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Based on observations and interview the facility failed to maintain the physical plant in a manner that ensured patient safety. Findings include:

During the physical plant tour on 8/18/10, at 10:30 a.m. the following observations were noted:
The tub room which served the patient rooms #162 to #165, had 3 unsecured containers of Cen Kleen IV. Cen Kleen was listed on the Material Safety Data Sheet (MSDS) as a hospital grade disinfectant that contained corrosive chemicals which could cause burns to eyes, skin and if ingested. In addition, in the three birthing rooms #123; #124 and #125 there were unsecured quart bottles of Vindicator located under the patient sink. Vindicator also known as Arsenal, was listed in the MSDS as a chemical which "direct contact will produce severe eye and skin irritation and/or burns possible irreversible damage."

In an interview with the facility management supervisor on 8/18/10, at 11:00 a.m. he stated that all cleaning/sanitizing chemicals should be secured so as to ensure patient safety. Currently the facility did not have a specific policy which addressed the need to secure toxic cleaning agents but the supervisor agreed there was a need for one.

Based on observation and staff interview, the Critical Access Hospital (CAH) failed to ensure that all drugs and biologicals were secure in 1 of 9 departments and in 4 of 5 offsite clinics utilizing medications. Findings include:

On 8/18/10, at 11:15 a.m. during the tour of the rehab services department, 12 bottles of dexamethasone (anti inflammatory agent) were observed to be stored in an unlocked refrigerator in a portable plastic box. Multiple items of staff foods were also observed in the refrigerator.

At this time, the physical therapist verified the medication's container was mobile and accessible to unauthorized personnel.


On 8/18/10, at 4:00 p.m. the Green Lake Medical Clinic was toured. In the hallway cupboard on the wall immediately adjacent to the patient exam rooms' hallway, multiple containers of medications were observed in an unlocked cupboard. The cupboard was easily accessible to anyone in either hallway. The cupboard was not able to be visualized by staff at the front desk, nor was it able to be monitored at all times by staff.

Multiple uncounted packages and containers of medications were observed in the unlocked cupboard including: Enablex 15mg, Valturna 150/160mg, Cymbalta 20mg and 60mg, Clarinex 5mg, Asmanex 110mg and 220mg, Cialis 5mg and 10mg, Byetta 5mcq, Singulair 10mg, Hyzaar 50/12.5mg, Celebrex 200mg, Lexapro 10mg, Crestor 5mg, 10mg and 20mg, Nexium 40mg, Januvia 100mg, Veramyst 275 mcq, and Niaspan 500mg.

At this time, registered orthopedic technician (ROT)-A verified the amount of the medications had not been counted and that they were not secure from unauthorized access during the day. She stated the cupboard was locked when the clinic closed. She added each clinic of the CAH determines their own procedures related to onsite medications.

The clinic area just behind the receptionist's desk was observed to have an unlocked refrigerator that contained multiple uncounted vaccines and biologicals that included: Act HIB, Adacel (Tdap) Pentacel, DT Pediatric, Daptacel, Gardasil, Havrix Adult and Peds (Hep A), Hepatitis B Adolesc/Peds, Hepatitis B Adult, IPOL, Mantoux, Menactra, MMR, Pneumonia, Prevnar, RotaTeq, Varicella, TD-Adjult (Decavac), and Typhim (Typhoid).

The area was observed to be able to be monitored by the receptionist during clinic hours.

On 8/18/10, at 4:40 p.m. ROT-A stated cleaning service personnel would clean after hours weekly and be unsupervised in the area. She verified the refrigerator was unable to be secured or locked.



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During the physical plant tour of the offsite clinic, Chain of Lakes Medical Clinic, on 8/19/10, at 8:15 a.m. the following observations were made: The clinic had a large unsecured cupboard which contained approximately 120 samples of prescription medications. These samples contained a variety of dosages and quantities. The medications included, but were not limited to: antianxiety medications, antipsychotics, antidepressants, sleeping medications, erectile dysfunction, bronchodilators, fluoroquinolones antibiotics, cardiovascular medication and antidiabetics.

In an interview with the License Practical Nurse (LPN) - A on 8/19/10, at 8:20 a.m. she stated the cabinet is not secured but patients are not in the vicinity of the unsecured cabinet unless accompanied by staff. However, the nurse was not able to address the security with regards to other clinic staff who could access these medications without any accountability.


