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The facility failed to provide and maintain a safe environment for patients and staff.

This is evidenced by the Life Safety Code deficiencies identified. See C-231

The facility failed to provide a safe environment by not properly storing oxygen cylinders.

Findings Include:

During the facility tour on 7/14/2010 with the Maintenance Technician is was observed that two oxygen cylinders were not securely stored to prevent tipping over. The oxygen cylinders were located in a storage closest on the acute care wing.

The facility failed to provide a clean environment by storing items in the sink base cabinet. Findings Include:

During the facility tour conducted on 7/14/2010 with the X-Ray Nurse at the Mackinac Island Campus it was observed that items were being stored under the sinks. Storage under the sink was observed in X-Ray, Laboratory, and Exam Rooms 1 thru 4. Items stored included paper towels, stuffed animals, gloves, and misc. patient care items.

During the facility tour conducted on 7/14/2010 with the Maintenance Tech at the Main Hospital Campus storage under the sink was observed in Med Room and the Laboratory. Items stored included paper towels, syringes, vases, and small lab equipment.

The facility failed to provide adequate lighting in the patient care area. Findings Include:

During the facility tour on 7/14/2010 with the Maintenance Tech the lighting level at the handwash sink serving the blood draw rooms measured 16 foot candles. This is below the minimum 30 foot-candles of illumination required per the Illuminating Engineering Society of North America, IESNA Publication CP29, Lighting for Health Facilities.

Based upon on-site observation and document review by Life Safety Code (LSC) surveyors on July 7, 2010, the facility does not comply with the applicable provisions of the 2000 Edition of the Life Safety Code.

See the K-tags on the CMS-2567 dated July 7, 2010 for Life Safety Code.

Based on observation, interview and record review the facility failed to ensure that patient care policies had been reviewed with the participation of one or more physician assistants and nurse practitioners (C-272), that unusable medications were not available for patient use (C-276), that a system for identifying, reporting, investigating and controlling communicable disease was used (C-276) and that patient care policies were reviewed at least annually by the group of professional personnel (C-278).

Based on interview and record review, the facility failed to ensure that it's policies were developed by a group of professionals including a Medical Doctor or Doctor of Osteopathy, one or more physician assistants, nurse practitioners, or clinical nurse specialists and at least one reviewer who is not a hospital employee. Findings include:

On 7/8/10 at approximately 1230, review of the facility's "Medical Staff Roster" revealed listings for seven Nurse Practitioners and one Physician's Assistant.

The Swing Bed policy manual provided by the facility did not include policies reviewed by a Nurse Practitioner or Physician's Assistant or a non-staff member.

There was no physician signature on the 9/3/10 policy titled "Policy and Procedure Structure, Standards and Management."

A policy dated 6/30/10 titled "Occurrence Reporting" was unsigned with signature spaces for "author, approved by and P & P Committee."

A policy titled "Acute care/swing bed diets" was signed 12/09 by a physician and the Certified Dietary Manager.

A policy titled "Restraint" was included in the "Swing Bed" binder provided. This policy was prepared on 8/29/97 and the "Reviewed by" line was blank.

On 7/7/10 at 0250 the Director of Nursing/Education/Acute Care stated that she was unaware of a restraint policy and that the hospital does not use restraints.

Based on observation, interview and record review the facility failed to develop and implement a policy designated to ensure that unusable drugs were not available for patient use. Findings include:

On 7/7/10 at 0910 the Pharmacy was toured with the Pharmacy Manager. The following observations were noted:
1. One blister package of Haldol, 1 mg. tablets, on a shelf, expired 6/10
2. Two boxes of Diazepam Suppositories, 10 mg., stored on an open shelf, in an unlocked refrigerator, expired 1/5/10
3. Two boxes labeled "ABHD" suppositories, stored in a refrigerator, expired 11/30/09
4. One gram Foraz preparation, on a shelf, expired 5/10
5. Thirty Norco (Hydrocodone/APAP) 7.5-325 mg tablets, on a shelf, labeled as packaged 2/26/10, with no expiration date
6. One blister pack of Ambien 5 mg tablets, on a shelf, with an expiration date of 12/26/10.

