University Dermatology Center Pc

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on document review and interview, the laboratory failed to achieve a passing score of 80% for KOH (potassium hydroxide) preparation in the subspecialty of Mycology for two consecutive events in 2018 (Event 3) and 2019 (Event 1). Refer to D-2046. D2046 MYCOLOGY CFR(s): 493.827(e) Failure to achieve an overall testing event score of satisfactory performance for two Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on document review and interview, the laboratory failed to achieve a passing score of 80% for KOH (potassium hydroxide) preparation in the subspecialty of Mycology for two consecutive events in 2018 (Event 3) and 2019 (Event 1). Findings Include: 1) Review of API (American Proficiency Institute) Performance Summary indicated the following failing scores for KOH preparation: a) Event 3/2018=50% b) Event 1/2019=50% 2) Medical record review indicated the following patients had KOH testing performed in 2018 and 2019 (PT=patient): a) PT#7=1/9/18 (KOH=Negative) b) PT#8=8/15/19 (KOH=Negative) 3) In interview on 9/18/19 at 2: 23 pm, SP-1 confirmed the above failing scores for KOH preparation. SP=staff person. Annual test volume for KOH=10. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on document review, lack of documentation, and interview, the laboratory failed to run a control slide of known reactivity for three of thirteen laboratory testing reports reviewed for H&E staining in the subspecialty of Histopathology. H&E=Hematoxylin and Eosin. Findings include: 1) Review of policy titled, "University Dermatology Center Histology Laboratory," signed by the laboratory director on 3/14/17, read on page 1, "Daily the histotechnician who completes the H&E staining will review the slide for quality control and record it in the Quality Control Log Book." 2) Upon request for quality control documentation for H&E staining/testing performed for these patients (PT=patients) on these dates; PT#2 (11-7- 18), PT#9 (10-19-18), and PT#11 (11-27-18), SP-1 indicated none was available. 3) In interview on 9/18/19 at 1:05 pm, SP-1 confirmed quality control for the above listed patients was not documented on the "Quality Control Log Book." Annual Histopathology testing=7,453. D6011 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(2) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(2) and provide a safe environment in which employees are protected from physical, chemical, and biological hazards. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on observation, document review, and interview, the laboratory director failed to monitor air quality (badges) and effectiveness of one of one ventilation hood in use by four of four staff members (SP1-4) who work with two of two hazardous chemicals (formaldehyde and xylene), used for H&E stains. SP=staff person. Findings include: 1) During tour of the laboratory on 9/18/19 at 9:38 am with SP-1, an Airfiltronix ventilation hood was observed in the Histopathology laboratory and SP-1 confirmed it was in use. The laboratory had a strong smell of chemicals/vapors. 2) Review of Laboratory Personnel Report (CLIA)-CMS 209, signed by the laboratory director on 9 /12/19, indicated staff members SP-1 thru SP-4 were high complexity testing personnel. CMS=Centers For Medicare and Medicaid. CLIA=Clinical Laboratory Improvement Amendments. 3) Review of policy titled, "University Dermatology Center Histology Laboratory Formaldehyde and Xylene Sensor," signed by the laboratory director on 7/12/12, read on page 1, "To ensure the safety of our Histotechnicians our laboratory is enrolled in a monitoring of vapors from potentially hazardous chemicals. This monitoring is to take place once any changes in location (moving) or chemicals are made..." "...These badges are to be worn by laboratory personnel during an 8 hour period to monitor their exposure to formaldehyde and Xylene vapors..." 4) Review of policy titled, "University Dermatology Center Histopathology Laboratory Quality Control for H&E Slides," signed by the laboratory director on 3/14/13 read, "H&E stains are changed to ensure adequate staining quality once a week at the end of the chosen work day." 5) Review of policy titled, "University Dermatology Center Histology Laboratory," signed by the laboratory director on 10/23/15, read on page 1 under "Department Ventilation," "Over the grossing area is an Airfiltronix ventilation hood and enclosed work area. This hood is used during grossing and any time reagents or chemicals are being used in the lab. The unit has a carbon filter that is changed every six months..." 6) Review of the following safety data sheets for Formaldehyde and Xylene (two chemicals being used in the laboratory) indicated the following: a) Xylene: "Version 1.7 Revision Date: 07 /14/15," read on page 2 of 21, "Precautionary statements: ...P260 Do not breathe dust /fume/gas/mist/vapors/spray...P271 Use only outdoors or in a well-ventilated area." The safety data sheet further read on page 6 of 21, "...Advice on safe handling Do not breathe vapours/dust...Provide sufficient air exchange and/or exhaust in work rooms..." b) Formaldehyde: "Issue Date: 12/30/2015 V1.0," read on page 1 of 6, "... Potential Health Effects Inhalation-May be harmful if inhaled. Causes respiratory tract irritation. May cause cancer...P260; Do not breathe fumes or mist...P305; If inhaled, move to fresh air..." On page 3 of 6, "...Avoid breathing vapor or mist. Use only with adequate ventilation. Wear appropriate respirator when ventilation is inadequate..." 7) In interview on 9/18/19 at 12:26 pm and 12:28 pm, respectively, SP-1 confirmed there was no badge monitoring documentation to review going back two years from the date of survey (for SP1-SP4) and the Airfiltronix hood had not been checked and/or documented regarding adequate ventilation function going back two years from the date of survey. Annual Histopathology testing=7,453. D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on document review, lack of documentation, and interview, the laboratory director failed to ensure two of four high complexity testing personnel (SP-3 and SP- 4) had annual competency performed in 2018. Findings include: 1) Review of Laboratory Personnel Report (CLIA)-CMS 209, signed by the laboratory director on 9 /12/19, indicated staff members SP-3 and SP-4 were high complexity testing personnel. SP-3 and SP-4 both had hire dates in 09/2001. CMS=Centers For Medicare and Medicaid. CLIA=Clinical Laboratory Improvement Amendments. 2) Upon request for 2018 annual competency documentation for SP-3 and SP-4, SP-1 indicated none was available for review. 3) In interview on 9/18/19 at 2:04 pm, SP-1 confirmed there was no annual competency documentation available for review in 2018 for SP-3 and SP-4. Annual test volume for Histopathology=7,453. -- 4 of 4 --