On 8/19/10, at 9:30 a.m. the offsite clinic at Eden Valley was toured. In an unsecured refigerator there were unlocked medications. The medications included vaccines for hepatitis, mantoux for tuberculosis testing, pneumonia, typhoid and several other types. The emergency kit for the clinic was in a portable plastic container sitting on a shelf in the same unsecured area. Contents of the emergency kit included the following: epinephrine ampule and injection, atropine, diphenhydramine and lidocaine.

In an interview with the LPN-C at 9:40 a.m. on 8/19/10, she stated that the medications were not secure and that cleaning staff worked in the clinic after hours.


On 8/19/10, at 12:00 p.m., the offsite clinic at Belgrade was toured with LPN-B. The clinic was not open. Unsecured medications were found in the refigerator, the stock supply cupboard and treatment room. The medications included, but were not limited to: antianxiety medications, antipsychotics, antidepressants, sleeping medications, erectile dysfunction, bronchodilators, fluoroquinolones antibiotics, cardiovascular medication and antidiabetics. In addition sample medications were on top of the x-ray table of the clinic. These were: two boxes of Dulera Monetasone inhaler and 2 seven days packs of Valturna.

In an interview with the LPN-B at 12:15 p.m. on 8/19/10, she stated that the medications were not secure and that cleaning staff worked in the clinic after hours.

Based on observation and interview the facility failed to ensure that proper sanitation measurers were taken in the kitchen. Findings include:

In the kitchen tour on 8/17/10 at 2:00 p.m. the following observations were made: A fan which was in use in the clean dish area, had a coating of black substance on the edge of each fan blade. There were 5 of 8 spatulas with cracked and missing sections along the edges. Two, 7 inch frying pans with non-stick coating were heavily scored and had peeling surfaces.
The floor along the wall by the stove and food preparation counter had an accumulation of a black substance.
The dietary manager agreed that these areas needed to be addressed so as to ensure an adequate sanitation.

Based on record review, policy review, and interview, the CAH (Critical Access Hospital) failed to ensure all entries made in the medical record were timed, dated, and authenticated for of 23 of 39 patients (P11, P12, P13, P14, P16, P17, P19, P21, P22, P26, ERP2, ERP3, ERP4, CRP1, P28, P1, P30, P31, P6, P15, P18, P20, P24 ) reviewed receiving services at the CAH. Findings include:


The following reports were not electronically signed and lacked dates and/or times of the entries in the patients' medical records.

P11 was admitted on 7/7/10, with a diagnosis of acute pancreatitis. The radiology reports dated 7/7/10, 7/8/10, and 7/10/10, lacked the time and date of the physician signature. The physician progress notes dated 7/8/10, and 7/11/10, lacked the time of the entries. The dietician progress note dated 7/12/10, lacked the time of the entry.

P12 was admitted on 6/20/10, with a diagnosis of diabetic ketoacidosis. The clinical resume (discharge summary) dictated 6/25/10, lacked a time and date of the physician signature. The radiology report dated 6/24/10, lacked the time and date of the physician signature. The 6/23/10, dietician progress note lacked the time of the entry. The standing orders sheet lacked a time and date of the physician signature. The verbal order dated 6/20/10, lacked the time and date of the physician signature.

P13 was admitted on 6/10/10, with a diagnosis of cesarean-section. The clinical resume (discharge summary) dictated 6/13/10, lacked the time and date of the physician signature. The physician progress note dated 6/12/10, lacked the time of the entry. The cesarean section post-op orders dated 6/10/10, and the discharge orders dated 6/13/10, lacked the time of the physician's signature. The operation report dated 6/10/10, lacked the time and date of the physician's signature.

P14 was admitted on 2/24/10, with diagnoses including severe malaise and hypoxia. The history and physical dictated 2/24/10, the radiology report dictated 2/25/10, and the clinical resume (discharge summary) dictated 2/26/10, lacked the time and date of the physician's signature.

P16 was admitted on 4/9/10, with a diagnosis of chronic obstructive pulmonary disease. The clinical resume (discharge summary) dictated 4/15/10, and radiology report dated 4/9/10, lacked the time and date of the physician's signature.

