All Children's Pediatric Clinic, Pa

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 review of the laboratory's submitted Form CMS 209, review of the laboratory's proficiency testing records from 2023, 2024 and 2025, and staff interview, the laboratory failed to ensure 4 of 7 testing personnel participated in proficiency testing for hematology. The findings included: 1. A review of the laboratory's submitted Form CMS 209 determined the facility identified 7 personnel who performed hematology testing. 2. A review of the laboratory's American Proficiency Institute's proficiency testing records from 2023 (events 2 and 3), 2024 (events 1, 2, and 3) and 2025 (event 1) determined only testing personnel #3, #5 and #7 participated in proficiency testing. The records showed: a) 2023 Event 2 performed by testing personnel #3 b) 2023 Event 3 performed by testing personnel #7 c) 2024 Event 1 performed by testing personnel #3 d) 2024 Event 2 performed by testing personnel #5 e) 2024 Event 3 performed by testing personnel #3 f) 2025 Event 1 performed by testing personnel #3 3. The technical consultant confirmed the finding in an interview conducted on 06/12/2025 at 0903 hours in the manager's office. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) (b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. 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 -- This STANDARD is not met as evidenced by: Based on review of laboratory policy, review of the laboratory's American Proficiency Institute (API) proficiency testing records from 2023 and 2024, and staff interview, the laboratory failed to test proficiency testing samples the same number of times as patient samples for 11 of 30 samples. The findings were: 1. A review of the laboratory's policy titled, "Proficiency Testing" determined: "PT specimens are to be treated the same as patient samples." 2. A review of the laboratory's policy titled, "Critical Values" (approved on August 10, 2015) determined: "The laboratory Personnel will repeat all CBC's outside the critical/panic value range ..." It went on to list the following critical value ranges: WBC 2.0 - 22.0 cu.mm HGB 7.5 - 18 g/dL HCT 24 - 55 % PLT 50 - 800 cu.mm 3. Review of the laboratory's API proficiency testing records from 2023 (events 1, 2 and 3) and 2024 (events 1, 2 and 3) identified the laboratory tested the following proficiency testing samples twice even though they did not meet the laboratory's repeat criteria policy. a) 2023 Hematology (event 1) Sample ID: HSY-05 Run 1: 03/10/2023 @ 16:22 Run 2: 03/10/2023 @ 16:24 b) 2023 Hematology (event 2) Sample ID: HSY-06 Run 1: 07/12/2023 @ 11:31 Run 2: 07/12 /2023 @ 11:32 Sample ID: HSY-09 Run 1: 07/12/2023 @ 11:38 Run 2: 07/12/2023 @ 11:45 Sample ID: HSY-10 Run 1: 07/12/2023 @ 11:43 Run 2: 07/12/2023 @ 11: 44 c) 2023 Hematology (event 3) Sample ID: HSY-12 Run 1: 11/15/2023 @ 16:00 Run 2: 11/15/2023 @ 16:02 Sample ID: HSY-13 Run 1: 11/15/2023 @ 16:03 Run 2: 11/15/2023 @ 16:04 Sample ID: HSY-14 Run 1: 11/15/2023 @ 16:05 Run 2: 11/15 /2023 @ 16:07 d) 2024 Hematology (event 1) Sample ID: HSY-04 Run 1: 03/20/2024 @ 10:51 Run 2: 03/20/2024 @ 16:48 e) 2024 Hematology (event 2) Sample ID: HSY- 09 Run 1: 07/22/2024 @ 16:40 Run 2: 07/22/2024 @ 16:47 Sample ID: HSY-10 Run 1: 07/22/2024 @ 16:50 Run 2: 07/22/2024 @ 16:51 f) 2024 Hematology (event 3) Sample ID: HSY-11 Run 1: 11/19/2024 @ 12:19 Run 2: 11/19/2024 @ 12:21 4. The technical consultant confirmed the findings in an interview conducted on 06/12/2025 at 900 hours in the manager's office. Key: CBC - complete blood count WBC - white blood cell HGB - hemoglobin HCT - hematocrit PLT - platelet cu.mm - cubic millimeter g/dL - grams per deciliter CMS - Centers for Medicare and Medicaid Services D5813 TEST REPORT CFR(s): 493.1291(g) (g) The laboratory must immediately alert the individual or entity requesting the test and, if applicable, the individual responsible for using the test results when any test result indicates an imminently life-threatening condition, or panic or alert values. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, review of the laboratory's critical value log from April 26, 2025 - June 9, 2025, review of patient test records from April 26, 2025 - June 9, 2025 and staff interview, the laboratory failed to have documentation of the notification of 4 of 11 critical values as required by its policy. The findings included: 1. A review of the laboratory's policy titled "Critical Values" (approved August 10, 2015) identified the laboratory's policy for the documentation of critical values as: "The Laboratory Personnel will repeat all CBC's soutside the critical/panic value range and immediately notify provider. Documentation must include: Who was notified, when was the person notified, and by who was the person notified." The policy defined the laboratory's critical values as: WBC 2.0 - 22.0 cu.mm HGB 7.5 - 18 g/dL HCT 24 - 55 % PLT 50 - 800 cu.mm 2. A review of the laboratorys critical value log from April 26, 2025 - June 9, 2025 determined the laboratory documented the -- 2 of 3 -- notification of 7 critical values. 3. A review of patient test records from April 26, 2025 - June 9, 2025 indentified 4 additional critical values which were not documented on the critical value log. They were: a) test date: 4/26/2025 patient ID: 12-15-18 WBC: 22.8 b) test date: 5/08/2025 patient ID: 10-29-17 WBC: 25.3 c) test date: 5/14/2025 patient ID: 4-25-20 WBC: 22.6 d) test date: 6/9/2025 patient ID: 12-22-13 WBC: 22.1 4. The technical consultant confirmed the finding in an interview conducted on 06/12 /2025 at 10:16 hours in the manager's office. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on May 2, 2025, 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's proficiency reports, the laboratory failed to achieve satisfactory 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 specialty of hematology (refer to D2131) and the analyte of hemoglobin (refer to D2130) resulting in an initial unsuccessful performance. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute's proficiency reports, the laboratory failed to achieve satisfactory performance for two of three events in 2024 and 2025 for the analyte of hemoglobin. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile report, the laboratory received the following unsatisfactory performances for hemoglobin in two of three events: 2024 API 2nd event 60% 2025 API 1st event 20% 2. Based on review of the American Proficiency Institute's proficiency reports, the laboratory received the following unsatisfactory performances for hemoglobin in two of three events: 2024 API 2nd event 60% 2025 API 1st event 20% D2131 HEMATOLOGY CFR(s): 493.851(g) (g) 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute's proficiency reports, the laboratory failed to achieve satisfactory performance for two of three events in 2024 and 2025 for the specialty hematology. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile report, the laboratory received the following unsatisfactory performances for the specialty of hematology in two of three events: 2024 API 2nd event 78% 2025 API 1st event 45% 2. Based on review of the American Proficiency Institute's proficiency reports, the laboratory received the following unsatisfactory performances for specialty hematology in two of three events: 2024 API 2nd event 78% 2025 API 1st event 45% 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. -- 2 of 3 -- This CONDITION 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's proficiency reports, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) 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's proficiency reports, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for the specialty hematology (refer to D2131) and the analyte of hemoglobin (refer to D2130) for two of three events in 2024 and 2025, resulting in an initial unsuccessful performance. -- 3 of 3 --

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 review of policies and procedures, proficiency testing records from 2021 , 2022, and 2023 and interview of facility personnel the laboratory failed to attain an acceptable score of 80% or higher in the 3rd testing event of 2021 for Bacteriology testing event . The findings included: 1. Review of the policy titled PROFICIENCY TESTING found: "Successful performance is considered to be passing 80% of all analytes in a subspecialty. Use the "Proficiency Testing Troubleshooting Checklist" and the "Proficiency Testing Remedial Action Log Sheet" to help resolve and document failed proficiency testing." 2. Review of the CMS 155 Individual Laboratory Report found the laboratory obtained a score of 0% in the 3rd Bacteriology testing event of 2021 . 3. Review of the American Proficiency Institute (API) proficiency testing records for 2021, 2022 and 2023 found that the laboratory failed to retain the 2021 3rd testing event for Bacteriology. The laboratory did not use the "Proficiency Testing Troubleshooting Checklist" and the "Proficiency Testing Remedial Action Log Sheet" to document

