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Based on interview and data/policy review the hospital governing body failed to ensure that all services performed under a contract were provided in a safe and effective manner.

Findings included: The nuclear medicine services provided under contract were not monitored for effectiveness and safety of services and quality of care under the hospital QAPI (Quality Assurance Performance Improvement) program.

During the review of the condition of participation for Radiology services conducted at 10:00 a.m. on 6/15/11, with the Radiology supervisor, reports of QAPI participation for all contracted services was requested. The supervisor verified there were two (2) outside contracts for Radiology services currently in effect.

The supervisor verified QAPI reports were performed for/by the diagnostic teleradiology services; however, a report could not be located for the contracted services that provided cardiac and nuclear imaging services and the director did not think they were ever included in the QAPI process and was not sure if they performed their own QA activity and/or if the information was shared with the hospital. The director also reported the imaging services provided, on average, about 40 tests per month. Review of governing body meeting minutes lacked evidence the contracted Radiology services (nuclear medicine) had been integrated into the QAPI reports.

During interview with the QAPI program director at 11:00 a.m. on 6/16/11, QAPI data was provided for teleradiology services; however, evidence was not located for participation in QAPI by the nuclear medicine provider. Contract records indicated the nuclear medicine contract had been in effect since 11/17/97.

Based on interview and data review the hospital failed to ensure data was collected for the Quality Assessment and Performance Improvement Program (QAPI) for all services provided under contract or arrangement.

Findings included: The nuclear medicine services provided under contract were not monitored for effectiveness and safety of services and quality of care under the hospital QAPI program.

During the review of Radiology services conducted at 10:00 a.m. on 6/15/11, with the Radiology supervisor, reports of QAPI participation for all contracted services was requested. The supervisor verified there were two (2) outside contracts for Radiology services currently in effect.

The supervisor verified QAPI reports were performed for/by the diagnostic teleradiology services; however, a report could not be located for the contracted services that provided cardiac and nuclear imaging services and the director did not think they were ever included in the QAPI process and was not sure if they performed their own QA activity and/or if the information was shared with the hospital. The director also reported the imaging services provided, on average, about 40 tests per month.

During interview with the QAPI program director at 11:00 a.m. on 6/16/11, QAPI data was provided for teleradiology services; however, evidence was not located for participation in QAPI by the nuclear medicine provider. Contract records indicated the nuclear medicine contract had been in effect since 11/17/97.

Based on observation, interview, and policy review the hospital failed to ensure outdated, unusable drugs were not available for patient use in 1 of 3 (Rochester Main Clinic Building) outpatient clinics reviewed.

Findings include: Outdated, single dose medication had not been disposed of properly in the outpatient clinic. The orthopaedic/sports medicine clinic was toured on 6/15/11, at 3:35 p.m. during which it was noted that in the clinics stock medication storage cupboard there were several Hyalgan medications for use in the stock medication cupboard and there was also one injectable medication "Hyalgan" labeled with a specific patients name. The syringe had been opened from its package and a portion of the medication had been used. Licensed Practical Nurse (LPN)-A was interviewed at 3:42 p.m. on 6/15/11, during which she stated that it was not the clinics usual practice to store individual patient medications in the stock medication area, but it had been done for this particular patient because the patient was going to return within two weeks for another injection when the remaining Hyalgan medication was going to be utilized. Additionally, LPN-A stated the partially used Hyalgan medication syringe had been initially opened and partially used on 1/3/2011 (5 months earlier).

Review of the drug manufacturers recommendations for Hyalgan use revealed the following information noted under the section "Precaution: The vial/syringe is intended for single use. The contents of the vial must be used immediately once the container has been opened. Discard any unused Hyalgan..."

Review of the hospital policy "Expiration Dating for Medications and Vaccines Revised 06/11" revealed the following: "After use, ampules and syringes are discarded in appropriately marked biohazard, sharps, and hazardous waste containers..."

The Director of Pharmacy Services was interviewed at 8:35 a.m. on 6/16/11, during which she confirmed the orthopaedic clinic should not be storing individual patient medications in the same area as their stock medications and the Hyalgan medication should be used according to the manufacturers recommendations.