P17 was admitted on 7/6/10, with diagnoses including fall with intracranial hemorrhage. The emergency room verbal physician orders, progress notes, and radiology report dated 7/6/10, and the clinical resume (discharge summary) dictated 7/12/10, lacked the time and date of the physician's signature. The rehab services progress notes dated 7/7/10, and 7/8/10, lacked the time of the entry by the occupational therapist. The rehab services progress notes dated 7/7/10, and 7/8/10, lacked the time of the entry by the physical therapist. Two telephone orders dated 7/7/10, lacked the time and date of the physician's signature.

P19 was admitted on 4/11/10, with a diagnosis of pulmonary embolus. The history and physical dictated 4/11/10, the radiology report dated 4/11/10, and the clinical resume (discharge summary) dictated 4/12/10, lacked the time and date of the physician's signature.
The rehab services progress note dated 4/12/10, lacked the time of the entry by the physical therapist.

P21 was admitted on 3/9/10, with diagnoses including suspected sepsis. The radiology report dated 3/9/10, and the clinical resume (discharge summary) dictated 5/11/10, lacked the time and date of the physician's signature.

P22 was admitted on 6/22/10, for delivery of newborn. The prepartum orders for labor dated 6/22/10, and the clinical resume (discharge summary) dictated 6/24/10, lacked the time and/or date of the physician's signature.

P26 was admitted on 2/3/10, with diagnoses including right breast lobular carcinoma. The clinical resume (discharge summary) dictated 2/4/10, lacked the time and date of the physician's signature. The rehab services progress notes dated 2/4/10, lacked the time of the entry by the occupational therapist.

ER(emergency room) P2 presented 5/10/10, with a diagnosis of appendicitis. The emergency room report dictated 5/21/10, the consultation report dictated 5/21/10, the radiology report dated 5/20/10, the physician's orders dated 5/21/10, and the report of operation dictated 5/21/10, lacked the time and date of the physician's signature.

ERP3 presented 3/23/10 with a left hand injury. The emergency room report dictated 3/24/10, lacked the time and date of the physician's signature.

ERP4 presented 5/31/10, with suicidal ideation. The emergency room report dictated 5/31/10, lacked the time and date of the physician's signature.

CR (cardiac rehab)P1's order dated 6/30/10, lacked the time of the entry by the physician.


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P3's chart review indicated that physician-A had not indicated a date or time for when the history and physical of 5/17/10,was signed. There wasn't a time or date when the physician signed the discharge summary of 5/20/10. This physician had not provide a date or time with. the signature on the progress note of 5/20/10.

P4's chart review indicated the physician-B had not provided a date or time when the emergency report of 1/24/10,was signed.

P5's chart review indicated the physician-A had not provided a date or time when the emergency room record of 3/19/10,was signed.

P25's chart review indicated the physician-C had not provided a date or time when verbal orders were given on 2/14/10. The discharge summary from the 2/18/10,did not have a date or time when the physician-C signed the report.

P28 was admitted for outpatient surgery on 8/18/10. The consultation report dictated 8/16/10, by physician-E was signed, but not dated or timed when authenticated. The Pre-op Physical Orders by physician-E was not timed when signed on 8/16/10. The Physician's Post-Operative Progress Note was not timed when signed by physician-E on 8/18/10


P1 was admitted for a Caesarean section on 6/30/10. The Clinical Resume dictated 7/08/10, was signed by physician-D, but not dated or timed when authenticated. The history and physical dictated 6/22/10, was signed by physician-D, but not dated or timed when authenticated

Other records reviewed on 8/18 and 8/19/2010 that contained no date and/or time when signed included the following: P30, P31, P6, P15, P18, P20 and P24.


The Medical Staff Rules and Regulations dated 7/28/2010, indicated at 2.9 that "authenticating entries" that "all clinical entries and dictated reports made by the attending practitioner must be dated and signed to be complete. The practitioner may fulfill this last requirement through a written signature, identifiable initials, or signature stamps provided the practitioner is the only one who possesses and uses the stamp." The document was silent on the requirement of time along with the signature and date.

The CAH's policy, "Standards For Medical Record Content" dated reviewed 9/2002, directed, "All encounters/entries are dated." However, the policy did not address timing related to entries in the medical record.

