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Based on observation, document review, and staff interview the Critical Access Hospital (CAH) surgical services staff failed to follow manufacturers recommendation when storing 8, 1 liter bags of Baxter intravenous (IV) solution in a fluid warmer. Failure to follow manufacturer's recommendations when warming IV fluids could potentially result in excessive bacterial growth, which could then potentially lead to an infection if the IV solution was used for a patient. The CAH perform 1,429 surgeries the past fiscal year.

Findings include:

1. Observations on 08/19/20 at approximately 10:00 AM revealed a fluid warmer in the surgical suite that contained 4, 1 liter IV bags of 0.9% Normal Saline and 4, 1 liter IV bags of Lactated Ringers.

2. Review of policy "Storage of Warmed Solutions," last reviewed 08/20, revealed in part, "...IV bags...can remain in the warming cabinet...at a temperature not to exceed 104 [degrees] F [Fahrenheit]..."

3. Review of "Clinical Bulletin" provided by the CAH, revealed in part, "See the following recommendations from Baxter, in regards to warming recommendations...IV solutions...can be warmed...to temperatures not exceeding...104 [degrees] F [Fahrenheit]..."

4. Review of temperature monitoring log instructed "Warmed Fluid do not exceed 110*[sic] F." Further review of the temperatures logged for July and August revealed fluid warmer temperatures higher than 104 had been recorded 34 out of 35 days.

5. During an interview on 08/19/20 at approximately 12:15 PM, the surgery manager confirmed that the CAH policy and manufacturer's recommendations required that IV fluids should not be warmed to a temperature higher than 104 degrees Fahrenheit, and acknowledged CAH had been storing IV fluids above 104 degrees Fahrenheit.

Based on review of records, policy, and staff interviews the Critical Access Hospital's (CAH) Administrative staff failed to ensure each patient that received anesthesia and surgical services had properly executed informed consents for 1 of 2 patient cesarean section births reviewed in obstetrics. (Patient # 5) Failure to inform all patients who received anesthesia and surgery of the options and consequences needed in order to make an informed consent to a procedure or treatment could potentially result in the patient having received an unwanted procedures. The Chief Nursing Executive (CNE) identified approximately 15 cesarean sections in the past fiscal year.

Findings include:

1. Review of Patient #5's medical record, delivery date 4/06/2020, revealed anesthesia consent form, "CONSENT TO PLACE EPIDURAL FOR LABOR PAIN CONTROL AND/OR CESAREAN SECTION" lacked the name of the CRNA it was to be performed by, date and time patient signed, witness signature, date and time.

Patient # 5's "CONSENT FOR SURGICAL AND DIAGNOSTIC PROCEDURES" lacked a description of the procedure, name of provider doing the procedure, name of practitioner who explained the procedure, date and time Patient #5 signed the consent, signature of the witness, date and time and name of CRNA who was to provide the anesthesia. Both consent forms contained only the patient name, no other blanks were filled in.

2. Review of "Consent for Surgery, Procedures, and Photographs or Videotapes" dated last reviewed 02/20, revealed in part, "Consent for Surgical and Other Procedures" shall be completely filled out before the patient is asked to read and sign it. will include..name and description of procedure, name of practitioner(s) performing procedure, date and time consent signed, signature of professional witnessing the consent."

3. During and interview on 8/20/2020 at approximately 8:00 AM, the Chief Nursing Executive acknowledged the consent forms for Patient #5's anesthesia and surgical procedure contained only the patient's signature and should have been fully completed before asking the patient to sign the two consent forms.

I. Based on observations, policy review and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure pharmacy oversight of sample medications in 3 of 3 provider-based outpatient services clinic. Failure of pharmacy oversight in the dispensing of sample medications could result in outdated, recalled, or otherwise unusable medications being available for physicians and mid-level providers to give to patients, as well as, the potential for theft of medications by unauthorized persons. The Clinic Nurse Manager identified 16,077 patients seen in the clinics in the past fiscal year.

Findings include:

1. Observation during tour of the Surgical, Internal Medicine and Women's Health Services on 8//18/20 at 2:00 PM with the Clinic Nurse Manager, revealed the clinics stored and utilized sample medications.

During an interview, at the time of the observation, the Clinic Nurse Manager reported when the samples are received by the nursing staff and the staff enter the medications on log sheets. She obtained the log sheets for review which showed separate sheets for each medication and documented information about the sample and reported each sample medication distributed is documented in the patient's medical record with the sample medications lot number and is trackable should there be a drug recall. The Clinic Nurse Manager reported the CAH pharmacist did not play a role in oversight of the sample medications in the clinic, although aware they stored sample medications. She confirmed documentation of varied content information on the multiple logs, incomplete documentation of information and inaccurate or lack of the total number of samples stored. The Clinic Nurse Manager estimated there are approximatley 403 sample medications stored in the three clinics.

