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Based on observation and staff interview, the Critical Access Hospital (CAH) failed to ensure the availability of drugs, biologicals, and equipment commonly used in life-saving procedures for prompt use when staff removed 1 of 1 Emergency Room (ER) crash cart from the ER for use in the operating room (OR). Removing the crash cart from the ER limited the availability of drugs, biologicals, and equipment used for treatment of life-threatening situations to patients presenting to the ER.

Findings include:

Observation of the ER occurred on 08/13/14 at 9:00 a.m. with an administrative nurse (#4) and showed one crash cart containing a defibrillator and various medications including cardiac glycosides, antiarrhythmics, antihypertensives, analgesics, anesthetics, and electrolytes and replacement solutions used in life-saving procedures.

Observation of the OR occurred on 08/13/14 at 2:15 p.m. with an administrative nurse (#4). During an interview, the administrative nurse (#4) stated in the case of an emergency during a surgery, staff would get the crash cart from the ER.

Based on observation and staff interview, the Critical Access Hospital (CAH) failed to ensure the environment remained as free of accident hazards as possible in regard to storage of hazardous chemicals in 1 of 1 nursing unit. Failure to limit access to chemicals placed confused and wandering patients and/or pediatric patients at risk due to ingestion or exposure.

Findings include:

A tour of the CAH physical environment occurred on the morning of 08/14/14 with a supervisory plant manager (#10). During the tour, an unlocked soiled/dirty utility room contained hazardous chemicals with warning labels. The chemicals and warning labels included:
* Soft scrub bleach: "Hazard to Humans . . ."
* Neutral Cleaner - pH neutralizer: "Caution: May Cause Eye Irritation . . ."
* Lysol quaternary disinfectant cleaner, one gallon: "Danger," and "Keep Out of Reach of Children"
* Lysol toilet bowl cleaner: "Hazard to Humans"

During the tour, an unlocked housekeeping room on the end of the north hallway contained hazardous chemicals including:
* Clorox bleach: "Danger: Corrosive"
* Clorox Germicidal cleaner: "Keep Out of Reach of Children - Danger"
* Lysol quaternary

On the morning of 08/14/14, the supervisory plant manager (#12) agreed unlocked chemicals posed a safety hazard.

Based on review of a written agreement, meeting minutes, review of the Medical Staff bylaws, and staff interview, the Critical Access Hospital (CAH) failed to ensure the written agreement identified the responsibility of credentialing and privileging; failed to keep the area used to provide CAH services separate from space leased for sleep laboratory services; and failed to follow its bylaws related to attendance of medical staff meetings. Refer to C 241.

1. Based on review of a written agreement, review of the Medical Staff bylaws, and staff interview, the Critical Access Hospital (CAH) failed to ensure the agreement identified the responsibility of credentialing and privileging for 2 of 2 physicians (Physician #1 and #2) providing services to the CAH through the agreement. Failure to designate responsibility, including credentialing and privileging of these physicians providing the contracted service, placed the patients at risk of receiving treatment from unqualified providers.

Findings include:

Review of the CAH's current Medical Staff Bylaws occurred on the afternoon of 08/12/14. The bylaws, revised February 2013, addressed the Medical Staff "Credentialing Function . . . to review the credentials of all applicants for Medical Staff appointment, reappointment, and clinical privileges, to make investigations of and interview such applicants as may be necessary, and to make a report of its finding and recommendations on the same . . ."

Review of the CAH's agreement for the service "to accept referrals to provide sleep monitoring, diagnostic, and scoring services" occurred on 08/14/14. The agreement, dated November 2003, stated: ". . . WHEREAS, PMC [Presentation Medical Center] desires to purchase certain sleep monitoring and report scoring services (i.e. 'testing services'); . . . [the contract agency] will provide physician interpretations of all tests performed . . . The interpretations provided by [the contracted agency] shall be provided by [the contracted agency's] Medical Director, or his designee." The agreement failed to address credentialing and granting of privileges for the providers/ physicians interpreting the results of the sleep studies performed at the CAH.

On the afternoon of 08/12/14, a roster identifying physicians/allied professionals appointed or re-appointed to the medical staff lacked the two physicians who provide the medical interpretation/review for sleep studies. During an interview on the afternoon of 08/13/14, an administrative staff (#12) stated the two physicians (Physician #1 and #2) provided the service. The staff member stated the CAH's medical staff and governing body do not appoint these physicians which included credentialing and granting of privileges.

