Island Coast Pediatrics Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Island Coast Pediatrics PA on 07/29/2025 - 07/30/2025. The laboratory is not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Conditions were cited: D2016 493.803 Condition: Successful Participation D6063 493.1403 Condition: Moderate Complexity Lab Director. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory did not have successful 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 -- performance in proficiency testing for three (2024 2nd event and 2025 1st and 2nd events) of four events (2024 2nd and 3rd events and 2025 1st and 2nd events) in the specialty of Hematology. Refer to D2130. D2123 HEMATOLOGY CFR(s): 493.851(c) (c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to participate in one (test event 2, 2024) of six test events (test events #3, 2023, #1 - #3, 2024, #1 - #2, 2025) reviewed resulting in a score of 0, unsatisfactory performance, for the specialty of Hematology. Findings included: 1. Review of the laboratory's College of American Pathologists (CAP) evaluation records revealed a score of 0%, unsatisfactory performance, for test event #2 in 2024 for the specialty of Hematology. 2. Testing Personnel A and the Laboratory Director confirmed on 7/29/25 at 1:45 p.m. the above. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory did not have successful performance in proficiency testing for three (2024 2nd event and 2025 1st and 2nd events) of four events (2024 2nd and 3rd events and 2025 1st and 2nd events) in the specialty of Hematology. Findings included: 1. Review of the laboratory's College of American Pathologists (CAP) evaluation records for 2024 2nd event and 2025 1st and 2nd events documented the lab failed to successfully participate in the speciality of Hematology for the analyte of Hematocrit (HCT) non-waived. 2024 2nd event -HCT non-waived 0% 2025 1st event-HCT non-waived 40% 2025 2nd event-HCT non- waived 20% 2. Testing Personnel A and the Laboratory Director confirmed on 7/29 /25 at 1:45 p.m., the above unsuccessful results for the analyte of Hematocrit (HCT) non-waived for the 2024 2nd event and 2025 1st and 2nd CAP proficiency events. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. -- 2 of 4 -- This CONDITION is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to ensure the laboratory maintained successful proficiency performance for three (2024 2nd event and 2025 1st and 2nd events) of four events (2024 2nd and 3rd events and 2025 1st and 2nd events) in the specialty of Hematology (refer to D6016) and failed to complete a competency on Technical Consultant #B for one (2023) of two years (2023, 2024) reviewed and failed to complete competencies for three (#A, #C, #D) of six (#A - #F) testing personnel (TP) selected for review for 2023 - 2024. (See D6030). D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to ensure the laboratory maintained successful proficiency performance for three (2024 2nd event and 2025 1st and 2nd events) of four events (2024 2nd and 3rd events and 2025 1st and 2nd events) in the specialty of Hematology. Refer to D2130. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to complete a competency on Technical Consultant #B for one (2023) of two years (2023, 2024) reviewed, and failed to complete competencies for three (#A, #C, #D) of six (#A - #F) testing personnel (TP) selected for review for 2023 - 2024. Findings included: 1. The Laboratory Policy & Procedure titled Proficiency/Laboratory Competency Testing Program with revision dates of 03/2/22, 04/24/24 and 01/31/25 was reviewed. The policy stated new employees would have two competencies completed in the first six months of employment and every employee would have a competency completed annually, observed and signed off by the Laboratory Director or designee. The policy also stated the Laboratory Director would observe the employees as part of their competency. The policy stated competency assessments would be completed on all staff. 2. Review of the CMS-209 Laboratory Personnel Report, signed and dated 07/28 /2025 by the Laboratory Director, documented two Technical Consultants (TC). TC #A, who is also the Laboratory Director, and TC #B. The CMS-209, signed and dated by the Laboratory Director 07/14/2023 for the previous survey was reviewed. TC #B was listed on the form. 3. TC #B's competencies for 2023 and 2024 were reviewed. There was no competency assessment for 2023. 4. The CMS-209 Laboratory -- 3 of 4 -- Personnel Report, signed and dated 07/28/2025 by the Laboratory Director and the CMS-209, signed and dated by the Laboratory Director 07/14/2023 for the previous survey were reviewed. A comparison of testing personnel (TP) listed on the form revealed the laboratory currently had six TP (#A - #F), four (#A, #C, #D, #E) of which were new (not previously listed on the 209). 5. TP competencies were reviewed. 5a. TP #A had competency form dated 12/10/2023, 04/01/2024, 12/19/2024 and 06/25/2024. 5b. TP #C had competency forms dated 04/14/2024, 12/19/2024, and 06/25/2025. 5c. TP #D had competency forms dated 12/19/2024 and 06/25/2024. All forms were signed by the Office Manager and Laboratory Director however, it was unclear who was completing the competencies and performing observation of the TP. 6. An interview was conducted with TP #A, Clinic Department Manager on 07/29 /2025 at 11:41 a.m. TP #A stated the Office Manager or Clinical Department Manager filled out the competency forms and conducted the observations then gave the forms to the Laboratory Director for signature. 7. An interview was conducted with the Laboratory Director on 07/29/2025 at 1:35 p.m. The Laboratory Director confirmed the above data. -- 4 of 4 --