Based on interview and policy review the hospital failed to develop policies that included all components for content of notification and counseling of recipients that may have received infectious blood and blood components. This has the potential to affect all patients who received blood transfusions.

Findings included: Laboratory policies lacked a method to ensure all required content of the notification was provided to the affected recipients of infectious blood and blood components.

During review of the laboratory services condition of participation at 8:30 a.m. on 6/14/11, the clinical laboratory supervisor provided policies for blood bank look back program dated 12/2008. The policy did indicate that patients who received infectious blood and blood components from the blood product supplier be contacted within 7 days, "to ensure the proper care and counseling of the recipient."

The policy noted the recipient's ordering provider would be notified by the hospital laboratory and provided with patient demographics and contact information for the patient. The lab supervisor verified the expectation was that the physician bear the responsibility to provide details of the notification to the recipient and the hospital laboratory only reported clinical information (Possible Recipient Transfusion-Transmitted Infection Case Report form) back to the blood services supplier. There was, however, no hospital policy that ensured the notification was completed and contained all required information that included a basic explanation of the need for HIV or HCV testing and counseling, enough oral or written information for an informed decision of testing and counseling and a list of programs or places where the person could obtain testing and counseling including any requirement or restrictions the program may impose.

The hospital policy also did not include a contingency for the hospital to provide the notification to the recipient in the event the ordering physician failed to make the proper notification and did not contain the required information to provide to the recipient.

The lab supervisor also reported the laboratory medical director should discuss the look back process with the medical staff to ensure notifications were properly provided and include a method for the hospital laboratory to provide the information if required.

Based on interview and record review the facility failed to maintain a current therapeutic diet manual that was approved by the dietician and medical staff. This had the potential to affect any patients served by the hospital.

Findings include: A current therapeutic diet manual had not been approved for over over 5 years. On 6/14/11 at 3:45 p.m. through 4:25 p.m. a tour of the facility's kitchen was conducted with the registered dietician (RD). During the tour it was noted the facility's therapeutic diet manual was last reviewed and approved by the registered dietician and medical staff on 5/19/05. In an interview at the time, the RD verified these findings and stated she was aware of the requirement to review, update and sign off on the manual every five years. The RD stated this was an over site on her behalf.

Based on observation, interview and policy review the hospital failed to have adequate procedures for the proper storage/disposal of contaminated biohazardous waste for 1 of 1 large waste receptacle utilized for such materials.

Findings included: Biohazardous waste materials were observed stored in an unsecured receptacle located outside the hospital loading/unloading zone area and not safe from unauthorized access to the materials contained within.

During the physical environmental tour conducted at 9:15 a.m. on 6/16/11, a red receptacle was noted located at the end of the loading/unloading dock area near the back parking lot of the hospital. The physical plant/maintenance director verified the receptacle contained red bagged biohazardous waste materials that were ready for pick up by the trash disposal vendor. No locking mechanism was noted on the receptacle and the supervisor could not verify if the container was actually secured in a manner that prevented unauthorized entry and removal of the materials.

The plastic receptacle for the biohazardous materials was a red color; however, signage that identified the contents as biohazardous waste was not apparent and viewable from all directions.

Based on observation and interview the hospital failed to ensure that toxic chemical cleaning solutions and Biohazardous Waste materials were stored in a safe manner. This has the potential to affect any children visiting the Birthing Center.

Findings include: The hospital failed to store cleaning solutions in locked cabinets.

During an environmental tours of the Birthing Center on 6/14/11 at 4:15 p.m., it was observed that cleaning solutions were available for use in an unlocked soiled utility room. The available products included: Oxivir disinfectant six (6) 32 oz spray bottle containers; 3 &1 Floor Cleaner a two (2) liter container that was 1/3 full; Non acid Bathroom Cleaner; General Purpose Cleaner two (2) liters; Two (2) Neutral Cleaner two liter bottles; Alpha-H B52 four (4) spray bottles; one (1) spray bottle of Super Spray buff; Ten (10) 16 oz bottles of Betadine; Six (6) 32 oz bottles of Hibiclens. In addition, in the cabinet under the sink was a container of Manu Klenz Concentrate.