2. Based on review of a written agreement and staff interview, the governing body failed to ensure the CAH kept the area used to provide CAH services separate from space leased for sleep laboratory services. Failure to keep CAH space separate from leased space limits the CAH's ability to provide services to the CAH's patients.

Findings include:

Review of the CAH's agreement for the service "to accept referrals to provide sleep monitoring, diagnostic, and scoring services" occurred on 08/14/14. The agreement, dated November 2003, stated: ". . . WHEREAS, PMC desires to purchase certain sleep monitoring and report scoring services (i.e. 'testing services'); . . . PMC agrees to provide space in which to provide testing services. a. The space provided by PMC is preferred to be a private room with a bed, and a bathroom. . ."

On the morning of 08/14/14, an administrative staff (#1) and a supervisory staff (#10) stated/confirmed the CAH utilized licensed and certified inpatient rooms/beds to provide the sleep laboratory services. The administrative staff stated the CAH does not utilize inpatient beds for any outpatient services.

3. Based on review of Medical Staff Bylaws and meeting minutes, the CAH failed to follow its bylaws related to attendance by 1 of 2 active physicians (#3) for 12 of 12 (August 2013 through August 2014) meetings held. Failure to enforce Medical Staff Bylaws regarding attendance to meetings has the potential to affect communication and medical care provided to patients.

Findings include:

Review of the CAH's current Medical Staff Bylaws occurred on the afternoon of 08/12/14. The bylaws, revised February 2013, stated "Attendance Requirements: Each Active Staff appointee shall be required to attend at least fifty percent of all regular Medical Staff meetings in each year but is expected to attend all meetings. . . . The failure of any person required to do so, to meet the foregoing requirements shall constitute grounds for non-reappointment to the Staff. . . ."

Review of 12 Medical Staff meeting minutes between August 7, 2013 and August 6, 2014 occurred on the morning of 08/13/14. The minutes included an attendance roster for each meeting. The minutes identified an active staff physician (#3) attended four of the meetings, had excused absences for six meetings, and un-excused absence for two meetings.

Based on observation, policy and procedure review, and staff interview, the Critical Access Hospital (CAH) failed to follow professional standards of care related to infection control practices observed during patient care on 3 of 3 days of survey (August 12-14, 2014). Failure to follow established infection control practices may allow transmission of organisms and pathogens from patients to staff, to other patients, or to visitors, and from one environment to another.

Findings include:

Review of the facility policy titled "Exposure Control Plan" occurred on 08/14/14. This undated policy stated, ". . . Hand Hygiene . . . 2. If hands are not visibly soiled, use an alcohol-based hand rub for routinely decontaminating hands. 3. Decontaminate hands before having direct contact with patients . . . 6. Decontaminate hands after contact with a patient's intact skin . . . 7. Decontaminate hands after contact with body fluids or excretions, mucous membranes, non-intact skin and wound dressings . . . 8. Decontaminate hands if moving from a contaminated body site to a clean body site during patient care . . . 10. Decontaminate hands after removing gloves. . . ."

- The following observations showed staff failed to perform hand hygiene after performing perineal cares and prior to moving onto other tasks:

*Observation on 08/12/14 at 2:10 p.m. showed two certified nursing assistants (CNAs) (#8 and #9) changed Patient #4's brief, incontinent of urine, as the patient remained in bed. After completing perineal cares, the CNA (#8) removed her gloves, assisted with repositioning the patient, lowered the bed, and placed the call light within reach before performing hand hygiene.

*Observation on 08/12/14 at 2:50 p.m. showed a CNA (#8) changed Patient #8's brief, incontinent of urine, removed her gloves, ambulated the patient back to her recliner, elevated her feet, placed the call light within reach, and turned the patient's heater on. The CNA failed to perform hand hygiene after perineal cares and prior to completing other tasks.

*Observation on 08/13/14 at 8:15 a.m. showed a CNA (#8) assisted Patient #7 with perineal cares, and without performing hand hygiene, changed her gloves, ambulated the patient to her recliner, and placed the patient's hygiene products in her drawer.

