Northeast Al Pediatrics

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 information received during the laboratory tour, a lack of documentation for throat cultures, and interviews with Testing Personnel #1 and the Laboratory Director, the laboratory failed to perform proficiency testing or implement another mechanism for accuracy verification on throat cultures, a moderate complexity test. This was noted from the previous survey (7/26/2022) to current survey (9/6/2023). The findings include: 1) During the entrance interview on September 6th, 2023, at 9:10 AM, the Laboratory Director stated the laboratory began performing throat cultures on all patients with a negative Strep A rapid test shortly after the last CLIA survey. However, when the surveyor requested proficiency testing for throat cultures, the Laboratory Director stated the Gadsden laboratory was performing proficiency testing since all the Strep A agar plates were received from the Gadsden laboratory. The surveyor explained the throat cultures were read at this laboratory, so proficiency testing was required for this laboratory. 2) During an interview on September 6th, 2023, at 11:30 AM, the Laboratory Director confirmed the laboratory was not performing any proficiency testing because they did not know it was required. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE 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 -- CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with Testing Personnel #1 and the Laboratory Director, the laboratory failed to document reviews of returned PT results for three of seven 2022-2023 events. The findings include: 1. A review of the API PT records revealed no documentation of a review from the Laboratory Director, or designee, for the following surveys: a) 2022 Hematology 3rd Event. b) 2023 Hematology 1st Event. c) 2023 Hematology 2nd Event. 2. During an interview on September 6, 2023, at 10:11 AM, Testing Personnel #1 and the Laboratory Director confirmed the above findings. 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 a review of the refrigerator temperature records, a lack of documentation of incubator temperatures, the manufacturer's package insert, and an interview with Testing Personnel #1, the Laboratory failed to ensure temperatures were documented for: 1) The refrigerator in which Hematology QC and Microbiology Taxo A discs were stored for 11 of 22 days in November 2022; and 2) The incubator for throat culture agar plates from the previous survey (7/26/2022) to the current survey (9/6 /2023). The findings include: 1. A review of the temperature records revealed the laboratory failed to document temperatures for the refrigerator in which the Cell Dyn+ Hematology Controls and the Microbiology BD Taxo A Discs were stored for the first half (1st-15th) of November 2022. 2. A review of the Cell Dyn 18+ Control package insert reveals, "Cell Dyn 18+ controls should be tightly capped and stored at 2-10 degrees Celsius." 3. A further review of the BD Taxo A Discs package insert reveals, "...store vial or cartridge to protect product integrity at 2 to 8 degrees Celsius." 4. A review of the Ivyx Scientific Incubator records revealed the laboratory failed to document any incubator temperatures from 7/26/2022 to 9/6/2023. 5. During an interview on September 6th, 2023, at 11:06 AM, Testing Personnel #1 confirmed the above findings. D5471 CONTROL PROCEDURES CFR(s): 493.1256(e)(1)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e)(i) Check each batch (prepared in-house), lot number (commercially prepared) and shipment of reagents, disks, stains, antisera, (except those specifically referenced in -- 2 of 4 -- 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. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on information received during the laboratory tour, a lack of documentation for throat cultures, and interviews with Testing Personnel #1 and the Laboratory Director, the laboratory failed to perform Quality Control (QC) on Becton Dickinson BBL Taxo A Bacitracin discs for throat cultures. This was noted from the previous survey (7/26 /2022) to the current survey (9/6/2023). The findings include: 1) During the entrance interview on September 6th, 2023, at 9:10 AM, the Laboratory Director stated the laboratory began performing throat cultures on all patients with a negative Strep A rapid test shortly after the last CLIA survey. However, when the surveyor requested QC for the BD BBL Taxo A Bacitracin discs for throat cultures, the Laboratory Director stated the Gadsden laboratory performed the QC since all discs were received from the Gadsden laboratory. The surveyor explained the throat culture testing was performed at this laboratory, thus QC on the Bacitracin discs was required to be performed at this laboratory. 2) During an interview on September 6th, 2023, at 11:30 AM, the Laboratory Director confirmed the laboratory was not performing any QC on the Bacitracin discs since the QC was performed at the Gadsden laboratory. The Laboratory Director stated he did not realize on-site QC must also be performed at this laboratory. 