On 7/7/10 at approximately 0930, the Pharmacy Manager was queried regarding whether the Pharmacy had policies for labeling medications packaged in the Pharmacy and how the expiration date for Pharmacy packaged medications was determined. The Pharmacy Manager stated that he was unaware of any policies relating to these issues.



18299

On 7/6/10 at approximately 1240, during a tour of the Campus 1 Emergency Department, the following was observed and verified by ER RN #1 and ER CNA:
1. One open bottle of Nitroglycerin tablets, with no date opened in room #1.
2. One open bottle of Nitroglycerin tablets, with no date opened in room #2
3. One open bottle of Nitroglycerin tablets, with no date opened in room #6.

The facility policy titled "Nitroglycerin S/L Tabs" states:
1. "The date when initially opened must be labeled on the container."
2. "Post 90 days after the date opened the tabs must be discarded due to deterioration."

On 7/7/10 at approximately 1010, during a tour of the Campus 2 Emergency Department, the following was observed and verified by ER Physician #2 and the hospital Chief Planning Officer:

Medication storage cupboard (was observed unlocked and unattended):
1. Labetolol HCL multiple dose open and not dated.
2. IV D5W 500cc (6 bags) expired 7/1/10
3. IV D5W 250cc (4 bags) expired 7/1/10

Crash Cart had the following expired medications:
1. Lidocaine pre-mix 250cc
2. Dopamine premix 2600 (2 bags)
3. Verapamil injectable (4)
4. Amiodarone HCL (3)
5. Epinephrine injectable (5)
6. Lidocaine injectable (2)
7. Adenocard (2)
8. Metoprolol (5)

Locked Narcotic cupboard had the following expired medication:
1. Amidate 40 mg/2ml multidose

Medication Storage Room had the following expired medications:
1. Guaifenesin Oral Suspension
2. Macrobid tabs
3. Erythromycin tabs
4. Hydrocortisone tabs (14)
5. Acetaminophen tabs (180)
6. Benadryl tabs (4)
7. Simethicone (18)

Based on policies reviewed and interview the agency failed to ensure an infection control system for identifying, reporting, investigating, and controlling infections and communicable diseases of patient's and personnel within the healthcare system had been identified. Findings include:

The meeting minutes submitted by the facility infection control coordinator on 7/7/2010 entitled; "Infection Control Subcommittee Meeting", dated, 4/13/2010, 5/11/2010, 6/8/2010 all documented the meetings were being held monthly for 6 months; "...as part of our LTC (long term care) Plan of Correction..."(sic). The content reflected issues being addressed specific to the long term care facility associated with the critical access hospital.
During an interview with the facility's infection control preventionist on 6/7/10 it was confirmed the infection control subcommittee meeting minutes presented were for the facility's separate long term care facility. The facility failed to document a system for identifying, investigating and controlling infections specific to the critical access hospital.
The agency's policy entitled; "Risk/Quality Management Plan" section VI, part C., #3 states; The purpose of the "Risk/Quality Management Oversight Committee" is to; "Receive reports and act on recommendations from the..... infection control committee." Review of the "Risk/Quality Management Oversight Committee Meeting dated 1/20/2010, and 3/16/2010 noted the; "Current Issues/Updates" section failed to provide objective information to update the committee on the status of infection control action plans.
Also; during observations on 7/6/10 on the acute care unit and 7/7/10 on the dialysis unit; it was noted items being stored under the handwash sinks of the respective units. The facility failed to perform generally accepted infection control practices.

Based on interview and record review the facility failed to ensure that policies were reviewed at least annually. Findings include:

On 7/9/10 from approximately 0900-1100, review of policies provided by the facility revealed:

1. Pharmacy policies (#2.00, #6.00, #10.01, #10.02, #10.04, #10.05) last reviewed in 2000.

2. A binder labeled "Swing Beds" contained: a policy titled "Medicare Eligibility Information and Application Process dated 5/07/01, an "Abuse Program Policy and Procedure" with a review date of 3/23/00, a "Fall or Suspected Falls" policy dated 4/13/00 and a policy for "Provision of Rehabilitative Skilled Therapy Services dated 9/14/99.

