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.

ANOKA-METRO REG TREATMENT CTR 3301 SEVENTH AVE NORTH ANOKA, MN 55303 Feb. 8, 2018
VIOLATION: PATIENT RIGHTS: NOTICE OF RIGHTS Tag No: A0117
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on interview and document review, the hospital failed to provide the Important Message (IM) from Medicare in a timely manner to 3 of 6 patients (P1, P2, P34) reviewed who had Medicare coverage while at the hospital.

Findings include:

P1's Face Sheet printed 1/25/18, identified P1 admitted on [DATE]. A Medicare insurance number was listed on the form. P1's initial Medicare Certification record dated 1/13/18, was signed by P1's physician who certified P1's admission was necessary for treatment and diagnostic purposes.

P1's CMS-R-193 (An Important Message From Medicare About Your Rights) notice identified several rights P1 had while admitted to the hospital including to receive Medicare covered services, be involved in decisions about their stay, and report concerns to the Quality Improvement Organization (QIO). The form was signed as received on 1/22/18 (10 days after admission to the hospital).

P1's medical record lacked any evidence P1 had been offered or declined the notice prior to signing it 10 days after admission.

P2's Face Sheet printed 11/28/17, identified P2 admitted on [DATE]. A Medicare insurance number was listed on the form. P2's initial Medicare Certification record dated 10/11/17, was signed by P2's provider who certified P2's admission was necessary for treatment.

P2's CMS-R-193 identified several rights P2 had while admitted to the hospital including to receive Medicare covered services, be involved in decisions about their stay, and report concerns to the Quality Improvement Organization (QIO). The form was signed as received on 10/25/17 (19 days after admission to the hospital).

P2's medical record lacked any evidence P2 had been offered or declined the notice prior to signing it 19 days after admission.

P34's medical record indicated an admission date of [DATE], at 3:21 p.m. and the important Message from Medicare was signed and dated as being received on 5/22/17. Three days following admission, rather than the required two days.

When interviewed on 2/7/18, at 9:25 a.m. the hospital financial counselor (FC)-A stated she was responsible to provide the CMS-R-193 notice(s) to patients when they admit to the hospital. P1 was covered under "straight Medicare" and P2's primary source of payment was Medicare. FC-A explained P1 and P2 had been presented the notice(s) prior to them being signed, however, they both refused. FC-A did not document these attempts or refusals in their respective records. FC-A added she "always kinda wondered," if she should be documenting these refusals in the record(s), however, never consulted with supervisors or anyone else to determine the process. Further, FC-A stated the hospital has between 100 to 200 patients a year with Medicare coverage, and the notice(s) should be given "within the first 48 hours" after admission.

A hospital policy on IM notification was not provided.
VIOLATION: PHARMACIST SUPERVISION OF SERVICES Tag No: A0501
Based on observation, interview and document review, the hospital failed to ensure nursing staff were trained and competent on low-level, sterile medication compounding. This had potential to affect any of the 91 in-house patients who could have required the medication on an as-needed (PRN) basis.

Findings include:

An United States Pharmacopeia (USP) 797 Table of Risk Level Characteristics dated 2009, identified three categories of risk level associated with compounding sterile medication(s). A "Low-Risk Level" was identified with the following characteristics:

- Mode with no more than three sterile ingredients,
- No more than two entries into any one sterile container or sterile administration device,
- Compounded using closed or sealed systems and,
- Compounded using only simple manipulations.

On 2/6/18, at 9:01 a.m. a tour of the "Unit E" medication room was completed with the director of pharmacy services (DP). DP stated each nursing unit (a total of six) used an Omnicell machine (unit dose dispensing system) to dispense medications to the nurses for administration. The Omnicell was opened and inspected. In this review, six clear plastic bags were inside and each contained a sealed box of Zyprexa 10mg/vial (an antipsychotic medication) along with a sealed vial of sterile water. DP stated these needed to be reconstituted (restored or mixed) for intramuscular (IM) administration, and nursing staff was responsible to do so when they needed to use it which "varies" in frequency "anywhere from once a day to once a week." DP added, two nurses were required to check the dosing to ensure accuracy before the medication was administered.

On 2/6/18, at 9:18 a.m. a tour of the "Unit G" medication room was completed with DP. A single Omnicell machine was inside the room which contained seven clear plastic bags with each having a sealed box of Zyprexa 10mg/vial (an antipsychotic medication) along with a sealed vial of sterile water. DP stated each of the six unit(s) has this medication stocked in the same form inside their respective Omnicell, however, the quantity would vary as some units may have more aggressive patients and need more in stock. Further, DP stated he did not consider reconstituting the medication to be the same as compounding medications.

When interviewed on 2/6/18, at 10:39 a.m. registered nurse (RN)-A stated she had worked at the hospital for nearly four years and was responsible to pass medications. RN-A explained she administered the IM Zyprexa "probably average twice a month." The medication was supplied in a powder form which staff mixed with a liquid saline by following the directions on the back of the medication box. RN-A stated she had received orientation on IM medication administration when she was hired, however, no specific teaching on medication compounding or reconstitution adding she was able to "get help" if she needed it.

On 2/6/18, at 1:30 p.m. an interview was held with DP, the executive director of ECT pharmacy service (EDP) and a staff pharmacist (PH)-A. DP stated compounding medications was the "extemporaneous mixing of existing products," and the nursing staff had never had any formal training or competencies completed with medication reconstitution as it would be the nursing supervisors' responsibility to do. DP had never completed any audits of the nursing staff doing medication reconstitution.

On 2/6/18, at 2:17 p.m. the chief nursing officer (CNO) and registered nurse supervisor (RN)-B were interviewed. It was stressed the nursing staff were only taking "one ingredient" and mixing it with sterile water, not multiple medications which would be considered more ''compounding' then. RN-B stated there were no formal competencies completed with nursing staff on reconstitution of medications as they come from nursing school with the knowledge to administer an IM medication.

