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Based on review of state licensing rules, policy review, record review, and staff interview, the Critical Access Hospital (CAH) failed to follow state licensing rules for operation of 1 of 1 outpatient birthing center.

Findings include:

The North Dakota Century Code Chapter 23-16, Licensing Rules for Hospitals in North Dakota, revised 07/01/09, stated, "23-16-01. Licensure of medical hospitals and state hospitals. . . . no person, partnership, association, corporation, limited liability company, county or municipal corporation, or agency thereof, which maintains and operates organized facilities for the diagnosis, treatment, or care of two or more nonrelated persons . . . where obstetrical or other care is rendered over a period exceeding twenty-four hours, may be established, conducted, or maintained in the state of North Dakota without obtaining annually a license . . ."

Review of the policy "Outpatient Birthing Center" occurred on 10/22/13. The undated policy stated, ". . . SERVICES: The outpatient birthing center operates 24 hours per day, seven days a week throughout the year, to care for patients needing obstetrical services. Maternal patients may be observed up to 23 hours after their delivery in the outpatient birthing center. . . ."

The CAH provided obstetrical care to two or more nonrelated persons for a period exceeding twenty-four hours and provided no evidence of licensure of the outpatient Birthing Center as a hospital.

- Review of Patient #1's medical record occurred on October 22-24, 2013. The record identified the patient presented to the Birthing Center at 10:41 p.m. on 10/20/13 and the CAH discharged the patient at 5:35 p.m. on 10/22/13 (42 hours and 54 minutes).

- Review of Patient #36's closed medical record occurred on October 21-23, 2013. The record identified the patient presented to the Birthing Center at 4:37 p.m. on 05/02/13 and the CAH transferred the patient to inpatient obstetrics (OB) at 6:25 p.m. on 05/03/13 (25 hours and 48 minutes).

The CAH furnished a list of 14 outpatients provided care at the outpatient birthing center during the timeframe of October 2-15, 2013. Review of the list indicated the CAH provided care exceeding 24 hours for the following 11 outpatients:

Outpatient #49 - arrived at 5:30 a.m. on 10/03/13 and discharged at 1:25 p.m. on 10/04/13 (31 hours and 55 minutes)
Outpatient #50 - arrived at 5:22 a.m. on 10/03/13 and discharged at 8:47 a.m. on 10/04/13 (27 hours and 25 minutes)
Outpatient #51 - arrived at 10:15 a.m. on 10/03/13 and discharged at 7:35 a.m. on 10/05/13 (45 hours and 20 minutes)
Outpatient #52 - arrived at 6:15 a.m. on 10/08/13 and discharged at 8:10 a.m. on 10/09/13 (25 hours and 55 minutes)
Outpatient #53 - arrived at 11:10 p.m. on 10/07/13 and discharged at 8:00 a.m. on 10/09/13 (32 hours and 50 minutes)
Outpatient #54 - arrived at 6:14 a.m. on 10/08/13 and transferred at 8:00 a.m. on 10/09/13 (25 hours and 46 minutes)
Outpatient #55 - arrived at 9:00 a.m. on 10/09/13 and discharged at 1:45 p.m. on 10/10/13 (28 hours and 45 minutes)
Outpatient #56 - arrived at 4:56 p.m. on 10/08/13 and discharged at 9:15 a.m. on 10/10/13 (40 hours and 19 minutes)
Outpatient #57 - arrived at 7:05 a.m. on 10/10/13 and discharged at 7:10 a.m. on 10/11/13 (24 hours and 5 minutes)
Outpatient #58 - arrived at 2:00 a.m. on 10/11/13 and discharged at 8:48 a.m. on 10/12/13 (30 hours and 48 minutes)
Outpatient #59 - arrived at 4:24 p.m. on 10/12/13 and discharged at 9:25 a.m. on 10/14/13 (41 hours and 1 minutes)

During an interview at approximately 3:30 p.m. on 10/21/13, an administrative OB nurse (#4) stated most patients spend approximately 24 hours post recovery at the outpatient Birthing Center prior to discharge.

During an interview the morning of 10/24/13, an administrative staff member (#5) stated the CAH did not include the time of the care provided to outpatients during delivery and recovery at the Birthing Center as part of the 24 hours allowed for outpatient care.

Based on observation, review of professional literature, and staff interview, the Critical Access Hospital (CAH) failed to maintain the physical environment to ensure safety of patients in 1 of 6 operating rooms ("minor" room), 1 of 1 specimen room in the main surgical area, and 1 of 1 utility room in the respiratory therapy area. Failure to maintain the environment limited the CAH's ability to ensure a clean and hazard free facility and placed patients at risk of contamination.

Findings include:

"Guidelines for Construction and Equipment of Hospital and Medical Facilities," 1992-93 edition, Chapter 7, Section 7.28, Subsection 7.28.B. Finishes stated, ". . . 7.28.B6. Wall finishes shall be washable. . . . In operating rooms, delivery rooms for caesarean sections . . . wall finishes shall be free of fissures, open joints, or crevices that may retain or permit passage of dirt particles. . . ."

- Observation of the "minor" room in the main surgical area occurred on the afternoon of 10/21/13 and showed a hole in the wall to the right of the doorway upon entrance to the room and another hole covered with masking tape up the side of the same wall.

Review of the OR log from July through October 2013 occurred on 10/24/13 and showed the CAH last used the "minor" room on 08/20/13 for colonoscopy procedures.

This deficient practice remained out of compliance from the complaint survey completed on July 24, 2013.

During an interview on the afternoon of 10/23/13, a maintenance department staff member (#11) stated he did not get a chance to fix the walls in the "minor" room.

- Observation of the specimen room in the main surgical area occurred on the afternoon of 10/21/13 and identified two gallons of paint sitting on the counter.

During an interview on the afternoon of 10/21/13, a surgical nurse (#9) stated she did not know why staff stored the paint cans in the specimen room.


15707


- Observation of the respiratory therapy area occurred on 10/23/13 at 1:30 p.m. with a respiratory therapist (RT) (#8). Observation of the utility room identified a triangular sink in one corner of the room. Observation of the cabinet under the sink identified the floor warped and discolored. The discoloration continued approximately half way up the cabinet walls. The RT (#8) stated approximately four to six months ago a leak occurred at the sink and environmental services staff repaired the sink. The staff member (#8) stated she submitted a repair requisition for the cabinet at the time of the damage, but environmental staff had not yet completed the repairs.

Based on observation, record review, review of the Critical Access Hospital (CAH) governing body bylaws, policy review, and staff interview, the governing body failed to ensure care in a safe environment consistent with the acuity and needs of the patients for 1 of 1 outpatient obstetrics unit (Birthing Center) (Refer to C241). Provision of care for high risk patients in the outpatient setting placed both the obstetric patients and their fetuses at risk for life threatening complications.

The survey team determined an Immediate Jeopardy situation existed on 10/24/13 at 10:35 a.m. related to high risk patients receiving care in the outpatient obstetrics unit. At 11:02 a.m., the survey team notified administrative staff members (#4, #5, #6, and #7) of the Immediate Jeopardy situation. The CAH provided the following plan of correction at 3:50 p.m. on 10/24/13: Effective immediately, the CAH will not allow new patients to enter the Birthing Center for labor or delivery. The CAH will ensure that its inpatient Obstetrics Department is prepared to receive patients and provide appropriate care and services for labor and delivery no later than 3:00 p.m. on 10/24/13. The CAH will assess all patients currently at the Birthing Center. All current patients who can be transferred to the hospital will be transferred by October 25, 2013. Any patients currently in labor will be allowed to finish labor and will be transferred to the hospital after labor. All currently scheduled inductions will be delayed until the inpatient unit is ready. All OB/GYN (obstetrics/gynecology) physicians with privileges at Mercy will be informed that the Birthing Center will be temporarily unavailable. This notice will be provided by October 25, 2013. Mercy's President and/or designee shall be responsible for ensuring continued compliance and will be responsible for overseeing the implementation of the Plan of Abatement. The survey team verified the CAH's plan and determined the Immediate Jeopardy situation abated on 10/24/13 at 3:58 p.m. Three registered nurses provided care to the one laboring patient remaining in the Birthing Center. Condition level noncompliance remained post abatement.

