees.
August 2014 documented 16 of 31 days with 1 or both daily temperatures between 47-52 degrees.
September 2014 documented 14 of 31 days documented 1 or both daily temperatures between 47-51 degrees. The refrigerator identified as the "IV" (intravenous fluids) refrigerator revealed 4 of 30 days with no recorded temperature. September 6,7,8 documented "no thermometer?"September the 21 documented no temperature and "Wire cut in 2 (sic) no reading".

CICU (Coronary Intensive Care Unit)
August 2014 documented 1 of 31 days with a temperature recorded at 34 degrees.
September 2014 documented 2 of 30 days with temperatures recorded at 34 degrees and 60 degrees.

ICU (Intensive Care Unit)
July 2014 the IV storage refrigerator documented 7/31 days with temperatures below 35 degrees. 4 of those were below freezing.
August 2014 the vaccine refrigerator documented 2 of 31 where 1 of both daily temperatures were between 47-48 degrees.

Emergency Room (ER)
July 2014 documented 3 of 31 days with 1 of both daily temperatures between 47-56 degrees.
August documented of 31 days with 1 or both daily temperatures between 47-54 degrees.

The refrigerator in the house supervisors office (used to store medications)
August 201426 of 31 days the daily temperature was recorded between 48-50 degrees.
September 2014 documentation revealed 8 of 31 days with recorded temperatures between 48-50 degrees.

All nine (9) refrigerators were found to have failed to maintain the internal temperature within safe parameters between 35 degrees and 46 degrees. This was confirmed by consulting pharmacist #39. Further review of the documentation revealed no corrective action was indicated. The medication was not removed to a working refrigeration unit, the medication was not checked for safe usage with the manufacturer or local health department and no request for service of any unit which did not maintain desired temperature was identified. This was also confirmed by consultant Pharmacist #39.

The above lack of documentation was discussed at length with the pharmacist and it was discovered that the job description for the pharmacy tech did not include checking the accuracy of the refrigerator and the pharmacist job description did not include oversight of the safe functioning of the refrigeration units or the pharmacy tech who was recording the data. It was also confirmed no pharmacist was reviewing the data for the refrigeration units.

Based on observation and interview, the facility failed to ensure equipment had electrical safety checks completed in the appropriate time frames. Two fans in the offsite cardiac rehabilitation area had past-due electrical safety checks. One fan in the offsite cardiac rehabilitation area had not been checked for electrical safety.

Findings include:

During a tour of the offsite cardiac rehabilitation area on 10/28/14 at 10:50am, the following was observed:
-a fan had a biomedical electrical safety check sticker dated 8/31/12 (due for re-checks in August 2013 and 2014);
-a fan had a biomedical electrical safety check sticker dated 12/07/09 (due for re-checks in December 2010, 2011, 2012, and 2013);
-a fan had no biomedical electrical safety check sticker, indicating it had not been checked for electrical safety.

During the tour, staff #16 confirmed this observation and reported the checks should occur annually.

Based on observation, document review and interview the facility failed to

A. monitor the quality care provided by 3 of its patient care related contracted services (Hospice, Dialysis, and Linen & Laundry).

Refer to A0308


B. separate clean supplies from soiled items in the dialysis storage area and in the dialysis treatment area. These finding have the likelihood to cause cross contamination of clean equipment and supplies which could increase the risk of infection to the patient by allowing clean equipment to come in contact with dirty equipment and supplies.

Refer to A0749

Based on observation and interview, the facility failed to separate clean supplies from soiled items in the dialysis storage area and in the dialysis treatment area. These finding have the likelihood to cause cross contamination of clean equipment and supplies which could increase the risk of infection to the patient by allowing clean equipment to come in contact with dirty equipment and supplies.

Findings:

Observation in the dialysis storage area and set up area on 10/272014 revealed clean and sterile supplies mixed with dirty items such as shipping cartons, a bottle of pink liquid, and unlabeled bottles containing a yellow liquid. There were two dialysis machines sitting side by side. One was ready for use and one was in the area for repair. The floor behind the machines was unsealed porous concrete. There were cases of supplies sitting directly on the floor. In the corner were boxes of open "clean" dialyzers with boxes of contaminated items, such as PVC cement, hoses, and other unclean items.

In the dialysis unit, there was a container of expired bicarb sitting on a dialysis machine in the small dialysis treatment room. In the larger room, there were unsecured medications and supplies.

An interview with staff # 2 on 10/27/2014 at approximately 1:30 p.m. confirmed the equipment repair is done in the same area as the clean equipment and supplies. In addition, staff #2 confirmed the condition of the storage area and the dialysis treatment area.