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Based on interview and document review the Critical Access Hospital (CAH/hospital) failed to ensure the following:

I. The Emergency Department's (ED) management followed their District-Wide Policy and Procedure when the Department's Policies and Procedures Manual was not reviewed yearly by the Department's Manager, presented to the Policy Department Committee (PDC), Medical Staff and Governing Board for approval. This failure had the potential for staff to not have a guide with limits and a choice of alternatives during the decision making process as the attempts to identify and resolve patient care and departmental issues arise. (C-0200)

II a. A medical equipment maintenance and inventory tracking program had been implemented; and
II b. Sterilized instruments that were stocked in the ED for immediate patient use were sterilized according to the manufacturer's specifications and hospital policy. (Refer to C-0204)

III. The Pediatric Emergency Cart (contains medications and supplies required in a life-threatening emergency) included the current Broselow reference tape (medical instruction for a pediatric emergency). The hospital's Pediatric Emergency Carts were stocked with a Broselow tape labeled version 2011A. The current Broselow reference tape was 2017. (Refer to C-0204)

The cumulative effect of these systemic issues resulted in the CAH's inability to ensure the provision of quality health care in a safe environment.

Findings:

During an interview on 8/23/17 at 2:10 p.m., Acting Chief Nursing Officer (ACNO) stated the process for policy and procedure development, revision or review was the responsibility of the Department Manager. Once completed, the policy is sent to the Policy Department Committee (PDC) for comments. The PDC after reviewing or revising the policy sends it to the Medical Staff for preliminary approval and the Governing Board for final approval. A request was made for a Policy and Procedure that guided staff with the CAH's policy and procedure process.

During a document review on 8/23/17 at 4:35 p.m., the District-wide Policy and Procedure titled, "Process for Writing and Approval of Policies and Procedures and Manuals with an "Effective Date" of 9/28/11 directed different levels of management to perform the following:

1. The Department Managers are responsible for creating, typing, revising and editing all of the policies and procedures of their department...

3. The "Effective Date" of the policy is the date the policy is approved by the Governing Board...

5. The 'Approval' box is to be signed by the Department Manager/Director.

6. Policies are to be submitted to the CAH Policy Department Committee (PDC) and Medical Staff for approval prior to going to the Governing Board for final approval ...

7. Managers are responsible for reviewing each policy and procedure annually and making revisions as appropriate. Once a policy has been reviewed, the Manager should indicate that review by placing their initials in the box provided at the top of the policy. If a policy is revised, the Manager should write "Revised, [date], [initials]"

Under Subtitle "B. Policy and Procedure Manuals # 2 "Department Managers are responsible for reviewing their policy and procedure manuals and submitting them for approval EACH year. Manuals are assigned quarterly dates that they are to be presented to the PDC, Medical Staff, and Governing Body..."

I. During the review of the Emergency Services Policy and Procedure Manual on 8/23/17, the Manual was organized as follows:

1. "Emergency Services Policy and Procedure Manual['s]" signature page including the Department Manager, Administrator, Medical Staff and Governing Board signatures and the date they individually signed the document. The LAST date written was 1/29/15, two years and seven months late for the Annual Review.

2. "Policy and Procedure Manual Revisions" Document dated 12/12/14 - "This is a comprehensive list of all changes to the Policy and Procedure Manual that had taken place since its approval by the Governing Board in 8/13. All policies and procedures that are contained in the Manual and are not listed here have been reviewed and have been found to be current and appropriate."

3. "Emergency Services Policy and Procedure Manual Table of Contents" listed 107 policies and procedures with a revision date of 12/17/14.

During a review of the ED's policies and procedures on 8/24/17, 20 of 20 policies and procedures revealed at least ONE or MORE of the requirements were missing from each policy:
1. Signatures from the Department Manager, Administration, Medical Staff, or Governing Body having a fully executed policy and procedure,
2. The "Effective Date" of the policy,
3. Formatting with the most up-to-date required signatures and the "Effective Date."

In addition, policies in the ED Department Manual were not listed in the Table of Contents (for ease of staff access) and updated policies (2017) were with outdated policies (2007) of the same subject matter.

During a group interview on 8/25/17 at 11:30 a.m., the Acting CNO, Manager A, Manager G, and Administrative Staff F stated the CAH's policies and procedures needed to ALL be standardized and updated.

During a review of the CAH's policy titled "Process for Writing and Approval of Policies and Procedures and Manuals" with an "Effective Date" of 9/29/11, indicated under Policy "...It is the policy of the [hospital] to have policies and procedures as appropriate to assist employees, practitioners, and volunteers in providing optimal patient care, operational efficiency, and financial stability."

Based on observation, interview and record review the Critical Access Hospital (CAH/Hospital) failed to ensure:

IIa. A medical equipment maintenance and inventory tracking program was implemented, and

IIb. Sterilized instruments stocked in the Emergency Department (ED) for immediate patient use were sterilized according to the hospital's policy.

These failures had the potential for staff to use equipment that was not safe, accurate and ready for patient use and not having the necessary instruments to perform a procedure or create an environment where there would be cross-contamination resulting in patient infections due to instruments not being sterilized.

III. The Pediatric Emergency Cart (contains medications and supplies required in a life-threatening emergency) included the current Broselow reference tape (medical instruction for a pediatric emergency). The Hospital's Pediatric Emergency Carts were stocked with a Broselow tape labeled version 2011A. The current Broselow reference tape was 2017. This failure resulted in the potential for pediatric patients, in an emergency, to be exposed to medical instructions that did not meet the 2015 PALS (Pediatric Advanced Life Support) standards.

Findings:

IIa. During an observation of the Emergency Department's (ED) on 8/21/17 at 3:15 p.m., medical equipment found in the patient care areas which included infusion pumps (infuses fluids, medication or nutrients into a patient's circulatory system); defibrillators (used to control the hearts beats by applying an electric current to the chest wall or heart; cardiac monitors, suction machines, etc. was checked for the dates the biomedical service technicians tested the equipment and performed their preventative maintenance. A defibrillator and an infusion pump did not have stickers indicating they had recently been checked by the biomedical company.

During an Environmental Tour on 8/22/17 at 1 p.m., Manager A was asked about the Hospital's Preventative Maintenance Schedule for tracking preventative maintenance of ALL hospital/clinic equipment. He presented verification of individual equipment maintenance testing, but did not have a master tracking list where the status of all equipment and the preventative maintenance could be seen at a glance.

During a phone interview on 8/23/17 at 11:45 a.m., Manager A, when asked regarding the missing labels on the defibrillator and IV pump, stated the biomedical company representative had informed him while he was onsite that he would have to return to complete the equipment testing. During continued discussion, Manager A stated, "We don't have a tracking method."

Manager A was asked for a policy related to preventative maintenance. No policy was submitted to the surveyor before the end of the survey.

IIb. During a tour of the ED on 8/21/17 at 3:15 p.m., in Room 2, there was a locked cabinet with three separate sections. Licensed Staff H unlocked the cabinet to check the contents. A suture kit and a pair of scissors did not have the sterilization date, and the initials of the person performing the sterilization process was not written on the packaging as required by the CAH's policy and procedure.

During an observation with concurrent demonstration and interview on 8/23/17, at 10 a.m., in the Environmental Service area, Unlicensed Staff I demonstrated the process for cleaning and disinfecting instruments and using the autoclave steam sterilization process. Staff I did not demonstrate the process of washing hands between donning and doffing gloves. Unlicensed Staff I concurred that between the two processes handwashing/sanitizing should have been performed, but was not done.

In continuing with the interview, Unlicensed Staff I indicated for proper packaging, all packages should be marked with the sterilization date, load number, description of enclosed product and initials of the person performing the process. Unlicensed Staff I stated the [following] items, that were stocked in the ED, were returned to be reprocessed should have been "caught" by the Materials Management Staff responsible for processing the instruments and/or by the Emergency Department Staff because they lacked one or more of the proper indicators that the sterilization process was complete including checking the identification tape or indicator stripe had changed colors:
(1) Suture Kit
(1) Iris Scissors
(2) Metzenbaum Scissors (surgical scissors designed for cutting delicate tissue and blunt dissection)
(1) Nail Clippers
(2) Needle Holders
(2) Clamps
(1) Weitlander (Retractor for retaining of shallow tissue in orthopedic and neurological cases)

During this same observation, Manager C was asked to explain why the process was not effective with the instruments having to be returned for reprocessing. Manager C did not answer the question.

During a review of the "Autoclave Steam Sterilization Process Policies" dated 5/28/15 indicated "...As each item is unloaded check to see that identification tape or indicator stripe has changed colors." and "All packages will be marked sterilization date, load #, description of enclosed product and initials of person performing the process. All packages not containing this information will be returned unused to central service."

Document review, on 8/25/17 at 10 a.m., indicated the Infection Preventionist's "Infection Prevention Quarterly Reports" were presented to the Medical Staff on the following dates with the following information:

MEDICAL STAFF MEETING- 11/16/2016 for the months of July, August, September 2016:

"Sterilization Process Review-
Random sterile instrument check: Infection Prevention performed a random check of sterile instruments in the Clinic. NINE packs were returned to Central Sterile for reprocessing. The following DEFECTS were found:
- 4 "wet" packs (evidenced by running ink and/or ink bleeding through paper to the sterile side),
- 2 pierced packets (sharp instruments were not appropriately double packed),
- 1 instrument with jaws not separated (tip separators are required for hinged instruments that will not passively stay open),
- 1 pack had no date/time/load number stamp, and
- 1 pack had crumbling, burned edges.
Sterilization issues were discussed with the Operations Manager.

Actions:
1. Instruments with sharp points will be double-packed,
2. Special non-running, nontoxic marking pens....were ordered,
3. All packs removed from sterilizer will be carefully inspected by the operator and reprocessed if any signs of compromise are found."

MEDICAL STAFF MEETING- 2/5/17 for the months of October, November, December 2016:

"Sterilization Process Review-

Random monthly self-check: NOT initiated for third or fourth quarter...
Results of random sterile instrument check (done quarterly by Infection Prevention)
- 2 packs of instruments with sharp tips single wrapped and tips unprotected,
- 8 hinged instruments with closed tips,
- 8 packs without date/time/load # stamp,
Reviewed findings with front line Operations staff person and made recommendations."

MEDICAL STAFF MEETING- 5/17/17 for the months of January, February, March:

"Sterilization Process Review-

Random monthly self-check of sterile instruments by Operations Manager: NOT DONE.

During an interview on 8/23/17 at 10 a.m., Manager C stated she was new to the position and concurred there were concerns to be addressed. She also stated they were in the process of training the Emergency Room Technicians to perform the Sterilization Process.

The "Autoclave Steam Sterilization Process Policies," dated 5/28/15 (There was no documentation of an annual Governing Board review, as per facility policy), indicated "Before storage check sterile items for the following: Items are completely dry, confirm the integrity of the outer wrap, confirm darkening of sterile indicator tape and that date prepared and initials are present. Rotate stock inventory and check it monthly in order to verify that no item is compromised. All packages will be marked sterilization dated, load #, description of the enclosed product and initials of the person performing the process. All packages not containing this information will be returned unused to central service."