Based on observation, record review, review of the Critical Access Hospital (CAH) governing body bylaws, review of CAH policies and procedures, and staff interview, the governing body failed to ensure care in a safe environment consistent with the acuity and needs of the patients for 1 of 1 outpatient obstetrics (OB) unit (Birthing Center). Provision of care for high risk patients in the outpatient setting placed both the obstetric patients and their fetuses at risk for life-threatening complications.

Findings include:

Review of the governing body's bylaws titled "Amended and Restated Bylaws of Mercy Medical Center" occurred on 10/22/13. These bylaws, effective 06/04/09, stated,
". . . Section 6.1 General Powers. . . . the Board of Directors shall establish corporate policies for, and formulate the basic rules and regulations governing, the operation and management of the Corporation, and shall generally oversee and be responsible for the planning of health care services and the quality of care . . .
Section 9.4.1 The Medical Staff shall be responsible to the Board of Directors for providing appropriate professional care to patients. . . .
Section 9.4.2 The Board of Directors . . . shall delegate to the Medical Staff initial authority for ensuring quality professional care is furnished to patients. . . ."

Review of the medical staff's bylaws titled "Mercy Medical Center Bylaws" occurred on 10/22/13. These bylaws, effective 02/02/13, stated,
". . . 4.3 Basic Responsibilities of Individual Staff Membership
Each member of the Medical Staff shall: . . .
4.3.2 provide his/her patients with an acceptable level of quality care . . ."

Review of the policy "Outpatient Birthing Center" occurred on 10/22/13. The undated policy stated, ". . . SERVICES: The outpatient birthing center operates 24 hours per day, seven days a week throughout the year, to care for patients needing obstetrical services. Maternal patients may be observed up to 23 hours after their delivery in the outpatient birthing center. Patients who develop post delivery complications requiring longer than 23 hour stay are transferred to the inpatient obstetrical unit. . . ."

- Observation of the inpatient OB unit occurred on 10/21/13 at 3:30 p.m. with an administrative OB nurse (#4). The nurse stated all vaginal deliveries occur in the outpatient Birthing Center. The nurse (#4) stated most patients spend approximately 24 hours post recovery at the outpatient Birthing Center prior to discharge. Nursing staff transfer patients requiring a longer stay to the inpatient OB unit. The nurse (#4) stated all Caesarian (C-section) births occur in an inpatient operating room and the patients recover on the inpatient OB unit.

The nurse (#4) stated the CAH has 14 Labor/Delivery/Recovery/Postpartum (LDRP) beds. There are eight LDRP beds at the Birthing Center, three LDRP beds on the inpatient OB unit designated as outpatient beds, and three located in the inpatient OB unit designated as inpatient beds.

- Observation of the outpatient Birthing Center occurred on 10/21/13 at 4:25 p.m. A labor and delivery nurse (#10) identified one current patient (Patient #1): a 28 year old pre-term patient at 29 weeks gestation with vaginal bleeding and a "low lying placenta." The nurse (#10) stated the patient was there for observation and could stay in the outpatient Birthing Center up to 48 hours.

Observation, on 10/21/13 at 4:55 p.m., showed Patient #1 resting in bed with a fetal heart monitor in place and intravenous (IV) fluids infusing. The patient stated she came to the outpatient Birthing Center the previous evening at approximately 11:00 p.m. due to "abnormal bleeding."

Review of Patient #1's medical record occurred on October 22-24, 2013. A nurse's note, dated 10/20/13 at 10:41 p.m., identified the patient presented to the Birthing Center with complaints of dark red bleeding since 7:00 a.m. that day. Physician's orders, dated 10/20/13 at 11:00 p.m., stated, "Observation - 29.4 wks [weeks], vaginal bleeding . . ." The record showed staff immediately placed a fetal heart monitor on the patient and inserted an IV at 11:15 p.m. The record showed continuous monitoring with the fetal heart monitor until the patient's discharge on 10/22/13 at 5:35 p.m. (approximately 43 hours after her arrival).

An interview with an administrative OB nurse (#4) occurred on 10/22/13 at 8:55 a.m. When asked how staff determine whether a patient should receive care in the outpatient Birthing Center or the inpatient OB unit, the nurse stated the CAH staff based their decision on the availability of staff trained in fetal monitoring and care during delivery. She stated nursing staff working in the inpatient OB unit provided postpartum and nursery care and are not trained in fetal monitoring or care during delivery.

