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Tag No.: C0222
I. Based on document review, observation, and staff interview, the Critical Access Hospital (CAH) nursing administrative staff failed to provide glucometers, appropriate for newborn, use for 2 of 2 glucometers in the obstetrical department. The CAH administrative identified 44 births per year.
Failure to provide glucometers appropriate for newborn use could potentially result in the glucometers providing inaccurate results, which could potentially cause staff to provide inappropriate and/or unecessary care to patients.
Findings include:
1. Review of the policy "Blood Screening for Hypoglycemia, Newborn", revised 2/09, revealed in part, "Newborns will have blood sugars done on as follows: Upon delivery..."
2. Observations on 2/7/11 at 1:00 PM, during a tour of the obstetrical department, revealed 2 of 2 Abbott Precision Xtra glucometers, 1 in each delivery room.
3. During an interview at the time of the tour, the Assistant Director of Nursing stated the nursing staff used the glucometers in the delivery rooms to check the blood sugar levels for all newborn babies delivered at the CAH.
4. Review of the manufacturer's instructions for the Precision Xtra glucometer test strips, revised 9/09, revealed in part, "Limitations of Procedure ... This test strip is not designed for use with ... neonatal ... samples."
5. During a further interview, at the time of the tour, the Assistant Director of Nursing acknowledged the manufacturer had not designed the glucometer test strips for use with newborn babies, and the nursing staff routinely used the glucometer test strips for newborn babies.
II. Based on observation, document review, and staff interview, the Critical Access Hospital (CAH) nursing administrative staff failed to ensure nursing staff documented the date they opened 1 of 1 bottle of glucometer test solution. The CAH administrative staff identified 44 births per year.
Failure to document the date staff opened the bottle of glucometer test solution could potentially allow staff to use the test solution after the manufacturer's shortened expiration date, potentially resulting in inaccurate test results, which could lead to patients receiving inappropriate and/or unecessary treatment.
Findings include:
1. Observations on 2/7/11 at 1:00 PM, during a tour of the obstetrical department revealed 1 of 1 bottle of MediSense Glucometer "Mid" Control Solution. The bottle of Control Solution lacked documented evidence that showed the date staff had first opened the bottle.
2. Review of the manufacturer's instructions for the MediSense Glucometer "Mid" Control Solution revealed in part, "When you open a new bottle, write the date of opening on the bottle label.... Do not use the control solution if it has been open for more than 90 days..."
3. During an interview, at the time of the tour, the Director of Nursing acknowledged the Glucometer Control Solution lacked documented evidence that showed the date staff had opened the bottle, as required by the manufacturer.
Tag No.: C0276
I. Based on observation, document review and staff interview the Critical Access Hospital (CAH) operating room staff failed to remove outdated supplies in 1 of 1 anterooms in the Post Anesthesia Critical Care Unit (PACU). The surgical staff reported approximately 17 surgical procedures monthly.
Failure to remove outdated pharmaceutical supplies in patient care areas could potentially result in patients receiving contaminated, outdated, and/or ineffective medications.
Findings include:
1. Observations during a tour of the PACU anteroom on 2/9/11 at 1:39 PM, revealed 36 of 36 bottles of Dantrolene Sodium 20 milligrams (mg) that had expired on 1/11.
2. During an interview on 2/9/11, at the time of the observation in PACU, Staff B, Operating room (OR) technician, acknowledged the outdated medications in the PACU. Staff B stated, "We all monitor for outdates on a monthly basis. The last check for expired supplies was 1/13/11. It [Dantrolene Sodium] should have been taken out. I will remove this now." Staff B stated the medication [Dantrolene Sodium] was used for malignant hyperthermia.
3. During an interview on 2/9/11 at 1:45 PM, the OR supervisor and the Director of Nursing (DON) acknowledged the outdated Dantrolene Sodium in the PACU and reported CAH staff would obtain the required amount of Dantrolene Sodium (36 vials) from a surrounding hospital prior to beginning 2 general surgical procedures scheduled for 2/10/11. The OR supervisor stated CAH staff had preformed 7 general surgical procedures from 2/1/11 to 2/9/11 (the Dantrolene Sodium expired on 1/11).
4. During an interview on 2/10/11 at 7:55 AM, the DON stated they were unable to obtain 36 vials of Dantrolene Sodium and stated, "the two general surgical procedures scheduled for today were rescheduled."
5. Review of CAH policy titled "Unit Inspection" dated 10/21/10 revealed in part: "...Drugs shall not be kept in stock after the expiration date on the label."
20126
II. Based on document review, observations, and staff interviews, the CAH staff failed to secure medications for patient use in the Ultra Sound, Physical Therapy (PT) and Bone Density units. The CAH administration reported a census of 3 in patients. The CAH Administration reported an approximate daily average (from 7/1/10 to 12/31/10) of 1.5 Ultra Sound procedures, 10 PT patients (2 inpatient, 8 out patients), and 5-6 monthly Bone Density procedures.
