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The hospital failed to promote and protect patient rights as follows:
1) Patient Rights information was not consitently provided [see A 117]
2) Grievance process information was not appropriately provided [see A 118]
3) The facility failed to identify each source of physical restraint implemented [ see A 159]
4) The facility made use of a physical restraint without a physician order or assessment [see A 161]
5) The hospital has incomplete seclusion policies [see A 167]
6) The hospital failed to renew restraint orders appropriately [see A 173]

Based on observation, interview and record review, the facility failed to document timely delivery of "An Important Message from Medicare" to 4 of 19 Medicare beneficiaries. Findings include:

On 3/1/10 at approximately 12 noon, patient #11 stated that she was informed earlier that day (3/1/10) that she was to be discharge from the Macomb site later that day and was not provided with a copy of "An Important Message from Medicare." Patient #11 was admitted 2/18/10. Review of the patient #11's medical record revealed no documentation that the Medicare notice had been provided. On 3/1/10 at approximately 12:15 p.m. the 5 Center Clinical Nursing Services Manager verified these findings.

On 3/2/10 at 9:35 a.m. record review at the Oakland facility revealed that patients #13 and #14 had no signed notices of the "Important Message from Medicare"in their charts. Per facility policy, a copy signed by the patient, verifying receipt within 2 days of admission, is to be retained in the patient's chart. Both patients had been at the facility more than 2 days. This information was verified by the employee #12, a Case Management Coordinator.

On 3/2/10 at approximately 1 p.m., patient #19's chart was reviewed with the Nursing Director-Macomb Site Lead. The patient was admitted on 2/26/10. The signed copy of the "Important Message from Medicare" letter was not found in the patient's chart.

On 3/2/10 at approximately 11 a.m. these findings were verified by the Director of Care Management. The facility policy titled "Issuing the Important Message from Medicare" states that the facility will put in place a process to issue this notice "upon admission and also within 1-2 days before discharge to all Medicare recipients." The process states that Registration associates shall have the patient sign a copy for the record or contact next of kin and mail the letter if the patient is unable to discuss or sign the letter.

Based on interview, document review, and observation, the hospital failed to inform admitted patients whom to contact to file a grievance. Findings include:

<1> Observations conducted respectively on 3-1- 2010 and 3-3-2010 on the hospital's Macomb Center and Oakland Center psychiatric units revealed that no information was available informing patients or guardians/personal representatives of the Center's for Medicare and Medicaid Services (CMS) 1-800 compliant hot line number or informing patients and guardians/personal representatives of the right to file a grievance with CMS. Examination of several patient rights booklets available on the psychiatric units revealed that the booklets did not contain any information regarding filing a grievance with CMS or the applicable CMS 1-800 complaint hotline number.

<2> Macomb Center and Oakland Center psychiatric unit managers interviewed respectively on 3-1-2010 and 3-3-2010 stated that psychiatric program staff did not have any information to provide to a patient or guardian/personal representative regarding a patient's or guardian's/personal representative's right to file a grievance with CMS or the applicable CMS 1-800 compliant hot line number.

<3> The 3-3-2010 review of the Oakland Center document entitled "Things to Know During Your Stay with Us" provided to a patient admitted to the Oakland Center's medical units revealed that the document did not include any information regarding a patient's or a guardian's/personal representative's right to file a grievance with CMS or the CMS 1-800 complaint hotline number. Review of the Macomb Center's version of the "Things to Know During Your Stay with Us" provided to patient ' s admitted to the Macomb Center ' s medical units revealed that it did include information regarding a patient ' s rights to file a grievance with the CMS designated State Agency and the CMS 1-800 complaint hotline number.

Based on interview, document review, and medical record review the hospital failed to ensure that the physical holding of a patient to administer forced medications is considered physical restraint. Findings include:

<1> Review of hospital Policy No. 612 entitled "Restraint of Patients on Non-Behavioral Health Units" revealed that while the Policy definition of Physical Restraint includes Human Physical Restraint (i.e. holding a patient in a manner that restricts his or her movement, including therapeutic holds) that constitutes behavioral restraint and requires a physician order, the policy does not note that the application of force to physically hold a patient in order to administer a medication against the patient's wishes is also considered restraint.