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III. During a concurrent tour, interview, and record review, on 8/21/17 at 3:15 p.m., in the Emergency Department, Manager C identified the pediatric emergency cart. Inspection of the cart showed that it contained a Broselow tape. Review of the Broselow tape showed "Version 2011A." Manager C reviewed the Broselow tape and acknowledged it was dated 2011.

Review of the American Academy of Pediatrics (professional association of pediatricians to promote health of infants, children, and adolescents) website at https://shop.aap.org/broselow-pediatric-emergency-tape/ showed the current Broselow reference tape was the 2017 version. The 2017 version of the tape is compliant with the 2015 PALS (pediatric advanced life support) Standards.

Based on observation, interview and record review the Critical Access Hospital (CAH) failed to ensure medical equipment preventative maintenance with a tracking inventory program had been implemented. This failure had the potential for staff to use equipment that was not safe, accurate and ready for patients' immediate use.

Findings:

During an observation of the Emergency Department's (ED) on 8/21/17 at 3:15 p.m., medical equipment found in the patient care areas included - infusion pumps (infuses fluids, medication or nutrients into a patient's circulatory system); defibrillators (used to control the hearts beats by applying an electric current to the chest wall or heart; cardiac monitors, suction machines, etc. was checked for the dates the biomedical service technician tested the equipment and performed the preventative maintenance. A defibrillator and an infusion pump did not have stickers indicating they had recently been checked by the biomedical company.

During an Environmental Tour on 8/22/17 at 1 p.m., Manager A was asked about the Hospital's Preventative Maintenance Schedule for tracking preventative maintenance of ALL hospital/clinic equipment. He presented verification of a few individual equipment maintenance testing, but did not have a master tracking list where the status of all equipment and the preventative maintenance could be seen at a glance.

During a phone interview on 8/23/17 at 11:45 a.m., Manager A, when asked regarding the missing labels on the defibrillator and IV pump, stated the biomedical company representative had informed him while he was onsite that he would have to return to complete the equipment testing. During continued discussion, Manager A stated, "We don't have a tracking method."

Manager A was asked for a policy related to preventative maintenance. No policy was submitted to the surveyor before the end of the survey.

Based on observation, interview, and record review, the Critical Access Hospital (CAH) failed to ensure the medication storeroom refrigerator was programmed with the correct temperature alarm settings. The refrigerator was programmed with a temperature range that was greater than allowed in the policy and procedure. This failure resulted in the potential for patients to be exposed to medications at other than the labeled strength.

Findings:

During a concurrent tour, interview, and record review, on 8/21/17 at 2:25 p.m., in the locked central supply area, Manager C identified an unlocked medication storage refrigerator. Inspection of the refrigerator showed that it contained medications and scheduled drugs. (Scheduled drugs are substances assigned a ranking by the national Drug Enforcement Agency based on potential for abuse, dependency, and addiction.) The scheduled drugs were secured inside a plastic box that was attached to a removable wire rack. Inside the plastic box were 25 vials of lorazepam (an antianxiety medication) 2mg (milligram)/ml (milliliter). The hospital was requested to provide the temperature monitoring logs for the medication storage refrigerator.

During an administrative record review, on 8/22/17 at 9:30 a.m., Manager E identified the hospital's 10067838 Lab Split Fridge (medication storage refrigerator), from 8/8/17-8/15/17, temperature graph. Review of the graph showed the refrigerator was set to alarm at a temperature of 8 degrees Celsius (C), or higher. Continued review showed the refrigerator was set to alarm at a temperature of 2 degrees C, or lower. Manager E reviewed the graph and acknowledged the high temperature alarm was set at 8 degrees C and the low was set at 2 degrees C.

During a concurrent interview and record review, on 8/22/17 at 10:46 a.m., Manager C identified the 10067838 Lab Split Fridge temperature graph. Manager C acknowledged the programmed high and low temperature alarms did not match the required temperature range in policy and procedure of 2.2 degrees Centigrade (C) (36 degrees Fahrenheit (F)) to 7.7 degrees C (46 F).

During a group interview and record review, on 8/22/17 at 1 p.m., Manager C identified the Split Fridge temperature graph. Consultant Pharmacist acknowledged the alarm setting documented on the graph did not match the hospital's required temperature ranges for the medication storage refrigerator (low was too cold and high was too hot).

An administrative record review, of the hospital's policy and procedure for Medication Storage (Effective Date: 3/26/15) showed Purpose:, I General Procedure:, 3. Medications shall be stored at appropriate temperatures:, A. "Refrigerator temperature shall be between 2.2 degrees Centigrade (C)(Celsius) (36 degrees Fahrenheit (F)) and 7.7 degrees C (46 F)." The strength of a medication may change if stored at the wrong temperature.

Based on observation, interview, and record review, the Critical Access Hospital (CAH) failed to ensure that the organizational structure was carried out in a safe manner as evidenced by the following:

The CAH failed to ensure the implementation of all policies and procedures for the provision of pharmaceutical (pharmacy) services. Four pharmaceutical service policy and procedures required a pharmacist to perform the required duties. The hospital did not staff a pharmacist to perform the required duties. These failures resulted in the potential for patients to be exposed to preventable medication errors (preventable event that may cause or lead to inappropriate medication use or patient harm). (Refer to C-0241)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the organizational structure was in compliance with the statutorily mandated Condition of Organizational Structure.

Based on observation, interview, and record review, the Critical Access Hospital (CAH) failed to ensure the implementation of all policies and procedures for the provision of pharmaceutical (pharmacy) services. Four pharmaceutical service policy and procedures required a pharmacist to perform the required duties. The CAH did not staff a pharmacist to perform the required duties. These failures resulted in the potential for patients to be exposed to preventable medication errors (preventable event that may cause or lead to inappropriate medication use or patient harm).

Findings:

During observations, on 8/21/17 from 1:30-4 p.m., and 8/22/17 from 7:45 a.m.-12:50 p.m., in the CAH, a pharmacist was not seen on duty.

During a concurrent group interview and record review, on 8/22/17 at 1 p.m., Manager C and Consultant Pharmacist identified the following policies and procedures: Filling Medication Orders, Controlled Substances (scheduled medications, narcotics) Security, General Pharmacy Operations, and Emergency Medication Supply (Crash Carts) (medications required in an emergency). Filling Medication Orders required a pharmacist to review physician orders for medications before they were administered. Controlled Substances Security required that access to scheduled medications in the pharmacy be limited to a pharmacist. General Pharmacy Operations required a pharmacist to be scheduled to work in the hospital 8-9:30 a.m., Monday through Friday. Emergency Medication Supply (Crash Carts) required a pharmacist to seal the emergency drug supply in the cart. Consultant Pharmacist acknowledged a pharmacist was not scheduled as required by policy and procedure. Consultant Pharmacist acknowledged a pharmacist did not perform the duties required by policy and procedures.

During an interview, on 8/23/17 at 11 a.m., the Administrator acknowledged the hospital's pharmaceutical service policy and procedures required a pharmacist to be scheduled 8-9:30 a.m., Monday through Friday. The Administrator acknowledged his role, and as a member of the governing body, was to ensure the implementation of policies and procedures to ensure the safe and effective provision of pharmaceutical services.

Based on observation, interview, and record review, the Critical Access Hospital (CAH) failed to ensure that the provision of services was carried out in a safe manner as evidenced by the following:

1. The CAH failed to ensure medications removed from the medication storeroom, using the night after-hour process (how to obtain medication when the storeroom is closed), followed the policy and procedure. The log did not contain the patient names (required information) for 305 out of 368 medications removed. This failure resulted in the potential for patients to be exposed to preventable medication errors (preventable event that may cause or lead to inappropriate medication use or patient harm). (Refer to C-0276 #1)

2. The CAH failed to ensure all scheduled (drugs with a potential for abuse) medications were secured as required by policy and procedure. The pharmacy storeroom kept its supply of injectable (administered through the skin) lorazepam (scheduled medication) outside of the required secured room. This failure resulted in the potential for the diversion (theft) of lorazepam. (Refer to C-0276 # 2)

3. The CAH failed to ensure it could account for all scheduled (controlled substances, medications with a potential for abuse and dependence) medications. The CAH did not have a process to ensure all medications removed from the scheduled medication lockers were administered to the corresponding patients. This failure resulted in the potential for undetected diversion (theft) of scheduled medications. (Refer to C-0276 #3)

4. The CAH failed to ensure a pharmacist was staffed in the hospital. The policy and procedures required a pharmacist to be staffed 8-9:30 a.m., Monday through Friday. The CAH did not staff a pharmacist as required by policy and procedure to perform the required duties. This failure resulted in the potential for patients to be exposed to preventable medication errors (preventable event that may cause or lead to inappropriate medication use or patient harm). (Refer to C-0276 #4)

5. The CAH failed to ensure a pharmacist reviewed medication orders (for allergies, correct dose, and correct use) before the drug was administered. The policy and procedure required a pharmacist to review the medication order before administration. The CAH did not staff a pharmacist to perform the required duty. This failure resulted in the potential for patients to be exposed to preventable medication errors (preventable event that may cause or lead to inappropriate medication use or patient harm). (Refer to C-0276 #5)

6. The CAH failed to ensure only a pharmacist had access to the scheduled (narcotic) medications in the medication storeroom per their policy and procedure. Hospital staff, other than the pharmacist, had access to the scheduled medications in the medication storeroom. This failure resulted in the potential for diversion (theft) of scheduled medications. (Refer to C-0276 #6)

7. The CAH failed to ensure the hospital's emergency carts (medications required in an emergency) were sealed by a pharmacist. The CAH's policy and procedures required that a pharmacist sealed the emergency carts. The carts were not sealed by a pharmacist. These failures resulted in the potential for patient to be exposed to a delay in receiving the medications required in an emergency. (Refer to C-0276 #7)

8. The CAH failed to ensure the medication storeroom refrigerator was programmed with the correct temperature alarm settings. The refrigerator was programmed with a temperature range that was greater than allowed in policy and procedure. These failures resulted in the potential for patients to be exposed to medications at other than labeled strength. (Refer to C-0224)

9. The CAH failed to develop and implement a policy and procedure for the removal of intravenous (IV, directly into a vein) solutions from their outer wrap (protective outer layer). (Refer to C-0271 #1)


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10. The CAH did not follow their policy and procedures for a "standardized process" for writing, reviewing, storing, and obtaining an annual approval of their policies and procedures and manuals for 10 of 10 Department Manuals reviewed. (Refer to C-0272)


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11. One patient (Patient 2) had no care plan to direct the care provided during her stay in the Critical Access Hospital. (Refer to C-0271 #2)

12. One patient's pressure ulcers (Patient 2) were not assessed and documented timely to evaluate the effectiveness of interventions and modify care as needed, and daily assessment was not done according to policy and procedure. (Refer to C-0271 #3)

13. The policy for discharge instructions was not followed for one patient (Patient 2) who was discharged to home without teaching related to care of her peripherally inserted central catheter (PICC), pressure ulcers, or urinary catheter, all of which posed a risk for infection or other complications. (Refer to C-0271 #4)

14. The policy for daily assessment of the necessity of vascular access devices (tubes into veins for administration of medications or fluids) was not followed for one patient (Patient 2), resulting in Patient 2's PICC remaining in place, for longer than necessary, increasing the risk for an infection of the blood stream. (Refer to C-0271 #5)

15. The facility to ensure nursing services were provided to meet the needs of the patients. (Refer to C-0294, C-0297, C0298)

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision of services were in compliance with the statutorily mandated Condition of Provision of Services.

