Uf Health North

Summary Statement of Deficiencies D0000 At the time of the announced, on-site recertification survey, UF Health North, was found to be NOT in compliance with the CLIA laboratory requirements of 42 CFR 493. . D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, there was no documentation to indicate that the laboratory took

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on 06 /22/2020 for UF Health North is not in compliance with Code of Federal Regulations (CFR), Part 493, Laboratory Requirements. 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 review of the laboratory's proficiency testing records for 2019 and 2020, the laboratory did not have successful performance in proficiency testing for the subspecialty of Compatibility testing. Refer to D2181. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on June Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 22, 2020 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for comparability testing for two out of three testing events in 2019 and 2020. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful performance in proficiency testing in the sub-specialty of Compatability testing. Findings include: On June 22, 2020 on or about 10:00 AM the American Proficiency Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the sub-specialty of Compatability testing, as shown below. Event #3, 2019 compatability testing-80% Event #1, 2020 compatability testing-80% D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing for Compatibility testing. Findings include: On June 22, 2020 on or about 10:00 AM, the American Proficiency Institute (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two out of three testing events for Compatibility testing. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2181. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing for Compatibility testing. Findings Include: The review of the American Proficiency -- 2 of 3 -- Institute (API) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on June 22, 2020 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores as shown below. Event #3, 2019 Compatibility testing-80% Event #1, 2020 Compatibility testing-80% -- 3 of 3 --

Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing results and staff interview, the laboratory had 1 out of 3 testing events in 2017 that had an analyte that received less than 80% in the specialty of Hematology. The findings include: Review of API proficiency testing results found the 3rd testing event in 2017 had a 0% for Body Fluid Cell Count which included Red Blood Cells and White blood Cells. During an interview on 7/2/18 at 12:21pm, the Laboratory Quality Manager confirmed the proficiency testing failures. D2182 ANTIBODY IDENTIFICATION CFR(s): 493.865(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing results and staff interview, the laboratory had 1 out of 3 testing events in 2017 and 1 event in 2018 that had an analyte that received less than 80% in the specialty of Antibody Identification. The findings include: Review of API proficiency testing results found the 3rd testing event in 2017 had a 50% for Fetal Screen, and the 1st event of 2018 had a result of 50% for Direct Antiglobulin Test. The interview on 7/2/18 at 12:21pm with the Laboratory Quality Manager confirmed the failures. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- D3021 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(1) Blood and blood products storage and distribution. If a facility stores or maintains blood or blood products for transfusion outside of a monitored refrigerator, the facility must ensure the storage conditions, including temperature, are appropriate to prevent deterioration of the blood or blood product. This STANDARD is not met as evidenced by: Based on record review and staff interview, the facility failed to ensure the temperatures of Plasma Thawer #1 and #2 were documented in the acceptable range of 36C +/- 1C for two of three months reviewed. (July 2017 and January 2018) The findings include: The record review of the "Plasma Thawer Quality Control" documents for July 2017 showed the following days temperatures of Plasma Thawer #1 were not in range per the policy "Helmer Plasma thawer Routine Operation and Maintenance": 7/12/17 - 37.2C, 7/13/17 - 37.3C, 7/14/17- 37.2C, 7/15/17 - 37.3C, 7/16 /17 - 37.3C, 7/17/17 - 37.3C, 7/18/17 - 37.4C, 7/19/17 - 37.4C, 7/20/17 - 37.4C, 7/21 /17 - 37.4C, 7/22/17 - 37.4C, 7/23/17 - 37.5C, 7/24/17 (Plasma Thawer 2 only) 37.5C, 7/25/17 - 37.4C, 7/26/17 - 37.4C, 7/27/17 - 37.3C, 7/28/17 - 37.4C, 7/29/17 - 37.4C, 7 /30/17 - 37.2C, and 7/31/17 - 37.4C. In January 2018, the Plasma Thawer temperature was documented as 37.1C on 1/8/18, 1/10/18, 1/22/18, 1/23/18, 1/24/18, and 1/27/18. The policy "Helmer Plasma Routine Operation and Maintenance" states "The temperature in the waterbath shall be at 36C +/- 1C when checked each day." The interview on 7/2/18 at 10:34am with the Blood Bank General Supervisor confirmed the temperatures were documented out of range. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on record review and staff interview, the facility failed to ensure the stains used for the Gram Stain procedure were not expired prior to patient testing in September 2017. The findings include: The record review of the quality control documentation for September 2017 showed the Iodine lot #6836-00 expired on 9/1/17 and was used until the end of the month. During this time, seven patients had Gram Stains in which the expired Iodine was used. The interview on 7/3/18 at 10:00am with the Microbiology General Supervisor confirmed the expired Iodine was used for patient testing. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on record review and staff interview, the facility failed to ensure the weekly and monthly maintenance required for the Helmer Plasma Thawer was performed for two of three months reviewed (July 2017 and January 2018). The findings include; The record review of the "Plasma Thawer Quality Control" documentation showed no record of the weekly cleaning or monthly lubrication being performed in July 2017. The review of the January 2018 documentation showed the weekly cleaning was performed but the monthly required lubrication was not documented. The policy titled "Helmer Plasma Thawer Routine Operation and Maintenance Procedure" states "The thawer must be cleaned weekly and after a broken component has contaminated the bath." The policy lists the requirement for the lubrication of the basket assembly lift- out rail under the section titled "Monthly Maintenance". The interview on 7/2/18 at 10: 34am with the Blood Bank General Supervisor confirmed the maintenance was not performed. -- 3 of 3 --