<2> Review of patient # 83's medical record, an 80 year old female who on 12-08-2009 was admitted to the Macomb site with a diagnosis of Dementia with Delusion and Behavioral disturbance, revealed that she was administered 5 mg of Haldol IM at 10 am and 6 pm on 12-10-2009. RN #39, interviewed 3-1-2010 stated that she recalled this particular patient as the patient had to be held to administer the Haldol. The RN stated that she did not consider the holding of a patient to administer medication against the patient ' s wishes a restraint episode.

<3> RN # 40, interviewed 3-1-2010, who compiles Macomb site's log of restraint episodes, stated that physically holding a patient is generally not reported for inclusion in the Center ' s restraint log and that holding a patient for forced administration of medication against a patient ' s is not considered physical restraint.

Based on interview and record review the facility failed to ensure that patient #9 was free of restraints that prevent functional use of both hands. Findings include:

On 3/2/10 at 9:45 a.m., patient # 9 was observed at the Oakland site, in bed, eating breakfast. Two bulky objects,identified as mitts, were observed at the foot of the bed. Each mitt measured approximately 3.5 inches thick and 11 inches long. The patient's nurse (employee #39) was asked to demonstrate the use of the device and explain why it was located at the foot of the bed. The nurse demonstrated how the mitts were applied, drawing the Velcro strap through the plastic wrist buckle. The wrist, hand and fingers were all contained in the mitt's single pocket. Nurse # 39 stated, "I took them off so she could eat breakfast" The nurse stated that he would assess the patient after breakfast to determine whether he would reapply the mitts.

The package instructions that came with the mitts state: "read all directions first before using product." ..."Restrictive devices should be used only after a full assessment of patient's needs, with proper medical authorization." The directions instruct the user to "check circulation often" and that the "patient should be checked every 60 minutes or more frequently"and to "use with side rails in the UP position."

The application directions state:
1."Place patient's hand in mitt and wrap ends around patient's wrist. Plastic buckle must be on bottom side of wrist."
2. "Run pile strap through buckle and pull firmly."
3. Secure pile strap by passing buckle over itself and pressing to section of hook strap attached to cuff to secure."

Under "General Precautions & Warnings," the product instructions state, "restrictive devices should be used only after a full assessment of patient's needs, with proper medical authorization" and recommends the use of a care plan "to minimize restraints and utilize least restrictive devices."

On 3/2/10 at 10 a.m. patient #9's clinical record was reviewed with the facility's Director of Inpatient Nursing Services. A nursing progress note indicated that he patient was admitted at 12:45 a.m. on 3/2/10 and was "combative with care" at that time. The next nursing note, at 3:30 a.m. states, "patient keep removing oxygen (nasal cannula)"... "mittens applied." There was no documentation of efforts to discourage removal of the oxygen nasal cannula prior to applying the mitts, no patient assessment following application of the mitts and no care plan for their use.

The facility Director of Inpatient Nursing Services stated that the facility does not consider the use of mitts to be a restraint. Facility policy #612, titled "Restraint of Patients on Non-Behavioral Health Units," defines a restraint as: "Any method of involuntarily restricting a person's freedom of movement, physical activity or normal access to his body." Mitts are included as "Protective/Adaptive Devices," described as "Devices used for postural support, to assist with, maintain, or enhance normal body functioning or to compensate for a specific physical deficit." Facility policy states that the use of these devices is to "follow customary care practices, patient plan or care or clinical pathway."

On 3/3/10 at approximately 3:45 p.m. patient #9 was observed asleep in bed. She was not wearing mittens but they were visible in the top drawer of her bedside table . Record review revealed no documentation related to the use of mitts since 3/2/10 at 3:30 a.m. There was no documentation of physician notification or a care plan for the use of mitts. This was verified by the facility's Director of Inpatient Nursing Services.

On 3/4/10 at approximately 9:45 a.m. the Director of Nursing-Site Lead for Macomb Center was asked to provide documentation regarding staff training regarding use of mitts. No documentation of staff training related to proper application of mitts was available. A powerpoint used for on-line staff training was provided. It defines a restraint as "any device or drug that is used with the intent of restricting the patients' movement or behavior."

Based on document review and interview, the hospital failed to ensure that it established a policy/procedure to be followed if a patient was secluded on one of the hospital ' s medical units or Emergency Department at the Macomb Center or Oakland Center. Findings include:

<1> Review of hospital Policy No 612 entitled "Restraint of Patients on Non-Behavioral Health Units" revealed that the policy included a definition of "Seclusion" consistent with the requirements found at 42 CFR 482.13(e)(1)(ii). Policy No. 612 did not provide any further information regarding the use of seclusion.

