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Based on document review, observation, and interview, it was determined that the Hospital failed to ensure adherence to infection control policies and procedures to help reduce and/or prevent the spread and cross contamination of infectious organisms. The cumulative effect of these systemic practices resulted in the Hospital's inability to ensure all patients were cared for in a safe and sanitary environment. As a result, the Condition of Infection Control (42 CFR 482.42) was not met. This potentially affected all patients and staff at the Hospital.

Findings include:

1. The Hospital failed to ensure adherence to infection control processes for endoscope reprocessing. (A749-A)

2. The Hospital failed to ensure staff maintained and enforced droplet precautions as required. (A749-B)

3. The Hospital failed to ensure staff followed infection control policies and procedures related to personal protective equipment (PPE) and dedicated equipment. (A749-C)

4. The Hospital failed to ensure all patients and visitors in isolation rooms were educated or given written material in regards to required infection prevention procedures. (A749-D).

A. Based on document review, observation, and interview, it was determined the Hospital failed to ensure adherence to infection control processes for endoscope reprocessing. This has the potential to affect all patients having endoscopic procedures.

Findings include:

1. The document titled, "VERIFY Chemical Monitoring Strips for Resert Solutions" was reviewed on 12/10/14. It indicated, "Frequency: Prior to each use to confirm MRC (Minimum Recommended Concentration). And under "Confirmation of MRC for RESERT Solutions Using VERIFY Chemical Monitoring Strips "4. Obtain sample of the Resert Solution to be used. a. AER (Automated Endoscope Reprocessor) - Dispense a 30 ml specimen of Resert Solution from AER (per AER instructions). Confirm temperature is between 68-75F. or 20 - 24C before proceeding.) b. Manual soaking - Confirm temperature is between 68 - 75F or 20-24C before proceeding...."

2. During a tour of the SPA (Special Procedures Area), conducted on 12/10/14 at 2:55 PM, it was observed that the SPA staff utilized 4 machines to reprocess the endoscopes which utilized Resert Solutions in the process. This process is considered a critical process for the endoscope cleansing.

3. The log book for documentation of the testing of the Resert Solution was reviewed for the months of September, October, and November 2014. In Sept 2014, the patient volume was 520 with 288 loads of scopes processed. Sixty-five of the dipstick tests on those loads were utilized with the solution being outside the required temperature range. In Oct 2014, the patient volume was 541 with 275 loads processed and 49 of the dipstick tests were utilized with the solution being outside the required temperature range. In Nov 2014, the patient volume was 521 with 242 loads processed and 59 of the dipstick tests were performed with the solution outside the required temperature range. The total for the three months was a volume of 1582 patients, 805 loads processed, and 173 dipstick tests performed with the solution temperature outside the required range.

4. During an interview with the Gastrointestinal Technician (E-7), conducted on 12/10/14 at 3:00 PM, it was stated that they use the testing dipsticks prior to each load. During an interview with the SPA Nurse Manager (E-1), conducted on 12/10/14 at 3:00 PM, it was stated that the reprocessing staff should have followed the directions for utilizing the dipsticks, taken a 30ml sample of the solution, wait until it cooled into the proper temperature range, and then performed the dipstick test. It was also verbalized that any test results in which the temperature of the solution was outside the required range, should have been reported to E-1.


tB. Based on document review, observation, and interview, it was determined the Hospital failed to ensure staff maintained and enforced droplet precautions as required. This has the potential to affect all patients/staff at the Hospital.

Findings include:

1. The policy and procedure titled, "Respiratory Hygiene/cough Etiquette in Healthcare Settings (With a revised date of Aug 2014) was reviewed on 12/11/14. It indicated under, "VII. Droplet Precautions: A. All health care personnel are to follow droplet precautions by wearing a mask in addition to following standard precautions for close contact with patients who have respiratory symptoms..."

2. During a tour of the 2E Oncology unit, conducted on 12/9/14 at 10:10 AM, at room 264 on 2E Oncology (had signage for droplet isolation) a Nursing Technician (E-8) came out of the room. Immediately after E-8 vacated he area, a male individual was sitting in a chair in the room without wearing a mask.

3. During an interview with the Surveillance Nurse (E-4), conducted on 12/9/14 at 10:13 AM it was stated that the individual sitting in the room should have had a mask on due to the droplet precautions and isolation. Also, it was stated that the Nursing Technician, E-8, should have advised the individual that he was required to wear a mask while in the room.




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C. Based on record review, observation, and interview it was determined that for 4 of 16 patients in isolation (Pts #2, #3, #5, and #6) the Hospital failed to ensure staff followed infection control policies and procedures related to personal protective equipment (PPE) and dedicated equipment. This has the potential to affect all patients receiving care.

Findings include:

1. The policy titled " Hand Hygiene " (revised August 2014) was reviewed on 12/9/2014 at 9:00 AM. Policy noted, " II. Policy Hand Hygiene is to be performed by ALL employees ...when exiting a patient room " .

2. An observational tour was conducted on 12/9/2014 at 11:00 AM -11:15 AM on 2 E Medical Unit with E #2 (2 E Medical Manager). Two physicians exited room #232 without performing hand hygiene.

3. During an interview conducted with the 2E Manager (E #2) on 12/9/2014 at 11:02 AM, E #2 stated, "Hospital policy of infection control was not being followed."