A hospital Medication Administration policy dated 9/5/17, identified a purpose to ensure "...staff are administering medication in an appropriate, safe and consistent manner." A series of "Procedures" were listed which included, "Nurses and trained medication administrators will be knowledgeable regarding the use, side effects, special warnings, or specific directions particular to that medication ...," and, "All injectable medications will be readied for administration and double checked by licensed nursing staff prior to administration." The policy lacked any information on compounding medications or the process to ensure this was completed accurately or safely.

A hospital policy on compounding medication(s) was requested, however, none was provided.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observation, interview and document review, the facility failed to ensure adequate contact time for disinfection of the common use glucometer (used to check blood sugar readings) for 2 of 2 observations (P6) of the blood glucose (BS) testing procedure.

Findings include:

P6 was admitted with a diagnosis list which included diabetes type II and with orders to check his BS four times daily (QID) with resulting administration of insulin according to a sliding scale. Neither the electronic nor paper record contained a diagnosis of a communicable disease.

During observation on 2/6/18, at 11:30 a.m. registered nurse (RN)-D accompanied P6 to the treatment room where she performed hand hygiene and applied gloves, obtained the common use glucometer (Accu-Check Inform II meter) from the docking station. She proceeded to obtain a blood sample from P6's finger and placed the drop of blood onto the glucometer strip and inserted the strip into the glucometer machine. Following completion of the blood glucose test, RN-D changed her gloves, obtained a single wipe from the CaviWipe's 1 container, wiped over the entire surface of the meter and placed the meter on a dry paper towel located on the treatment room counter. She stated she had to allow the glucometer to air dry before returning it to the docking station. The surface of the glucometer was observed to be totally evaporated and dry in less than 30 seconds. At that time, RN-D indicated the glucometer machine was disinfected and ready for use. The manufacturer's recommended "contact/wet time" as noted on the container listed: "For use as a disinfectant: use a towelette to thoroughly wet the surface. Repeated use of the product may be required to ensure that the surface remains visibly wet for 1 minute at room temperature." RN-D stated she was not aware of the need to ensure the surface remained wet for one minute before allowing the surface to air dry and confirmed the glucometer had not remained visibly wet as per the manufacturer's recommendation for proper disinfection.

On 2/6/18, at 11:40 a.m. RN-J who was identified as the facility's principal nursing educator, was also present and observed the procedure. She indicated she had previously timed the dry time for a CaviWipe 1, and found if the surface was allowed to air dry after wiping it took less than 22 seconds. The rational for performing this procedure was to demonstrate the need to continuously wipe the glucometer for 1 minute to ensure the surface remained wet for the required one minute as indicated on the manufacturer's instructions to ensure disinfection. RN-J indicated this demonstration had been presented at both new employee orientation and also the mandatory skills fair conducted in May of 2017.

P6's BS testing with the common use glucometer was again observed on 2/7/18, at 7:15 a.m. with RN-E present. RN-E verified Unit B had one common use glucometer and it was utilized for all patients who required BS testing on the B unit. Following completion of the BS test, RN-E changed her gloves, obtained a wipe from the CaviWipe 1 container, wiped over the surface of the glucometer, tossed the wipe into the trash and placed the glucometer on a dry paper towel on the treatment room counter. RN-E indicated she had to allow the glucometer to air dry for 1 minute before returning it to the docking station. When asked about the manufacturer's recommendation, RN-E stated she was unaware the surface of the glucometer had to remain wet for 1 minute before allowing to air dry and confirmed it had taken less than 30 seconds for the surface of the meter to dry at present. RN-E indicated there was a second patient (P28) on the unit who also received BS checks on a twice weekly basis, but this was not the day it was to be checked.

RN-F was interviewed on 2/7/18, at 7:25 a.m. and he also verbalized the same process at RN-E for cleansing/disinfection of the common use glucometer after use. RN-F further indicated he was not aware of the need to ensure the meter surface remained visibly wet for 1 minute before allowing to air dry nor was he aware of the amount of actual time required for the surface to dry.

The nurse practitioner (NP), who served as the medical provider for the B unit, was interviewed on 2/8/18, at 8:50 a.m. and indicated she had spoken with the facility pharmacy staff regarding the need for utilization of a separate glucometer for P28 and had been told a separate machine was "not necessary as long as the meter was cleansed/disinfected adequately." The NP clarified adequately cleansed/disinfected meant according to the manufacturer's recommendations.

On 2/8/18, at 9:05 a.m. during a group interview, RN-C and RN-J confirmed education related to disinfection of the glucometer had been provided to all nursing staff at the time of orientation and again during the skills fair in May 2017. RN-C and RN-J confirmed no audits or infection control projects had been completed with regard to monitoring staff with the cleansing/disinfecting procedure of the common use blood glucose machine.

During a contact with Medtrex the CaviWipe 1 manufacturer on 2/7/18, at 2:00 p.m. the manufacturer representative indicated they were not able to verify disinfection/decontamination of "anything" if the recommendation for the surface being cleansed/disinfected did not remain wet for the recommended one minute as directed on the label.

The facility policy/procedure Titled: Roche diagnostics Accu-Chek Inform II System Portable System for Testing of Capillary Whole Blood Glucose: Staff Responsibilities: The nurse educator or designee is responsible for the training program for certifying operators to perform finger stick glucose testing. The unit (meter) must be cleansed and disinfected after each use. Disinfect the unit by using additional Cavi Wipe 1 cloths to wipe down the unit(meter) ensuring it remains wet for one minute. Air dry the meter on a clean paper towel before the next use.