Based on observation, interview, and record review, the Critical Access Hospital (CAH) failed to develop and implement policies for provision of patient care as evidenced by:
1. There was no policy for storage and labeling of intravenous (IV, directly into a vein) fluids after removal of the bags' outer wrappers;

2. One patient (Patient 2) had no care plan to direct the care provided during her stay in the CAH;

3. One patient's pressure ulcers (Patient 2) were not assessed and documented timely to evaluate the effectiveness of interventions and modify care as needed, and daily assessment was not done according to policy and procedure;

4. The policy for discharge instructions was not followed for one patient (Patient 2) who was discharged to home without teaching related to care of her peripherally inserted central catheter (PICC - a long, thin tube that goes into your body through a vein in the upper arm and into a large vein near the heart), pressure ulcers (localized damage to the skin as a result of intense or prolonged pressure), or urinary catheter (a tube inserted into the bladder to drain urine), all of which posed a risk for infection or other complications;

5. The policy for daily assessment of the necessity of vascular access devices (tubes into veins for administration of medications or fluids) was not followed for one patient (Patient 2), resulting in Patient 2's PICC remaining in place, for longer than necessary, increasing the risk for an infection of the blood stream;

These failures resulted in provision of care that was not directed by facility-wide policies and procedures, which could negatively impact the well-being of patients.

Findings:

1. During a concurrent tour, interview, and record review, on 8/21/17 at 3:15 p.m., in the emergency department, a storage cabinet was identified. Inspection of the locker showed that it contained IV fluids. Continued inspection showed the protective outer wrappers was opened for one bag of normal saline (salt water) 1000 ml (milliliter) and one bag of dextrose (sugar water) 10% 250 ml IV bag. Review of each of the bags' labeling did not show an expiration date that was based on the opening of the outer wrapper. Manager C acknowledged the IV bags were not labeled with an expiration date that was based on the opening of the outer wrapper. (Removal of IV bags from the outer wrappers can result in a change in the solutions, potentially exposing patients to medications at other than the labeled strength.)

During a concurrent tour, interview, and record review, on 8/21/17 at 3:30 p.m., in the inpatient nursing unit medication room, an IV fluid storage area was identified. Inspection of the area showed that it contained one lactated ringers (electrolyte) 5% dextrose 1000 ml IV bag that was removed from its outer wrapper. Review of the bag's labeling did not show an expiration date that was based on the opening of the outer wrapper. Manager C acknowledged the IV bag was not labeled with an expiration date that was based on the opening of the outer wrapper.

During an interview, on 8/22/17 at 8 a.m., Manager C stated Consultant Pharmacist communicated to her that normal saline bags are good for two weeks when removed from their outer wrapper. Manager C stated the hospital's policy and procedures did not provide a process for storing and labeling IV bags with opened outer wrappers.

2. Review of Patient 2's clinical record revealed she was admitted to a swing bed of the CAH on 6/20/17 to complete intravenous (administered into a vein) antibiotic therapy for an infection, and was discharged to home on 7/3/17.

During interview and concurrent record review, on 8/22/17 at 3:30 p.m., the Acting Chief Nursing Officer (ACNO) stated the CAH used paper, not computerized, care plans for patients in swing beds. The paper care plans were then scanned and added to the electronic medical record after the patient was discharged from the CAH. ACNO was unable to locate any care plan in Patient 2's electronic medical record.

During an interview on 8/24/17 at 9:40 a.m., ACNO confirmed no care plan, either paper or electronic, could be located for Patient 2. When asked if lack of a documented care plan prevented the facility from demonstrating it had implemented interventions to promote healing or prevent worsening of Patient 2's pressure ulcers, ACNO stated, "Yes."

3. Review of Patient 2's electronic medical record revealed an initial nursing assessment, dated 6/20/17, which reflected a 1.5 centimeter slit or Stage II pressure ulcer over the coccyx (tailbone). (Stage II pressure injury involves partial-thickness loss of skin, exposing the underlying tissue.)

A nurse's note, entered 6/22/17 at 5:17 p.m., indicated, "[Patient has Stage 2 wound coccyx area this AM. Wound measures [width 2.75 centimeters x height 1.75 centimeters x depth unable to determine]. Pt given shower with intention of dressing wound after shouer (sic). When pt returns to room, wound has greatly increased in size and skin is torn in two additional places. Wounds measured and order for wound care initiated."

Review of a wound assessment sheet, dated 6/22/17, reflected two wounds, numbered one and two. Wound #1 was documented as described above. Wound #2, also on the coccyx, measured [width 2.25 centimeters x height 1.2 centimeters x depth unable to determine].

A discharge nurse's note on 7/3/17 at 3:36 p.m. indicated, "[Foam] dressing dry and intact." No documentation of the number, size, or condition of Patient 2's wounds at time of discharge could be located in the medical record. The medical record contained no assessment of Patient 2's wounds between 6/22/17 and her discharge on 7/3/17, a period of 11 days.

During an interview with concurrent record review, on 8/22/17 at 3:30 p.m., the Acting Chief Nursing Officer (ACNO) was asked about her expectation for documentation of wound assessments. ACNO stated a wound assessment sheet, which includes measurements of all wounds, should be completed with each scheduled dressing change. ACNO confirmed the size and appearance of Patient 2's wounds should have been documented at least weekly, since the physician order included cleaning and covering the wounds weekly and as needed if the dressing was soiled.

Review of facility policy and procedure titled Pressure Ulcer Assessment, Prevention and Treatment, effective 10/28/04, indicated, "The Pressure Ulcer/Wound Care Report Sheet:...e. will have documentation by a licensed nurse daily until the wound is resolved."

4.. Review of Patient 2's initial nursing assessment indicated she had a peripherally inserted central catheter (PICC) in her upper right arm at the time of admission, as well as a urinary catheter draining her bladder. Patient 2's initial nursing assessment also reflected a 1.5 centimeter slit or Stage II pressure ulcer over the coccyx (tailbone).

A discharge note on 7/3/17 at 3:36 p.m. indicated, "Patient discharged to home with all medications, left facility via gurney ambulance transport at [2:40 p.m.] Discharge paperwork sent with EMS (emergency medical service) transport. Home medication regime continued and medication reconciliation sent home to daughter. PICC line patent, flushes well, dressing dry and intact. [Foam] dressing dry and intact. Orders to follow up with [primary care provider]."

Review of the "Discharge Med Rec (medication reconciliation) Report" indicated it listed Patient 2's medications with dosages, frequency, when the last dose was given, and when to start taking at home. The space for "patient signature" indicated "unable to sign," beneath which two registered nurses signed. The areas of the form for comments and notes were both blank. There were no instructions for care of the PICC, the urinary catheter, or the wounds. The instruction to follow-up with her primary care provider in three days was not included on the discharge information.

During an interview with concurrent record review on 8/24/17 at 10:15 a.m., the Acting Chief Nursing Officer (ACNO) confirmed Patient 2's medical record contained no documentation of patient teaching prior to or at the time of discharge. ACNO stated the "Discharge Med Rec Report" was the documentation provided to each patient when they are discharged. ACNO stated Patient 2's family was not present at the time of discharge, and Patient 2 was sent home by ambulance.

During a subsequent interview on 8/25/17 at 11:40 a.m., ACNO confirmed Patient 2 was not referred to any outside nursing agency for care or teaching regarding her PICC, urinary catheter, and wounds after discharge. ACNO stated, "Yes, referral would have been appropriate."

Policies and procedures related to discharge planning, patient teaching, and discharge instructions were requested on 8/25/17 at 10:30 a.m. A policy and procedure titled ""Discharge Instructions," effective 2/28/17, was provided by ACNO at 11:40 a.m. ACNO stated it was the only policy related to discharge instructions she could locate, and it applied to the hospital even though it referenced discharge from the emergency room.

Review of facility policy and procedure revealed, "It is the policy of the [healthcare district] to give clear and appropriate Discharge Instructions from our Emergency Room."

Review of Patient 2's clinical record from an acute care hospital revealed Patient 2 presented to the emergency department on 7/3/17 at 11:50 p.m., approximately nine hours after discharge from the CAH, with altered mental status and fever of 102.3 (normal 98.6).

5. Review of Patient 2's clinical record revealed she was admitted 6/20/17 to complete intravenous antibiotic therapy for an infection and was discharged to home on 7/3/17. Patient 2's initial nursing assessment indicated she had a PICC line in her upper right arm at the time of admission. Patient 2's discharge nursing note indicated the PICC remained in place when she was discharged home.

Review of facility policy and procedure titled Central Venous Catheter Care, effective 3/6/14, section Preexisting CVC (Upon Admission), indicated "6. A Daily Necessity evaluation is to be performed and documented each day. Obtain a physician order to discontinue lines that are deemed no longer necessary at the earliest opportunity."

During an interview on 8/24/17, Acting Chief Nursing Officer (ACNO) was asked to demonstrate how daily necessity evaluation for the PICC was documented. ACNO demonstrated how the insertion site (location of the line entering the skin) was assessed for indications of infection every time medication was administered through it. ACNO stated the line was necessary because Patient 2 was receiving intravenous antibiotics. When asked about the PICC's continued necessity after Patient 2's antibiotic therapy was completed on 6/30/17 and why it was considered necessary to discharge the patient to home with the PICC in place, ACNO stated, "Dr. [staff physician] probably wouldn't discontinue it in case it was needed later. The patient was supposed to follow up with her doctor within three days." No "Daily Necessity evaluation," as specified in the facility policy and procedure, was located in Patient 2's medical record.

Based on interview and document review, the Critical Access Hospital (CAH) did not follow their policy and procedures for a "standardized process" for writing, reviewing, storing, and obtaining an annual approval of their policies and procedures for a sampling of 10 of 10 Department Manuals reviewed. These failures had the potential to result in the delivery of unsafe patient care due to a high degree of understanding, cooperation, efficiency, and unity among hospital employees not being established and sustained over time.

Findings:

A review on 8/23/17 of the CAH's "District-Wide" Department policy titled, "Process for Writing and Approval of Policies and Procedure and Manuals" with an "Effective Date" of 9/29/11. This document was used to direct Administrative Staff how policies should be created, revised, reviewed, stored and approved by the Hospital Policy Department Committee (PDC), the Medical Staff with final approval of the Governing Body. This policy had NOT been signed by Administration, Medical Staff or the Governing Body and there was no indication it was being reviewed on an annual basis. The policy also indicated the [Department] Policy Manuals will be submitted annually with a "Face Sheet" signed and dated by the Manager, and a memo listing any new, revised, and/or deleted policies.

