Mcallen Primary Care Clinic Inc

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with the CLIA regulations. The conditions not met were: D5400 - 42 C.F.R. 493.1250 Condition: Analytic systems D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director D6033 - 42 C.F.R. 493.1409 Condition: Technical Consultant 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 review of the laboratory's submitted Form CMS 209, review of the laboratory's American Proficiency Institute's hematology proficiency testing records from 2022, and staff interview, the laboratory failed to have documentation of 1 of 4 personnel participating in proficiency testing. The findings include: 1. A review of the laboratory's submitted Form CMS 209 revealed the laboratory identified 4 testing personnel who performed hematology testing. 2. A review of the laboratory's American Proficiency Institute's hematology proficiency testing records from 2022 (events 1, 2 and 3) revealed 1 of 4 testing personnel did not participate in proficiency testing for hematology. They were (as listed on the CMS 209): Testing personnel 4 3. The laboratory was asked to provide documentation of the identified testing personnel participating in hematology proficiency testing in 2022. No documentation was provided. 4. The technical consultant confirmed the findings in an interview on 10/17 /2023 at 1005 hours in the physician assistant's office. NOTE: THIS IS A REPEAT DEFICIENCY FROM THE SURVEY CONDUCTED 12/21/2021. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the laboratory's records and staff interview, the laboratory failed to meet the requirements for analytic systems. The findings include: 1. The laboratory failed to follow its own procedure for flagged CBC results (refer to D5401). 2. The laboratory failed to have documentation of performing calibrations as required (refer to D5437). NOTE: THIS IS A REPEAT DEFICIENCY FROM THE SURVEY CONDUCTED 12/21/2021. 3. The laboratory failed to have documentation of performing calibration verifications as required (refer to D5439). NOTE: THIS IS A REPEAT DEFICIENCY FROM THE SURVEYS CONDUCTED 1/25/2016, 11/15 /2017, 1/29/2020 AND 12/21/2021. 4. The laboratory failed to monitor quality control results over time (refer to D5441). NOTE: THIS IS A REPEAT DEFICIENCY FROM THE SURVEY CONDUCTED 12/21/2021. 5. The laboratory failed to verify new lots of quality control material (refer to D5469). NOTE: THIS IS A REPEAT DEFICIENCY FROM THE SURVEYS CONDUCTED 1/29/2020 AND 12/21/2021. KEY CBC - complete blood count D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy for addressing flagged CBC results, review of a sampling of patient test records from September 1, 2023 to October 16, 2023, and staff interview, it was revealed the laboratory failed to have documentation of following its policy for 4 of 8 flagged results. The findings include: 1. A review of the laboratory's policy titled "Policy for Handling Flagged CBC Differentials" (approved by the laboratory director on 03/01/2022) identified: "It will be the policy of this laboratory to rerun flagged CBC results. If the second run still shows flags, then the lab will evaluate flagged differentials according [to] the procedures in the unit's operator manual... If the flags disappear, then report that result. If the flags persist, follow manufacturer's instructions. The lab can also cross out or not report the flagged CBC results in their LIS system." 2. A sampling of patient test records from September 1, 2023 to October 16, 2023 identified 8 patient records with flagged results. The flagged results for 4 of these patients were not retested or not resolved after repeat testing. Further review of the patient test records showed the flagged results were reported to the providers. They were: a) Date: 09/01/2023 Sample ID: 1090123725 Flag: L5 not retested b) Date: 09/13/2023 Sample ID: 1091323129 Flag: L1 flag on initial and retest c) Date: 09/27/2023 Sample ID: 1092723530 Flag: L1 flag on initial and retest d) Date: 10/02/2023 Sample ID: 1100223647 Flag: L5 not retested -- 2 of 11 -- 3. The laboratory was asked to provide documentation it followed the policy for resolving flags prior to reported the identified patient results. No documentation was provided. 