- The web-site "mayoclinic.com" defines preeclampsia as "high blood pressure and excess protein in the urine after 20 weeks of pregnancy in a woman who previously had normal blood pressure. Even a slight increase in blood pressure may be a sign of preeclampsia. Left untreated, preeclampsia can lead to serious - even fatal - complications for you and your baby . . . risk factors . . . First pregnancy . . . Age. The risk of preeclampsia is higher for pregnant women younger than 20 and older than 40. Diabetes and gestational diabetes. Women who develop gestational diabetes have a higher risk of developing preeclampsia as the pregnancy progresses. . . complications of preeclampsia may include: . . . Preeclampsia increases your risk of placental abruption, in which the placenta separates from the inner wall of your uterus before delivery. Severe abruption can cause heavy bleeding and damage to the placenta, which can be life-threatening for both you and your baby. . . . "

Review of the policy "Stages of Labor - Patient Observation & [and] Care" occurred on 10/23/13. The policy, dated December 2002, stated, "Policy: Labor and delivery patients will be observed and cared for during the labor process while ruling out high risk factors . . . .
2. Maternal Risk Factors
a. Pregnancy induced hypertension
b. Gestational diabetes . . ."

Review of Patient #15's closed medical record occurred on October 22-24, 2013. A History and Physical (H&P), dated 10/18/13, stated, "History of Present Illness: Admission for induction of labor: 17 year old female presents with c/o [complaints of] Induction of labor for preclampsia. c/o prenatal care complicated by an episode of marginal placental abruption at 33 weeks . . . C/o worsening headache, blurred vision for past 2 days. . . . Assessments: 1. HIGH RISK PREGNANCY . . ."

The record identified Patient #15 arrived at the outpatient Birthing Center on 10/18/13 at 7:45 p.m. for induction of labor due to preeclampsia and delivered on 10/19/13 at 12:54 p.m. The patient remained in the outpatient Birthing Center until 10/19/13 at 6:30 p.m., when staff transferred her and her baby (Patient #16) to the inpatient OB unit. The patient spent approximately 23 hours in the outpatient Birthing Center.

During an interview on 10/22/13 at 3:30 p.m. an administrative obstetrics nurse (#4) again stated all OB patients in labor present to the outpatient Birthing Center. She stated the CAH has no criteria to assess which patients can safely deliver in the outpatient center and which require care in the inpatient setting. The nurse (#4) stated scheduled C-sections also present to the outpatient Birthing Center where staff perform a non-stress test (a test to assess the fetus's heart rate and movement) and provide pre-operative care. After staff complete the non-stress test, they transfer the patient to the inpatient operating room for the C-section, and following the C-section, patients recover in the inpatient OB unit.

- Review of Patient #14's closed medical record occurred on October 24, 2013. The record showed Patient #14 presented to the outpatient birthing center on 04/24/13 at 5:00 a.m. for a repeat C-section and showed staff attached the fetal heart monitor to the patient. The record indicated Patient #14 experienced labor contractions approximately every three to five minutes lasting 60-80 seconds. Staff inserted an IV, administered IV fluids, and transferred Patient #14 to the operating room at 7:00 a.m. for inpatient surgery.


12763


- Review of Patient #36's closed medical record occurred on October 21-23, 2013. A Progress Note, dated 04/25/13, identified Patient #36 as 39 years old and stated the following, "Assessments: 1. Pregnancy, first. . . 2. HIGH RISK PREGNANCY. . . 3. Diabetes mellitus complicating pregnancy, antepartum. . . 4. Blood coagulation disorder. . . " The Progress Note also identified a past medical history of pulmonary embolus (2006), Type II diabetes, and lung cancer at age 23.

The record identified on 05/02/13 at 4:37 p.m., Patient #36 "Presents to L&D for induction of labor. . . . Also has history of pulmonary embolism 2006 and Type 2 diabetes." At 4:45 p.m, "Patient [#36] admitted to LDR [Labor, Delivery, and Recovery] [Bed] 3." Interview with an administrative obstetrics nurse (#4) indicated LDR3 is in the outpatient Birthing Center. This staff member also confirmed Patient #36 presented to the Birthing Center, but was later taken to the hospital and admitted for a
C-section.