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 information received during the laboratory tour, a lack of documentation for throat cultures, and interviews with Testing Personnel #1 and the Laboratory Director, the laboratory failed to perform Quality Control on Hardy Diagnostics Agar plates for throat cultures. This was noted from the previous survey (7/26/2022) to current survey (9/6/2023). The findings include: 1) During the entrance interview on September 6th, 2023, at 9:10 AM, the Laboratory Director stated the laboratory began performing throat cultures on all patients with a negative Strep A rapid test shortly after the previous survey. However, when the surveyor requested QC on the Hardy agar plates for throat cultures, the Laboratory Director stated the Gadsden laboratory was performing QC since all the Strep A agar plates were received from the Gadsden laboratory. The surveyor explained the throat culture testing was performed at this laboratory, so the laboratory was required to document an inspection of the media, and implement a mechanism to check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms. 2) During an interview on September 6th, 2023, at 11:30 AM, the Laboratory Director confirmed -- 3 of 4 -- the laboratory was not performing any QC on the agar plates since QC was performed at the Gadsden laboratory. 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 a review of the personnel records and an interview with the Laboratory Director, the Laboratory Director failed to ensure Testing Personnel #2 provided appropriate educational documentation prior to performing patient testing. This was noted for one of two testing personnel. The findings include: 1. A review of the personnel records revealed no educational documentation for Testing Personnel #2. 2. During an interview on September 6, 2023, at 9:43 AM, the above noted findings were reviewed and confirmed with the Laboratory Director. D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. This STANDARD is not met as evidenced by: Based on reviews of the American Proficiency Institute (API) proficiency testing (PT) records, temperature records, a lack of throat culture quality control documentation, and an interview with the Laboratory Director, the Technical Consultant failed to provide adequate technical and scientific oversight of the laboratory. These failures were noted to occur from previous survey on 7/26/2022 to the current survey. The findings include: 1. A review of the laboratory records revealed the Technical Consultant failed to provide adequate technical and scientific oversight to ensure the following: (A) PT results for three of seven 2022-2023 events had documentation of review. (Refer to D5211) (B) Temperatures were documented for the refrigerator in which Hematology QC and Microbiology Taxo A discs were stored for 11 of 22 days in November 2022; and the temperatures were monitored and recorded for the throat culture incubator from the previous survey (7/26/2022) to the current survey.(Refer to D5413). (C) Proficiency testing was performed, or another mechanism for accuracy verification was implemented for throat cultures, a moderate complexity test. (Refer to D2000). (D) Quality Control (QC) on Becton Dickinson BBL Taxo A Bacitracin discs for throat cultures was performed. (Refer to D5471). (E) Quality Control on Hardy Diagnostics Agar plates for throat cultures was performed. (Refer to D5477). 2. During the exit interview and summation on September 6, 2023, at 12:45 PM, the above noted findings were reviewed and confirmed with the Laboratory Director. -- 4 of 4 --

Summary Statement of Deficiencies 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 a review of the CASPER reports and American Proficiency Institute (API) Proficiency Testing (PT) records, the laboratory failed to successfully participate in PT testing for Platelets (PLTs) for two consecutive events, Events #2 and #3, 2022. These failures resulted in an initial unsuccessful participation. The findings include: Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- 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 a review of the CASPER reports and American Proficiency Institute (API) Proficiency Testing (PT) records, the laboratory failed to satisfactorily perform in PT testing for Platelets (PLTs) for two consecutive events, Events #2 and #3, 2022. The findings include: 1. A review of the CASPER report revealed the laboratory scored the following: a) Event #2, 2022 PLTs = 40 % b) Event #3, 2022 PLTs = 60 % 2. A review of the API PT records confirmed the above noted findings. -- 2 of 2 --

Summary Statement of Deficiencies D2123 HEMATOLOGY CFR(s): 493.851(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 a review of the American Proficiency Institute (API) proficiency testing records and an interview with the off-site Laboratory Supervisor, the laboratory failed to submit results within the timeframe specified by the proficiency testing provider. This was noted for one out of nine 2019 to 2022 API events. The findings include: 1. A review of the API records revealed the 2021 API Hematology event #1 survey received a score of zero percent due to "Failure to Participate". 