Pediatrics Wellness Of Northern New York

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on surveyor's review of 2020 American Proficiency Institute (API) proficiency testing (PT) attestation statements and an interview with the laboratory testing person, the laboratory failed to rotate the testing of PT samples among eight personnel, who routinely perform sub-specialty Bacteriology/throat cultures tests. The same person performed two 2020 events as indicated by the signed attestation statements. FINDINGS. The laboratory testing person confirmed on December 11, 2020 at approximately 10:00 AM, the surveyor's findings that the same testing person performed two test events 2020. There were seven other testing personnel who routinely perform sub-specialty Bacteriology/throat cultures. 2020 second event TH 6 - TH 10 2020 third event TH 11- TH 15 D2020 BACTERIOLOGY CFR(s): 493.823(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 surveyor's review of the first event of 2020 API PT summary report and confirmed in an interview with the laboratory testing person, at the time of survey, the laboratory failed to obtain an overall score for the sub-specialty Bacteriology/throat 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 -- cultures. The following score was assigned: 2019 second event = 40% this is an unsatisfactory PT performance. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor's review of API PT records for calendar years 2019, 2020 and confirmed in an interview with the laboratory testing person, at the time of survey, the laboratory failed to retain API PT records and documentation for sub-speciality Bacteriology/throat cultures to include signed attestation forms and a signed PT summary reports for the all three events in 2019 and 2020. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on the surveyor's review of API PT reports and an interview with the laboratory testing person, at the time of survey, the laboratory failed to review and evaluate for the API PT for the sub-specialty bacteriology/throat cultures for all three events in 2019 and 2020. FINDINGS: The laboratory testing person confirmed on December 11, 2020 at approximately 10:30 AM, that the laboratory director failed to review and evaluate the API PT results for all three events in 2019 and 2020 for the sub-specialty Bacteriology/throat cultures. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on a surveyor's review of Quality Assessment (QA) policy,

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on surveyor's review of the laboratory's Quality Assessment (QA) policies and procedures and confirmed in an interview with the testing person at the time of this survey, the laboratory failed to follow their established QA policy and procedure for the calendar year of 2017. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on surveyor's review of the laboratory's QA policy & procedure and an interview with the testing person, the laboratory director failed to maintain the laboratory's established QA program to assure quality laboratory services. Refer to D5291. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --