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1111 11TH STREET

HAWARDEN, IA 51023

No Description Available

Tag No.: C0152

Based on personnel record review, policy review and staff interview, the facility failed to ensure 1 of 4 contracted employees, selected for review, received the mandatory 2 hour abuse training within six months of their hire date (Staff B).

235 B16.5b. A person required to report cases of dependent adult abuse pursuant to sections 235B.3 and 235E.2, ... shall complete two hours of training relating to the identification and reporting of dependent adult abuse within six months of initial employment or self-employment which involves the examination, attending, counseling, or treatment of adults on a regular basis.
e. A person required to complete both child abuse and dependent adult abuse mandatory reporter training may complete the training through a program which combines child abuse and dependent adult abuse curricula and thereby meet the training requirements of both this subsection and section 232.69 simultaneously. A person who is a mandatory reporter for both child abuse and dependent adult abuse may satisfy the combined training requirements of this subsection and section 232.69 through completion of a two-hour training program ...

Failure to ensure all staff, attending CAH patients, receive dependent adult abuse training may result in failure to report potential abusive situations placing patients at risk.

Findings include:

1. Review of the policy, "Mandatory Education," effective 10/2017, revealed all new employees much undergo training on mandatory reporting of dependent adult and child abuse within the first six months after the start of employment with the CAH.

2. Review of Laboratory Technician B's personnel file revealed Laboratory Technician B started working at the CAH on 3/19/18. Laboratory Technician B's personnel file lacked evidence Laboratory Technician B completed the mandatory training on reporting dependent adult and child abuse.

3. During an interview on 7/10/19, at 11:40 AM, the Human Resources Director confirmed Laboratory Technician B failed to complete the required mandatory reporting training for dependent adult and child abuse.

No Description Available

Tag No.: C0195

Based on document review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure
the network hospital (Hospital B) reviewed 1 of 1 Quality Assurance (QA) program. Failure to ensure the network hospital reviewed the QA plan coult ptentially result in the CAH staff developing a substandard QA plan and the network hospital staff failing to detect the substandard QA plan, which could potentially impact the CAH's QA efforts to provide high quality patient care. The CAH's administrative staff identified a census of 1 on entrance, with an average daily census of 2.7 patients per day.

Findings include:

1. Review of the "Critical Access Hospital Program Medicare Rural Hospital Flexibility Program Network Agreement,, effective 2/27/08, revealed in part: "[Hospital B's name]... assist the CAH to implement its QA Plan, to review findings under the CAH's QA Plan, and to propose improvement plans and or/recommend corrective action."

2. During an interview on 7/11/19 at 8:35 AM, the Director of Quality confirmed staff at Hospital B did not review findings from the CAH's QA Plan, propose improvement plans, or recommend corrective action, as required by the network agreement.

No Description Available

Tag No.: C0226

I. Based on observation, document review and staff interview, the Critical Access Hospital (CAH) pharmacy staff failed to check and document the temperature of a refrigerator storing intravenous (IV) Diltiazem (a heart medication) and IV Fosphenytoin (medication used to treat seizures) located in the pharmacy office on 11 out of 35 days reviewed. Failure to ensure CAH pharmacy staff checked and documented the temperature in the refrigerator could potentially result in patients receiving medications that do not work in the body as expected, resulting in unintended consequences or side effects. The CAH's administrative staff identified a census of 1 on entrance, with an average daily census of 2.7 patients per day.

Findings include:

1. Observations on 7/9/19 at approximately 10:30 AM, during a tour of the pharmacy office, revealed a refrigerator that contained 10 vials of Diltiazem 25 milligrams (mg) per 5 milliliters (ml), 5 vials of Fosphenytoin 500 mg per 10 ml, and 12 vials of Diltiazem 125 mg per 25 ml.

2. Review of the refrigerator temperature log from June 5, 2019 to July 9, 2019, at the time of the tour, revealed the pharmacy staff failed to document refrigerator temperatures 11 out of 35 days, on week-ends and holidays, when the pharmacy staff was not in the pharmacy office.

3. Review of the manufacturer's recommendations for Diltiazem revealed in part: "Store diltiazem...injection under refrigeration 2 degrees - 8 degrees C [Celsius]. Destroy after 1 month at room temperature."

