Flushing Road Internal Medicine & Pediatrics

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 CMS database and the American Proficiency Institute (API) proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS approved proficiency testing program for the chemistry analyte: Chloride. Findings include: Review of the CMS database and the API proficiency testing reports showed unsatisfactory performance for 2 of 3 proficiency testing events. Refer to 2096 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 CMS database and the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to achieve satisfactory performance for the chemistry analyte: Chloride for 2 of 3 consecutive testing events. Findings include: Unsatisfactory performance for 2 of 3 consecutive proficiency testing events constitutes unsuccessful performance for Chloride. Chloride PT event Score 3rd event 2021 20% 2nd event 2022 0% -- 2 of 2 --

Summary Statement of Deficiencies D5022 TOXICOLOGY CFR(s): 493.1213 If the laboratory provides services in the subspecialty of Toxicology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on record review and interview with Technical Consultant (TC) #2, the laboratory failed to meet the requirements for the specialty in Toxicology as specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. Findings include: 1. The laboratory failed to verify the performance specifications for 6 drug analytes - Barbiturates, 6-Monoacetylmorphine, Methadone, Ecstasy, Opiates, and Oxycodone. Refer to D5421. . 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 record review, lack of documentation, and interview with Technical Consultant (TC) #2, the laboratory failed to verify the accuracy of its chemistry prostate specific antigen (PSA) testing at least twice annually for 3 (2019 and 2020) of 4 events for 2 years reviewed. Findings include: 1. A record review of the "Test Check List" compared to the documentation of 2 times a year verification of accuracy revealed a lack of documentation for the PSA testing as follows: a. 2019 - no documentation for December b. 2020 - no documental for June and December 2. 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 -- When requested, the laboratory was not able to provide documentation showing the verification of accuracy was completed at least twice annually for 1 event in 2019 and 2 events in 2020 for the PSA testing. 3. An interview on 6/10/2021 at 11:11 am, TC2 confirmed the laboratory had not performed the twice annually verification of accuracy for the PSA testing. 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 record review, lack of documentation, and interview with Technical Consultant (TC) #2, the laboratory failed to verify the performance specifications for 6 analytes (Barbiturates, 6-Monoacetylmorphine (6-AM), Methadone, Ecstasy, Opiates, and Oxycodone) of 6 toxicology analytes during the 3 (March to June 2021) months of operation. Findings include: 1. A review of the laboratory's patient test reports revealed the laboratory was performing and reporting out drug testing for 6 analytes (Barbiturates, 6-AM, Methadone, Ecstasy, Opiates, and Oxycodone) from March to June 2021. 2. A review of the laboratory's performance verification documentation for the new Hobra Pentra 400 chemistry analyzer revealed a lack of documentation of verification of performance specifications for the 6 analytes (Barbiturates, 6-am, Methadone, Ecstasy, Opiates, and Oxycodone) prior to the reporting of patient drug tests. 3. When requested on 6/10/2021 at 11:11 am by the surveyor, the verification of performance specification data for the 6 drug analytes was not available. 4. An interview on 6/10/2021 at 12:45 pm, TC2 confirmed the verification of performance specification data was not made available to the surveyor or completed prior to testing and reporting out patient results. D5803 TEST REPORT CFR(s): 493.1291(b) Test report information maintained as part of the patient's chart or medical record must be readily available to the laboratory and to CMS or a CMS agent upon request. This STANDARD is not met as evidenced by: . Based on record review, lack of documentation, and interview with Technical Consultant (TC) #2, the laboratory failed to have available for the surveyor the patient's final test report maintained as part of the patients' electronic medical record (EMR) for 1 ( #4) of 14 patient records reviewed. Findings include: 1. A record review for 1 ( #4) of 14 patient records reviewed revealed a lack of documentation in the EMR system for bacteriology Clostridium difficile testing. 2. An interview on 6/10 /2021 at 11:45 am, TC2 confirmed the final patient test results were not available in the EMR system for the surveyor to review on the day of the survey. -- 2 of 2 --