Physician's Orders identified on 05/03/13 at 6:25 p.m. (more than 25 hours after presenting to L & D) the hospital admitted Patient #36 to inpatient obstetrics for delivery by C-section. Interview with an administrative nursing staff member (#6) on the afternoon of 10/22/13 confirmed the hospital admitted Patient #36 at this time.


20497

Based on observation and staff interview, the Critical Access Hospital (CAH) failed to store drugs and biologicals in a secure manner to prevent access by unauthorized personnel in 1 of 2 operating room areas (Day Surgery Center). Failure of the CAH to adequately secure and restrict access of drugs and biologicals created an opportunity for unsafe and unauthorized use of medications.

Findings include:

Observation in the Day Surgery Center on 10/21/13 at 4:30 p.m. showed an unlocked medication cart stored in the corridor outside the operating rooms. The medication cart contained three vials of lidocaine, two vials of dextrose, two vials of calcium chloride, four vials of sodium bicarbonate, six vials of furosemide, and eighteen vials of dantrium.

During an interview on 10/21/13 at 4:30 p.m., a surgical nurse (#9) identified the unlocked medication cart as the "Malignant Hyperthermia" cart for the Day Surgery Center. She confirmed the cart lacked a break away lock and stated they were unsure of where the key was to lock the cart.

Based on record review, review of professional reference, and staff interview, the Critical Access Hospital (CAH) failed to analyze causative factors of medication errors and implement corrective action to prevent further errors in administration of medications for six of six months reviewed (April through September 2013) as evidenced by review of 11 of 11 medication error/occurrence reports. Failure to take a proactive approach to medication errors/occurrences has the potential to affect all patients served by the CAH.

Findings include:

Berman and Snyder, "Fundamentals of Nursing, Concepts, Process, and Practice", 9th ed., Pearson Education, Inc., New Jersey, page 862, stated, ". . . When administering any drug, regardless of the route of administration, the nurse must do the following: 1. Identify the client. Errors can and do occur, usually because one client gets a drug intended for another. . . . 3. Administer the drug. Read the MAR carefully . . . Certain aspects of medication administration are important for the nurse to check each time a medication is administered. . . . Right medication . . . Right dose . . . right time . . . right route . . . right client . . ."

Review of the CAH's Incident Activity Listing (a form used to document incidents, including medication errors) from April 2013 to September 2013 identified the following:
* Six incidents of Lovenox (an anticoagulant medication) omitted or administered late.
* One incident of Bicitra (an antacid) ordered for "now" and not administered to the patient.
* One incident of an IV (intravenous) antibiotic medication administered to the wrong patient.
* One incident of an antibiotic medication administered intravenously rather that orally.
* One incident of the wrong dose of Kayexalate (used to treat high potassium levels in the blood) administered.

The incident reports lacked evidence the CAH analyzed the errors/occurrences to determine the effects to the patient, identified trends or patterns, and lacked evidence of corrective action to decrease the chances of further errors.

An interview occurred on the afternoon of 10/23/13 with two administrative staff members (#17 and #18). The staff member (#17) stated the Pharmacy and Therapeutics (P&T) Committee meets quarterly. Review of the Infection Control/Pharmacy & Therapeutics Meeting Minutes revealed the committee met twice in the past year, October 2012 and August 2013. The CAH bylaws require this committee to meet quarterly (four times a year).


15707

Based on policy review, minutes review, and staff interview, the Critical Access Hospital (CAH) failed to have the required group of professionals annually review their health care policies for 1 of 1 year reviewed (2012). Failure to have the required group annually review their policies limits the CAH's ability to ensure staff members properly treat and care for their patients.

Findings include:

Review of the policy "Policy and Procedure Development, Revision, Review" occurred on 10/23/13. This policy, effective 05/98, stated,
"Purpose
Ensure that policies and procedures are reviewed every year and developed, revised or deleted as necessary according to state, federal or [name of accrediting agency] regulations, or when changes in standards of practice occur. . . ."

Review of the 2012 Policies and Procedures Committee Minutes occurred on 10/23/13. These minutes lacked evidence of annual policy review by the required group of professionals including a physician; a physician assistant, nurse practitioner, or clinical nurse specialist; and a non-staff member.