4. Review of the manufacturer's recommendations for Fosphenytoin revealed in part: "Store under refrigeration at 2 degrees C to 8 degrees C. The product should not be stored at room temperature for more than 48 hours."

5. During an interview at the time of the tour, the Pharmacist acknowledged the pharmacy staff failed to monitor the temperature of the refrigerator every day. The Pharmacist confirmed the medication refrigerator had a temperature alarm to indicate if the temperature went outside the required temperature range, but the pharmacy staff would not know if the refrigerator's temperature had gone outside the required range if the pharmacy staff did not monitor the area or if the refrigerator returned to the required temperature before staff returned on the next business day.



II. Based on observation, document review and staff interview, the Critical Access Hospital (CAH) pharmacy staff failed to check and document the temperature of the fluid warmer located in the Pre-Op/Post-Op Room. Failure to ensure CAH pharmacy staff checked and documented the temperature in the fluid warmer could potentially result in the staff administering IV fluids outside the comfortable temperature range or fluids which remained at a higher temperature than the fluid manufacturer recommended, potentially resulting in excessive bacterial grown, potentially resulting in the patient potentially developing a life threatening infection. The CAH administrative staff reported the surgical services staff performed an average of 12 surgeries per year and 150 endoscopies per year.

Findings include:

1. Observations on 7/9/19 at approximately 12:45 PM, during a tour of the Pre-Op/Post-Op Room, revealed a fluid warmer that contained 2 one liter bags of intravenous (IV) normal saline in plastic overpouches as packaged from the manufacturer.

2. Review of Manufacturer's Recommendations for IV solutions in plastic bag containers revealed in part: "IV solutions of volumes 150 ml [milliliters] or greater can be warmed in their plastic overpouches to temperatures not exceeding 104 degrees for a period no longer than 14 days."

3. Review of the CAH's policy "8577 Warmed Fluids," effective 01/10/18, revealed in part: "The pharmacist will be responsible for monitoring the fluids in the warmer, exchanging fluids every 7 days or removing expired product."

4. During an interview at the time of the tour, the Operating Room Supervisor acknowledged surgical services staff did not monitor and document the fluid warmer temperatures that contained IV fluids.

5. During an interview on 7/9/19 at 2:20 PM, the Pharmacist confirmed the pharmacy staff did not monitor the temperatures of the fluid warmer and the pharmacy staff would not know if the fluid warmer's temperature went outside the required range.

No Description Available

Tag No.: C0272

Based on review of policies/procedures, meeting minutes, and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure the required group of professionals, including a physician and a mid-level provider, reviewed all patient care policies annually for 19 of 19 patient care departments (Discharge Planning, Pharmacy, Skilled Nursing, Nursing, Laundry/Housekeeping, Nutrition/Dietary, Radiology, Infection Control, Health Information, Quality, Maintenance/Bio-Med, Organ Donation, Anesthesia/Sterile Processing/Surgery, Emergency Room, Physical Medicine and Rehabilitation, Diabetes, Cardiac Rehabilitation, Laboratory, and Senior Life Solutions). Failure to ensure the required group of professionals reviewed all patient care policies annually could potentially result in failure to identify patient care needs not addressed in the CAH policies/procedures. The CAH administrative staff identified a census of 1 patient at the beginning of the survey.

Findings include:

1. Review of the CAH policy "Critical Access Hospital Committee," revised 4/28/16, revealed in part, "...Approve annual policy and procedure revisions for all patient services departments...."

2. Review of the "CAH Policy Committee Meeting Minutes," dated 12/6/2018, revealed the staff gave approval for new policies and policies with changes for Discharge Planning, Pharmacy, Skilled Nursing, Nursing, Laundry/Housekeeping, Nutrition/Dietary, Radiology, Infection Control, Health Information, and Quality.

The CAH Policy Committee Meeting Minutes lacked documentation of annual approval for all patient care policies for Discharge Planning, Pharmacy, Skilled Nursing, Nursing, Laundry/Housekeeping, Nutrition/Dietary, Radiology, Infection Control, Health Information, and Quality.

