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300 WEST HUTCHINGS STREET

WINTERSET, IA 50273

No Description Available

Tag No.: C0206

Based on review of the blood bank agreement, Medical Staff Meeting minutes, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the CAH's Medical Staff approved the updated blood bank agreement. The Laboratory administrative staff reported the laboratory had 27 units of blood products available to CAH patients at the beginning of the survey.

Failure to ensure a current, approved blood bank agreement was in place could potentially interrupt the availability of blood products needed for emergencies resulting in patient harm and/or death.

Findings include:

1. Review of the "Blood Supply and Services Agreement", dated October 1, 2011, signed by the Chief Nursing Officer on 9/30/2011 and the agreement lacked approval by the CAH's Medical Staff.

2. Review of the CAH's Medical Staff Meeting minutes October 2011 revealed the Blood Bank Agreement Amendment lacked approval by the CAH's Medical Staff.

3. During an interview on 11/20/18 at 4:30 PM, Chief Clinical Officer, acknowledged the Blood Bank Agreement Amendment dated October 1, 2011 lacked approval by the CAH's Medical Staff.

No Description Available

Tag No.: C0222

Based on observation and staff interview, the critical access hospital's (CAH) administrative staff failed to ensure staff performed preventative maintenance on 2 of 2 new Passport 12 Mindray Cardiac Monitors, 1 of 1 Fast Flow Fluid Warmer, 1 of 1 Mortara ECG Unit in the Emergency Department (ED), 1 of 2 treadmills and 1 of 1 Salter Aire Nebulizer in the CardioPulmonary Rehab Department. Failure to perform preventative maintenance could potentially result in the equipment failing to perform if needed in an emergency situation, and potentially result in significant disability or death. The CAH's administrative staff identified an average of 275 emergency patients per month and 32 cardiopulmonary rehab patients per month.


Findings include:

1. Observations during a tour of the Emergency Department on 11/210/18 at 9:00 AM revealed a Passport 12 Mindray cardiac monitor (a machine that monitors the heart rate and rhythm), and a Level 1 Fast Flow Fluid warmer without preventive maintenance stickers in Treatment room # 2, a Passport 12 Mindray Cardiac monitor without a preventive maintenance sticker in the Trauma Room, and a Mortara ECG Unit (a machine that measures heart rate and rhythm used to look for abnormalities that may effect heart function), without a preventive maintenance sticker in the ED hallway outside the ED treatment rooms.

2. Observations during a tour of the CardioPulmonary Rehab department revealed 1 of 2 treadmills without a preventive maintenance sticker and a Salter Aire Nebulizer (a device for producing a fine spray of liquid, used for inhaling medicine) with a preventive maintenance sticker dated 4/2016.

3. During an interview on 11/20/2018 at 2:15 PM the Clinical Engineer revealed the 2 Passport 12's, Fast Flow Fluid Warmer, the ECG machine and the equipment had not had preventative maintenance and were not listed in the preventative maintenance inventory. The 1 of 2 treadmills in CardioPulmonary Rehab was not listed in the biomedical preventive maintenance equipment inventory and the Salter Aire Nebulizer, dated 4/2016, had been deleted from the preventative maintenance inventory.

4. During an interview on 11/20/2018 at 2:15 PM the Facilities Manager reported there was not a policy regarding the preventive maintenance of clinical equipment.

5. During a tour of the Emergency Department on 11/20/2018 at 9:00 the Director of Nursing Services revealed she did not know how new clinical equipment were added to the preventative maintenance inventory system.

No Description Available

Tag No.: C0224

Based on observation and staff interviews, the Critical Access Hospital's administrative staff failed to ensure the radiology staff documented how long they stored intravenous (IV) contrast dye and normal saline in 1 of 1 warmer in the CT Scanner room. Failure to document when the staff placed the IV contrast and normal saline could potentially result in the staff leaving the IV contrast and normal saline in the warmer longer than the manufacturers recommended. If the staff left the IV contrast and normal saline longer than the manufacturers recommendations, bacteria could potentially grow in the IV contrast and normal saline, potentially resulting in a life threatening infection. The radiology manager identified the staff performed approximately 8,600 radiology exams in Fiscal Year 2018.

