Massachusetts General Hospital
Summary of 2010 CMS Validation Survey Findings

If you have any questions or comments about the CMS validation survey or the findings, please contact John Belknap, MGH director of Corporate Compliance at, (617) 726-5109; or Gregg Meyer, MD, MGH/MGPO Senior Vice President for Quality and Safety at, (617) 724-9194.


Given the technical detail of the survey report and plans of correction, we have summarized the highlights of both below. We have included the section of regulation cited in each finding for easy reference. The report itself has been redacted to protect patient privacy, and the PDF is included in the link at the end of this summary.

  1. Compliance with Federal, State and local laws (§ 482.11)
  2. What did CMS find?

    During a review of the personnel file of a re-hired MGH Police and Security Officer, CMS surveyors were unable to locate that employee’s criminal background check. However, the criminal background check was completed within the timeframes required by MGH policy.

    Why is this important?

    To ensure the personal safety of patients and staff, employees must pass a criminal background check to be employed by the hospital. This includes any employees who leave but are subsequently re-hired into the organization.

    What are we doing about it?

    A copy of the criminal background check was provided to CMS, and is now included in that employee’s personnel file. The MGH remains in full compliance with this standard.

  3. Governing Body (§ 482.12)
  4. What did CMS find?

    CMS surveyors identified issues in our processes of privileging and credentialing our physician staff and health professionals in expanded roles such as Physicians’ Assistants (PAs) and Nurse Practitioners (NPs). CMS regulations require that the Board of Trustees approve the privileges and credentials of all members of our physician staff and allied health professionals in expanded roles before they begin practicing in our institution. The regulations also require that our medical staff bylaws include explicit criteria for granting such privileges.

    The surveyors identified instances where staff, whose credentials had been reviewed by our Chiefs of Service, began practicing prior to the date of official MGH Board of Trustees approval. CMS also deemed that our medical staff bylaws were not specific enough in identifying criteria for the granting of privileges and credentials. Finally, they felt that the information presented to the Board for credentialing and privileging was incomplete.

    Why is this important?

    Clinical privileges and credentials delineate which services our providers are allowed to render to our patients. The standards and processes that support the granting of these privileges and credentials must be explicit and rigorous. Given its role , the Board of Trustees has been involved in this process. Nevertheless, the timing of Board review could be improved, and the documentation of this process – including medical staff bylaws and any materials reviewed by the Board of Trustees – must be complete and accurate.

    What are we doing about it?

    The MGH is revising its process for obtaining Board of Trustees approval for credentials and privileges so that it complies with CMS standards. All physician staff and allied health professionals in expanded roles will be required to receive approval from either a special subcommittee of the Board on privileges, or from the full Board prior to beginning clinical practice. The information presented to the Board on privileges and credentials will be expanded to meet all elements required by CMS standards. Finally, the medical staff bylaws will also be amended to more fully reflect the criteria for granting both credentials and privileges.

  5. Patient Rights (§ 482.13)
  6. What did CMS find?

    Based on a list of MGH safety events provided to the survey team, CMS surveyors reviewed a medically-complex patient that experienced a serious event involving physiologic monitoring during January 2010. The crisis alarm setting on this patient's heart monitor had been inadvertently turned off, delaying the response of the care team to a medical emergency. Tragically, the patient died. Immediately following the incident, MGH staff contacted the hospital's Center for Quality & Safety, which reported the incident to the Department of Public Health. The hospital also began a comprehensive investigation to identify the underlying causes and to put immediate revised safety measures in place, including inspecting every one of the hospital’s 1,100 cardiac monitors, as well as the volume levels of the alarms.

    In addition to the physiologic monitor issue, surveyors identified several areas in which the MGH was not meeting the Conditions of Participation related to the use of restraints and seclusion of patients. Specifically, surveyors found deficiencies in the documentation of physician orders specifying the type of restraint that was to be used, restraints that had been reapplied following a surgical procedure without a new or updated physician order for those restraints, the lack of revised nursing plans of care as the needs for restraint evolved over time, documentation of training about the use of restraints, and telephonic notification of CMS when reporting deaths of patients for which restraints had been used.