Review of "CAH Policy Committee Meeting Minutes," dated 4/18/2019, revealed the staff gave approval for new policies and policies with changes for Maintenance/Bio-Med, Organ Donation, Anesthesia/Sterile Processing/Surgery, Emergency Room, Physical Medicine and Rehabilitation, Diabetes, Cardiac Rehabilitation, Laboratory, and Senior Life Solutions.

The CAH Policy Committee Meeting Minutes lacked documentation the staff gave annual approval of all patient care policies for Maintenance/Bio-Med, Organ Donation, Anesthesia/Sterile Processing/Surgery, Emergency Room, Physical Medicine and Rehabilitation, Diabetes, Cardiac Rehabilitation, Laboratory, and Senior Life Solutions.

3. During an interview on 7/10/2019 at 11:35 AM, the Director of Patient Care Services verified the CAH Committee only reviewed and approved new policies and policies that had revisions. The Director of Patient Care Services further acknowledged the required group of professionals, including a physician and mid-level provider, failed to annually review the CAH's existing policies.

No Description Available

Tag No.: C0277

Based on document review and and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure timely physician notification for the occurrence of a medication error for 3 of 13 medication errors reviewed. (Patient #3, Patient #4, and Patient #5). Failure to notify the physician of medication errors could potentially result the provider not knowing about the medication error and either failing to take steps to address the consequences of the medication error, or the provider making a medical decision without the knowledge of the medication error, either way potentially resulting inappropriate treatment or even a fatal reaction. The CAH administrative staff reported a census of 1 patient on entrance, and an average daily census of 2.7 patients per day.

Findings include:

1. Review of "Medication Errors and Events Management" last approved 01/2018, revealed in part: "When an incident involving a medication related occurrence....is discovered, the staff determines immediate corrective action necessary for the patient, including notification of the practitioner. This notificaiton should take place within 24 hours of the incident, sooner depending upon the severity of the error and the patient's condition."

2. Review of medication errors from July 2018 to June 2019 revealed:

a. The nursing staff made a medication error on 7/31/18 at 9:45 AM which involved Patient #3. Patient #3's medication error paperwork lacked documentation the nursing staff notified the practitioner responsible for Patient #3's medical care of the medication error.

b. The nursing staff made a medication error on 7/19/18 at 11:26 AM which involved Patient #4. Patient #4's medication error paperwork lacked documentation the nursing staff notified the practitioner responsible for Patient #4's medical care of the medication error.

c. The nursing staff made a medication error on 7/21/18 at 7:26 AM which involved Patient #5. Patient #5's medication error paperwork lacked documentation the nursing staff notified the practitioner responsible for Patient #5's medical care of the medication error.

3. During an interview on 7/10/19 at 11:15 AM, the Director of Quality acknowledged the medication error paperwork for Patient #3, Patient #4, and Patient #5 lacked documentation the nursing staff notified the patient's provider of the medication error.

PATIENT CARE POLICIES

Tag No.: C0278

I. Based on document review, observation, and staff interview, the Critical Access Hospital (CAH) failed to ensure 1 of 1 observed Certified Registered Nurse Anesthetist (CRNA, a nurse with specialized training to administer medications used during procedures to ensure patients do not feel pain) cleansed the rubber stopper on 2 of 2 medication vials prior to removing the medication from the vials for 2 of 2 observed patients (Patient #1 and Patient #2). Failure to cleanse the stopper could potentially result in the CRNA introducing bacteria, viruses, or fungi into the medication and then administering the contaminated medication to the patient. Administering contaminated medication could potentially result in the patient developing a life threatening infection. The CAH's administrative staff identified a census of 1 on entrance, with an average daily census of 2.7 patients per day. The CAH administrative staff reported the surgical services staff performed an average of 150 endoscopies per year.

Findings include:

1. Observations on 7/9/19 at 8:48 AM, prior to Patient #1's colonoscopy (examination of colon with flexible tube) revealed CRNA A removed the plastic cover on the top of a 20 milliliter vial containing Propofol (a medication used to ensure patients do not feel pain). CRNA A then removed the medication from the vial with a needle attached to a 20 ml syringe. CRNA A failed to cleanse the vial stopper with 70% isopropyl alcohol prior to removing the medication from the vial.