4. The technical consultant confirmed the findings in an interview on 10/17 /2023 at 1315 hours in the laboratory. Key CBC - complete blood count LIS - laboratory information system 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 the manufacturer's instructions for the storage of BD Vacutainer tubes, surveyor observation of supplies stored in the laboratory, review of laboratory room temperature logs from August 2022 to August 2023, and staff interview, the laboratory failed to ensure supplies were stored at the temperature required by the manufacturer on 23 of 396 days. The findings include: 1. A review of the manufacturer's instructions for the storage of BD Vacutainer tubes identified the manufacturer's defined acceptable storage temperature as 4 - 25C (39.2 - 77.0F). 2. Surveyor observation of supplies stored in the laboratory on 10/17/2023 at 1030 hours identified the following BD Vacutainer tubes: 109 BD K2 EDTA (ref 367861) 100 BD Serum tubes (ref 36781) 100 BD Sodium Citrate (ref 36083) 100 BD SST (ref 367988) 3. A review of the laboratory's room temperature records from August 2022 to August 2023 identified the laboratory's defined acceptable room temperature as 15 -32C (59 - 90F). Further review identified the following days where the documented room temperature exceeded the manufacturer's acceptable range on 23 of 396 days. The days/temperatures were: Date Temperature 8/5/22 79F 8/7/22 80F 8/8/22 79F 8/11 /22 82F 8/12/22 86F 8/13/22 82F 8/14/22 82F 8/15/22 85F 8/16/22 86F 8/26/22 79F 9 /1/22 79F 11/3/22 80F 11/16/22 79F 11/21/22 78F 11/25/22 80F 11/30/22 81F 1/1 /2023 78F 5/26/23 79F 7/19/23 78F 7/22/23 78F 7/23/23 78F 7/27/23 79F 8/20/23 78F 3. The laboratory was asked to provide documentation of performing

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the CMS (Centers for Medicare and Medicaid Services) national database and verified with the proficiency testing company, American Proficiency Institute (API). The laboratory was found to be NOT in compliance with the conditions of participation of the CLIA program based on the following CONDITION LEVEL DEFICIENCIES: 493.803 Successful participation [proficiency testing] 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: Based on a desk review of proficiency testing records obtained from the CMS (Center 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 -- 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 had unsuccessful participation in the specialty of chemistry for the analyte of sodium (refer to D2096). 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 a desk review of the CMS 155 report and proficiency testing records from American Proficiency Institute (API), it was determined the laboratory failed to successfully participate 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 sodium resulting in an initial proficiency testing failure. The findings include: 1. A review of the CMS 155 report revealed the laboratory received the following unsatisfactory scores (passing = >80%) for the analyte sodium: Third testing event 2022 0% Second testing event 2023 60% 2. A desk review of the laboratory's American Proficiency Institute's results from the third event of 2022 and the second event of 2023 confirmed the proficiency testing scores: Third testing event 2022 0% Second testing event 2023 60% 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: -- 2 of 3 -- 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 an HHS approved proficiency testing program (refer to D2096). -- 3 of 3 --

Summary Statement of Deficiencies D0000 The laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCY: D5400 - 42 C.F.R. 493.1250 Condition: Analytic Systems 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 Intakes: TX00299620 Complaint TX00299620 was substantiated. The laboratory was surveyed on January 29, 2019 in response to complaint TX00299620 for compliance with CMS 42 CFR Inspection requirements applicable to all CLIA certified and CLIA- exempt laboratories. The laboratory was found to be out of compliance at: D5200 - 42 C.F.R. 493.1230 Condition: General laboratory systems; D5300 - 42 C.F.R. 493.1240 Condition: Preanalytic systems; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representatives were given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. 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 observation, review of manufacturer's instructions, review of laboratory patient test logs, and confirmed in interview of facility personnel, the laboratory failed to follow the manufacturer's instructions for Uriscan Urine strips. The findings were: 1. Surveyor observation on January 29, 2019 at 0815 during the initial tour of the laboratory revealed 1 vial of Uriscan Urine strips (lot number 38728, expiration date: 9-30-19) was not closed. The container was located on the countertop by the sink and the lid was not screwed on properly and left loosely on top of the container. 