HospitalInspections.org

Based on record review and interview the facility staff failed to maintain a complete and accurate medical record for two of forty-two patients in the survey sample. (Patient #20 and Patient #5)

The findings included:

1. Review of Patient #20's medical record revealed the patient received three blood transfusions. Review of the facility's "Transfusion Record and Checklist" revealed nursing staff had failed to identify, which of the twelve products the patient had been administered.

An interview was conducted on September 11, 2012 at 9:25 a.m., with Staff #2 and Staff #3. Staff #2 and Staff #3 reviewed Patient #20's medical record. Staff #3 acknowledged the "Transfusion Record and Checklist" was incomplete. Staff #2 reported the nursing staff had failed to identify, which blood product had been administered to Patient #20.


09881

2. Medical record #5 was reviewed on 9/10/12, at 1:30 p.m., at the nursing station. Patient #5 (Medical record #5) was admitted to the Acute Care facility on 9/5/12. Admitting Diagnosis from the Emergency Room was Diverticulitis [Inflammation of one or more pouches (diverticula) in the wall of the large intestine (colon)]. A verbal order was written on 9/7/12, at 7:45 p.m., by a licensed practical nurse, to transfuse Patient #2, with two units of Fresh Frozen Plasma (Plasma is used to carry many parts of the blood through the blood stream and keep the acid-base balance of the body). No physician's signature was available for the Surveyor to review on 9/10/12. The medical record was not signed within forty eight hours, per the agency's policy, making the medical record incomplete.

The Director of Quality Management acknowledged during interview, that the verbal order had not been signed within 48 hours per the facility's policy. This interview occurred on the Acute Care Facility of the hospital on 9/10/12, at 2:18 p.m.

Based on observations made during a tour of the facility's Clean Utility Room for Oncology, select document review and interviews it was determined that Pharmacy failed to ensure Revonto, a drug used for malignant Hyperthermia was stored in accordance with the manufacturer's specifications. Specifically, 36 vials of Revonto were stored in a locked refrigerator with a temperature reading of 43 degrees Fahrenheit. The product information leaflet found in each box of Revonto stated the drug should be stored at room temperature.

The findings were:

A tour of the facility's Clean Utility Room for Oncology was conducted on September 11, 2012 beginning at or about 2 PM. The room contained a locked Emergency Cart with a refrigerator. The Director for Surgical Services unlocked the cart for inspection. The refrigerator was opened and contained 36 vials of unreconstituted Revonto 20 mg(s). Revonto is used for Malignant Hyperthermia, a condition that may occur very quickly during surgery and requires immediate attention to prevent death. The Director was asked why the medication was stored in the refrigerator and he/she responded by saying, we've always stored it like that. The product information leaflet was removed from one of the boxes and read in part, "Store unreconstituted product at 20 - 25 degrees Celsius (68-77 degrees Fahrenheit) ... and avoid prolonged exposure to light. The Chief Nursing Officer (CFO), who was also on the tour commented that the Pharmacist had a reason for storing it that way and he was immediately called. The Pharmacist arrived shortly and confirmed he had read in some literature that it was acceptable to store Revonto in a refrigerator. The Pharmacist also stated he would get that literature to confirm.

Later that same afternoon the CFO handed this writer information from the Pharmacist. The information came from, "Http://ull.chemistry.uakron.edu/erd/Chemicals/10000/9719.html, and read in part,
"Dantrolene
- 1-((5-p-Nitrophenyl)furfurylidene)amino)hydantoin,
- 1-{{5-(4-Nitrophenyl)furan-2-yl}methylideneamino}midazolidine-2,4-dione.

Storage: Keep in a cool, dry, dark location in a tightly sealed container or cylinder....
Small spills/leaks: STORAGE PRECAUTIONS: You should store this material in a refrigerator."


An Internet search for Revonto (Dantrolene Sodium) information was conducted by this writer on September 12, 2012. The web site, "Http://revonto.com/faqs.asp," was reviewed and a portion of that read, "How do we store Revonto? There has been no change to the storage requirements. Store unreconstituted product at 20-25 degrees C (68-77 degrees F) ..."

Another web search at http://www.rxlist.com also confirmed the same findings as listed above.

On September 13, 2012 at or about 8:54 AM, the company/manufacturer of Revonto was called by this writer. Questions were asked regarding the storage temperature of unreconstituted Revonto; three people confirmed the storage temperature of unreconstituted Revonto should be 68-77 degrees Fahrenheit.

Prior to the exit conference on September 13, 2012, the CNO acknowledged the above findings and stated that they have ordered replacement Revonto.

