Brownsville Medical Clinic Pa

Summary Statement of Deficiencies D0000 493.51 Notification requirements for laboratories issued a certificate of compliance Laboratories issued a certificate of compliance must meet the following conditions: (a) Notify HHS or its designee within 30 days of any change in-- (1) Ownership; (2) Name; (3) Location; (4) Director; or (5) Technical supervisor (laboratories performing high complexity only). (b) Notify HHS no later than 6 months after performing any test or examination within a specialty or subspecialty area that is not included on the laboratory ' s certificate of compliance, so that compliance with requirements can be determined. (c) Notify HHS no later than 6 months after any deletions or changes in test methodologies for any test or examination included in a specialty or subspecialty, or both, for which the laboratory has been issued a certificate of compliance. This requirement is not met as evidenced by: Based on observation of the laboratory, review of laboratory records, the Aspen 116 database, and interview with the lead testing personnel, the laboratory failed to notify the state agency of change in specialties within six months of the change in 2019. The findings include: 1) Observation of the laboratory on January 9, 2020 at 8:00 a.m. revealed the Cell-Dyn 1700 Complete Blood Count (CBC) instrument on the counter. The instrument was not being used for patient testing for CBC. 2) Review of the laboratory's

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies titled "Quality Assurance Review"and "Personnel Assessment", the form titled "Personnel Assessment", and interview with testing personnel number one, the laboratory failed to establish policies for competency assessment of testing personnel as specified in subpart M in 2017 and 2018. The findings include: 1. Review of the laboratory's policy titled "Quality Assurance Review" revealed the following two statements under the section titled "Personnel Assessment": The medical director will review the competency of lab personnel annually. Opportunities for continuing education are made available to personnel should there be a deficiency. 2. Review of a second laboratory policy titled "Personnel Assessment" revealed the following single statement: "Personnel will be reviewed for competency of lab personnel at least semi-annually during the first year of patient testing and annually thereafter." 3. Review of the form titled "Evaluation of Lab Personnel" used for documenting testing personnel competency for testing personnel numbers one and two in 2017 and 2018 revealed that the methods used for competency assessment did not include the six required elements. The required elements include: Direct observation of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; Monitoring the recording and reporting of test results; Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; Direct observation of performance of instrument maintenance and function checks; Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- testing samples; and Assessment of problem solving skills. 4. Interview on April 10, 2018 at 12:30pm with testing personnel number one confirmed the laboratory failed to establish policies for competecny assessment of testing personnel as specified in subpart M in 2017 and 2018. -- 2 of 2 --