Findings include:

1. Observations on 11/19/18 at approximately 1:30 PM during a tour of the CT (computerized tomography) scanner control room revealed 1 of 1 fluid warmer (a device designed to keep intravenous fluids at a controlled temperature). Observations inside the fluid warmer revealed 13 vials of 50 mL (milliliters) 0.9% normal saline (a fluid used to dilute medications), 6 vials of 50 mL IsoVue-300 IV contrast, and 11 vials of 100 mL IsoVue 300 IV contrast. All of the vials lacked evidence of the date the radiology staff placed the vials in the warmer.

2. During an interview on 11/20/18 at 2:00 PM, the Radiology Manager stated the manufacturer of the 0.9% normal saline allowed the radiology staff to warm the fluid for up to 2 weeks. The warming process resulted in the fluid expiring 2 months prior to the 0.9% normal saline's original expiration date. The IsoVue manufacturer allowed the radiology staff to warm the fluids, if the radiology staff monitored and dated the IsoVue when they placed the IsoVue in the warmer.

The Radiology Manager acknowledged the staff failed to document the date they placed the IsoVue and 0.9% normal saline in the warmer.

No Description Available

Tag No.: C0259

Based on review of documents and policy/procedures, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure a physician reviewed the care provided by 2 of 2 sampled mid-level providers to emergency room patients (Physician Assistant (PA) B and C).

The hospital staff identified the mid-level providers provided care to the emergency room patients from October 2017 to September 2018 as follows:

- PA B: 495 patients
- PA C: 444 patients

Failure to ensure a physician periodically reviews, in conjunction with the mid-level providers, the care provided by the mid-level practitioners affects the facility's ability to assure the mid-level providers are consistently providing quality care to its patients.

Findings include:

1. Review of policy titled "Mid-level Practitioner", last approved 12/2017, revealed the following in part, ..."The mid-level provider will participate with a physician in a periodic review of the patient's health records at Madison County Memorial Hospital. Outpatient medical records will be reviewed, periodically (10% of patient records)., for quality and appropriateness of diagnosis and treatment. The physician reviewer will share his results with the mid-level practitioner. . . ."

2. Review of documentation lacked evidence the mid-level provider participated with a physician in a periodic review of the patient's health records.

3. During an interview on 11/21/18 at 9:00 AM, with the Director of Nursing (DON) acknowledged the lack of evidence the mid-level provider participated with a physician in a periodic review of the patient's health records.

No Description Available

Tag No.: C0264

Based on review of documents and policy/procedures, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure the mid-level practitioner participated with a physician to review the CAH's patient records periodically for 2 of 2 sampled mid-level providers (Physician Assistant (PA) B and C).

The hospital staff identified the mid-level providers provided care to the emergency room patients from October 2017 to September 2018 as follows:

- PA B: 495 patients
- PA C: 444 patients

Failure of the mid-level practitioner to participate in the review of CAH patient records periodically with the physician could potentially result in mid-level practitioners misdiagnosing patients and/or providing inappropriate or substandard patient care.

Findings include:

1. Review of policy titled "Mid-level Practitioner", last approved 12/2017, revealed the following in part, ..."The mid-level provider will participate with a physician in a periodic review of the patient's health records at Madison County Memorial Hospital. Outpatient medical records will be reviewed, periodically (10% of patient records)., for quality and appropriateness of diagnosis and treatment. The physician reviewer will share his results with the mid-level practitioner. . . ."

2. Review of documentation lacked evidence the mid-level provider participated with a physician in a periodic review of the patient's health records.

3. During an interview on 11/21/18 at 9:00 AM, with the Director of Nursing (DON) acknowledged the lack of evidence the mid-level provider participated with a physician in a periodic review of the patient's health records.

