Pedia-Care Physicians Llc

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 the lack of Temperature Logs (TL) and interview with Testing Personnel (TP), the laboratory failed to have record temperatures for the Incubator and room where Bacteriology testing is performed. from 6/20/25 to 7/23/25. The finding includes: 1. The laboratory did not have a TL log for the incubator. 2. The laboratory did not have a temperature and humidity log for the main laboratory. 3. The TP confirmed on 7/23/25 at 11:00 am the laboratory did not have a TL for the incubator or the main laboratory. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (1) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in 493.1261 (a)(3)) and identification systems (systems using two or more substrates or two or more reagents, or a combination) when prepared or opened for positive and negative reactivity, as well as graded reactivity, if applicable. 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 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records, Bacitracin discs in use and interview with the Testing Personnel (TP) the laboratory failed to check each lot number and shipment of Bacitracin Discs for positive and negative reactivity from 6 /20/25 to 7/23/25. The finding includes: 1. There was no record of Bacitracin QC for Lot # 4096554 currently in use. 2. Approximately 13 patients run and reported. 3. The TP confirmed on 7/23/24 at 11:00 am that the laboratory did not perform QC on Bacitracin disc as stated above. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (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. This STANDARD is not met as evidenced by: Based on surveyor review of Quality Control (QC) records and interview with the Testing Personnel (TP), the laboratory failed to check each batch of Selective Strep Agar (SSA) used for Throat Culture (TC) tests for sterility, its ability to support growth and select or inhibit specific organisms and document the physical characteristics of the media from 6/20/25 to 7/23/25. The findings include: 1. There was no documented evidence the above mentioned QC was performed on SSA lot # 656070 and 659051. 2. Approximately 13 patients were run and reported. 3. The TP confirmed on 7/23/25 at 11:00 am that the laboratory did not perform QC as stated above. Note: This was previously cited. -- 2 of 2 --

Summary Statement of Deficiencies D2021 BACTERIOLOGY CFR(s): 493.823(b) 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 surveyor review of the Proficiency Testing (PT) records and interview with Testing Personnel (TP), the laboratory failed to participate in PT for Bacteriology from the American Proficiency Institute (API) for calendar year 2022. TP#1 confirmed on 8/15/23 at 10:45 am that the laboratory did not participate in Bacteriology PT from API for calendar year 2022. D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on an in-office review of the laboratory's requirements for a New Jersey State Clinical Laboratory License (NJCLL) under New Jersey Statutes Annotated: N.J.S.A. 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 -- 45:9-42.28. License; necessity; categories, the laboratory failed to maintain NJCLL for calendar year 2023. A Surveyor for the Clinical Laboratory Improvement Services (CLIS) confirmed on 8/3/23 that the laboratory did not have a NJCLL license for 2023. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on surveyor review of Quality Control (QC) records, Procedure Manual (PM) and interview with the Testing Personnel (TP), there was no QC procedure for the inhibition ability of Selective Strep Agar (SSA) media from 7/12/21 to date of the survey. The TP #1 confirmed on 8/15/23 at 11:38 am there was no QC procedure for the inhibition ability of Selective Strep Agar (SSA) media D5409 PROCEDURE MANUAL CFR(s): 493.1251(e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in 493.1105(a)(2). This STANDARD is not met as evidenced by: Based on surveyor review of the Procedure Manual (PM) and interview with the Testing Personnel (TP), the laboratory failed to record a discontinuance date for procedures not performed in the laboratory from 7/12/21 to the date of survey. The finding includes: 1. There were no discontinuance dates for Urine culture procedures in the PM. 2. The TP #1 as listed on the CMS-209 form confirmed on 8/15/23 at 10: 45 am that a discontinuance date was not documented. 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 surveyor review of the Quality Control (QC) records and interview with Testing Personnel (TP), the laboratory failed to check each new lot number and -- 2 of 3 -- shipment of Selective Strep Agar (SSA) media for it ability to inhibit specific organisms from 7/12/21 to the date of the survey. The TP #1 confirmed on 8/15/23 at 11:30 am the laboratory did not perform the above mentioned QC on SSA media. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on surveyor review of the Lab Log Book, Test Records (TR) and interview with the Testing Personnel (TP), the laboratory failed to maintain an accurate record system for Bacteriology tests from 7/12/21 to the date of the survey. The findings include: 1. All Bacteriology TR from 7/12/21 to date of survey did not have a culture read time or date. 2. The TP#1 confirmed at 11:45 am on 8/15/23 the laboratory did not maintain accurate record system. 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; This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with Testing Personnel l(TP), the Laboratory Director (LD) failed to ensure PT samples were tested for Bacteriology from the American Proficiency Institute (API) for calendar year 2022. TP #1 confirmed on 8/15/23 at 11:45 am that the LD did not ensure PT samples for Bacteriology were tested for calendar year 2022. -- 3 of 3 --

