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Based on observation, document review, and staff interview, the Critical Access Hospital (CAH) failed to ensure that all operating room staff documented the shortened (90 day) expiration date on 1 of 1 bottle of Cidex OPA test strip containers once opened, in accordance with the manufacturer's directions for use. The CAH identified 11 inpatients at entrance.

Failure to write the shortened expiration date on the container could potentially allow staff testing the Cidex OPA to receive incorrect readings, resulting in the disinfecting solution not containing the Minimum Effective Concentration of the disinfecting compound, and not killing all infectious organisms on equipment. If the disinfecting compound does not kill all infectious organisms, the instruments could pass the infectious organisms to another patient, resulting in the spread of infectious diseases.

Findings include:

1. Observations made during a tour of the operating room on 3/8/10 at 3:40 PM revealed 1 of 1 opened bottle of Cidex OPA test strips in use. [CAH staff use Cidex OPA test strips to ensure the active ingredient in Cidex OPA, ortho-phthalaldehyde, did not fall below the minimum effective concentration, and lack strength to appropriately disinfect items] The manufacturer documented an unopened expiration date of 10/10 on the bottle. The bottle lacked documentation that showed the date CAH staff opened the bottle, or 90 day expiration date. The bottle's label indicated the bottle contained 60 test strips. The surveyor counted 71 test strips.

2. Review of the manufacturer's directors for Cidex OPA test strips revealed, "The shelf life (expiration date) for the unopened CIDEX OPA Solution Test Strips is stamped on the immediate container label. When opening the bottle for the first time, record the date opened in the space provided on the label. PRECAUTIONS: Do not use any remaining strips 90 days after opening the bottle.... Improper storage or use of test strips may result in false readings."

3. During an interview at the time of the tour, the Director of the Operating Rooms acknowledged staff did not label the bottle of Cidex OPA test strips with the date first opened, or the 90 day expiration date. The Director of the Operating Rooms could not provide an explanation why the bottle of test strips contained more strips than the manufacturer stated it included in the bottle.

Based on observation, document review, and interview, the Critical Access Hospital (CAH) operating room staff responsible for cleaning 2 of 2 colonoscopes failed to follow the manufacturer's directions for cleaning the colonoscopes. The CAH staff identified an average of 5 endoscopies performed at the CAH per week.

Failure to follow the manufacturer's directions for cleaning the colonoscopes could potentially lead to ineffective disinfection potentially resulting in transmission of infectious organisms between patients.

Findings include:

1. Observations made during a tour of the operating rooms on 3/8/10 at 3:40 PM, revealed that 1 of 1 irrigation tubes currently available for use in the colonoscope contained residual water.

2. During an interview on 3/8/10 at 3:40 PM, the Director of the Operating Rooms stated operating room staff connected the irrigation tube to the colonoscope, and used the same irrigation tube for every procedure performed during the day. According to the Director of the Operating Rooms, the operating room staff do not sanitize the irrigation tube between procedures performed. The operating room staff clean and sanitize the irrigation tube after the physician had finished all endoscopic procedures for the day. Operating room staff wash the irrigation tube with an enzymatic solution. After washing the irrigation tube with the enzymatic cleaner, operating room staff force compressed oxygen through the irrigation tubing, and then force isopropyl alcohol [rubbing alcohol] through the irrigation tubing to remove all traces of water. The Director of the Operating Rooms stated staff failed to either dry the irrigation tubing, or clean the irrigation tubing after staff completed all endoscopic procedures for the day.

3. Review of the policy, "Cleaning and disinfecting [endo]scopes", revised 9/09, revealed in part, "... the scope will be cleaned per manufacturers's directions."

4. Review of the "Pentax EC-3831LK video GI scope owner's manual", provided by the Director of the Operating Rooms, revealed in part, "The irrigation tube ... should be attached... Fresh (or reused actively effective) disinfecting solution should be flushed through this connection..."

5. Observations on 3/10/10 at 1:15 PM showed Surgical Technician A cleaning the colonoscope in the dirty utility area of the operating rooms. Surgical Technician A flushed the irrigation tubing with enzymatic cleaner, rinsed the enzymatic cleaner with tap water, blew oxygen through the irrigation tubing, and then flushed isopropyl alcohol [rubbing alcohol] through the irrigation tubing. Surgical Technician A failed to expose the irrigation tubing to a high level disinfecting solution, as recommended by the manufacturer.

6. During an interview on 3/10/10 at 3:15 PM, Pentax Medical Corporation's National Service Manager stated, "The [irrigation tubing] must be cleaned after every patient. The [irrigation tubing] must be exposed to a high level disinfectant..." "The [irrigation tubing] is part of the colonoscope, and must be cleaned after every patient, alcohol must be run through the tubing after cleaning, and [the tubing] must be dried after every patient."

7. Observations on 3/10/10 at 1:15 PM showed Surgical Technician A cleaning the colonoscope in the dirty utility area of the operating rooms. Surgical Technician A failed to flush all lumens with alcohol before using forced air drying.