No Description Available

Tag No.: C0276

I. Based on observation, document review, and staff interview, the Critical Access Hospital's (CAH) administrative staff failed to ensure 1 of 1 observed Certified Registered Nurse Anesthetist (CRNA A) cleansed medication stoppers and intravenous (IV) access ports with alcohol prior to administering medications. Failure to cleanse the medication stoppers and IV access ports with alcohol could potentially result in bacteria, viruses, or fungi from the medication stopper or IV access port getting into the sterile fluid and contaminating the fluid. The contamination could potential result in the patient developing a life-threatening infection. The Nurse Manager of Surgery and Specialty Clinics revealed the surgical services staff performed 50-60 surgical procedures per month.

Findings include:

1. Observations on 11/20/18 during a surgical procedure revealed the following:

a. at 10:34 AM, CRNA A removed the plastic cap from a vial of lidocaine (a numbing medication) and removed the lidocaine from the vial with a syringe and needle. CRNA A failed to cleanse the stopper of the lidocaine vial prior to removing the lidocaine from the vial.

b. at 10:34 AM, CRNA A removed the plastic cap from a vial of Versed (a medication to relax patients prior to surgery) with a syringe and needle. CRNA A failed to cleanse the stopper of the Versed vial prior to removing the Versed from the vial.

c. at 10:34 AM, CRNA A removed the plastic cap from a vial of Fentanyl (a strong pain medication for surgery) with a syringe and needle. CRNA A failed to cleanse the stopper of the Fentanyl vial prior to removing the Fentanyl from the vial.

d. at 10:34 AM, CRNA A removed the plastic cap from a vial of succinylcholine (a muscle relaxing medication for surgery) with a syringe and needle. CRNA A failed to cleanse the stopper of the succinylcholine vial prior to removing the succinylcholine from the vial.

e. at 10:34 AM, CRNA A removed the plastic cap from a vial of rocuronimum (a muscle relaxing medication for surgery) with a syringe and needle. CRNA A failed to cleanse the stopper of the rocuronimum vial prior to removing the rocuronimum from the vial.

f. at 10:40 AM, CRNA A touched the IV access port after administering the Versed. CRNA A then administered Fentanyl via the IV access port without cleansing the IV access port after touching it.

g. at 10:42 AM, CRNA A removed the plastic cap from a vial of propofol (a sedative medication for surgery) with a syringe and needle. CRNA A failed to cleanse the stopper of the propofol vial prior to removing the propofol from the vial. CRNA A administered the propofol to the patient without first cleansing the IV access port with alcohol.

h. at 10:47 AM, CRNA A administered the rocuronimum to the patient without first cleansing the IV access port with alcohol.

i. at 10:55 AM, CRNA A removed the plastic cap from a vial of Fentanyl with a syringe and needle. CRNA A failed to cleanse the stopper of the Fentanyl vial prior to removing the Fentanyl from the vial. CRNA A administered the Fentanyl to the patient without first cleansing the IV access port with alcohol.

j. at 11:10 AM, CRNA A administered the Fentanyl to the patient without first cleansing the IV access port with alcohol.

k. at 11:10 AM, CRNA A administered the Fentanyl to the patient without first cleansing the IV access port with alcohol.

l. at 11:25 AM, CRNA A removed the plastic cap from a vial of Toradol with a syringe and needle. CRNA A failed to cleanse the stopper of the Toradol vial prior to removing the Toradol from the vial. CRNA A administered the Toradol to the patient without first cleansing the IV access port with alcohol.

m. at 11:26 AM, CRNA A removed the plastic cap from a vial of Zofran (a strong anti-nausea medication) with a syringe and needle. CRNA A failed to cleanse the stopper of the Zofran vial prior to removing the Zofran from the vial. CRNA A administered the Zofran to the patient without first cleansing the IV access port with alcohol.

n. at 11:26 AM, CRNA A administered Robinul (a medication to reverse the general anesthesia) to the patient. CRNA A failed to cleanse the IV port with alcohol prior to administering the Robinul to the patient.

o. at 11:26 AM, CRNA A administered neostigmine (a medication to reverse the general anesthesia) to the patient. CRNA A failed to cleanse the IV port with alcohol prior to administering the neostigmine to the patient.