2. A review of the API records revealed the laboratory performed the 2021 API Hematology event #1 survey on March 17, 2021. However, the laboratory failed to submit the results by the due date of March 31, 2021, the cutoff date specified by API. 3. During an interview on July 26, 2022, at 11:49 AM, the off-site Laboratory Supervisor confirmed the laboratory failed to submit results by the due date. . D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- This STANDARD is not met as evidenced by: Based on a review of the API (American Proficiency Institute) proficiency testing (PT) records and an interview with the off-site Laboratory Supervisor, the laboratory failed to retain PT records for one of nine 2019 - 2022 API surveys. The findings include: 1. A review of the API PT records revealed the laboratory failed to retain the PT records for API 2019 Event #2. The scores for this survey were pending during the previous CLIA survey review on 6/27/2019. 2. During the exit interview and summation on July 26, 2022, at 3:15 PM, the above noted findings were reviewed and confirmed with the off-site Laboratory Supervisor who stated the records were at the Gadsden laboratory. The surveyor agreed the laboratory could submit the documentation by July 29, 2022, however no additional records were received by the CLIA office. . D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) Hematology proficiency testing (PT) records and an interview with the off-site Laboratory Supervisor, the laboratory failed to perform an internal evaluation of Hematology results not submitted within the required timeframes specified by API. This was noted for one of nine 2019 to 2022 surveys. The findings include: 1. A review of the API records revealed no API evaluation for the 2021 Hematology event #1 survey. 2. A review of the API records revealed the laboratory performed the 2021 API Hematology event #1 survey on March 17, 2021. However, the laboratory failed to submit the results by March 31, 2021, the cutoff date specified by API. (Refer to D2123.) 3. A further review of the PT records revealed no documentation of an internal evaluation of the laboratory's results when compared to API results (available on the website) to ensure no

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 a review of the 2017 - 2019 API (American Proficiency Institute) proficiency testing (PT) records, personnel records, and an interview with the Laboratory Director, the surveyor determined the laboratory failed to ensure proficiency testing samples were rotated between all personnel who routinely performed moderate complexity Hematology testing on patients. This was noted on seven of seven surveys reviewed. The findings include: 1. A review of API attestation statements revealed the following: A) 2017-Events #1 and #2: performed by a previous testing personnel who resigned in 2017 B) 2017-Event #3 was performed by TP #3 C) 2018-Events #1, #2, and #3; 2019 Event #1 performed by TP #1 None of the surveys were performed by TP #2. 2. A review of the personnel files revealed TP #1 and #2 were full time employees in the clinic (hired 11/7/2017 and 8/14/2017 respectively) and had been qualified to perform moderate complexity Hematology testing since 5/17/2018 (the date of their initial competency evaluations.) 3. During an interview on 6/27/2019 at 12:30 PM, the Laboratory Director confirmed the laboratory had failed to rotate the Hematology proficiency testing among all personnel who routinely performed patient CBC (Complete Blood Count) testing. The surveyor explained the laboratory must ensure all testing personnel included on the CMS-Form 209 (Laboratory Personnel Report) must periodically participate in the performance of proficiency testing. Thus the above noted findings were confirmed. 4. This is a repeat deficiency. . D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE 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 -- CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on reviews of the installation and validation records for the Abbott Cell Dyn Emerald Hematology analyzer, patient records and an interview with the Laboratory Director, the surveyor determined the laboratory failed to ensure a complete validation of the manufacturer's performance specifications, including reportable range, accuracy, and normal reference range verification was performed before patient testing began. The findings include: 1. A review of the installation procedures for the Abbott Cell Dyn Emerald Hematology analyzer revealed a calibration, precision (reproducibility) study and three levels of quality controls (QC) were performed on 1 /22/2019. The records also included three levels of QC run five times each, and instrument printouts of the "Linearity" also run on 1/22/2019. However, there was no documentation the data was analyzed and evaluated to determine the accuracy and reportable ranges of the analyzer, as stated in the manufacturer's performance specifications. There was also no documentation of the reference range verification for the laboratory's patient population. 2. The validation and installation records for the Cell Dyn Emerald also failed to include the Laboratory Director's (or the Technical Consultant's) signature and date indicating review and approval of the new procedures before patient testing began on 1/23/2019. 