The CAH provided no other evidence of annual review of their policies and procedures by the required group of professionals.

During an interview at 09:50 a.m. on 10/23/13, an administrative staff member (#7) confirmed the required group of professionals had not reviewed their policies in 2012.

Based on observation, record review, policy review, and staff interview, the Critical Access Hospital failed to ensure provision of care in accordance with the patient's needs for 1 of 1 active obstetric (OB) patient (Patient #2) and 1 of 1 closed OB patient's record (Patient #15) transferred from the outpatient Birthing Center to the inpatient OB unit. Failure to complete an admission assessment does not allow staff to determine the unique needs of each patient and provide care in accordance.

Findings include:

Review of the policy "Admission of Patient" occurred on 10/24/13. The policy, revised in July 2012, stated, "Policy: Patients are admitted to Mercy Medical Center by physician order and are assessed by a RN [registered nurse] per policy. Patients are placed in a unit and room that meets medical need, nursing, privacy, and infection control needs. . . . "

- Observation on 10/21/13 at 4:20 p.m. showed Patient #2 occupied a bed in the inpatient OB unit. Review of Patient #2's active medical record occurred on October 22-24, 2013. The record showed the patient delivered on 10/20/13 at 10:24 p.m. in the outpatient Birthing Center. The record failed to identify when staff transferred the patient to the inpatient OB unit and lacked an admission assessment to determine her unique care needs at the time of her transfer to the inpatient OB unit.

- Review of the closed medical record for Patient #15 occurred on October 22-24, 2013. The record showed the patient delivered on 10/19/13 at 12:54 p.m. Staff transferred Patient #15 to the inpatient OB unit on 10/19/13 at 6:30 p.m. The record failed to identify nursing staff performed an admission assessment to determine the patient's unique care needs for her inpatient stay.

During an interview on 10/22/13 at 3:30 p.m., an administrative OB nurse (#6) stated staff used one chart for the entire stay (from entrance to the outpatient Birthing Center through discharge as an inpatient at the Critical Access Hospital). She stated staff admit patients to the outpatient Birthing Center for delivery and do not perform an admission assessment when the patients enter the inpatient OB unit.

During an interview on 10/22/13 at 4:30 p.m. an administrative staff member (#5) stated the CAH did not admit patients to the outpatient Birthing Center. He stated admission occurs when staff transfer the patient to the inpatient OB unit.

Based record review, review of hospital policy, review of professional literature, and staff interview, the Critical Access Hospital (CAH) failed to ensure nursing staff read back and verified verbal and/or telephone orders received from the patient's provider for 9 of 36 closed patient records (Patient #14, #17, #22, #25, #26, #29, #30, #32, and #35) reviewed. Failure of nursing staff to repeat and verify verbal or telephone orders to ensure accuracy may result in medication and/or treatment errors.

Findings include:

Review of the CAH policy titled ""Physician Orders" occurred on 10/25/13. This policy, revised October 2010, stated, ". . . Order requirements: . . . All verbal and telephone orders are written and read back to the physician as received 'verbal read back' . . ."

Berman and Snyder, "Kozier and Erb's Fundamentals of Nursing, Concepts, Process, and Practice," ninth edition, Pearson Education Inc., Upper Saddle River, New Jersey, 2012, page 269, stated, ". . . Telephone Orders: Primary care providers often order a therapy (e.g. [for example], a medication) for a client by telephone. . . . While the primary care provider gives the order, write the complete order down on the physician's order form and read it back to the primary care provider to ensure accuracy. . . . Have the primary care provider verbally acknowledge the read-back of the verbal/telephone order. Then indicate on the physician's order form that it is a verbal order (VO) or telephone order (TO). . . ."

Review of Patient #14, #17, #22, #25, #26, #29, #30, #32, and #35's closed medical records occurred on October 22-24, 2013. The records showed nursing staff received verbal and telephone orders from the patients' providers throughout their hospital stays. The nursing staff did not specify whether they read back and verified the verbal and telephone orders.


32641


During an interview on 10/24/13 at 9:40 a.m., an administrative staff nurse (#1) stated nursing staff must specify orders received from the patient's provider as verbal or telephone and must perform the "read back and verified" process to ensure accuracy of the order. The nurse stated nursing staff must document this process within the patient's medical record.