2. Observation during tour of the Internal Medicine Clinic storage closet, on 8/18/20 at 2:30 PM with Clinic Nurse Manager revealed the closet stored approximatley 350 sample medications in a variety of categories identified as diabetic, anticoagulants, GERD, GOUT, Bowel, Depression, Respiratory, smoking, supplements, Blood Pressure, Anigna, Seizure, Migraine, Hormones, and Pain available for patient use.

Observation during a tour of the Surgical clinic, on 8/18/20 at approximately 3:00 PM, revealed a cabinet containing 3 sample bowel prep kits available for patient use.

During an interview on 8/18/20, at 3:10 PM, the Director of Pharmacy confirmed she knew the Provider Based Outpatient Services Clinisc stored sample medications but did not have a role in oversight of the medications. She reported professional pharmacy standards would include accurate accounting of medications received, dispensed and an accurate inventory of medications on hand. The Director of Pharmacy acknowledged, without an accurate accounting of inventory, the CAH could not ensure unauthorized diversion of the medications and she would not be able to inform the clinic of medication recalls, since did not know what medications were stored in the clinic.

During an interview on 8/18/19, at 2:40 PM, the Professional Services Clinic Manager acknowledged the lack of complete and accurate accounting of the clinics sample medications and withour accurate accounting inventory, she could not ensure unauthorized diversion of the medications..

Review of policy "Dispensing sample medication", revieweded 10/2019, revealed the policy failed to identify the need for pharmacy oversight of drug samples within the CAH. The policy also lacked guidance for accurate accounting of medications recieved, dispensed, and accurate inventory of medications available for use.





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II. Based on observation, document review, and staff interview, the Critical Access Hospital's (CAH) administrative staff failed to ensure the staff removed outdated medications from the Physical Therapy treatment room. Failure to remove outdated medications from the CAH's supplies, available for patient use, could potentially result in the staff using expired medications for patient use after the manufacturer's expiration date, potentially resulting in the staff using medications on a patient after the date which the manufacturer guaranteed the sterility and efficacy of the medication. The Physical Therapy administrative staff identified an average of approximately 200 patients seen per month.

Findings included:

1. Observation on 08/19/2020, during a tour of the Physical Therapy Department, revealed outdated medications:
Biofreeze (9) individual packets expired 02/2020 (pain relief ointment used for fast acting, long lasting relief for joint pain and muscle soreness)
Neomycin Sulfate (11) individual packets expired 08/2019 (antibiotic ointment used to prevent or treat skin infections caused by bacteria)
Povidone Iodine Swabsticks (4) individual packets expired 05/2020 (a first aid antiseptic in the prevention of skin infections in minor cuts, scrapes, and burns)

2. Review of "Checking Expiration Dates for Medications and Supplies" effective 08/2020, revealed "supplies will be checked for expiraion dates quarterly in January, April, July, and October...Medications expired or close to expiration date shall be pulled from the shelf and returned to pharmacy for replacement."

3. Weekly cleaning log reviewed did not contain an area for documentation of expiration dates or for task completed.

4. During an interview on 08/19/2020, at the time of the observation, the Physical Therapist Manager acknowledged the therapy staff failed to remove the expired medication from the supply cabinet and no documentation was provided for task completion.

Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) x-ray staff failed to ensure staff secured 1 of 1 radiation exposure cord to not allow staff access into the x-ray room during completion of radiologic tests of patients. The CAH x-ray staff reported completing an average of 628 x-rays per month. Failure to secure radiation exposure cords could allow staff access to the x-ray room while performing an x-ray procedure and exposing staff to unnecessary radiation.

Findings include:

1. Observations during tour of the radiology department on 8/19/2020 at 3:00 PM, with the Radiology Manager, revealed 1 of 1 exposure cord in the general x-ray room the staff failed to secure, which allowed a staff member to enter approximately 3 feet into the x-ray room and still activate the x-ray machine.

2. Review of the CAH policy "Radiation Safety for Employee & Patient," dated 12/2019, revealed in part, "The technologist should always stand behind the lead lined control booth when making an exposure...he/she should assume a position behind the lead lined control booth."

3. During an interview on 8/19/2020 at 03:00 PM. the Radiology Manager confirmed the staff failed to secure the radiation exposure cord which would allow staff to access into the x-ray room during x-ray procedures.

