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Based on document review, observation, and interview, it was determined the Critical Access Hospital (CAH) failed to ensure outdated emergency biologicals were monitored and not available for patient use. This has the potential to affect all patients serviced by the CAH.

Findings:

1. The CAH policies titled "Expirations and Outdates" (approved 11/26/12) and "Outdated Supplies" (revised 6/7/14) were reviewed on 8/17/16 at approximately 3:05 PM. The policies stated each Department with biologicals were responsible for checking monthly for outdates.

2. A tour of the ER was conducted on 8/16/16 at approximately 11:05 AM with the Director of Nursing (E#1). In the ER #1, the entire Broselow Pediatric Resuscitation System (a pediatric resuscitation system made up of seven color coded pouches, one each for a specific weight range of pediatric patients) was expired June 2015.

3. An interview was conducted with E#1 on 8/16/16 at approximately 11:15 AM. E#1 stated "I don't think this (the Broselow Bag) was put on the Checklist (Crash Cart Checklist) and was overlooked."

Based on observation during the survey walk-through, staff interview, and document review during the Life Safety Code portion of a Re-Certification Survey conducted on August 24, 2016, the surveyor finds that the facility failed to provide and maintain a safe environment for patients and staff.

This is evidenced by the number, severity, and variety of Life Safety Code deficiencies that were found. Also see C231.

Based on document review, observation, and interview, it was determined the Critical Access Hospital (CAH) failed to ensure patient care equipment was maintained in safe operating condition. This has the potential to affect all patients serviced by the CAH with an average daily census of approximately 7 inpatients per day, an average of approximately 1,092 outpatients per month, and an average of approximately 75 surgical patients per month.

Findings include:

1. The CAH policy titled "Maintenance Inspection of Equipment 485-623(b)(1)" was reviewed on 8/17/16 at approximately 2:00 PM. The policy stated "Purpose: To define the procedure for inspection, maintenance and repair of equipment to ensure it is in safe operating condition... The PM (Preventive Maintenance) program is evaluated annually with the COO (Chief Operating Officer)".

2. An observational tour of the Surgery Department was conducted on 8/17/16 at approximately 9:35 AM with the Surgery Manager (E#7). The following patient care equipment lacked any preventive maintenance tag:
a. In the Pre-Surgical Waiting Room, one gooseneck examination lamp.
b. In the Dirty Utility, one Ultrasonic Washer machine (used to clean excess bioburden from surgical instruments).

3. An interview was conducted on 8/17/16 at approximately 9:40 AM with E#7. E#7 stated uncertainty as to why the gooseneck examination lamp and the Ultrasonic Washer lacked preventive maintenance tags. E#7 contacted the Preventive Maintenance personnel and was told the items were not on their Preventive Maintenance list and should be.

Based on observation during the survey walk-through, staff interview, and document review during the Life Safety Code portion of a Re-Certification Survey conducted on August 24, 2016, the surveyor finds that the facility does not comply with the applicable provisions of the 2000 Edition of the NFPA 101 Life Safety Code.
See the Life Safety Code deficiencies identified with K-Tags.

Based on document review and interview, it was determined the Governing Body failed to ensure reappointment of physician/surgeons included a current request for privileges for 4 of 7 (MD#1, MD#3, MD#4, and MD#5) and failed to include an evaluation of services for 7 of 7 (MD#1, MD#2, MD#3, MD#4, MD#5, MD#6, and MD#8). This has the potential to affect all patients serviced by the Critical Access Hospital with a current average daily inpatient census of 7 patients, a current average monthly outpatient census of 1,092 patients, and an average monthly surgery census of 75 patients.

Findings include:

1. The Critical Access Hospital Medical Staff Bylaws (Re-adopted 4/16/14) were reviewed on 8/18/16 at approximately 9:45 AM. The Bylaws stated "Article VII - Appointment and Reappointment Section 3 - Reappointment... Prior to the last Governing Board meeting in the Medical Staff year... shall review all pertinent information available on each practitioner scheduled for periodic appraisal for the purpose of determining qualification for their reappointment..."

2. Seven physicians/surgeons reappointment credential files were reviewed on 8/18/16 at approximately 9:45 AM. The files lacked the following:
a. Four out of seven credential files lacked a current request for privileges along with the application for reappointment: MD#1, MD#3, MD#4, MD#5. The privilege requests in these files were undated and aged yellow.
b. Seven out of seven credential files lacked an evaluation of services along with the reappointment approval: MD#1, MD#2, MD#3, MD#4, MD#5, MD#6, and MD#8.