Based on record review, review of hospital policy, and staff interview, the Critical Access Hospital (CAH) failed to ensure all medical records contained provider orders, including the date of the order and the signature of the person authorizing the order, for 2 of 12 active patient records (Patient #7, and #8) and 1 of 36 closed patient records (Patient #22) reviewed. Failure to ensure providers dated and signed orders limited the CAH's ability to verify accurate treatment necessary for patient safety and quality of care.

Findings include:

Review of the hospital policy titled "Transfusion Procedure for Blood and Blood Components" occurred on 10/24/13. This policy, revised October 2011, stated, ". . . The consent form is signed by the patient (or the authorized representative of the patient if patient is unable to), physician and witnessed by the nursing staff. . . ."

Review of Patient #7, and #8's active medical record and Patient #22's closed medical record occurred on October 22-23, 2013. Review of the records showed the provider failed to sign and date the following:
* The blood transfusion consent forms for Patient #7 and #22.
* The Department Record Physician Order Sheet for Patient #8.


32641


During an interview on 10/24/13 at 9:40 a.m., an administrative nurse (#1) stated all providers must sign and date all orders written in the medical record, including the blood transfusion consent forms.

Based on observation and staff interview, the Critical Access Hospital (CAH) failed to provide safeguards against loss, destruction, or unauthorized use of medical records for 1 of 2 medical record storage areas in the basement of the hospital (storage room across from the pain clinic). Failure to store records in a secure manner limited the CAH's ability to prevent loss or destruction of records and to ensure the maintenance of patient confidentiality.

Findings include:

Observation on 10/23/13 at 5:00 p.m. identified an unlocked storage room containing medical records in the basement across from the pain clinic. The latch on the door to the storage room was broken.

During an interview on 10/23/13 at 5:00 p.m., a maintenance staff member (#11) confirmed the latch on the door was broken.

Based on bylaws review, policy review, report review, and staff interview, the Critical Access Hospital (CAH) failed to ensure the Quality Assurance (QA) program evaluated all patient care services and other services affecting patient health and safety for 12 of 12 months reviewed (July 2012-June 2013). Failure to ensure departments report to the QA Committee limits the CAH's ability to identify risk factors affecting patient care and implement corrective action if necessary.

Findings include:

Review of the governing body's bylaws titled "Amended and Restated Bylaws of Mercy Medical Center" occurred on 10/22/13. These bylaws, effective 06/04/09, stated, ". . . Section 8.8 Medical Staff and Quality Improvement Committee
The Medical Staff and Quality Improvement Committee also shall have the responsibility for monitoring hospital performance relative to the quality of patient care and overall service quality. It shall perform these duties and responsibilities by reviewing policies, programs, activities, and data to assure the integration of Mercy Medical Center's Mission, Core Values, and the principles of continuous quality improvement in all activities and affairs of the organization. . . ."

Review of the medical staff's bylaws titled "Mercy Medical Center Bylaws" occurred on 10/22/13. These bylaws, adopted 02/03/11 and revised 02/02/13, stated,
". . . 14.3 Quality and Peer Review Committee
14.3.2 Duties
The Committee's primary function is to improve patient care through identification of opportunities for improving the system in which care is delivered. The quality and appropriateness of services will be reviewed, evaluated and recommendations made to the Medical Executive Committee based on the results of the monitoring activities. . . ."

Review of the policy titled "Mercy Medical Center Quality Management Program FY [Fiscal Year] 2013" occurred on 10/23/13. This undated policy stated,
"Purpose
Mercy Medical Center (MMC) has implemented a Quality Management Plan to provide an ongoing, effective, systematic process to monitor, evaluate and improve services and care provided to its customers. . . .
Authority and Responsibility
The Mercy Medical Center Governing Board has delegated the Board of Directors Quality Committee the authority and responsibility for implementing, maintaining, evaluating and reporting on the Quality Management Plan and other quality related activities. . . .
Department Quality Activities
. . . all departments providing direct patient care services are required to establish an annual plan. . . ."