3. In an interview on 6/27/2019 at 12:30 PM, the Laboratory Director confirmed the above noted findings. . D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on a review of the installation and validation documentation for the Abbott Cell Dyn Emerald Hematology analyzer and an interview with the Laboratory Director, the Laboratory Director failed to ensure the initial validation procedures were reviewed, approved and signed/dated (by the Laboratory Director and/or the Technical Consultant) as verifying the manufacturer's performance specifications for the analyzer, before patient testing began. The findings include: 1. A review of the Abbott Cell Dyn Emerald's installation documentation revealed no review and approval (as indicated by a signature and date) by the Laboratory Director (or the previous Technical Consultant) of the initial verification procedures performed on 1/22/2019. -- 2 of 4 -- Records revealed patient CBC (Complete Blood Count) testing on this analyzer began on 1/23/2019. 2. In an interview on 6/27/2019 at 12:30 PM, the Laboratory Director confirmed the above noted findings. . D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on a review of personnel listed on Form CMS-209, a review of laboratory processes and procedures, and an interview with the Laboratory Director, the surveyor determined the laboratory failed to fill the position of the Technical Consultant (TC) after the previous TC had left in April 2019. The findings include: 1. During a review of personnel listed on the Form CMS-209 (Laboratory Personnel Report), the surveyor noted the name of the same Technical Consultant included on the CMS-209 for the previous survey on 5/16/2017. 2. During an interview with the Laboratory Director on 6/27/2019 at 12:35 PM, the surveyor reviewed the deficiencies noted so far in the survey process (refer to D5421 and D6066) , and asked who was performing the responsibilities as the TC, and when was their last on-site visit. The Laboratory Director explained the laboratory had not had a TC since "April or May" 2019, and it had been "a while" since the TC had been on site. (He was unsure of the exact dates.) The surveyor then crossed off the TC listed on the form, and explained CLIA regulations required this position to be filled, however the Form CMS-209 should reflect their current staffing, not the previous personnel. The surveyor further stated the laboratory was required to employ a qualified individual with experience to perform the Technical Consultant's oversight responsibilities or a mandatory Condition deficiency had to be cited. . D6034 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 The laboratory must employ one or more individuals who are qualified by education and either training or experience to provide technical consultation for each of the specialties and subspecialties of service in which the laboratory performs moderate complexity tests or procedures. The director of a laboratory performing moderate complexity testing may function as the technical consultant provided he or she meets the qualifications specified in this section. This STANDARD is not met as evidenced by: Based on a review of personnel listed on Form CMS-209, a review of laboratory processes and procedures, and an interview with the Laboratory Director, the surveyor determined the laboratory failed to fill the position of the Technical Consultant (TC) after the previous TC had left in April 2019. The findings include: 1. Refer to D6033. . D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) -- 3 of 4 -- Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. This STANDARD is not met as evidenced by: Based on a review of personnel listed on Form CMS-209 (Laboratory Personnel Report), a review of the personnel files, and an interview with the Testing Personnel (TP) #1 and #2, the surveyor determined the laboratory failed to ensure two of two new testing personnel had documentation of training for moderate complexity testing completed before performing patient testing. The findings include: 1. A review of Form CMS-209 revealed two of the three testing personnel listed had been hired since the previous survey on 5/16/2017. A review of the test menu for this laboratory revealed moderate-complexity testing personnel performed CBC's (Complete Blood Counts) and waived testing. 2. A review of the personnel files revealed TP #1 was hired on 11/7/2017, and TP #2 was hired 8/14/2017. Three generic competency evaluations were included in each of the testing personnel files, however there was no documentation of training in the files for TP #1 or #2, or indication of the scope of their responsibilities in the laboratory. 3. During an interview on 6/27/2019 at 12:20 PM, the surveyor asked TP #1 and #2 about documentation of their initial training in the operation of the Medonic Hematology analyzer (in use in 2017, 2018 and early 2019 until 1/4/2019.) TP #1 stated the generic competency evaluations dated 5/17 /2018 in their files was documentation of their training. The surveyor explained the Laboratory Director or Technical Consultant should document the tests they were trained to perform, and specify the scope of the training (including proficiency in the performance of quality control, proficiency testing, calibrations, maintenance, and trouble-shooting) along with the pre-analytical and post-analytical procedures associated with the testing. TP #1 confirmed the laboratory had not done this. SURVEYOR ID#32558 Licensure and Certification Surveyor -- 4 of 4 --