North Pinellas Childrens Medical Center Inc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at North Children's Medical Center Inc. on 12/07/2022 - 12/13/2022 The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following Conditions were cited: D5400 - Analytic Systems D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document room temperatures where waived cartridges, test kits, and testing equipment were being stored and waived testing was being performed for Strep A, Influenza A and B, Respiratory Syncytial Virus (RSV), FLU + SARS Antigen, and SARS Antigen tests for two of two years reviewed (October 2020 - December 2022). Findings Included: Review of the Manufacturer Instructions (MI) for the Strep A, Influenza A and B, RSV, Flu + SARS Antigen, and SARS Antigen Cartridges used on the Sofia analyzer revealed a storage temperature of "15 - 30 degrees Celsius." Review of the MI for the SARS Antigen test revealed "Specimens processed Reagent Tubes (rehydrated) have an in-use stability of up to 1 hour at room temperature, 59 to 86 degrees Fahrenheit (15 - 30 degrees Celsius), out of sunlight." Additionally, the laboratory conducted waived urinalysis testing. Review of the MI for operating conditions of the urinalysis instrument revealed "Optimum Operating Temperature Range was 22 to 26 degrees Celsius." Review of the laboratory's temperature logs revealed no temperature log was maintained for the room where the waived testing was being performed and waived 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 -- test kits, cartridges, and equipment were stored. On 12/07/22 at 3:00 PM, the Office Manager stated that the testing personnel did not know the room temperature needed to be documented in the room where the waived testing was being performed. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on proficiency record review and interview with the Laboratory Director, the laboratory failed to retain documentation of signed attestation statements and documentation that proficiency testing (PT) results had been reviewed for Hematology for 9 out of 9 testing events reviewed for two of two years reviewed (2020 - 2022). Findings included: Record review of the laboratory's procedure manual signed by the Laboratory Director on 07/24/2020 revealed a "Proficiency Testing Policy" with "Proficiency Testing Procedure and Guidelines" to include: "The laboratory will maintain a copy of all records, including a copy of the proficiency testing program report program forms used by the laboratory to record proficiency testing results, including the attestation statement provided by the proficiency testing program signed by the analyst and the Medical Director. The policy section for "Evaluation of Proficiency Testing Results" showed "All proficiency testing results should be reviewed by the persons performing the testing and the Medical Director. Signatures attesting this review should be noted on each report summary." Review of the American Proficiency Institute (API) instructions revealed that "Testing Personnel and the laboratory director must physically sign an attestation statement for all PT results and retain the signed statement (or a copy) for a minimum of 2 years." Review of 9 proficiency records to include API 3rd Event 2020, API 1st, 2nd, and 3rd Event 2021, API 1st, 2nd, and 3rd Event 2022, 2022 Off-Schedule PT for Medical Laboratory Evaluation (MLE) submitted 06/06/2022, and 2022 Off Schedule PT Evaluation Wisconsin State Laboratory of Hygiene (WSLH) submitted 06/30/2022 had not been signed by the Lab Director or Testing personnel and did not include documentation that PT test results had been reviewed by the laboratory director or staff. Interview with the Laboratory Director on 12/07/2022 at 12:30 PM. revealed she did not know that she and the testing personnel needed to sign the attestation statements, and she needed to document that she had reviewed the proficiency testing results along with the persons performing the testing. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on February 10, 2022 for North Pinellas Childrens Medical Center Inc. North Pinellas Childrens Medical Center Inc., is not in compliance with Code of Federal Regulations (CFR), Part 493, Laboratory Requirements. 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 review of the laboratory's proficiency testing records for 2021 the laboratory had subsequent unsuccessful performance in proficiency testing for the specialty of hematology. Refer to D2130. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review of the Centers for Medicare 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 -- & Medicaid Services (CMS) 153 and 155 reports, on February 10, 2022 at 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analytes white blood cell differential for three out three testing events in 2021. D2130 HEMATOLOGY CFR(s): 493.851(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 the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory had subsequent unsuccessful participation in proficiency testing for the specialty of hematology. Findings include: On February 10, 2022 on or about 10:00 AM the American Proficiency (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory had unsuccessful proficiency testing scores for three out of three testing events for the analyte, white blood cell differential, as shown below. Event #1, 2021 white blood cell differential- 32% Event #2, 2021 white blood cell differential-28% Event #3, 2021 white blood cell differential-0% 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. This CONDITION is not met as evidenced by: Based on the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the specialty of hematology. Findings include: On February 10, 2022, on or about 10:00 AM, the American Proficiency Institute (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had subsequent unsatisfactory proficiency testing score for the analyte, white blood cell differential, in the specialty of hematology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2130. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing in the specialty of hematology. Findings Include: The review of the American Proficiency Institute (API) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on February 10, 2022 on or about 10: 00 AM showed that the laboratory received unsatisfactory proficiency testing scores for three out of three testing events as shown below. Event #1, 2021 white blood cell differential-32% Event #2, 2021 white blood cell differential-28% Event #3, 2021 white blood cell differential-0% -- 3 of 3 --