    CMS surveyors also identified concerns that could potentially compromise patient privacy. These included the accessibility of the “green books”—which contain information on patient vital signs—on the inpatient units to individuals who did not have a need to know about patient information, visibility of white boards displaying patient identifiers and room numbers on some patient care units, video camera screens that were visible to those who had no need to view the patient, protected health information that was overheard in several off-site practices, and concerns related to protected health information that could be accessed from offsite computers over the web through email.

    Finally, CMS expressed concerns about the hospital’s response to patient complaints and grievances, specifically that acknowledgement letters to those who have submitted complaints must include a date stating when the complainant should expect to receive a response.

    Why is this important?

    It is important for the hospital to ensure that it is taking the best possible care of every patient and family. As an integral part of providing high quality patient care, physiologic monitors must function safely and effectively. The clinicians who use those monitors to care for patients must be able to hear them clearly on patient care units so that they can respond to medical emergencies in a timely way.

    Part of high-quality care also involves using the best practices for patient restraints. Restraints are used when necessary for the safety of the patients and those with whom the patient interacts, including family members, other patients and caregivers. Understanding that the restraint needs of patients can change frequently, hospital staff must continually reassess and re-document the use of restraints. When necessary, the least restrictive type of restraint should be used, and this determination should involve appropriate physician orders and documentation. Proper training is essential to ensure that all those involved in the use of restraints understand the various types of restraints, when they are called for, how they are to be used and how often to reassess their continued use.

    Patient privacy is at the very core of quality patient care. The MGH takes protection of patient privacy and confidential personal health information very seriously, and it is committed to taking the steps necessary to ensure that every reasonable effort is made to maintain patient confidentiality and privacy throughout the hospital.

    When patients have a concern or complaint about any aspect of their care, treatment, services, billing, or any other component of their health care experience, they must have a safe place to air these concerns and understand that their issues will be addressed in a timely, appropriate and fair manner. The Office of Patient Advocacy performs that role for the MGH. It is important for those complaints to be acknowledged and responded to in a timely manner, and to ensure that the hospital is doing this, patients must receive some sort of notice as to when they can expect to hear from the hospital about the resolution of the issue raised.

    What are we doing about it?

    High quality, safe patient care is the MGH’s highest priority. Should a patient safety concern arise, we take the situation very seriously, investigate it thoroughly, and take timely and appropriate steps to ensure that similar events cannot happen in the future. The MGH responded immediately and robustly to the physiologic monitoring incident prior to the CMS visit. The 'off’ option for crisis alarms was disabled on all bedside cardiac monitors, and at central monitoring stations on patient care units. Monitors were also set with standard default and minimum volume levels. A two-part educational program was launched for all staff on care units to ensure competency in using physiologic alarm, and reinforce the patient safety implications of responding to alarms in a timely way. Finally, as an interim step to enhance the timeliness of response to cardiac monitors, a nurse was stationed at every central monitoring station on general care (i.e.-non-ICU) units 24 hours per day, 7 days per week while the educational plans and other changes were implemented.

    As a permanent solution, the hospital accelerated its existing plan to install distributed speaker systems on all units with centralized physiologic monitors so that alarms can be clearly heard throughout the unit. The hospital’s biomedical engineering department has also developed a multi-step verification process when installing new and replacement bedside and central monitors to ensure they can be clearly heard in all parts of a patient care unit. All monitors will be carefully inspected as part of periodic scheduled maintenance. Bi-weekly audits evaluating the timeliness of response to physiologic alarms have, and will continue to be conducted on all general care units. Finally, the hospital is monitoring its safety reporting system for any physiologic monitoring-related issues reported by staff. These reports will be shared with senior nursing leadership for correction plans as appropriate.

    Regarding the use of restraints, the MGH has convened a multidisciplinary team to address the overall care and management of patients requiring restraint. As part of the improvement initiative, the team will review issues including the assessment of patients to determine if less restrictive methods would be effective in protecting the patient and to ensure that this assessment is documented in the medical record; documentation of the type of restraint device and extremities restrained; and documentation of the attempts to discontinue restraints when patient becomes less agitated. In addition, the team will review the restraint orders to ensure that they are up-to-date, have been filed by a physician and are using the least restrictive type of restraint.