During an interview on 8/23/17 at 2:10 p.m., Acting Chief Nursing Officer (ACNO) stated the process for policy and procedure development, revision or review was the responsibility of the Department Managers. In turn, they send it to the Policy Department Committee (PDC) for comments. The PDC, after reviewing or revising the policy, sends it to the Medical Staff for preliminary approval and the Governing Board for final approval. ACNO stated these policies were stored in manuals and on the computer. When searching on the computer there should be three folders, a "draft", "current" folder an "old archived" folder.

During a computer search on 8/25/17 at 9:05 a.m., the policy "Process for Writing and Approval of Policies and Procedure and Manuals" indicated all Procedures/Manuals were located on the computer's "F" Drive; however the ACNO retrieved the manuals/policies from the "S" Drive. ACNO stated she was not certain when the change occurred, the rationale for the change, or why the policy had not been changed to reflect the S Drive replacing the F Drive.

Ten of 22 Departments' Policy and Procedure Manuals were requested for a sample review. Ten of ten manuals (Accounting, Acute Nursing, Central Supply/Service, Clinic, Emergency Services, Human Resource, Infection Prevention and Employee Health Manual, Pathology / Lab Services, Performance Improvement / Utilization Management /Risk Management, and Safety and Emergency Preparedness) were missing one or more of the following documents:

1. The policies in the Department Manuals were not reviewed/revised and approved by the Department Manager on an annual basis for addition, deletion and revision;

2. The Policy and Procedure Manual had a document requiring the signatures of the Department Manager, Administrator, Medical Staff and Governing Board with the date they individually signed the document. Some or all of the signatures were not completed on this document;

3. The 'Policy and Procedure Manual Revisions' Document is a comprehensive list of all changes to the Policy and Procedure Manual that had taken place since the last approval by the Governing Board. The document was not in the manual(s); and

4. The Table of Contents (Includes policies related to the specific department) were either not current, not in the manual, or numbered correctly.

During an interview on 8/23/17 at 11:05 a.m., the Administrator stated the policies and procedures needed work.

During an interview on 8/25/17 at 8:20 a.m., Administrative Staff F stated, "All policies and procedures haven't been checked every year."

During an interview on 8/25/17 at 12 p.m., the ACNO, Manager A, Manager D and Administrative Staff F stated the CAH's policies and procedures needed to be standardized and reviewed. The staff stated it was difficult to manage all the CAH's policies and procedures for their departments given all their job responsibilities.

During a review of the CAH's policy titled, "Process for Writing and Approval of Policies and Procedures and Manuals" indicated, "...It is the policy of the......to have policies and procedures as appropriate to assist employees, practitioners, and volunteers in providing optimal patient care, operational efficiency, and financial stability."

Based on observation, interview, and record review, the Critical Access Hospital (CAH) failed to ensure the implementation of policies and procedures as evidenced by:

1. The CAH failed to ensure medications were removed from the medication storeroom, using the night after-hour process (how to obtain medication when the storeroom is closed), according to policy and procedure. The pharmacy log (required information) did not contain the patient names for 305 out of 368 medications removed. This failure resulted in the potential for patients to be exposed to preventable medication errors (preventable event that may cause or lead to inappropriate medication use or patient harm).

2. The CAH failed to ensure all scheduled medications (controlled substances, medications with a potential for abuse and dependence) were secured as required by policy and procedure. The pharmacy storeroom kept its supply of injectable (administered through the skin) lorazepam (an antianxiety scheduled medication) outside of the required secured room. This failure resulted in the potential for the diversion (theft) of lorazepam.

3. The CAH failed to ensure it could account for all scheduled medications (controlled substances, medications with a potential for abuse and dependence). The CAH did not have a process to ensure all medications removed from the scheduled medication lockers were administered to the corresponding patients. This failure resulted in the potential for undetected diversion (theft) of scheduled medications.

4. The CAH failed to ensure a pharmacist was staffed in the CAH. The policy and procedures required a pharmacist to be staffed 8-9:30 a.m., Monday through Friday. The CAH did not staff a pharmacist as required by policy and procedure to perform the required duties. This failure resulted in the potential for patients to be exposed to preventable medication errors (preventable event that may cause or lead to inappropriate medication use or patient harm) .

5. The CAH failed to ensure a pharmacist reviewed medication orders (for allergies, correct dose, and correct use) before the drug was administered. The policy and procedure required a pharmacist to review the medication order before administration. The CAH did not staff a pharmacist to perform the required duty. This failure resulted in the potential for patients to be exposed to preventable medication errors (preventable event that may cause or lead to inappropriate medication use or patient harm).

6. The CAH failed to ensure only a pharmacist had access to the scheduled medications (controlled substances, medications with a potential for abuse and dependence) in the medication storeroom per policy. CAH staff, other than the pharmacist, had access to the scheduled medications in the medication storeroom. This failure resulted in the potential for diversion (theft) of scheduled medications.

7. The CAH failed to ensure the CAH's emergency carts (medications required in an emergency) were sealed by a pharmacist. The CAH's policy and procedures required that a pharmacist seal the emergency carts. The carts were not sealed by a pharmacist. This failure resulted in the potential for patients to be exposed to a delay in receiving the medications required in an emergency.

Findings:

1. During a concurrent tour and interview, on 8/22/17 at 10:40 a.m., in the pharmacy storeroom, Manager C identified the night after-hours log. Manager C was asked if a pharmacist reviewed the log to ensure there was a physician order to match each medication removed. Manager C stated she did not know if a pharmacist reviewed the log to ensure there was a physician order to match each medication removed.

During a concurrent group interview and record review, on 8/22/17 at 1 p.m., Manager C identified the CAH's night after-hours log. Consultant Pharmacist and Manager C acknowledged that not all log entries documented the patient name as required by the CAH.

Review of the pharmacy's Pharmacy Entry Log for the period 4/28/17 through 8/17/17, showed 63 of 368 entries documented a patient name.

Review of the CAH's policy and procedure for Obtaining Medications After Hours (Effective Date: 3/8/00) showed, "Purpose:, A. Floor Stock Procedure, 2. In the event that the required drug is not in the floor stock (already stocked on the patient care unit) medications, the Acute Charge Nurse or ER (emergency room) nurse may enter the Pharmacy to obtain medication. Only pre-packaged medications may be removed from the pharmacy and a written record of such withdrawals must be made...A. The nurse will record the required information in the After Hours Log provided. The record shall include the name and strength of the drug, the amount taken, the date and time, the name of the patient, the patient's room number, and the signature of the designated nurse."

2. During a concurrent tour, interview, and record review, on 8/21/17 at 2:25 p.m., in the locked central supply area (outside of the secured medication storeroom), Manager C identified an unlocked medication storage refrigerator. Inspection of the refrigerator showed that it contained medications and scheduled drugs. The scheduled drugs were secured inside a locked plastic box that was attached to a removable wire rack. Inside the plastic box were 25 vials of lorazepam 2mg (milligram)/ml (milliliter). During the interview, Administrative Staff K opened the locked door to the central supply area and entered the room in search of copy paper. Manager C acknowledged Administrative Staff K had unauthorized access to the medications stored in the unlocked drug refrigerator.

During an interview, on 8/22/17 at 1 p.m., Consultant Pharmacist acknowledged drugs inside the medication storage refrigerator were not secured from unauthorized access.

Review of the CAH's policy and procedure for Medication Storage (Effective Date: 3/26/15) showed, Purpose:, II. The Drug Room, 3. "All Scheduled medications are stored in separate locked cabinets in the Drug room...4. The Drug Room has a refrigerator designated for medications only...The refrigerator is locked at all times..."

3. During a group interview, on 8/21/17 at 1:30 p.m., the Acting Chief Nursing Officer (ACNO) and Manager C were requested to describe the medication ordering and administration process. Their description included the nurse removed the medication from the drug storage area. Scheduled medications would be signed out from the locked cabinet. The nurse would administer the medication at the patient's bedside. Administration of the medication would be documented in the electronic (computer) medical record (EMR).

During a concurrent tour and interview, on 8/21/17 at 2:15 p.m., in the locked central supply area, Manager C identified the secured pharmacy storeroom. Inspection of the storeroom showed it contained medications and scheduled drugs. The scheduled medications were secured inside of a locked steel cabinet. The cabinet was secured to the wall. Manager C was requested to describe how the CAH controlled scheduled medications. Manager C's description included that she did not have access to the medications inside the steel cabinet. In addition, her description included that only designated nurses within the CAH had access to the medications inside the cabinet.

During a group interview on 8/22/17 at 1 p.m., Consultant Pharmacist (by phone) and Manager C were asked to describe how the CAH accounted for all of its scheduled medications. Their description did not include a procedure to ensure the medication removed from the cabinet was documented as administered to the patient.

Review of the CAH's policy and procedure for Controlled Substances Security (Effective Date: 1/29/2015) showed, Procedure:, Monitoring Use of Controlled Substances, A. "In order to comply with applicable state and federal laws, the nursing and pharmacy staff will account for every controlled substance administered to a patient or dispensed to a nursing unit."

4. During observations, on 8/21/17 from 1:30-4 p.m., and 8/22/17 from 7:45 a.m.-12:50 p.m., in the CAH, a pharmacist was not seen on duty.

During a concurrent group interview and record review, on 8/22/17 at 1:25 p.m., Manager C identified the CAH's policy and procedure for General Pharmacy Operations. Consultant Pharmacist and Manager C acknowledged the policy required the CAH to staff the pharmacy with a pharmacist registered with the California Board of Pharmacy. Consultant Pharmacist and Manager C acknowledged the policy required the pharmacy was to be staffed 8-9:30 a.m., Monday through Friday. Consultant Pharmacist acknowledged the CAH pharmacy was not staffed by a pharmacist as required by policy and procedure.

Review of the CAH's policy and procedure for General Pharmacy Operations (Effective Date: 3/26/15) showed, Procedure:, 1. Staffing: "The CAH pharmacy is staffed by a registered pharmacist who is delegated the Director of Pharmacy. The Pharmacy Director is responsible for operating the pharmacy efficiently and smoothly and will provide the best possible service to the patient in all areas of medication utilization. In the absence of the Pharmacy Director, a fully qualified registered pharmacist will fill in and will be given the responsibility for the operation of the pharmacy service...The registered pharmacist will be available 24 hours each day whenever possible. The regular business hours for the pharmacist are 8:00 a.m. to 9:30 a.m. Monday through Friday..."

5. During a group interview, on 8/21/17 at 1:30 p.m., ACNO and Manager C were requested to describe the medication ordering and administration process. Their description included a physician or nurse would enter a medication order into the electronic (computer) medical record (EMR). A nurse would verify (reviewed for correctness) the order in the EMR which released the medication to appear in the medication administration record (record of medication administration (MAR)). The nurse would then remove the medication from the drug storage area. The nurse would administer the medication at the patient's bedside. Administration of the medication would be documented in the MAR. ACNO acknowledged that a pharmacist was not required in the processing of a medication order through administration to a patient and documentation in the MAR.