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on September 13, 2021 for North Pinellas Childrens Medical Center, Inc. North Pinellas Childrens Medical Center Inc., lab is not in compliance with Code of Federal Regulations (CFR), Part 493, Laboratory Requirements. 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 review of the laboratory's proficiency testing records for 2021, the laboratory did not have successful performance in proficiency testing in the specialty of hematology. Refer to D2130. Findings include: Review of the American Proficiency Institute (API) proficiency testing records and the review of the Centers 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 -- for Medicare & Medicaid Services (CMS) 153 and 155 reports, on September 13, 2021 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the analyte, white blood cell differential for two consecutive testing events in 2021. D2130 HEMATOLOGY CFR(s): 493.851(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 the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful performance in proficiency testing in the specialty of hematology. Findings include: On September 13, 2021 on or about 10:00 AM the American Proficiency Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the analyte, white blood cell differential, as shown below. Event #1, 2021 white blood cell differential-32% Event #2, 2021 white blood cell differential-28% 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. This CONDITION is not met as evidenced by: Based on the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the specialty of hematology. Findings include: On September 13, 2021 on or about 10:00 AM, the American Proficiency Institute (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two consecutive testing events for the analyte, white blood cell differential, in the specialty of hematology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2130. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing in the specialty of hematology. Findings Include: The review of the American Proficiency Institute (API) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on September 13, 2021 on or about 10: 00 AM showed that the laboratory received unsatisfactory proficiency testing scores for two consecutive testing events as shown below. Event #1, 2021 white blood cell differential-32% Event #2, 2021 white blood cell differential-28% -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at North Pinellas Children's Medical Center Inc. on 08/26/20. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review from American Proficiency Institute (API) and interview with the Office Manager, the facility failed to maintain the API hematology proficiency testing report for one (3rd Event 2019) out of 7 testing events reviewed (2018 2nd and 3rd Events, 2019 1st, 2nd, 3rd Events, and 2020 1st and 2nd Events). Findings included: Record review of API proficiency testing documentation revealed there was no evidence that the Hematology API proficiency testing for the 2019 3rd Event had been performed (tests included White Blood Count, Red Blood Count, Hemoglobin, Hematocrit, Platelets, Mean Corpuscular Volume, Red Blood Cell Distribution Width, Mean Concentrate Hemoglobin, Mean Corpuscular Hemoglobin Concentrate, and White Blood Cell Differential). Interview on 08/26/20 at 11:40 a.m. with the Office Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Manager revealed she performed the Hematology 2019 3rd event with guidance from another office's office manager because she had not previously performed proficiency testing. The Office Manager did not know what happened to the paperwork. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on employee competency records and interview with the Office Manager, the laboratory failed to perform competency assessments on 1 (#B) out of 5 (#A, B, C, D, and E) Testing Personnel since her date of hire. Findings included: A review of the CMS 209, Laboratory Personnel Report, revealed Employee #B was a Testing Personnel. A review of employee competency records for 2018 through 2020 revealed no competency records were present for Testing Personnel #B. Testing Personnel #B was hired on 01/03/20. Interview on 08/26/20 at 11:30 a.m. with the Office Manager (Testing Personnel #B) revealed she forgot to have her 6 month competencies performed. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) 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 lack of documentation and interview with the Office Manager, the laboratory failed to verify manufacturer's recommended ranges for Hematology controls, before testing patients, on the hematology instrument for two out of two years (2018-2020). Findings included: An attempt to review Hematology quality control records revealed no quality controls records were present to verify manufacturer's recommended ranges for the new lot of quality controls for the Hematology instrument for two out of two years (2018-2020). Interview on 08/26 /2020 at 1:00 PM with the Office Manager revealed she did not know to verify the quality control manufacturer's recommended ranges for a new lot of Hematology controls before testing with patients. This is a repeat deficiency. -- 2 of 2 --

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 interview with the Laboratory manager and record review of the Form CMS 209 and American Proficiency Institute (API) proficiency testing, the laboratory failed to rotate proficiency testing to include all testing personnel who perform patient testing for 5 of 5 API Hematology Testing Events reviewed (3rd Event 2016, 1st, 2nd, and 3rd Events 2017, and 1st Event 2018). Findings Included: Review of the Form CMS 209, signed and dated by the Laboratory Director on 06/25/2018, revealed 11 Testing Personnel (#A, B, C, D, E, F, G, H, I, J, K). Review of API Hematology proficiency testing revealed Testing Person #A was the only person who performed the proficiency testing for the 5 of 5 API Hematology Testing Events reviewed ( 3rd Event 2016, 1st, 2nd, and 3rd Events 2017, and 1st Event 2018). Interview with the Laboratory Manager on 07/03/2018 at 12:15 PM. confirmed that Testing Personnel A was the only person performing proficiency testing even though Testing Person #A- #K all performed patient testing. 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: 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 -- Based on review of American Proficiency Institute (API) proficiency testing results and interview with the Laboratory Manager, the laboratory failed to score at least 80% for White Blood Cell (WBC) in 1 out of 5 (3nd testing event 2016 through 1st testing event in 2018) testing events reviewed in the specialty of Hematology. Findings Included: Review of API proficiency testing results revealed the 2nd testing event in 2017 had a score of 40% for WBC. An interview on 07/03/18 at 12:00 PM with the Laboratory Manager confirmed the proficiency testing failure. 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 Laboratory Manager, the laboratory failed to document the room temperature and humidity for four months out of two years reviewed (2017-2018). Findings Included: Review of the Hematology instrument manual revealed the test device required an instrument room temperature of 18 - 32 degrees Celsius and a maximum humidity of 80%. Review of the Routine Maintenance Quality Control (Q.C.) and Quality Assurance (Q.A.) Documentation Log revealed no documentation of room temperature and humidity for four months ( April 2017, November 2017, January 2018, and May 2018). Interview with the Laboratory Manager on 07/03/2018 at 12:30 PM confirmed that the room temperature and humidity were not being consistently recorded. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) 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 Laboratory Manager, the laboratory failed to verify the quality control manufacturer's recommended range for -- 2 of 3 -- the Hematology controls that were used on the hematology instrument for two out of two years (2017-2018). 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 (2017-2018). Interview on 07/03/2018 at 1:00 PM the Laboratory Manager stated the laboratory did not know to verify the quality control manufacturer's recommended ranges for new lot of Hematology controls. -- 3 of 3 --