    For privacy concerns identified by CMS surveyors, the MGH has already removed and/or relocated various white boards with patient names and taken steps to eliminate the specific issues identified regarding the possible access to patient names and information on several units. New cases are being constructed and installed to hold the green books containing patient information, and video monitoring has been changed in several places to ensure that the image is accessible only to the appropriate people who are directly in front of the video monitor screen. Regarding patient information that could be accessible via email on an offsite computer, the MGH has engaged in a hospitalwide campaign to require anyone who uses laptops from home or other offsite locations to have those laptops encrypted. In addition, an educational campaign is under way to explain privacy concerns about using email to access information about patients. The hospital is requiring staff to discontinue accessing private patient information via the website from an unencrypted offsite computer.

    The Office of Patient Advocacy has established specific time frames for review and resolution of grievances, including a time frame for the written response to the complainant that includes the date that the issues will be addressed. Reports of complaints and concerns will be created and these will be sent quarterly to quality and safety oversight committees. In addition, random audits will ensure that the appropriate documentation is ongoing.

  7. Quality Assessment and Performance (§ 482.21)
  8. What did CMS find?

    As part of the review, CMS surveyors questioned staff in various departments throughout the hospital about quality assurance and improvement efforts. In some of the locations, those staff members questioned were unable to describe in sufficient detail the departmental Quality Assessment and Performance Improvement (QAPI) efforts and explain how those departmental efforts tie into the larger institutional quality program.

    Why is this important?

    Delivering the highest quality and safest care to patients and families is the responsibility of all staff members. To ensure the most successful and broadest possible quality program, staff throughout the hospital must be familiar with it, understand the various quality efforts in their particular departments and programs, and be knowledgeable about how their quality efforts fit into the larger overarching quality program for the hospital.

    What are we doing about it?

    The MGH is focused on improving the integration of department-based quality programs into the hospital’s overall quality program by using the existing Quality Oversight Committee to receive reports about department-specific quality activities. The Quality Oversight Committee reports to the General Executive Committee and to the Board of Trustees Subcommittee on Quality of both the hospital and physicians organization. The Quality Oversight Committee is developing a schedule of updates for departments throughout the hospital to report on their individual quality measures and performance improvement activities to the oversight group at least once a year.

  9. Medical Staff (§ 482.22)
  10. What did CMS find?

    Similar to the findings under the Governing Body referenced in item #2, the CMS survey team cited the MGH for issues with our privileging and credentialing processes. Specifically, there were instances where physicians and allied health professionals in expanded roles (e.g. – Nurse Practitioners and Physician Assistants) began practicing prior to approval from the MGH Board of Trustees. Additionally, CMS did not believe that the information on privileging and credentialing currently presented to the Board of Trustees was complete enough.

    Finally, while MGH clinical policies and procedures have included requirements for the completion of history and physicals, our medical staff bylaws did not include these requirements.

    During survey, CMS also raised concerns about means of verifying the educational credentials of our physicians, known as “primary source verification.” The MGH clarified its existing primary source verification process with CMS, and they have accepted it as being in full compliance with regulations.

    Why is this important?

    Clinical privileges and credentials delineate which services our providers are allowed to render to our patients. The standards and processes that support the granting of these privileges and credentials must be explicit and rigorous. Given its role in overseeing hospital operations, the Board of Trustees has been involved in this process. Nevertheless, the timing of Board review could be improved, and the documentation of this process – including medical staff bylaws and any materials reviewed by the Board of Trustees – must be complete and accurate.

    What are we doing about it?

    The MGH is revising its process for obtaining Board of Trustees approval for credentials and privileges so that it complies with CMS standards. All physician staff and allied health professionals in expanded roles will be required to receive approval from either a special subcommittee of the Board on privileges, or from the full Board prior to beginning clinical practice. The information presented to the Board on privileges and credentials will be expanded to meet all elements required by CMS standards. Finally, the medical staff bylaws will also be amended to reflect the criteria for granting credentials and privileges, as well as specific requirements for history and physicals.

