Sanford Pediatrics, Pa

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of operator's manual for the Cell-Dyn Emerald hematology analyzer, review of calibration records, and interview with testing personnel (TP #6) 7/30/21, the laboratory failed to perform calibration of the Cell-Dyn Emerald hematology analyzer at least every 6 months from 7/20/19 until 7/22/21, a period of approximately 24 months in which calibrations were not performed. Findings: Review of operator's manual for the Cell-Dyn Emerald hematology analyzer revealed under Section 6, page 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 -- 6-3 "When to Calibrate...At least every 6 months." Review of calibration records for Cell-Dyn Emerald hematology analyzer revealed the laboratory performed a calibration on 7/20/19, the next calibration was performed on 7/22/21. A period of approximately 24 months in which calibrations were not performed. Interview with TP #6 at approximately 1:45 p.m. confirmed the laboratory failed to perform calibrations of the Cell-Dyn Emerald hematology analyzer as required. She stated the laboratory ended their service contract and failed to realize it included shipment of calibration reagents so they didn't realize it needed to be performed. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records for Hardy Diagnostics Strep Select Agar (SSA), review of laboratory records, review of quality assurance (QA) records, review of monthly laboratory meeting notes and interview with TP #6 7/30/21, the laboratory failed to perform QC of the SSA media as required from 8/2/19 until 4/6 /21, approximately 19 months. 488 patients were tested. Findings: Review of QC records for SSA media revealed on 8/2/19 the statement that the laboratory was unable to continue QC of the throat culture plates (SSA media) due to manufacturer back order of control organisms from their supplier HealthLink. There was no documentation QC was performed again until 4/6/21, approximately 19 months in which QC for the SSA media was not performed. Review of laboratory records revealed a statement entitled "Temporary suspension of IQCP". "August 02, 2019... Unable to continue ..QC..Plan at this time. Strep plate...controls are on manufacturer back order. Health Link products no longer available, awaiting alternate controls.... December 16, 2019...Strep...controls continues to be unavailable for order...March 20, 2020...continue to be unable to order Strep plate controls due to COVID-19 pandemic....March 22, 2021...Order Strep plate controls placed through McKesson... April 6, 2021...Received Strep A & B controls...from Microbiologics...". The records failed to show documentation from manufacturer's that controls were unavailable. The records also failed to document if alternative manufacturer's were contacted for availability of controls. Review of QA records from 8/2/19 through 4/6/21 for "Strep Select Agar Quality Control" revealed the laboratory directors' initials under the column indicated for review but no documentation of "Any issues or

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of laboratory proficiency testing (PT) enrollment records, and interview with office staff 01/11/18, the laboratory failed to enroll in a proficiency testing program for the 2018 calendar year. Review of PT enrollment records revealed no record of 2018 PT enrollment. Interview with office staff at approximately 11:00 a. m. confirmed the laboratory had not enrolled in a PT program for the 2018 calendar year. This deficiency was corrected on site at time of survey. 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 review of 2016 and 2017 College of American Pathologists (CAP) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- proficiency testing (PT) records 01/11/18, the laboratory failed to ensure that all attestation statements were signed as required by the personnel who performed the testing. Review of CAP Attestation Forms revealed the statement, ..."The laboratory director or designee and the testing personnel must sign on the result form." Review of 2016 CAP PT event FH1-C revealed the attestation statement was not signed by the testing personnel. Review of 2017 CAP PT event FH1-C revealed the attestation statement was not signed by the testing personnel. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of 2016 and 2017 College of American Pathologists (CAP) proficiency testing (PT) records 01/11/18, the laboratory failed to verify the accuracy of the zero scores obtained in CAP PT events and failed to document