8. Review of the "Pentax EC-3831LK video GI scope owner's manual", provided by the Director of the Operating Rooms, revealed the following, in part, "Warning: Prior to storage it is important that no residual water be left within any internal channel/lumens [water or air passages] of the endoscope or accessories. Thoroughly dry all instrument surfaces to reduce the potential for bacterial colonization [growth of bacteria] during storage. Ethyl alcohol [drinking alcohol] followed by compressed air, ... should be used to facilitate drying of the internal channels."

9. During an interview on 3/9/10 at 3:15 PM, Pentax Medical Corporation's National Service Manager stated, "I always teach people to flush alcohol through [all channels] after cleaning the colonoscopes."

10. During an interview on 3/10/10 at 3:00 PM, the Director of the Operating Rooms stated operating room staff used compressed oxygen to blow the liquid out of the colonoscopes because compressed oxygen is the only compressed gas available in the area, and contained less moisture than compressed air. The staff did not follow the manufacturer's directions for cleaning the colonoscopes "because its always been done that way."

Based on document review, observation, and staff interview, the Critical Access Hospital's (CAH) Imaging Services Director failed to provide dosimetry badges to all staff in the operating room during surgical procedures utilizing the C-Arm fluoroscope. The CAH staff perform an average of 3 surgical procedures utilizing the C-Arm fluoroscope per month, and 6 staff members present in the room during procedures utilizing the C-Arm fluoroscope.

Failure to provide dosimetry badges could potentially result in exposure of staff to unintentional and unknown amounts of ionizing radiation, potentially causing cancer or death.

Findings include:

1. During an interview on 3/8/10 at 3:40 PM, the Director of the Operating Rooms stated the CAH performed C-Arm fluoroscope procedures in the operating room. The Imaging Services Director did not provide all staff in the operating room with dosimetry badges to monitor exposure to ionizing radiation.

2. During an interview on 3/10/10 at 8:10 AM, the Director of the Operating Rooms stated during a procedure using a C-Arm fluoroscope, 1 surgeon, 1 anesthesia provider, 2 assistants to the surgeon, 1 circulating nurse, and 1 Radiology Technologist are present in the room, and potentially exposed to ionizing radiation. The Director of the Operating Rooms stated the operating room staff wore lead aprons and thyroid shields during C-Arm fluoroscope procedures, but did not wear dosimetry badges. However, the Imaging Services Director had ordered dosimetry badges for operating room staff present during C-Arm fluoroscope procedures.

3. During an additional interview on 3/10/10 at 10:10 AM, the Director of the Operating Rooms stated the Imaging Services Director had not order dosimetry badges for the operating room staff.

4. Review of policies and procedures revealed that the CAH staff failed to develop and implement policies and procedures that educated staff exposed to radiation, of the potential danger when exposed to excess amounts of radiation, or policies and procedures that required all staff exposed to ionizing radiation to wear dosimetry badges.

5. On 3/11/10 at 9:30 AM, the Assistant Administrator presented the survey team with a purchase order, dated 3/10/10, to Landau for 10 radiation monitoring badges.

Based on policy review, document review, and staff interviews, the CAH hospital staff failed to document individual or group activities provided to skilled patients, and ensure the plan of care included activity goals for 5 of 5 open (#1, 2, 3, 4, and 5) and 5 of 5 closed skilled records reviewed (#6, 7, 8, 9, and 10). Failure to provide an activity program that meets the physical and psychosocial needs of the individual patient could potentially impede the physical and psychological well being of patients. The hospital reported a current census of 5 skilled patients.

Findings include:

1. Review of Wayne County Hospital Skilled Nursing Care Policy titled "Activities", approved 3/2010, revealed in part, "The policy will provide a structure for staff in assessing and implementing an activity plan for residents. Implementing activities for the swing bed residents will provide social interaction, reality orientation, maintain or increase physical activity level, and increase feelings of self esteem and wellbeing. The Swing Bed Activities Coordinator, under the direction of the Swing Bed Nurse Manager/Case Manager, is responsible for the assessment, planning, implementation and evaluation of the activities program for the skilled level and private pay nursing level residents. Residents will be interviewed about their activity level, activity interest, and activity goals. An appropriate activity plan will be initialed on all swing bed residents who stay more than 72 hours."

2. Review of the open medical record for Patient #1, admitted to the skilled unit on 3/5/10, revealed staff did not complete an activities assessment. Review of the Activity Progress Note, Monthly Tracking sheet, and Nurses Notes revealed staff did not document any individual or group activities provided to patient #1. Review of the chart also revealed the Care Plan, initiated on 3/5/10, and reviewed on 3/8/10, lacked activity goals.

3. Review of the open medical record for Patient #2, admitted to the skilled unit on 1/30/10, revealed staff completed the activity assessment on 2/3/10. Review of the activity specialist's documentation in the Activity Progress Notes, and Monthly Tracking sheets on 2/3/10, 2/8/10, 2/17/10, 2/24/10, and 3/3/10 revealed patient #2 received family visits, watched TV, received reading material, and visits from staff. Review of the Nursing Notes revealed nursing staff did not provide individual or group activities. Review of the chart also revealed the Care Plan, initiated on 1/30/10, reviewed on 1/31/10, 2/15/10, 2/19/10, 2/20/10/2/26/10, 3/3/10, 3/6/10 and 3/8/10, lacked activity goals.