On 8/19/10, at 10:40 a.m. the medical records director stated she was unaware all signatures had to be dated and timed.

On 8/19/10, at 2:50 p.m. the director of nursing verified these findings and stated she was unaware all signatures required the date and time.

Based on observation, staff interview, and record review, the Critical Access Hospital (CAH) failed to maintain the confidentiality of record information and provide safeguards against loss, destruction, or unauthorized use at 3 of 5 offsite clinics.
Findings include:

On 8/18/10, at 4:00 p.m. the Green Lake Medical Clinic was toured. Multiple shelves containing patient records were observed in the room directly behind the receptionist's desk. The patient records were able to be monitored by the receptionist during the clinic hours.

On 8/18/10, at 4:40 p.m. the registered orthopedic technician (ROT)-A stated cleaning service personnel would clean after hours weekly and be unsupervised in the area. She verified the medical records of patients would be accessible to unauthorized personnel at that time.


On 8/19/10, at 9:30 a.m. the offsite clinic at Eden Valley was toured. Patient records were observed unsecured in the hallway by an exit door
In an interview with the LPN-C at 9:40 a.m. on 8/19/10, she stated that the patient records were not secure and that unauthorized personnel would have access to the record. She also added the cleaning staff worked in the clinic after hours and were not authorized personnel.


On 8/19/10, at 12:00 p.m., the offsite clinic at Belgrade was toured with LPN-B. The clinic was not open. Unsecured patient records were present around the reception area and also in the basement. Although the basement door had a lock in the door, the key was in the lock

In an interview with the LPN-B at 12:15 p.m. on 8/19/10, she stated that the patient records were not secure and that unauthorized personnel would have access to the record. She also added the cleaning staff worked in the clinic after hours and were not authorized personnel.

Based on interview, record review, and medical staff rules and regulations review, the Critical Access Hospital (CAH) failed to ensure a post-anesthesia follow-up report was completed on 6 of 7 (P28, P13, P26, P1, P30, P31) patients reviewed who received anesthesia services. Findings include:

P28 was admitted for outpatient surgery on 8/18/10. On The "Post Anesthetic Note" by certified registered nurse anesthetist (CRNA)-A was not completed. Although the CRNA had signed, there was no date or time or other details of the patient's status when the documentation was reviewed on 8/19/10 at 11:00 a.m.


P13 was admitted on 6/10/10, for a cesarean section. The 6/10/10, "Post Anesthetic Note" had been signed by the CRNA-A. However, no information was included with the signature including the date, time, or any other details related to the patient's status.


P26 was admitted on 2/3/10, for a right breast mastectomy. The 2/3/10, "Post Anesthetic Note" had been signed by the CRNA-A. However, no information was included with the signature including the date, time, or any other details related to the patient's status.

P1 was admitted on 6/30/10, for a cesarean section. The 6/30/10, "Post Anesthetic Note" had been signed by the CRNA-A. However, no information was included with the signature including the date, time, or any other details related to the patient's status.

P30 was admitted on 8/04/10, for a cholecystectomy. The 8/04/10, "Post Anesthetic Note" had been signed by the CRNA-A. However, no information was included with the signature including the date, time, or any other details related to the patient's status.

P31 was admitted on 1/06/10, for a mastectomy. The 1/06/10, "Post Anesthetic Note" had been signed by the CRNA-A. However, no information was included with the signature including the date, time, or any other details related to the patient's status.

The Medical Staff Rules and Regulations dated 7/28/2010, indicated at "4.2.3 Post-Anesthesia, a post-anesthetic visit shall be made by the CRNA and an appropriate not (including date and time) recorded on the chart between 3 and 24 hours after surgery

On 8/19/10, at 2:50 p.m. the director of nursing verified these findings.

Based on interview and review of the quality assurance (QA) plans/programs the facility failed to ensure, the physical plant operations had a QA program to improve their services. Findings include:

During an interview on 8/18/10, at 10:30 a.m. the director of the physical plant stated that at this time there wasn't any quality assurance program in place. He was new to his position and would be planning on implementing some program in the near future.

In an interview with the director of the facility wide quality management program on 8/19/10, at 12:10 p.m. it was confirmed that physical plant operations needed to develop a QA program.