Corinth Family Medical Center

Summary Statement of Deficiencies 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 review of the Centers of Medicare and Medicaid Services (CMS) database proficiency Casper report and interview with laboratory TP #3 at 12:30 p.m. on 7/20 /22, the laboratory failed to enroll and participate in an HHS approved proficiency testing (PT) program for Hematology - CBC (Complete Blood Count) performed on the Cell Dyn 1800 hematology analyzer. The laboratory must enroll and participate in an approved program for the specialties performed by the laboratory. Findings Include: 1. Based on review of the CMS data base proficiency Casper report, the laboratory did not enroll in an approved program for CBC for the year 2022. 2. There was no documentation on the day of survey of enrollment in an HHS approved proficiency program for hematology for 2022. 3. TP #3 confirmed in an interview at 12:30 p.m. on 7/20/22 that the laboratory was not enrolled in proficiency testing for CBC testing. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient 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 -- 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 surveyor review of proficiency testing (PT) records for 2020 and 2021, surveyor review of the Centers for Medicare & Medicaid Services (CMS) 209 personnel form and confirmation by testing personnel (TP) #3 at 11:00 a.m. on 7/20 /22, the laboratory failed to allow TP who routinely perform CBC testing on the patient samples to participate in proficiency testing events for 2020 and 2021. Findings include: 1. Review of proficiency records since the last survey on 9/16/20 revealed all 3 events for CBC for 2020 and 2021 were performed by TP #3. 2. TP #3 in an interview at 11:00 a.m. on 7/20/22 confirmed that CBC testing on patient samples is routinely performed by TP#1, TP#2, and TP#3 as listed on the CMS-209. 3. Neither TP #1 nor TP#2 participated in the proficiency testing events for CBC in the years 2020 and 2021. THIS IS A REPEAT DEFICIENCY 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 Cell Dyn 1800 hematology analyzer maintenance records from 9/16/20 through 7/20/22 and interview with the testing personnel (TP) #3 as listed on the CMS-209 at 11:00 a.m. on the day of survey, the laboratory failed to document as performed the monthly maintenance on the Cell Dyn 1800 analyzer as required by the manufacturer. Findings include: 1. Review of the Cell Dyn 1800 records revealed the following maintenance had not been documented as performed for 5/21, 7/21, 12/21 and 2/22 since the last survey 9/16/20. Monthly required maintenance: a. Rinse Lyse Inlet Lines b. Rinse Reagent Inlet Lines B. TP #3 in an interview at 12:30 p.m. on 7/20 /22 confirmed that maintenance was not documented on the Cell Dyn 1800 log. THIS IS A REPEAT DEFICIENCY D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on review of the Cell Dyn 1800 hematology calibration records from 9/16/20 through 7/20/22 and interview with TP #3 at 12:30 p.m. on 7/20/22, the laboratory failed to perform calibration on the Cell Dyn 1800 hematology every 6 months as required by the manufacturer. Findings include: 1. Review of the Cell Dyn 1800 calibration records revealed calibration was performed on 10/1/20 and 10/3/20 and has not been performed since then. These calibration time frames exceed the 6 month mandatory calibration requirement of the manufacturer. 2. Interview with TP #1 at 12: 30 p.m. on 7/20/22 confirmed that CBC calibrations were not performed every 6 months as evidenced by the calibration records available. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 surveyor review of proficiency testing (PT) records for the 2nd and 3rd events of 2019, 1st and 2nd events of 2020, the (CMS) Centers for Medicare & Medicaid Services 209 personnel form and confirmation by laboratory testing personnel (TP) #2 at 3:00 pm on 9/16/2020, the laboratory failed to ensure that all testing personnel who routinely perform CBC (complete blood count) testing participated in proficiency testing for CBC's. Findings include: 1. Review of attestation statements for proficiency testing revealed that all PT testing for CBC was performed by TP#2. 2. The CBC proficiency testing was not rotated between TP#1 and TP#2 who routinely test CBC's. 3. During an interview with TP #2 at 3:00 pm on the day of survey she confirmed that all CBC proficiency testing events had been performed by her. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. 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 -- This STANDARD is not met as evidenced by: Based on review of laboratory specimen collection and labeling policies, observation of CBC (Complete Blood Count) samples, and interview with Testing Personnel (TP) at 2:00 pm on the day of survey, 9/16/20, the laboratory failed to follow the written policy and procedure for labeling of patient specimens. Findings include: 1. Review of the laboratory's written labeling policy states specimens will be labeled with the patient's full name or chart number, date and time of collection. 2. Hematology microtubes observed in the lab were labeled with the patient's initials and date of birth only. 2. Interview with TP #1 and #2 at 2:00 pm on the day of survey confirmed CBC specimens were not labeled according to the laboratory labeling policy. 