3. An interview was conducted with the Director of Nursing (E#1) on 8/18/16 at approximately 12:00 PM. E#1 stated ".... (the staff member in charge of Medical Staff credentialing) is new to that position and can't find the evaluation of services. We aren't sure where they are. As for the privilege requests, the ones that are there are definitely old and I'm not sure new ones were filled out, but they should have been."

A. Based on document review and interview, it was determined for 1 of 1 (Pt #5) patient, reviewed for restraint usage, the Critical Access Hospital (CAH) failed to ensure restraints were utilized in accordance with policy. This has the potential to affect all patients requiring the use of restraints in the CAH.

Findings include:

1. The CAH policy titled "Restraints Policy" (reviewed 8/7/15) was reviewed on 8/16/16 at approximately 12:00 PM. The policy stated "The use of restraint must be:... In accordance with the order of a physician...The condition of the restrained patient must be continually assessed, monitored and reevaluated... Orders for restraint must specify: reason... type of restraint... extremity or body part(s) to be restrained and the duration (time frame) for restraint application... Restraint Parameters... The condition of the restrained patient will be continually assessed, monitored and reevaluated at observed intervals not greater than 15 minutes for behavioral... This will be documented on the restraint flowsheet."

2. Pt #5's record was reviewed on 8/16/16 at approximately 1:30 PM. Pt #5 was admitted to the Emergency Room (ER) via ambulance on 5/17/16 at 9:00 PM with the Chief Complaint of Behavioral Change. At 9:00 PM, ER nursing documentation stated "Primary Assessment.... Very combative with staff despite restraints and redirection" and "Nurses Notes... Restraints applied..." At 10:00 PM ER nursing documentation stated "d/c'd (discontinued) restraints". The record lacked an order for the restraints, lacked the type of restraints utilized, and lacked every 15 minute continuous monitoring during the use of restraints.

3. An interview was conducted with the Director of Nursing (E#1) on 8/17/16 at approximately 12:00 PM. E#1 reviewed Pt #5's record and verbally agreed the record lacked a physician order, type of restraint, and every 15 minute continuous monitoring while restrained.

B. Based on document review and interview, it was determined for 1 of 5 (Pt #3) patients, discharged from the Emergency Room (ER), the Critical Access Hospital (CAH) failed to ensure patients discharged from the ER received discharge instructions in accordance with policy. This has the potential to affect all patients serviced by the ER with a current average daily census of approximately 7 patients per day.

Findings include:

1. The CAH policy titled "Discharge Education for Emergency Room Patients" (reviewed 8/7/16) was reviewed on 8/16/16 at approximately 3:15 PM. The policy stated "Procedure: All patients discharge from the Emergency Room will receive condition-appropriate instructions for home care and appropriate referrals... 5. Patient will sign discharge instruction sheet: a. Original stays with the chart and one (1) copy is given to the patient."

2. Pt #3's record was reviewed on 8/16/16 at approximately 12:05 PM. Pt #3 presented to the ER on 8/6/16 with the Chief Complaint of Abdominal Pain. ER physician documentation stated "Go Directly to.... (an outlying Hospital) ER... go by car to ER at... (an outlying Hospital)". ER nursing documentation stated "Pt. D/C'd (discharged) to.... (an outlying Hospital)" with spouse. The record lacked any discharge instruction sheet and lacked documentation of the referral being made to the outlying Hospital.

3. An interview was conducted with the ER nurse (E#4) on 8/16/16 at approximately 12:05 PM, during the record review. E#4 stated "There should be a discharge instruction sheet and documentation that they (the outlying Hospital) were contacted with the referral."

4. An interview was conducted with the Director of Nursing (E#1) on 8/16/16 at approximately 12:30 PM. E#1 reviewed Pt #3's record and verbally agreed the record lacked any discharge instruction sheet and/or documentation of the referral being made to the outlying Hospital.

A. Based on document review and interview, it was determined for 2 of 2 (Pts #8 and #18) surgical patients, reviewed for narcotic control throughout the Operating Room (OR) and Phase I Recovery, the Critical Access Hospital (CAH) failed to ensure control of all controlled substances throughout the surgery/recovery process. This has the potential to affect all patients undergoing surgical intervention with an average monthly census of 75 patients.

Findings include:

1. The CAH policy titled "Controlled Substances in the OR (Operating Room)" (last reviewed 6/20/16 was reviewed on 8/17/16 at approximately 3:25 PM. The policy stated "Purpose: To provide an accurate accounting of all controlled drugs in the operating room... Procedure: 3. When obtaining narcotics for use during a procedure, the nurse will sign the narcotics out on a Narcotic Request Form. Anesthesiology will use this same form... Used and unused narcotics will be accounted for on this form... 4. Wasted narcotics must be witnessed and signed for by two registered nurses. Anesthesia will record their drug use and waste on the Narcotic Request sheet. This will be reflected on the Narcotic Count Record."