<2> Macomb Site Lead Nursing Director, interviewed 3-2-2010, confirmed that the hospital did not have a seclusion policy that would apply if a patient was secluded on one of the hospital's medical units or in the Emergency Department's safe/observation room.

Macomb Site Lead Nursing Director Interviewed RN #2 further confirmed that the hospital does not have a policy that prohibits the seclusion of a patient on a hospital medical unit or in the hospital's Emergency Department's safe/observation room.

<3> Review of hospital Policy No. 125 entitled "Seclusion" revealed that it only applies to the hospital ' s psychiatric inpatient units.

Based on document and medical record review, the hospital failed to ensure in 3 of 7 restrained patients that that the order for restraint used to ensure the physical safety of the non-violent or non-self-destructive patient was renewed as authorized by hospital policy. Findings include:

<1> 3-1- 2010 review of hospital Policy No. 612 entitled " Restraint of
Patients on Non-Behavioral Health Units " revealed that the policy states:

(a) " An order must be obtained (for safety/medical restraint) as soon as possible, but no more than 12 hours after initiation. The physician must conduct a face to face evaluation and assessment within 24 hours of restraint application for any patient restrained for safety purposes. (Section POLICY - Safety/Medical Restraint B 2) ."

(b) " Restraints used to maintain the safety of the patient must be re-evaluated and reordered a minimum of every 24 hours (Section POLICY -Safety/Medical Restraint B 2) ."

<2> 3-1-2010 review of the physician's Safety/Medical Restraint Order sheet revealed that check boxes consisting of the following options are to be completed as clinical justification for the ordering of restraint: (a) Cognitive impairment interferes with care, (b) Interferences with medical devices, and (c) Wandering interferes with care. The physician order form does not provide space for noting behavioral specific assessment findings (i.e. patient attempting to extubate self, remove IV lines, remove bandages, etc) that constitute the primary factor for ordering restraint.

<3> Review of patient medical records revealed that in the following instances physician progress note documentation written at the time that the physican re-ordereed restraints did not reference assessment findings regarding patient behaviors requiring restraint use or that the patient required restraint interventions for patient safety:

(a) Patient #87, restraints for patient safety re-ordered 1-19-2010 @ 1100.

(b) Patient #97, restraints for patient safety re-ordered 2-13-2010 @ 0900, 2-14-2010 @ 0900, 2-15-2010 @ 0900, 2-16-2010 @0900, and 2-17-2010 @ 0900.

(c) Patient # 98, restraints for patient safety re-ordered 2-13-2010 @1300, and 2-14-2010 @1300.

Based on record review, interview and policy review, it was determined that the hospital failed to ensure that physician's orders were dated, timed and authenticated in a timely manner for 27 of 47 patients. Findings include:

On 3/3/10 at 1:40 p.m., 6 closed records (patient #s 76, 77, 78, 79, 80, 81) were reviewed. All patients had been discharged from the facility for more than 30-days. All 6 patient records contained incomplete physician's orders; missing signatures, dates, or times. On 3/4/10 at 9:30 a.m., these findings were verified with the Operations Manager of Health Information Management.

Facility policy 2.7 MO-Page 1,titled "Orders: Diagnostic and Therapeutic Written, Telephone, Verbal" states:
2. "All orders should include the date, time, and appropriate signature."
3. "All orders should be signed by a physician or licensed and credentialed designee within 48 hours."


27408


On 3/02/10 between 1:00 pm and 5:00 pm while reviewing open and closed medical records of the Surgical Department, and the Medical Surgical Units, 10 of 12 medical records (#22, #65, #72, #73, #74, #107, #109, #111, #113, and #114) were absent of physician signatures, dates and times on the verbal and telephone orders. The closed charts were incomplete. The open charts were flagged with "sign here" tabs dating back to February 23, 2010.




28267

On 3/01/10 between 11:00 am and 4:00 pm while reviewing open medical records while on tour of the Emergency Department, Intensive Care Units, and the Stepdown Unit 5 of 7 medical records (#23, #24, #25, #26, and #29) were absent of physician signatures, dates and times on the verbal and telephone orders. The charts were flagged with "sign here" tabs dating back into February 2010.


