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Tag No.: C0276
Based on observation and interview, the Facility failed to ensure expired medications were not available for patient use in two (Emergency Department and Pharmacy) of five (Nursing Station, Surgery, Emergency Department, Pharmacy and Post Anesthesia Care Unit) medication areas. The potential existed for all patients to receive expired medications of decreased potency. Findings follow:
A. A tour of the Emergency Department was conducted on 05/20/15 between 0840 and 0930 in which the following expired medications were observed:
1) Floor Stock in Room #1
a) One vial of Sensorcaine 0,5% expired 03/15;
b) Fourteen single dose vials of Sterile Water expired 05/01/15;
c) One KERR Insta-Char expired 04/15; and
d) Two single dose vials of 0.9% Sodium Chloride 10 milliliter (ml) expired 07/01/14.
2) Floor Stock in Room #2-three multi-dose vials of Sterile Water for Injection expired 02/01/15.
3) Adult Emergency Cart in Room #1
a) One vial of Sterile Water expired 05/01/15;
b) Three Magnesium Sulfate 2 ml for Injection expired 03/15;
c) Two Pitressin 1 ml for Injection expired 02/15;
d) One Procainamide for Injection expired 05/01/15;
e) One Dextrose 5% 500 ml expired 10/14; and
f) One Dopamine 400 milligrams (mg)/500 ml expired 02/15.
4) Pediatric Emergency Cart in Room #1
a) One Sodium Bicarbonate 8.4% Adult Injectable expired 04/01/15;
b) One Sodium Bicarbonate 8.4% Pediatric Injectable expired 03/01/15;
c) Two Etamidate 20 mg/10 ml expired 03/15;
d) One Atropine 1 mg/10 ml expired 04/01/15;
e) One Glucagon Emergency Kit expired 02/15;
f) Three Epinephrine 1 mg/ml expired 04/01/15;
g) Two Magnesium Sulfate 2 ml expired 04/15; and
h) Two KERR Insta-Char expired 02/15.
B. A tour of the Pharmacy was conducted on 05/20/15 between 0930 and 1100 in which the following expired medications were observed:
1) One Azithromycin 500 mg tablet expired 04/15;
2) Eleven Ropinirole 1 mg tablets expired 01/15;
3) Three Vitamin D3 1000 unit tablets expired 02/15;
4) Twenty-seven Vitamin B6 50 mg tablets expired 04/14;
5) Twenty Vitamin B6 50 mg tablets expired 04/15;
6) Two Glucagon Emergency Kits expired 04/15;
7) One Enalapril AT 1.25 mg/ml expired 02/15; and
8) Five Pneumococcal Vaccine Polyvalent expired 01/22/15.
C. An interview was conducted with the Director of Nursing (DON) on 05/20/15 at 0930. The DON stated the medications referred to in the Emergency Department had expired. An interview was conducted with the Director of Pharmacy (DOP) on 05/20/15 at 1025. The DOP stated the medications referred to in the Pharmacy had expired.
Based on observation and interview, the Facility failed to ensure opened multi-dose vials of medication were discarded after 28 days in one (Surgery) of five (Nursing Station, Emergency Department, Surgery, Pharmacy and Post Anesthesia Care Unit) medication areas resulting in the unusable drugs being available for patient use. The potential existed for the sterility of the medications to be compromised and administered to patients. Findings follow:
A. On 05/19/15 at 1320, a tour of Surgery was conducted. The following multi-dose vials of medication were observed in the anesthesia cart in Operating Room #1 that were open and exceeded 28 days from date of initial entry:
1) One vial of Labetalol 100 milligrams (mg)/20 milliliters (ml);
2) One vial of Sensorcaine 0.5%; and
3) One vial of Lidocaine 1%.
B. An interview was conducted with the Surgery Director on 05/19/15 at 1330. The Surgery Director stated the three multi-dose vials of medication exceeded the 28 day requirement of maintaining multi-dose vials of medication once opened.
C. An interview with the DOP on 05/20/15 at 0925 revealed it was the policy of the hospital to date multi-dose vials of medication upon initial entry and dispose after 28 days.