  11. Nursing Services (§ 482.23)
  12. What did CMS find?

    The CMS survey team expressed concerns that for several patients we had not assessed for pain and medicated as necessary. Upon review of clarifying evidence from the hospital, CMS agreed that this was not the case. Nevertheless, there were still instances where patient records did not consistently include a timeframe for pain reassessment depending on the drug, route of administration and other clinical factors. The surveyors also identified instances where the documentation of pressure ulcers lacked a few elements required by CMS regulation.

    During inspection, CMS surveyors observed a few medications in the process of being administered at the bedside that were not secured in accordance with regulations. Finally, the surveyors noted an instance where blood transfusions had only one out of the 2 signatures required by our policy.

    Why is this important?

    Pain assessment is a vital tool to diagnosis and treatment, and its reassessment should be tailored any applicable clinical factors. Pressure ulcers lead to both discomfort and potential clinical complications like infections. Thus, they must be carefully documented and tracked in the patient record.

    Medications are used in virtually every phase of patient care, and careful attention must be paid to keeping them accessible only to those who need them at the time they are needed. Finally, blood transfusions are a routine part of clinical care, but serious complications can result from giving a patient the wrong type of blood. For that reason, the MGH requires 2 signatures from staff when transfusing blood to minimize the possibility of error.

    What are we doing about it?

    In response to the issues around pain assessment and pressure ulcers, the hospital is revising its pain management and skin assessment policies and procedures so that they include the required elements of documentation. To improve the security of medications at the bedside, the hospital’s Medication Education, Safety and Approval Committee (MESAC) is reviewing all medication security policies for consistency. A computer-based training module will be launched to reeducate staff about medication security practices.

    Finally, to ensure adherence to the MGH’s rigorous processes around blood transfusion verification, a multidisciplinary team is auditing transfusion records of a representative sample of patients to identify patterns of non-compliance. Staff re-education efforts will be tailored around the results of these audits.

  13. Medical Record Assessment (§ 482.24)
  14. What did CMS find?

    CMS surveyors identified several issues with patient medical records. Specifically, the surveyors found problems with the legibility of some of the progress notes, identified some inconsistencies with the timing of physician orders and noticed several missing signatures and consent forms. Also, the surveyors were concerned about the security of information that is accessed from laptops and computers external to the hospital, particularly through email. In addition, the reviewers found some issues with the process of “thinning” the record, specifically regarding what parts of the record should stay on the unit for patients with lengthy in-hospital stays.

    Why is this important?

    An organized, complete, fully documented and accessible medical record is a vital part of ensuring high-quality care and fostering smooth communication among caregivers involved in a patient’s care. The medical record provides information about a patient’s medical history, progress, setbacks, issues, nuances and course. It gives caregivers diagnostic information and tells a story of how a patient is responding to particular treatments. Having this important information up-to-date and available for providers is essential to working with patients and families to make the best decisions at every point over the course of an illness.

    What are we doing about it?

    The hospital is required to maintain a medical record for each inpatient and outpatient. These medical records must be accurately written, promptly completed, properly filed and retained, and accessible, and the hospital must use a system of author identification and record maintenance to ensure the integrity of the authentication and to protect the security of all record entries. The MGH is revising its current policy and procedures to clarify the documentation requirement. Educational materials are being developed, and an implementation/evaluation plan is being established. Information Systems is collaborating with caregivers and others to help facilitate documentation with the new electronic acute care documentation system to reduce inconsistencies. The completion of the implementation of an electronic health record, currently in the planning phases for our inpatient areas and fully implemented for our outpatient services, will help clinicians become fully compliant with this requirement. In the interim, resources will be added to ongoing record reviews to increase scrutiny of medical records, and feedback will be given to clinicians who are deficient on this standard. Monthly compliance status will be sent to all service chiefs to inform them of the documentation status of clinicians in their departments, and the compliance status will be reported to the Clinical Policy and Records Committee.