Based on observations, interviews, and record review the infection control officer failed to ensure policies to prevent the spread of infections were implemented as evidenced by:

1. Operating room (OR) staff failed to change mop water between cleaning OR suites after operations.

2. The staff did not disinfect direct patient equipment between patients.

3. Expired supplies were available to be used during direct patient care.

The findings included:

1. An interview conducted on September 11, 2012 at 3:40 p.m., with Staff #20 revealed the OR staff were responsible for cleaning the OR suites between cases. Staff #20 verbalized the process for mopping the OR suite floors between cases. Staff #20 reported the mop-heads were changed between each OR suite. When asked if the mop water was changed between suites Staff #20 stated "No." Staff #20 reported the purpose for changing the mop-heads between each suite was to prevent the spread of infections. Staff #20 stated, "It makes sense that the water should be changed for the same reason." Staff #20 acknowledged that by not changing the mop water infectious material would be spread by the new mop-head. Staff #20 reported being unaware whether the policy directed that the mop water needed to be changed between OR suites.

2. Observations conducted on September 11, 2012 from 10:40 a.m. to 11:38 a.m. with Staff #2 and Staff #22 during the tour of the radiology department revealed:
· The fluoroscope table had tape and tape residue on the left side at the head and foot of the table. Staff #22 acknowledged the tape and the tape residue prevented the table from being disinfected between patients.
· The C-T table cover had evidence of a clear substance along both sides. Staff #22 identified the substance as "contrast used during procedures." Staff #22 stated, "The contrast is sticky and hard to remove." Staff #22 used a disinfectant cloth with minimum effort and removed the visible drips of contrast. Staff #22 acknowledged the contrast was "fairly easy" to remove from the sides of the cover. Staff #22 stated, "I will have the staff wipe down the sides of the cover between patients." Staff #22 acknowledged the left side of the C-T cover had seven puncture-like tears. Staff #22 acknowledged if the staff did not wipe the C-T table under the cover the table would not be disinfected between patients.
· Radiology (X-Ray) room an angled positioning sponge did not have an intact surface. Three of the corners of the angled positioning sponge were torn.
· The ultra-sound table had multiple tears at the foot and right side of the pad. The surface was not intact and could not be disinfected between patients.

An interview was conducted on September 11, 2012 at approximately 11:40 a.m., with Staff #2, Staff #3 and Staff #22. Staff #2 reported awareness of the need to disinfect patient surfaces between patients. Staff #22 reported being unaware of policy or monitoring audits to ensure equipment had been disinfected between patients.

An observation conducted on September 12, 2012 at approximately 2:08 p.m., with Staff #3 and Staff #20 revealed the fracture table in OR #1 had a tear on the left side near the foot of the surface.

An interview was conducted on September 12, 2012 at 2:10 p.m. with Staff #3 and Staff #20. Staff #20 acknowledged the surface of the fracture table could not be disinfected between patients.


18724

3. During a tour of the Oncology's Clean Utility Room on September 11, 2012 beginning at or about 2 PM, the following expired items were identified in cabinets and or drawers:

Eleven (11) Closed Catheter Needle Systems (needles used for starting intravenous therapy or drawing blood),
Three (3) Monojet needles, and
Eleven (11) Chloraprep One Step, a cleaning preparation used to clean intravenous ports before use.

Expiration dates ranged from March to June of 2012.

The Director of Surgical Services and Chief Nursing Officer both acknowledged the above findings during the tour.

Based on observations made during a tour of the Central Supply area of the hospital's Surgical Suite, select policy review and interview, it was determined that the facility's staff failed to maintain appropriate standards of medical practice. Specifically, expired STERRAD stripes were used in the instrument sterilizer to verify sterilization had taken place.

The findings were:

A tour of the facility's Surgical Suite occurred on September 11, 2012 beginning at approximately 1:15 PM. The facility operates two (2) types of sterilizers for surgical instruments and equipment. The STERRAD, is a sterilizer that uses hydrogen peroxide to sterilize instruments and equipment. Specific protocols/procedures are written and must be followed to assure that anything placed in the sterilizer has been appropriately treated. The STERRAD requires the use of a chemical indicator strip as well as a biological indicator to assure sterilization has taken place. Indicators demonstrate that proper sterilization has taken place when their color strip turns from red to yellow at the end of the sterilization process. Two boxes of STERRAD Chemical indicator strips were sitting on a counter next to the STERRAD machine and had expiration dates stamped on the bottom of the boxes that read, expires 04/12 (April 2012). The Central Supply (CS), person and the Chief Nursing Officer both looked at the boxes and acknowledged the stripes were expired.

An interview with the Central Supply person at that same time confirmed that they were the actual strips used for the STERRAD machine.

The hospital's policy, Sterrad NX Sterilizer, was reviewed in the facility's Administrative Conference Room on September 13, 2012 beginning at 9 AM and read in part, "Chemical indicator goes inside each pouch and/or tray. A second indicator must be placed on the outside of the tray.... They are taped to the outside of the trays after sterilization."