Failure to secure medications could result in unauthorized access, usage, and distribution of medications.
Findings include:
1. Review of the CAH policy "Medication Security," revised 8/05, showed in part, "...all drugs stored in the [CAH] shall be accessible only to authorized personnel..."
Review of the CAH policy, "Unit Inspection" dated 1/2002 showed in part, "...All drug storage areas within this hospital will be inspected at least quarterly by a pharmacist or nurse ...The purpose is to ensure proper storage of medications...the pharmacist will direct the monthly inspection of all drug storage areas in the hospital. A written record of these inspections will be maintained...Drugs shall be accessible only to responsible personnel designated by the hospital..."
2. Observation, during the initial tour of the Bone Density unit, accompanied by the Radiology Manager, on 2/8/11 at 10:15 AM, revealed the Bone Density Room was unlocked and located off the hallway used to access the acute patient area.
Observation in the Bone Density Room revealed one box with 23 bottles of E Z HD Barium Sulfate and another box with 23 bottles of Redi-CAT 2 Barium Sulfate suspension on the counter. The lower unlocked cupboard had 2 open boxes with a total of 19 glass bottles of IsoVue 300 and 2 bottles of Liquid Polibar Plus. The unlocked upper cupboard had 13 individual boxes of Lo So Prep bowel cleansing system, 3 boxes that contained 54 bottles of Gastrografin and 3 vials of Magnevist.
Follow up observation on 2/9/11 at 4:00 PM revealed the Bone Density room was unlocked with the above supplies in the unlocked cupboard and on the counter. The Surveyor notified the Administrator and Assistant Administrator of the unlocked room with unsecured medications. The Assistant Administrator assured tha he/she would lock the room immediately. The Assistant Administrator secured the Bone Density room at this time.
Observation, during the initial tour of the Ultra Sound unit, accompanied by the Radiology manager, on 2/8/11 at 9:50 AM, revealed an unlocked Ultra Sound room and a vial of Lidocaine in an unlocked cupboard. The Radiology Manager confirmed the Ultra Sound room remained unlocked at all times and housekeeping personal cleaned the room after hours. The Radiology Manager stated, "I'm not sure why the Lidocaine is in the cupboard, but it should be locked up."
Observation, during the initial tour of the PT unit, accompanied by the PT Manager, on 2/8/11 at 8:30, revealed an unlocked file drawer in an unlocked office of the PT unit. The unlocked file contained 6 vials of Dexamethasone. The PT Manager stated, "We are not able to lock this file drawer, so these medications should be placed in the files that can be locked." The PT Manager stated the housekeepers cleaned the office after hours, so "they would have access to the medications."
4. During an interview on 2/8/11 at 10:20 AM, the Pharmacist Technician stated that staff should secure all and the responsibility remained with the Pharmacy Technician to assure the all drugs were securely stored. The Pharmacy Technician stated he/she was not aware of any medications stored in the Ultra Sound or Bone Density rooms.
Tag No.: C0301
Based on observations, review of documents and staff interviews, the Critical Access Hospital (CAH) staff failed to maintain patient medical records in a secure and confidential manner. The CAH radiology staff reported approximately 2 inpatients daily and approximately 10 outpatients daily. The CAH nursing staff reported approximately 7 inpatients daily. The CAH physical therapy staff reported approximately 2 inpatients daily and approximately 8 outpatients daily. The CAH laboratory staff reported approximately 360 inpatient laboratory and approximately 2,847 outpatient procedures monthly.
Failure to secure medical records against unauthorized access could potentially result in identity theft or unauthorized disclosure of personal medical information.
Findings include:
1. Review of CAH policy titled "Secure Filing of Medical Records" reviewed 10/21/10 revealed in part "...Medical records housed within the hospital shall be kept in secure areas at all times. Medical records shall not be left unattended in areas accessible to unauthorized individuals...Health Information Management is responsible to safeguard the medical records against use by unauthorized individuals."
2. Observation, in the Radiology Department, on 2/8/11 at 10:15 AM, revealed an unlocked file room that contained patient radiological films and patient information.
Observations, during a tour of the Radiology Department, on 2/8/11 at 10:20 AM, revealed files with patient information on films in the x-ray reading room. A note attached to the door leading into the x-ray reading room documented, "Please make sure this door is unlocked when you leave." The Radiology Manager present at the time of the observation stated, "We use to lock this door but staff were losing or forgetting keys and having maintenance open it for us. We decided to leave this unlocked, this has been the process for approximately 1 year."