4. The hospital policy titled "Infection Prevention & Control Manual Category Specific Diseases and Conditions Methicillin-Resistant Staphylococcus Aureus (MRSA) " (revised August 2013) was reviewed on 12/9/2014 at 4:00 PM. Policy notes, " III. A.2" Gloves and gowns are worn by all personnel when entering room. "

5. The policy titled " Infection Control Manual Category Specific Diseases, Subject: Clostridium Difficile " (revised September 2014) was reviewed on 12/10/14 at 2:00 PM. Policy notes, " Under Section " III F.1. When possible, each patient will be assigned his or her own equipment to minimize cross contamination. Disposable thermometers and stethoscopes are provided in the isolation carts " .


6. Pt #2's record was reviewed on 12/09/14. The record noted Pt. #2 was admitted 12/8/2014 with the diagnoses of confusion and colostomy disruption. Pt #2 was placed on contact isolation 12/9/2014 for precautionary measures.

7. During an interview conducted with Pt. #2 on 12/9/2014 at 04:15 PM, Pt #2, stated " they use the machine that rolls to do my temperature". (referring to a portable electronic monitoring machine for blood pressure, pulse and temperature).


8. Pt. #3's record was reviewed 12/10/14. The record noted Pt #3 was admitted on 12/4/2014 with a diagnoses of chronic pulmonary disease and congestive heart failure. Pt. #3 was placed on contact isolation 12/5/2014 for precautionary measures.

9. During an interview conducted with Pt. #3 on 12/9/2014 at 04:15 PM, Pt #3 stated " they take my temperature with the blood pressure machine " . (referring to a portable electronic monitoring machine for blood pressure, pulse and temperature).


10. Pt. # 5's record was reviewed on 12/9/14. The record noted, Pt. #5 was admitted on 11/30/14 with diagnosis of pyoderma gangrenosum. Pt. #5 was placed in contact isolation on 12/1/14.

11. During an interview conducted with Pt. #5 on 12/9/2014 at 11:10 AM, Pt. #5 stated, " they take my temperature with the vitals cart. (referring to the mobile electronic monitoring machine for blood pressure, pulse and temperature.)

12. Pt. #6's record was reviewed on 12/10/14. The record noted Pt #6 was admitted on 12/7/2014 with a diagnoses of cellulitis and limb ischemic. Contact precautions were initiated 12/9/2014.

13. During an interview conducted with Pt. #6 on 12/10/14 at 1:30, Pt #6 stated " they take my temperature with the rolling cart. (referring to the mobile vital signs cart)

14. During an interview conducted with E #3 on 12/9/14 at 4:30 PM, E #3 stated "there were no disposable thermometers in Pts #2, #3, #5 or #6's rooms."


D. Bainfection prevention procedures.

1. The policy titled " Infection Control Manual Category - Specific Diseases Subject :Clostridium Difficile " (revised September 2014) was reviewed on 12/10/2014 at 2:00 PM. Policy notes, " H. Patient and Family Education. 2. Clostridium Difficile General Information Pamphlet should be provided to patient and/or family at the time the patient is placed in Contact Precautions " .

2. The policy titled " Infection Prevention & Control Manual Category: Specific Diseases and Conditions Methicillin-Resistant Staphylococcus Aureus (MRSA) (revised August 2013) was reviewed on 12/09/2014 4:00PM. Under section II. F. " Patients must be informed of the isolation procedure and the reason it is instituted .... II. G. " Each patient should receive the MRSA and Standard Precautions brochure and/or " Frequently Asked Questions " flier " . III. 7. " Visitors must perform hand hygiene upon entry and exit of room " .

3. Pt. #3's record was reviewed 12/10/14. The record noted Pt #3 was admitted 12/4/2014 with a diagnoses of chronic pulmonary disease and congestive heart failure. Pt. #3 was placed on contact isolation 12/5/2014 for precautionary measures.

4. During an interview conducted with Pt #3 on 12/10/2014 at 4:30 PM, Pt #3 stated " the infection is in my heart. I have not received any booklets. Nobody has explained any infection education to me " . There was not a Clostridium Difficile Pamphlet in the patient room.

5. Pt # 10's record was reviewed on 12/9/14. The record noted Pt. #10 was admitted on 12/5/2014 with a diagnoses of Right Abdominal Abscess and cellulitis. On 12/7/2014 the lab notified the nursing unit of a positive culture for MRSA. Nursing issued an order for contact Isolation precautions on 12/7/14.

6. An interview was conducted with Pt #10 on 12/9/2014 at 9:40AM. Pt #10 stated " I have an infectious disease, that is flesh eating in my arm and belly. I have had no education on my disease. I did not receive any pamphlets. Should my family wear gloves and gowns?

7. During an interview conducted with Pt #10's family member (mother) on 12/10/2014 at 3:00 PM, Pt #10's family member stated, "We had not received any information or education regarding an infection by nursing staff prior to entering the room. We didn't know what the sign on the door meant."

8. During an interview with an Infection Preventionist, conducted on 12/11/14 at 3:45 PM, it was stated that patient's and family should be educated in infection control procedures related to the patient's illness.sed on document review and interview, it was determined for 2 of 16 (Pt. #3 and #10) patients, the Hospital failed to ensure all patients and visitors in isolation rooms were educated or given written material in regards to required