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 Cell Dyn 1800 hematology analyzer records available the day of survey and interview with Testing Personnel (TP) at 2:30 pm, the laboratory director failed to ensure that verification procedures were performed during installation of the hematology analyzer to determine accuracy, precision and reportable ranges. The Cell Dyne 1800 was installed for CBC (complete blood count) testing in February 2019. Findings: 1. Review of installation records for the Cell Dyn 1800 hematology analyzer revealed only a calibration and correlation with another clinic were performed during installation. There was no documentation of performance verification to include accuracy, precision and reportable ranges on the day of survey to ensure the analyzer was properly installed and adequate for patient testing. 2. Interview with TP#1 and TP#2 at 2:30 pm on the day of survey revealed that the installation records available included all testing done during installation. There was no documentation of verification that the normal ranges in use were appropriate for the laboratory's patient population. 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 Cell Dyn 1800 hematology analyzer maintenance records from its installation on 2/11/19 until the day of survey, 9/16/20, and interview with laboratory Testing Personnel (TP) #2 as listed on the CMS Personnel Form 209 at 3: 30 pm on the day of survey, the laboratory failed to document as performed the -- 2 of 4 -- monthly maintenance on the Cell Dyn 1800 analyzer as required by the manufacturer. Findings include: 1. Review of the Cell Dyn 1800 records revealed the following maintenance--required monthly--had only been documented as performed once on the hematology analyzer since installation on 2/11/19. performed in March 2019: a. Rinse Lyse Inlet Lines b. Rinse Reagent Inlet Lines 2. Interview with the laboratory TP #2 at 3:30 pm on the day of survey confirmed monthly maintenance was not documented as performed on the Cell Dyn 1800 for the period from April 2019 through September 2020. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

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 Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 2/6/2020, the laboratory has not successfully participated in proficiency testing for WHITE BLOOD CELL (WBC) DIFFERENTIAL. Findings include: Our records indicate the following proficiency testing scores for your laboratory for WHITE BLOOD CELL (WBC) DIFFERENTIAL: PROFICIENCY TESTING PROVIDER: American Proficiency Institute WHITE BLOOD CELL (WBC) DIFFERENTIAL: Year 2019 2nd Event 0% Year 2019 3rd Event 0% Scores less than 80% for this analyte or parameter indicate 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 for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. D2130 HEMATOLOGY CFR(s): 493.851(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 Surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 2/6/2020, the laboratory has not successfully participated in proficiency testing for WHITE BLOOD CELL (WBC) DIFFERENTIAL. Findings include: Our records indicate the following proficiency testing scores for your laboratory for WHITE BLOOD CELL (WBC) DIFFERENTIAL: PROFICIENCY TESTING PROVIDER: American Proficiency Institute WHITE BLOOD CELL (WBC) DIFFERENTIAL: Year 2019 2nd Event 0% Year 2019 3rd Event 0% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. -- 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: Based on review of temperature records since last survey, 5/17/16 through 5/21/18 and confirmation with test personnel #2 at 3:30 pm on the day of survey 5/21/18, the laboratory failed to monitor and document the temperature of the laboratory room and refrigerator. Findings include: On the following days temperatures of the laboratory room and refrigerator were not documented as performed: July 16, 2016 through July 29, 2016 February 28, 2017 through May 21, 2018 Maintaining appropriate temperatures according to the instructions of the manufacturer is essential for optimal test performance. A. The Medonic CA 620 rinse and diluent should be stored at temperature of 4-35 degrees Celsius(C). B. The Medonic CA 620 hematology analyzer instrument specifications require a room temperature of 18-32 degrees C. C. The Medonic CA 620 Quality Control and calibration material refrigerator storage requirement is 2-10 degrees C and needs to warm up each day at room temperature before testing. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system 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 must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on Boule Medonic CA 620 calibration documentation and interview with testing personnel at 4:30 pm on the day of survey, 5/21/18, the laboratory failed to perform calibration on the Medonic CA 620 hematology analyzer at least once every 6 months according to the frequency required by the manufacturer. Calibration has not been documented as performed since 4/26/17. This time frame exceeds the 6 month manufacturer's calibration requirement. THIS IS A REPEAT DEFICIENCY D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved