Island Coast Pediatrics Pa

Summary Statement of Deficiencies D0000 An on-site announced CLIA recertification survey was conducted at Island Coast Pediatrics on 04/10/2024 - 04/16/2024. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to retain temperature logs for room temperatures for two out of two years (2022 - 2024). Findings Included: Review of the policy titled Quality Assurance Program (revised 4/22/22 and signed by the previous Clinical Department Manager) revealed under the subheading Quality Control: Room and Room Humidity are recorded daily every "AM [morning], NOON, and PM [anytime after 12:00 PM]" and saved for two years. Review of the temperature charts revealed the laboratory did not retain the electronic room temperature and humidity documentation from 04/15/2022 - 03/06/2024. On 04/10 /2024 at 12:00 PM, the Clinical Department Manager and the Human Resource Manager stated the information technology personnel could only retrieve room temperature and room humidity data 30 days from the date of survey. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. 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 -- This STANDARD is not met as evidenced by: Based on record review of College of American Pathologists (CAP) proficiency testing and interview with staff, who had been delegated to sign for proficiency testing results, the laboratory failed to document

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 4/14/22 at Island Coast Pediatrics Pa, a clinical laboratory in Cape Coral, Florida. Island Coast Pediatrics Pa was found NOT in compliance with Code of Federal Regulations (CFR), Part 493, requirements for clinical laboratories. . 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 record review and interview with laboratory staff, the laboratory failed to have quality controls (QC) in acceptable range prior to reporting patient results for 1of 31 days in March 2022. The findings include: Record review of the laboratory's QC records for March 2022 showed on 3/7/22, the low level control for the hematology test of Platelet was out of range at 48 (acceptable range was 52-103), the normal level control for the hematology test of Platelet was 174 (acceptable range was 185-255). The laboratory failed to document

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory staff, the laboratory did not calibrate the cell counter every six months. Findings include: Review of the operator's manual and hematology quality control records and maintenance records for the past two years on 03/06/18 revealed that the laboratory calibrated the cell counter on 08/23 /16 and the next calibration was on 05/08/17. The operator's manual indicated that the cell counter should be calibrated at least every six months. During an interview with the office supervisor at 11:40 a.m. on 03/06/18, she confirmed the there was no documentation to indicate that the cell counter had been calibrated between August, 2016 and May, 2017. 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 --