2. An interview was conducted with the Operating Room/Phase I Recovery Registered Nurse (E#6) on 8/17/16 at approximately 9:35 AM with the Surgery Director (E#7) present. When asked to explain the process for obtaining and disposing of narcotics from pre-anesthesia through discharge from Phase I Recovery, E#6 stated the following:
a. Anesthesia signs out an "Anesthesia Narcotic Request Sheet".
b. Anesthesia documents narcotic usage on the "Anesthesia Record".
c. Anesthesia documents on the "Post-Anesthesia Care Unit Order Sheet" under "E. Substance Wasted As Stated By The Anesthesia Provider... (narcotic name).... Amount Wasted..." and this is signed by the Anesthesia Provider and witnessed by the Phase I Recovery Nurse.
d. E#6 further stated "They (Anesthesia) don't actually waste it (the narcotic). They give it to us (the Phase I Recovery Nurse) in case the patient needs it in recovery. If we don't use it, we (the Phase I Recovery Nurses) will waste it and put it on the narcotic sheet. If we use it, we (the Phase I Recovery Nurse) will make a note next to the Anesthesia "Amount Wasted" of what we actually wasted and initial it and also put it on the narcotic count sheet."

3. Pt #8's Surgery/Phase I Recovery narcotic documentation was reviewed on 8/17/16 at approximately 11:00 AM. Pt #8 was admitted to the CAH on 8/15/16 and underwent a Stoma Revision.
a. The "Anesthesia Narcotic Request Sheet" stated MD #4 (Anesthesiologist) was "Issued" 2 Fentanyl 100 mcg (micrograms) vials and 2 Versed 2 mg (milligram) vials.
b. The "Anesthesia Record" stated Pt #8 was given a total of 50 mcg of Fentanyl and 1.5 mg of Versed.
c. The "Narcotic Request Sheet" stated "Used 50 mcg... Wasted 50 mcg... (of Fentanyl)... Used 1.5 mg Versed (was written twice)... Wasted 0.5 mg (also written twice)..." The "Post-Anesthesia Care Unit Order Sheet" stated for Fentanyl: "Wasted 50 mcg..." and Versed: "Wasted 0.5 mg". Both were signed by MD#4 and one Registered Nurse.
d. The Phase I Recovery note stated Pt #8 was given Fentanyl 25 mcg, for a total of 75 mcg given.
e. There was no documentation as to what was done with the second 100 mcg vial of Fentanyl or clarification as to whether one or both vials of Versed were used and/or wasted. The narcotic record stated Pt #8 received 50 mcg total of Fentanyl instead of 75 mcg and that 50 mcg was wasted instead of 25 mcg.

4. Pt #18's Surgery/Phase I Recovery narcotic documentation was reviewed on 8/17/16 at approximately 10:30 AM. Pt #18 was admitted to the CAH on 8/9/16 and underwent an Aortagram and Renal Angiogram.
a. The "Anesthesia Narcotic Request Sheet" stated MD #4 (Anesthesiologist) was "Issued" 2 Fentanyl 100 mcg (micrograms) vials and 2 Versed 2 mg (milligram) vials.
b. The "Anesthesia Record" stated Pt #18 was given a total of 50 mcg of Fentanyl and 3 mg of Versed.
c. Both the "Narcotic Request Sheet" and the "Post-Anesthesia Care Unit Order Sheet" stated for Fentanyl: "Used "50 mcg... Wasted 50 mcg..." and for Versed: "Used 3 mg... wasted 1 mg" and was signed by MD#4 and two Registered Nurses.
d. The Phase I Recovery note stated Pt #18 was given Fentanyl 25 mcg. An entry was made on the "Anesthesia Record" Sheet" next to the "Wasted 50 mcg" which Anesthesia had documented that "25 mcg wasted".
e. There was no documentation as to what was done with the second 100 mcg vial of Fentanyl.

5. An interview was conducted with the Pharmacy Director (E#8) on 8/17/16 at approximately 11:00 AM. E#8 reviewed the records of Pts #8 and #18 for controlled substance documentation and the practice stated by E#6 through OR and PACU Phase I. E#8 verbally agreed the controlled substance practice and documentation do not accurately reflect where the narcotics are, the amount present, what personnel had them, and who wasted them throughout the OR and PACU Phase I process. "We need to look at this process and change this to better show what is really going on (with the Fentanyl and Versed). There is too much room for error."

