Pittsburg Hospital, Llc

Summary Statement of Deficiencies D0000 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 a review of reagent instructions for use (IFU), laboratory policy, laboratory documents, and confirmed in an interview, the laboratory failed to follow its own policy for acceptability criteria for 13 of 20 patients used in establishing a new normal patient range for one of one Prothrombin Time (PT) coagulation reagent lot rollover reviewed in 2022. The findings included: 1. Review of the PT reagent, RecombiPlasTin 2G, instructions for use, section "Instrument/test procedures" had the following caution statement: "Enter the ISI value from the insert and establish the Mean of the PT Normal Range with each new lot." 2. Review of the laboratory policy titled "Protime" had the following form titled "Medication History Form For Normal Range Study" and the following questions: "1. Are you taking any antibiotics: Yes No If yes, please list antibiotics: _____ 2. Do you take Vitamin K? Yes No 3. Do you take birth control? Yes No 4. Do you take thyroid medication? Yes No 5. Do you take aspirin? Yes No 6. Does your diet consist of a large amount of green leafy vegetables (10-12 servings), per week? Yes No If any of the above questions were answered "yes", this specimen is invalid for the normal range study. Collect a different patient specimen." 3. Review of laboratory documents for RecombiPlastin 2G, lot number N1117610, normal range study evaluated on 8/18/2022 had the following 13 patients who answered yes to one or more questions but were included in the normal range study: Patient 1: Answered 'yes' to taking Vitamin K, and daily Aspirin. Patient 4: 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 -- Answered 'yes' to taking thyroid medication and a diet of 10-12 servings a week of green leafy vegetables. Patient 5: Answered 'yes' to taking thyroid medication, daily aspirin, and a diet of 10 to 12 servings a week of green leafy vegetables. Patient 6: Answered 'yes' to taking vitamin K. Patient 7: Answered 'yes' to taking vitamin K. Patient 8: Answered 'yes' to taking vitamin K. Patient 10: Answered 'yes' to taking thyroid medication and daily aspirin. Patient 12: Answered 'yes' to taking birth control. Patient 14: Answered 'yes' to taking vitamin K and aspirin. Patient 15: Answered 'yes' to a diet of 10 to 12 servings a week of green leafy vegetables. Patient 16: Answered 'yes' to taking vitamin K and a diet consisting of 10-12 servings a week of green leafy vegetables. Patient 17: Answered 'yes' to antibiotics. Patient 25: Answered 'yes' to taking daily aspirin. 4. In an interview on 5/10/2023 at 09:45 hours, in the conference room, the Director of Laboratory Services confirmed that patients who did not meet the acceptability criteria for a normal range study had been utilized in the new lot RecombiPlastin Prothrombin Time normal patient range study. 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 instrument operator's manuals, laboratory maintenance logs, and interview with facility personnel, the laboratory failed to perform and document all required monthly maintenance procedures for 5 of 12 months reviewed between May 2022 and May 2023. The findings included: 1. Based on review of the Dimension EXL chemistry analyzer operator's manual, in Chapter 7 - Maintenance, under Monthly Maintenance, the manual stated: "The seven monthly maintenance procedures are: Cleaning the Clot Check Drain on the IMT Port Replacing IMT Pump tubing Cleaning the IMT System Replacing Instrument Air Filters Styletting HM Wash Probes Replacing HM Pump Heads on wash station Cleaning the R2 and R3 drains" 2. Based on review of laboratory maintenance logs, the laboratory failed to perform and document the following maintenance procedures: July 2022 - Replace IMT Pump Tubing, Replace/Clean air filters, Stylette HM Wash Probes, Replace HM Pump heads, Clean R2 Drain August 2022 - Clean the R2 Drain December 2022 - Replace IMT Pump tubing, Clean IMT System, Replace/Clean air filters, Stylette HM Wash Probes, Replace HM Pump heads, Clean R2 Drain February 2023 - Replace HM Pump Heads and Clean R2 Drain April 2023 - Clean the R2 Drain 3. In an interview at 15:00 hours on 5/10/23 in the laboratory, General Supervisor 2 (as listed on the CMS-209 Laboratory Personnel Report) stated the "if it wasn't documented on the log, it may not have got done." -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey performed on March 23, 2023, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6076 - 42 C.F.R. 493.1441 Condition: Laboratory Director, high complexity 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 proficiency desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute proficiency testing records, the laboratory failed to 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 -- successfully participate (100%) in three of four consecutive testing events in 2021 and 2022 for the subspecialty of compatibility resulting in unsuccessful performance. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for 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 proficiency desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, and American Proficiency Institute (API) proficiency testing records from 2021 and 2022, the laboratory failed to achieve a testing event score of satisfactory performance (100%) for three of four consecutive testing events in the subspecialty of compatibility testing. Findings include: 1. A review of the CASPER Report 155 listed the following scores for the API PT Program for compatibility testing: 2021 Event 3: 80% 2022 Event 1: 60% 2022 Event 3: 60% 2. A desk review of the American Proficiency Institute (API) proficiency testing records from 2021 and 2022 confirmed that the laboratory received unsatisfactory consecutive scores for the subspecialty of compatibility testing in 2021 event 3, and 2022 events 1 and 3. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in an HHS-approved proficiency testing program in the subspecialty of compatibility testing. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on a proficiency desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory -- 2 of 3 -- director failed to ensure successful participation in an HHS-approved proficiency testing program in the subspecialty of compatibility testing for three of four consecutive events from 2021 and 2022. Refer to D2181. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on June 10, 2022, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) evaluation reports, the laboratory failed to achieve successful 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 -- performance in two of two consecutive testing events for Compatibility Testing in the specialty of Immunohematology, resulting in unsuccessful performance. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for 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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute (API) Comparative Evaluations, the laboratory failed to achieve satisfactory performance in two of two consecutive testing events for Compatibility Testing in the specialty of Immunohematology between 2021 and 2022. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute (API) Comparative Evaluations, the laboratory received the following unsuccessful performance for the analyte Compatibility Testing in the specialty of Immunohematology in two of two consecutive events: 2021 API 3rd event 80% 2022 API 1st event 60% Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. For Compatibility Testing, any score less than 100% is unsatisfactory performance. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for Compatibility Testing in the specialty of Immunohematology. Refer to D6088. D6088 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4) The laboratory director must ensure that the laboratory is enrolled in an HHS- approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency -- 2 of 3 -- Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for two of two consecutive events in 2021 and 2022 for Compatibility Testing in the specialty of Immunohematology. Refer to D2181. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An onsite survey conducted May 16th and May 17th, 2022 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a review of proficiency testing records,

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: . Based on review of American Proficiency Institute (API) proficiency testing (PT) documentation for 2018 and 2019, the laboratory failed to test PT samples for manual cell counts on body fluids in the same manner as patient specimens. Findings: 1. API PT documentation for manual cell counts on body fluids for 2018 and 2019 revealed the following results: 3rd event 2018 Basophils Sample Reported Expected Score BFL-03 0 0-3 Acceptable BFL-04 0 0-3 Acceptable Eosinophils BFL-03 0 0-6 Acceptable BFL-04 0 0-6 Acceptable Lymphocytes BFL-03 66 0-35 Unacceptable BFL-04 0 0-36 Acceptable Monocytes BFL-03 0 0-21 Acceptable BFL-04 0 0-21 Acceptable Neutrophils BFL-03 34 62-100 Unacceptable BFL-04 0 60-100 Unacceptable 1st event 2019 Basophils Sample Reported Expected Score BFL-01 0 0- 3 Acceptable Eosinophils BFL-01 0 0-7 Acceptable Lymphocytes BFL-01 56 0-36 Unacceptable Monocytes BFL-01 16 0-21 Acceptable Neutrophils BFL-01 28 60-100 Unacceptable 2. In an interview at the site on 05-15-2019, when questioned regarding unacceptable results for lymphocytes and neutrophils, technical consultant 1, who also serves as general supervisor 2 (CMS form 209) stated that the laboratory did not report patient results for differential counts on body fluids and that proficiency testing was being performed for educational use. . 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 -- 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 procedure manual and staff interview, the laboratory had no written procedure for performance of D-dimer testing using the ACL TOP 300 hematology analyzer. Findings: 1. In the course of the survey, documentation regarding the laboratory procedure for performance of D-dimer testing was requested. Review of the laboratory procedure manual revealed no such procedure was included. 2. In an interview at the site on 05-16-2019, technical consultant 2 stated she was in the process of rewriting that policy. No written or electronic copy was available or could be offered during the survey. . D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: . Based on review of blood product storage temperature documentation, surveyor observation and staff interview, the laboratory failed to provide an audible alarm for monitoring of storage temperatures in the freezer used to store fresh frozen plasma (FFP). Findings: 1. Blood product storage temperature charts for 2017, 2018 and 2019 were reviewed. It was noted that no evidence of alarm checks appeared on charts for the freezer used to store FFP. 2. Visual inspection of the freezer revealed that no audible alarm system for temperature monitoring was installed. 3. In an interview at the site on 05-15-2019, technical consultant 2, who also serves as general supervisor 1, stated she was unaware of the requirement for an audible alarm on freezers used for blood product storage. -- 2 of 2 --