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2845 GREENBRIER RD

GREEN BAY, WI 54311

MEDICAL RECORD SERVICES

Tag No.: A0450

Based on review of medical records, review of pertinent policy and staff interview the hospital failed to ensure that all entries in the medical record were authenticated for 9 of 18 (#7, #8, #10, #11, #12, #14, #15, #17 and #18) patients.

Findings include:

Facility policy titled Medical Records/Patient's Health Information states under G. 1. "All clinical entries in the patient's record must be legible, accurately dated, timed (military time) and individually authenticated."

On 01/12/10 between 1: 00 p.m. and 1:40 p.m. and on 01/13/10 between 9:20 a.m. and 10:20 a.m., Surveyor #22198 along with Registered Nurse (RN) I reviewed medical records for Patients #8, #10, #11, #12, #14, #15, #17 and #18.

Per record review of Patient #8's Home Medication Reconciliation Form/Physician Order sheet, the physician failed to time or date the order for medication.

Per record review, Patient #10 had surgery on 12/20/09; however the post anesthesia documentation was authenticated with 12/18/09 at 10:15 a.m. (2 days prior to the surgery).

On a Home Medication Reconciliation Form/Physician Order sheet 2 separate sections were completed. The RN completed the top half of the form documenting the medication for Patient #10, however failed to time the order or define if the medication order was a Verbal (VO) or Telephone order (TO). The second half of the form was completed by 2 different staff. The physician who ordered the first 2 medications failed to time and date the order. The Physician Assistant (PA) who wrote the last medication order failed to time and date the order. The physician failed to authenticate the PA's order per hospital protocol and PAs Privileging Application form. (Reviewed and confirmed by Surveyor #22198 and Director of Risk Management R on 01/13/10 at 11:00a.m.).

A 12/19/09 at 16:45 (4:45 p.m.) the physician authentication to a TO had a time that was not legible.

Per record review, on 12/08/09 Patient #11 had lumbar surgery; however on 01/13/10 (36 days after the surgery) the operative report has not been authenticated by the surgeon.

The Pre-operative flow sheet was incomplete and not authenticated.

On Home Medication Reconciliation Form/Physician Order sheet, the physician failed to time an order for medication.

A pre-printed physicians order date 12/08/09 entitled; "Preoperative Order Form-Lumbar Fusion" completed by someone other than the physician. This was confirmed by RN I, however the writer failed to document the order as a verbal or telephone order, failed to document which physician had given the order, and failed to authenticate the documentation and the additions written in on the pre-printed physicians order form.

Per record review Patient #12 had a consent that was signed by her mother, however the hospital staff who completed this form failed to authenticate this noted by an empty "witness" line. The consent was not dated or timed.

On Home Medication Reconciliation Form/Physician Order sheet dated 12/21/09, the RN wrote a medication order, however failed to identify if the physicians order was a telephone (TO) or verbal order (VO). The physician failed to time his authentication.

On Home Medication Reconciliation Form/Physician Order sheet dated 12/24/09, the physician failed to time the order.

Per record review Patient #14 - 2 separate Home Medication Reconciliation Form/Physician Order sheet, the physician failed to time the order.

On 12/11/09 3 orders one written at 8:30 a.m., 10:15 a.m. and 11:40 a.m. were written as VO/TOs. The authentication was identified by RN I, however neither RN I, Director of Quality or Surveyor #22198 could identify if there was a time or date after each signature because what ever was written after the signature was not legible.

Surveyor #22198, RN I or Director of Quality A could not identify the date or time.

Diagnostic Imagining Record of Administration: Computed Tomography dated 12/11/09 at 8:10 a.m. noted both oral and intravenous contrast was given to the Patient #14, however the technician who signed the form failed to document the lot number. Director of Quality A confirmed the hospital technicians are not trained, certified or licensed to give injectable medication. No one authorized to provide injectable contrast medication signed the form.

Per record review Patient #15 had a form entitled "Documentation Clarification and Addendum" date 12/22/09 was not timed.

On a Home Medication Reconciliation Form/Physician Order sheet dated 12/21/09 given as a TO, the writer failed to time the medication order. Physician failed to authenticate the telephone order.

A physicians order written 12/22/09 was not timed.

A Diagnostic Imagining Record of Administration: Computed Tomography dated 12/21/09 at 12:10 p.m. noted Intravenous (IV) contrast was given to the Patient #15, by a technician. Director of Quality A confirmed the hospital technicians are not trained, certified or licensed to give injectable medication. No one authorized to provide injectable contrast medication signed the form. The stamped form was incomplete and failed to identify if Patient #15 was diabetic or on Metformin, or if the radiology nurse was notify.

Per record review Patient #17 had a physician's TO dated 12/21/09 at 9:00 a.m. that was not authenticated.

The Physicians Assistant (PA) wrote two orders on 12/21/09 at 12:40 p.m. and 1:10 p.m., however per PA privileging and documentation policy, neither order was authenticated by the physician.

Per record review a pre-printed order form entitled; "Adult PCA (Patient Controlled Analgesic) was written a W.O. (this was identified as standing order; pre-written protocols).

Director of Quality A confirmed to Surveyor #22198, the pre-written protocols to provide guidance to the nursing staff. Director of Quality confirmed to Surveyor #22198, nurses are suppose to be documenting if the physician gave them a verbal or telephone order, however nurses are not to initiate written protocols without a physicians order.

On 12/30/0 2141(9:41 p.m.) a TO was written however the physician failed to authenticate the order.

A VO written 01/03/10 12:15 p.m. had an authentication that was not legible to identify if there was a time and date.

Also present during these record reviews was Director of Quality A.

A clinical record review was completed on Patient #7's open Surgical record on 1/13/2010 at 11:40 a.m. Patient #7 was admitted to the hospital on 1/6/2010 and underwent a procedure for the prostate gland.

Between the dates of 1/6/2010 and the time of clinical record review (1/13/2010), Patient #7's clinical record contained the following: one preprinted order set that was not timed by the physician, and one preprinted order set that was not dated, timed or signed by the physician; one verbal order that was not dated, timed or signed by the physician; and five telephone orders that were not dated, timed or signed by the physician.

These findings were confirmed by Supervisor 'J' and Director 'C' at the time of the clinical record review.

CONTENT OF RECORD: ORDERS DATED & SIGNED

Tag No.: A0454

Based on review of medical records, review of pertinent policies and staff interviews the hospital failed to ensure that all verbal and telephone orders were authenticated to meet the 48 hour requirement.

Findings include:

Facility policy titled Practitioner Orders states under D. b. "Verbal orders must be 1.) Authenticated by the practitioner giving the order within 48 hours."

Per review of PA privileging and staff interview on 01/13/10 at 11:00 a.m. Director of Risk Management R, confirmed PA's must have all orders authenticated by the physician, therefore PA's orders fall under the same 48 hour requirement for authentication of physicians orders.

Per Surveyor #26711:

A clinical record review was completed on Patient #7's open surgical record on 1/13/2010 at 11:40 a.m. Patient #7 was admitted to the hospital on 1/6/2010 and underwent a procedure for the prostate gland.

Between the dates of 1/6/2010 and the time of clinical record review (1/13/2010), Patient #7's clinical record contained the following: one preprinted order set that was not timed by the physician, and one preprinted order set that was not dated, timed or signed by the physician; one verbal order that was not dated, timed or signed by the physician; and five telephone orders that were not dated, timed or signed by the physician.

These findings were confirmed by Supervisor 'J' and Director 'C' at the time of the clinical record review.

Per Surveyor #22198

On 01/12/10 between 1:00 and 1:40 p.m. and on 01/13/10 between 9:20 a.m. and 10:20 p.m. Surveyor #22198 along with RN I reviewed both paper and electronic records for Patient's #8, #10, #11, #14, #15, #17 and #18.

Also present and acknowledged findings was Director of Quality A.

Per record review of Patient #8, on 01/06/10 a telephone order (TO) was written, however the writer failed to document the time of the order, and the physician who authenticated the order failed to time the order.

A TO was written on 01/08/10 however the writer failed to time the order, and as of today 01/13/10 the order had not been authenticated by a physician.

Per record review Patient #10 was discharged on 12/24/09. An order was written by the Physicians Assistant (PA) however the PA failed to time or date the order, and the physician failed to authenticate the order.

On 12/19/09 at 1645 (4:45 p.m.) a TO was written, however the authentication was illegible and a time could not be identified.

On 12/19/09 at 2110 (9:10 p.m.) an order was written as "clarification" order. The writer failed to document if the order was obtained verbally or by telephone, and the physician failed to authenticate the order.

Per record review for Patient #11. Patient #11 was admitted on 12/08/09. A pre-printed Preoperative physician ' s order form dated 12/08/09 was not timed, and had hand written additions.