The Material Safety Data Sheets (MSDS) for the Manu Klenz was reviewed on 6/16/11 and indicated that it could cause irritation to the eyes & skin and could cause nausea, vomiting and diarrhea if swallowed. The MSDS sheet for the Betadine indicated that if the product got in the eyes it should be thoroughly rinsed, and if a large quantity was ingested vomiting should be induced & a physician consulted to monitor the person's thyroid.
A refrigerator in the soiled utility room was observed to be labled "Biohazardous Waste". The Registered Nurse (RN) OB (obstetrics) manager stated they stored placentas following deliveries for one week so the lab would not have to store them.


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During the physical environment tour conducted on 6/16/11 at 8:45 a.m. the utility room on the birthing center was noted to contain various containers of cleaning supplies located on the work surface and/or the lower shelves/cabinets. Included with the supplies were bottles of Oxivir Tb for surface cleaning and Manu-Klenz for cleaning/disinfecting of instruments.

The physical plant/maintenance director verified the location of the supplies and stated, "These supplies should be secured; they should be on a high shelf or if low, secured by a child proof door latch." The director also stated if they were to be stored as they were located in the utility room, the outside door should have a locking mechanism installed. A MSDS for the Manu-Klenz was requested and provided; the MSDS identified classification as a material causing toxic effects and irritation to the skin, eyes and gastrointestinal tract.

Based on observation, interview and policy review, the hospital failed to perform an adequate "Time Out" prior to surgery for 1 of 3 surgeries (S1) observed.

Findings include: The surgical staff failed to conduct a formal "Time Out" prior to performing surgery for S1 as required per hospital policy. Surgical patient (S1) was scheduled for a left shoulder rotator cuff repair on 6/14/2011. S1' s date of birth is 6/18/1949. There was a diagnosis to include but not limited to recurrent rotator cuff tear, left shoulder, restless leg syndrome, obesity and hypertension.

S1 was taken into the operating room 5 on 6/14/2011, at 10:53 a.m. The orthopedic surgeon arrived in the operating room right after the patient. The surgeon was observed to assist with positioning of the patient for the surgical procedure and stated, "we are doing a left shoulder right?" The other operating room staff did not stop to participate and complete the time out procedure. The nurse anesthetist and anesthesiologist were observed preparing the anesthetic agent for administration at 10:53 a.m. The surgeon, after scrubbing and applying sterile gown and gloves proceeded to drape the patient, leaving the left arm and shoulder exposed. After the surgical site had been draped, an injection of a local anesthetic was given and the procedure started. There was no verbal identification of the patient prior to the procedure being started. At no time was an attempt made by any of the surgical staff in the operating room to ask for a formal "Time Out " to ensure the right patient, right body part and right procedure was being performed.

Review of S1's record revealed an "Operating Room Record." On the record was documented a "Time Out" which indicated S1 had been identified verbally, by identification band, patient verification of procedure, by consent and by the surgeon. The record indicated the nurse anesthetist had documented the time out at 11:15 a.m. on 6/14/11. Although the surveyor had been present in the operating room from 10:53 a.m. until 11:40 a.m., at no time had these procedures been.

On 6/14/2011 at 3:00 p.m. the operating room supervisor, circulating nurse A (CN-A) and circulating nurse B (CN-B) were interviewed. CN-A verified that a time out was not done. The operating room supervisor, CN-A and CN-B confirmed that a time out should have been performed prior to the surgical procedure.

The policy "Time Out before a Procedure" dated 9/10, was reviewed on 6/15/2011 at 3:00 p.m. The procedure indicated that: (1.) in the operating room, the surgeon is responsible for calling the time out prior to starting the procedure; (2.) In other invasive procedure areas, the person performing the procedure is responsible for calling the time out before the procedure begins; (3.) All team members are required to stop other activities and pause for the duration of the time out; (4.) The time out must include verifying the following: correct patient identity, correct side and site, agreement on the procedure to be done, correct patient position, availability of any special equipment or special requirements; (5.) If discrepancies are noted during the time out, the team must stop and reconcile the discrepancy before moving forward with the procedure; (6.) It is the responsibility of each team member to stop moving forward with the procedure if a time out has not been conducted.