Based on observation and interview, the Facility failed to ensure the unused portion of single dose medications were disposed of and not available for use on more than one patient. The deficient practice occurred in two (Nursing Station, Emergency Department) of five (Nursing Station, Emergency Department, Surgery, Post Anesthesia Care Unit, Pharmacy) medication areas. The potential existed for contamination of the medications and for the spread of infection between patients. Findings follow:
A. On 05/19/15 at 1415 an opened five hundred milliliter single dose container of Sterile Water for Irrigation and an opened five hundred milliliter single dose container of Sodium Chloride for Irrigation containing no preservatives were observed in Room #3 in the Emergency Department.
B. On 05/19/15 at 1255, an opened single dose vial of Furosemide containing no preservative was observed at the Nursing Station.
C. An interview with Licensed Practical Nurse #1 (LPN#1) on 05/19/15 at 1300 revealed the opened single dose vial of Furosemide had not been discarded and was available for patient use on more than one patient.
D. The DON was interviewed on 05/19/15 at 1415 regarding the opened containers of Sterile Water for Irrigation and the Sodium Chloride for Irrigation. It was revealed the solutions were used on more than one patient even though they were single dose medications.
Tag No.: C0278
Based on review of policies and procedures, review of 2010 AORN's (Association of Perioperative Registered Nurses) Perioperative Standards and Recommended Practices, review of Cidex Manufacturer's instructions, observation and interview, it was determined the Facility failed to assure expired sterile instruments and supplies were not available for patient use in five (Operating Room (OR) #1, Emergency Room (ER) #1, ER #2, ER Triage and ER Trauma) of eight (OR #1, OR #2, OR Storage Room, Endoscopy Decontamination Room, ER #1, ER #2, ER Triage and ER Trauma) areas toured; operating rooms were not damp dusted with alcohol in two of two (#1 and #2) ORs toured; aerosolized disinfectants were not used in two of two (#1 and #2) ORs toured; overhead lights were not free of dust in one of one (ER Trauma) ER Trauma Room toured; sterile supplies and unsterile equipment were separated in one of one (OR Storage Room) OR Storage Room toured; and Cidex (high level disinfectant) temperatures were not monitored in one of one (Endoscope Decontamination Room) Endoscope Decontamination Room toured. Failure to assure expired sterile instruments and supplies were not available for patient use did not assure their integrity had not been compromised rendering them unsterile; failure to assure operating rooms were not damp dusted with alcohol did not assure the operating rooms were disinfected with an EPA (Environmental Protection Agency) registered disinfectant; failure to assure aerosolized disinfectants were not used in an operating room did not assure staff were not exposed to harmful airborne chemicals; failure to assure overhead lights were free of dust did not assure they were sanitized; failure to assure sterile supplies and unsterile equipment were separated did not assure the sterility of supplies was not compromised from coming in contact with unsterile equipment; and failure to monitor Cidex temperatures did not assure the efficacy of the product used to disinfect endoscopes. Those failed practices were likely to affect all patients and staff in the Facility. Findings follow:
A. Review of AORN's "Recommended Practice for Environmental Cleaning in the Perioperative Setting, 2010" revealed "alcohol should not be used to disinfect large environmental surfaces. Alcohol is not an EPA-registered disinfectant. Alcohol is an antiseptic and not a detergent. Alcohol does not remove soil or debris. Cleaning and disinfection methods that produce mist, aerosols or dust (Spray bottles containing disinfectant) should not be used."
B. Review of policy "Cleaning in Operating Suite" revealed "Lysol cleanser is used in this area for wiping down equipment, furniture, Phone, suction holders, carts, walls and mopping."
C. Review of policy "Aseptic Surveillance Operating Room" revealed "Furniture, surgical lights and equipment should be damp dusted before the first scheduled procedure of the day. Damp dusting should be done with a clean, lint-free material moistened with a hospital approved germicidal agent (alcohol)."
D. During tour of the ORs and interview 05/19/15 at 1320 with the Director of Surgery, cans of Lysol spray were observed in each of the two ORs. On interview, the Director of Surgery stated, "the ORs are cleaned with alcohol at the beginning of each day and Lysol spray is used between cases to clean the rooms." When asked which nationally recognized practice standards were used in the perioperative department, she answered, "AORN".
