All Childrens Pediatric Clinic

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representatives at the entrance and exit conferences. The facility representatives were given an opportunity to provide evidence of compliance with the noted deficiency, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and certification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on December 20, 2021, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory failed to achieve successful 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 -- performance in two of three testing events for the analyte Group A Strep (molecular), resulting in unsuccessful performance in the specialty of Bacteriology (refer to D2020, D2021, and D2028). D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory failed to attain an overall score of at least 80% for the specialty of Bacteriology. The findings included: 1. API 2021 - 1st event laboratory received an unsatisfactory score of 70% for Bacteriology. 2. API 2021 - 2nd event laboratory received an unsatisfactory score of 0% for Bacteriology. 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory failed to return proficiency testing results to the proficiency testing program within the time frame specified by the program resulting in a score of zero (0%). The findings included: 1. The laboratory failed to return the proficiency testing results for the 2nd testing event of 2021 within the time frame specified by the program for Bacteriology. 2. This failure to return the results within the specified time frame resulted in a score of 0% and unsatisfactory performance for the specialty of Bacteriology. D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory failed to achieve satisfactory performance (80% or greater) for two consecutive testing events resulting in unsuccessful PT performance. The findings included: 1. API 2021 - 1st event the laboratory received an unsatisfactory score of 70% for Bacteriology. 2. API 2021 - 2nd event the laboratory received an unsatisfactory score of 0% for Bacteriology. 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute proficiency testing records, the laboratory director failed to provide overall management and direction of the laboratory services. The findings included: Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for Bacteriology (refer to D6016). 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for Bacteriology (refer to D2020, D2021, D2028). -- 3 of 3 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. 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 review of manufacturer's instructions, review of patient test records from March 8, 2021, and confirmed in interview of facility personnel, the laboratory failed to provide documentation of following the manufacturer's instructions when performing Quidel Sofia2 Flu+SARS Antigen testing. The findings were: 1. Review of the manufacturer's instructions for the QUIDEL Sofia2 Flu+SARS Antigen stated, "All operators using your product must be appropriately trained in performing and interpreting the results of your product in accordance with the authorized labeling." 2. Review of patient test records from March 8, 2021 (the first day of patient testing) found the laboratory tested the following patients when the laboratory failed to provide documentation of training operators: Specimen #1 Date of Service: 03-08- 2021 Result: Negative Specimen #2 Date of Service: 03-08-2021 Result: Negative Specimen #3 Date of Service: 03-08-2021 Result: Positive Specimen #4 Date of Service: 03-08-2021 Result: Negative Specimen #5 Date of Service: 03-08-2021 Result: Negative 3. The laboratory was asked to provide documentation of following the manufacturer's instructions to train operators in performing and interpreting results 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 -- for Sofia 2 Flu+SARS Antigen testing. No documentation was provided. 4. The results were confirmed in interview with the technical consultant on March 9, 2021 at 10:00 hours in the patient exam room. D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on surveyor observation, review of laboratory policies, and confirmed in interview of facility personnel, the laboratory failed to document specimen collection time for Group A, C, and G testing on the Solana analyzer for 8 of 8 specimens collected from March 5, 2021 to March 8, 2021. The findings were: 1. Surveyor observation on March 9, 2021 at 08:55 hours in the laboratory found the following throat swab specimens in the laboratory refrigerator: Specimen 1 Date Collected: 03- 06-2021 No Time of Collection Specimen 2 Date Collected: 03-08-2021 No Time of Collection Specimen 3 Date Collected: 03-05-2021 No Time of Collection Specimen 4 Date Collected: 03-05-2021 No Time of Collection Specimen 5 Date Collected: 03- 08-2021 No Time of Collection Specimen 6 Date Collected: 03-08-2021 No Time of Collection Specimen 7 Date Collected: 03-08-2021 No Time of Collection Specimen 8 Date Collected: 03-08-2021 2. Review of the laboratory's policy titled "Test Requisitions" stated, " ...It should also have the specimen collection date and time, the specimen source, and the patient's name, age, gender, as needed for identification, and patient clinical information." 3. Review of the manufacturer's instructions for the Solana Complete Strep Assay (PIM305000EN00 (10/16) under "Specimen Collection, Storage and Handling" it stated, "... Analytical studies performed with contrived specimens containing Streptococcus pyogenes and Streptococcus dysgalactiae, near LOD (2x LOD) demonstrated that samples can be stored at 25C 2C for 2 days and then at 2C to 8C Solana Strep Complete Assay Page 5 of 18 for up to 6 more days before testing or at ? -15C or ? -70C for up to 32 days before testing with the Solana Strep Complete Assay. Specific requirements for shipping specimens should follow recommendations found in section 42 and 49 of the Code of Federal Regulation, CFR." 4. Interview with the testing person at 08:40 hours in the laboratory confirmed the findings. She confirmed that the time of collection was not documented. She went on to say that the specimens were pending testing due to the facility being out of molecular grade reagent water necessary to perform the testing. Key: LOD - Limit of Detection CFR - Code of Federal Regulations -- 2 of 2 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representatives at the entrance and exit conferences. The facility representatives were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Proficiency Institute (API) . The facility was found to be out of compliance with the conditions of participation of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.803 successful participation in a proficiency testing program 493.1403 laboratories performing moderate complexity testing; laboratory director 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: 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 a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Proficiency Institute (API), it was determined the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate in the specialty of Bacteriology. Refer to D2028. D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of CMS form 155 and American Proficiency Institute API records found that the laboratory failed to attain a score of at least 80% for the speciality of Bacteriology. Findings: 1. API 2017 - 3rd event laboratory received an unsatisfactory score of 0% for Bacteriology. 2. API 2018 - 1st event laboratory received an unsatisfactory score of 70% for Bacteriology. D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of American Proficiency Institutes (API) proficiency testing records, it was determined that laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two out of three consecutive testing events. The laboratory failed to achieve satisfactory performance for Bacteriology. Two out of three unsatisfactory scores results in unsuccessful PT performance. Findings: 1. API 2017 - 3rd event the laboratory received an unsatisfactory score of 0% for Bacteriology. 2. API 2018 - 1st event the laboratory received an unsatisfactory score of 70% for Bacteriology. 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 a desk review of laboratory proficiency testing performance it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016 -- 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 a desk review of proficiency testing results it was revealed that the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in a HHS approved proficiency testing program. Refer to D2028. -- 3 of 3 --