Based on observation, document review, and staff interviews, the Critical Access Hospital (CAH) failed to ensure outpatients who registered for outpatient services were informed of their visitation rights including the ability to receive designated visitors, but not limited to a spouse, domestic partner (including same-sex domestic partner) and another family member, in advance of furnishing care for Laboratory, X-ray, Physical Therapy/Occupational Therapy/Speech Therapy, Diabetic Education, Chemotherapy, Emergency care, Infusion/Injection, Internal Medicine, Women's and Surgical Services . Failure to provide all outpatients, with visitation rights information could potentially result in limiting/restricting access of visitors to patients that infringed on their right to have a support person present when they are provided any type of care, services, or treatment modalities. The CAH administrative staff reported 45,558 outpatients registered for outpatient services in the last fiscal period.

Findings include:

1. Based on observation on 8/17/2020 at approximatley 3:00 PM of the Emergency Room Registration area and on 8/18/2020 at 2:30 PM of Women's, Internal Medicine, and Surgical Services registration areas revealed the lack of Visitor's Rights or Patient Rights and Responsibilities brochure available to outpatients that registered for care and services.

2. Review of CAH policy/procedure "Patient Visitation ", dated approved 8/14, revealed in part, ". . .Prior to providing care, the Hospital shall inform each patient..in writing..of patient visitation rights..."
Review of outpatient medical records revealed lack of documentation that visitation rights had been provided upon registration in advance of care when appropriate.

3. During an interview on 8/17/2020 at 2:51 PM , Staff H Receptionist, stated she registered Laboratory, and other outpatients. Staff H revealed she was not aware of the requirement to provide outpatient visitiation rights at registration prior to receiving care and that there was no written information regarding a patient's visitation rights available at the registration desk.

During an interview on 8/18/2020 at 2:49 PM, Intermal Medicine Receptionist I, stated that she registered outpatients for Internal Medicine services. Staff I revealed she was not aware of the requirement to provide outpatient visitation rights prior to receiving care and that there was no written information regarding a patient's visitation rights available at the registration desk to give patients.

During an interview on 8/18/2020 at 2:49 PM Nurse Manager of Outpatient Clinics and 8/19/20 at 5:00 PM, Chief Nursing Executive acknowledged that the hospital's outpatients do not receive Visitation Rights information.

Based on observation, review of policies/procedures, and staff interviews, the Critical Access Hospital (CAH) Women's Health Services, Internal Medicine and Surgical Services staff failed to protect all confidential patient information from unauthorized access in 3 of 3 Outpatient Clinics. Failure to secure medical records against unauthorized access could result in identity theft and/or unauthorized disclosure of personal medical information. The CAH clinic administrative staff identified a combined average of 16,077 out-patient clinic visits over the past fiscal year.


Findings include:

1. Observation on 8/18/20 at 2:30 PM, during a tour of Women's Health Services, Internal Medicine Services, and Surgical Services with the Nurse Manager of Outpatient Services, revealed 3 of 3 FAX machines located in an unlocked area of each nursing office space and unlocked individual provider offices with open stacked vertical files on desks in provider's offices.

2. During an interview on 8/18/20 at the time of the tour, Nurse Manager of Outpatient Services revealed the Outpatient Service areas are locked when the departments are closed. Housekeeping staff have access to the locked departments and clean in the evening when the departments have no staff present. Fax machines are not secured and private patient information is received after hours and sits on the Fax machines until staff transported the information to the individual provider office. The Nurse Manager of the Outpatient Services reported the Providers do not lock their individual offices and that private patient information is left in open stacked vertical files on the provider's desk. The Nurse Manager of Outpatient Services acknowledged this private and confidential patient information was not secured as hospital policy required.

During an interview on 8/19/20 at approximately 4:45 PM Nurse Manager of Outpatient Services revealed the following:
a. Women's Health Services received approximately 20 Faxes per week after the clinic had closed and had 3 unsecured provider offices
b. Surgical Services received approximately 15 Faxes per week after the clinic had closed and had 1 unsecured provider office
c. Internal Medicine received approximately 150 Faxes per week after the clinic had closed and had 5 unsecured provider offices

3. During an interview on 8/18/2020 at 3:04, at the time of the tour, Clinic Provider Physician J, acknowledged his office is not locked and that private, confidential patient information is placed in his desk top vertical files until he had time to address it and could remain in the unsecured file for several days.

4. Review of policy "Patient Records", reviewed 6/19, revealed in part, "Patient records..will be stored in a safe and confidential manner."

I. Based on document review and staff interview, the Critical Access Hospital (CAH) failed to ensure anesthesia staff (CRNA F, CRNA G) documented the date and time of the post anesthesia evaluation for 2 of 5 Patients (Patient #2, Patient #4) who received anesthesia for their surgeries. Failure to appropriately date and time the completion of a post anesthesia evaluation may result in an inadequate medical record that could adversely affect a patient's medical care. The CAH performed 1,429 surgeries the past fiscal year.