2. Review of the manufacturer's instructions for the Uriscan Urine strips (Rev. 12/2016-12-15) under, "Handling Procedure" it stated, " ...After removing a test strip, immediately replace the cap completely." 3. Review of patient test logs from Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- January 29, 2019 revealed that no patients had been tested for the day. It could not be determined how long the vial of Uriscan Urine strips had been left open. 4. Interview with the technical consultant at 10:30 hours in the laboratory confirmed the findings. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on direct observation and confirmed in interview of facility personnel, the laboratory failed to meet general laboratory systems requirements (refer to D5201). D5201 CONFIDENTIALITY OF PATIENT INFORMATION CFR(s): 493.1231 The laboratory must ensure confidentiality of patient information throughout all phases of the total testing process that are under the laboratory's control. This STANDARD is not met as evidenced by: Based on surveyor observations, and confirmed in interview of facility personnel, the laboratory failed to ensure patient confidentiality was protected throughout all phases of the testing process. The findings were: 1. Surveyor observations made at 09:00 hours and 10:30 hours on January 29, 2019 revealed facility personnel escort patients and visitors through a room that contained patient medical records. The room provided a walkway to get from one side of the clinic to the other. Patient information such as name and date of birth were visible on the outside of the patient's charts. 2. An interview with the nursing administrator on 01/29/2019 at 15:00 hours in the office confirmed the findings. She stated that the records could be sent to storage because those records were for urgent care patients that had electronic medical records. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on surveyor observations, review of manufacturer's instructions, review of patient records, and confirmed in interview of facility personnel, the laboratory failed to provide overall quality in its pre-analytic systems as evidenced by: 1. The -- 2 of 7 -- laboratory failed to follow manufacturer's instructions for proper storage of specimens prior to testing. (refer to D5311-I) 2. The laboratory failed to follow its own specimen labeling policy. (refer to D5311-II) 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. This STANDARD is not met as evidenced by: I. Based on surveyor observations, review of laboratory policy, review of manufacturer's instructions, review of laboratory environmental records, review of patient final reports, and confirmed in interview of facility personnel, the laboratory failed to follow manufacturer's instructions for preanalytic specimen handling requirements. NOTE: As of the date of the survey, January 29, 2019, the laboratory was not performing in-house patient testing for Comprehensive Metabolic Panel or Lipid Profile. The laboratory has sent out tests for Comprehensive Metabolic Panel and Lipid Profile since October 8, 2018. The laboratory was performing patient correlations. The findings were: 1. Surveyor observation on January 29, 2019 at 09:00 hours in the room where the laboratory refrigerator was located revealed patient samples were stored in the refrigerator. The refrigerator contained samples that had been previously tested and patient samples that were pending testing. 2. Review of the laboratory's policy titled, "Procedures for Specimen Submission and Handling" approved by the laboratory director on October 1, 2015 stated, "This laboratory will have written policies and procedures for methods used for the preparation of patients, specimen collection, specimen preservation and conditions for transportation ..." The laboratory's policy did not indicate preanalytic specimen storage requirements as required by the manufacturer. 