- Observation on 08/13/14 at 9:50 a.m. identified a nurse (#4) changed the dressing on Patient #5's left thigh. Observation showed drainage on the dressing. After changing the dressing, the nurse (#4) continued to wear the same pair of gloves and disposed of the dressing change supplies, placed the linen in a hamper, removed her gloves, disinfected the patient exam table and pillow with a disinfectant wipe, took the "dirty" scissors and tweezers to central supply for sterilization, and began charting on the procedure at the nurse's station. The nurse failed to perform hand hygiene after completing the dressing change and prior to exiting the patient's room.

- Observation on 08/14/14 at 9:15 a.m. identified a nurse (#4) assisted Patient #21 into an exam room in the Emergency Room. After assessing the patient and taking her vitals, the nurse left the room to call the doctor at the nurse's station. The nurse (#4) failed to perform hand hygiene prior to exiting the exam room.

During an interview on 08/14/14 at 11:00 a.m., an administrative nurse (#1) stated she expected staff to perform hand hygiene immediately after completing perineal cares and prior to moving on to other tasks, before and after patient contact, and after completing dressing changes.

Based on record review, professional reference review, and staff interview, the Critical Access Hospital (CAH) failed to assess and document the effectiveness of medications given to patients on an as needed (prn) basis for 4 of 9 active patient (Patient #1, #2, #4, #8) and 1 of 11 closed patient (Patient #10) records reviewed. Failure to evaluate the patients' response to prn medications limited the nursing staff's ability to assess whether the medication achieved the desired effect or if the patients experienced any side effects or adverse reactions from the medication.

Findings include:

Berman and Snyder, "Kozier & Erb's Fundamentals of Nursing: Concepts, Process, and Practice," 9th ed., Pearson Education, Inc., New Jersey, page 870, states, ". . . Administering Oral Medications . . . Evaluation . . . Return to the client when the medication is expected to take effect (usually 30 minutes) to evaluate the effects of the medication on the client. . . ."

- Review of Patient #8's active medical record occurred on 08/14/14. The record indicated the patient used prn medications for anxiety and mild pain, and showed physician orders for Xanax (used to treat anxiety) 0.25 milligrams (mg) every eight hours prn and Motrin (used to treat mild pain) 400 mg every six hours prn.

Patient #8's medication administration record (MAR) and chart notes showed the following administration times and patient responses for the prn medication:
*Xanax:
08/04/14 at 4:03 p.m. - no response documented.
08/06/14 at 12:25 p.m. - no response documented until 4:50 p.m. (four and a half hours later).
08/07/14 at 2:50 p.m. - no response documented until 6:46 p.m. (four hours later).
*Motrin:
08/03/14 at 8:44 a.m. - no response documented until 7:09 p.m. (over 10 hours later).
08/04/14 at 8:11 a.m. - no response documented until 4:25 p.m. (over eight hours later).
08/06/14 at 8:42 p.m. - no response documented.
08/07/14 at 8:39 a.m. and 2:50 p.m. - no response documented for both administrations until 6:46 p.m. (four to ten hours later).
08/10/14 at 6:59 p.m. - no response documented.

Review of Patient #8's chart notes and MARs failed to include evidence nursing staff assessed and documented the effectiveness or the patient's response to the prn medication and/or did so within a reasonable amount of time.


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- Review of Patient #1's active medical record occurred on August 12-14, 2014. The record indicated the patient used prn medications for pain, and showed physician orders for Oxycodone (used to treat pain) 5 mg every four hours prn and Vicodin 5/325 (hydrocodone 5 mg and acetaminophen 325 mg) (used to treat pain) every four hours prn.

Patient #1's August MAR and chart notes showed the following administration times and patient responses for the prn medication:
*Vicodin
08/08/14 at 6:19 p.m. - no response documented until 9:02 p.m. (almost three hours later).
*Oxycodone
08/09/14 at 12:49 a.m. - no response documented.
08/09/14 at 4:38 a.m. - no response documented until 8:30 a.m. (over four hours later).
08/09/14 at 5:57 p.m. - no response documented until 11:19 p.m. (over five hours later).
08/10/14 at 8:53 a.m. - no response documented until 7:09 p.m. (over 10 hours later).
08/10/14 at 8:24 p.m. - no response documented until 9:55 p.m. (over one hour and thirty minutes later).
08/11/14 at 10:00 a.m. - no response documented until 11:27 a.m. (almost one hour and thirty minutes later).
08/12/14 at 1:03 a.m. - no response documented until 3:00 a.m. (almost two hours later).
08/13/14 at 12:55 a.m. - no response documented.