E. On observation 05/19/15 at 1320, in OR #1, 23 packages of 2-0 Vicryl suture expired 01/15. The Director of Surgery verified the findings at the time of observation.
F. On observation 05/19/15 at 1340 in the Endoscopy Decontamination Room, a container was under a hood filled with blue liquid. When asked, the Director of Surgery confirmed the liquid to be Cidex. When asked if the temperature was monitored, she stated, "no".
G. Review of Manufacturer's instructions for Cidex revealed "High Level Disinfection: Cidex Solution is indicated for use as a High Level Disinfectant when used or reused, according to the Instructions for Use for up to a maximum of 14 days at 25 degrees Celsius with an immersion time of at least 45 minutes."
H. Review of Emergency Department policy "Restocking duties" revealed "Check that all tables and cabinets are clean; check date on all sterile supplies, dust and wipe all shelves and drawers; check all ER supplies and medications for outdates and restock."
I. On observation 05/20/15 at 0845 in ER #2, 27 packages of 3-0 Surgilon suture expired 03/15 and 12 packages of 5-0 Silk expired 01/15. Findings were verified with the Director of Nursing at the time of observation.
J. On observation 05/20/15 at 0900 in ER #1, 10 packages of 5-0 Plain Gut suture expired 01/15 and 12 packages of 5-0 Silk expired 01/15; one sterile peel package of nasal forceps expired 06/25/14 and one sterile peel packaged nasal speculum expired 07/02/14; one sterile peel packaged "ER Cut down set" expired 05/07/15; and one sterile peel packaged "Tracheotomy" expired 05/07/15. Findings were verified with the Director of Nursing at the time of observation.
K. On observation 05/20/15 at 0920 in ER Triage Room, two sterile peel packaged vaginal speculums expired 04/30/15; one sterile peel packaged vaginal speculum expired 05/13/15; and one sterile peel packaged vaginal speculum expired 05/19/15. Findings were verified at the time of observation with Registered Nurse #3.
L. On observation 05/20/15 at 0925 in ER Trauma Room, two overhead lights had heavy layers of dust which did not assure they were sanitary. Findings were verified with the Director of Nursing at the time of observation.
Tag No.: C0294
Based on review of clinical records, review of policies and procedures, review of Nursing Skills Evaluation Forms, review of Medication Administration and Calculation tests and interview it was determined the Facility failed to assure nursing staff were competent to administer moderate sedation for four of four (#11, #12, #14, #15) patients who underwent endoscopic procedures. Failure to assure staff were trained and evaluated in moderate sedation practices did not assure staff had the knowledge and experience with sedation medications used or skills to assess, interpret and intervene in the event of complications and was likely to affect all patients undergoing procedures performed under moderate sedation in the Facility. Findings follow:
A. Review of "Procedure Note" for Patient #11 revealed a colonoscopy was performed 05/06/15 under sedation using Versed and Demerol. Review of "Endoscopy Procedure Record" for Patient #11 dated 05/06/14 revealed Versed and Demerol were administered by Registered Nurse (RN) #1.
B. Review of "Procedure Note" for Patient #12 revealed an esophagogastroduodenoscopy (EGD) was performed 05/06/15 under sedation using Versed and Demerol. Review of "Endoscopy Procedure Record" for Patient #12 dated 05/06/15 revealed Versed and Demerol were administered by RN #2.
C. Review of "Procedure Note" for Patient #14 revealed a colonoscopy was performed 04/22/15 under sedation using Versed and Demerol. Review of "Endoscopy Procedure Record" for Patient #14 dated 04/22/15 revealed Versed and Demerol were administered by RN #1.
D. Review of "Procedure Note" for Patient #15 revealed a colonoscopy was performed 04/17/15 under sedation using Versed and Demerol. Review of "Endoscopy Procedure Record" for Patient #15 dated 04/17/15 revealed Versed and Demerol were administered by the Surgery Director.
E. Review of "Nursing Skills Evaluation Form" revealed no evidence competencies for moderate sedation were included or evaluated.
