The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

SITKA COMMUNITY HOSPITAL 209 MOLLER DRIVE SITKA, AK 99835 July 14, 2017
VIOLATION: QA - QUALITY OF PATIENT CARE Tag No: C0336
.
Based on record review and interview the facility failed to ensure the Quality Assurance Committee evaluated all services at the CAH that would directly affect patient health and safety. Findings:

Record review on 7/11/17 at 3:15 pm of the Quality Improvement dashboard and meeting minutes revealed no quality performance initiatives were listed for essential facility services; pharmacy self-assessment report on compounding or annual review of services.



During an interview on 7/11/17 at 3:15 pm the Quality Improvement Manager confirmed the findings that essential services had no performance initiatives and there had been no annual review of services.




.
VIOLATION: QUALITY ASSURANCE Tag No: C0337
.
Based on record review the facility failed to ensure the Quality Assurance Committee provided an annual review of CAH services to the governing body. Findings:

Record review on 7/13/17 of the governing body meeting minutes from 1/2015 - 7/2017 revealed no agenda or minutes to reflect a review the CAH services, specifically an annual review of services.



.
VIOLATION: COMPLIANCE FED, ST, AND LOCAL LAWS AND REGS Tag No: C0812
.

Based on record review and interview the facility failed to ensure notice of advanced directives had been documented in the medical record. Findings:

Record review of the admission Nursing Assessments for MR #'s 1-12 revealed no documentation of advanced directives had been reviewed, offered, or declined.

During an interview on 7/14/17 at 10:30 am the HIM Manager and this Surveyor reviewed the 12 MR records for advanced directive documentation and it was not found.

During an interview on 7/10/17 at 12:00 pm, the facility was asked to provide the admission packet provided to patients at the time of admission. The Administrative Assistant stated they did not have one.

Review on 7/14/17 of the "Admission of a Patient Policy" last review 12/2015, revealed "The admitting Nurse will: ... G. ...Advanced Directive information packet and guidelines will be reviewed. It will be documented that the packet was given or declined on the Nurse Admission Assessment.


.
VIOLATION: AGREEMENT WITH NETWORK HOSPITAL Tag No: C0862
Based on interview the facility failed to ensure a transfer agreement with an acute care hospital was in place. Findings:

During an interview on 7/10/17 at 12:00 pm the facility was provided a written request for a copy of a transfer agreement with an acute care hospital.

During a second interview on 7/14/14 at 9:30 am the Administrative Assistant was asked again for a copy of the transfer agreement. No transfer agreement was provided at the time of exit.


.
VIOLATION: PHYSICAL PLANT AND ENVIRONMENT Tag No: C0910
.


Based on record review and interview the facility failed to ensure the facility department reported any quality measures or critical Life Safety Code inspections to the quality committee. Findings:

Refer to LSC citations K353; K908; K918 and Health citations C-0222 and C-0330.



.
VIOLATION: MAINTENANCE Tag No: C0914
.

Based on record review and interview the facility failed to ensure: 1) fire dampers; 2) medical gas; and 3) sprinkler inspections had occurred as required by NFPA Standards; 4) identify the name of equipment on the facility maintenance list; 5) provide documentation of completion and or due dates of all items on facility equipment list; and 6) provide documentation the staff performing quarterly sprinkler inspections, medical gas and generator maintenance were competent to do so. Findings:

Fire Dampers

Record review on 7/13/17 of the Life Safety Services, fire damper inspection dated 2/16-19/2016 revealed 30 fire, smoke, or fire/smoke combination dampers to be inoperable and an additional 21 fire dampers were identified as inaccessible.

During an interview on 7/13/17 the Facility manager stated no date had been determined for the repair of the damper. An Immediate Jeopardy citation was issued on 7/14/17 based on these findings.
Definition: Fire damper-used in ventilation duct to prevent the spread of smoke and or fire.

Medical Gas

Record review on 7/13/17 of the Medical Gas Systems inspection report, dated 1/26/16, revealed "P-1 [violation] must be corrected immediately - patient safety risk" and a "P-3 [violation] shall be corrected at time of remodeling."

Further review of the inspection report revealed 7 "P-1 must be corrected immediately violations."

During an interview on 7/13/17 at 1:00 pm the Facility Manager confirmed the 7 high priority 1 violations had not been corrected.

Sprinklers

Record review on 7/13/17 revealed the quarterly sprinkler inspections that had been completed in the last 12 months had not been completed by a qualified person.

During an interview on 7/13/17 the Facilities Manager confirmed quarterly sprinkler inspections had not been completed by a certified or other qualified person.

Record review of the preventative maintenance list for facility equipment revealed the list did not identify the equipment other than numbers for most of the content. In addition, the list had a date due of 1/1/2017.

Record review of the preventative maintenance list for the facility equipment revealed an issue date of 1/1/2017.

During an interview on 7/13/17 at 1:45 pm the Facility Manager stated no facility staff had documentation of training to inspect the sprinklers, generator, or medical gas.


.
VIOLATION: EMERGENCY FUEL & WATER Tag No: C0229
Based on interview the facility failed to ensure the provision of emergency fuel and water in the event of a disaster. Additionally, the facility risk assessment did not identify this as a priority. Findings:

During an interview on 7/13/17 the Facility Manager stated the facility did not have a risk assessment or plan for emergency water or fuel to sustain care and services in the event of a disaster.


.
VIOLATION: PATIENT CARE POLICIES Tag No: C1016
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


.

Based on observation, interview and record review the facility failed to ensure safe storage of medication and supplies and safe medication compounding policies and practice. These failed practices placed all patients at risk for infection transmission and inappropriate access of drugs and biologicals. Findings:

Unsecured biologicals and supplies/Emergency Department

Observations on 7/10-14/17 revealed both doors to the emergency department to be unlocked.

