Five Towns Pediatrics Pc

Summary Statement of Deficiencies 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 review of Centers for Medicare & Medicaid Services (CMS) Proficiency Testing (PT) Certification and Survey Provider Enhanced Reporting system (CASPER 0155D) and American Proficiency Institute (API) summary reports, lack of

Summary Statement of Deficiencies 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 a quality control (QC) records review and an interview with the laboratory director on January 21, 2022 about 11 am, the laboratory did not to follow the manufacturer's instruction on performing external QC upon opening of new vial. Finding: The QC was performed only once on December 12/11/2020 within 3 years of 2019, 2020, and 2021. Approximately 1,165 urine analysis patient tests were performed at this time period. PLEASE NOTE: THIS IS A RECITE DEFICIENCY FROM THE SURVEY CONDUCTED ON SEPTEMBER 26, 2016 AND AUGUST 29, 2018. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor's review of laboratory records and an interview with the laboratory director on January 21, 2022 about 11:30am, the laboratory failed to establish a written policy that includes the six required components of person's competency, initial, semi annual during the first year of testing and annually thereafter. The six 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 -- required components are: 1. direct observation of routine patient test performance, including preparation. specimen handling and testing; 2. monitoring the recording and reporting of test results; 3. review of intermediate results of worksheets, quality control records, proficiency testing results, and preventive maintenance records; 4. direct observation of performance of instrument maintenance and function checks; 5. assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and, 6. assessment of problem solving skills. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE 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 review of American Proficiency Institute (API) Proficiency Testing (PT) reports and interview with the laboratory director on January 21, 2022 about 10:30 am, the laboratory did not evaluate and document

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 proficiency testing (PT) desk review of the Center for Medicare and Medicaid Services (CMS) PT data reports and PT summary reports from the American Proficiency Institute (API) PT program, the laboratory failed to participate successfully in proficiency testing for the Sub-specialities Bacteriology & Virology and for the test analyte's Group A Strep & Bacti Respiratory Panel and Molecular Virology Respiratory Panel. The following scores were assigned: 2021 second event = 0% (non-participation) 2021 third event = 0% (non-participation) This is considered unsuccessful PT performance for non-participation. Refer D2028 and D2064. 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 -- 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 PT desk review of the CMS PT data reports and PT summary reports from API PT program, the laboratory failed to participate successfully in proficiency testing for the Sub-speciality Bacteriology and the test analyte's Group A Strep & Bacti Respiratory Panel The following scores were assigned: 2021 second event = 0% (non- participation) 2021 third event = 0% (non-participation) This is considered unsuccessful PT performance for non-participation. D2064 VIROLOGY CFR(s): 493.831(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 PT desk review of the CMS PT data reports and PT summary reports from API PT program, the laboratory failed to participate successfully in proficiency testing for the Sub-speciality Virology and the Molecular Virology Respiratory Panel. The following scores were assigned: 2021 second event = 0% (non-participation) 2021 third event = 0% (non-participation) This is considered unsuccessful PT performance for non-participation. 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 PT desk review of the CMS PT data reports and the API PT summary reports, the laboratory director failed to fulfill the laboratory director's responsibilities to ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, for the proficiency testing for the Sub- specialities Bacteriology & Virology and for the test analyte's Group A Strep & Bacti Respiratory Panel and Molecular Virology Respiratory Panel. 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 -- 2 of 3 -- 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 PT desk review of the CMS PT data reports and the API PT summary reports, the laboratory director failed to fulfill the laboratory director's responsibilities laboratory director's responsibilities to ensure that the laboratory achieved a satisfactory performance and successfully participate in a PT program, approved by CMS, sub-specialities Bacteriology & Virology and for the test analyte's Group A Strep & Bacti Respiratory Panel and Molecular Virology Respiratory Panel. The following scores were assigned: 2021 second event = 0% (non-participation) 2021 third event = 0% (non-participation) This is considered unsuccessful PT performance for non-participation. -- 3 of 3 --

Summary Statement of Deficiencies 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's review of the manufacturer's packet insert for Siemens Multistix, Influenza A&B Sofia device , Alere i Influenza A&B and interview with the laboratory supervisor, the laboratory failed to follow the manufacturer's requirements for performing external positive and negative controls with each new vial opened for the urine Multistix and failed to follow the manufacturer's requirements for performing external positive and negative controls with each new kit of Influenza A&B opened. FINDINGS: 1. The laboratory is using Siemens Multistix on Clinitek Status Plus instrument. The packet insert for the urine Multistix requires that external controls be performed with each new Vial of Multistix opened. 2. On August 29, 2018 at approximately 12:30 PM the laboratory supervisor confirmed surveyor's findings that documentation for the required external control testing was not available for calendar year 2017. 3. Approximately 500 patients specimens were tested and reported for urinalysis during above time frame. 4. The laboratory is using both the Influenza A&B Sofia kit/device and Alere i Influenza A&B kit. The manufacturer of the Sofia and the Alere i require that external positive and negative controls (provided in the kits) be performed with each new lot number/shipment. Documentation for the required external control testing was not available at survey from 1/22/18 thru 2/2/18 and from 2/7/18 through 2/13/18. 5. Approximately 390 patient specimens were tested and reported for Influenza A&B during the above time frames. PLEASE NOTE: THIS IS A RECITED DEFICIENCY FROM THE SURVEYS CONDUCTED ON SEPTEMBER 26, 2016. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE 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 the surveyor's review of Wisconsin State Laboratory of Hygiene (WSLH) Proficiency Testing (PT) reports and an interview with the laboratory supervisor, the laboratory failed to evaluate, perform and document remedial action for the PT scores of less than 100% for the following analytes: 2018 first event: Leukocytes = 60% Hematocrit = 40% Red Blood Cells = 80% Lymphocytes = 80% Influenza Respiratory Panel (RP) = 60% 2017 third event: Bacteriology = 70% 2017 second event: Throat culture = 80% Lead = 60% 2017 first event: Lead 8% D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on surveyor's review of Proficiency Testing (PT) records and an interview with the laboratory supervisor, the laboratory failed to follow the twice year verification policy for urine colony count and perform the verification in the calendar years 2016, 2017 and up to survey date. Findings: On August 29, 2018 at approximately 12:00 PM the laboratory supervisor confirmed surveyor findings that to fulfill the twice per year verification for urine colony count, the laboratory was enrolled in PT program. However, the PT module that was selected by the laboratory was an incorrect module. The laboratory was enrolled in growth/no growth urine culture PT module and not for the colony count module. PLEASE NOTE: THIS IS A RECITE DEFICIENCY FROM THE SURVEY CONDUCTED ON SEPTEMBER 26, 2016. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's Quality Assessment (QA) policy /procedure and an interview, at the time of the onsite survey, with the laboratory supervisor, the laboratory failed to follow their established written QA policy and have a mechanism to monitor, assess and when indicated correct problems identified in the general laboratory system for bacteriology and hematology testing, to prevent recurrence of the original problem. D5403 PROCEDURE MANUAL -- 2 of 5 -- CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)