  15. Pharmacy Administration (§ 482.25)
  16. What did CMS find?

    CMS surveyors identified several instances in which medications were unsecured for short periods of time, specifically when a medication cart was left unattended as a staff member filled an Omnicell unit. In addition, surveyors were concerned about some medications that were not stored in accordance with manufacturer’s recommendations, including the storage temperature and the time and date on labels as to when medication was removed from refrigeration. One issue involved food that was left in a medication refrigerator.

    Why is this important?

    Proper storage, handling and safeguarding of medications is essential to ensure that the medications are the highest quality and safe as possible for patients. In addition, keeping medications – especially certain medications that may be potentially dangerous or problematic when used incorrectly – safe and secure is important in a place where powerful drugs are used to treat and prevent disease. The hospital uses various systems to ensure that medications are secure, including locked rooms and areas to house medications, and the use of Omnicell units that limit access to medications to only those with specific authorization. The hospital has designated refrigeration units that are to be used for medications only, and other items, including food should not be stored in these units.

    What are we doing about it?

    The MGH has refreshed its process for handling and storing medications to ensure that the medications are logged in appropriately and that the label contains the time and date when any warming began. In addition, when patient-specific medications arrive on the unit, a designated staff member will alert the appropriate nurse, who will then place the medications into the Omnicell unit. Training will occur to ensure that staff members understand new processes and procedures as well as the processes that are ongoing to re-emphasize proper and safe handling of medications. The training will also remind staff that food is not to be stored in medication refrigerators. Routine audits will help ensure that compliance is ongoing.

  17. Physical Environment (§ 482.41)
  18. What did CMS find?

    CMS surveyors reviewed nearly all of the MGH inpatient and ambulatory clinical facilities on the main campus, as well as most of the off-site satellite locations, looking carefully at various issues including life safety code concerns, environment of care and accessibility. The surveyors identified several instances of non-compliance for sprinkler heads, fire doors, blocked egress, gaps and places of potential penetration at smoke doors, medical gas containers, dust in the vents and problems with utility doors.

    Why is this important?

    Maintaining the safest possible environment is essential to protecting patients, families, visitors, staff, volunteers and others in the unlikely event of a fire or some other hazardous situation. The hospital is committed to creating as safe an environment as possible.

    What are we doing about it?

    Most of the issues that were identified during the survey were resolved immediately or in the initial days and weeks after the surveyors visit and represent the challenges of ongoing maintenance in a facility the size of the MGH. The hospital has removed equipment identified as blocking smooth access through doors and down passageways. In those cases in which equipment needs to be close at hand for the use and safety of particular patients, the equipment is on wheels and is easily movable. The hospital has removed materials that were stacked high and did not allow the appropriate clearance space under sprinkler heads. The hospital also is installing sprinklers in certain areas identified as being out of the range of the current sprinkler system. In addition, repairs or replacements have been completed to those smoke doors that could potentially allow penetration of smoke. Staff responsible for maintaining fire safety equipment is being re-educated to ensure that everyone is fully aware of all the requirements and regulations as well as new processes for ongoing evaluation. The hospital will be monitoring and issuing regular reports informing key quality and safety committees about the progress of these efforts.

  19. Infection Control (§ 482.42)
  20. What did CMS find?

    The CMS survey team identified instances where staff members were not using disinfectants used to clean patient rooms in accordance with manufacturer’s guidelines. They also observed a cold pack stored in a patient food refrigerator, which is against both hospital policy and CMS regulations. The survey team also observed an MGH employee that failed to wear gloves while disinfecting a piece of exercise equipment. Finally, while the MGH does have a system in place for tracking employee illness, that system did not include our volunteer staff.

    The CMS surveyors also raised concerns about our process for tracking post surgical discharge infections. After providing additional information on the MGH’s infection control policies and practices, CMS has accepted that we are in full compliance with the relevant standards.

    Why is this important?