2. Observations on 7/9/19 at 9:26 AM, prior to Patient #2's colonoscopy (examination of colon with flexible tube) revealed CRNA A removed the plastic cover on the top of a 20 milliliter vial containing Propofol (a medication used to ensure patients do not feel pain). CRNA A then removed the medication from the vial with a needle attached to a 20 ml syringe. CRNA A failed to cleanse the vial stopper with 70% isopropyl alcohol prior to removing the medication from the vial.

3. During an interview at the time of the observation of Patient #2, CRNA A acknowledged CRNA A did not cleanse the stoppers on the vials with 70% isopropyl alcohol prior to removing the medication from the vials for Patient #1 and Patient #2.

4. Review of pharmacy policy "8524 Infection Control in the Pharmacy," effective 12/7/17, revealed in part: "When using a vial, the rubber stopper is swabbed with 70% alcohol prior to puncture."

5. During an interview on 7/10/19 at 4:15 PM, the Pharmacist acknowledged that the pharmacy policy applies to anyone giving medication in the CAH and all staff should wipe the rubber stopper with 70% alcohol prior to removing medication from vials.



II. Based on observation and staff interviews, Critical Access Hospital (CAH) surgical services staff failed to monitor and document temperature and humidity in the surgical suite (1 Endoscopy Procedure Room, 1 Post Anesthesia Recovery Room, 1 decontamination room, 1 central sterilizer room, and sterile storage area). Failure to monitor temperature and humidity in the surgical suite could potentially result in the buildup of humidity that contains bacteria that can fall onto sterilized surfaces, operating tools, or possibly into an open wound, potentially causing serious infections in patients. The CAH administrative staff reported the surgical services staff performed an average of 12 surgeries per year and 150 endoscopies per year.

Findings include:

1. Observations during a tour of the surgical suite on 7/9/19 at approximately 1:00 PM, revealed the surgical services staff lacked documentation for temperature and humidity in all areas of the surgical suite except the OR.

2. During an interview at the time of the tour, the Surgery Supervisor confirmed that surgery staff did not perform any type of temperature or humidity monitoring for Endoscopy Room, Endoscopy cleaning room, Decontamination Room or adjacent areas in the OR Suite. The Surgery Supervisor also stated the CAH based their surgical policies on the AORN (Association of peri-Operative Registered Nurses, a nationally recognized guideline agency) guidelines.

3. Review of the AORN Guidelines for Environment of Care, copyright 2018, revealed in part: "The health care organization should create and implement a systematic process for monitoring HVAC [Heating, Ventilation, Air Conditioning] performance parameters and a mechanism for resolving variances...The HVAC system is intended to reduce the amount of environmental contaminates (eg, microbial laden skin squames, dust, lint) in the surgical suite."

4. During an interview on 7/11/19 at approximately 10:00 AM, Surgery Supervisor confirmed surgical services staff followed AORN standards and acknowledged CAH staff did not follow the AORN recommendation to monitor temperature and humidity monitoring in the surgical suite.




III. Based on observation, document review and staff interview, the Critical Access Hospital (CAH) failed to ensure appropriate monitoring and documentation of appropriate cleaning of the Ultrasonic Cleaner (used to disinfect surgical instruments). Failure to monitor and document appropriate cleaning could potentially result in the Ultrasonic Cleaner not functioning adequately and failing to remove all bacteria or other infectious agents from the surgical instruments, potentially allowing the bacteria or other infectious agents to pass to the next patient, potentially resulting in the next patient developing a life-threatening infection. The hospital's administrative staff identified the surgical services staff performed an average of 12 surgical procedures per year.

Findings include:

1. Observation on 7/9/19 at approximately 1:00 PM, during a tour of Decontamination Room, revealed the CAH surgical staff used a Healthmark Ultrasonic Cleaner to pre-clean surgical instruments.

2. During an interview at the time of the tour, the RN Surgery Supervisor revealed the surgical services staff performed Sonocheck (test used to ensure Ultrasonic Cleaner is cleaning properly) once each week on Mondays.

3. Review of the "SonoCheck Test Log," dated 8/20/18 to 7/8/19, revealed the surgical services staff failed to consistently document SonoCheck tests once each week.