2. Review of the policy "Medication Administered Intravenous," effective 12/2017, revealed the policy lacked a requirement for the hospital staff to cleanse the stopper of the medication vial prior to removing the medication from the vial or for the staff to cleanse the IV access port prior to administering medications to the patient.

3. During an interview on 11/21/18 at 8:30 AM, the Pharmacist acknowledged CRNA A should have cleansed the stoppers of the medication vials prior to removing the medication from the vial. The Pharmacist also acknowledged CRNA A should have cleansed the IV access port with alcohol prior to administering medications to the patient.



II. Based on observation, document review, and staff interview, the CAH administrative staff failed to ensure 1 of 1 observed CRNA (CRNA A) discarded 2 of 2 syringes drawn up during prior surgical procedures. Failure to discard syringes after the surgical procedure could potentially result in contamination of the syringe with bacteria, viruses, and fungi. Contamination of the syringe could potentially result in an infection from the first patient transmitting to another patient, resulting in a life-threatening infection. The Nurse Manager of Surgery and Specialty Clinics revealed the surgical services staff performed 50-60 surgical procedures per month.

Findings include:

1. Observations on 11/20/18 at 10:37 AM revealed CRNA A drew up succinylcholine in a syringe. CRNA A labeled the syringe with the medication, strength, when he drew it up, and who drew it up.

2. Observations on 11/20/18 at 3:50 PM revealed the syringe of succinylcholine CRNA A drew up at 11/20/18 at 10:37 AM was still sitting on his anesthesia machine. Observations also revealed a syringe of rocuronimum drawn up on 11/20/18 at 12:40 PM.

3. Review of the policy "Medication Administered Intravenous," effective 12/2017, revealed the policy lacked information on how long the staff could keep the medication in a syringe once they drew the medication out of a sterile vial.

4. During an interview on 11/21/17 at 8:30 AM, the Pharmacist revealed CRNA A should have discarded the syringes after the surgical procedure where CRNA A drew the medication into the syringe. The Pharmacist acknowledged the medication should only stay in the syringe for an hour after CRNA A withdrew the medication from the vial.



III. Based on observation, document review, and staff interview, the CAH's administrative staff failed to ensure 1 of 1 observed CRNA (CRNA A) discarded 2 of 2 multi-dose vials after opening them in a direct patient care area (operating room). Failure to discard multi-dose vials after using the vials in a direct patient care area could potentially result in bacterial contamination from the environment getting into the vial and contaminating the vial. If the bacteria contaminated the vial, the bacteria could potentially pass to the next patient and potentially cause the next patient to develop a life-threatening infection. . The Nurse Manager of Surgery and Specialty Clinics revealed the surgical services staff performed 50-60 surgical procedures per month.

Findings include:

1. Observations on 11/20/18 at 11:26 AM revealed CRNA A removed Robinul from a multi-dose vial (a vial designed for use on multiple patients, if medication is not withdrawn in a patient care area) in the operating room. CRNA A then removed neostigmine from a multi-dose vial in the operating room. CRNA A had previously labeled the vials with the date he first opened the vials, 11/1/18 at 9:19 AM. CRNA A returned the labeled vials to his medication cart.

2. Observations on 11/20/18 at 3:50 PM of CRNA A's medication cart revealed the medication cart still contained the vials of Robinul and neostigmine dated 11/1/18 at 9:19 AM. CRNA A performed 2 additional surgical procedures between the observations on 11/20/18 at 11:26 AM and 11/20/18 at 3:50 PM.

3. Review of the policy "Medication Administered Intravenous," effective 12/2017, revealed the policy lacked a requirement for the staff to discard multi-dose medication vials if the staff withdrew medication in a direct patient care location such as an operating room.

4. During an interview on 11/21/18 at 8:30 AM, the Pharmacist acknowledged if CRNA A opened a multi-dose vial of medication in the operating room, CRNA A should discard the multi-dose vial at the end of the surgical procedure and not use the multi-dose vial for another patient.