3. A Nursing policy titled "Labeling & Retainment of Multi-Dose Medications" was dated 8/27/03.

4. A policy titled "Review of Mackinac Straits Hospitals CAH Total Program," dated 10/03, last reviewed 10/05, states that hospital policies and procedures will be evaluated annually.

5. A policy titled "Policy and Procedure Structure, Standards and Management," dated 9/3/09, states: "All policies and procedures shall be reviewed and revised as needed but at least as frequently as every three years."

Based upon interview and medical record review, the hospital failed to ensure that all patients had properly executed consent forms for treatment. Findings include:

On July 8, 2010 at approximately 0930 in the second floor conference room, the surveyor was accompanied by the Chief Planning Officer, Chief Nursing Officer, Director of Social Services and Director of Nursing ED and Acute Care. Mackinac Straits Hospital and Health Center Patient Contract for Swing Bed Care was reviewed. Item number 2 states in part; that the "...patient acknowledges receipt of a copy of the hospital policy and responsibilities of swing bed nursing care ..." It was verified by staff present that there is not a hospital policy as identified in item number 2. Swing bed patients are provided a booklet entitled Rights and Responsibilities published by MASA (Michigan Association of Homes and Services for the Aging).

The Swing Bed Contract also states in part; "I have discussed my condition/the patient's condition with the above named physician who has explained the intended medical care, testing and treatment to the extent now known." Staff present verified that there is not a mechanism in place to document or assure that the physician has provided such explanation at the time the contract is signed. It was noted in 1 of 6 current swing bed inpatients' (pt #19) medical records, that the swing bed contract had been signed prior to the physician's examination of the patient.

Based on medical record review and interview the facility failed to ensure that physician signatures were applied to verbal Physician orders in four (#1, #2, #3 and #4) of nine open medical records. Findings include:

On 7/6/10 from approximately 1100-1300, medical record review revealed that four current patients had unsigned physicians's orders. Patient #1 had unsigned Physician orders dated 4/28/10 and 5/6/10. Patient #2 had unsigned orders dated 6/25/10 and 7/2/10. Patient #3 had unsigned Physician orders dated 5/31/10, 6/10/10, 6/16/10 and 6/17/10. Patient #4 had unsigned Physician orders dated 6/7/10, 6/9/10 and 6/11/10. These findings were verified by the Director on Nursing /Education/Acute Care.


18299


MR #'s 22 and 23: The patient's "Code Status Form(s)" dated 5/11/10 and 5/1/10 respectively indicate selection of item B; "Extraordinary measure are not to be used to prolong life...." There were no documented physician orders acknowledging the each patients "No Code" wishes.

Based on interview and record review the facility failed to maintain on-going processes for program evaluation and quality assurance review. The facility failed to arrange for an on-going periodic program evaluation (C0331), a periodic review to determine whether utilization of services was appropriate (C0335) and ensure an effective quality assurance program (C0336.)

Based on record review and interview the facility failed to ensure a periodic (at least annual) review of it's total program. Findings include:

On 7/8/10 and 7/9/10, the facility's policies, Board Meeting Minutes, Gift of Life reports, Risk/Quality Management reports and minutes, and Medical Staff Minutes were reviewed. There was no evidence of an annual program evaluation report with data on clinical record reviews, annual review of health policies and evaluation to determine whether utilization of services was appropriate. On 7/9/10 these findings were confirmed by the Risk Manager/Infection Preventionist.

A policy titled "Review of Mackinac Straits Hospitals CAH Total Program," last reviewed 10/05, specifies guidelines for annual evaluation involving all departments, including utilization review, quality improvement, infection control and ancillary services.

Based on record review and interview the facility failed to conduct an annual program evaluation to determine whether services were appropriate and policies were followed. Findings include:

On 7/8/10 and 7/9/10, the facility's policies, Board Meeting Minutes, Gift of Life reports, Risk/Quality Management reports and minutes, and Medical Staff Minutes were reviewed. There was no evidence of an annual program evaluation report with data on clinical record reviews, annual review of health policies and evaluation to determine whether utilization of services was appropriate. These findings were confirmed by the Risk Manager/Infection Preventionist on 7/9/10.