4. Review of a sample policy from the manufacturer, provided by the CAH, revealed in part: "According to ...AAMI [Association for the Advancement of Medical Instrumentation, an organization which provides standards to guide sterility assurance in hospitals] ST79 (a nationally recognized guideline on cleaning surgical instruments) every medical facility that has a medical sonic cleaner must put in place a cleaning verification process that consists of defining a cleaning process and its critical aspects so that each step is fully verifiable...to ensure that it can be followed completely, accurately, and without variation by all individuals who perform it...The efficacy of the ultrasonic cleaner should be tested each day the sonic cleaner is used. The results of the testing shall be documented as part of the proof of process."

5. During an interview on 7/11/19 at 10:00 AM, the Surgery Supervisor confirmed CAH surgical services staff followed AAMI standards. The Surgery Supervisor acknowledged the CAH was not meeting the requirements listed in AAMI ST79 to verify the efficacy of the ultrasonic cleaner.

QUALITY ASSURANCE

Tag No.: C0340

Based on document review, policy review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure 1 of 1 applicable surgeons selected for review (Surgeon C), received outside entity peer review by the appropriate entity, to evaluate the appropriateness of diagnosis and treatment furnished to patients at the Critical Access Hospital. Failure to ensure all medical staff members received outside entity peer review by the appropriate entity, affects the CAH's ability to assure physicians provide quality care to the CAH patients. The CAH administrative staff identified Surgeon C provided care to 78 patients from July 10, 2018 to July 11, 2019.

Findings include:

1. Review of the CAH network agreement, effective March 1, 2008, revealed in part, "This network agreement, entered into this 1st day of March 2008, by [Hospital B's name] ... and Hawarden Community Hospital, a Critical Access Hospital (CAH) ..."

2. Review of the "Peer Review Services Agreement," with the CAH network hospital (Hospital B), effective September 2014, revealed in part "This agreement is between [Hospital B's name] ... and Hawarden Community Hospital, a Critical Access Hospital ... wishes to engage the services of an objective, retrospective peer reviewer for purposes of reviewing the quality of care provided by or in Hawarden Community Hospital ..."

3. Review of the CAH policy "Medical Staff Peer Review," revised 11/2013, revealed in part, " ... Hawarden Community Hospital, as a member of a rural health network has an agreement with respect to credentialing and quality assurance with at least: One hospital that is a member of the network ..."

4. Review of the "Peer Review Services Agreement," effective September 2014, revealed in part "This Peer Review Services Agreement is made and entered into by and between Hawarden Community Hospital and [Hospital C's name] ... [Hospital C's name] shall, upon the request, evaluate the diagnosis and treatment provided by physicians at CAH ..."

5. Review of the external peer review completed for Surgeon C, revealed staff at Hospital C conducted the external peer review.

6. During an interview on 7/10/19 PM, the Director of Quality reported the CAH staff utilized surgeons at Hospital C to perform the surgical external peer review and confirmed the CAH lacked a network agreement with Hospital C.

No Description Available

Tag No.: C0361

Based on document review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure all swing bed patients received the required Swing Bed Patient Rights for 1 of 1 swingbed patient admission packed reviewed. Failure to present all of the required rights to the swing bed patients and/or their legal representative could result in the patients and/or their legal representatives being unaware of all their rights as swing bed patients while they are continuing to receive skilled level of care. The lack of knowledge prevented the swing bed patients from potentailly exercising all of their rights. The CAH administrative staff identified a census of 1 swing bed patient on entrance and an average of 4.5 swing bed admissions per month.

Findings include:

1. Document review of the skilled level patient's admission packet revealed CAH failed to include information related to skilled bed patient rights, including:

a. In the case of a resident adjudged incompetent under the laws of a State by a court of competent jurisdiction, the rights of the resident devolve to and are exercised by the resident representative appointed under State law to act on the resident's behalf. The court-appointed resident representative exercises the resident's rights to the extent judged
necessary by a court of competent jurisdiction, in accordance with State law.

b.The resident has the right to be informed of, and participate in, his or her treatment, including:

c. The right to be fully informed in language that he or she can understand of his or her total health status, including but not limited to, his or her medical condition.