During a group interview, on 8/22/17 at 1 p.m., Manager C and Consultant Pharmacist were asked if the CAH followed the policy and procedure for Filling Medication Orders. Consultant Pharmacist stated that a pharmacist did not review medication orders before the drug was administered.

During observations, on 8/21/17 from 1:30-4 p.m., and 8/22/17 from 7:45 a.m.-12:50 p.m., in the CAH, a pharmacist was not seen on duty.

Review of the CAH's policy and procedure for Filling Medication Orders (Effective Date: 3/26/15) showed, Procedure:, 1. Non-Stat Medication Orders:, All non-stat (not an emergency) orders will be filled in the pharmacy upon receipt of a written order....A. The pharmacist reviews the physician's order and interprets it., B. The pharmacist checks the patient's medication profile before filling to ensure accuracy of the nurse's interpretation and suitability of the dosage form, timing of medication administration, duplication, interactions or allergies., C. The pharmacist clarifies any problems or questions on the order, consulting with the prescriber when necessary., D. The pharmacist enters the order onto the patient profile (EMR)..." At this point the nurse would administer the ordered medication and document the action in the EMR.

6. During a concurrent tour and interview, on 8/21/17 at 2:15 p.m., in the locked central supply area, Manager C identified the locked pharmacy storeroom. Inspection of the storeroom showed it contained medications and scheduled drugs. The scheduled medications were secured inside of a locked steel cabinet. The cabinet was secured to the wall. Manager C was requested to describe how the CAH controlled scheduled medications. Manager C's description included that she did not have access to the medications inside the steel cabinet. In addition, her description included that only designated nurses within the CAH had access to the medications inside the cabinet.

During a group interview, on 8/22/17 at 1 p.m., Manager C and Consultant Pharmacist were asked if the CAH followed the policy and procedure for Controlled Substances Security. Consultant Pharmacist stated that access to controlled substances in the pharmacy storeroom was not limited to the pharmacist.

During observations, on 8/21/17 from 1:30-4 p.m., and 8/22/17 from 7:45 a.m.-12:50 p.m., in the CAH, a pharmacist was not seen on duty.

Review of the CAH's policy and procedure for Controlled Substances Security (Effective Date: 1/29/15) showed, Procedure:, Access to Medication Areas and Nurses' Station:, 1. Pharmacy Drug Room, 2. "Access to controlled substances in the Drug Room is limited to the pharmacist."

Review of the CAH's policy and procedure for Floor Stock Medications (Effective Date: 1/29/15) showed, Procedure:, 4. "The pharmacist or pharmacy technician will fill the approved medications, but only the pharmacist will fill the controlled substances."

7. During a concurrent tour, interview, and record review, on 8/21/17 at 3:15 p.m., in the emergency department, Manager C identified the pediatric emergency cart. Inspection of the cart showed that the contents were secured with two plastic seals. Manager C was requested to describe the process to stock medications into the crash cart. Manager C's description included that the drug contents of the cart were sealed with a plastic lock. The plastic lock was only supplied by pharmacy. Manager C's description did not include that the cart was sealed by a pharmacist

During a concurrent group interview and record review, on 8/21/17 at 1 p.m., Manager C identified the CAH's policy and procedure for Emergency Medication Supply (Crash Carts). Consultant Pharmacist acknowledged the policy required a pharmacist to seal the crash cart. Consultant Pharmacist acknowledged the CAH's crash carts were not sealed by a pharmacist.

Review of the CAH's policy and procedure for Emergency Medication Supply (Crash Carts) (Effective Date: 1/29/15) showed, Procedure:, 1. "After the crash cart is stocked it will be sealed with a red plastic lock by the pharmacist..."

Based on interview and record review, the Critical Access Hospital (CAH) failed to provide care to meet the needs of one patient (Patient 2) as evidenced by:

1. Patient 2 had no care plan to demonstrate interventions to promote healing and prevent worsening of pressure ulcers present on admission or her responses to any treatments provided during her stay in the Critical Access Hospital;

2. Patient 2's pressure ulcers (Patient 2) were not assessed and documented timely to evaluate the effectiveness of interventions and modify them as needed;

3. Patient 2 was discharged to home with multiple potential sources of infection which included a peripherally inserted central catheter (PICC - a long, thin tube that goes into the body through a vein in the upper arm and into a large vein near the heart), pressure ulcers (damage to the skin due to prolonged pressure), urinary catheter (a tube inserted into the bladder to drain urine) without any documented teaching of infection prevention measures or care of her wounds, PICC, or urinary catheter.

These failures had the potential to result in localized or widespread infection which could lead to pain, increased debility, and death.

Findings:

On 7/10/17, the California Department of Public Health received an Entity Reported Incident related to worsening of a pressure ulcer during Patient 2's hospitalization in a swing bed at the Critical Access Hospital (CAH).

On 7/31/17, the California Department of Public Health received a complaint alleging Patient 2 had a pressure ulcer which worsened during her stay as a swing bed patient of the Critical Access Hospital. The complaint also alleged Patient 2 required return to the emergency department of an acute care hospital hours after discharge from the CAH.

Review of Patient 2's clinical record revealed she was admitted to a swing bed of the CAH on 6/20/17 from a general acute care hospital (GACH) to complete intravenous (administered into a vein) antibiotic therapy for an infection, and was discharged to home on 7/3/17.

1. During interview and concurrent record review, on 8/22/17 at 3:30 p.m., the Acting Chief Nursing Officer (ACNO) stated the CAH used paper, not computerized, care plans for patients in swing beds. The paper care plans were then scanned and added to the electronic medical record after the patient was discharged from the CAH. ACNO was unable to locate any care plan in Patient 2's electronic medical record. ACNO stated the paper care plan might be in medical records awaiting scanning.

During an interview on 8/24/17 at 9:30 a.m., Health Information Management Staff O (HIM Staff O) stated she could not locate any paper medical records related to Patient 2's hospitalization. When asked who scanned documents into the electronic medical records, HIM Staff O stated "everybody scans." HIM Staff O stated nurses can scan documents into the records, and the medical records department will scan "whatever is left" after the patient is discharged.

During an interview on 8/24/17 at 9:40 a.m., ACNO confirmed no care plan, either paper or electronic, could be located for Patient 2. When asked if lack of a documented care plan prevented the facility from demonstrating it had implemented interventions to promote healing or prevent worsening of Patient 2's pressure ulcers, ACNO stated, "Yes."

2. Review of Patient 2's electronic medical record revealed an initial nursing assessment, dated 6/20/17, which reflected a 1.5 centimeter slit or Stage II pressure ulcer over the coccyx (tailbone). (Stage II pressure injury involves partial-thickness loss of skin, exposing the underlying tissue.)

A nurse's note, entered 6/22/17 at 5:17 p.m., indicated, "[Patient has Stage 2 wound coccyx area this AM. Wound measures [width 2.75 centimeters x height 1.75 centimeters x depth unable to determine]. Pt given shower with intention of dressing wound after shouer (sic). When pt returns to room, wound has greatly increased in size and skin is torn in two additional places. Wounds measured and order for wound care initiated."

Review of a wound assessment sheet, dated 6/22/17, reflected two wounds, numbered one and two. Wound #1 was documented as described above. Wound #2, also on the coccyx, measured [width 2.25 centimeters x height 1.2 centimeters x depth unable to determine].

A nurse's note entered 7/11/17 at 10:28 a.m. (seven days after Patient 2 was discharged from the CAH) indicated, "Late entry. As noted on 6/22/17. Pt returned from shower with skin open in 2 additional areas. Upon inspection, skin covering buttocks area appears to have consistency of a blister which has broken open while showering. Skin appears very fragile and thin, wounds measured as reflected in wound assessment and order for wound care initiated. Wound is covered with [a foam dressing] and transparent dressing. Pt consistently turned [every two hours] during shift. [Will continue to monitor.]"

A discharge nurse's note on 7/3/17 at 3:36 p.m. indicated, "[Foam] dressing dry and intact." No documentation of the number, size, or condition of Patient 2's wounds at time of discharge could be located in the medical record. The medical record contained no assessment of Patient 2's wounds between 6/22/17 and her discharge on 7/3/17, a period of 11 days.

During an interview with concurrent record review, on 8/22/17 at 3:30 p.m., the Acting Chief Nursing Officer (ACNO) was asked about her expectation for documentation of wound assessments. ACNO stated a wound assessment sheet, which includes measurements of all wounds, should be completed with each scheduled dressing change. ACNO confirmed the size and appearance of Patient 2's wounds should have been documented at least weekly, since the physician order included cleaning and covering the wounds weekly and as needed if the dressing was soiled.

Review of facility policy and procedure titled Pressure Ulcer Assessment, Prevention and Treatment, effective 10/28/04, indicated, "The Pressure Ulcer/Wound Care Report Sheet:...e. will have documentation by a licensed nurse daily until the wound is resolved."

3. Review of Patient 2's initial nursing assessment also indicated she had a peripherally inserted central catheter (PICC) in her upper right arm at the time of admission. Patient 2's initial nursing assessment also reflected a 1.5 centimeter slit or Stage II pressure ulcer over the coccyx (tailbone).

A discharge note on 7/3/17 at 3:36 p.m. indicated, "Patient discharged to home with all medications, left facility via gurney ambulance transport at [2:40 p.m.] Discharge paperwork sent with EMS (emergency medical service) transport. Home medication regime continued and medication reconciliation sent home to daughter. PICC line patent, flushes well, dressing dry and intact. [Foam] dressing dry and intact. Orders to follow up with [primary care provider]."

Review of the "Discharge Med Rec (medication reconciliation) Report" indicated it listed Patient 2's medications with dosages, frequency, when the last dose was given, and when to start taking at home. The space for "patient signature" indicated "unable to sign," beneath which two registered nurses signed. The areas of the form for comments and notes were both blank. There were no instructions for care of the PICC, the urinary catheter, or the wounds. The instruction to follow-up with her primary care provider in three days was not included on the discharge information.

During an interview with concurrent record review on 8/24/17 at 10:15 a.m., the Acting Chief Nursing Officer (ACNO) confirmed Patient 2's medical record contained no documentation of patient teaching prior to or at the time of discharge. ACNO stated the "Discharge Med Rec Report" was the documentation provided to each patient when they are discharged. ACNO stated Patient 2's family was not present at the time of discharge, and Patient 2 was sent home by ambulance.

During a subsequent interview on 8/25/17 at 11:40 a.m., ACNO confirmed Patient 2 was not referred to any outside nursing agency for care or teaching regarding her PICC, urinary catheter, and wounds after discharge. ACNO stated, "Yes, referral would have been appropriate."

Policies and procedures related to discharge planning, patient teaching, and discharge instructions were requested on 8/25/17 at 10:30 a.m. A policy and procedure titled ""Discharge Instructions," effective 2/28/17, was provided by ACNO at 11:40 a.m. ACNO stated it was the only policy related to discharge instructions she could locate, and it applied to the hospital even though it referenced discharge from the emergency room.

Review of facility policy and procedure revealed, "It is the policy of the [healthcare district] to give clear and appropriate Discharge Instructions from our Emergency Room."

Review of Patient 2's clinical record from the GACH revealed Patient 2 presented to the emergency department on 7/3/17 at 11:50 p.m., approximately nine hours after discharge from the CAH, with altered mental status and fever of 102.3 (normal 98.6). Patient 2 was readmitted to the GACH.

Review of the GACH physician's admission history and physical, dated 7/4/17 at 4:25 p.m., revealed admission diagnoses of altered mental status, urinary tract infection, and a wound over her sacrum or tailbone. The physician's assessment and plan, wherein each problem with corresponding plan was listed, included sepsis (infection in the blood) with a plan to rule out urine versus the sacral wound versus the PICC as the infection source

Review of a GACH document titled "Inpatient Wound Assessment and Recommendation, dated 7/4/17, revealed one pressure wound over the sacrum measuring 11 centimeters long, 9 centimeters wide, and 0.3 centimeters deep. The entire wound bed was nonviable (dead) tissue, with moderate drainage of fluid. The assessment indicated the wound was unstageable. According to the National Pressure Ulcer Advisory Panel, an unstageable pressure injury is "Full-thickness skin and tissue loss in which the extent of tissue damage within the ulcer cannot be confirmed because it is obscured by [dead tissue]. If [dead tissue] is removed, a Stage 3 or Stage 4 pressure injury will be revealed."

Review of the GACH Physician Discharge Summary, dated 7/6/17, revealed a discharge diagnoses of altered mental status and sacral wound.

Based on interview and record review, the Critical Access Hospital (CAH) failed to ensure the safe administration of ketamine as evidence by:

1. The CAH failed to ensure there was a physician order for the administration of ketamine (anesthetic, provides pain relief, sedation and memory loss). The CAH administered ketamine for a procedure in the emergency department. The medical record did not contain a physician order for the medication or a medication administration record that identified who administered the medication, the dose, the date and time and route of administration. This failure resulted in the potential for the patient to be exposed to a preventable medication error (preventable event that may cause or lead to inappropriate medication use or patient harm) and the potential the patient would be exposed to preventable adverse effects of ketamine (slow breathing.

2. The CAH failed to ensure a patient who received ketamine (anesthetic, provides pain relief, sedation and memory loss) for conscious sedation (pain blocked while awake) met all the required discharge criteria. The Conscious Sedation Flowsheet did not document all four discharge criteria were met before the patient was sent home. This failure resulted in the potential for a patient to be exposed to the preventable adverse effects of conscious sedation (slow breathing).


Findings:

1. During a concurrent interview and medical record review, on 8/22/17 at 3:05 p.m., Acting Chief Nursing Officer (ACNO) identified Patient 1's electronic (computer) medical record (EMR). Review of the EMR showed Patient 1 was admitted to the emergency room (ER) on 8/11/17. Further review showed an emergency department report, dated 8/12/17 at 6:10 p.m., authored by Physician L. Review of the report showed CAH Course: "...We attempted to start IVs (tube to administer medication directly into a vein) on the patient but we were unsuccessful. I then offered to give the patient ketamine. She opted to go with that. Accordingly, we gave her 250 mg (milligram) of ketamine IM (intramuscular, into a muscle). We got good results with that. She did have a significant tachycardia (fast heart rate) from the ketamine but her state of consciousness was depressed so that she was unable to feel the procedures..." ACNO reviewed the EMR and acknowledged the ER notes documented Patient 1 received a 250 mg dose of ketamine. The CAH was requested to show documentation of a physician's order for the ketamine or medication administration record (who, dose, date, time and route). The requested information was not provided before the end of the survey.

2. Further review of Patient 1's record and concurrent interview with ACNO on 8/22/17 at 3:05 p.m. showed a conscious sedation flowsheet (undated and untimed) that showed ketamine 250 mg IM administered as 12:22 a.m. Review of the flowsheet showed discharge criteria (all must be present before discharge). "Cardiovascular function within normal limits (vital signs stable, SaO2 (amount of oxygen in the blood) WNL (with normal limits)), Patient's protective reflexes (automatic processes to protect the body) are present and patient is alert and oriented x3 (person, place, date, and time), Patient can ambulate (walk) unaided without difficulty, Discharge & Conscious Sedation Instructions given and patient verbalized understanding of them." The check boxes next to each item were unmarked. None of the four boxes were checked as having been met. ACNO reviewed the flow sheet and acknowledged the discharge criteria were not documented as having been present before discharge.

Review of the CAH's policy and procedure for Procedural Sedation (Conscious Sedation) showed, Procedure:, After Treatment:, A. Continuous monitoring and vital signs every 30 minutes until patient meets discharge criteria as stated on Procedural Sedation Flow Sheet., Discharge Criteria (all must be present before discharge), "Cardiovascular function within normal limits (vital signs stable, SaO2 WNL), Patient's protective reflexes are present and patient is alert and oriented x3, Patient can ambulate unaided without difficulty, Discharge & Procedural Sedation Instructions given and patient verbalizes understanding of them."

Based on interview and record review, the facility failed to develop and keep current a care plan for one patient (Patient 2). This failure had the potential to prevent Patient 2 from achieving identified goals related to her hospital stay.

Findings:

Review of Patient 2's clinical record revealed she was admitted 6/20/17 to complete intravenous (administered into a vein) antibiotic therapy and was discharged to home on 7/3/17.

During interview and concurrent record review, on 8/22/17 at 3:30 p.m., the Acting Chief Nursing Officer (ACNO) stated the CAH used paper, not computerized, care plans for patients in swing beds. The paper care plans were then scanned and added to the electronic medical record after the patient was discharged from the CAH. ACNO was unable to locate any care plan in Patient 2's electronic medical record. ACNO stated the paper care plan might be in medical records awaiting scanning.

During an interview on 8/24/17 at 9:30 a.m., Health Information Management Staff O (HIM Staff O) stated she could not locate any paper medical records related to Patient 2's hospitalization. When asked who scanned documents into the electronic medical records, HMI Staff O stated "everybody scans." HMI Staff O stated nurses can scan documents into the records, and the medical records department will scan "whatever is left" after the patient is discharged.

During an interview on 8/24/17 at 9:40 a.m., ACNO confirmed no care plan, either paper or electronic, could be located for Patient 2. When asked if lack of a documented care plan prevented the facility from demonstrating it had implemented interventions to prevent worsening of Patient 2's pressure ulcer, ACNO stated, "Yes."

Based on interview and record review, the Critical Access Hospital (CAH) failed to maintain complete and accurate medical records as evidenced by:

1. One patient's electronic medical record (Patient 2) contained no documentation for 11 days of the status of a pressure ulcer present on admission (Refer to C-0302 #1);
2. One medication order for Patient 2 was transcribed incorrectly on admission, resulting in administration of medication inconsistent with physician orders (Refer to C-0302 #2);
3. The electronic medical record for Patient 2 contained no care plan for provision of care while a patient in a swing bed of the Critical Access Hospital (Refer to C-0302 #3);
4. Patient 2's electronic medical record lacked daily justification for continuing a central vascular access device (a potential source of infection or other complications), as specified in facility policy and procedure (Refer to C-0302 #4);
5. Physician Orders for Life Sustaining Treatment were incomplete for two of two patients (Patients 3 and 4) currently in swing beds of the Critical Access Hospital (Refer to C-0302 #5);

These systemic failures had the potential to result in care that was inappropriate for, or inconsistent with, the patients' current needs based on ongoing assessment or the patients' wishes. These failures also had the potential to negatively impact continuity of care when previous assessments or treatments were not documented.

Based on interview and record review, the facility failed to maintain complete and accurate medical records as evidenced by:

1. The electronic medical record for one patient (Patient 2) contained no documentation for 11 days of the status of a pressure ulcer present on admission;
2. One medication order for one patient (Patient 2) was transcribed incorrectly on admission, resulting in administration of medication inconsistent with physician orders;
3. The electronic medical record for one patient (Patient 2) contained no care plan for provision of care while a patient in a swing bed of the Critical Access Hospital;
4.The electronic medical record for one patient (Patient 2) lacked daily justification for continuing a central vascular access device (a potential source of infection or other complications), as specified in facility policy and procedure;
5. Physician Orders for Life Sustaining Treatment were incomplete for two of two patients (Patients 3 and 4) currently in swing beds of the Critical Access Hospital;

These failures to document thoroughly and accurately had the potential to result in care that was inappropriate for the patients' current needs based on ongoing assessment, or care that was inconsistent with patients' wishes. These failures also had the potential to negatively impact continuity of care when previous assessments or treatments were not documented.

Findings:

1. Review of Patient 2's electronic medical record revealed the patient was admitted to a swing bed of the Critical Access Hospital (CAH) on 6/20/17 from a general acute care hospital (GACH) for continued treatment of an infection with intravenous (into a vein) antibiotic therapy. Patient 2's initial nursing assessment reflected a 1.5 centimeter slit or Stage II pressure ulcer over the coccyx (tailbone). (A pressure ulcer is localized damage to the skin as a result of intense or prolonged pressure. Stage II pressure injury involves partial-thickness loss of skin, exposing the underlying tissue.)

A nurse's note, entered 6/22/17 at 5:17 p.m., indicated, "[Patient has Stage 2 wound coccyx area this AM. Wound measures [width 2.75 centimeters x height 1.75 centimeters x depth unable to determine]. Pt given shower with intention of dressing wound after shouer (sic). When pt returns to room, wound has greatly increased in size and skin is torn in two additional places. Wounds measured and order for wound care initiated."

Review of a wound assessment sheet, dated 6/22/17, reflected two wounds, numbered one and two. Wound #1 was documented as described above. Wound #2, also on the coccyx, measured [width 2.25 centimeters x height 1.2 centimeters x depth unable to determine].

A nurse's note entered 7/11/17 at 10:28 a.m. (seven days after Patient 2 was discharged from the CAH) indicated, "Late entry. As noted on 6/22/17. Pt returned from shower with skin open in 2 additional areas. Upon inspection, skin covering buttocks area appears to have consistency of a blister which has broken open while showering. Skin appears very fragile and thin, wounds measured as reflected in wound assessment and order for wound care initiated. Wound is covered with [a foam dressing] and transparent dressing. Pt consistently turned [every two hours] during shift. [Will continue to monitor.]"

A discharge nurse's note on 7/3/17 at 3:36 p.m. indicated, "[Foam] dressing dry and intact." No documentation of the number, size, or condition of Patient 2's wounds at time of discharge could be located in the medical record. The medical record contained no assessment of Patient 2's wounds between 6/22/17 and her discharge on 7/3/17, a period of 11 days.

Review of Patient 2's clinical record from the GACH revealed Patient 2 returned to the acute care hospital emergency department on 7/3/17 at 11:50 p.m., approximately nine hours after discharge from the CAH, with altered mental status and fever of 102.3 (normal 98.6). Patient 2 was readmitted to the GACH.

Review of the GACH physician's admission history and physical, dated 7/4/17 at 4:25 p.m., revealed admission diagnoses of altered mental status, urinary tract infection, and sacral wound. The physician's assessment and plan, wherein each problem with corresponding treatment plan was listed, included "sepsis [rule out] urine [versus tissue injury versus peripherally inserted central catheter] as source," and a severe sacral wound that was not present [prior to] transfer to [skilled nursing facility] per wound care. (The skilled nursing facility to which the physician referred was a swing bed in the Critical Access Hospital.)

Review of a GACH document titled "Inpatient Wound Assessment and Recommendation, dated 7/4/17, revealed one pressure wound over the sacrum measuring 11 centimeters long, 9 centimeters wide, and 0.3 centimeters deep. The entire wound bed was nonviable (dead) tissue, with moderate drainage of fluid. The assessment indicated the wound was unstageable. According to the National Pressure Ulcer Advisory Panel, an unstageable pressure injury is "Full-thickness skin and tissue loss in which the extent of tissue damage within the ulcer cannot be confirmed because it is obscured by [dead tissue]. If [dead tissue] is removed, a Stage 3 or Stage 4 pressure injury will be revealed."

During an interview with concurrent record review, on 8/22/17 at 3:30 p.m., the Acting Chief Nursing Officer (ACNO) was asked about her expectation for documentation of wound assessments. ACNO stated a wound assessment sheet, which includes measurements of all wounds, should be completed with each scheduled dressing change. ACNO confirmed the size and appearance of Patient 2's wounds should have been documented at least weekly, since the physician order included cleaning and covering the wounds weekly and as needed if the dressing was soiled.

Review of facility policy and procedure titled Pressure Ulcer Assessment, Prevention and Treatment, effective 10/28/04, indicated, "The Pressure Ulcer/Wound Care Report Sheet:...e. will have documentation by a licensed nurse daily until the wound is resolved."

2. Review of Patient 2's electronic medical record on 8/22/17 revealed the patient was admitted to a swing bed of the Critical Access Hospital on 6/20/17 from an acute care hospital for continued treatment of an infection with intravenous antibiotic therapy. Patient 2's physician orders at the time of admission included "haloperidol 2 [milligrams or mg.] (4 mg) [by mouth three times a day], indicating the medication came in a 2 mg. tablet/capsule and the patient should be given a dose of 4 mg. or two tablets/capsules. The order was signed as "noted," by Licensed Staff M on 6/20/17 at 9 p.m. On a separate document titled Physician Orders, Licensed Staff M documented, on 6/20/17 at 9:10 p.m., "All admission orders 24 [hour check]."

("Noting" an order indicates a licensed nurse has entered it into the appropriate locations in a patient's medical record and the order has been communicated to relevant departments. "Twenty-four hour chart checks" are commonly done daily as a double-check to ensure all physician orders issued during the previous 24 hours are transcribed accurately and completely.)

Review of Patient 2's Physician Orders in the electronic medical record revealed an order for "haloperidol tab [2 mg] (Haldol)" with a frequency of three times daily and a dosage of 2 milligrams, entered 6/20/17 at 3:46 p.m.

During an interview and concurrent record review, on 8/24/17 at 10:15 a.m., the Acting Chief Nursing Officer (ACNO) confirmed the electronic order did not match the original order. ACNO stated, "That's a transcription error." ACNO confirmed the 24 hour check was done by the same nurse who entered the original order, and the transcription error was not identified. ACNO stated, "I've told them not to do that because mistakes get missed when they check their own work."

3. Review of Patient 2's clinical record revealed she was admitted 6/20/17 to complete intravenous antibiotic therapy for an infection and was discharged to home on 7/3/17.

During interview and concurrent record review, on 8/22/17 at 3:30 p.m., the Acting Chief Nursing Officer (ACNO) stated the CAH used paper, not computerized, care plans for patients in swing beds. The paper care plans were then scanned and added to the electronic medical record after the patient was discharged from the CAH. ACNO was unable to locate any care plan in Patient 2's electronic medical record. ACNO stated the paper care plan might be in medical records awaiting scanning.

During an interview on 8/24/17 at 9:30 a.m., Health Information Management Staff O (HIM Staff O) stated she could not locate any paper records related to Patient 2's hospitalization. When asked who scanned documents into the electronic medical records, HMI Staff O stated "everybody scans." HMI Staff O stated nurses can scan documents into the records, and the medical records department will scan "whatever is left" after the patient is discharged.

During an interview on 8/24/17 at 9:40 a.m., ACNO confirmed no care plan, either paper or electronic, could be located for Patient 2. When asked if lack of a documented care plan prevented the facility from demonstrating it had implemented interventions to prevent worsening of Patient 2's pressure ulcer, ACNO stated, "Yes."

4. Review of Patient 2's clinical record revealed she was admitted 6/20/17 to complete intravenous antibiotic therapy for an infection and was discharged to home on 7/3/17. Patient 2's initial nursing assessment indicated she had a peripherally inserted central catheter (PICC - a long, thin tube that goes into your body through a vein in the upper arm and into a large vein near the heart) in her upper right arm at the time of admission. Patient 2's discharge nursing note indicated the PICC remained in place when she was discharged home.

Review of facility policy and procedure titled Central Venous Catheter Care, effective 3/6/14, section Preexisting CVC (Upon Admission), indicated "6. A Daily Necessity evaluation is to be performed and documented each day. Obtain a physician order to discontinue lines that are deemed no longer necessary at the earliest opportunity."

During an interview on 8/24/17, Acting Chief Nursing Officer (ACNO) was asked to demonstrate how daily necessity evaluation for the PICC was documented. ACNO demonstrated how the insertion site (location of the line entering the skin) was assessed for indications of infection every time medication was administered through it. ACNO stated the line was necessary because Patient 2 was receiving intravenous antibiotics. When asked about the PICC's continued necessity after Patient 2's antibiotic therapy was completed on 6/30/17 and why it was considered necessary to discharge the patient to home with the PICC in place, ACNO stated, "Dr. [staff physician] probably wouldn't discontinue it in case it was needed later. The patient was supposed to follow up with her doctor within three days." No "Daily Necessity evaluation," as specified in the facility policy and procedure, was located in Patient 2's medical record.

The Centers for Disease Control and Prevention (a federal agency charged with protecting and advancing the nation's health) "Guidelines for the Prevention of Intravascular Catheter-Related Infection (2011), Section 2.2 Central Venous Catheters," Recommendation 10 indicates, "Promptly remove any intravascular catheter that is no longer essential." The recommendation is classified as Category IA, indicating it is "strongly recommended for implementation and strongly supported by well-designed experimental, clinical, or epidemiologic studies."

5. Review of the clinical record for Patient 3 indicated Physician Orders for Life-Sustaining Treatment (POLST) was signed by Patient 3 on 3/30/17. The form was not signed by a physician.

Directions for Health Care Provider on the back of the POLST form indicated, "To be valid a POLST form must be signed by (1) a physician, or by a nurse practitioner or a physician assistant acting under the supervision of a physician and within the scope of practice authorized by law and (2) the patient or decisionmaker..."

Review of the clinical record for Patient 4 indicated a Physician Orders for Life-Sustaining Treatment (POLST) was signed by the patient and by a physician on 5/17/17. Section A of the POLST indicated Patient 4 selected "Do Not Attempt Resuscitation/DNR (Allow Natural Death)." The directions for Section A indicated it applies if the patient has no pulse and is not breathing, and "If patient is NOT [emphasis in original] in cardiopulmonary arrest, follow orders in Sections B and C." Section B Medical Interventions, whereby a patient may choose full treatment, selective treatment, or comfort-focused treatment, contained no marks in any of the selection boxes. Section C Artificially Administered Nutrition, whereby a patient may choose long-term, trial period, or no artificial means of nutrition, including feeding tubes, also contained no marks in any of the selection boxes. Directions for Health Care Provider, on the back of the POLST form, indicated "Any incomplete section of POLST implies full treatment for that section."

Section D, in which the physician documents with whom the patient's preferences were discussed, did not reflect the physician spoke with either Patient 4 or with a legally recognized decisionmaker. The Directions for Health Care Provider indicate "POLST must be completed by a health care provider based on patient preferences and medical indications.

Review of facility policy and procedure titled "Physician Orders for Life-Sustaining Treatment," effective 3/26/15, indicated "It is the policy of the [CAH] to have the admitting physician fill out a Physician Orders for Life-Sustaining Treatment (POLST) form for all patients on observation and all patients admitted to an acute, swing or skilled nursing (SNF) bed....At the time that it is decided that a patient will be admitted to the hospital for observation, acute stay, swing bed or skilled nursing bed the admitting physician will meet with the patient and fill out the POLST form per the patient's wishes...."

7. Not having the collection and analysis of quality assurance (maintenance of quality) indicators (data) for pharmaceutical (pharmacy) services. (Refer to C-0336)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the periodic evaluation and quality assurance review was in compliance with the statutorily mandated Condition of Periodic Evaluation and Quality Assurance Review.



28521

Based on observation, interview and record review, the Critical Access Hospital (CAH) failed to ensure the Periodic Program Evaluation (Annual Program Review/Annual Hospital Evaluation Report) contained all the required elements as evidenced by-

1. Not having an annual evaluation of the CAH's total program. (Refer to C-0331)
2. Not describing the utilization of the CAH's services (number of acute, swing bed, and outpatients served for each department) and the volume of each service that includes all departments. (Refer to C-0332)
3. Not having an Annual Hospital Evaluation with policies review. (Refer to C-0272, C-0334)
4. Not demonstrating the health care (ALL) policies of the CAH were being implemented, evaluated and/or revised, dated, and signed by the designated Managers, Administrative and Medical Staff and the Governing Body. (Refer to C-0334)
5. Not providing the most recent Annual Hospital Evaluation (Refer to C-0335)
6. Not demonstrating the health care (ALL) policies of the CAH were being implemented, evaluated and/or revised, dated, and signed by the designated Managers, Administrative and Medical Staff and the Governing Body. (Refer to C-0335)

Based on interview and record review the Hospital failed to have an "Annual Hospital Evaluation Report". This failure had the potential for the Critical Access Hospital (CAH/Hospital) to not meet the care, health and safety needs of patients and the community.

Findings:

During an interview on 8/25/17 at 12:30 p.m., Administrative Staff F stated an Annual Evaluation of the hospital's performance was not done last year. Administrative Staff F was asked to submit the last Annual Hospital Evaluation submitted to the Governing Board. Administrative Staff F submitted a document titled, "Annual Hospital Evaluation July 2007 - June 2008".

Review on 8/25/17 of the Governing Boards' Minutes did not conclusively indicate an "Annual Hospital Evaluation Report" was presented to the Governing Board. The Governing Board Meeting Minutes included the following information:

6/30/16 and 7/28/16:
Annual Hospital Evaluation Report - Administrative Staff N - (Presented Aug 27, 2015) - Next report due August 2016.

8/25/16:
Annual Hospital Evaluation Report - Administrative Staff N - (August 2017) - Presented after Board Development due to Administrative Staff N not being in attendance at the beginning of the meeting. [There was no indication in reading the minutes that the report was discussed.]

9/27/16, 10/27/16 1/26/17, 2/28/17, 3/30/17, 4/27/17 and 5/25/17:
"Annual Hospital (Evaluation) Report- Administrative Staff N - (Aug 2017) - no report."