Findings include:

1. Review of "Medical Staff Rules and Regulations," approved by the Governing Board 08/29/18, revealed in part, "The author of every entry, in the medical record, must take a specified action to identify himself as the author...of the entry, timing and dating of the entry..."

2. Review of medical records on 08/19/20 at 11:45 PM revealed the following:

a. On 07/10/20 at approximately 10:30 AM, Patient #2 received IV Propofol (drug used for deep sedation) during a colonoscopy (exam of intestine that uses a long, flexible tube with a camera). Review of post anesthesia documentation revealed CRNA F failed to document the date and time of the post anesthesia examination.

b. On 07/31/20 at approximately 7:00 AM, Patient #4 received IV Versed (a drug used for sedation) during a cataract extraction and introcular lens implant. Review of post anesthesia documentation revealed CRNA G failed to
document the date and time of the post anesthesia examination.

3. During an interview on 08/19/20 at 12:30 PM, CRNA E explained the process CAH CRNAs use to ensure patients are evaluated after receiving anesthesia. CRNA E acknowledged the medical record did not include the required date and time of the post anesthesia evaluation.




II. Based on document review and staff interview, the Critical Access Hospital (CAH) failed to ensure anesthesia staff (CRNA E, CRNA G) documented the time of the post anesthesia evaluation for 2 of 5 patients (Patient #1, Patient #3) who received anesthesia for their surgeries. Failure to appropriately date and time the completion of a post anesthesia evaluation may result in an inadequate medical record that could adversely affect a patient's medical care. The CAH performed 1,429 surgeries the past fiscal year.

Findings include:

1. Review of "Medical Staff Rules and Regulations," approved by the Governing Board 08/29/18, revealed in part, "The author of every entry, in the medical record, must take a specified action to identify himself as the author...of the entry, timing and dating of the entry..."

2. Review of medical records on 08/19/20 at 11:45 PM revealed the following:

a. On 07/20/20 at approximately 10:35 AM, Patient #3 received general anesthesia during a laparoscopic cholecystectomy (removal of gallbladder using a flexible tube with a camera placed through small incisions in the abdomen). Review of post anesthesia documentation revealed CRNA G failed to note the time the post anesthesia exam was completed.

b. On 07/10/20 at approximately 10:00 AM, Patient #1 received IV Propofol during a colonoscopy. Review of post anesthesia documentation revealed CRNA E failed to note the time the post anesthesia exam was completed.

3. During an interview on 08/19/20 at 12:30 PM, CRNA E explained the process CAH CRNAs use to ensure patients are evaluated after receiving anesthesia. CRNA E acknowledged the medical record did not include the required documentation of the time of the post anesthesia evaluation.




III. Based on document review and staff interview the CAH failed to ensure anesthesia staff (CRNA F) perform a post-anesthesia evaluation on 1 of 2 (Patient #5) following a casarean section delivery. Failure to perform a post anesthesia evaluation may result in unidentified serious adverse effects of anesthesia, delayed recovery and poor outcomes. The CAH performed 15 casarean deliveries in the past fiscal year.

1. Review of "Medical Stff Rules and Regulations," approved by the Governing Board 08/29/18, revealed in part, "the post-anesthesia follow-up report must be written ..prior to discharge from...anesthesia services... evaluation must include..Cardiopulmonary status; Level of consciousness; follow-up care..observations..Any complications occurring during post-anesthesia recovery."

2. On 4/16/20 at approximately 0612 AM, Patient #5 received IV Ketamine (drug used for anesthesia) during a casarean section to surgically deliver a baby. Review of anesthesia records revealed CRNA F failed to perform a post anesthesia evaluation.

3.During an interview on 8/20/2020 at approximately 8:00 AM, Chief Nursing Executive acknowledged the medical record lacked a post-anesthesia evaluation required for all surgical patients who received anesthesia.

Based on observation, policy review, and staff interview, the Critical Access Hospital (CAH) failed to ensure that the infection preventionist(s)/infection control professional(s) responsible for the infection prevention and control program individual (or individuals), had been appointed by the Governing Body, and that the appointment was based on the recommendations of medical staff leadership and nursing leadership. Failure to comply with regulations could potentially hinder the infection prevention and control program including surveillance, prevention, and control of hospital-acquired infections (HAI)s, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and address any infection control issues, potentially causing harm to patients and their safety.

Findings include:

1. Interview with Infection Control Preventionist on 08/19/2020 confirmed that new regulations had been received from CMS, however, an appointment from the Governing Body had not been made.

2. Interview with Chief Nursing Executive (CNE) on 08/20/2020 confirmed that the Infection Control Preventionist had not been appointed by the Governing Board.