d. The right to be informed, in advance, of changes to the plan of care.

e. The right to request, refuse, and/or discontinue treatment, to participate in or refuse to participate in experimental research, and to formulate an advance directive.

f. Choice of attending physician. The resident has the right to choose his or her attending physician.

g. The right to retain and use personal possessions, including furnishings, and clothing, as space permits, unless to do so would infringe upon the rights or health and safety of other residents.

h. The right to share a room with his or her spouse when married residents live in the
same facility and both spouses consent to the arrangement.

i. The facility must provide immediate access to a resident by immediate family and other relatives of the resident, subject to the resident's right to deny or withdraw consent at any time;

j. The facility must provide immediate access to a resident by others who are visiting with the consent of the resident, subject to reasonable clinical and safety restrictions and the resident's right to deny or withdraw consent at any time;

k. The resident has a right to choose to or refuse to perform services for the facility and the facility must not require a resident to perform services for the facility. The resident may perform services for the facility, if he or she chooses, when-

l. The resident has the right to send and receive mail, and to receive letters, packages and other materials delivered to the facility for the resident through a means other than a postal service, including the right to:

m. The facility must-

(i) Inform each Medicaid-eligible resident, in writing, at the time of admission to the nursing
facility and when the resident becomes eligible for Medicaid of-

(A) The items and services that are included in nursing facility services under the State plan and for which the resident may not be charged;
(B) Those other items and services that the facility offers and for which the resident may be
charged, and the amount of charges for those services; and

(ii) Inform each Medicaid-eligible resident when changes are made to the items and services
specified in §483.10(g)(17)(i)(A) and (B) of this section.

n. The facility must inform each resident before, or at the time of admission, and periodically during the resident's stay, of services available in the facility and of charges for those services, including any charges for services not covered under Medicare/Medicaid or by the facility's per diem rate.

o. The resident has a right to personal privacy and confidentiality of his or her personal and medical records.

2. During an interview on 7/10/19 at approximately 10:00 AM, the Director of Patient Care Services confirmed the CAH did not distribute these rights to their swing bed patients.

No Description Available

Tag No.: C1000

Based on document review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to include in 1 of 1 visitation policy the visitation rights of patients that set forth any clinically necessary or reasonable restriction or limitations that the CAH may need to place on such rights, and the reasons for the clinical restriction or limitation. Failure to include the visitation rights of patients, including those setting forth any clinically necessary or reasonable restrictions or limitations that the CAH may need to place on such rights, and the reasons for the clinical restrictions or limitations, may result in limiting/restricting access of visitors to patients that infringed on their right to have a support person when they are provided any type of care, services, or treatment. The CAH's administrative staff identified a census of 1 on entrance, with an average daily census of 2.7 patients per day.

Findings include:

1. Review of the CAH policy "Patient Right and Responsibilities," last approved 6/2011, revealed the policy lacked reasons for any clinical restrictions or limitations that could be placed on patient's right not to have visitors.

2. During an interview 7/10/19 at 4:00 PM, the Director of Patient Care Services acknowledged CAH's patient's rights policy did not specify reasons for any clinical restrictions or limitations that could be placed on a patient's right to have visitors.

No Description Available

Tag No.: C1001

Based on document review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to inform each patient of their visitation rights in 1 of 1 patient's rights brochure, including those setting forth any clinically necessary or reasonable restrictions or limitations that the CAH may need to place on such rights, and the reasons for the clinical restriction or limitation. Failure to inform each patient of their visitation rights could potentially result in limiting/restricting access of visitors to patients that infringed on their right to have a support person when they are provided any type of care, services, or treatment. The CAH's administrative staff identified a census of 1 on entrance, with an average daily census of 2.7 patients per day.

Findings include:

1. Review of the brochure "Patient Rights Information," upadated 1/11/17, revealed the brochure lacked reasons for clinical restrictions or limitations that could be placed on patient's right to have visitors.

2. During an interview 7/10/19 at 4:00, PM, the Director of Patient Care Services confirmed Patient Rights Information is provided to all patients at registration or admission. Director of Patient Care Services acknowledged CAH failed to include in their patient right's brochure any clinical restrictions or limitations that could be placed on a patient's right to have visitors.