RN I confirmed the hand writing was not the physicians, but was identified as a nurses. The nurse failed to identify if the orders were verbal or telephone order. There were two signatures from the same physician. One authentication was dated 10/02/09 at 1430 (2:30 p.m.) (2 months prior to Patient #11s admission). The second signature was authenticated on 12/22/09 (14 days after order was initiated).

Director of Quality A confirmed neither authentication met the requirement for authentication of VO/TO.

Per record review for Patient #14, identified 3 VO/TO orders that did not have the time they were authenticated.

One TO dated 12/11/09 at 11:30 a.m. failed to have an authentication.

A TO dated 12/11/09 at 17:30 (5:30 p.m.) was authenticated; however the date on the authentication was 12/25/09 at 11:12 a.m. (14 days after the order was written).

Per record review Patient #15 had a TO written 12/21/09 at 1:30 a.m., however the physician failed to authenticate the TO.

A pre-printed "ICU (Intensive Care Unit) Admission Orders" (3 pages form) had only page 2 and 3. The orders were initiated as TO 12/21/09 at 1:30 a.m., 2 additional TO orders were written on the form; however the physician failed to authenticate any of the orders.

On 12/22/09 at 1720 (5:20 p.m.) a TO was written, however the authentication failed to include a time.

Per record review Patient #17 had a TO written on 12/21/09 at 9:00 a.m., however the physician failed to authenticate the TO.

The Physicians Assistant (PA) wrote 2 orders on 12/21/09 at 12:40 p.m. and 1:10 p.m., however the physician failed to authenticate the PA's orders.

Per record review Patient #18 on 12/30/09 at 2141 (9:41 p.m.) had a TO written, however the physician failed to authenticate it.

On 01/03/10 at 12:15 p.m. a VO was written, however the authentication failed to include the time.

CONTENT OF RECORD: DISCHARGE SUMMARY

Tag No.: A0468

Based on review of medical records and staff interview the hospital failed to ensure that 2 of 18 (#12 and #13) had discharge summaries.

Findings include:

Facility policy titled Medical Records/Patient Health Information states under F.1 "A discharge summary must be recorded for all patients..." 2. "The discharge summary must indicate any specific instruction given to the patient and/or significant other relating to physical activity, medication, diet and follow-up care. If no instructions were required, a record entry must be made to that effect."


On 01/12/10 between 1:00 and 2:00 p.m. Surveyor #22198 and Registered Nurse (RN) reviewed the paper and electronic records for Patients #12 and #13, however were unable to identify a discharge summary in either record.

PHARMACIST SUPERVISION OF SERVICES

Tag No.: A0501

Based on observation, policy and procedure review, and staff interview, the hospital failed to appropriately monitor and document the incoming and outgoing of sample medications.

Findings include:

Hospital policy PC-025, titled "Drug Samples" states in the policy statement, "Sample medications must be logged, tracked, dispensed and disposed according to The Joint Commission standards & State/Federal laws and regulations."

In the policies "Guidelines", under letter B, the policy states, "Drug samples in the ED [Emergency Department] and Urgent Care departments will be maintained by the staff in those departments...5. A dispensing log will be maintained to provide appropriate drug control...The dispensing log will contain the following information: a. Name of the patient (see sticker), b. Date of dispensing (see sticker), c. Quantity dispensed, d. Name and dosage of drug dispensed.

On page two of the policy letter 'J' states, "The pharmacy will monitor the places where the ED & Urgent Care departments store sample medications on a quarterly basis for formulary & control compliance."

A tour of the hospital's west side Urgent Care clinic was conducted on 1/12/2010 at 9:00 a.m. with Director 'D' and Lead Registered Nurse (RN) 'E'. From a locked cabinet RN 'E' removed sample medications and forms for the incoming samples and the outgoing samples.

The incoming sample form (dated 8/19/09-12-8-09) indicates that Levaquin (an antibiotic) 750 mg (milligrams) came into the Urgent Care center on 9/17/09 (#2), 10/20/09 (#4), 11/25/09 (#6) and 12/8/09 (#8). The # sign is equivalent to the number of tablets.

The Urgent Care center also received several 500 mg samples (# unknown).

The outgoing sample form (dated 2/13/09-12/8/09) indicates that Levaquin was dispensed on 10/20/09, 5 tablets.

Nurses failed to document the Levaquin dosage (mg) (500 mg or 750 mg) on the accountability log.

No other Levaquin was documented as outgoing on the log.

There are 13 doses of Levaquin 750 mg unaccounted for on the outgoing sample form between 10/20/09 and 1/12/2010.

The outgoing sample form has 7 entries for dispensed medications, including the Levaquin, between 2/13/09 and 12/8/09. These entries are identified by name only and do not include the dosage that was dispensed.

These findings were confirmed with Director 'D' and Lead RN 'E' at the time of the observation.

Per interview with Pharmacy Manager 'Q' on 1/12/2010 at 2:40 p.m., Manager 'Q' stated that, "The pharmacy technicians go to the clinic on a quarterly basis to make sure the outdates are taken care of, but the clinic staff are responsible for the ins and outs on the medications." The pharmacy does not check the sample logs for accuracy.

SECURE STORAGE

Tag No.: A0502

Based on observation and staff interview, the hospital failed to ensure medications are secure and not accessible to unauthorized staff, patients, and/or visitors.

Findings include:

A tour of the hospital's west side clinic was conducted on 1/12/2010 at 9:00 a.m. with Director 'D'. In the Urgent Care area an emergency cart, which contained emergency medications, was observed in a treatment room that at times is unmonitored and could be accessed by unauthorized staff, patients, and/or visitors. This cart was equipped with a breakaway lock making tampering possible.

This finding was confirmed by Director 'D' and Lead Registered Nurse (RN) 'E' at the time of the observation.

A tour of the hospital's west side surgical center was conducted on 1/12/2010 at 9:45 a.m. with Director 'D'. In the surgery area an emergency cart, which contained emergency medications, was observed to have a breakaway lock. Per Lead RN 'F', the cleaning company cleans the area at night when staff are not in the area. These staff could access the medications in the cart since the breakaway lock does not prevent tampering.

This finding was confirmed by Director 'D' and Lead RN 'F' at the time of the observation.

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on review of policy, observation and staff interviews the infection control program failed to include all patient care areas in its surveillance.

Findings include:

Review of policy #IC-101 entitled: " Infection Control Program 2009" noted on page 2 of 7:
D. "Demographics"
1. "The Infection Control program for surveillance, prevention and control of infections is organization-wide and includes all inpatient, outpatient, service/diagnostic and support service departments (Addendum A). The design of the infection control activities includes consideration of the organization's unique characteristics."

On 01/12/10 between 8:20 a.m. and 10:00 a.m. during tour and observation with Supervisor/Case Manager Registered Nurse (RN) B the following was identified:

Medical/Surgical (M/S) 1 at 8:25 a.m. a butterfly catheter package that is sterile until open, was found opened and placed back into the container where it had the potential to be used.

Life Scan Blood Sugar machine had 2 red spots of dried on fluid on the machine.

RN O confirmed she was able to wipe the 2 red spots from the machine.

In the kitchenette area an instant ice tea package was open and ice tea dust was lying in the drawer

At 9:00 a.m. during a tour of M/S 3 a pill cutter had white residue on the blade and in the base of the pill cutter. A metal pill crusher had white residue on the pummel and in the base of the crusher. Supervisor/Case manager RN B confirmed the pill cutter and pill crusher both contained unidentifiable pill residue in and on them.

The kitchenette had open coffee removed from the individual packet sitting inside a coffee filter lying inside a drawer. A portion of the coffee packet was lying inside the filter on top of the coffee. Supervisor/Case manager RN B told Surveyor #22198 the portion of coffee packet was probably left there to identify if the coffee were regular or decaffeinated however acknowledged the coffee should not be open and sitting inside the drawer.

2 cans of soda were found open and sitting on top of the refrigerator, however during an interview Certified Nursing Assistant (CNA) P told Surveyor #22198, the open soda cans were not from day shift staff, and probably left there by night shift.

At 9:15 a.m. during the tour of ICU (Intensive Care Unit) 4 packages of a powder to thicken liquid were expired.

A covered linen cart stored in the hall, had 5 pillows sitting on top of the cover.

O2 tanks both used and un-used were stored in the clean and sterile supply room. There was no separation between the used and un-used tanks, and the un-used O2 tanks were up against a rack of clean supplies.

At 9:35 a.m. a tour and observation in the Labor and Delivery (L & D) identified O2 tanks both used and un-used were stored in the clean and sterile supply room. There was no separation between the used and un-used tanks, and the un-used O2 tanks were up against a rack of clean supplies.

Review of findings on 01/12/10 at 4:00 p.m. with Director of Quality A acknowledged that the Infection Control Officer needed to review and update surveillance.