Review of Patient #1's chart notes and August MAR lacked evidence nursing staff assessed and documented the effectiveness or the patient's response to the prn medications and/or did so within a reasonable amount of time.

- Review of Patient #4's active medical record occurred on August 12-14, 2014. The record indicated the patient used prn medications for pain, nausea, insomnia, and stomach upset, and showed a physician order for Tylenol (used to treat pain) 650 mg every four hours prn, Zofran (used to treat nausea) 4 mg every six hours prn, Maalox (used to treat stomach upset) 15 milliliters (ml) four times daily prn, and Ambien (used to treat insomnia) 5 mg at bedtime prn.

Patient #4's August MAR and chart notes showed the following administration times and patient responses for the prn medication:
*Tylenol
08/01/14 at 3:47 p.m. - no response documented.
08/13/14 at 10:25 p.m. - no response documented until 5:07 a.m. (over six hours and thirty minutes later).
*Ambien
08/05/14 at 1:05 a.m. - no response documented.
*Maalox
08/11/14 at 10:09 p.m. - no response documented until 12:00 a.m. (almost two hours later).
*Zofran
08/11/14 at 4:31 a.m. - no response documented until breakfast (approximately two hours and thirty minutes later).
08/13/14 at 10:25 p.m. - no response documented until 5:07 a.m. (over six hours and thirty minutes later).

Review of Patient #4's chart notes and August MAR lacked evidence nursing staff assessed and documented the effectiveness or the patient's response to the prn medications and/or did so within a reasonable amount of time.

- Review of Patient #2's active medical record occurred on August 12-14, 2014. The record indicated the patient used prn medications for pain, and showed a physician order for Tylenol (used to treat pain) 650 mg every four hours prn.

Patient #2's August MAR and chart notes showed the following administration times and patient responses for the prn medication:
*Tylenol
08/10/14 at 8:39 a.m. - no response documented until 2:10 p.m. (over five hours later).
08/11/14 at 10:38 p.m. - no response documented.

Review of Patient #2's chart notes and August MAR lacked evidence nursing staff assessed and documented the effectiveness or the patient's response to the prn medications and/or did so within a reasonable amount of time.

- Review of Patient #10's closed medical record occurred on 08/14/14. The record indicated the patient used prn medications for pain and nausea; and showed physician orders for Morphine (used to treat moderate to severe pain) 2 mg intravenous (IV) every two hours prn, Zofran (used to treat nausea) 8 mg IV every six hours prn, Dilaudid (used to treat moderate or severe pain) 2 mg/milliliter (ml) 0.5 ml IV every two hours prn, and Percocet (used to treat moderate pain) 5/325 mg one to two tablets every four hours prn.

Patient #10's MAR and chart notes showed the following administration times and patient responses for the prn medication:
*Morphine:
05/27/14 at 8:29 a.m. - no response documented, next administration at 10:04 a.m. (one and a half hours later) - response documented at 11:23 a.m. (one hour and 20 minutes later).
11:58 a.m. - no response documented, next administration at 1:42 p.m. (one hour and forty-five minutes later) - response documented at 2:45 p.m. (one hour later).
*Zofran:
05/27/14 at 8:31 a.m. - no response documented until 11:17 a.m. (almost three hours later).
*Dilaudid:
05/27/14 at 3:17 p.m. - no response documented, next administration at 5:20 p.m. (two hours later) - response documented at 6:30 p.m. (one hour later).
7:56 p.m. - no response documented, next administration at 9:59 p.m. (two hours later) - no response documented.
05/28/14 at 12:06 a.m. - no response documented, next administration at 2:38 a.m. (two and a half hours later) and 5:51 a.m. (nearly three hours and 15 minutes later) - no response documented.
8:25 a.m. - no response documented until 10:06 a.m. (one and a half hours later).
*Percocet
05/28/14 at 10:06 a.m. - no response documented until 12:50 p.m. (nearly three hours later).
2:39 p.m. - no response documented until next administration at 5:22 p.m. (nearly three hours later) - no response documented until 9:10 p.m. (nearly four hours later).
9:52 p.m. - no response documented.
05/29/14 at 3:48 a.m. - no response documented.
7:45 a.m. - response documented at 8:47 a.m. (one hour later).
2:11 p.m. - no response documented until 5:01 p.m. (nearly three hours later).

