OSHA requirements are set by statute, standards and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at http://www.osha.gov.
May 16, 1995
MEMORANDUM FOR: MICHAEL G. CONNORS REGIONAL ADMINISTRATOR FROM: JOHN B. MILES, JR., DIRECTOR DIRECTORATE OF COMPLIANCE PROGRAMS SUBJECT: Face and Eye Protection for Phlebotomists
This memorandum is in response to your letter dated January 23, requesting that we review bloodborne pathogens standard citations issued to the American Red Cross by the Cleveland Area Office. You asked that an interpretation be provided on whether face protection is required for phlebotomists. In OSHA's view, exposure to blood during phlebotomy is not reasonably anticipated and face and eye protection is not required.
As you know, the selection of personal protective equipment for occupational exposure to bloodborne pathogens is based on reasonably anticipated exposure. During routine phlebotomy it is not reasonably anticipated that blood will reach the eyes or mouth of the employee and eye or face protection is not required. This is particularly true in a blood donor center since the donor is a volunteer and is not typically unruly or out of control.
In this particular case, the accident reports dating from 1992 to 1994 show that only 2 of the 17 exposure incidents occurred while drawing blood. One exposure incident (which occurred on October 26, 1992) appears to have affected a third party (the Health Historian) in the near proximity and not the nurse performing the actual blood draw. If the interpretation of the incident is accurate, then that exposure incident could not have been anticipated. That leaves one recorded exposure that occurred while a phlebotomist was removing a needle from a donor for the three year time period studied. This data further supports that blood splashes to the face and eyes of phlebotomists are rare.
The remaining 15 exposure incidents recorded in that time period have been reviewed, and appear to be incidents that occurred while employees were conducting lab tasks. In these situations when laboratory technicians are conducting blood-related lab activities, there may be a reasonably anticipated exposure to blood and eye or face protection or some other control method may be required.
In summary, please bear in mind that phlebotomy involves the drawing of blood from a vein rather than from an artery which is under pressure. If the phlebotomist mistakenly tries to draw blood from an artery, then a splash of blood could occur. In this case, there may be a skill deficiency which requires training. A properly trained phlebotomist is not reasonably anticipated to experience a splash of blood to the eye and face and eye or face protection is not required.
We hope this answers your concerns. If you have any further questions please contact Wanda Bissell at (202) 219-8036.
January 23, 1995
MEMORANDUM FOR: JOHN B. MILES, JR., DIRECTOR DIRECTORATE OF COMPLIANCE PROGRAMS FROM: MICHAEL G. CONNORS REGIONAL ADMINISTRATOR SUBJECT: PROTECTION FROM BLOODBORNE PATHOGENS (AMERICAN RED CROSS)
As a result of multiple complaints received in the Cleveland Area Office against the local chapter of the American Red Cross an inspection of that facility was conducted between July 25 and August 24, 1994. A brief synopsis of the results of that inspection is attached for your information. Prior to issuing any citations Cleveland contacted the Chicago Regional Office and discussed their findings, and we were in agreement with their proposals. As you will see, they successfully settled the case at an informal conference and all apparent violations were affirmed, including the requirement that phlebotomists be provided protection against blood splashes to their faces, e.g. face shields.
Subsequent to this settlement the Cleveland chapter had discussions with their national headquarters and Jean Otter, Director of Regulatory Affairs, apparently had discussions with the Office of Health Compliance Assistance (please see attached memorandum to Nora V. Hirschler, MD, dated 11/8/94). The resulting draft article which was prepared for inclusion in Blood Bank Week (copy attached) presents a viewpoint that seemingly contradicts what we have required at the Cleveland location, and could create problems for us should we receive more complaints and/or conduct a followup inspection at this facility.
We have shared copies of these documents with Dr. Angela Presson in the Office of Occupational Medicine and have discussed the matter with her on several occasions. Based on our conversations and the background information which we supplied, Dr. Presson is of the opinion that some form of protection would seem to be warranted, although she indicated that a barrier may work just as well as a face shield for the phlebotomists specifically conducting venipuncture operations. There does not seem to be any disagreement among us that protection must be provided for people involved in the other tasks associated with the drawing of blood. We firmly believe that given the history of documented face splashes at this location that we were correct in citing all tasks, although the American Red Cross seems to feel otherwise. We believe that control measures for all potentially exposed employees are readily available and quite feasible to implement.