Reviewed on 10/23/13, the QA reports for monitoring conducted in FY 2013 (July 2012-June 2013) indicated the following departments did not submit reports:
Day Surgery - 1st, 2nd, 3rd, and 4th quarters
Anesthesia - 1st, 2nd, 3rd, and 4th quarters
Maintenance - 1st, 2nd, 3rd, and 4th quarters
Post Anesthesia Recovery - 2nd, 3rd, and 4th quarters
Respiratory - 2nd and 4th quarters

During interview the afternoon of 10/23/13, an administrative staff member (#7) confirmed the above listed departments had not submitted quarterly QA reports in FY 2013 and she expected departments to submit quarterly reports.

Based on bylaws review, policy review, credentialing files review, and staff interview, the Critical Access Hospital (CAH) failed to have a network hospital or a quality improvement organization (QIO) or equivalent evaluate the quality and appropriateness of the treatment furnished by 5 of 5 physicians' (Physicians #1, #2, #3, #4, and #5) reappointment records reviewed. Failure to have a network hospital or a QIO or equivalent evaluate the quality and appropriateness of the treatment furnished by the physicians limits the CAH's ability to ensure the physicians furnished quality and appropriate care to the CAH's patients.

Findings include:

Review of the medical staff's bylaws titled "Mercy Medical Center Bylaws" occurred on 10/22/13. These bylaws, adopted 02/03/11 and revised 02/02/13, stated, ". . .
4.3 Basic Responsibilities of Individual Staff Membership
Each member of the Medical Staff shall: . . .
4.3.2 provide his/her patients with an acceptable level of quality care . . .
8.2 Professional Criteria for Evaluating Applications . . .
8.2.5 Each final decision on reappointment and Privileges must consider information that relates to the applicant's competence and criteria that relate to quality of care. . . ."

Review of the governing body's bylaws titled "Amended and Restated Bylaws of Mercy Medical Center" occurred on 10/22/13. These bylaws, effective 06/04/09, stated, ". . . 9.4.2 The Board of Directors . . . shall delegate to the Medical Staff initial authority for ensuring quality professional care is furnished to patients. The Medical Staff shall discharge this responsibility through a continuing review, analysis, and appraisal of the quality of care rendered by members of the Medical Staff and other practitioners with delineated clinical privileges . . ."

Review of the policy titled "Medical Staff Peer Review" occurred on 10/23/13. This policy, revised 06/2012, stated,
"Policy: Mercy Medical Center and the medical staff are responsible for the quality of care provided to the patient population . . .
Definitions: . . . An outside reviewer shall be defined as an organization or individual appointed by the facility to perform review on cases as outlined in the 'External Review' description of this policy. . . .
Procedure: . . .
10. Trending reports of quality data will be presented to Quality and Peer Review Committee and/or Department Chairs for use in performance improvement activities as appropriate.
11. Physician quality data is reviewed and provided to the Credentialing Committee at the time physician is re-credentialed. . . .
External Review: Circumstances in which external peer review may be obtained include, but are not limited to:
- Ambiguous or conflicting recommendation from internal reviewers . . .
- When no physician on the medical staff has the expertise in the specialty under review
. . .
- The likelihood of legal recourse predominates the issues in question. . . .
-When a physician under review reports reviewer or committee as biased. . . .
- Medical Executive Committee request. . . ."

Review of the 2012-2013 physician's credentialing files occurred on 10/24/13 and included the following:
* Physician #1 reappointed 04/05/12
* Physician #2 reappointed 08/01/13
* Physician #3 reappointed 08/01/13
* Physician #4 reappointed 08/01/13
* Physician #5 reappointed 10/03/13

Reviewed on 10/24/13, the "Medical Staff Quality Peer Review Committee Case Review Data Base" 2013 records lacked evidence a network hospital or a QIO or equivalent evaluated the quality and appropriateness of the treatment furnished by Physicians #1-#5.

Upon request on 10/24/13, the CAH failed to provide evidence a network hospital or a QIO or equivalent evaluated the quality and appropriateness of the treatment furnished by Physicians #1-#5.

During interview at approximately 12:45 p.m. on 10/24/13, an administrative staff member (#7) confirmed Physicians #1-#5 provided services to the CAH's patients, and the CAH did not have a network hospital or QIO or equivalent evaluate the quality and appropriateness of the diagnosis and treatment furnished by these physicians.