A policy titled "Review of Mackinac Straits Hospitals CAH Total Program," last reviewed 10/05, specifies guidelines for annual evaluation involving all departments, including utilization review, quality improvement, infection control and ancillary services

Based on interview and record review the facility failed to ensure an effective quality assurance program to evaluate the quality of services and patient outcomes. Findings include:

From 7/7/10-7/9/10 the facility's documentation of Risk/Quality Management process and data were reviewed. A flow chart was provided by the RM/IP (Risk Manager/Infection Preventionist) indicating that one committee (Medication Safety) and three subcommittees (Safety, Performance Improvement and Infection Control) report to the Quality Oversight Committee on a quarterly basis, followed by a quarterly report to the Board of Directors.

Risk/Quality Management Oversight Committee meeting minutes for 1/20/10 and 3/16/10 were reviewed. The Medication Safety Committee reported one goal, to meet monthly at the January meeting. There was no discussion of any data. This committee made no report at the March 2010 meeting. In the 1/20/10 Safety Subcommittee report a problem with out-dated information sheets for chemicals was discussed. No follow-up information was provided at the March 2010 meeting. The March 2010 Quality Rounds report stated that Acute Care was going pretty well, with no action plans in place. There was a reference to complaints but no data was provided in the minutes. There was no discussion of complaint trending or follow-up. In January 2010, the Infection Control subcommittee reported illnesses in two departments but no outcome or action plan was noted.

At the March 2010 meeting it was reported that the RM/IP has a binder of subcommittee action plans in her office, available for review upon request. No tracking or trending information was reported at either meeting. At the 1/20/10 meeting there was a reference to an attached occurrence report but no documentation indicating any committee discussion of specific occurrences or trends.

.At the 3/16/10 meeting, no occurrence report data was provided. According to a facility report, there were 26 patient occurrences in January and February 2010. Review of the Risk/Quality Management Oversight Committee's minutes revealed that some departments did not report in January and March 2010. At the 1/20/10 meeting, quarterly reports were not provided by the following departments: Diabetic Education, Lab, and Radiology. At the 3/16/10 meeting the following departments did not report: Cardiac-Rehab, Business Office, Housekeeping, Materials Management and Physical Therapy. The RM/IP confirmed that there was no expectation that departments provide a quarterly report to the Risk/Quality/Management Committee.

Board of Director's Meeting Minutes dated 1/6/10 revealed that no Quality Assessment report was provided. The 1/27/10 Board minutes state: "The LTC (long-term care) Resident Occurrence Reports...for the Third and Fourth Quarter 2009 were handed out and asked to be reviewed for the next meeting."
Third and fourth quarter 2009 occurrence reports provided to the Board lumped falls, medication errors, patient's leaving Against Medical Advice, death and "other" into one number for hospital patients.

On 7/7/10 at approximately 1525, the Risk Manager/Infection Preventionist (RM/IP) was interviewed regarding hospital quality assurance activities, processes and documentation. The RM/IP confirmed that she was unaware of the late reports to the Organ Procurement Organization (OPO) in 2010 (see C0336)and that OPO data was not reported to the Risk/Quality Management Oversight Committee. The RM/IP also confirmed that there is no facility policy or procedure specifying what data the facility's Risk/Quality Management Oversight Committees (R/QMOC) collects and reviews nor how frequently individual departments must report to quality assurance data to the R/QMOC or the Board of Directors.

Based on interview and record review the facility failed to ensure that timely referrals following patient deaths were made to the organ procurement agency in February and June 2010. Findings include:

On 7/8/10 at approximately 0945 the facility's organ procurement program was reviewed with the Director of Nursing Education/Acute Care (DON/ED/AC) and Risk Manager/Infection Preventionist (RM/IP). The facility provided a policy titled "Donation Protocols,"dated 11/25/03. The policy states: "hospital staff shall notify (name of organization) within 1/2 hour of death." According to facility policy, patients #26 and #37 were not reported in a timely manner.