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the conditions of participation found in the CLIA regulations at 42 CFR 493 and recertification is recommended. The laboratory is no longer performing bacteriology testing and the certificate will be updated to reflect the changes. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on review of laboratory proficiency testing records and staff interview, it was revealed the laboratory failed to test proficiency samples in the same manner it tested patient samples. The findings were: 1. A review of the laboratory's Proficiency Testing policy revealed: "PT specimens are to be treated the same as patient samples. The lab should document all steps taken in PT performance." 2. A review of the laboratory's American Proficiency Institute's proficiency testing records from 2019 (events 1, 2, and 3), 2020 (events 1, 2, and 3), and 2021 (events 1 and 2) revealed the repeated testing when no repeat criteria was met: HSY-02 Tested twice - no repeat criteria met 03-20-2019 @ time not legible 03-20-2019 @ time not legible HSY-03 Tested twice - no repeat criteria met 03-20-2019 @ time not legible 03-20-2019 @ time not legible HSY-04 Tested twice - no repeat criteria met 03-20-2019 @ time not legible 03-20-2019 @ time not legible HSY-05 Tested twice - no repeat criteria met 03-20-2019 @ time not legible 03-20-2019 @ time not legible HSY-06 Tested twice - no repeat criteria met 07-23-2019 @ 15:54 07-23-2019 @ 15:57 HSY-07 Tested twice - no repeat criteria met 07-23-2019 @ 16:14 07-23-2019 @ 16:15 HSY-09 Tested twice - no repeat criteria met 07-23-2019 @ 16:19 07-23-2019 @ 16:21 HSY-10 Tested twice - no repeat criteria met 07-23-2019 @ 16:25 07-23-2019 @ 16:26 HSY- 08 Tested twice - no repeat criteria met 07-29-2020 @ 11:05 07-29-2020 @ 11:07 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 -- HSY-10 Tested twice - no repeat criteria met 07-29-2020 @ 11:11 07-29-2020 @ 11: 13 HSY-01 Tested twice - no repeat criteria met 03-25-2021 @ 14:28 03-25-2021 @ 14:29 HSY-04 Tested twice - no repeat criteria met 03-25-2021 @ 14:25 03-25-2021 @ 14:26 3. An interview with the technical consultant on 09/07/2021 at 14:15 hours in the office after her review of the records confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted 09/10/2019. This facility was found NOT in compliance with the CLIA conditions for specialties/subspecialties surveyed for 42 CFR: 493.1250 Analytic systems 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 surveyor observation, review of manufacturer's instructions, and confirmed in interview of facility personnel, the laboratory failed to follow the manufacturer's instructions to monitor revised expiration dates for Kenlor Liquid H.pylori human IgG Antibody Serum Control. The findings were: 1. Surveyor observation on 09/10/19 at 0900 hours in the laboratory found the following expired item: 1 bottle of Kenlor Liquid H. Pylori Human IgG Antibody Serum Control Kit, Lot number: 50303 Expiration date: February 2021 Date opened 09/09/2019 The laboratory failed to label the reagent with the revised expiration date. 2. Review of the manufacturer's instructions for the Kenlor Liquid H. Pylori Human IgG Antibody Serum Control Kit (rev. 150303-056925) under, "Storage and Stability" it stated, "The product is stable up to the expiration date printed on the label if kept at 2- 8 C and 6 months at room temperature. Once opened it is stable for 60 days." 3. Interview with the technical consultant on 09/10/2019 at 09:30 hours in the laboratory confirmed the findings. Key: C- Celsius IgG- Immunoglobulin G H. - Helicobacter D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of laboratory policy, review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records, and confirmed in interview of facility personnel, the laboratory failed to perform proficiency testing samples the same way as patient samples. The findings were: 1. Review of the laboratory's policy titled, "Proficiency Testing" no approval date by the laboratory director, it stated, " ...PT specimens are to be treated the same as patient samples. The lab should document all steps taken in PT performance. All records and reports will be maintained for two years." 2. Review of the laboratory's policy titled, "Critical Values" approved by the laboratory director on August 10, 2015 stated, "The laboratory Personnel will repeat all CBC's outside the critical/panic value range ..." It went on to list the following ranges: WBC 2.0 - 22.0 cu.mm HGB 7.5 - 18 g/dL HCT 24 - 55 % PLT 50 - 800 cu. mm 3. Review of the laboratory's API proficiency testing records revealed the following PT samples were not handled the same way as patient samples. Each sample was tested twice even though, they did not match the laboratory's repeat criteria policy. 