Pediatricare Associates

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: a) Based on surveyor review of the Final Report (FR) for SARS-CoV-2, Flu A, Flu B and Respiratory Syncytial Virus (RSV) and interview with the Testing Personnel (TP) the laboratory failed to ensure that the FR included the name and address of the laboratory where testing was performed on the date of survey. The finding includes: 1) Three out of three FR did not have the name and address of the laboratory where testing was performed 2) The TP confirmed on 5/16/23 at 11:00 am that the FR did not have name and address of the laboratory where testing was performed. b) Based on surveyor review of the Test Report (TR) and interview with the Testing Personnel (TP), the laboratory failed to report Covid 19 testing accurately on the date of survey. The finding includes: 1. The laboratory performed COVID 19 non Food and Drug Administration (FDA) cleared tests. 2. A review of three out of three Covid 19 TR revealed that the The FDA COVID EUA statement "This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories." did not appear on the TR when printed. 3. The GS confirmed on 10/6/22 at 3:00 pm that COVID 19 tests were not reported accurately. . 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 -- D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on the surveyor review of the Final Reports (FR), and interview with the Testing Personnel (TP), the laboratory failed to have accurate Reference Interval (RI) for SARS-CoV-2, Flu A, Flu B and Respiratory Syncytial Virus (RSV) Analysis run on the Cepheid GeneXpert Xpress analyzer at the time of survey. The findings include: 1. A review of the FR revealed the FR did not have a RI for the above mentioned analytes. 2. The TP confirmed on 5/16/23 at 10:40 am that laboratory failed to have RI. -- 2 of 2 --

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on surveyor review of the COVID 19 Cepheid Xpert Xpress, patient test results and interview with the Testing Personnel (TP), the laboratory failed to report Negative COVID 19 test results to the State of New Jersey (NJ) from 2/9/21 to the date of the survey. The findings include: The laboratory did not report as follows: 1. The Laboratory did not report negative COVID 19 results to the State of NJ. 2. The Laboratory performed approximately 2 COVID 19 tests per day up to the date of the survey. 3. The TP #1 listed on CMS form 209 confirmed at 11:30 am on 4/6/2021 that the laboratory did not report COVID test results to the state. 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 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 -- 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: a) Based on review of the Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to check each new lot number and shipment of BBL Group A select agar for, sterility from 7/23/18 to the date of the survey. The TP #1 listed on CMS form 209 confirmed on 4/6/21/20 at 10:50 am the laboratory did not perform the above QC. b) Based on review of the Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to check each new shipment of BBL Group A select agar for, the ability to support growth and select or inhibit organisms from 1/3/20 to 3/16/20. The TP #1 listed on CMS form 209 confirmed on 4/6/21 at 10:50 am the laboratory did not perform the above QC. -- 2 of 2 --

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on surveyor review of the COVID 19 Cepheid Xpert Xpress, patient test results and interview with the Testing Personnel (TP), the laboratory failed to report Negative COVID 19 test results to the State of New Jersey (NJ) from 2/9/21 to the date of the survey. The findings include: The laboratory did not report as follows: 1. The Laboratory did not report negative COVID 19 results to the State of NJ. 2. The Laboratory performed approximately 2 COVID 19 tests per day up to the date of the survey. 3. The TP #1 listed on CMS form 209 confirmed at 11:30 am on 4/6/2021 that the laboratory did not report COVID test results to the state. 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 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 -- 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: a) Based on review of the Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to check each new lot number and shipment of BBL Group A select agar for, sterility from 7/23/18 to the date of the survey. The TP #1 listed on CMS form 209 confirmed on 4/6/21/20 at 10:50 am the laboratory did not perform the above QC. b) Based on review of the Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to check each new shipment of BBL Group A select agar for, the ability to support growth and select or inhibit organisms from 1/3/20 to 3/16/20. The TP #1 listed on CMS form 209 confirmed on 4/6/21 at 10:50 am the laboratory did not perform the above QC. -- 2 of 2 --

Summary Statement of Deficiencies 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 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 surveyor review of the Procedure Manual, Competency Assessment (CA) records and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to establish a Competency Assessment (CA) procedure with the required elements from 7/20/16 to the date of the survey. The TP # 2 listed on the CMS form 209 confirmed on 7/23/18 at 1:00 pm that a CA procedure was not established accurately. 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 --