4. Review of the open medical record for patient #3, admitted to the skilled unit on 3/1/10, revealed staff completed the activity assessment, but did not write the date on the form when staff completed the activity assessment. Review of the Activity Specialist's documentation in the Activity Progress Notes and Monthly Tracking sheets from 3/3/10, revealed patient #3 received family visits, reading material, and visits from staff. The Nursing Notes lacked documentation nursing staff provided individual or group activities to patient #3. Review of the chart also revealed the Care Plan, initiated on 3/1/10, and reviewed on 3/3/10 and 3/7/10, lacked activity goals.

5. Review of the open medical record for patient #5, admitted to the skilled unit on 2/18/10, and readmitted on 3/3/10, revealed staff completed the first activity assessment on 2/24/10. The Activity Specialist documented int he Activity Progress Notes and Monthly Tracking sheets on 2/24/10, patient #4 reviewed reading material, visits from staff, and watched TV. Staff did not complete the activity assessment upon readmission to the skilled unit on 3/3/10. The Activity Progress Review also lacked documentation of the readmission to the skilled unit. The Activity Progress Notes, Monthly Tracking sheets, and Nursing Notes lacked documentation of individual or group activities provided to patient #4. Review of the Nursing Notes revealed nursing staff did not offer individual or group activities to patient #4. Review of the chart also revealed the Care Plan, initiated on 2/18/10 and 3/3/10, reviewed on 2/25/10, 3/6/10, and 3/9/10, lacked activity goals.

6. Review of the open medical record for patient #5, admitted to the skilled unit on 3/4/10, revealed staff did not complete the activity assessment, and did not document in the Activity Progress Notes, Monthly Tracking sheet, or Nursing Notes any individual or group activities offered to patient #5. Review of the Care Plan, initiated 3/5/10, and reviewed on 3/8/10, revealed the Care Plan lacked activity goals.

7. Review of the closed medical record for patient #6, admitted to the skilled unit on 1/18/10, and discharged on 1/22/10, revealed staff completed the activity assessment on 1/20/10. The Activity Specialist documented on 1/20/10, in the Activity Progress Notes and Monthly Tracking sheet, patient #6 received family visits, reading material, visits from staff, and watched TV. The Nursing Notes lacked documentation of nursing staff providing individual or group activities to patient #6. Review of the chart also revealed the Care Plan, initiated on 1/18/10, and reviewed on 1/22/10 and 3/7/10, lacked activity goals.

8. Review of the closed medical record for patient #7, admitted to the skilled unit on 12/8/09, and discharged on 12/17/09, revealed staff completed the activity assessment on 12/9/09. The Activity Specialist documented on 12/9/09 and 12/15/09, in the Activity Progress Notes and Monthly Tracking sheet, patient #7 reviewed reading material, visits from staff, and watched TV. The Nursing Notes lacked documentation nursing staff provided individual or group activities to patient #7. Review of the chart also revealed the Care Plan, initiated on 12/8/09, lacked activity goals.

9. Review of the closed medical record for patient #8, admitted to the skilled unit on 11/27/09, and discharged on 12/1/09, revealed staff failed to complete the activities assessment. Staff also did not document in the Activity Progress Notes, Monthly Tracking sheet, or Nursing Notes, and individual or group activities provided to patient #8. Review of the Care Plan, initiated on 11/27/09, revealed the Care Plan lacked activity goals.

10. Review of the closed medical record for patient #9, admitted to the skilled unit on 11/1/09, and discharged on 11/3/09, revealed staff failed to complete the activity assessment. Staff also failed to document in the Activity Progress Notes, Monthly Tracking sheet, or Nursing Notes, any individual or group activities provided to patient #9. Review of the chart also revealed the Care Plan, initiated on 11/1/09, lacked activity goals.

11. Review of the closed medical record for patient #10, admitted to the skilled unit on 10/22/09, and discharged on 10/22/09, revealed staff completed the activity assessment on 10/21/09. The Activity Specialist documented on 10/21/09 in the Activity Progress Notes and Monthly Tracking sheet, patient #10 received family visits, reading material, visits from staff, and watched TV. The nursing notes lacked documentation of individual or group activities provided to patient #10. Review of the chart also revealed the Care Plan, initiated 10/20/09, lacked activity goals.

12. During an interview on 3/10/10 at 3:45 PM, the Chief Nursing Officer (CNO) stated, "the Activity Specialist only comes to the hospital one day a week, on Wednesdays. If the patient is admitted for a short period of time, the activity assessment doesn't get done. Nursing staff are to document activities offered to patients in the Nursing Notes of the skilled patients charts." The CNO also stated, "activity goals are not put on skilled patients' care plans."