Summary Statement of Deficiencies D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: . Based on record review and interview, the Technical Consultant #1 (TC1) does not meet the Technical Consultant qualification requirements at 493.1411 for the subspecialty of bacteriology. Findings include: 1. The laboratory failed to have a qualified Technical Consultant evaluate the competency of testing personnel performing bacteriology testing. Refer to D6046. D6034 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 The laboratory must employ one or more individuals who are qualified by education and either training or experience to provide technical consultation for each of the specialties and subspecialties of service in which the laboratory performs moderate complexity tests or procedures. The director of a laboratory performing moderate complexity testing may function as the technical consultant provided he or she meets the qualifications specified in this section. This STANDARD is not met as evidenced by: . Based on record review and interviews, the laboratory failed to have a qualified Technical Consultant evaluate the competency of testing personnel performing bacteriology testing for 1 (Testing Personnel #1) of 2 testing personnel listed on the CMS-209 form. Findings include: 1. A record review of the "Competency Assessment 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 Clinical Laboratory Personnel" form dated 7/29/2020 for Testing Personnel #1 performing Clostridium difficile antigen and toxin testing revealed their competency was assessed by Technical Consultant #1 (TC1). 2. An interview on 8/19/2020 at 9:23 am with TC1 confirmed they were not qualified as a Technical Consultant in the subspecialty of bacteriology. 3. An interview on 8/19/2020 at 10:05 am with Testing Personnel #1 confirmed TC1 performed their competency assessment. -- 2 of 2 --

Summary Statement of Deficiencies D0000 . A survey for the addition of a specialty was completed on February 11, 2020. During the survey, it was determined that Immediate Jeopardy (IJ) existed for the following condition-level deficiencies: Bacteriology- 42 CFR 493.1201 D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: . Based on record review and interview with Technical Consultant #1 (TC1), the laboratory failed to enroll in a proficiency testing program for C. difficile antigen and toxin testing for 2019. Findings include: 1. A record review of the laboratory's patient test log revealed the laboratory started testing patients for C. difficile antigen and toxin on 5/24/2019. 2. A record review of the laboratory's established "Proficiency Testing" policy revealed a section stating, "The lab will enroll and participate in Proficiency Testing on an annual basis." 3. A record review of the laboratory's documents revealed a lack of proficiency testing records for C. difficile antigen and toxin testing. 4. The surveyor requested proficiency testing records for 2019 on 2/11 /2020 at 10:43 am and the records were not made available. 5. An interview on 2/11 /2020 at 10:43 am with TC1 confirmed the laboratory was not enrolled in a proficiency testing program for C. difficile antigen and toxin testing for 2019. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- D5002 BACTERIOLOGY CFR(s): 493.1201 If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1261, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: . Based on document review and interview, the laboratory failed to meet Bacteriology requirements as specified in 493.1230 through 493.1256. Findings include: 1. The laboratory failed to verify performance specifications for C. difficile antigen and toxin testing before reporting patient test results. Refer to D5421. 2. The laboratory failed to perform and document control procedures for C. difficile antigen and toxin testing each day of patient testing. Refer to D5445. 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 record review and interview with Technical Consultant #1 (TC1), the laboratory failed to assess employee competency for Testing Personnel #1 (TP1) in 2019. Findings include: 1. A record review of the laboratory's patient test log revealed the laboratory started testing patients for C. difficile antigen and toxin on 5/24/19 performed by TP1, a new employee. 2. A record review of the laboratory's competency assessments revealed a lack of documentation in 2019 for TP1. 3. A record review of the laboratory's established "Employee Evaluations" policy revealed a section stating, "All new laboratory employees will have a competency evaluation after their initial training, at the 6 month interval, and every year thereafter. The Competency Evaluation form will be filled-out. The monthly QA Review sheet will be followed to make sure employee evaluations are performed on time." 3. An interview on 2/11/2020 at 10:21 am with TC1 confirmed competency assessments were not performed in 2019 for TP1. 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 record review and interview with Technical Consultant #1 (TC1), the -- 2 of 4 -- laboratory failed to establish performance specifications for C. difficile antigen and toxin testing before reporting patient test results for 7 (patients #1-#7) of 7 patients receiving testing. Findings include: 1. A record review of the laboratory's patient test log revealed the following patients were tested for C. difficile antigen and toxin: a. Patient #1 performed on 5/24/19 b. Patient #2 performed on 5/24/19 c. Patient #3 performed on 8/7/19 d. Patient #4 performed on 10/16/19 e. Patient #5 performed on 11/7/19 f. Patient #6 performed on 11/6/19 g. Patient #7 performed on 1/13/2020 2. A review of the laboratory's records revealed a lack of verification of performance specifications for C. difficile antigen and toxin testing. 3. An interview on 2/11/2020 at 8:55 am with TC1 confirmed the laboratory did not verify performance specifications for the C. difficile antigen and toxin test system before testing and reporting results for patients. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant #1 (TC1), the laboratory failed to perform and document control procedures for C. difficile antigen and toxin testing for 6 (5/24/2019, 8/7/2019, 10/16/2019, 11/6/2019, 11/7/2019, 1/13 /2020) of 6 days patients were tested. Findings include: 1. A record review of the laboratory's patient test log revealed patient specimens were tested on the dates listed below: a. 5/24/2019 b. 8/7/2019 c. 10/16/2019 d. 11/6/2019 e. 11/7/2019 f. 1/13/2020 2. A record review of the laboratory's established "Quality Control" policy revealed a section stating, "All results must be recorded and evaluated every time they are run." 3. A record review of the laboratory's "C. DIFF QUIK CHEK COMPLETE Laboratory Procedure" signed by the laboratory director on 5/24/2019, revealed a section titled "Quality Control" stating, "The reactivity of the C. DIFF QUIK CHEK COMPLETE kit should be verified upon receipt using the Positive Control and negative control (diluent). the Positive Control is supplied with the kit (gray-capped bottle). The Positive Control confirms the reactivity of the other reagents associated with the assay, and is not intended to ensure precision at the analytical assay cut-off. Diluent is used for the negative control. Additional tests can be performed with the controls to meet the requirements for local, state and/or federal regulations and/or accrediting organizations." 4. The surveyor requested records of quality control performed for the dates listed above on 2/11/2020 at 9:02 am and they were not made available. 5. An interview on 2/11/2020 at 9:02 am with TC1 confirmed control procedures were not performed on days when patient testing was performed. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and -- 3 of 4 -- assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Consultant #1 (TC1), the Technical Consultant failed to perform and document training for 1 (Testing Personnel #1) of 1 testing personnel performing C. difficile antigen and toxin testing. Findings include: 1. A review of the laboratory's records revealed a lack of documentation of training performed for Testing Personnel #1. 2. An interview on 2 /11/2020 at 9:39 am with TC1 confirmed training documentation for Testing Personnel #1 was not available. -- 4 of 4 --

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 CMS database and review of the American Proficiency Institute (API) final proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS approved proficiency testing program for the endocrinology analyte triiodothyronine (T3). Findings include: Review of the CMS database and the API proficiency testing reports showed unsatisfactory performance for two of three proficiency testing events in 2019 for the endocrinology analyte: T3. Refer to D2098 and D2107. D2098 ENDOCRINOLOGY 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 -- CFR(s): 493.843(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 review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to attain a score of at least 80% of acceptable responses for the triiodothyronine (T3) analyte, which is unsatisfactory performance for the testing events. Findings include: PT Event T3 Score 1st event 2019 20% 3rd event 2019 60% D2107 ENDOCRINOLOGY CFR(s): 493.843(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 review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to achieve satisfactory performance for the endocrinology analyte triiodothyronine (T3) in two of three consecutive testing events. Findings include: Unsatisfactory performance for two of three consecutive proficiency testing events constituting unsuccessful performance for T3: PT Event T3 Score 1st event 2019 20% 3rd event 2019 60% -- 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 the CMS database and review of the American Proficiency Institute (API) final proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS approved proficiency testing program for the chemistry analytes calcium and chloride. Findings include: Review of the CMS database and the API proficiency testing reports showed unsatisfactory performance for two of three proficiency testing events in 2019 for the chemistry analytes: calcium and chloride. Refer to D2087 and D2096. D2087 ROUTINE CHEMISTRY 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 -- 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 review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to attain a score of at least 80% of acceptable responses for the calcium and chloride analytes, which is unsatisfactory performance for the testing events. Findings include: PT Event Calcium Score 1st event 2019 40% 3rd event 2019 40% PT Event Chloride Score 2nd event 2019 60% 3rd event 2019 40% 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 review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to achieve satisfactory performance for the chemistry analytes calcium and chloride in two of three consecutive testing events. Findings include: Unsatisfactory performance for two of three consecutive proficiency testing events constituting unsuccessful performance for calcium and chloride: PT Event Calcium Score 1st event 2019 40% 3rd event 2019 40% PT Event Chloride Score 2nd event 2019 60% 3rd event 2019 40% -- 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 the CMS database and review of the American Proficiency Institute (API) final proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS approved proficiency testing program for the chemistry analyte sodium. Findings include: Review of the CMS database and the API proficiency testing reports showed unsatisfactory performance for two of three proficiency testing events for the chemistry analyte: sodium. Refer to D2087 and D2096. D2087 ROUTINE CHEMISTRY 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 -- 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 review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to attain a score of at least 80% of acceptable responses for the sodium analyte, which is unsatisfactory performance for the testing events. Findings include: PT Event Score 1st event 2019 40% 2nd event 2019 20% 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 review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to achieve satisfactory performance for the chemistry analyte sodium in two of three consecutive testing events. Findings include: Unsatisfactory performance for two of three consecutive proficiency testing events constituting unsuccessful performance for sodium: PT event Score 1st event 2019 40% 2nd event 2019 20% -- 2 of 2 --

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: . Based on observation, procedure review, and interview with Technical Supervisor #2 (TS2), the laboratory failed to keep beverages out of the refrigerator designated for laboratory reagents, quality control, and patient specimens. Findings include: 1. An observation by the surveyor during the laboratory tour on 4/24/19 at 8:55 am revealed a bottle of coffee creamer in the door of the laboratory refrigerator containing patient specimens, quality control, and reagents. 2. A review of the laboratory's procedure manual revealed a policy in the "Lab Rules" section stating, "No eating, drinking, or applying of make up." 3. An interview with TS2 on 4/24/19 at 9:00 am confirmed coffee creamer was present in the laboratory refrigerator. 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: . Based on observation and interview with Technical Supervisor #1 (TS1), the 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 -- laboratory failed to label reagents on the AIA-360 TOSOH analyzer with the preparation dates, expiration dates, and lot numbers. Findings include: 1. During a tour of the laboratory on 4/24/19 at 8:55 am, the surveyor observed a lack of documentation and labeling of preparation dates, expiration dates, and lot numbers for the wash and diluent reagents in use on the AIA-360 TOSOH analyzer. 2. An interview with TS1 on 4/24/19 at 9:06 am confirmed the lack of documentation and labeling of preparation dates, expiration dates, and lot numbers on the above mentioned reagents. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Supervisor #1 (TS1), the laboratory failed to perform calibration verification for the Prostate Specific Antigen (PSA) assay for 2 (second event of 2017 and first event of 2018) of 4 testing events at least once every 6 months. Findings include: 1. A record review revealed a lack of documentation of calibration verification for the AIA-360 TOSOH analyzer PSA assay during the second testing event of 2017 and the first testing event of 2018. 2. An interview with TS1 on 4/24/19 at 12:05 pm confirmed the calibration verification was not completed at least every 6 months in 2017 and 2018. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: . Based on record review and interview, the laboratory failed to provide the -- 2 of 3 -- educational requirements for 1 (Testing Personnel #1) of 1 who performs moderately complex hematology and chemistry testing. Refer to D6065. D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: . Based on record review and interview with Technical Supervisor #1 (TS1), the laboratory failed to ensure all testing personnel met the educational requirements for 1 (Testing Personnel #1) of 1 testing personnel. Findings include: 1. A record review of credentials for Testing Personnel #1 revealed a lack of documentation of educational requirements for performing moderately complex laboratory testing. 2. During the interview on 4/24/19 at 9:15 am, TS1 confirmed the above findings. 3. The laboratory was given 5 additional days to supply the necessary educational documents. The documents were not received. -- 3 of 3 --