IV. Based on observation, document review, and staff interviews, the CAH's administrative staff failed to ensure 1 of 1 observed CRNA during an operative procedure (CRNA A) did not push sterile needles and syringes through the paper packaging. Pushing sterile syringes and needles allows the sterile areas of the needles and syringes to come in contact with the non-sterile outside of the packaging and potentially allow paper fibers to fall into the sterile fluid pathway, potentially contaminating the sterile fluid and potentially allowing the fibers to go into the patient's blood stream. Allowing the sterile parts of the needle and syringes to contact the non-sterile packaging could potentially result in bacteria, viruses, and fungi from the packaging to get into the patient's blood stream, and potentially cause a life threatening infection. Allowing the paper fibers to get into the patient's blood stream could potentially result in the patient developing a blood clot or allergic reaction related to the patient's body's response to the foreign material.


Findings include:

1. Observations on 11/20/18 during a surgical procedure revealed CRNA A preparing medications for the surgical procedure. CRNA A performed the following actions:

a. at 10: 34 AM, CRNA A removed 0.9% normal saline (sterile liquid for diluting medication) from a vial. CRNA A pushed the sterile needle and syringe through the paper packaging, instead of peeling the packaging apart and maintaining the sterility of the needle and syringe.

b. at 10:34 AM, CRNA A removed Fentanyl from a vial. CRNA A pushed the sterile needle and syringe through the paper packaging, instead of peeling the packaging apart and maintaining the sterility of the needle and syringe.

c. at 10:34 AM, CRNA A removed succinylcholine from a vial. CRNA A pushed the sterile needle and syringe through the paper packaging, instead of peeling the packaging apart and maintaining the sterility of the needle and syringe.

d. at 10:34 AM, CRNA A removed rocuronimum from a vial. CRNA A pushed the sterile needle and syringe through the paper packaging, instead of peeling the packaging apart and maintaining the sterility of the needle and syringe.

e. at 11:25 AM, CRNA A removed Toradol from a vial. CRNA A pushed the sterile needle and syringe through the paper packaging, instead of peeling the packaging apart and maintaining the sterility of the needle and syringe.

f. at 11:26 AM, CRNA A removed Zofran from a vial. CRNA A pushed the sterile needle and syringe through the paper packaging, instead of peeling the packaging apart and maintaining the sterility of the needle and syringe.

g. at 11:26 AM, CRNA A removed Robinul from a vial. CRNA A pushed the sterile needle and syringe through the paper packaging, instead of peeling the packaging apart and maintaining the sterility of the needle and syringe.

h. at 11:26 AM, CRNA A removed neostigmine from a vial. CRNA A pushed the sterile needle and syringe through the paper packaging, instead of peeling the packaging apart and maintaining the sterility of the needle and syringe.


2. Review of the policy "Medication Administered Intravenous," effective 12/2017, revealed the policy lacked a requirement for the CAH staff to maintain the sterility of needles and syringes when the staff removed them from the packaging.


3. During an interview on 11/21/18 at 8:30 AM, the Nurse Manager of Surgery and Specialty Clinics acknowledged CRNA A should not open sterile needles and syringes by pushing them through the paper, and instead should peel the packaging apart to maintain the sterility of the needle and syringe.

No Description Available

Tag No.: C0277

Based on review of policy/procedure, documentation, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure timely physician notification for the occurrence of a medication error for 6 of 10 medication errors reviewed. (Patient #1, Patient #2, Patient #3, Patient #4, Patient #5). The CAH administrative staff reported a census of 4 patients. Failure to notify the physician of medication errors could potentially result in life threatening conditions that could lead to serious harm.

Findings include:

1. Review of the CAH Pharmacy policy/procedure "Medication Variance Report", effective date 12/2017, stated in part, " Complete a variance report at time of occurrence or at the time the occurrence is noted." "A completed medication variance includes prescriber notification with time and date."

2. Review of the medication errors from January 2018 to October 2018 revealed 6 of 10 medication errors lacked the time the prescriber was notified of the medication errors for Patients #1,2,3,4,5.