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 5/11/21 at Island Coast Pediatrics Pa, a clinical laboratory in Estero, Florida. Island Coast Pediatrics Pa is not in compliance with the Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. The following is a description of the noncompliance. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of the Hematology instrument manual used by the laboratory, lack of documentation, and interview with the Clinical Department Manager, the laboratory failed to document the room temperature and humidity for two out of two years reviewed (2019-2021). The findings included: Review of the Hematology instrument manual revealed the test device required an instrument room temperature of 64 - 90 degrees Fahrenheit (18 - 32 degrees Celsius) and a maximum humidity of 80%. Review of the Quality Assurance revealed no policy for recording room temperature and humidity. Interview on 5/11/21 at 3:25 p.m., the Clinical Department Laboratory Manager stated that she did not know that the room temperature and humidity needed to be recorded. . D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) 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 -- Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the lack of record review, and interview with the Clinical Department Manager, the laboratory failed to verify the quality control manufacturer's recommended range for the Hematology controls that were used on the hematology instrument for two out of two years (2019-2021). The findings included: Review of Hematology quality control records revealed the lack of quality controls records for verification of quality control manufacturer's recommended ranges for the new lot of Hematology controls for two out of two years (2019-2021). Interview on 5/11/21 at 2: 15 p.m., the Clinical Department Manager stated the laboratory did not know to verify the quality control manufacturer's recommended ranges for new lot of Hematology controls. . 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 record review, and interview with the Clinical Department Manager, the laboratory director failed to perform the quality assurance (QA) activity of reviewing quality control records for two out of two years (2019 - 2021). The findings included: Review of quality control records revealed that there was no quality assurance (Laboratory Director signature) documentation for two out of two years (2019 to 2021). Interview on 5/11/21 at 3:20 p.m., the Clinical Department Manager stated that she did not know that the Laboratory Director should review the quality control records. . D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform -- 2 of 3 -- 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on record review, and interview with Clinical Department Manager, the Laboratory Director failed to ensure that staff followed a written procedure that described the process for documenting the competency assessment of 5 (Consultants #H, #I, #J, #K, and #L) out of 5 Technical Consultants for two out of two years (2019- 2021). The findings included: Record review of competency assessments revealed the Laboratory Director had not performed competency assessment on 5 (Consultants #H, #I, #J, #K, and #L) out of 5 Technical Consultant for two out of two years (2019- 2021). Record review of the laboratory's procedure manual showed a Quality Assurance Program policy that included a section titled "Personnel" that stated "Personnel are evaluated during the first year of employment or when new methodologies are incorporated. Thereafter, evaluations are performed yearly." But the policy did not include how to determine the competency for the Technical Consultant. Interview on 5/13/21 at 3:30 p.m., the Clinical Department Manager stated the Technical Consultants did not perform testing and she did not know that the laboratory should have a procedure for determining the competency of the Technical Consultant. . 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 record review, and interview with the Clinical Department Manager, the Technical Consultant (who is also the Laboratory Director) failed to perform semi- annual competencies on 2 (Personnel #B, and #C ) out of 3 newly hired Testing Personnel. The findings included: Review of employee files revealed that Testing Personnel #B had a hire date as of 10/3/19 and competency evaluations were conducted 1/29/20 and 1/2/21. Testing Personnel #C had a hire date of 12/3/19 and competency evaluations were conducted 2/03/20 and 1/1/2021. Interview on 5/11/21 at 2:00 p.m., the Clinical Department Manager confirmed that semi-annual competency evaluations had not been completed for Testing Personnel #B and #C. -- 3 of 3 --

Summary Statement of Deficiencies D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the laboratory did not receive at least 80 percent on two proficiency testing events over the past two years. Findings include: The surveyor reviewed the past two years of proficiency testing results on 05/01/2019 and found the following unsatisfactory results. 1. For the second testing event of 2017, the laboratory received an unsatisfactory score of 60 percent for platelets. 2. For the third testing event of 2018, the laboratory received an unsatisfactory score of 60 percent for cell identification or white blood cell (WBC) differential. During an intrview with the office supervisor at 10:40 a.m on 05/01/2019, she confirmed that they had received unsatisfactory scores for those two events. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(4)(iv) Ensure that an approved