2017 Hematology (event 2) Sample ID: HSY-07 Run 1: 07/24/2017 @ 16:10 Run 2: 07/24/2017 @ 16:15 2018 Hematology (event 1) Sample ID: HSY-02 Run 1: 03/19/2018 @12:30 Run 2: 03/19/2018 @ 12:31 2018 Hematology (event 2) Sample ID: HSY-07 Run 1: 07/17/2018 @ 09:44 Run 2: 03/17/2018 @ 09:46 2018 Hematology (event 2) Sample ID: HSY-08 Run 1: 07/17/2018 @ 09:48 Run 2: 07/17 /2018 @ 09:50 2018 Hematology (event 2) Sample ID: HSY-09 Run 1: 07/17/2018 @ 09:52 Run 2: 07/17/2018 @ 09:53 2018 Hematology (event 2) Sample ID: HSY-10 Run 1: 07/17/2018 @ 09:55 Run 2: 07/17/2018 @ 09:56 2018 Hematology (event 3) Sample ID: HSY-12 Run 1: 11/14/2018 @ 15:36 Run 2: 11/14//2018 @ 15:37 2018 Hematology (event 3) Sample ID: HSY-13 Run 1: 11/14/2018 @15:39 Run 2: 11/14 /2018 @ 15:41 2018 Hematology (event 3) Sample ID: HSY-15 Run 1: 11/14/2018 @ 15:48 Run 2: 11/14/2018 @ 15:50 2019 Hematology (event 1) Sample ID: HSY-02 Run 1: 03/20/2019 @ 17:11 Run 2: /2019 @ 17:12 2019 Hematology (event 1) Sample ID: HSY-03 Run 1: 03/20/2019 @ 17:14 Run 2: 03/20/2019 @ 17:15 2019 Hematology (event 1) Sample ID: HSY-04 Run 1: 03/20/2019 @ not legible Run 2: /2019 @ not legible 2019 Hematology (event 1) Sample ID: HSY-05 Run 1: 03/20 /2019 @ not legible Run 2: 03/20/2029 @ not legible 2019 Hematology (event 2) Sample ID: HSY-07 Run 1: 07/23/2019 @ 16:14 Run 2: 07/23/2019 @ 16:15 2019 Hematology (event 2) Sample ID: HSY-09 Run 1: 07/23/2019 @ 16:19 Run 2: 07/23 /2019 @ 16:21 2019 Hematology (event 2) Sample ID: HSY-10 Run 1: 07/23/2019 @ 16:25 Run 2: 07/23/2019 @ 16:26 4. The findings were confirmed in interview with Testing Personnel #1 (as listed on Forms CMS-209) on September 10, 2019 at 10:28 hours when she revealed that the prior laboratory manager had instructed them to repeat the PT samples and compare them. Key: CBC - complete blood count WBC - white blood cell HGB - hemoglobin HCT - hematocrit PLT - platelet cu.mm - cubic millimeter g/dL - grams per deciliter CMS - Centers for Medicare and Medicaid Services -- 2 of 9 -- D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on surveyor observations, review of manufacturer's instructions, review of quality control records, patient records, and confirmed in interview of facility personnel, the laboratory failed to monitor the overall quality of its analytic systems as evidenced by: 1. The laboratory failed to follow the manufacturer's instructions for proper cleaning and decontamination procedures for the Quidel Solana anlyzers (refer to D5411-A). 2. The laboratory failed to follow the manufacturer's instructions for proper pipetting technique when using a high performance micropipette (refer to D5411-B). 3. The laboratory failed to ensure verification studies were complete prior to testing patients when it implemented two Quidel Solana analyzers in October 2017 (refer to D5421). 4. The laboratory failed to perform external positive and negative quality control each day of patient testing for the Quidel Solana (refer to D5449). 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: B. Based on surveyor observation, review of manufacturer's instructions, patient results, and confirmed in interview of facility personnel, the laboratory failed to follow the manufacturer's instructions for pipetting technique when using a VWR Signature Ergonomic High Performance Pipettor. The findings were: 1. Surveyor observation made on 09/10/2019 at 13:44 hours revealed Testing Personnel #2 (as listed on Form CMS-209) performing a patient run of Quidel Solana Streptococcus A and Quidel Solana Streptococcus C & G. It was observed that when using the blow- out micropipette after introducing 50uL of sample to the test well and mixing he would aspirate varied amounts of sample and discard the sample into the trash. 2. Review of the manufacturer's instructions for the VWR Signature Ergonomic High Performance Pipettor under, "Dispensing" it stated, "Press the push button to the second stop to expel any remaining liquid." 3. Review of the manufacturer's instructions for the Solana Strep Complete Assay (CLM305001EN00(11/16) under, "Test Procedure: 9. Transfer 50 uL of the diluted specimens to the labeled GAS Reaction Tube, mix the solution by pipetting up and down 3 to 5 times and close the cap, and transfer 50 uL of the same specimen to the labeled Strep C/G Reaction Tube, mix the solution by pipetting up and down a minimum of 3 to 5 times, close the cap. The solutions should be clear and free of solid material." And; "Limitations: The main laboratory technique required is pipetting. Good laboratory technique is essential for -- 3 of 9 -- the proper performance of this assay ..." 