Random observations on 7/10-7/14/17 between 6:00 am and 7:30 pm revealed the emergency room had no staff or patients present.

Observations on 7/10/17 at 3:00 pm revealed the emergency code cart, containing emergency medications, had a ziptie-like lock in place. The loop of the lock was too large and the cart was easily opened with access to the medications.

During an interview on 7/10/17 the ED Charge Nurse confirmed the 2 doors leading into the emergency room were never locked.

During an interview on 7/14/17 the ED Charge Nurse confirmed the facility never locked the entrance/exit door to the facility identified as the emergency room Entrance.

Unsecured biologicals and supplies/Acute care

Observations on 7/10/17 between 12:00 - 1:30 pm of the 4 acute care rooms, #123; 125; 127 and 129, revealed a cabinet mounted on the wall in each room. The cabinets had been stocked with multiple 10 cc prefilled normal saline syringes; razors and sterile syringes. In addition, 2 of the cabinets had sterile syringe packages with the hypodermic needle.

Compounding

Record review on 7/13/17 of the Pharmacist self-assessment USP 797 checklist, completed by the Pharmacist in March of 2017, revealed the facility was non-compliant with multiple USP 797 compounding practices. In summary of the 18 page check list, the facility failed to develop and implement:

-Standard operating policy and procedures for compounding;

-document education, training and competency of staff performing compounding;

-design and or implement environmental and engineering controls;

-provide the Quality Assurance Committee with the oversite of the USP 797 self-assessment.

Record review on 7/13/17 of the "Patients Receiving Chemo-Therapy" list, dated from 2015-2017 revealed 28 patients had received one or more doses of IV chemo therapy.

Record review on 7/13/17 of MR #2 admitted on [DATE], revealed on the Physician orders and medication administration record, 4 medications (thiamine, folic acid, multivitamins, and magnesium) had been added to a 1000 cc bag of normal saline and infused.

Review of the Quality Assurance and Governing Body meeting minutes from 2016 -2017 revealed no documentation of the USP 797 assessment findings completed by the Pharmacist in March of 2017.

During an interview on 7/14/17 at 9:30 am the Pharmacist confirmed compounding of 4 medications into a single bag of IV fluids should not be done outside of an ISO 5 environment; the facility had no policy on the number of medications to be compounded into one bag of IV fluids; and no nursing staff education, training or competency had been implemented on compounding.

Review of the Federal Drug Administration "Compounding Progress Report" dated 2/2017, revealed "Compounded drugs can serve an important medical need for patients. However, if a compounded drug does not meet appropriate quality standards (e.g., if an injectable drug is contaminated, or if a tablet contains too much active ingredient), it could cause serious injury or death. Therefore, in implementing and enforcing the compounding related provisions of the FD&C Act, FDA seeks to strike a balance between preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them while protecting patients from the risks associated with compounded drugs that are not produced in accordance with the applicable requirements of federal law."

Review of the U.S Pharmacopeia (USP), the definition of compounding is "The preparation, mixing, assembling, altering, packaging, and labeling of a drug, drug-delivery device, or device in accordance with a licensed practitioner's prescription, medication order, or initiative based on the practitioner/patient/pharmacist/compounder relationship in the course of professional practice."


.
VIOLATION: PERIODIC EVALUATION & QA REVIEW Tag No: C0330
Based on the LSC survey findings the Quality Assurance Committee failed to:1) identify and ensure all service lines reported quality measures to the committee so actions could be taken on critical health and life safety concerns identified during this survey. Findings:


Reference LSC citation K353:

Record review on 7/13/17 revealed no quarterly sprinkler inspections had been completed in the last 12 months.

During an interview on 7/13/17 the Facilities Manager confirmed quarterly sprinkler inspections had not been completed by a certified and or other qualified person.

Reference LSC citation K908:

Record review on 7/13/17 of the Medical Gas Systems inspection report, dated 1/26/16, revealed under definitions of violation ratings: "P-1 [violation] must be corrected immediately - patient safety risk" and a "P-3 [violation] shall be corrected at time of remodeling."

Further review of the inspection report revealed 7 "P-1 must be corrected immediately violations."

During an interview on 7/13/17 at 1:00 pm the Facility Manager confirmed the 7 high priority 1 (P-1) violations had not been corrected and had no documentation of correction for the addition citations on the inspection report dated 1/26/16.

Reference LSC citation K908:


Observation, during the LSC tour, on 7/13/17 with the Facility Manager revealed no remote stop located outside of the generator room.

During an interview on 7/13/17 at 11:45 am the Facility Manager stated no annual maintenance had been done on the generator, the generator had not had a certified mechanic inspection, and he had no certification for the maintenance of the generator.


Reference Health Citation C-0220 and C-0222


.
VIOLATION: ANNUAL PROGRAM EVALUATION Tag No: C0331
Based on interview the facility failed to provide an annual review of CAH services. Findings:

During an interview on 7/10/17 at 12:00 pm the facility was provided a written request for a copy of the CAH annual review of services.

During a second interview on 7/14/14 at 9:30 am the Administrative Assistant was asked again for a copy of the annual review of services and stated the facility did not have one.



.
VIOLATION: PERIODIC EVALUATION OF SERVICES Tag No: C0332
Based on interview the facility failed to provide an annual review of CAH services to include the volume of services and number of patients served for each service. Findings:

During an interview on 7/10/17 at 12:00 pm the facility was provided a written request for a copy of the CAH annual review of services.

During a second interview on 7/14/14 at 9:30 am the Administrative Assistant was asked again for a copy of the annual review of services and stated the facility did not have one.



.