The facility's contract with the Organ Procurement Organization (OPO) calls for reporting within one hour of death in most circumstances. An OPO report titled "Referral Statistics" indicated that the facility listed three deaths in February 2010 and two referrals received. The report indicated that one of these referrals was made six or more hours after the patient's death. The report also indicated that two of five patient deaths reported in June 2010 were made late, one in the 1-3 hour range and one in the 3-6 hour range. The DON/ED/AC confirmed that two 2010 referrals had not been made in a timely manner. The RM/IP stated that she had not reviewed this report. A patient "Death Log" binder from the Emergency Department did not fully correspond to OPO report.

When queried regarding whether the facility had a system to report and analyze all deaths the RM/IP stated that she was not sure whether all deaths would be reported as occurrences, and become part of a data base. Per a facility report titled "Patient Occurrences" there were no reports of deaths as occurrences from 1/10-5/10. According to an unsigned copy of a facility policy, titled "Occurrence Reporting," dated 6/30/10, only "unexpected deaths" would be reported as occurrences. The RM/IP was unable to identify a facility report or process that monitors reporting of deaths to the OPO.

Based on record review and interview, it was determined that one (#1) of nine current patients and one discharged patient were physically restrained without a physicians's order or documentation of other monitoring. Findings include:

On 7/6/10 from 1100-1300, review of patient #1's record revealed that he was admitted to the facility on 4/6/10. The "Admission Care Plan Form" noted the use of "hand pads at noc." The patient's nurse, employee #18, stated that the hand pads were "like mittens" and had been used on this patient around the time of admission due to agitated behavior. An untimed nurses note on 4/8/10 states: "Mitten applied to left hand. Right hand remains flaccid." A second note that date, timed 2000, states: "Pt asleep and unresponsive at this time. Patient groans with turning and repositioning...mitten on left hand." The section of the daily nursing note for 4/8/10 for restraint use was left blank.

On 7/6/10 at 1450, employee #18 described the mitts as "soft and padded, with netting on the back." Neither a physician's order for the use of mitts nor any other documentation regarding release protocols was noted in patient #1's clinical record. The Director of Nursing/Education/Acute Care stated that it was her understanding that the facility did not use mitts was unaware of a restraint policy

During an interview on 7/9/10 at approximately 1000 the Director of Nursing Education/Acute Care (DON/ED/AC) confirmed that no physician's order or assessments related to the use of mitts were found in patient #1's clinical record. A pair of mitts matching nurse #18's description of the mitts was provided for inspection. The mitts had Velcro wrist closures, netting and measured approximately 12" long by 7" wide by 3" high. These observations were confirmed by the Chief Nursing Officer and DON/ED/AC.

The facility policy for Restraints (dated 8/29/97) provided in the Swing Bed manual, states: "Extremity restraints, mitts-discouraged, used only as a temporary measure with physician notification and order."
Patient #1 was in a Swing bed and there was documentation that #1's wife had been provided with a copy of a booklet titled "Rights and Responsibilities," by the Michigan Association of Homes and Services for the Aging. On page 3, (l) the book states: "A patient is entitled to be free from mental and physical abuse and from physical and chemical restraints, except those restraints authorized in writing by the attending physician for a specified and limited time...the restraint may only be applied by a qualified professional who shall set forth in writing the circumstances requiring the use of restraints and who shall promptly report the action to the attending physician." There was no documentation indicating that patient #1's wife was informed of the use of restraints. On 7/7/10 at approximately 1000, the patient's wife was asked whether any restraints, including mitts, had been used on patient #1 during his hospital stay. Patient #1's wife stated responded that restraints had not been used.


26688

On 7/7/10 at approximately 3:30PM, patient #9's closed medical record was reviewed with the Director of Nursing of ED and Acute Care present. Patient #9 was admitted to the Emergency Department on 6/22/10 at 1053. A physician's order for 4-point restraints was written, with no time documented. A nurse's note written at 3:15 PM states: "patient physically restrained...4-point tie downs applied." A 4:25 PM nurse's note states: "restraints loosened and released 1 extremity at a time." The physician's order does not include the type of restraint, duration or purpose for the restraint being applied. There was not documentation in the record which identified any patient monitoring to ensure health and safety, such as circulation checks or nourishment provision. Hospital policy for restraint application and use was requested from the Director of Nursing of ED and Acute Care Services. The Director of Nursing of ED and Acute Care Services verified that there was not a hospital policy for restraint use and also verified the above medical record findings.