Inasmuch as this issue has the potential to become one of national significance and demands uniformity of enforcement across the country, we are requesting that you review this material and provide us an interpretation in this matter. If you or your staff have any questions or need further information please contact Bill Wiehrdt of my staff at 312-353-5977.
MEMORANDUM DATE: November 8, 1994 TO: Nora V Hirschier, MD Medical Director FROM: Jean Otter, MT(ASCP)SBB Director, Regulatory Affairs RE: OSHA Inspection
I was finally able to speak to Wanda Bissell in the Office of Health Compliance Assistance at OSHA. She stated that the use of face shields during phlebotomy is not needed. She did state that face shields should be available in the event that a procedure becomes out of control. She also indicated that face shields should be worn when there is the possibility of a splash or splatter, such as during phlebotomy of an unruly child or an uncooperative patient. The onus is on the employer to establish the risk.
If you disagree with a citation from your inspection you can contest this. The first step after discussion with the inspector would be an informal conference with the area director.
Attached is a DRAFT article that we would like to publish this week in Blood Bank Week to alert other facilities of this OSHA citation. Thank you for alerting us to this situation and I hope that you will keep us apprised of the status of your discussion with OSHA. Let me know if I can be of any further assistance.
During a recent OSHA inspection, a blood bank facility was cited for not requiring the use of face shields during volunteer donor phlebotomy. The OSHA inspector based the citation on two exposure episodes which occurred over a two year period, during which time over 400,000 units of blood were collected.
The OSHA blood borne pathogen standard requires the use of a face shield when the possibility of contamination can be reasonably anticipated. Wanda Bissell, Office of Health Compliance Assistance, OSHA, stated that a face shield should be worn when there is the possibility of a splash or splatter, such as when drawing an unruly child or an uncooperative patient. She also indicated that face shields are not needed for routine phlebotomy. She went on to say that the onus is on the employer to establish the risk. Face shields should be available in the event that a procedure becomes out of control.
If a facility receives a citation that they feel is inappropriate, they can contest that citation. The first step after discussion with the inspector should be an informal conference with the area director.
This inspection was initiated by several complaints which were received in our office. On May 4, 1994 a non formal complaint was received alleging that employees were not provided with the appropriate personal protective equipment. (Attachment A). On May 16, 1994 the Red Cross responded to the complaint stating that volunteer blood donors pose a lesser risk and the CDC did not require gloves to be worn when blood is drawn. During this period, two other formal complaints were received alleging the same hazards. (Attachment B&C).
On July 25, 1994 an inspection was conducted by CSHO, Audrey Profitt-Henry. Present at the opening conference were Gloria Cervelli, Senior Director of Human Resources and Carolyn Kean, Director of Donor Services. Copies of the complaint were provided to the employer and each item was discussed.
With regards to the use of gloves Ms Kean stated that as of August 1, all employees will be required to wear gloves as a result of new policies being set by the National Office. However, she did state, that they did not have face shields, but, they had placed an order. This she said was decided on their own prior to OSHA's visit.
Following the discussion of the complaint items CSHO requested copies of the Exposure Control Plan, 200 logs, Hazard Communication Program and other pertinent information. A physical inspection was conducted, at which time some employees were interviewed. Upon reviewing the OSHA 200 logs, several entries of blood splashes were noted. This led CSHO to conduct an extensive review of the accident reports. The employer was informed that CSHO will return at a later date to conduct more interviews.
On August 2,1994 CSHO returned to the facility to review all of the accident reports for exposure incidents which had occurred during 1992, 1993 and 1994. The following incidents were recorded.
On 4.30.92 a Phlebotomist at a blood donation center, was splashed in the eye and face with blood, while removing the needle from the arm of a donor.
On 10.26.92 a Health Historian at a blood donation center, was splashed in the eye with blood when the nurse squeezed the finger of a donor.
On 6.26.92 a Phlebotomist at a blood donation center, was splashed in the eye with blood when transferring the needle from one tube to the other during a blood draw.
