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Tag No.: C0234
Based on interview it could not be determined the Facility regular inspections of the Facility were conducted by the local Fire Department due to a lack of documentation available for review. The failed practice had the potential to affect the health and safety of all patients, staff and visitors because the Fire Department familiarity of the potential hazards and physical layout of the Facility was not assured. The failed practice had the potential to affect three of three patients on census on 08/12/14 and all staff and visitors. The findings follow:
In an interview on 08/13/14 at 1215 the Maintenance Director verified there was no documentation of Fire Department inspection available for review.
Tag No.: C0271
Based on review of policies and procedures, observation and interview, it was determined the Facility failed to assure patient care policies were current. The failed practice did not assure staff were able to access current policies to use as guidance in delivering patient care or performing tasks and had the potential to affect all patients admitted to the Facility. Findings follow:
A. Review of Policy, "Emergency Room Infection Control" revealed Thermometers: soiled thermometers will be placed in a covered dish (1) to which warm water (6 ounces) and Betadine (2 ounces) will be added and left to soak for one hour. Thermometers are to be washed individually ...in the Betadine solution using a gauze 4x(by)4. During tour of the Facility on 08/12/14 from 1320 to 1430, hand-held digital thermometers were observed on the Nursing Unit and in the Emergency Department. During interview with the Nurse Manager on 08/14/14 at 1220, she confirmed individual thermometers were no longer used in the Facility and were replaced with digital ones.
B. Review of Policy, "Surveillance, Investigation and evaluation of Nosocomial Infections" revealed two days post operative or post discharge the Recovery Room nurse will call the patient at home and ask if they have any problems. One week later the Recovery Room Nurse will again contact the patient and repeat the process. Two weeks later the Recovery Room Nurse will again contact the patient and repeat the process. If no problems are found the patient will not be called again. If problems do occur the patient will be followed until the Physician gives the order to stop. During interview with the Administrator on 08/13/14 at 1415, she confirmed the Recovery Room nurses no longer followed that process.
C. Review of Policy, "Medication Ordering" revealed Essential Steps: transcribe orders onto the medication portion of the patient's care card. Slash order and put the time, date and the nurse's first initials, last name and title. Tear off the carbon copy of the physician's order and place on pharmacy clip board. Pharmacist will pick this up on his next round. If medication needs to be started immediately, the Charge or designated Nurse is to go to the Pharmacy, get the medication and sign it out in the sign out book. During tour of the Facility, Omni-Cell Medication Dispensing Systems were observed on the Nursing Unit and in the Emergency Room. On interview with the Nurse Manager during the tour, she confirmed medications were managed through the Omni-Cell System which allowed medication orders to be entered electronically.
D. Review of Policy, "Resterilization of Sterile Supplies" revealed all sterile supplies wrapped in cloth will be redone every 30 days. During interview with the Logistics Technician on 08/14/14 at 1230 she confirmed cloth wraps were not used for sterile instrument sets, only disposable products.
E. Review of Policy, "Autoclave Quality Control Sterilization Indicators and Controls" revealed Pressure Sensitive Tape: color impregnated tape with adhesive backing. All items, in muslin wrap, prepared in Sterile Processing shall carry this tape. Any item processed in plastic/paper pouch and sealed with tape (even if a drug store fold is incorporated) shall carry an expiration date of 30 days. During interview with the Logistics Technician on 08/14/14 at 1230 she confirmed muslin is not used in the Facility and pouches were heat sealed, not sealed with tape.
F. Review of Policy, "Sterilization of Endoscopy Equipment" revealed after cleaning is completed, endoscopes are taken to Surgical workroom and placed in Steris processor for sterilization. During tour of the Facility on 08/12/14, basins of Cidex OPA were observed on the counter in the Endoscopy Suite. The Logistics Technician confirmed the Facility did not use a Steris processor, they soaked scopes in Cidex OPA and rinsed them manually.
G. Review of Policy, "Recall of Sterilized Items" revealed Muslin wrapped items are considered sterile for 30 days from current date. During interview with the Logistics Technician on 08/14/14 at 1230 she confirmed cloth (Muslin) wraps were not used for sterile instrument sets, only disposable products.