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 lack of Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to enroll in an approved PT program for Throat Culture testing from January 2019 to the date of survey. The TP #2 as listed on CMS form 209 confirmed on 7/12/21 at 9:45 am the laboratory was not enrolled in PT testing. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the Procedure Manual (PM) and interview with the Testing Personnel (TP), the laboratory failed to ensure that an approved PM was available to all testing personnel from 8/22/18 to the date of the survey. The finding includes: 1. 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 -- The laboratory could not provide a PM that was approved and signed by the current laboratory director. 2. The TP #2 as listed on CMS form 209 confirmed on 7/12/21 at 10:15 am that the PM was not approved and signed by the Laboratory Director. D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: Based on the surveyor review of the Patient Charts (PC), Test Reports (TR) and interview with the Testing Personnel (TP), the laboratory failed to have TR in one out of six PC reviewed from Ausgust 2018 to the date of the survey. The TP # 2 as listed on CMS form 209 confirmed on 7/12/21 at 11:00 am there was no TR in the PC. 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 an office review of the laboratory's performance in Proficiency Testing (PT) surveys, the Laboratory Director (LD) failed to provide appropriate direction to the laboratory personnel to ensure that the PT surveys are performed satisfactorily and compliance with the CLIA regulations are maintained. 1. The LD failed to ensure that the laboratory was enrolled in a PT program. Cross refer to D6015 2. The LD failed to ensure that PT samples were tested for Throat Culture tests. Cross refer to D6016 3. The LD failed to ensure that the established QC program was maintained. Cross Refer to D6020 D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on surveyor review of Proficiency Testing (PT) and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to ensure the laboratory was enrolled in an approved PT program from January 2019 to the date of the survey. The TP # 2 as listed on CMS form 209 confirmed on 7/12/21 at 9:45 am the laboratory was not enrolled in PT. -- 2 of 3 -- 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; This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to ensure that PT samples were tested for Throat Culture (TC) tests from January 2019 to the date of the survey. The TP #2 listed on CMS form 209 confirmed on 7/12/21 at 9:45 am that the LD did not ensure PT TC samples were tested. D6020 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 the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to ensure that the QC program is maintained for laboratory services provided from 8/22/18 to the date of the survey. The findings include: 1. The LD did not review Throat Culture (TC) QC. 2. The TP # 2 as listed on CMS form 209 confirmed on 7/12/21 at 10:00 am the LD did not ensure the QC program is maintained. -- 3 of 3 --

Summary Statement of Deficiencies 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 lack of the Competency Assessment (CA) records, reviewed via faxed copy in the office and interview with the Testing Personnel (TP), the laboratory failed to perform CA correctly on two out of two TP in 2017. The findings include: 1. The laboratory used Performance Review form to document CA but did not have the following: a. All six tools to be accessed. b. Name of the test. c. What records were reviewed and how TP were accesssed. 2. This was confirmed with the TP # 1 via phone on 8/24/18 at 10:00 am. 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; 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 -- This STANDARD is not met as evidenced by: Based on lack od the Procedure Manual on site and interview via phone with the Testing Personnel (TP), the Laboratory Director failed to establish a Competency Assessment (CA) procedure with the required elements from 8/16/16 to the date of the survey. The TP # 1 listed on the CMS form 209 confirmed via on 8/24/18 at 10:00 am that a CA procedure was not established. -- 2 of 2 --