3. During an interview on 11/20/2018 at 11:45 AM, the Quality Improvement/Performance Excellence Manager reported the medication variance report form had recently changed, it now had a check box in front of the phrase "notify physician" and did not ask for the time the prescriber was notified. The Quality Improvement/Performance Excellence Manager revealed she notified the prescriber when she reviewed the medication variance report form and noted the information was missing.

The Quality Improvement/Perfromance Excellence Manager acknowledged the form lacked the time of prescriber notification and that the prescriber was not notified at the time of the medication error or at the time the error was discovered for Patients # 1,2,3,4,5.

PATIENT CARE POLICIES

Tag No.: C0278

I. Based on observation, document review, and staff interview, the Critical Access Hospital's administrative staff failed to ensure the surgical services staff followed the manufacturer's instructions when using ChloraPrep in 1 of 1 observed surgical procedure. Failure to follow the manufacturer's instructions for use with ChloraPrep could potentially result in the surgical disinfectant failing to kill all of the bacteria, viruses, and fungi on the patient's skin, and cause the patient to potentially develop a life-threatening surgical site infection. The Nurse Manager of Surgery and Specialty Clinics identified the surgical services staff performed approximately 50-60 surgical procedures per month.

Findings include:

1. Observations on 11/21/18 at 10:54 AM revealed the Nurse Manager for Surgery and Specialty Clinics was preparing a patient's abdomen for surgery. The Nurse Manager for Surgery and Speciality Clinics applied ChloraPrep solution to the patient's abdomen in a scrubbing motion. She finished applying the ChloraPrep solution to the patient's abdomen at 10:54 AM. At 10:55 AM, the surgeon started to place surgical drapes (sterile paper coverings used to prevent surgical infections) over the patient's abdomen.

2. Review of the manufacturer's instructions for ChloraPrep, not dated, revealed in part, "do not drape ... until solution is completely dry (minimum of 3 minutes on hairless skin...)."

3. During an interview at 11/21/18 at 10:30 AM, the Nurse Manager for Surgery and Specialty Clinics acknowledged the manufacturer required staff to wait 3 minutes for the ChloraPrep to dry after staff finished applying the ChloraPrep.


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II. Based on observation, document review and staff interviews the Crititcal Access Hospital's (CAH) Emergency Department (ED) staff failed to correctly label the enzymatice cleaner in such a way that the contents of the spray bottle could be identified by staff and failed to follow the manufacturer's directions for use when cleansing contaminated instruments. Enzymatic cleaning is a special method used to remove foreign material from surgical instruments prior to the disinfection process. Failure to follow the enzymatic cleaner's manufacturer's instructions for use may result in inadequate instrument cleaning leading to inadequate disinfection of the surgical instruments and the potential for infections.

Findings include:

1. Observation on 11/21/2018 at 10:00 AM in the ED soiled utility room revealed an incorrectly labeled spray bottle identified by the Director of Nursing Services as enzymatic cleaner.

2. Review of Policy "Cleaning and Transportation of Instruments" effective 12/2017, revealed in part, "Emergency room....Aseptizyme (Enzymatic)-Soak instruments in diluted solution (1 cc-1 cup)....

3. During an interview on 11/21/2018 at 10:00 AM in the ED soiled utility room the Director of Nursing Services pulled out the stock bottle of Enzymatic Detergent from a cabinet and reported this solution was poured into the spray bottle on the counter. The Director of Nursing Services acknowledged the label on the spray bottle was incorrect and revealed the enzymatic solution was not diluted per manufactureres instructions listed on the stock bottle

No Description Available

Tag No.: C0283

Based on observation, document review, and staff interview, the Critical Access Hospital's administrative staff failed to ensure the radiology staff regularly checked 38 of 38 lead shielding devices for cracks and holes in the lead shielding. Failure to check the lead shielding devices resulted in the radiology staff failing to identify cracks and holes which developed between times the radiology staff checked the lead shielding devices. Failure to identify cracks and holes in the lead shielding devices could potentially result in the radiology staff exposing patients and staff to undesired radiation, potentially causing genetic damage or cancer. The Radiology Manger identified the radiology staff performed approximately 8,600 radiology procedures in Fiscal Year 2018.