10/5/16, 12/27/16, 1/16/17, 6/13/17, 7/17/17, 8/11/17:
The Special Governing Board Meeting or Special Organizational Meeting Minutes did not mention the Annual Hospital Evaluation Report.

6/22/17, 7/27/17:
The minutes did not mention the Annual Hospital Report.

Review of the hospital's policy titled, "Performance Improvement Program Annual Evaluation" indicated, "The program is evaluated annually in the month of July and reported to the Medical Staff and Governing Board in August. Data is from the previous fiscal year of July 1 through June 30."

Review of the CAH's policy, "District Plan for Provision of Patient Care" with an "Effective Date" of 2/28/17 indicated "The Governing Board is responsible for assuring that an annual evaluation of the District's total program is performed ..."

Based on interview and document review the Critical Access Hospital (CAH) did not provide for the most recent Annual Hospital Evaluation describing the utilization of the CAH's services (number of acute, swing bed, and outpatients served for each department) and the volume of each service that includes all departments. This failure had the potential for the CAH not to be able to show trends, justification to build services, and the foresight for a community-wide knowledge base.

Findings:

During an interview on 8/25/17 at 12:30 p.m., Administrative Staff F stated an Annual Evaluation of the hospital's performance was not done last year. Administrative Staff F was asked to submit the last Annual Hospital Evaluation submitted to the Governing Board. Administrative Staff F submitted a document titled, "Annual Hospital Evaluation July 2007 - June 2008".

Review of the hospital's policy titled, "Performance Improvement Program Annual Evaluation" indicated, "The program is evaluated annually in the month of July and reported to the Medical Staff and Governing Board in August. Data is from the previous fiscal year of July 1 through June 30."

Review of the CAH's policy, "District Plan for Provision of Patient Care" with an "Effective Date" of 2/28/17 indicated "The Governing Board is responsible for assuring that an annual evaluation of the District's total program is performed ..."

Based on interview and document review the Critical Access Hospital (CAH/Hospital) failed to-
1. Have the most recent Annual Hospital Evaluation, and
2. Demonstrate that the health care and in fact, all policies of the CAH were being implemented, evaluated, reviewed and/or revised and stored as evidenced by the CAH's policies for 10 of 10 Department Manuals reviewed were not dated, signed by the designated Managers, Administrative and Medical Staff and approved by the Governing Body.

These failures had the potential to result in the delivery of unsafe patient care due to a high degree of understanding, cooperation, efficiency, and unity among hospital employees not being established and sustained over time. (Cross Reference C-0272, C-0331)

Based on interview and document review the Critical Access Hospital (CAH/Hospital) failed to have the most recent Annual Hospital Evaluation which included-
1. An evaluation of the hospital services offered to patients and whether those services fulfilled patient/resident health care needs;
2. Demonstrate that the health care and in fact, all policies of the CAH were being followed, evaluated, reviewed and/or revised as evidenced by the CAH's policies for 10 of 10 Department Manuals reviewed were not dated/outdated, signed by the designated Managers, Administrative and Medical Staff and approved by the Governing Body.

These failures had the potential to result in the delivery of unsafe patient care due to a high degree of understanding, cooperation, efficiency, and unity among hospital employees not being established and sustained over time. (Cross Reference C-0272, C-0331)

Based on observation, interview, and record review, the hospital failed to ensure the collection and analysis of quality assurance (maintenance of quality) indicators (data) for pharmaceutical (pharmacy) services. The hospital's policy and procedures required a staff pharmacist to perform required duties. The organization did not collect data for the analysis of pharmacy services to determine a pharmacist did not perform the required duties. The hospital did not staff a pharmacist to perform the required duties. These failures resulted in the potential for patients to be exposed to preventable medication errors (preventable event that may cause or lead to inappropriate medication use or patient harm).

Findings:

During observations, on 8/21/17 from 1:30-4 p.m., and 8/22/17 from 7:45 am-12:50 p.m., in the hospital, a pharmacist was not seen on duty.

During a concurrent group interview and record review, on 8/22/17 at 1 p.m., Manager C identified the following hospital policies and procedures: Filling Medication Orders, Controlled Substances (scheduled medications, narcotics) Security, General Pharmacy Operations, and Emergency Medication Supply (Crash Carts) (medications required in an emergency). Filling Medication Orders required a pharmacist to review physician orders for medications before they were administered. Controlled Substances Security required that access to scheduled medications in the pharmacy to have been limited to a pharmacist. General Pharmacy Operations required a pharmacist to be scheduled to work in the hospital 8-9:30 am, Monday through Friday. Emergency Medication Supply (Crash Carts) required a pharmacist to seal the emergency drug supply in the cart. Pharm 1 acknowledged a pharmacist was not scheduled as required by policy and procedure. Pharmacist Consultant acknowledged a pharmacist did not perform the duties required by policy and procedures.

During an interview, on 8/22/17 at 1:50 p.m., Administrative Staff G was requested to describe the hospital's quality assurance process improvement program (data used to measure and improve a process). Administrative Staff G's description did not include, for the past year, that pharmacy reported quality assurance data for the analysis of the safe and effective use of medications.

Based on interview and record review, the facility failed to ensure safe discharge of one patient (Patient 2) when the patient was discharged to home without evidence of teaching related to care of a peripherally inserted central catheter (PICC - a long, thin tube that goes into your body through a vein in the upper arm and into a large vein near the heart), a urinary catheter (a tube inserted into the bladder for the drainage of urine), or pressure ulcers. This failure had the potential to result in localized or widespread infection which could lead to death.

Findings:

Review of Patient 2's electronic medical record on 8/22/17 revealed the patient was admitted to a swing bed of the Critical Access Hospital on 6/20/17 from an acute care hospital for continued treatment of an infection with intravenous (into a vein) antibiotic therapy. Patient 2's initial nursing assessment indicated she had a peripherally inserted central catheter in her upper right arm at the time of admission, and a urinary catheter to drain her bladder. Patient 2's initial nursing assessment also reflected a 1.5 centimeter slit or Stage II pressure ulcer over the coccyx (tailbone). (A pressure ulcer is localized damage to the skin as a result of intense or prolonged pressure. Stage II pressure injury involves partial-thickness loss of skin, exposing the underlying tissue.)

A nurse's note, entered 6/22/17 at 5:17 p.m., indicated, "[Patient has Stage 2 wound coccyx area this AM. Wound measures [width 2.75 centimeters x height 1.75 centimeters x depth unable to determine]. Pt given shower with intention of dressing wound after shouer (sic). When pt returns to room, wound has greatly increased in size and skin is torn in two additional places. Wounds measured and order for wound care initiated."

Review of a wound assessment sheet, dated 6/22/17, reflected two wounds, numbered one and two. Wound #1 was documented as described above. Wound #2, also on the coccyx, measured [width 2.25 centimeters x height 1.2 centimeters x depth unable to determine].

A nurse's note entered 7/11/17 at 10:28 a.m. (seven days after Patient 2 was discharged from the CAH) indicated, "Late entry. As noted on 6/22/17. Pt returned from shower with skin open in 2 additional areas. Upon inspection, skin covering buttocks area appears to have consistency of a blister which has broken open while showering. Skin appears very fragile and thin, wounds measured as reflected in wound assessment and order for wound care initiated. Wound is covered with [a foam dressing] and transparent dressing. Pt consistently turned [every two hours] during shift. [Will continue to monitor.]"

A discharge note on 7/3/17 at 3:36 p.m. indicated, "Patient discharged to home with all medications, left facility via gurney ambulance transport at [2:40 p.m.] Discharge paperwork sent with EMS (emergency medical service) transport. Home medication regime continued and medication reconciliation sent home to daughter. PICC line patent, flushes well, dressing dry and intact. [Foam] dressing dry and intact. Orders to follow up with [primary care provider]."

Review of the "Discharge Med Rec (medication reconciliation) Report" indicated it listed Patient 2's medications with dosages, frequency, when the last dose was given, and when to start taking at home. The space for "patient signature" indicated "unable to sign," beneath which two registered nurses signed. The areas of the form for comments and notes were both blank. There were no instructions for care of the PICC, the urinary catheter, or the wounds. The instruction to follow-up with her primary care provider in three days was not included on the discharge information.

During an interview with concurrent record review on 8/24/17 at 10:15 a.m., the Acting Chief Nursing Officer (ACNO) confirmed Patient 2's medical record contained no documentation of patient teaching prior to or at the time of discharge. ACNO stated the "Discharge Med Rec Report" was the documentation provided to each patient when they are discharged. ACNO stated Patient 2's family was not present at the time of discharge, and Patient 2 was sent home by ambulance.

During a subsequent interview on 8/25/17 at 11:40 a.m., ACNO confirmed Patient 2 was not referred to any outside nursing agency for care or teaching regarding her PICC, urinary catheter, and wounds after discharge. ACNO stated, "Yes, referral would have been appropriate."

Review of Patient 2's clinical record from an acute care hospital revealed Patient 2 presented to the emergency department on 7/3/17 at 11:50 p.m., approximately nine hours after discharge from the CAH, with altered mental status and fever of 102.3 (normal 98.6).

Policies and procedures related to discharge planning, patient teaching, and discharge instructions were requested on 8/25/17 at 10:30 a.m. A policy and procedure titled ""Discharge Instructions," effective 2/28/17, was provided by ACNO at 11:40 a.m. ACNO stated it was the only policy related to discharge instructions she could locate, and it applied to the hospital even though it referenced discharge from the emergency room.

Review of facility policy and procedure revealed, "It is the policy of the [healthcare district] to give clear and appropriate Discharge Instructions from our Emergency Room."

Based on interview and record review, the Critical Access Hospital (CAH) failed to develop a comprehensive care plan for one patient in a swing bed (Patient 2). This failure had the potential to result in care that was inadequate or inappropriate to help Patient 2 reach the goals of care during hospitalization.

Findings:

Review of Patient 2's clinical record revealed she was admitted 6/20/17 to complete intravenous antibiotic therapy for an infection, and was discharged to home on 7/3/17.

During interview and concurrent record review, on 8/22/17 at 3:30 p.m., the Acting Chief Nursing Officer (ACNO) stated the CAH used paper, not computerized, care plans for patients in swing beds. The paper care plans were then scanned and added to the electronic medical record after the patient was discharged from the CAH. ACNO was unable to locate any care plan in Patient 2's electronic medical record. ACNO stated the paper care plan might be in medical records awaiting scanning.

During an interview on 8/24/17 at 9:30 a.m., Health Information Management Staff O (HIM Staff O) stated she could not locate any paper records related to Patient 2's hospitalization. When asked who scanned documents into the electronic medical records, HMI Staff O stated "everybody scans." HMI Staff O stated nurses can scan documents into the records, and the medical records department will scan "whatever is left" after the patient is discharged.

During an interview on 8/24/17 at 9:40 a.m., ACNO confirmed no care plan, either paper or electronic, could be located for Patient 2. When asked if lack of a documented care plan prevented the facility from demonstrating it had implemented interventions to prevent worsening of Patient 2's pressure ulcer, ACNO stated, "Yes."