3. Review of the manufacturer's instructions for Alfa Wasserman chemistry analyzer under, "Specimen Collection, Storage and Handling" stated: ALT (P/N 909060-3 Rev-C 9/17) "Specimen stable for 7 days at 4-8 degrees Celsius and -20 degrees Celsius." Direct Bilirubin (P/N 909060-13 Rev C 9/17) "Specimen stable for 7 months at 4-8 degrees Celsius or 6 months at -20 degrees Celsius." Total Bilirubin (P/N 909060-25 Rev C 9/17) "Specimen stable for 7 days at 4-8 degrees Celsius and for 6 months at -20 degrees Celsius." Calcium-Arsenazo (P/N 909060-7 Rev C 9/17) "Specimen stable for 3 weeks at 4-8 degrees Celsius and for 8 months at -20 degrees Celsius." Albumin (P/N 909060-1 Rev C 9/17) "Specimen stable at 4 degrees Celsius for up to 72 hours and frozen at -20 degrees Celsius for 6 months or indefinitely at -70 Celsius." Total Protein (P/N 909060-28 Rev C 11/15 "Specimen stable at 4 degrees Celsius for up to 72 hours and frozen at -20 degrees Celsius for 6 months or indefinitely at -70 degrees Celsius." Creatinine (P/N 909060- 12 Rev E 9/17 "Specimen stable for 7 days when refrigerated (4-8 degrees Celsius) and for 3 months when frozen at -20 degrees Celsius." Total Protein (P/N 909060-28 Rev C 11/15 "Specimen stable at 4 degrees Celsius for up to 72 hours and frozen at -20 degrees Celsius for 6 months or indefinitely at -70 degrees Celsius." Alkaline Phosphatase (P/N 909060-2 Rev C 1/18 "Specimens stable for 7 days at 4-8 degrees Celsius and 2 months at -20 degrees Celsius." Cholesterol (P/N 909060 Rev C 11/17) "Specimen stable for 7 days at 4-8 degrees Celsius and 3 months at -20 degrees -- 3 of 7 -- Celsius." Triglycerides (P/N 909060-29 Rev B 9/13 "Specimen stable for 4-7 days at 4 degrees Celsius." BUN/UREA (P/N 909060-6 Rev D 9/17 "Specimen stable at 7 days refrigerated (4-8 degrees Celsius) or frozen at -20 degrees for 1 year. HDL-C (P /N 909060-18 Rev D 9/17 "Specimen stable when stored in the refrigerator at 4 degrees Celsius for 1 to 7 days Avoid repeated freezing and thawing." Glucose (P/N 909060-16 Rev E 12/17 "Specimen stable for 8 hours a 25 degrees Celsius, 72 hours at 4 degrees Celsius." ALT (P/N 909060-3 Rev C 9/17 "Specimen stable for 7 days at 4-8 degrees Celsius and -20 degrees Celsius." Carbon Dioxide (P/N 909060-11 Rev C 9/17 "Specimen stable for 7 days at 4-8 degrees Celsius and for 2 weeks at -20 degrees Celsius." AST (P/N 909060-5 Rev C 9/17 "Specimen activity is stable for 28 days at 4 degrees Celsius and at least one year at -20 degrees Celsius." 4. Review of the laboratory's refrigeration logs from July, August, and September 2018 revealed the laboratory documented temperature readings below the manufacturer's acceptable storage range for 65 out of 65 dates reviewed as follows: July 2, 2018 2.9 degrees Celsius July 3, 2018 3.0 degrees Celsius July 4, 2018 3.2 degrees Celsius July 5, 2018 3.0 degrees Celsius July 6, 2018 2.9 degrees Celsius July 9, 2018 3.3 degrees Celsius July 10, 2018 3.1 degrees Celsius July 11, 2018 2.9 degrees Celsius July 12, 2018 3.1 degrees Celsius July 13, 2018 3.3 degrees Celsius July 16, 2018 3.1 degrees Celsius July 17, 2018 2.8 degrees Celsius July 18, 2018 3.1 degrees Celsius July 19, 2018 3.3 degrees Celsius July 20, 2018 3.4 degrees Celsius Jully 23, 2018 3.3 degrees Celsius July 24, 2018 3.1 degrees Celsius Jully 25, 2018 2.9 degrees Celsius July 26, 2018 3.1 degrees Celsius July 27, 2018 3.3 degrees Celsius July 30, 2018 2.9 degrees Celsius July 31, 2018 3.0 degrees Celsius August 1, 2018 3.7 degrees Celsius August 2, 2018 3.1 degrees Celsius August 3, 2018 2.9 degrees Celsius August 6, 2018 3.1 degrees Celsius August 7, 2018 3.3 degrees Celsius August 8, 2018 2.9 degrees Celsius August 9, 2018 3.1 degrees Celsius August 10, 2018 3.4 degrees Celsius August 13, 2018 2.8 degrees Celsius August 14, 2018 2.9 degrees Celsius August 15, 2018 3.1 degrees Celsius August 16, 2018 3.3 degrees Celsius August 17, 2018 3.4 degrees Celsius August 20, 2018 3.3 degrees Celsius August 21, 2018 3.1 degrees Celsius August 22, 2018 2.9 degrees Celsius August 23, 2018 3.1 degrees Celsius August 24, 2018 3.3 degrees Celsius August 27, 2018 2.9 degrees Celsius August 28, 2018 3.0 degrees Celsius August 29, 2018 3.2 degrees Celsius August 30, 2018 3.0 degrees Celsius August 31, 2018 2.9 degrees Celsius September 3, 2018 3.0 degrees Celsius September 4, 2018 2.9 degrees Celsius September 5, 2018 3.2 degrees Celsius September 6, 2018 3.0 degrees Celsius September 7, 2018 2.9 degrees Celsius September 10, 2018 3.3 degrees Celsius September 11, 2018 3.1 degrees Celsius September 12, 2018 2.9 degrees Celsius September 13, 2018 3.1 degrees Celsius September 14, 2018 3.3 degrees Celsius September 17, 2018 2.8 degrees Celsius September 18, 2018 2.9 degrees Celsius September 19, 2018 3.1 degrees Celsius September 20, 2018 3.3 degrees Celsius September 21, 2018 3.4 degrees Celsius September 24, 2018 3.1 degrees Celsius September 25, 2018 3.2 degrees Celsius September 26, 2018 3.1 degrees Celsius September 27, 2018 3.4 degrees Celsius September 28, 2018 2.9 degrees Celsius 5. A random review of patient results from the July, August, and September testing dates revealed the following patient samples were performed when patient samples were not stored according to the manufacturer's instructions (see patient alias list). 