Findings include:

1. Observations during a tour of the radiology department on 11/19/18 at approximately 1:30 PM revealed many lead aprons and other lead shielding devices (lead lined aprons and other devices used to protect patients and staff from undesired exposure to radiation).

2. Review of the policy, "Inspection of Radiation Protective Equipment," revised 2/28/01, revealed in part, "Radiation protective equipment will be inspected ... every six months."

3. Review of the "Radiation Protection Equipment [Quality Control]" document revealed the radiology staff last checked the lead shielding devices for cracks and holes on 10/6/16 (over 2 years prior).

4. During an interview on 11/20/18 at 2:00 PM, the Radiology Manager acknowledged the radiology staff failed to check the lead shielding devices since 10/6/2016. The Radiology Manager checked the lead shielding equipment on 11/19/18 and provided the results from the checks.

5. Review of the "Radiation Protective Equipment [Quality Control]" document revealed 8 of the 38 lead shielding devices had developed cracks or holes between 10/6/2016 and 11/19/2018, including 1 lead shielding device which required the radiology staff to discard the lead shielding device.

No Description Available

Tag No.: C0308

Based on observation, document review, and staff interview, the Critical Access Hospital's administrative staff failed to ensure the radiology staff kept patient medical information secure from unauthorized access in 1 of 1 ultrasound room. Failure to keep patient medical information confidential could potentially result in theft of a patient's information and potentially result in identify theft. The Radiology Manager identified the radiology staff performed approximately 600 ultrasound procedures in Fiscal Year 2018.

Findings include:

1. Observations on 11/19/18 at approximately 1:30 PM during a tour of the ultrasound room revealed a log indicating when the ultrasound staff disinfected the ultrasound probe. The log included the date of service and the patient's name for 52 patients. For 6 patients, who received care after 10/31/18, the log also included the patients' date of birth. The log was located on the inside of the unlocked cabinets located in the room.

During the observations, the door was left open when ultrasound staff was not in the room. Observations revealed 2 unescorted patients walk by the ultrasound room, without any hospital or clinic staff in the area.

2. Review of the policy, "Confidentiality of Patient and Corporate Information," last approved 12/2017, revealed in part, "Confidential patient information includes, but is not limited to, any information regarding a patient, ... examination, ... which includes, but is not limited to, ... documents, ... and any other means of presenting information regarding a patient. Confidential payment information is privileged."

3. During an interview at the time of the tour, the Radiology Manager acknowledged the log contained confidential patient information and the ultrasound staff failed to secure the information from access by unauthorized individuals.

QUALITY ASSURANCE

Tag No.: C0337

Based on review of the Quality Improvement Plan, Quality Improvement activities, and staff interviews, the Critical Access Hospital (CAH) quality improvement staff failed to evaluate all patient care services provided for 3 of 3 contracted patient care services. (Teleradiology, MRI - Magnetic Resonance Imaging, and Nuclear Medicine) The CAH administrative staff reported a census of 4 patients at the beginning of the survey. The CAH administrative staff reported 8595 Teleradiology reads, 199 MRI exams, and 75 Nuclear Medicine exams for the Fiscal Year End 2018.

Failure to monitor and evaluate all patient care services for quality of care could potentially expose patients to inappropriate and/or substantial care.

Findings include:

1. Review of CAH policy titled "CQI Plan", dated 12/2017, revealed, in part. ". . .The Quality Improvement Plan is a guideline to provide an organized system to continually and objectively evaluate all aspects of care provided to our patients. . . ."

2. Review of QI (Quality Improvement) Committee Meeting minutes from November 22, 2017 through October 17, 2018 lacked evidence that Teleradiology, MRI - Magnetic Resonance Imaging, and Nuclear Medicine monitored, evaluated and reported quality improvement activities regarding patient care services.

3. During an interview on 11/21/18 at 8:40 AM, the Quality Improvement/Performance Excellence Manager, acknowledged that Teleradiology, MRI - Magnetic Resonance Imaging, and Nuclear Medicine monitored, evaluated and reported quality improvement activities regarding patient care services.