H. Review of Policy, "Adoption Procedure" revealed Principle: to insure the adoption of an infant is carried out while maintaining all proper moral and legal obligations. During interview with the Nurse Manager on 08/14/14 at 1220, she confirmed the Facility did not deliver babies and the policy was not utilized.
I. Review of Policy, "Staffing" revealed Anesthesia is provided by (Named) CRNA (Certified Registered Nurse Anesthetist) under the direction of (Named) Dr. (Doctor). During interview with the Nurse Manager on 08/15/14 at 1015, she confirmed (Named) CRNA and (Named) Doctor no longer worked at the Facility.
J. Review of Policy, "Exclusion of Specimen - Tissues and Devices from Exam" revealed unless otherwise ordered by the attending physician, the following tissues and/or devices are not to be sent to the Laboratory for examination by a Pathologist. Hernia sacs, scars, varicose veins, contents of abdominal aneurysms, pacemaker packs and leads, ribs which are removed for operative exposure, vascular prosthetic materials, orthopedic implant fixation and prosthetic devices, placenta, vaginal mucosa, IUDs (inter uterine devices), bone implant and teeth and circumcision foreskin. During interview with the Nurse Manager on 08/14/14 at 1220, she confirmed surgical procedures conducted at the Facility consisted of GI (gastroenterology), podiatry and a few ear procedures.
K. Review of Policy, "Surgical Procedures" revealed Surgical procedures performed at (Named) Hospital requiring a Physician MD (Medical Doctor) Assistant: open chest procedures, Cesarean Section. The Medical Staff of (Named) Hospital approved this list on January 7, 1985 at the General Staff meeting. During interview with the Nurse Manager on 08/14/14 at 1220, she confirmed surgical procedures conducted at the Facility consisted of GI (gastroenterology), podiatry and a few ear procedures.
L. Review of Surgery Call List, located in the Policies and Procedures Manual, revealed Staff #1, #2, #3 and Physician #1 were listed as available for call. During interview with the Nurse Manager on 08/15/14 at 1015, she confirmed Staff #1, #2, #3 and Physician #1 were no longer affiliated with the Facility.
Tag No.: C0272
Based on interview, it was determined the Facility failed to assure policies were developed by a group of professionals which included at least one member not on the CAH (Critical Access Hospital) staff. The failed practice did not assure unbiased opinions provided by a non-staff member were included when developing policies and had the potential to affect all patients admitted to the Facility. Findings follow:
During interview with the Administrator on 08/15/14 at 0945, she confirmed she and the Nurse Manager developed the policies for the Facility.
Tag No.: C0276
Based on the review of Omnicell Activity Logs and interview, the Facility failed to ensure a nurse from each shift signed the "Discrepancies/End of Shift" section of the Omnicell Activity Logs at the change of shifts as required by hospital policy to ensure accountability of medications. The deficient practice occurred on one (Medical/Surgical) of two (Medical/Surgical, Emergency Room) Nursing Units in which Omnicell Automated Dispensing Units were utilized. The extent of the deficient practice on the Medical/Surgical Omnicell was 18 of 20 shifts failed to provide two signatures regarding discrepancies at the change of shifts. The poential existed to affect drug security. Findings follow:
A. A review of the Omnicell Activity Logs was conducted on 08/13/14 at 1045 for the time period 08/01/14-08/10/14. The "Discrepancies/End of Shift" section on the logs for the Omnicell located at the Medical Surgical Unit revealed 18 of 20 shifts lacked two signatures of nurses at the change of shifts as required.
B. An interview was conducted with the Nurse Manager on 08/13/14 at 1100. It was verified two signatures were required by hospital policy for the "Discrepancies/End of Shift" section on the Omnicell Activity Logs. In addition, it was verified 18 shifts lacked two signatures of nurses.