Review of Patient #10's chart notes and MARs failed to include evidence nursing staff assessed and documented the effectiveness or the patient's response to the prn medication and/or did so within a reasonable amount of time.

During an interview on 08/14/14 at 11:00 a.m., an administrative nurse (#1) stated staff should evaluate the effectiveness of as needed medications no later than two hours after administration (which contradicted professional standards of practice).

Based on observation and review of professional reference, the facility failed to ensure staff correctly administered insulin to 1 of 1 patient (Patient #1) observed receiving insulin via insulin pen. Failure to prime insulin pens may result in patients receiving inaccurate doses of medication.

Findings include:

Review of the manufacturer's instructions for NovoLog FlexPen occurred on 08/14/14. This insert stated, ". . . Small amounts of air may collect in the cartridge during normal use. To avoid injecting air and to ensure proper dosing: . . . E. Turn the dose selector to select 2 units. F. Hold your NovoLog FlexPen with the needle pointing up. Tap the cartridge gently with your finger a few times to make any air bubbles collect at the top of cartridge. G. Keep the needle pointing up, press the button all the way. The dose selector turns to zero. A drop of insulin should appear at the needle tip. If not, change the needle, and repeat the procedure . . . ."

- Observation of medication pass on 08/13/14 at 11:15 a.m. showed a nurse (#5) administered insulin to Patient #1. During the observation, the nurse (#5) dialed the dose selector on the patient's NovoLog FlexPen to the number of units prescribed by the provider. Prior to administering the ordered dose of insulin to Patient #1, the nurse failed to "prime" or expel the air from the attached needle with two units of insulin.

- Observation of medication pass on 08/13/14 at 4:47 p.m. showed a nurse (#6) administered insulin to Patient #1. During the observation, the nurse (#6) expelled one unit of insulin from the needle on the insulin pen and then dialed the dose selector on the patient's NovoLog FlexPen to the number of units prescribed by the provider. The nurse failed to "prime" or expel the air from the attached needle with two units of insulin as per manufacturer's instructions.

- Observation of medication pass on 08/14/14 at 10:58 a.m. showed a nurse (#7) administered insulin to Patient #1. During the observation, the nurse (#7) pointed the insulin pen to the side and expelled one unit of insulin from the needle on the insulin pen. The nurse (#7) dialed the dose selector on the patient's NovoLog FlexPen to the number of units prescribed by the provider. The nurse failed to "prime" the attached needle with two units of insulin and with the needle pointed up as per manufacturer's instructions.

Based on review of professional literature, record review, and staff interview, the Critical Access Hospital (CAH) failed to ensure the medical record included complete instructions to the patient upon discharge for 1 of 3 closed surgical patient (Patients #15) records and 2 of 4 closed emergency department (ED) patient (Patient #17 and #20) records reviewed. Failure to ensure patients received complete discharge instructions has the potential to place the patient at risk of improper care.

Findings include:

Berman and Snyder, "Kozier and Erb's Fundamentals of Nursing, Concepts, Process, and Practice," 9th ed., Pearson Education Inc., Upper Saddle River, New Jersey, 2012, page 262, stated, ". . . If the discharge plan is given directly to the client and family, it is imperative that instructions be written in terms that can be readily understood. For example, medications, treatments, and activities should be written in layman's terms, and use of medical abbreviations . . . should be avoided. . . ."

- Review of Patient #15's closed medical record occurred on 08/13/14 and identified the CAH admitted the patient for outpatient surgery on 04/23/14 for a hammertoe correction of the third, fourth, and fifth digits of the right foot. The record included a form titled, "Discharge", which included post-operative instructions regarding medications, appointments, driving, disposition, etcetera (etc.). The post-operative medication section of the form listed, "Vicodin [used to treat moderate pain] . . . every 4-6 [medical symbol/abbreviation for hours] PRN [as needed] . . ."

During an interview on 08/14/14 at 1:20 p.m., a staff nurse (#3) stated the "Discharge" form included post-operative instructions and confirmed the CAH provided the form to the patient.