On 11.13.92 an employee in the Apheresis Department was splashed in the face with blood, when a line broke on the Spectra instrument.
On 2.2.94 an employee in the Component Lab was splashed in the face with Plasma while separating the tubing from a plasma unit.
On 3.7.94 a Phlebotomist at a blood donation center, was sprayed with blood up her nose, on her mouth and on her neck while heat sealing a tubing.
On 2.18.94 an employee in the Component Lab, was splashed on the face, eyes and mouth with blood, while breaking a seal.
On 5.1.92 an employee in the Component Lab was splashed in the eye with plasma while extracting plasma from the units.
On 8.16.93 an employee in the Component Lab was splashed in the face with plasma, while the employee was folding the plasma bag.
On 8.17.93 an employee in the Component Lab was splashed in the eye with plasma, while expressing blood plasma.
On 11.1.93 an employee in the Technical Service Department was splashed in the face and eyes with liquid from a donor tube.
On 5.17.94 a Registered Nurse in the Apheresis Department was sprayed on her hands and head with plasma, while checking the units.
On 3.16.93 a Mobile Unit Attendant, at a donation center was splashed in the mouth, eyes and face with blood while heat sealing.
On 4.13.94 a Registered Nurse at a donation center was splashed in the eye with blood while heat sealing.
On 5.9.94 an employee in the Component Lab was splashed around the mouth with plasma while separating the plasma.
On 5.28.93 a head nurse working at a donation center was splashed in the face, mouth and clothing with blood, while heat sealing.
On 6.10.93 a Mobile Unit attendant was splashed in the eye with blood while heat sealing.
Following the review other employees who work an the mobile units were interviewed, including the Union Steward. Three of the employees related incidents in which they were splashed with blood on their clothing and shoes. The employees stated that they had to launder their clothing themselves. One employee stated that they were told not to report such spills. But, that they should clean their clothing with the disinfectants provided.
On 8.9.94 CSHO did a scan report and found that the Red Cross was previously cited for violations of not providing face shields and or goggles, as well as other Bloodborne Pathogen violations. Copies of some of the violations were obtained.
On 8.24.94 a closing conference was held. Present were David Plate, Chief Executive Officer; Tom Grooms, Chief Financial Officer; Carolyn Kean, Gloria Cerelli and Dr. Nora Hirshler, Medical Director. Each violative condition was discussed and the employer had disagreements with every one. With regards to the gloves, Mr Plate stated that it was employee misconduct. He also questioned whether or not CSHO had observed the employees at work at the donation sites. He was informed that CSHO had not visited any of the sites but based the citations on the interviews and documentation which was provided.
Meanwhile, Dr. Hirshler kept insisting that the Red Cross was exempt from using such personal protective equipment, due to the fact that the donors are low risk. CSHO informed the employer that the exemption was specifically for gloves for those phlebotomist who were not in training and who did not have any cuts and bruises. CSHO informed him that there were three instances of exposures, where employees did have cuts and bruises and were not wearing gloves. At this moment, Mr Plate stated that the organization was in financial difficulty and that they will challenge the violations. He was informed that he would have his opportunity to raise his objections at an informal conference with the Area Director.
Mr Plate also informed CSHO that the FDA had recently inspected their facility and there were only two violations and he had personally received a call from Elizabeth Dole congratulating him on the good work. With that said, CSHO informed him that if there were other information or documentation he had that would support his objections, he should present it at the informal conference.
On 8.31.94 one of the mobile units was stationed in the Federal Building. CSHO decided to observe first hand how the employees worked at the donation centers. CSHO requested to speak with the head nurse who was informed of the reasons CSHO wanted to observe. But, she informed CSHO that she would have to check with her boss. Permission was granted and Ann Gorman was sent to accompany CSHO.
CSHO observed the employees heat sealing and the great potential of exposure to the eyes and mouth. Hence, the need for the goggles and or face shields or a more appropriate shield. During this visit, the employee was using a piece of plastic bag as a shield over the Hematron machine. CSHO also observed that when the employees were sitting their lab coats did not completely cover their thighs and legs. Hence the need for even longer coats or pants covers.