3. During an interview on 2/8/11 at 10:20 AM, the Radiology Manager acknowledged the file room had been left unattended, unsecured and that the door to the room was closed when staff left for the day but not locked. The Radiology Manager reported housekeeping staff cleaned the area unsupervised and had access to the patient information.
During an interview on 2/8/10 at 10:55 AM, Staff A, Radiological technician, reported confidential patient information in the radiology file room and radiology reading room was left unsecured when radiological staff were not present in either area. Staff A stated, "Both doors are not locked when we leave, our policy would be that patient med record information should be secured at all times."
20126
3. Observations, during a tour of the Laboratory Department, on 2/9/11 at 3:20 PM, revealed an accordion folder with confidential patient information and pending and final laboratory results for inpatients and outpatients on shelves above the secretary's desk. The Laboratory Manager reported that the housekeeping had unattended access to the area when they cleaned and that they should definitely not have access.
Observations, during a tour of the Laboratory Department, on 2/9/11 at 3:35 PM, revealed 5, unlocked, standing files that contained confidential patient information. The Laboratory Department manager reported at the time of the observation, housekeeping staff would have unauthorized access to confidential patient information in the standing files.
4. Observation, during the initial tour of the Physical Therapy (PT) unit, with the PT Manager, on 2/8/11 at 8:30, revealed 4 sets of unlocked file drawers in the unlocked office of the PT unit. The drawers contained patient files with protected information. The PT Manager acknowledged staff had not locked the files and did not think staff had ever locked the file drawers, The PT Manager further acknowledged that the files contained protected information and were not secure from unauthorized access because the housekeepers cleaned the office after hours unattended.
Tag No.: C0331
Based on document review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to include 1 of 1 Speech Therapy program in the annual Total Program Evaluation. The CAH administrative staff identified 35 speech therapy visits during the prior year.
Failure to include all programs in the Total Program Evaluation could potentially result in the CAH staff failing to appropriately evaluate the usage and necessity of all programs.
Findings include:
1. Review of the policy "Annual Evaluation of CAH Services", not dated, revealed in part, "This evaluation shall at a minimum include: ... volume of services provided both directly and under arrangement."
2. Review of the Total Program Evaluation from July 2009 to July 2010, on 2/9/11 at 8:30 AM, revealed the Total Program Evaluation lacked documented evidence that showed CAH administrative staff had included Speech Therapy in the Total Program Evaluation.
3. During an interview on 2/9/11 at 9:30 AM, the Administrator stated the CAH staff provided Speech Therapy services at the CAH under contract, and acknowledged the CAH administrative staff failed to include Speech Therapy in the Total Program Evaluation.
Tag No.: C0340
I. Based on document review, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure 4 of 15 medical staff members selected for review received any external peer review. The CAH administrative staff identified 76 members of the medical staff.
Failure to ensure all medical staff members received external peer review could potentially expose patients to inappropriate medical care.
Findings include:
1. Review of credential files on 2/9/11 at 2:00 PM revealed the following:
a. Review of Radiologist C's credential file revealed the credential file lacked documented evidence of any external peer review.
b. Review of Pathologist D's credential file revealed the credential file lacked documented evidence of any external peer review.
c. Review of Certified Registered Nurse Anesthetist (CRNA) E's credential file revealed the credential file lacked documented evidence of any external peer review.
d. Review of Ear, Nose, and Throat Surgeon F's credential file revealed the credential file lacked documented evidence of any external peer review.
2. Review of the policy "External Medical Staff Peer Review", revised 4/05, revealed in part, "The external peer review for the hospital's CAH review will consist of a review of a representative sample of closed medical records..."
3. During an interview on 2/9/11 at 2:10 PM, the Health Information Management (HIM) Director stated CAH staff did not send any medical records of patients who received treatment from Surgeon F, the radiologists, pathologists, or CRNAs for external peer review.
II. Based on document review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure 1 of 15 medical staff members selected for review received external peer review from an equivalent peer. The CAH administrative staff identified 76 members of the medical staff.
Failure to ensure all medical staff members received external peer review from a true peer could potentially expose patients to inappropriate medical care.
Findings include:
1. Review of credential files on 2/9/11 at 2:00 PM revealed General Surgeon A's credential file lacked documented evidence of external peer review by a surgeon.
2. Review of the policy "External Medical Staff Peer Review", revised 4/05, revealed in part, "The external peer review for the hospital's CAH review will consist of a review of a representative sample of closed medical records..."
3. During an interview on 2/9/11 at 2:10 PM, the Health Information Management (HIM) Director stated they sent medical records to another CAH in the network. The outside CAH had the medical records reviewed by family practice physicians. The outside CAH did not have a general surgeon review the medical records of patients that received care from General Surgeon A. The HIM Director acknowledged that they failed to ensure the physician reviewer for Surgeon A had enough knowledge to appropriately evaluate the medical records presented.