The Emergency Clinic At The Pearl

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 review of the manufacturer's instructions for the Roche CoaguChek XS, review of patient test records from January 2023 to December 2023, and staff interview, the laboratory failed to following the manufacturer's instructions for 15 of 16 patients tested. The findings included: 1. A review of the manufacturer's instructions for the Roche CoaguChek XS (2022-02 V5.0) under the section titled "Purpose" determined: "This system is ideally suited to monitor coagulation values in people who are taking oral anticoagulation medication." 2. A review of CoaguChek XS testing records from January 2023 to December 2023 identified the laboratory performed testing on 16 patients. 3. A review of the patients records determined 15 of the 16 patients did not have a history of taking oral anticoagulation medication. They were: Date Identification Number 1/4 RODAN002 1/4 ZAMSA00 1/15 STOJE01 1 /17 MOTMA000 2/17 PAPWI000 4/28 NORST000 8/25 FRYBA000 10/21 LEWMI000 10/23 MCOJA000 11/17 DIALA000 11/23 MONPE000 11/30 SALMA007 12/13 MERSE000 12/22 BARRA004 12/22 MEACA001 4. The technical consultant confirmed the findings in an interview conducted on 04/11/2024 at 1300 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 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 -- least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of the laboratory's maintenance logs from January 2022 to December 2023 and staff interview, the laboratory failed to perform manufacturer required maintenance on the Sysmex XP-300 hematology analyzer for four of eight quarters in 2022 and 2023. Findings include: 1. A review of the laboratory's maintenance log "XP-300 MAINTENANCE LOG" determined quarterly maintenance was required on the Sysmex XP-300 hematology analyzer: a. Clean Sample Rotor Valve (SRV) 2. Further review of the laboratory's maintenance logs from January 2022 to December 2023 identified four months in which Clean Sample Rotor Valve (SRV) maintenance was not performed. They were: July 2022 January 2023 April 2023 July 2023 3. The laboratory was asked to provide documentation of maintenance, and none was provided. 4. The technical consultant confirmed the findings in an interview on 04/11 /2024 at 1048 hours in the office. D5785

Summary Statement of Deficiencies D0000 The laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCY: D6063 - 42 C.F.R. 493.1412 Condition: Testing Personnel Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representative was given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. 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 Noted deficiencies and plans of correction were discussed with the laboratory representative at the entrance and exit conferences. The facility representative was 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 chemistry for the analyte Calcium, Total. (refer to D2096) D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. 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 satisfactory score of at least 80% of acceptable responses for each analyte in the subspecialty of chemistry for the analytes of Albumin, Total Calcium, Chloride, Creatinine, Glucose, Magnesium, Sodium, Potassium, and BUN. The findings were: 1. API 2019 - 2nd event the laboratory received unsatisfactory scores as follows: Albumin 20% Total Calcium 60% Chloride 40% Creatinine 0% Glucose 20% Magnesium 60% Potassium 60% Sodium 20% BUN 0% 2. API 2020 - 1st event the laboratory received an unsatisfactory score of 40% for Total Calcium. D2088 ROUTINE CHEMISTRY CFR(s): 493.841(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Review of the CMS report 155 and American Proficiency Institute (API) proficiency testing records found that the laboratory failed to achieve a satisfactory score of at least 80% for the overall chemistry testing event score. Findings: 1. API 2019 - 2nd event the laboratory received an overall unsatisfactory event score of 38% for chemistry. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in 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 desk review of proficiency testing records, it was determined the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two consecutive testing events or two out of three consecutive testing events in the specialty of Chemistry for the analyte Total Calcium. Two out of three unsatisfactory -- 2 of 3 -- scores results in unsuccessful PT performance. Findings: 1. API 2019 - 2nd event the laboratory received an unsatisfactory score of 60% for Total Calcium. 2. API 2020 - 1st event the laboratory received an unsatisfactory score of 40% for Total Calcium. 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) 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 D2096) -- 3 of 3 --