Advocare Mid-Jersey Pediatrics, Pa

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on surveyor review of the Operators Manual (OM), Procedure Manual (PM), Work Records (WR) and interview with the Testing Personnel (TP) the laboratory failed to follow the OM for "9.2 System Information Messages" from 1/18/24 to the date of survey. The findings include: 1. The OM stated "Indicator TU, possible orifice blockage: Run prime cycle amid then re-analyze. Action: Run a "prime cycle", before re-analyzing the sample"" 2. Two out of five WR had an indicator code TU for White Blood Cell Count (WBC). 3. There was no evidence that the aforementioned procedure was followed 4. The TP confirmed on 5/21/24 at 10:45 am that the laboratory did not follow the OM. 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 --

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor observation of the Quality Control (QC) material in use and interview with the Office Manager (OM), the laboratory failed to label the control material used in Hematology testing with a new expiration date after opening from 9 /10/19 to date of the survey. The findings include: 1) There was no expiration date written on the QC material. 2) The OM confirmed on 1/18/22 at 2:00 pm controls were not labeled correctly. Note: This was previously cited 9/10/19 D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor observation of the Quality Control (QC) results and interview with the Office Manager (OM), the laboratory use expired QC for Hematology tests run on the Medonic M-series analyzer from 1/13/22 to the date of survey. The findings include: 1. Boule Con-Diff Tri-Level controls Lot 221050 expired 1/13/22. 2. 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 -- Approximately 16 patients were run and reported. 3. The OM confirmed on 1/18/22 at 2:50 pm that the laboratory used expired QC. Note: This was previously cited 9/10/19 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: (a) Based on surveyor review of Calibration (Cal) records, Procedure Manual (PM) and interview with the Office Manager (OM), the laboratory failed to perform and document Calibration procedures at least once every six months for Hematology Tests performed on the Modonic M-series analyzer in the calendar year 2020. The findings include: 1. A review of C records revealed that the laboratory performed Cal once in the calendar year 2020. 2. The OM confirmed on 1/18/21 at 1:30 pm that the laboratory failed to perform and document Cal once every six months. (b) Based on surveyor review of Calibration (Cal) records, Procedure Manual (PM) and interview with the Office Manager (OM), the laboratory failed to meet acceptable Cal limits for Hematology Tests performed on the Modonic M-series analyzer from 5/19/20 to the date of survey. The findings include: 1. A review of Cal records revealed that the laboratory failed Cal on 5/19/20 as follows: (a) Red Blood Cell Count (RBC) five out of four Cal sample runs. (b) Platelets (PLT) two out of five Cal sample runs. (c) Hemoglobin (HCG) five out of five Cal sample runs. (d)White Blood Cell Count (WBC) five out of five cal sample runs. 2. A review of Cal records revealed that the laboratory failed Cal on 6/3/21 as follows: (a) Mean Corpuscular Volume (MCV) five out of five cal samples runs. 3. The OM confirmed on 1/18/21 at 1:30 pm that the laboratory failed to failed to meet acceptable Cal limits. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on surveyor review of the Personnel Files (PF) and interview with the Office -- 2 of 3 -- Manager (OM), the Laboratory Director (LD) failed to have appropriate education documentation for all Testing Personnel (TP) performing laboratory testing on the date of survey. The findings include: 1. The laboratory did not have education or training records for two out of eleven TP listed on the CMS form 209. 2. The OM confirmed on 1/18/22 at 1:40 pm the above records were not on file. -- 3 of 3 --

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor observation of the Quality Control (QC) material in use and interview with the Testing Personnel (TP), the laboratory failed to label the control material used in Hematology testing with an open and new expiration date after opening from 9/26/17 to date of the survey. The findings include: 1) There was no open and expiration date written on the QC material. 2) The TP #9 listed on CMS form 209 confirmed on 9/10/19 at 10:10 am controls were not labeled. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor observation of Quality Control (QC) material in use, review of the Boule Con-Diff Tri Level Control Kit Manufacture's Package Insert (MPI) and interview with the Testing Personnel (TP), the laboratory used expired QC material for the Hematology testing performed on the Medonic analyzer from 9/26/17 to the 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 -- date of survey. The findings include: 1. The MPI stated open vial stability was for 14 days. 2. The laboratory did not know control material expired 14 days after opening. 3. TP stated that "control material on average lasted 21 days". 4. The TP stated that the laboratory "runs on average approximately 5-6 patients per day". 5. Approximately 170 patients were run and reported with expired QC . 4. The TP #9 confirmed on 9/10/19 at 11:00 am that the laboratory used expired QC material. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on lack of Personnel Files and interview with the Testing Personnel (TP), the Laboratory Director failed to have training documented for one out of nine TP from July 2019 to the date of the survey. The findings include: 1. There was no documentation of training for throat and urine culture testing. 2. There was no documentation of training for hematology tests performed on the Medoic analyzer. 3. The TP #9 confirmed on 9/10/19 at 10:00 am that training records were not available. 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 and interview with the Testing Personnel (TP), the Laboratory Director (LD) failed to establish a Competency Assessment (CA) procedure with the required elements for Throat Culture, Urine Culture and Hematology tests performed on the Medonic analyzer from 9/26/17 to the date of the survey. The TP #9 listed on CMS form 209 confirmed on 9/10/19 at 9:30 am that a CA procedure was not established. -- 2 of 2 --