28273


During record review on 03/01/10 and 03/03/10, 6 of 6 records reviewed (patients #34, 35, 62, 104, 115 and 145) contained incomplete physician orders. Patient #34's medical record contained a physician's order dated 02/25/10 as a telephone order that did not contain a physician's signature, date or time. Patient #35's medical record contained a physician's order dated 02/25/10 as a telephone order that did not contain a physician's signature, date or time. Patient # 62's medical record contained a physician's order dated 01/10/10 as a verbal order that did not contain a physician's signature, date or time. Patient # 104's medical record contained a physician order dated 02/02/10 as a telephone order that contained no physicain's signature, date or time. Patient #115's medical record contained a physician's order dated 01/16/10 as a standing order that did not contain a physician's signature, date or time. Patient #145's medical record contained a physician's order dates 01/11/10 as a telephone order that did not contain a physician's signature, date or time.

Based on policy review, record review and interview, the facility failed to ensure that verbal orders are authenticated within 48 hours. Findings include:

St. John Macomb-Oakland Hospital policy 2.7 MO reads 3. "All orders should be signed by a physician or licensed and credentialed designee within 48 hours." Review of in-patient medical records on 03/01/10, revealed that 2 of 2 records (patient #34 and patient #35) had telephone orders written on 02/25/10 that had not yet been authenticated by a physician.
During interview with staff #24 on 03/01/10 at 1:00 PM, it was confirmed that telephone and verbal orders are to be signed by the physician within 48 hours.

During review of closed medical records on 03/03/10, it was revealed that 4 of 4 patient records (#62, #104, #115 and #145) contained verbal orders or telephone orders that were not signed by the physicians. All 4 records were more than 30 days since discharge.
During interview with staff #21 on 03/03/10 at 1:30 PM, it was confirmed that all orders are to be authenticated by the physician within the 48 hour time frame.

Based on interview and record review the facility failed to complete medical records within 30 days of discharge. Findings include:

On 3/4/10 at approximately 11 a.m. the Lead Health Information Management Assistant provided data indicating that on 3/2/10 there were 333 patient charts that were incomplete at least 30-days post discharge. The following areas were analyzed to determine delinquency: history and physical, discharge summary, progress notes, consultations, operative report, and medication reconciliation.

On 3/04/10 at approximately 10:25 am during a tour of the Surgical Department, in the sterile processing area, the crash cart had four (4) boxes of Epi 1:10,000 that expired in 1/2010. Staff #29 confirmed the findings.



28267

Based on observation and interview the facility failed to ensure that outdated, mislabeled, or otherwise unusable drugs were not available for patient use. Findings include:

On 3/04/10 at approximately 10:45 am during a tour of the Emergency Department, the medication room refrigerator had one (1) vial of Lantus insulin open and not dated and five (5) cartridges of Tetanus vaccine that expired in 12/09. Staff #15 confirmed the finding.

On 3/04/10 at approximately 1:30 pm during a tour of the Stepdown Unit next to the Intensive Care Units in the medication room was a bottle of Hydrogen Peroxide open and not dated. In the hallway in the "heart cart" was a bottle of Lidocaine 1% open and not dated. Staff # 19 confirmed the finding.

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 A-710.

Based upon on-site observation and document review by Life Safety Code (LSC) surveyors, 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 for Life Safety Code dated March 9, 2010.

The Oakland campus does not provide sufficient facilities to provide basic care as evidenced by:

1. PACU patient cubicles only measured 5 feet by 8 feet versus the required 8 feet by 10 feet. As such they do not provide emergent access, or effective sneeze/coughing isolation distances between patients.

2. Pre-operative preparation patient cubicles only measured 6 feet by 8 feet versus the required 8 feet by 10 feet. As such they do not provide emergent access, or effective sneeze/coughing isolation distances between patients.

Supplies and equipment were not safely kept as evidenced by:

1. Uncleanable acoustical ceiling pads were found in Oakland campus air borne isolation rooms 413A, 413B, 513A, 513B, 613A, 613B, endoscopy, and PACU on March 3, 2010. As such air borne pathogens from one patient could be trapped and later released to infect other patients or staff.
2. Doors between air borne isolation rooms and adjoining ante-rooms at the Oakland campus are not equipped with required closers to rooms 413A, 413B, 513A, 513B, 613A, 613B, endoscopy, and PACU on March 3, 2010. As such air borne contaminants are not automatically contained in the room.
3. No handwashing facilities were found in the Oakland campus histology room on March 3, 2010. As such proper hand hygiene cannot be maintained.
4. The required reduced pressure zone backflow device was not found on March 4, 2010 on the Macomb campus radiology film processor to protect the hospital ' s drinking water supply from chemicals used in film processing.
5. Crash carts at the Macomb campus were not kept within line of sight of a continuously staffed location (nurse station) on 2 Northwest (2), 3 Center (2), 4 Center, 5 Center, 6 Center, 7 Center, and 7 West on March 2, 2010 as needed to provide security for medications.
6. Defibrillators were not plugged into emergency powered receptacles on March 2, 2010 to ensure that they are always available on 2 Northwest, 3 Center, 4 Center, 5 Center, and 7 West inpatient nursing units at the Macomb campus.
7. Crash carts were found stored (with the defibrillator plugged in) in the corridors of 4th and 6th floor inpatient nursing units on the Oakland campus on March 3, 2010. As such the required means of egress is not maintained.
8. The Macomb campus pharmacy was found in contain a shipping pallet, coffee maker, soft drink cans, several coffee cups, refrigerator storing staff food, Tupperware , coat rack, and purse on the morning of March 4, 2010. Each of these items could potentially contaminate pharmaceuticals. Shipping pallets cannot be cleaned and cannot be cleaned underneath. Staff food and drink is strictly prohibited from any patient care support area. Staff personal items can transmit disease from home or public settings.
9. Patient care supplies were found kept outside of shipping boxes in an open warehouse environment at the Macomb campus on the afternoon of March 4, 2010 where they were exposed to friable fireproofing and the extreme accumulations of dust on top of exposed ductwork and piping.

Required safety equipment was not provided as follows:

1. The required MiOSHA compliant eyewash was not found during the March 3, 2010 survey in the Oakland campus lab, at the Macomb campus 6 West dialysis suite on March 2, 2010, or downstairs at the Macomb campus on March 4, 2010 where boiler additives are handled.

2. The required MiOSHA compliant trench shower was not found on March 3, 2010 in the Oakland campus lab.

Adequate lighting was not provided to support various tasks as listed below:

1. Levels of artificial illumination were measured and did not meet standards at the Oakland campus as follows:
a. Only 60 - 80 footcandles (fc) in operating room #5 versus the required 150 fc;
b. Only 12 fc in radiology room #2 versus the required 30 fc;
c. Only 7 fc in the 5th floor common shower versus the required 30 fc.

2. Levels of artificial illumination were measured and did not meet standards at the Macomb campus as follows:
a. Only 45 - 95 footcandles (fc) in operating room #7 versus the required 150 fc;
b. Only 2 fc in 4 Center and 5 Center equipment storage rooms versus the required 20 fc;
c. Only 6 fc in the 5 Center common shower versus the required 30 fc;
d. Only 7 fc in the toilet room serving patient room 553 versus the required 30 fc;
e. Only 4 fc in the 5 West common shower versus the required 30 fc;
f. Only 23 fc in the 4 Center common shower versus the required 30 fc;
g. Only 4 fc in the 4 West common male shower versus the required 30 fc.

Based on record review, interview and policy review, the facility failed to follow policies and procedures for responsibilities of organ procurement. Findings include:
St. John Macomb-Oakland Hospital policy 2.29 MO, reads under 4. "report all deaths within 1 hour."

Review of the documentation from the Gift of Life provided by Macomb Center on 03/02/10, revealed that during the period of 02/01/10 to 03/01/10 there were 10 of 56 (Patient #s 125 - 134) deaths that were not reported within the 1 hour time frame.
Interview with staff # 6 and 7 on 03/02/10 at 12:40 PM, they confirmed that the deaths were not reported to the Gift of Life within 1 hour.
Review of documentation from the Gift of Life provided by Oakland Center on 03/03/10, revealed that during the period of 12/01/09 to 01/01/10 there were 9 of 28 (Patient #s 135 - 143) deaths that were not reported within the 1 hour time frame.
Interview with staff # 11 on 03/03/10 at 9:45 AM, she confirmed that the deaths were not reported within the 1 hour time frame established by the hospital policy.

Based on observation, it was determined that standards of care were not maintained for surgical supplies. Findings include:

At approximately 2:00 P.M. on March 3rd during a tour of the Oakland campus surgical suite poor infection control practice [the potential cross contamination of supplies] was witnessed. Several plastic wrapped sterile packs were discovered to be stored on the floor of a supply room. When the surveyor indicated the packs were not stored in a manner that promoted safe and clean supplies, the surgical nurse manager #1 picked them up and placed them on the shelves with other clean packs [making them available for immediate use] without attempting to segregate the packs from clean supplies or attempting to ensure that the packs were adequately clean.