    Maintaining a sanitary environment that prevents the spread of infectious diseases helps keep our patients and staff safe. This includes, among many other important practices, using any disinfecting agents properly, practicing proper hand hygiene, and keeping certain articles out of patent food refrigerators. In addition, volunteers are part of the patient care process, so their illnesses should be tracked alongside those of our employed staff.

    What are we doing about it?

    The MGH is in the process of re-training employees that clean patient rooms so that disinfecting agents are used in a manner consistent with manufacturers’ guidelines. The hospital also reinforced proper hand hygiene practice for cleaning equipment with appropriate staff. The cold pack in the patient food fridge cited in the report was removed immediately, and the employees in the cited area were re-educated on our patient nourishment refrigerator policy. Finally, volunteers will be added to our system for tracking employee illnesses.

  21. Surgical Services (§ 482.51)
  22. What did CMS find?

    CMS surveyors had concerns about the accessibility of malignant hyperthermia (a rare but serious complication of administering certain anesthetic agents) treatment kits in areas throughout the hospital, particularly those areas outside of the Operating Room where general anesthesia is used. Specifically, surveyors were concerned about the time it might take from the request of such a kit to when that kit actually arrives at the scene. During the survey, a malignant hyperthermia kit was ordered from the Operating Room from a location in another part of the hospital, and surveyors found that in this particular instance, the time that it took from request to delivery was too long.

    Why is this important?

    Malignant hyperthermia is a rare, but life-threatening disorder that some people have that causes a rapid rise in the body temperature and muscle contractions when an affected person receives general anesthesia. Swift treatment is the best way to prevent the complications of this disorder, and the accessibility of a special kit that contains the medications and materials needed to reverse the effects is vital.

    What are we doing about it?

    The surgical divisions, in collaboration with the clinical director of the Department of Anesthesia, Critical Care and Pain Medicine, have reviewed the policy for responding to malignant hyperthermia and are re-educating clinicians in the Department of Anesthesia, Critical Care and Pain Medicine and all units where anesthesia is administered about the disorder and the protocol for responding to the problem. Such education includes information about where the standard malignant hyperthermia kits are located, how to obtain the malignant hyperthermia kits and how to access those anesthesiologists and others trained to respond to such a situation. Training also is focusing on the standard protocol for responding to a malignant hyperthermia emergency to ensure that it is well understood by all staff in all areas where this issue could occur.

  23. Disposal of Radioactive Materials (§ 482.53b)
  24. What did CMS find?

    During survey, a member of our staff was unable to tell CMS the location of the off-campus disposal site for certain radioactive materials. However, it was, and remains, the responsibility of the hospital’s Radiation Safety Officer to confirm the proper disposal of radioactive materials. After reviewing this information, CMS deemed the MGH to be in full compliance with the standard.

    Why is this important?

    Radioactive materials are used as a part of routine part of diagnosis and treatment. Safe handling and disposal is necessary to mitigate any risks to health and safety from these materials.

    What are we doing about it?

    The MGH has, and will continue to maintain an active and robust radiation safety program that ensure that all relevant employees know how to safely handle and dispose of any radioactive materials used as a part of diagnosis or treatment. In addition, the program confirms the proper disposal of any materials sent outside of the hospital.

  25. Rehabilitation Services (§ 482.56)
  26. What did CMS find?

    The CMS surveyors identified instances where physician orders for rehabilitative services – such as Physical Therapy, Occupational Therapy, and Speech Therapy – were either incomplete (i.e.—missing a reason for referral), or not present in the medical record.

    Why is this important?

    Rehabilitative services are integral to a patient’s overall course of care. The accurate and complete documentation of referrals to these services, including the reason for referral, is an important element to patient care coordination. For that reason, CMS regulations require complete and valid physician orders for rehabilitative services provided during a hospitalization, or in an ambulatory care setting.

    What are we doing about it?

    The hospital’s medical staff will be reeducated regarding the need to document a reason for referral when ordering rehabilitation services. In addition, the hospital is evaluating options to improve both paper-based and electronic documentation processes for rehabilitation orders. Any paper forms will include mandatory fields for “reason for referral”, and our electronic provider order entry system will also include a mandatory field for “reason for referral."



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