6. An interview with the technical consultant on January 29, 2019 at 11:00 hours in the laboratory confirmed the findings. She stated that the facility was preparing to start patient testing again and as part of that process they were reviewing the manufacturer's specimen stability requirements. II. Based on surveyor observations, review of laboratory policy, and confirmed in interview of facility personnel, the laboratory failed to follow its own policy for specimen labeling. The findings were: 1. Surveyor observation on January 29, 2019 at 13:30 hours revealed a patient bring their urine specimen to the laboratory and then leave the area. -- 4 of 7 -- The sample was labeled with the patient's first and last name. The patient's urine sample was placed in the sink with 6 other patient specimens. If the facility had a patient with the same name, the patient's sample could not be uniquely identified. 2. Review of the laboratory's policy titled, "Specimen Identification" approved by the laboratory director on October 1, 2015, it stated, "Each specimen must have unique identifiers such as patient name, birth date, social security number or other identifying number ...patient's name, secondary ID, time and date of collection, initials of specimen collector." 3. An interview with testing person one (as listed on Form CMS- 209) on January 29, 2019 at 13:35 hours confirmed the findings. She revealed that sometimes she would label the sample with the sticker that had two identifiers on it but sometimes she would run it as is. She had the specimen recollected. Key: AST - aspartate aminotransferase HDL - high density lipoprotein ALT - alanine aminotransferase BUN/UREA - blood urea nitrogen Rev - revision P/N - part number CMS - Centers for Medicare and Medicaid Services 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 surveyor observation, review of manufacturer's instructions, review of laboratory environmental records, and confirmed in interview of facility personnel, the laboratory failed to define an acceptable temperature range for the storage of patient samples when stored refrigerated. The findings were: 1. Surveyor observation on January 29, 2019 at 08:15 hours during an initial tour of the laboratory revealed the temperature reading for the laboratory refrigerator where patient samples were stored was 1.0 degrees Celsius. 2. Review of the manufacturer's instructions for Alfa Wasserman chemistry analyzer under, "Specimen Collection, Storage and Handling" stated: ALT (P/N 909060-3 Rev-C 9/17) "Specimen stable for 7 days at 4-8 degrees Celsius and -20 degrees Celsius." Direct Bilirubin (P/N 909060-13 Rev C 9/17) "Specimen stable for 7 months at 4-8 degrees Celsius or 6 months at -20 degrees Celsius." Total Bilirubin (P/N 909060-25 Rev C 9/17) "Specimen stable for 7 days at 4-8 degrees Celsius and for 6 months at -20 degrees Celsius." Calcium-Arsenazo (P/N 909060-7 Rev C 9/17) "Specimen stable for 3 weeks at 4-8 degrees Celsius and for 8 months at -20 degrees Celsius." Albumin (P/N 909060-1 Rev C 9/17) "Specimen stable at 4 degrees Celsius for up to 72 hours and frozen at -20 degrees Celsius for 6 months or indefinitely at -70 Celsius." Total Protein (P/N 909060-28 Rev C 11/15 "Specimen stable at 4 degrees Celsius for up to 72 hours and frozen at -20 degrees Celsius for 6 months or indefinitely at -70 degrees Celsius." Creatinine (P/N 909060- 12 Rev E 9/17 "Specimen stable for 7 days when refrigerated (4-8 degrees Celsius) and for 3 months when frozen at -20 degrees Celsius." Total Protein (P/N 909060-28 Rev C 11/15 "Specimen stable at 4 degrees Celsius for up to 72 hours and frozen at -20 degrees Celsius for 6 months or indefinitely at -70 degrees Celsius." Alkaline Phosphatase (P/N 909060-2 Rev C 1/18 "Specimens stable for 7 days at 4-8 degrees Celsius and 2 months at -20 degrees Celsius." Cholesterol (P/N 909060 Rev C 11/17) -- 5 of 7 -- "Specimen stable for 7 days at 4-8 degrees Celsius and 3 months at -20 degrees Celsius." Triglycerides (P/N 909060-29 Rev B 9/13 "Specimen stable for 4-7 days at 4 degrees Celsius." BUN/UREA (P/N 909060-6 Rev D 9/17 "Specimen stable at 7 days refrigerated (4-8 degrees Celsius) or frozen at -20 degrees for 1 year. HDL-C (P /N 909060-18 Rev D 9/17 "Specimen stable when stored in the refrigerator at 4 degrees Celsius for 1 to 7 days Avoid repeated freezing and thawing." Glucose (P/N 909060-16 Rev E 12/17 "Specimen stable for 8 hours a 25 degrees Celsius, 72 hours at 4 degrees Celsius." ALT (P/N 909060-3 Rev C 9/17 "Specimen stable for 7 days at 4-8 degrees Celsius and -20 degrees Celsius." Carbon Dioxide (P/N 909060-11 Rev C 9/17 "Specimen stable for 7 days at 4-8 degrees Celsius and for 2 weeks at -20 degrees Celsius." AST (P/N 909060-5 Rev C 9/17 "Specimen activity is stable for 28 days at 4 degrees Celsius and at least one year at -20 degrees Celsius." 