Discussions were held with the Supervisor and the Area Director. A decision was made not to issue repeat violations nor to assess high penalties due to the fact that the Red Cross was a non profit organization and this may create some hardship. On September 9, 1994 citations were issued to the Red Cross. On September 26, CSHO received a call from Gloria Cervelli. She stated that they had received the violations on September 20, 1994 and that they were not coming in for an informal conference and would not contest the citations. But, would like an extension on the abatement dates. CSHO informed her that she should make the request in writing.
However upon discussing the issue with the Area Director at a later date, he informed CSHO that the Red Cross will have to have an informal conference before the abatement date is extended. They were notified and an informal was scheduled for October 12, 1994.
Meanwhile, on September 28, CSHO was contacted by Joe Zanoni from the SEIU Chicago office to inquire whether or not there was an informal scheduled or the Red Cross was contesting the citations. At this time he was informed that they had not and they were still within the time frame to contest. At this time Mr Zanoni expressed his praise for the good work by OSHA and his dissatisfaction with the manner in which the Red Cross had treated their employees.
On October 12, 1994 an informal was held, present were Nadina Doughtry, Quality Assurance Officer; Jane Mesnard, Education Officer; Carolyn Kean; Gloria Cervelli and Maria Margevicius, Union Organizer. At the conference the employer presented documentation to show that the items were abated. However, they felt that they did not need to require the phlebotomists to wear face shields and or goggles since there were only two instances noted and the donors blood were not infected. Nevertheless, they signed the settlement agreement with a 25% reduction and requested a clarification on this issue from the National Office. The abatement date to implement the engineering controls was extended.
On November 1, 1994 final abatement was received, penalties were paid and the file was closed on November 8, 1994.
Date: Complaint Number 76499896 Employer Name: American Red Cross Site Location (Street, City, State, ZIP) 3747 Euclid Avenue Mailing Address (If different) (Street, City, State, ZIP) Cleveland, OH 44115 Telephone Number: 216-431-3010
Management Official David Plate
Type of Business blood collection
1. Employees were ordered to draw blood without proper personal protective equipment. Needleguards which are to be used when transferring blood to test tubes were unavailable and employees were ordered to work without them. This exposed them to possible needlesticks and possible HIV-HBV contraction.
Date: Complaint Number 76499961 Employer Name: American Red Cross Site Location (Street, City, State, ZIP) 3747 Euclid Avenue Mailing Address (If different) (Street, City, State, ZIP) Cleveland, OH 44115 Telephone Number: 216-431-3010
Management Official David Plate
Type of Business blood donations
1. Employee is required to handle blood and is not provided any personal protective equipment, should their work clothes become contaminated the employer does not wash them, instead the employees are required to take the items home and wash them themselves.
2. Employees are supplied with lab coats and gloves, but face shields, shoe covers or leg covers are not provided.
3. Test tube racks are not decontaminated. Employees are not informed of the risk.
4. blood boxes are not decontaminated. Employees are not required to wear gloves when handling these boxes.
5. Dimension 256 is used for cleaning. Employees are experiencing burning nasal passages and respiratory distress. Employees were not informed of the need to use face shields or proper ventilation while using the product.
Date: Complaint Number 76498682 Employer Name: American Red Cross Site Location (Street, City, State, ZIP) 3747 Euclid Avenue Mailing Address (If different) (Street, City, State, ZIP) Cleveland, OH 44115 Telephone Number: 216-431-3010
Management Official David Plate
Type of Business blood bank
1. Employees in the Apheris Department have experienced burning eyes, headaches and chronic sinus infections. The employees suspect the air quality and filters are the source of these problems.
2. Appropriate personal protective equipment (shoe covers, leg covers or long lab coats), are not provided to employees working on the mobile units. They have had blood spilled on their pants.
3. Employees in the Apheris Department are not provided with goggles or face shields to prevent blood splashing during processing of blood.
4. Test tube racks are not decontaminated. Employees handle them without the use of gloves and volunteers in the centers are not notified of the dangers and to use gloves.
5. Employees have to launder their clothing when blood is splashed as a result of inadequate personal protective equipment.
6. Employees use a product called Dimension 256 for daily cleaning. Employees are not provided with goggles or faceshields when using this product.
7. Employees in the Apheris Department use Cidex to clean soiled equipment. No personal protective equipment or ventilation are provided.