6. An interview was conducted with E#7 on 8/17/16 at approximately 3:45 PM. E#7 spoke with MD#4 and further confirmed "What... (E#6) said was correct. They (Anesthesia) give everything (the unopened and remainder of any Fentanyl and Versed whether ordered or not) to the PACU nurse. We (the PACU nurses) put the unopened vials back in the narcotic box and waste whatever isn't used in the PACU (Phase I) Their documentation doesn't say any of that."

B. Based on observation, interview, and document review, it was determined the Critical Access Hospital (CAH) failed to ensure warmed irrigation solutions were labeled with expiration dates to prevent the potential for cross contamination. This has the potential to affect all patients serviced by the CAH Surgery Department with a average monthly census of approximately 75 patients.

Findings include:

1. A tour of the Surgery Department was conducted on 8/17/16 at approximately 9:35 AM with the Surgery Manager (E#7). Two blanket warmers, also used for warming of irrigation solutions were observed. In Phase I Recovery, the Warming Cabinet was observed to read a temperature of 114 degrees Fahrenheit (F) and contained three 1,000 ml (milliliters) bottle of Normal Saline Irrigation. In the Operating Room, the Steris Amsco Warming Cabinet was observed to read a temperature of 115 degrees F and contained twelve 1,000 ml bottles of Sterile Water and six 1,000 ml bottles of Normal Saline. All the bottles lacked the dates as to when they were placed in the warmers and/or when they would expire.

2. An interview was conducted with the Surgery Registered Nurse (E#6) on 8/16/16 at approximately 10:05 AM. When asked what process the CAH utilized to determine how long warmed irrigation solutions were good for, E#6 stated "We follow AORN (Association of periOperative Registered Nurses)."

3. On 8/16/16 at approximately 10:25 AM, E#6 presented the "AORN Journal September 2012 Vol (volume) No (number) 3, page 297" recommendations for warmed irrigation fluids. "Recommendation II" stated "The perioperative nurse should verify that fluids used for irrigation and distention media at temperatures other than room temperature are warmed or cooled as appropriate and stored in a safe manner... follow fluid manufacturers' warming and cooling instructions, avoid overheating fluids and maintain fluid temperature according to the safe temperature range as determined by the fluid manufacturer, rotate inventory and label fluid containers with expiration dates to help reduce waste, and place a "do not rewarm" label on unopened fluid containers that are taken from warming cabinets."

4. The "Baxter 0.9% Sodium Chloride Irrigation" and "Baxter Sterile Water for Irrigation" labels were reviewed on 8/16/16 at approximately 10:25 AM. Both stated "Cautions: Warm in oven to not more than 50... C (Celcius) for a maximum of 60 days. Discard after 60 days of warming."

5. An interview was conducted with E#7 on 8/16/16 at approximately 11:30 AM. E#7 stated "We need to start labeling those (the irrigation fluids) with when they are put in the warmers and when they will be expired."

A. Based on observation and interview, it was determined the Critical Access Hospital (CAH) failed to ensure inhalation medication utilized in Pulmonary Function Testing (PFT) was dispensed in a safe manner to prevent the potential for cross contamination. This has the potential to affect all patients who undergo PFT with an average monthly census of 5 patients.

Findings include:

1. A tour of the Respiratory Therapy Department was conducted on 8/17/16 at approximately 11:00 AM with the Respiratory Therapy Director (E#9). An open inhaler of Ventolin was observed on a stand in the room where PFTs are performed.

2. An interview was conducted with E#9 on 8/17/16 at approximately 11:00 AM. When asked if the Ventolin inhaler was used on more than one patient, E#9 stated "Yes, we use a separate spacer for each patient and clean the boot (the inhalation opening of the inhaler) with alcohol in between patients". When asked for the manufacturer guidelines for use of the Ventolin inhaler on more than one patient with spacers and prevention of potential cross contamination, E# 9 was unable to produce the information.

3. An interview was conducted with the Director of Nursing (E#1) on 8/17/16 at approximately 3:00 PM. E#1 stated "I can't see how that (using a Ventolin inhaler on more than one patient with a separate spacer) would be ok. There would not be any way to prevent a patient from exhaling or breathing into the spacer and possibly contaminate the inhaler."

B. Based on observation, document review, and interview, it was determined the Critical Access Hospital (CAH) failed to ensure can openers were cleaned to prevent potential cross contamination. This was observed for 2 of 3 can openers in the Dietary Department. This has the potential to affect all patients and visitors served by the CAH Dietary Department.