Based on observation, review of manufacturer guidelines for Succinylcholine, and interview, the Facility failed to have a procedure to ensure Succinylcholine stored at room temperature on one of one anesthesia cart in Surgery would not exceed manufacturer guidelines of storing the medication for more than 14 days at room temperature. The potential existed for the Succinylcholine to be stored at room temperature in excess of 14 days resulting in a decrease in potency of the medication to be administered to surgery patients. Findings follow:
A. A tour of Surgery was conducted on 08/12/14. At 1405, one multidose vial of Succinylcholine was observed stored at room temperature in the anesthesia cart. There was no procedure to indicate how long the Succinylcholine had been stored at room temperature.
B. A review of the manufacturer storage guidelines was conducted on 08/12/14 at 1515. The review revealed Succinylcholine is to be stored under refrigeration or may be stored at room temperature not to exceed 14 days. Storage at room temperature exceeding 14 days could lead to decrease in potency of the medication.
C. An interview was conducted with the Administrator on 08/12/14 at 1410. It was verified there was no procedure to ensure the Succinylcholine had not been stored at room temperature in excess of 14 days.
Based on review of Pharmacy policies 7.19 and 8.3, review of the list of nurses authorized to enter the Pharmacy, review of Pharmacy Log Sheets and interview, the Facility failed to ensure hospital policy was followed in allowing only authorized nurses to enter the Pharmacy in the absence of a Pharmacist. Four of twenty entries into the Pharmacy between 08/02/14-08/12/14 were made by unauthorized nurses in the absence of a Pharmacist. The potential existed to affect drug security in the Pharmacy. Findings follow:
A. Pharmacy policy 7.19 was reviewed on 08/13/14 at 0900. The policy reflected only authorized nurses could enter the Pharmacy in the absence of a Pharmacist.
B. Pharmacy policy 8.33 was reviewed on 08/13/14 at 0910. The policy reflected a log book would be maintained in the Pharmacy for nurses to complete in the absence of a Pharmacist when obtaining medications.
C. A list of nurses authorized to enter the Pharmacy in the absence of a Pharmacist as well as Pharmacy Log Sheets for the time period 08/02/14-08/12/14 was reviewed on 08/13/14 at 1410. It was revealed four of twenty entries into the Pharmacy in the absence of a Pharmacist was done by unauthorized nurses.
D. An interview was conducted with the Nurse Manager on 08/13/14 at 1430 in which the findings were verified.
Based on review of the Pharmacy Policy and Procedure Manual, review of Pharmacy policy 7.09, and interview, the Pharmacy Director failed to ensure the manual was reviewed and approved annually so that current policies would be reflected as required by Pharmacy policy. The last date the manual was approved was 11/29/10. The lack of current policies had the potential to affect all Pharmacy personnel. Findings follow:
A. Policy 7.09 of the Pharmacy Policy and Procedure Manual was reviewed on 08/13/14 at 1230. The policy reflected the Pharmacy Policy and Procedure Manual would be reviewed and approved annually.
B. The complete Pharmacy Policy and Procedure Manual was reviewed on 08/13/14 at 0900. Evidence provided was the last annual review to ensure policies were current was 11/29/10. The result was policies that were not current were reflected in the manual. Examples include but not limited to were the following:
1) No policies were present regarding the current Omnicell drug distribution system;
2) List of nursing personnel authorized to enter Pharmacy in absence of a Pharmacist was not current-Policy 7.19;
3) Expiration dating of multidose vials reflected 60 days instead of current standard of 28 days-Policy 8.19; and
4) There were references to Intensive Care Unit (ICU) Occurrences, but Facility did not have an ICU-Policy 5.03.
C. An interview was conducted with the Nurse Manager on 08/13/14 at 1400 in which the findings were verified.
Based on observation and interview, the facility failed to ensure outdated medications were not available for patient use in two (Clean Supply Room, Pharmacy) of four (Clean Supply Room, Pharmacy, Medical/Surgical Unit, Surgery) medication areas. The potential existed for outdated medication, with a decrease potency, to be administered to patients. Findings follow:
A. A tour of the facility was conducted on 08/12/14 and 08/13/14. On 08/12/14 at 1345, the following intravenous solutions were observed in the Clean Supply Room:
1) Eight Dextrose 5% 1000 milliliter (ml) expired 06/01/14; and
2) One Dextrose 5%/Sodium Chloride 0.45% 1000ml expired 07/01/14.