F. Review of "Medication Administration and Calculation" test revealed no evidence competencies for moderate sedation were included for testing.
G. Review of policies and procedures revealed no evidence a policy for moderate sedation competencies was included.
H. During interview with the Director of Nursing on 05/20/15 at 1525, she confirmed there were no competencies for moderate sedation and verified findings listed as A-G.
Tag No.: C0297
Based on observation and interview, it was determined staff failed to follow Manufacturer's instructions to date glucose test strips after opening in one of one (Nursing Unit) Nursing Unit toured. Failure to date glucose test strips did not assure testing would be accurate in determining the amount of insulin to administer a patient based on their blood glucose level. The failed practice was likely to affect all insulin dependent diabetic patients in the Facility. Findings follow:
A. During tour of the Nursing Unit, one canister of AgaMatrix Presto Test Strips (glucose test strips) was observed in the Medication Room which was opened but not dated.
B. Review of AgaMatrix Presto Test Strips manufacturer's instructions revealed, "Do not use AgaMatrix Presto Test Strips beyond the expiration date or 90 days after first opening the vial. This may cause inaccurate results. Write the discard date (90 days from first opening) on the test strip vial".
C. During interview with the Director of Nursing on 05/19/15 at 1305, she confirmed the test strips were not dated.
Tag No.: C0298
Based on review of clinical records and interview, it was determined nursing staff failed to develop care plans to manage diabetes, pain, incontinence, nausea, vomiting, anemia, medication management, hypoglycemia, or smoking for 8 (#1-8) of 15 (#1-#15) in-patients. Failure to develop care plans consistent with patients' needs did not assure staff interventions were measured against goals for improvement or revised when goals were not met. The failed practice was likely to affect all patients admitted to the hospital. Findings follow:
A. Review of "History and Physical" for Patient #1 revealed he was brought to the Emergency Room with fever, diarrhea, and incontinence on 05/17/15. He complained of back pain, suprapubic pain and nausea. A Foley urinary catheter was placed and he was admitted for further treatment. His blood sugar was elevated. Review of "Care Plan" dated 05/17/15 revealed no evidence interventions for the management of Foley urinary catheter or elevated blood sugar, pain or nausea was included in Patient #1's nursing plan of care.
B. Review of "History and Physical" for Patient #2 revealed she was admitted 05/18/15 with a long history of COPD (Chronic Obstructed Pulmonary Disease) and continued to smoke. She had a history of diabetes and hypertension. She presented with shortness of breath, non-productive cough and wheezing. Review of "Care Plan" dated 05/18/15 revealed no evidence interventions for the management of diabetes, hypertension or smoking was included in Patient #2's nursing plan of care.
C. Review of "History and Physical" for Patient #3 revealed he was admitted 05/18/15 for nausea, vomiting, diarrhea, abdominal distension. Review of "Care Plan" dated 05/18/15 revealed no evidence interventions for the management of nausea, vomiting, diarrhea, or the potential for pain with abdominal distension was included in Patient #3's nursing plan of care.
D. Review of "History and Physical" for Patient #4 revealed he was admitted 05/18/15 for anemia and blood glucose of 228. Review of "Care Plan" dated 05/18/15 revealed no evidence interventions for the management of anemia or diabetes was included in Patient #4's nursing plan of care.
E. Review of "History and Physical" for Patient #5 revealed he was admitted 05/12/15 with congestive heart failure, chronic renal insufficiency, atrial fibrillation, chronic urinary retention and he self-catheterized. Review of "Care Plan" dated 05/12/15 revealed no evidence interventions for the management of congestive heart failure, atrial fibrillation, chronic urinary retention and self-catheterization were included in Patient #5's nursing plan of care.
F. Review of "History and Physical" for Patient #6 revealed he was admitted 05/08/15 for hypoglycemia, metastatic lung cancer with chronic left pleural effusion and chronic pain. Review of "Care Plan" dated 05/08/15 revealed no evidence interventions for the management of hypoglycemia, metastatic lung cancer or pleural effusion, or chronic pain were included in Patient #6 ' s nursing plan of care.