Findings include:

1. An observational tour of the Dietary Department was conducted on 8/17/16 at approximately 11:15 AM with the Dietary Manager (E#10). Two of three can openers were observed with a large amount of brownish food debris on the cutting surface.

2. The CAH policy titled "Cleaning Frequency" (no date of review) was reviewed on 8/17/16 at approximately 2:00 PM. The policy stated "Cleaning Frequency b) To prevent cross-contamination, kitchenware and food-contact surfaces of equipment shall be washed, rinsed, and sanitized after each use and following any interruption of operations during which time contamination may have occurred."

3. An interview was conducted with E#10 during the tour. E#10 also observed the brownish food debris on two of three can openers and stated "These are to be cleaned after each use."

C. Based on document review and interview, it was determined for 9 of 9 refrigerators/freezers, the Critical Access Hospital (CAH) failed to ensure temperatures were monitored and recorded daily. This has the potential to affect all patients and visitors serviced by the Dietary Department.

Findings include:

1. The CAH policy titled "Closing Supervisor" (effective date 1/1/11) was reviewed on 8/17/16 at approximately 3:00 PM. The policy stated "Check and record temperatures of all reach in coolers and freezers."

2. The refrigerator/ freezer temperature logs for May, June, and July 2016 were reviewed 8/17/16 at approximately 3:00 PM. Nine of nine refrigerator/ freezer temperature logs lacked daily temperature monitoring and recording of both refrigerator and freezer temperatures as follows:

a. May 2016: ranged six to ten of thirty one days.
b. June 2016: ranged four to seven of thirty days.
c. July 2016: ranged one to five of thirty one days.

3. An interview was conducted with the Dietary Manager (E#10) on 8/17/16 at approximately 3:00 PM. E#10 had reviewed the refrigerator/ freezer temperature logs and verbally agreed refrigerator/ freezer temperatures were not monitored and recorded daily in accordance with the CAH policy.

D. Based on document review and interview, it was determined the Critical Access Hospital (CAH) failed to ensure both automatic and manual dishwasher monitoring was followed in accordance with policy. This has the potential to affect all patients and visitors serviced by the Dietary Department.

Findings include:

1. The CAH policy titled "HACCP (Hazard Analysis and Control Points) - Based SOPs (Standard Operating Procedures): Cleaning and Sanitizing Food Contact Surfaces" (no date of review) was reviewed on 8/17/16 at approximately 3:00 PM. The policy stated "Monitoring: Foodservice employees will: 2. In a 3 -compartment sink (manual), on a daily basis:... Take the water temperature in the first compartment of the sink.. If using chemicals to sanitize, test the sanitizer concentration by using the appropriate test kit for the chemical... 3. In a dishmachine (automatic), on a daily basis:... For hot water sanitizing dishmachine, ensure that food contact surfaces are reaching the appropriate temperature by placing a piece of heat sensitive tape on a smallware item... "

2. The Automatic and manual dishwasher logs for May, June, and July 2016 were reviewed on 8/17/16 at approximately 3:00 PM. Both dishwashers lacked daily monitoring as follows:
a. Automatic dishwasher:

May 2016: two of the presented twenty eight days.
June 2016: four of the presented twenty six days.
July 2016: six of the presented eighteen days.

b. Manual dishwasher:
May 2016: two of thirty one days.
June 2016: two of thirty days.
July 2016: ten of thirty one days.

3. An interview was conducted with the Dietary Manager (E#10) on 8/17/16 at approximately 3:00 PM. E#10 had reviewed the automatic and manual dishwasher monitoring logs and verbally agreed both had not been monitored and recorded daily as required.

Based on document review and staff interview, it was determined for 1 of 4 (Pt #9) surgical patients, the Critical Access Hospital (CAH) failed to ensure the informed surgical consent was signed by the ordering physician.
Findings include:

1. The CAH policy titled "Informed consent" (revised 1/10) was reviewed on 8/16/16 at approximately 2:00 PM. The policy stated "Documentation by the physician in the medical record shall include: that the discussion was held with the patient; that the informed consent was obtained..."

2. Pt #9's record was reviewed on 8/16/16 at approximately 11:50 AM. Pt #9 was admitted to the CAH on 8/15/16 with the diagnoses Gastritis, Nausea, and Vomiting. The CAH consent for an endoscopic procedure lacked documentation the procedure was discussed with the patient by the ordering physician.

3. An interview was conducted with charge nurse of medical/surgical unit (E #5) on 8/16/16 at approximately 12:00 PM. E #5 stated "I don't use this form". E #5 could not find any additional documentation in Pt #9's medical record of the ordering physician discussing the endoscopic procedure with the patient.