B. The Pharmacy was toured on 08/13/14 at 1300 in which the following medications were observed expired:
1) Two Arixtra 2.5 milligram (mg)/0.5ml Injectable expired 04/14; and
2) Twenty-six Potassium Chloride 20mg/10ml expired 08/01/14.
C. An interview was conducted with the Administrator on 08/12/14 at 1350 in which it was verified there were outdated intravenous solutions in the Clean Supply Room. On 08/13/14 at 1310, an interview was conducted with Pharmacy Technician #1 in which it was verified there were outdated medications in the Pharmacy.
Tag No.: C0278
Based on review of policies and procedures, observation and interview, it was determined the Facility failed to assure only currently dated supplies were available for patient use. The failed practice created the potential for patients to received outdated supplies which could affect any patient receiving those supplies. Findings follow:
A. Review of Policy, "Emergency Room Infection Control" revealed supplies Update: all sterile supplies are to be checked before use in order to avoid using outdated supplies.
B. A tour of the Facility was conducted 08/12/14 from 1320-1430 with the Nurse Manager. Observations revealed:
1) In the Clean Holding Room, six bottles of sterile 1" (inch) plain packing gauze expired 02/2013, two bottles of sterile ¼" plain packing gauze expired 07/2013, two bottles of sterile ¼" plain packing gauze were expired 05/2014 and two bottles of sterile ¼" plain packing gauze expired 06/2014.
2) In the Sterile Processing Workroom, three size 4 sterile LMA (Laryngeal Mask Airway) expired 07/28/14.
3) In the Operating Room, one box of sterile medium Ligaclips expired 07/14 and one box of sterile medium/large Ligaclips expired 07/14.
4) In the Operating Room's Ante Room, 184 gray topped specimen tubes expired 04/14, one box of sterile Penrose drains expired 09/13 and one box of sterile Penrose drains expired 01/14.
C. Findings were verified with the Nurse Manager at the time of observation.
D. During tour of the Ultrasound Room on 08/14/14 at 1000, the following were observed:
1) Five Amniotic membrane perforators expired 11/2010,
2) One tube sterile surgical lubricant bacteriostatic expired 01/2012,
E. Findings were verified with the Radiology Director at the time of observation.
Tag No.: C0279
Based on review of Medical Staff Meeting Minutes for November 2013 through August 2014, and interview, it was determined the Facility failed to ensure the Diet Manual was approved by the Medical Staff. The failed practice did not allow the Medical Staff to ensure the Diet Manual was updated and reflected current practices and had the potential to affect all patients in the Facility. Findings follow.
A. Review of Medical Staff Meeting Minutes for 11/13 through 08/14 revealed no evidence the Diet Manual had been approved by the Medical Staff.
B. Findings were confirmed by the Certified Dietary Manager on 08/13/14 at 1000.
Tag No.: C0280
Based on review of Dietary Policies and Procedures and interview, it was determined the Facility failed to ensure the Policy and Procedure Manual was reviewed annually. The failed practice did not ensure the policies were up to date and reflected current practices and created the potential to affect all patients utilizing Dietary Services. Findings follow:
A. Review of the Dietary Policy and Procedure Manual revealed a review date of 06/12/13.
B. Findings were confirmed by the Certified Dietary Manager on 08/13/14 at 1000.
Tag No.: C0337
Based on review of Medical Staff Meeting Minutes for November 2013 through August 2014 and interview, it was determined the Facility failed to provide evidence of Quality Assurance being reported to the Medical Staff. The failed practice did not ensure the Medical Staff was knowledgeable as to the status of the quality indicators and thus were not aware of which items needed corrective action. Findings follow.
A. Review of Medical Staff Meeting Minutes for November 2013 through August 2014 revealed no evidence of Quality Assurance being reported to the Medical Staff.
B. Findings were confirmed by the Administrator on 08/13/14 at 1300.