G. Review of "History and Physical" for Patient #7's revealed she was admitted 05/12/15 for coronary artery disease, fever, osteomyelitis of the hand. Review of "Care Plan" dated 05/12/15 revealed no evidence interventions for the management of coronary artery disease, fever, or osteomyelitis were included in Patient #7's nursing plan of care.
H. Review of "History and Physical" for Patient #8 revealed he was admitted 05/12/15 for diabetes, peripheral vascular disease, cellulitis of the lower extremity and smoked. Review of "Care Plan" dated 05/12/15 revealed no evidence interventions for the management of diabetes, peripheral vascular disease, cellulitis or smoking were included in Patient #8's nursing plan of care.
I. Findings listed as A-H were verified with the Director of Nursing during record review 05/21/15 at 1040.
Tag No.: C0336
Based on review of QA (Quality Assurance) Meeting Minutes for May 2014 through April 2015 and interview, it was determined the Facility failed have an effective QA Program in that 12 of 14 Departments were not submitting departmental data to the Quality Director on a monthly basis as stated in the QA Plan. The failed practice did not ensure the Quality Director was knowledgeable as to the status of the quality indicators, and thus was not aware of which items needed corrective action. Findings follow.
A. Review of the QA Plan stated, "Each Quality Assurance Unit will be required to submit to the Quality Assurance Department a summary each month. This summary of activities will be reported according to the prescribed format. Summaries will be due in the Quality Assurance Coordinator's office on the Second Wednesday of each month at the time of the monthly meeting ...The results of monitoring activity will be reported on the monthly report and submitted to the Quality Assurance Coordinator for inclusion into the centrally integrated system of the Hospital Quality Assurance Program."
B. The following Departments as defined by the facility QA Plan did not report the completed QA activity summaries to the Quality Director for: (time period of May 2014 through April 2015)
1) Dietary - 12 of 12 months were not reported
2) Discharge Planning - 12 of 12 months were not reported
3) Emergency Room - 4 of 12 months were not reported
4) Lab - 1 of 12 months was not reported
5) Nursing - 4 of 12 months were not reported
6) Pharmacy - 12 of 12 months were not reported
7) Radiology - 1 of 12 months was not reported
8) Infection Control - 11 of 12 months were not reported
9) Surgery - 4 of 12 months were not reported
10) Central Supply - 5 of 12 months were not reported
11) Medical Records - 12 of 12 months were not reported
12) Swing Bed - 4 of 12 months were not reported
C. In an interview on 05/20/15 at 1335, the Chief Executive Officer confirmed the QA from the above departments were not being reported to the Quality Director on a monthly basis as stated in the QA Plan.
Tag No.: C0337
Based on review of Medical Staff Meeting Minutes, Governing Body Meeting Minutes, QA (Quality Assurance) Meeting Minutes, QA Plan and interview, it was determined the Facility failed to report QA data to Medical Staff and Governing Body as stated in the QA Plan. The failed practice did not ensure the Governing Body 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 the QA Plan stated "The ultimate authority and responsibility for the performance of hospital-wide quality assurance rests with the Board of Governors of the Hospital. Authority for assuring high quality patient care and services performed by members of the Medical Staff is delegated to the Medical Staff, in accordance with the Medical Staff By-laws, as approved by the Board of Governors".
B. Review of Medical Staff and Governing Body Meeting Minutes for May 2014 through April 2015 revealed QA was not reported.
C. In an interview on 05/19/15 at 1300, the Chief Executive Officer confirmed QA was not being reported to Medical Staff and Governing Body.
Tag No.: C0385
Based on interview, it was determined the Facility failed to assure activities for Swing- Bed patients were directed by a licensed or registered Activities Director or that a Therapeutic Recreation Specialist was consulted by a staff member designated as the Activities Director. Failure to assure an Activities Director was employed, contracted or consulted did not assure patients received therapeutic activities to promote improvement in their condition while hospitalized. The failed practice was likely to affect all Swing Bed patients admitted to the Facility. Findings follow:
During interview with the Director of Nursing on 05/20/15 at 1100, she stated staff would organize activities for patients but the Facility did not have an Activities Director on staff.