The CAH failed to provide discharge instructions written in terms the patient could understand. The instructions failed to include specific information on the strength/dose of the Vicodin.

- Review of Patient #17's closed medical record occurred on 08/13/14 and identified the patient presented to the ED on 03/10/14 with abdominal pain and diarrhea. The medical provider diagnosed Patient #17 with pyelonephritis and recommended admission, but the patient discharged against medical advice. The record showed the CAH provided patient care instructions to Patient #17 regarding diagnosis, treatment, follow-up, etc. The instructions listed, ". . . Levaquin [an antibiotic] 750 mg [milligrams] 1 PO [by mouth] daily x [times] 7 days, Toradol [used to treat inflammation and pain]10 mg 1 PO q [every] 6 hrs [hours] prn . . . F/U [follow up] in the clinic i [sic] 4 days . . ."

The CAH failed to provide discharge instructions written in terms the patient could understand.

- Review of Patient #20's closed medical record occurred on 08/13/14 and identified the patient presented to the ED on 06/01/14 with cough, dyspnea, abdominal pain, and mouth/throat pain. The medical provider diagnosed Patient #20 with an acute exacerbation of chronic obstructive pulmonary disease (COPD) and bronchitis and discharged the patient home from the ED. The record showed the CAH provided patient care instructions to Patient #20 regarding diagnosis, treatment, follow-up, etc. The instructions listed, ". . . Sulfa/Trimeth [an antibiotic] # 6 tabs sent [medical abbreviation for with] pt [patient]. Rx [prescription] for remainder. . . . 2. Take steroid dose pack as directed. # 21 tabs sent [medical abbreviation for with] pt. . . . 4. Use Duoneb txs [treatment] every 4 hours . . ."

The CAH failed to provide discharge instructions written in terms the patient could understand. The instructions failed to include specific information regarding the strength/dose and frequency of the Sulfa; name, strength/dose, and frequency of the steroid; and the name and strength/dose of the duoneb.

During an interview on 08/14/14 at 1:35 p.m., an administrative nurse (#1) stated she expected staff to document all instructions including new medications or prescriptions for medications in terms the patient could understand with no medical abbreviations.

Based on review of the North Dakota Department of Health, Division of Health Facilities provider files, this facility has not sustained correction of this issue. This requirement was found to be out of compliance during the previous survey completed on 05/25/11.

Based on policy review and staff interview, the Critical Access Hospital (CAH) failed to ensure a network hospital or a quality improvement organization (QIO) or equivalent, evaluated the quality and appropriateness of the diagnosis and treatment furnished by the physicians for 2 of 2 active medical staff (Physician #3 and #4) who provided treatment to the CAH's patients. Failure to have an arrangement and ensure this evaluation occurred by an outside entity, by physicians/providers with the same qualifications/privileges, has the potential to affect patient outcomes.

Findings include:

Review of the policy titled "MEDICAL SERVICES QUALITY IMPROVEMENT/PEER REVIEW PLAN" occurred on 08/13/14. This policy, approved on 12/04/13, stated,
"I. QUALITY IMPROVEMENT/PEER REVIEW GOALS:
A. Assure that the Medical Services QI [Quality Improvement] Plan/Peer Review Plan is effective in monitoring key indicators of care and identifying opportunities to improve patient care, staff performance, and patient safety. . . .
D. Determine appropriate action(s) to undertake in effort to improve medical care services/performance. . . .
II. SCOPE OF SERVICES: . . .
Presentation Medical Center [PMC] collaborates with [Name of entity] to improve the quality of care for patients admitted to the hospital. PMC will participate in those quality projects and peer review activity initiatives deemed appropriate for a facility of our size and scope. Presentation Medical Center will maintain an agreement with an appropriate qualified entity, (as defined in the state rural health care plan), for peer review. . . .

External peer review will be conducted as deemed appropriate. An independent medical reviewer/review organization will be selected for this function. . . .

III. RESPONSIBILITIES:
The Medical Staff is responsible for the performance of all QI/peer review activities relevant to the scope of medical services . . ."

During interview on the afternoon of 08/13/14, a supervisory staff member (#12) stated the CAH does not seek outside review on any of the active medical staff physicians unless the CAH identified issues regarding that physician.