Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of 2017-2018 API (American Proficiency Institute) Hematology proficiency testing records and an interview with the office manager (also testing personnel #1), the laboratory failed to ensure attestation statements were signed by the Laboratory Director for three of three surveys. The findings include: 1. A review of the API Hematology proficiency testing records revealed no signature of the Laboratory Director on attestation statements for the following survey events: A. second event in 2017 B. third event in 2017 C. first event in 2018. 2. In an interview on 6/21/2018 at 9:03 AM, the office manager reviewed the proficiency testing records with the surveyor, and confirmed the above noted findings. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of Quality Control (QC) records for the Medonic Hematology analyzer, patient data logs, policy and procedure manual, and an interview with the office manager ( also testing personnel # 1), the laboratory failed to ensure QC was 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 -- within acceptable range before performing and reporting patient results. The findings include: 1. A review of the QC records for the Medonic Hematology analyzer revealed no record of QC performed on 2/19/2017 and 2/27/2017. The QC records also revealed only one level of QC was acceptable on 3/25/2017 and 6/23/2017. 2. A review of the patient data logs revealed the following: A. 2/19/2017 one patient Complete Blood Count (CBC) performed. B. 2/27/2017 two patients CBC's performed. C. 3/25/2017 two patients CBC's performed. D. 6/23/2017 one patient CBC performed. 3. A review of the General lab policy entitled "Quality Control" states when either internal or external quality control is not acceptable no patient results will be reported. 4. In an interview on 6/21/2018 at 12:04 PM, the office manager confirmed the above noted findings. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of personnel records, policy and procedure manual, and an interview with the office manager (also testing personnel #1), the surveyor determined that the Technical Consultant (TC) failed to perform a semi-annual evaluation during the first year of employment for one of one Testing Personnel (TP). The findings include: 1. A review of personnel records revealed there was no semi-annual evaluation performed for TP #3, who had been hired in February of 2017 and initially trained in April of 2017 to perform moderate complexity testing. 2. The policy entitled "competency assessment" "...... the competency of testing personnel must be assessed semi-annually for the first year of patient testing and annually thereafter." 3. In an interview on 6/21/2018 at 10:16 AM, when asked if the laboratory had any documentation of TP #3 semi-annual evaluation, the office manager stated "No". Thus, the above noted findings were confirmed. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on a review of personnel records, policy and procedure manual, and an interview with the office manager (also testing personnel #1), the surveyor determined the Technical Consultant failed to evaluate two of three Testing Personnel (TP) at least annually. The findings include: 1. A review of personnel records revealed there were no annual evaluations in 2017 for TP #1 or TP #2. Both had been previously qualified to perform moderate complexity testing since the previous survey conducted on 11/17/2016. 2. The policy entitled "competency assessment" "....... the competency of testing personnel must be assessed semi-annually for the first year of patient testing and annually thereafter." 3. In an interview conducted on 6/21/2018 at 10:16 AM, the office manager stated that she and TP #2 did not have annual evaluations performed in -- 2 of 3 -- 2017. Thus the above noted findings were confirmed. Jeremy Westry, BS, MT (ASCP) Licensure and Certification Surveyor -- 3 of 3 --