Nea Baptist Clinic - Main Laboratory

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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: Based on observation and interview with laboratory staff, the laboratory had supplies available for use after their expiration date. Findings follow: A) During a tour of the laboratory on 1/15/25 at 3:10 pm, one (of one) opened container of Wright Stain, Modified (lot SLCL9514, REF WS128-4L, Sigma-Aldrich, expiration date 8/1/2023) was observed in the laboratory, available for use beyond the expiraton date. B) In an interview on 1/15/25 at 3:21 pm the lab director, confirmed that the item, identified above, had exceeded the expiration date and was available in the laboratory. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 review of the 2023 CMS Casper Reports 096D, 0153D, and the American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to have initial successful participation in proficiency testing for the analyte Lactate dehydrogenase (LDH). 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 as cited at D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 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 review of the 2023 CMS Casper Reports 096D, 0153D and American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to have satisfactory participation in proficiency testing for the analyte LDH. Survey Findings follow: A. A review of the proficiency testing results revealed the laboratory received a score of 0% for the analyte LDH in the first proficiency testing event of 2023. B. A review of the proficiency testing results revealed the laboratory received a score of 0% for the analyte LDH in the second proficiency testing event of 2023. 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 2023 proficiency testing results, it was determined the laboratory director failed to ensure that the proficiency testing samples are tested as required under Subpart H of this part. 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 review of the 2023 proficiency testing event, it was determined the laboratory director failed to ensure the laboratory successfully participated in proficiency testing for the Chemistry test of LDH. -- 2 of 2 --

Summary Statement of Deficiencies 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: Through observation, review of temperature records, lack of documentation and interview it was determined that the laboratory failed to monitor the temperature on each day of operation of one of four rooms in which supplies with storage temperature requirements were stored Findings follow: A) During a tour of the laboratory on 3/13 /23 at 08:45 a.m. four separate rooms containing items with a temperature storage requirement; #1 the main laboratory, #2 storage/break room, #3 the Women's Clinic and #4 Women's Clinic storage room were observed. B) During a review of the laboratory's temperature records it was noted that temperature records for room #3, the storage/break room was not presented. C) During a tour of the laboratory on 4/14 /23 at 01:20 p.m. 15 cases of 1,000 BD EDTA blood collection tubes lot# 2200107 expiration date 2023-11-30, 15 cases of 1,000 BD EDTA blood collection tubes lot # 2227125, and 3000 BD Gel Heparin blood collection tubes lot # 2292111 all with a storage temperature requirement of 4 degrees C. to 25 degrees C. were observed in room #3 the storage/break room D) Upon request, the laboratory could not present the temperature records for the storage/break room #3 in which the supplies identified above were stored,. F) In an interview on 4/14/23 at 1:20 p.m. the laboratory staff 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 -- member ( number 4 on the CMS 209 form) confirmed that the daily temperature of the room, in which the supplies identified above were stored, had not been monitored and recorded. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Through review of package inserts, observation, and interview it was determined that the laboratory did not change expiration dates on control materials after opening as required by manufacturer. Finding follow: A) Review of the package insert for Coulter 6C Hematology controls revealed that the product expires in 16 days after vial is opened and put into use and the expiration dates should be changed as required after opening. B) During a tour of the laboratory on 4/14/23 at 10:00 a.m.the surveyor observed a plastic container with three vials of Coulter 6C hematology controls , lot #'s 123175150, 133284140 and 143194150 . The vials did not have new expiration dates or dates put into use indicated on the testing materials or the container and were identified as the controls currently in use. C) In an interview on 4/14/23 at 10:50 a.m. laboratory staff member (number 6 on form CMS 209) confirmed that no amended expiration date or date when put into use were written on the vials or container. D5783

Summary Statement of Deficiencies 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: . Through a review of the new instrument validation, which was performed on 08/20 /2021 for the Vitros 7600 Chemistry analyzer, as well as interviews with staff, it was determined the laboratory failed to validate the reportable range established by the manufacturer for five of twenty-five Chemistry tests validated on the Vitros 7600. Survey Findings follow: A. A review of the Analytical Range Verification for Amylase (AMYL) on the Vitros 7600 revealed analytical range listed on the documentation as 30-1200 the laboratory only documented verification to 893.3; the analytical range verification for Alkaline Phosphatase (ALKP) on the Vitros 7600 listed on the documentation as 20-1500 the laboratory only documented verification to 1185.05; the analytical range verification for Total Bilirubin (TBIL) on the Vitros 7600 listed on the documentation as 0.1-27 the laboratory only documented verification to 17.93; the analytical range verification for Direct Low-Density Lipoprotein (dLDL) on the Vitros 7600 listed on the documentation as 30-350 the laboratory only documented verification to 117.02 and the analytical range verification for Creatine Kinase (CK) on the Vitros 7600 listed on the documentation as 20-1600 the laboratory only documented verification to 1471.1. B. The surveyor requested documentation for verification of the full analytical range of the listed analytes. None was provided. C. In an interview at 10:00 on 10/6/2021, the laboratory 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 -- director confirmed the laboratory did not validate the full reportable range for CK, AMYL, TBIL, dLDL and ALKP claimed by the manufacturer of the Vitros 7600. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Through a review of policy and procedure manual, quality control (QC) records for 2021, patient medical records, lack of documentation as well as interviews with staff, it was determined that patients were reported when results of quality control failed to meet the laboratory's criteria for acceptability. Survey findings follow: A. A review of the policy and procedure manual revealed the protocol for Chemistry QC: "Two levels of quality control will be run each day of patient testing. Patient will not be report until QC is acceptable." B. A review of chemistry quality control results for March and August of 2021 (two of eight months), revealed on 8/3/2021 Performance Verifier Level 1 was out of range for Glucose, Urea and Uric Acid with no documentation of an acceptable quality control results for Performance Verifier Level 1. C. A review of medical records revealed on 8/03/2021 the laboratory reported 160 Comprehensive Metabolic Panels with only one level of control in range for Glucose, Urea and Uric Acid. D. In an interview on 10/06/2021 at 10:00, laboratory director confirmed that patients were reported when the quality control results were outside of the laboratory's acceptable range. -- 2 of 2 --

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 review of 2018 CMS Casper Reports 0155D, 0153D, and the American Proficiency Institute (API) proficiency testing results, it was determined the laboratory failed to have initial successful participation in proficiency testing for the analyte of Digoxin (DIG). As evidenced by: Failure to achieve satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance as cited at D2087. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 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 review of 2018 CMS Casper Reports 0155D and 0153D and API proficiency testing results, it was determined the laboratory failed to have satisfactory participation in proficiency testing for the analyte of Digoxin (DIG). As evidenced by: A. The laboratory received a sore of 0% in first proficiency testing event of 2018 for the analyte DIG. B. The laboratory received a score of 60% in the third proficiency testing event of 2018 for the analyte DIG. 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 review of the 2018 proficiency testing results, it was determined the Laboratory Director failed to ensure that