3. Review of laboratory refrigeration records from July, August, September 2018 and January 2019 revealed the laboratory had defined its acceptable refrigerator range as "2-8 Celsius." 4. The laboratory failed to define an acceptable refrigeration range according to the manufacturer's instructions. 5. Review of patient results from July, August, and September 2018 revealed the following patients were tested when the laboratory had stored specimens outside the manufacturer's acceptable refrigeration range (see patient alias list). 6. An interview with the technical consultant on January 29, 2019 at 11:00 hours in the laboratory confirmed the findings. Key: AST - aspartate aminotransferase HDL - high density lipoprotein ALT - alanine aminotransferase BUN/UREA - blood urea nitrogen Rev - revision P/N - part number 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 surveyor observations and confirmed in interview of facility personnel, the laboratory failed to ensure reagents were labeled with identification, concentration, storage, and dates. The findings were: 1. Surveyor observation January 29, 2019 at 08: 15 hours during an initial tour of the facility revealed a clear container with a green lid sitting on top of the Sysmex hematology analyzer. The contents were clear. The container was not labeled with any identifying information on it. 2. The laboratory failed to ensure reagents were properly labeled with identifying information as to concentration, storage requirements, and dates. 3. An interview with the technical consultant at 10:30 hours in the laboratory confirmed the findings. 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: -- 6 of 7 -- Based on surveyor observations, review of laboratory policy, review of manufacturer's instructions, review of environmental records, review of patient results, and confirmed in interview of facility personnel, the laboratory director failed to provide overall management and direction of the laboratory. (refer to D6007 and D6011) D6007 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(1) 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)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: Based on surveyor observations, review of laboratory policy, review of manufacturer's instructions, review of environmental records, review of patient results, and confirmed in interview of facility personnel, the laboratory director failed to ensure the laboratory followed manufacturer's instructions for preanalytic specimen handling. (refer to D5311) D6011 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(2) 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)(2) and provide a safe environment in which employees are protected from physical, chemical, and biological hazards. This STANDARD is not met as evidenced by: Based on surveyor observations, review of laboratory policy, and confirmed in interview of facility personnel, the laboratory director failed to provide a physically safe environment for laboratory personnel. The findings were: 1. Surveyor observation made on January 29, 2019 at 08:15 hours in the laboratory during the initial tour of the laboratory revealed the phlebotomy chair was located in the laboratory entrance. 2. The surveyor observed facility personnel (laboratory testing persons and non-testing persons) turn sideways to enter or leave the laboratory if a patient blood collection was being performed. Further, the surveyor observed patients in the laboratory for phlebotomy draws throughout the survey process. 3. Review of the laboratory's policy titled, "Laboratory Safety" approved by the laboratory director on October 1, 2015, stated, "Only staff members who work in the lab should be allowed in the lab. Patients should not be allowed in the lab." The laboratory did not follow its own policy to ensure patients were not allowed in the laboratory. 4. The above findings were confirmed in interview of the Nursing Administrator on January 29, 2019 at 15:00 hours. When asked if there was documentation or occasions of employee exposures in the laboratory, she stated, "Yes." -- 7 of 7 --

Summary Statement of Deficiencies D0000 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 --