4. Review of patient records for the patient run of Quidel Solana Streptococcus exams performed on September 10, 2019 revealed the following: Patient Alias 1 Date of Birth: 11-30-2013 Group A Strep: Positive Group CG Strep: Positive Patient Alias 2 Date of Birth: 10-25-2017 Group A Strep: Negative Group CG Strep: Negative Patient Alias 3 Date of Birth: 11-27-2012 Group A Strep: Negative Group CG Strep: Invalid Patient Alias 4 Date of Birth: 06-30-2014 Group A Strep: Negative Group CG: Negative Patient Alias 5 Date of Birth: 05-07-08 Group A Strep: Negative Group CG: Negative Patient Alias 6 Date of Birth: 07-27- 2012 Group A Strep: Negative Group CG: Negative 5. Interview with Testing Personnel #2 (as listed on Form CMS-209) in the laboratory on 09/10/2019 confirmed the findings. He confirmed that sometimes he would get invalids and like this time, the test has to be repeated. Key: CMS - Centers for Medicare and Medicaid Services 42141 A. Based on surveyor observation, manufacturer's instructions, patient results and confirmed in interview of facility personnel, the laboratory failed to follow manufacturer's instruction for cleaning the Solana instrument. The findings were: 1. Surveyor observation made in the laboratory on 09/10/2019 at 13:45 hours revealed Testing Personnel #2 (as listed on Form CMS-209) cleaned the Solana with Sodium Chloride solution using a cotton swab. 2. Review of the manufacturer's instructions under "Maintenance and Cleaning" UM2027801EN00 (12/15) it states "Solana should be cleaned regularly. Use a damp cloth to clean the Solana. If dirt is persistent, rub the surface of the Solana with a cloth that has been moistened with pure alcohol (isopropanol or ethanol). Do not use aggressive cleaning agents such as acetone. If the inside of the Solana is contaminated, please contact Quidel Technical Support: 800.874.1517. For more persistent stains and for disinfecting the instrument, it is possible to clean the surface with a cloth dipped in 10% bleach solution followed by wiping with water. The procedure can be repeated 2 to 3 times. It its also possible to use the 70% alcohol to wipe off the remaining traces of bleach. Spillage of potentially infectious material should be wiped off immediately with absorbent paper tissue and the contaminated areas wiped with 10% bleach solution. Materials used to clean spills, including gloves, should be disposed of as biohazardous waste." 3. The laboratory failed to follow the manufacturer's instructions when cleaning the Quidel Solana analyzer. 4. Review of patient records for the patient run of Quidel Solana Streptococcus exams performed on September 10, 2019 revealed the following: Patient Alias 1 Date of Birth: 11-30-2013 Group A Strep: Positive Group CG Strep: Positive Patient Alias 2 Date of Birth: 10-25-2017 Group A Strep: Negative Group CG Strep: Negative Patient Alias 3 Date of Birth: 11-27-2012 Group A Strep: Negative Group CG Strep: Invalid Patient Alias 4 Date of Birth: 06-30-2014 Group A Strep: Negative Group CG: Negative Patient Alias 5 Date of Birth: 05-07-08 Group A Strep: Negative Group CG: Negative Patient Alias 6 Date of Birth: 07-27-2012 Group A Strep: Negative Group CG: Negative 4. Interview with Testing Personnel #2 (as listed on Form CMS-209) in the laboratory on 09/10/2019 confirmed the findings. He confirmed that he would clean the reaction holes with a cotton swab and Sodium Chloride solution. 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: -- 4 of 9 -- Based on surveyor observation and confirmed personnel interview, the laboratory failed to ensure expired items were not available for use. The findings were: 1. Direct observation during tour of the laboratory on 09/10/19 at 09:00 hours, revealed the following: Gold blood collection BD Vacutainer tubes (Ref 367989) Quantify: 1 unopened pack of 100 Lot number 8225985 Expiration date 2019-08-31 2. Interview with technical consultant on September 10, 2019 at 09:00 hours confirmed findings. Key BD- Becton Dickinson Ref- Reference D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE 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 surveyor observation, review of laboratory verification records and confirmed in interview of facility personnel, the laboratory failed to review and evaluate verification studies prior to testing patients on 2 of 2 Quidel Solana molecular analzyers implementeed in October 2017. The findings were: 1. Surveyor observation made on August 10, 2019 during the initial tour of the facility revealed the laboratory had 2 Quidel Solana molecular analyzers available for patient testing. Instrument 1 (Serial Number 17020710) Instrument 2 (Serial Number 15020248) 2. Review of laboratory verification records for 2 of 2 Quidel Solana molecular analyzers revealed that in October 2017, the laboratory ran verification panels on each of the analyzers. However, prior to patient testing, the laboratory failed to review and evaluate the raw verification data. The verification data had not been reviewed and evaluated as of the date of the survey, September 10, 2019. 3. The findings were confirmed in interview of the technical consultant on September 10, 2019 at 11:30 hours in the office. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of the laboratory policy, manufacturer's instructions, maintenance records and confirmed in interview of facility personnel, the laboratory failed to have documentation of performing weekly, monthly and quarterly maintenance according to the manufacturer's instructions for the Sysmex automated hematology analyzer. The findings were: 1. A review of the laboratory policy "Instrument Operation and Maintenance" states "Maintenance of each piece of laboratory instrumentation shall be in accordance with manufacturer's recommendations. Document all maintenance performed on the test systems in use. Also document repairs and remedial action on -- 5 of 9 -- all test systems." 2. A review of the instrument operator manual Sysmex Automated Hematology Analyzer XP-300 (revision May 2014) states: Weekly - Clean SRV Tray Monthly - Clean Transducer and waste chamber Quarterly - Clean SRV 3. A review of the laboratory's hematology maintenance records from August 2017 to May 2019 revealed the laboratory failed to document the following maintenance May 2018 Monthly maintenance not documented October 2018 Weekly maintenance (4 out of 4 weeks not documented) March 2019 Quarterly maintenance not documented July 2019 Quarterly maintenance not documented September 2019 Weekly maintenance (1 of 4 weeks missing) Monthly maintenance not documented 4. An interview with the technical consultant on 09/10/2019 at 14:00 hours in the office after her review of the records, confirmed the findings. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory policy, review of quality control records, review of the laboratory's submitted Form CMS-116, and confirmed in interview of facility personnel, the laboratory failed to perform a positive and negative quality control each day of patient testing for the Quidel Solana. The findings were: Note: The laboratory's IQCP (Individual Quality Control Plan) study was performed on a previous Solana analyzer that is no longer located at the facility. The laboratory did not perform IQCP studies for the current two Solana analyzers in use. Therefore, the laboratory did not develop IQCP studies and must perform external positive and negative quality control each day of patient testing. 1. Review of the laboratory's policy titled, "Control Policy" approved by the laboratory director on March 3, 2006, it stated, "For qualitative testing, the laboratory will include a positive and negative control on every day of use of each qualitative procedure." 2. Review of the laboratory's quality control records from January 1, 2019 to September 10, 2019 revealed that external quality control was performed as follows: Instrument 1 (Serial Number 17020710) January 11, 2019 January 31, 2019 February 20, 2019 March 8, 2019 March 20, 2019 March 29, 2019 May 2, 2019 May 16, 2019 June 13, 2019 July 3, 2019 July 24, 2019 September 6, 2019 Instrument 2 (Serial Number 15020248) January 9, 2019 February 28, 2019 March 7, 2019 March 20, 2019 March 29, 2019 May 2, 2019 May 16, 2019 June 13, 2019 July 3, 2019 July 24, 2019 September 6, 2019 3. According to the submitted CMS Form-116, the laboratory performs 2,400 bacteriology exams annually. See attached Patient Alias List for patients tested from January 1, 2019 to September 10, 2019 when an external positive and negative quality control was not performed each day of patient testing. 4. The findings were confirmed in interview of the technical consultant on September 10, 2019 at 13:30 hours in the office. Key: CMS - Centers for Medicare and Medicaid Services D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness -- 6 of 9 -- of